Search

Favorite Blogs

Making DJ Jurisdiction Easier to Maintain

| June 22, 2021

Trimble Inc. v. PerDiemCo LLC

Decided on May 12, 2021

Opinion by: Dyk, Newman, and Hughes

Summary:

How many letters, emails, and/or telephone calls from an out-of-state patent owner to an alleged patent infringer does it take to establish specific personal jurisdiction over that out-of-state patent owner in the alleged infringer’s home state? Somewhere between 3 and 22, depending on the nature of those communications.

Procedural History:

Trimble and Innovative Software Engineering (ISE) filed a lawsuit in its home state (California), seeking declaratory judgment that it doesn’t infringe out-of-state (Texas) PerDiemCo’s patents. The district court dismissed the case for lack of specific personal jurisdiction over PerDiemCo, relying on Red Wing Shoe Co. v. Hockerson-Halberstadt, Inc., 148 F.3d 1355, 1361 (Fed. Cir. 1998) (“[a] patentee should not subject itself to personal jurisdiction in a forum solely by informing a party who happens to be located there of suspected infringement” because “[g]rounding personal jurisdiction on such contacts alone would not comport with principles of fairness.”). The Federal Circuit reversed, finding specific personal jurisdiction.

Background:

PerDiemCo is a Texas LLC owning eleven geofencing patents monitoring a vehicle’s entry or exit from a preset area, electronically logging hours and activities of the vehicle’s driver. PerDiemCo’s sole owner, officer, and employee is Robert Babayi, a patent attorney living and working in Washington, DC, who rents office space in Marshall, Texas, that had never been visited.

Trimble is incorporated in Delaware and headquartered in Sunnyvale, CA. ISE is a wholly owned subsidiary LLC of Trimble, headquartered in Iowa.

Mr. Babayi sent a letter to ISE in Iowa offering a nonexclusive license and including an unfiled patent infringement complaint for the Northern District of Iowa and a claim chart detailing the alleged infringement. ISE forwarded that letter to Trimble’s Chief IP Counsel in Colorado, who was the point of contact for this matter. Mr. Babayi communicated “at least twenty-two times” by letter, email, and telephone calls with Trimble’s IP Counsel in Colorado, to negotiate and to further substantiate infringement allegations, including Trimble’s products, more patents, and more claim charts. PerDiemCo also threatened to sue in the Eastern District of Texas, identifying local counsel.

Personal Jurisdiction Primers:

PerDiemCo’s communications with Trimble’s IP Counsel in Colorado are considered, for personal jurisdiction, purposefully directed to the company at its headquarters (in California), not to the location of counsel. See, Maxchief Investments Ltd. v. Wok & Pan, Ind., Inc., 909 F.3d 1134, 1139 (Fed. Cir. 2018).
- “[A] tribunal’s authority [to exercise personal jurisdiction over a defendant] depends on the defendant’s having such ‘contacts’ with the forum State that ‘the maintenance of the suit’ is ‘reasonable, in the context of our federal system of government,’ and ‘does not offend traditional notions of fair play and substantial justice.’” “The contacts needed for [specific] jurisdiction often go by the name ‘purposeful availment.’” Ford Motor Co. v. Mont. Eighth Jud. Dist. Ct., 141 S. Ct. 1017, 1024 (2021) (quoting Int’l Shoe Co. v. Washington, 326 U.S. 310, 316-317 (1945)).
- From Burger King Corp. v. Rudzewicz, 471 U.S. 462 (1985) and World-Wide Volkswagon Corp. v. Woodson, 444 U.S. 286 (1980), courts determine whether the exercise of jurisdiction would “comport with fair play and substantial justice” by considering five factors: (1) the burden on the defendant; (2) the forum State’s interest in adjudicating the dispute; (3) the plaintiff’s interest in obtaining convenient and effective relief; (4) the interstate judicial system’s interest in obtaining the most efficient resolution of controversies; and (5) the shared interest of the several States in furthering fundamental substantive social policies.

Decision:

In Red Wing, a cease-and-desist letter was deemed “more closely akin to an offer for settlement of a disputed claim rather than an arms-length negotiation in anticipation of a long-term continuing business relationship.” Accordingly, in Red Wing, this court held that “[p]rinciples of fair play and substantial justice afford a patentee sufficient latitude to inform others of its patent rights without subjecting itself to jurisdiction in a foreign forum.” However, this year’s Supreme Court Ford decision and other post-Red Wing Supreme Court decisions have emphasized that “analysis of personal jurisdiction cannot rest on special patent policies.”

Repeated communications stent into a state may create specific personal jurisdiction, depending on the nature and scope of such communications. Quill Corp. v. North Dakota, 504 U.S 298, 308 (1992). And, the out-of-state defendant’s “negotiation efforts, although accomplished through telephone and mail, can still be considered as activities ‘purposefully directed’ at residents of [the forum].” Inamed Corp. v. Kuzmak, 249 F.3d 1356, 1362 (Fed. Cir. 2001) (applying Quill). Personal jurisdiction was held to be reasonable after the out-of-state defendant sent communications to eleven banks located in the forum state identifying patents, alleging infringement, and offering non-exclusive licenses, rejecting Red Wing and its progeny as having created a rule that “the proposition that patent enforcement letters can never provide the basis for jurisdiction in a declaratory judgment action.” Jack Henry & Associates, Inc. v. Plano Encryption Technologies LLC, 910 F.3d 1199, 1201, 1206 (Fed. Cir. 2018); see also, Genetic Veterinary Sciences, Inc. v. Laboklin, GmbH & Co. KG, 933 F.3d 1302, 1312 (Fed. Cir. 2019).

Beyond the sending of communications into a forum, DJ jurisdiction can also be premised on other contacts, such as “hiring an attorney or patent agent in the forum state to prosecute a patent application that leads to the asserted patent, see Elecs. for Imaging, Inc. v. Coyle, 340 F.3d 1344, 1351 (Fed. Cir. 2003); physically entering the forum to demonstrate the technology underlying the patent to the eventual plaintiff, id., or to discuss infringement contentions with the eventual plaintiff, Xilinx, Inc. v. Papst Licensing GmbH & Co. KG, 848 F.3d 1346, 1357 (Fed. Cir. 2017); the presence of ‘an exclusive licensee … doing business in the forum state,’ Brekenridge Pharm., Inc. v. Metabolite Labs., Inc., 444 F.3d 1356, 1366-67 (Fed. Cir. 2006); and ‘extra-judicial patent enforcement’ targeting business activities in the forum state, Campbell Pet Co. v. Miale, 542 F.3d 879, 886 (Fed. Cir. 2008).”

The Supreme Court’s recent Ford decision reinforces “that a broad set of a defendant’s contacts with a forum are relevant to the minimum contacts analysis.” In Ford, personal jurisdiction could be exercised over Ford even though the two types of vehicles involved in the accident were not sold in the forum states. Specific personal jurisdiction simply “demands that the suit ‘arise out of or relate to the defendant’s contacts with the forum.’” So, the broader efforts by Ford in selling similar vehicles and having dealerships in the forum states established specific personal jurisdiction.

Unlike Red Wing, which involved a total of three letters (asserting patent infringement and offering a nonexclusive license), this case involved twenty-two communications, “an extensive number of contacts with the forum in a short period of time [three months].” And unlike Red Wing “solely…informing a party who happens to be located [in the forum state] of suspected infringement,” this case’s communications continually amplified threats of infringement, including continually adding more patents, more products, suggesting mediation to reach a settlement on infringement allegations, and threat of suit in EDTx, identifying counsel that PerDiemCo planned to use. As such, “PerDiemCo’s attempts to extract a license in this case are much more akin to ‘an arms-length negotiation in anticipation of a long-term continuing business relationship’ over which a district court may exercise jurisdiction.”

As for whether specific personal jurisdiction would comport with fair play and substantial justice, the court found no fairness concerns as follows:

Burden on the defendant: PerDiemCo’s office in Texas is “pretextual” (not an operating company, but merely an IP portfolio owner, with no employees in Texas) and is far from Washington, DC where Mr. Babayi lives and works. So, if Texas is ok, so is California.
Forum state’s interest in adjudicating the dispute: ND Cal. has significant interest since Trimble is a resident there.
Plaintiff’s interest in obtaining convenient and effective relief: Trimble is near the federal district court.
Interstate judicial system’s interest in obtaining the most efficient resolution of controversies: no favor either way.
The shared interest of the several states in furthering fundamental substantive social polices: not applicable.

Takeaways:

This case is a good refresher for specific personal jurisdiction in the DJ action arena for patent owners and accused infringers.

Red Wing is NOT overturned. Quite the contrary, the court quotes from the Supreme Court’s recent Ford decision that treats “isolated or sporadic [contacts] differently from continuous ones,” and confirms that “Red Wing remains correctly decided with respect to the limited number of communications involved in that case.” The court only emphasizes that “there is no general rule that demand letters can never create specific personal jurisdiction.”

In Red Wing, the patentee’s first letter asserted patent infringement and offered a nonexclusive license. The second letter granted an extension of time for a response and asserted more products as infringing the patent. The third letter rebutted Red Wing’s noninfringement analysis and continued to offer to negotiate a nonexclusive license. So, there was some “amplification” in the second letter, just like in this case. But, the continued back and forth negotiations in Red Wing was much more limited than in this case. Where do we cross the Red Wing threshold and enter into specific personal jurisdiction for a DJ action? It is not as simple as somewhere between 3 and 22. It is the nature of the communications – the continuing of negotiations “to extract a license” that likens the behavior/communications to “an arms-length negotiation in anticipation of a long-term continuing business relationship.”

From this case, patent owners must be careful to avoid continued communications, whether by letter, email, or telephone, that as a whole can be construed to be a continuation of negotiations to extract a license or “an arms-length negotiation in anticipation of a long-term continuing business relationship.” If the desired nonexclusive license doesn’t look promising after just a handful of contacts, this case suggests that it is safer for the patent owner to hold off further back and forth negotiations and file a complaint in the patent owner’s preferred forum state, otherwise risk a DJ action in the accused infringer’s home court. For the accused infringer, this case suggests that stringing the patent owner out and creating more back and forth communications would help secure specific personal jurisdiction for a DJ action in the accused infringer’s home court.

Full Opinion Download

Lying in a Deposition – Never a Good Policy

| June 2, 2021

Cap Export, LLC v. Zinus, Inc.

Decided on May 5, 2021

Summary

Rule 60(b)(3) relieves a patent challenger of a final judgment entered in favor of a patentee where the patent challenger with due diligence could not discover a later-revealed fraud committed by the patentee during the underlying litigation in which the deposed patentee’s witness lied to conceal his knowledge of on-sale prior art determined to be highly material to the validity of the patent.

Details

Zinus owns U.S. Patent No. 8,931,123 (“the ’123 patent”) entitled “Assemblable mattress support whose components fit inside the headboard.” The invention allows for packing various components of a bed into its headboard compartment for easy shipping in a compact state. The concept may be seen in one of the ‘123 patent figures:

The application that resulted in the ‘123 patent was filed in September 2013.

In 2016, Cap Export, LLC (“Cap Export”) sought declaratory judgment of invalidity and noninfringement of the ‘123 patent in the Central District of California. The lawsuit eventually resulted in the district court upholding the validity of the ‘123 patent claims as not anticipated or obvious over all prior art references considered. The final judgment stipulated and entered in favor of Zinus included payment of $1.1 million in damages to Zinus, and a permanent injunction against Cap Export[1]. Particularly relevant to the present case is the fact that in the course of the lawsuit, Cap Export deposed Colin Lawrie, Zinus’s president and expert witness, as to his knowledge of various prior art items.

In 2019, Zinus sued another company for infringement of the ‘123 patent. This second lawsuit prompted Cap Export to learn that Zinus’s group company had bought hundreds of beds manufactured by a foreign company which apparently had a bed-in-a-headboard feature, before the filing date of the ‘123 patent. Colin Lawrie, the aforementioned Zinus’s president, appears to be involved in this transaction as the purchase invoice was signed by Lawrie himself.

Cap Export then timely filed a Rule 60(b)(3) motion for relief from the final judgment, alleging that Lawrie during the previous deposition lied to Cap Export’s counsel. Some questions and answers highlighted in the case include:

Q. Prior to September 2013 had you ever seen a bed that was shipped disassembled in one box?
A. No.
Q. Not even—I’m not talking about everything stored in the headboard, I’m just saying one box.
A. No, I don’t think I have.

In the Rule 60(b)(3) proceeding, Lawrie admitted that his deposition testimony was “literally incorrect” while denying intentional falsity because he had misunderstood the question to refer to a bed contained “in one box with all of the components in the headboard,” rather than a bed contained “in one box” (where most laypersons should know of the latter, if not the former).

The district court was not convinced, pointing to the fact that Cap Export’s counsel had rephrased the question to distinguish the two concepts. Also, emails were discovered showing repeated sales of the beds at issue to Zinus’s family companies, the record which Zinus admitted had been in its possession throughout the underlying litigation.

The district court set aside the final judgement under Rule 60(b)(3), finding that the purchased beds were “functionally identical in design” to the ’123 patent claims, and that Lawrie’s repeated denials of his knowledge of such beds amounted to affirmative misrepresentations. Zinus appealed.

On appeal, the Federal Circuit affirmed.

FRCP Rule 60(b)(3)

Rule 60(b)(3) relieves a losing party of a final judgment where an opposing party commits “fraud … , misrepresentation, or misconduct.” The Ninth Circuit applies an additional requirement that the fraud not be discoverable through “due diligence”[2]. A movant must prove by clear and convincing evidence that the opposing party has obtained the verdict in its favor through fraudulent conduct which “prevented the losing party from fully and fairly presenting the defense.” Since the issue is procedural, the Federal Circuit follows regional circuit law and reviews the district court decision for abuse of discretion.

Due Diligence in Discovering Fraud

Zinus’s main contention was that the due diligence requirement is not satisfied, arguing that the key evidence would have been discovered had Cap Export’s counsel taken more rigorous discovery measures[3] specific to patent litigation.

The Federal Circuit disagreed, finding that due diligence in discovering fraud is not about the lawyers’ lacking a requisite standard of care, but rather, the question is “whether a reasonable company in Cap Export’s position should have had reason to suspect the fraud … and, if so, took reasonable steps to investigate the fraud.”

Here, Cap Export met the requirement because there was no reason to suspect the fraud in the first place. Lawrie’s repeated denials in the deposition testimony, combined with the impossibility to reach the concealed evidence despite numerous search efforts by Cap Export and the general unavailability of such evidence, forestalled an initial suspicion of fraud which would otherwise call for further inquiry into the possible misconduct.

Opponent’s Fraud Preventing Fair and Full Defense

The Federal Circuit also found that the district court had not abuse its discretion in judging other parts of Rule 60(b)(3) jurisprudence.

As to the existence of fraud, the Federal Circuit approved the district court’s finding of affirmative misrepresentations. There is no clear error where the district court rejected Lawrie’s explanation that the false testimony arose from misunderstanding and was unintentional, which lacks credibility given the fact that the deposition occurred within a few years from the sales at issue.

As to the frustration of fairness and fullness, the Federal Circuit noted that Rule 60(b)(3) standard does not require showing that the result would have been different but for the fraudulently withheld information, but showing the evidence’s “likely worth” is sufficient to establish the harm. As such, the concealed prior art does not have to “qualify as invalidating prior art,” but being “highly material” suffices.

The Federal Circuit endorsed the district court’s judgment that the concealed evidence “would have been material” and its unavailability to Cap Export prevented it from fully and fairly presenting its case. The determination rests on the underlying factual findings that the on-sale prior art is “functionally identical in design” to the ‘123 patent claims, and that without the misrepresentations, the evidence would have been considered by the court in its obvious and anticipation analysis.

The Opinion’s closing remarks appear to suggest an implication of the procedural rules such as Rule 60(b)(3) in allowing the patent system to achieve its core purpose of serving the public interest. Legitimacy of patents is preserved by warding off fraudulent conduct in proceedings before the court, the establishment which works only where parties give entire information for a full and fair determination of their controversy.

Takeaway

A favorable verdict procured through fraud will be vacated under Rule 60(b)(3).

Due diligence requirement under Rule 60(b)(3) is unique to the Ninth Circuit. In cases involving the patentee’s knowledge about prior art, reasonableness in the patent challenger’s discovery and investigation tactics, even if they didn’t expose a lie, likely satisfies this additional requirement.

To establish the evidentiary value of the concealed prior art in a Rule 60(b)(3) motion, a showing that the information is “highly material” to presenting the movant’s case, if not “invalidating” the patent, would be sufficient.

In the present case, the second lawsuit filed by the patentee (i.e., the lying party) led to the discovery of its own fraud. What could the patent challenger have done to safeguard against the patentee’s lies in the first lawsuit? Perhaps taking patent-specific standard discovery measures such as those noted at footnote 3 might help. Watch out for a patentee’s past transactions involving products manufactured by a third party, which might be “highly material” on-sale prior art simply because of its functional or design similarity to the patent claims.

After a final judgment is entered, a losing party may benefit from monitoring the opponent’s litigation activity involving the patent at issue, which might lead to discovery of previously unknown information, allowing for a potential Rule 60(b)(3) relief.

Full Opinion Download

[1] And a third-party defendant added during the litigation. The parties on Cap Export’s side are referred to collectively as Cap Export.

[2] The Federal Circuit notes that the diligence requirement is at odds with the plain text of Rule 60(b)(3) and does not appear to be adopted in other regional courts of appeals. Compare Rule 60(b)(2), which states that “newly discovered evidence that, with reasonable diligence, could not have been discovered in time to move for a new trial.”

[3] Such as “[to] specifically seek prior art [in a written discovery request]; … [to] depose the inventor of the ’123 patent; and [to take] a deposition of Lawrie … [specifically] under Federal Rule of Civil Procedure 30(b)(6).”

Category: Case Summary
Tags: FRCP 60(b)(3) > misrepresentation of prior art knowledge

Inventors’ Agreements will not protect a former employer from the inventors’ future related work

| May 27, 2021

Bio-Rad Laboratories, Inc. v. International Trade Commission, 10X Genomics Inc.

Decided on April 29, 2021

Before Taranto, Chen and Stoll. Opinion by Taranto.

Summary:

Bio-Rad attempted to assert that language in inventors’ agreements which were signed by two of the named inventors in the patents asserted against Bio-Rad made the patents their intellectual property by being subject to assignment. The CAFC disagreed noting that the agreements were too general is scope as asserted and 10X had failed to assert an earlier conception date.

Details

Background

10X Genomics Inc. filed a complaint against Bio-Rad Laboratories, Inc. with the International Trade Commission, alleging that Bio-Rad’s importation and sale of microfluidic systems and components used for gene sequencing or related analyses violated section 337 of the Tariff Act of 1930, 19 U.S.C. § 1337.

The ITC found that Bio-Rad infringed the patent claims at issue and also that 10X practiced the claims, the latter fact satisfying the requirement of a domestic industry relating to the articles protected by the patent. Bio-Rad argued on appeal that the Commission erred in finding that Bio-Rad infringes the asserted claims of the patents, in finding that 10X’s domestic products practice the asserted claims of the ’530 patent, and in rejecting Bio-Rad’s indefiniteness challenge to the asserted claims of the ’530 patent. The CAFC disagreed and affirmed the Commission. These aspects of the appeal are not the subject of this paper.

In addition, the ITC rejected Bio-Rad’s defense that it could not be liable for infringement because it co-owned the asserted 10X patents under assignment provisions that two of the named inventors signed when they were employees of Bio-Rad (and its predecessor), even though the inventions claimed were not made until after the employment.

Regarding the timeline of invents of the work of the two inventors, around mid-2010, the two named inventors of the 10X patents—Dr. Hindson and Dr. Saxonov—were working for a company called QuantaLife, Inc., which Dr. Hindson had co-founded. Each of them signed an agreement (Dr. Hindson in 2009, Dr. Saxonov in 2010) that provided, as relevant here:

(a) Employee agrees to disclose promptly to the Company the full details of any and all ideas, processes, recipes, trademarks and service marks, works, inventions, discoveries, marketing and business ideas, and improvements or enhancements to any of the foregoing (“IP”), that Employee conceives, develops or creates alone or with the aid of others during the term of Employee’s employment with the Company . . . .
(b) Employee shall assign to the Company, with-out further consideration, Employee’s entire right to any IP described in the preceding subsection, which shall be the sole and exclusive property of the Company whether or not patentable.

In 2011, Bio-Rad acquired QuantaLife, and Drs. Hindson and Saxonov became Bio-Rad employees. In October of that year, they each signed an agreement that provided, as relevant here:

All inventions (including new contributions, improvements, designs, developments, ideas, discoveries, copyrightable material, or trade secrets) which I may solely or jointly conceive, develop or reduce to practice during the period of my employment by Bio-Rad shall be assigned to Bio-Rad.

Drs. Hindson and Saxonov left Bio-Rad in April 2012, and together they formed 10X in July 2012. By August 2012, 10X filed the first of several provisional patent applications that focused on using microcapsules in capsule partitions or droplet partition. By January 2013, the 10X inventors had conceived of a different architecture: “gel bead in emulsion” (GEM). The GEM architecture involves “part-tioning nucleic acids, DNA or RNA, in droplets together with gel beads that are used to deliver the barcodes into the droplet,” where the “barcodes are released from the gel beads using a stimulus.” The asserted 10X patent claims all involve this architecture. The CAFC found that the common core of the inventions in the asserted 10X patents is the use of gel beads with releasably attached oligonucleotide barcode molecules as a system for delivery of barcodes to nucleic acid segments.

After 10X began selling its products, including the GemCode and Chromium products, Bio-Rad released its own ddSEQ™ system, whose ordinary use, 10X alleges, practices its patents. The ddSEQ system uses oligonucleotide molecules that are attached to a gel bead and can be released from the bead via a stimulus.

Opinion

On appeal, Bio-Rad renewed its argument, made as a defense to infringement, that it co-owns the three assert-ed patents based on the assignment provisions in the employment contracts signed by Drs. Hindson and Sax-onov. The CAFC noted that it is undisputed that, if Bio-Rad is a co-owner, it cannot be an infringer, per 35 U.S.C. § 262 (“[E]ach of the joint owners of a patent may make, use, offer to sell, or sell the patented invention . . . without the consent of and without accounting to the other owners.”). However, co-ownership itself was disputed.

The CAFC first noted that Bio-Rad did not present an alternative conception date (earlier than January 2013), and it lost the opportunity to argue conception of certain claim elements while Drs. Hindson and Saxonov were at QuantaLife.

The Court reasoned that Bio-Rad has furnished no persuasive basis for disturbing the Commission’s conclusion that the assignment provisions do not apply to a signatory’s ideas developed during the employment (with Bio-Rad or QuantaLife) solely because the ideas ended up contributing to a post-employment patentable invention in a way that supports co-inventorship of that eventual invention.

Examining the employee agreements, the CAFC found that the assignment provisions are limited temporally. The assignment provision of the QuantaLife agreement reaches only a “right to any IP described in the preceding section,” and the preceding (disclosure-duty) section is limited to IP “that Employee conceives, develops or creates alone or with the aid of others during the term of Employee’s employment with the Company,” before adding a limitation, stating: “All inventions . . . which I may solely or jointly conceive, develop, or reduce to practice during the period of my employment by Bio-Rad shall be assigned to Bio-Rad.”. Based thereon, the Court concluded that the most straightforward interpretation is that the assignment duty is limited to subject matter that itself could be protected as intellectual property before the termination of employment.

The Court went on to note that Bio-Rad did not argue or demonstrate, that a person’s work, just because it might one day turn out to contribute significantly to a later patentable invention and make the person a co-inventor, is itself protectible intellectual property before the patentable invention is made. Specifically, the CAFC stated:

Such work is merely one component of “possible intellectual property.” Bio-Rad Reply Br. at 3. In the case of a patent, it may be a step toward the potential ultimate existence of the only pertinent intellectual property, namely, a completed “invention,” but the pertinent intellectual property does not exist until at least conception of that invention. See, e.g., REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 958 (Fed. Cir. 2016); Dawson v. Dawson, 710 F.3d 1347, 1353 (Fed. Cir. 2013); Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227–28 (Fed. Cir. 1994).

The panel reviewed the current fact pattern in light of previous decisions on the issue of inventor’s employment agreements. Of note, regarding the FilmTec case (FilmTec Corp. v Hydranautics, 982 F.2d 1546, 1548 (Fed. Cir. 1992)) cited by Bio-Rad involved language of an agreement, and language of the statutory command embodied in the agreement, that expressly assigned ownership to the United States of certain inventions as long as they were “conceived” during performance of government-supported work under a contract. The panel noted that in the Filmtec case the Court had examined the claimed invention, namely, a composition conceived during the term of the agreement, where conception meant the “‘formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.’” Id. at 1551–52 (quoting Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986)).

We noted that the inventor, continuing to work on the invention after the agreement ended, added certain “narrow performance limitations in the claims.” See id. at 1553. But we treated the performance limitations as not adding anything of inventive significance because they were mere “refine[ments]” to the invention already conceived during the term of the agreement. See id. at 1552–53. We held the claimed inventions to have been conceived during the agreement—something that Bio-Rad accepts is not true here. We did not deem a mere joint inventor’s contribution to a post-agreement conception sufficient. (Emphasis added).

The CAFC additionally reviewed the Stanford case (Bd. of Trustees of the Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832, 837 (Fed. Cir. 2009), aff’d on different grounds, 563 U.S. 776 (2011)), also relied on by Bio-Rad, involved quite different contract language from the language at issue. The case involved a Stanford employee who was spending time at Cetus in order to learn important new research techniques; as part of the arrangement, the Stanford employee signed an agreement with Cetus committing to assign to Cetus his “right, title, and interest” in the ideas, inventions, and improvements he conceived or made “as a consequence of” his work at Cetus. The CAFC noted that the Stanford case was not a former-employee case and the language at issue in Stanford did not contain the temporal limitation set forth in the agreements at issue. The Court concluded by noting that the agreement at issue here did not contain the broad “as a consequence of” language at issue in Stanford.

The Court also examined the relevant aspects of the governing law of California which provides a confirmatory reason not to read the assignment provision at issue here more broadly. California law recognizes significant policy constraints on employer agreements that restrain former employees in the practice of their profession, including agreements that require assignment of rights in post-employment inventions. The Court noted that substantial questions about compliance with that policy would be raised by an employer-employee agreement under which particular subject matter’s coverage by an assignment provision could not be determined at the time of employment, but depended on an unknown range of contingent future work, after the employment ended, to which the subject matter might sufficiently contribute. The reasons behind the policy being that such an agreement might deter a former employee from pursuing future work related to the subject matter and might deter a future employer from hiring that individual to work in the area. The CAFC concluded that the contract language at issue does not demand a reading that would test the California-law constraints and they would not “test those constraints here by adopting a broader reading of the contract language than the straightforward reading we have identified.”

Finally, Bio-Rad had argued that Drs. Hindson and Saxonov conceived of key aspects of the claimed inventions, if not the entirety of the claims, at QuantaLife/Bio-Rad. The Commission had determined that many of these “ideas” are at a level of generality that cannot support joint inventorship or (sometimes and) involve nothing more than elements in the already-published prior art. Specifically, Bio-Rad contended that at least three ideas developed at QuantaLife were not publicly known in the prior art at the time Drs. Hindson and Saxonov were working on them: tagging droplets to track a sample-reagent reaction complex, using double-junction microfluidics to combine sample and reagent, and using oligonucleotides as bar-codes to tag single cells within droplets. After analysis of these concepts, the Court found that these contentions, by their terms, look to a time long before the January 2013 conception date for the inventions at issue and Bio-Rad did not deny that these ideas were in the published prior art by the time of the conception of the inventions at issue or that they were, by then, readily available to the co-inventors on the patents involved. Hence, the Court concluded that the contentions are insufficient to establish co-inventorship.

Specifically, the Court found that to accept Bio-Rad’s contention after giving the required deference to the Commission’s factual (and, in one instance, procedural) rulings would require that they find joint inventorship simply because Drs. Hindson and Saxonov, while at Bio-Rad (or QuantaLife), were working on the overall, known problem—how to tag small DNA segments in microfluidics using droplets—that was the subject of widespread work in the art.

Decision

The CAFC concluded that Bio-Rad had not demonstrated proper ownership of “ideas” as comported to be assigned to them by the two inventors employment agreements. The general concepts relied upon by Bio-Rad were insufficient as Bio-Rad had failed to assert an earlier conception date. As such, the Court affirmed the Commission’s ruling.

Take away

Broad language in an employment agreement assigning rights to inventions will not suffice to protect an entity from future work performed by the employees at a different entity.

Employee agreements assigning rights to inventions conceived while employed need to be structured such that they are clear as to what is conceived is considered the property of the entity. The entity should take steps to clarify “conception” during employment to provide evidence thereof.

Full Opinion Download

Category: Case Summary
Tags: assignment > Inventor's agreements

An Improvement in Computational Accuracy Is Not a Technological Improvement

| May 20, 2021

In Re: Board of Trustees of the Leland Stanford Junior University

Decided on March 25, 2021

Prost, Lourie and Reyna. Opinion by Reyna.

Summary:

This case is an appeal from a PTAB decision that affirmed the Examiner’s rejection of the claims on the grounds that they involve patent ineligible subject matter. Leland Stanford Junior University’s patent to computerized statistical methods for determining haplotype phase were held by the CAFC to be to an abstract idea directed to the use of mathematical calculations and statistical modeling and that the claims lack an inventive concept that transforms the abstract idea into patent eligible subject matter. Thus, the CAFC affirmed the rejection on the grounds that the claims are to patent ineligible subject matter.

Details:

Leland Stanford Junior University’s (“Stanford”) patent application is to methods for determining haplotype phase which provides an indication of the parent from whom a gene has been inherited. The application discloses methods for inferring haplotype phase in a collection of unrelated individuals. The methods involve using a statistical tool called a hidden Markov model (“HMM”). The application uses a statistical model called PHASE-EM which allegedly operates more efficiently and accurately than the prior art PHASE model. The PHASE-EM uses a particular algorithm to predict haplotype phase.

Representative claim 1 recites:

1. A computerized method for inferring haplotype phase in a collection of unrelated individuals, comprising:
receiving genotype data describing human genotypes for a plurality of individuals and storing the genotype data on a memory of a computer system;
imputing an initial haplotype phase for each individual in the plurality of individuals based on a statistical model and storing the initial haplotype phase for each individual in the plurality of individuals on a computer system comprising a processor a memory;
building a data structure describing a Hidden Markov Model, where the data structure contains:
a set of imputed haplotype phases comprising the imputed initial haplotype phases for each individual in the plurality of individuals;
a set of parameters comprising local recombination rates and mutation rates;
wherein any change to the set of imputed haplotype phases contained within the data structure automatically results in re-computation of the set of parameters comprising local recombination rates and mutation rates contained within the data structure;
repeatedly randomly modifying at least one of the imputed initial haplotype phases in the set of imputed haplotype phases to automatically re-compute a new set of parameters comprising local recombination rates and mutation rates that are stored within the data structure;
automatically replacing an imputed haplotype phase for an individual with a randomly modified haplotype phase within the data structure, when the new set of parameters indicate that the randomly modified haplotype phase is more likely than an existing imputed haplotype phase;
extracting at least one final predicted haplotype phase from the data structure as a phased haplotype for an individual; and
storing the at least one final predicted haplotype phase for the individual on a memory of a computer system.

The PTAB determined that the claim describes receiving genotype data followed by mathematical operations of building a data structure describing an HMM and randomly modifying at least one imputed haplotype to automatically recompute the HMM’s parameters. Thus, the PTAB held that the claim is to patent ineligible abstract ideas such as mathematical relationships, formulas, equations and calculations. The PTAB further found that the additional elements in the claim recite generic steps of receiving and storing genotype data in a computer memory, extracting the predicted haplotype phase from the data structure, and storing it in a computer memory, and that these steps are well-known, routine and conventional. Thus, finding the claim ineligible under steps one and two of Alice, the PTAB affirmed the Examiner’s rejection as being to ineligible subject matter.

On appeal, the CAFC followed the two-step test under Alice for determining patent eligibility.

1. Determine whether the claims at issue are directed to a patent-ineligible concept such as laws of nature, natural phenomena, or abstract ideas. If so, proceed to step 2.

2. Examine the elements of each claim both individually and as an ordered combination to determine whether the claim contains an inventive concept sufficient to transform the nature of the claims into a patent-eligible application. If the claim elements involve well-understood, routine and conventional activity they do not constitute an inventive concept.

Under step one, the CAFC found that the claims are directed to abstract ideas including mathematical calculations and statistical modeling. Citing Parker v. Flook, 437 U.S. 584, 595 (1978), the CAFC stated that mathematical algorithms for performing calculations, without more, are patent ineligible under § 101. The CAFC determined that claim 1 involves “building a data structure describing an HMM,” and then “repeatedly randomly modifying at least one of the imputed haplotype phases” to automatically recompute parameters of the HMM until the parameters indicate that the most likely haplotype is found. The CAFC also found that the steps of receiving genotype data, imputing an initial haplotype phase, extracting the final predicted haplotype phase from the data structure, and storing it in a computer memory do not change claim 1 from an abstract idea to a practical application. The CAFC concluded that “Claim 1 recites no application, concrete or otherwise, beyond storing the haplotype phase.”

Stanford argued that the claim provides an improvement of a technological process because the claimed invention provides greater efficiency in computing haplotype phase. However, the CAFC stated that this argument was forfeited because it was not raised before the PTAB.

Stanford also argued that the claimed invention provides an improvement in the accuracy of haplotype predictions rendering claim 1 a practical application rather than an abstract idea. However, the CAFC stated that “the improvement in computational accuracy alleged here does not qualify as an improvement to a technological process; rather, it is merely an enhancement to the abstract mathematical calculation of haplotype phase itself.” The CAFC concluded that “[t]he different use of a mathematical calculation, even one that yields different or better results, does not render patent eligible subject matter.”

Under step two, the CAFC determined that there is no inventive concept that would transform the use of the claimed algorithms and mathematical calculations from an abstract idea to patent eligible subject matter. The steps of receiving, extracting and storing data are well-known, routine and conventional steps taken when executing a mathematical algorithm on a regular computer. The CAFC further stated that claim 1 does not require or result in a specialized computer or a computer with a specialized memory or processor.

Stanford argued that the PTAB failed to consider all the elements of claim 1 as an ordered combination. Specifically, they stated that it is the specific combination of steps in claim 1 “that makes the process novel” and “that provides the increased accuracy over other methods.” The CAFC did not agree stating that the PTAB was correct in its determination that claim 1 merely “appends the abstract calculations to the well-understood, routine, and conventional steps of receiving and storing data in a computer memory and extracting a predicted haplotype.” The CAFC further stated that even if a specific or different combination of mathematical steps yields more accurate haplotype predictions than previously achievable under the prior art, that is not enough to transform the abstract idea in claim 1 into a patent eligible application.

Comments

A key point from this case is that an improvement in computational accuracy does not qualify as an improvement to a technological process. It is merely considered an enhancement to an abstract mathematical calculation. Also, it seems that Stanford made a mistake by not arguing at the PTAB that the claimed invention provides the technological advance of greater efficiency in computing haplotype phase. The CAFC considered this argument forfeited. It is not clear if this argument would have saved Stanford’s patent application, but it certainly would have helped their case.

Category: Case Summary
Tags: 35 U.S.C. §101 > patent eligible subject matter

If it cannot be made, it does not exist!

| May 11, 2021

Raytheon Technologies Corp. v. General Electric Co. (Fed. Cir. 2021)

Decided on April 16, 2021

Lourie, Hughes, and Chen (author).

Summary:

“A typical obviousness inquiry often turns on whether an asserted prior art reference teaches a particular disputed claim limitation or whether a skilled artisan would have been motivation at the time of the invention to combine the teachings of difference references.” In this case, the court tackled the question of enabling disclosure in the prior art reference, and what is required.

Raytheon owned U.S. Patent 9,695,751 (herein ‘751) directed to gas turbine engines. Raytheon appealed a final inter partes review decision of the Patent Trial and Appeal Board (the Board) finding claims 3 and 16 where unpatentable as obvious in view of the reference Knip. Claims 3 and 16 where the only pending claims after Raytheon disclaimed all other claims cited in the inter partes review.

“[T]he ‘751 patent generally claims a geared gas turbine engine with two turbines and a specific number of fan blades and turbine rotors and/or stages.” Further, the “key distinguishing feature of the claims is the recitation of a power density range that the patent describes as being ‘much higher than in the prior art.'”

Knip is a 1987 NASA technical memorandum that envisions superior performance characteristics for an imagined “advanced [turbofan] engine” “incorporating all composite materials.” Such a construction was undisputedly unattainable at that time, [but] an imagined application of these “revolutionary” composite materials to a turbofan engine allowed the author of Knip to assume aggressive performance parameters for an “advanced” engine including then-unachievable pressure ratios and turbine temperatures.” Although the reference discloses numerous performance parameters, it did not explicitly disclose SLTO thrust, turbine volume or power density as per the ‘751 patent. (SLTO = Sea Level Takeoff).

The Board ultimately found Knip rendered obvious the ‘751 patent because “it provided enough information to allow a skilled artisan to “determine a power density as defined in claim 1, and within the range proscribed in claim 1.” (Claim 3 was a dependent claim incorporating all limitation of claim 1; claim 16 depended on claim 15 which included the same argued limitations as claim 1).

The CAFC found that the PTAB erred by focusing on whether Knip enables a skilled artisan to calculate the power density of Knip’s contemplated “futuristic engine,” rather than considering “whether Knip enabled a skilled artisan to make and use the claimed invention.”

Specifically, “[i]n general, a prior art reference asserted under §103 does not necessarily have to enable its own disclosure, i.e., be ‘self-enabling,’ to be relevant to the obviousness inquiry.” That is, “a reference that does not provide an enabling disclosure for a particular claim limitation may nonetheless furnish the motivation to combine, and be combined with, another reference in which that limitation is enabled.” Thus, “[I]n the absence of such other supporting evidence to enable a skilled artisan to make the claimed invention, a standalone §103 reference must enable the portions of its disclosure being relied upon” This is “the same standard applied to anticipatory references.”

Here, the sole reference was Knip, and so the CAFC emphasized the question as being whether Knip enables the claimed invention not whether a skilled artisan “is provided with sufficient parameters in Knip to determine, without undue experimentation, a power density” as per the Boards focus. That CAFC noted that this position could have carried weight “if GE had presented other evidence to establish that a skilled artisan could have made the claimed turbofan engine with the recited power density. But no such other evidence was presented.”

Therefore, according to the CAFC, “Knip’s self-enablement (or lack thereof) is not only relevant to the enablement analysis, in this case it is dispositive.”

The CAFC discussed GE’s expert testimony finding it to be lacking, because its expert constructed “a computer model simulation of Knip’s imagined engine” rather than “suggesting that a skilled artisan could have actually built such an engine.” In contrast, Raytheon’s expert presented unrebutted evidence of non-enablement… detailing the unavailability of the revolutionary composite material contemplated by Knip.”

Lastly, GE had argued that a skilled artisan could achieve the claimed power density by optimizing Knip’s engine. The Board had affirmed this on the basis of “result-effective variable.” That CAFC rejected this, stating that “[i]f a skilled artisan cannot make Knip’s engine, a skilled artisan necessarily cannot optimize its power density.”

Accordingly, the CAFC reversed the PTAB’s finding.

Take-away:

“[I]f an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.”
If a single reference is used in a 103 rejection, and that single reference is non-self enabling, then allegations of optimization by the PTO is improper. That is, “if a skilled artisan cannot make..[it], a skilled artisan necessarily cannot optimize it…”

Category: Case Summary
Tags: enabling disclosure; burden of proof > obviousness > Self-enabling

UNDERSTANDING STANDING IN AN IPR

| May 4, 2021

The enactment of inter partes review (IPR) on September 16, 2012 as part of the America Invents Act has created some interesting issues. IPRs replaced the prior inter partes reexamination process. In an inter partes reexamination, claims of a patent are reexamined (as in a “normal” examination by an examiner) to confirm/determine patentability. In an IPR, however, claims are challenged, i.e., the validity of the claims is determined by the Patent Trial and Appeal Board (PTAB). Such a validity challenge had previously been conducted by a jury in district courts instead of by an administrative agency such as the PTAB.

The use of an administrative agency has raised several issues under the U.S. Constitution. For example, the Supreme Court heard oral argument on March 1, 2021 in Arthrex, Inc. v. Smith & Nephew, Inc. to decide (1) whether, for purposes of the Appointments Clause, U.S. Const. Art. II, § 2, Cl. 2, administrative patent judges of the US Patent and Trademark Office are principal officers who must be appointed by the President with the Senate’s advice and consent, or “inferior officers” whose appointment Congress has permissibly vested in a department head, and (2) Whether, if administrative patent judges are principal officers, the court of appeals properly cured any Appointments Clause defect in the current statutory scheme prospectively by severing the application of 5 U.S.C. 7513(a) to those judges.

Another issue which may find its way to the Supreme Court is standing for a party to appeal a decision in an IPR. The U.S. Constitution limits its grant of the “judicial power” to “Cases” or “Controversies” under Article III, § 2. As such, any party that appeals to the CAFC must have standing under Article III for the CAFC to consider the merits of the case. For a party to have standing, it must show (1) an injury in fact, (2) a casual connection between the injury complained of, and (3) a likelihood that the injury will be redressed by a favorable decision. See Lujan v. Defenders of the Wildlife, 504 U.S. 555, 560-561 (1992). An injury in fact is a legally protected interest which is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical. Id. at 560.

Standing has become an issue in IPRs since any party can file a request for an IPR, but not every party can appeal. A person does not need to have Article III standing to file an IPR petition and obtain a PTAB decision because Article III requirements do not apply to administrative agencies like the PTAB. On the other hand, Article III requirements apply to the CAFC.

The philosophy for the requirement of standing is to ensure “that the plaintiffs have a stake in the fight and will diligently prosecute the case . . . while, at the same time, ensuring that the claim is not abstract or conjectural so that resolution by the judiciary is both manageable and proper.” Canadian Lumber Trade All. V. United States, 517 F.3d 1319, 1333 (FED. Cir. 2008). This philosophy is similar to the duty of disclosure during patent prosecution to ensure that the strongest patent claims issue.

Several recent cases are of interest in that some parties were deemed to have standing whereas others were deemed to lack standing. One of the most recent cases on standing is General Electric Company v. Raytheon Technologies Corporation decided on December 23, 2020 which found that GE did have standing to appeal. What makes this case particularly interesting is another decision earlier that year between the same parties where GE was found to lack standing.

So, what was the difference in these cases?

We need to examine several decisions from the CAFC to have a better understanding of standing in an IPR. All these decisions involve competitors. These cases include:

Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168 (Fed. Cir. 2017)

JTEKT Corp. v. GKN Auto. Ltd., 898 F.3d 1217 (Fed. Cir. 2018)

AVX Corporation v. Presidio Components, Inc., 923 F.3d 1357 (Fed. Cir. 2019)

General Electric Company v. United Technologies Corporation, F.3d 1xxx (Fed. Cir. 2020)

General Electric Company v. Raytheon Technologies Corporation, F.3d 1xxx (Fed. Cir. 2020)

Phigenix – No Standing

Phigenix failed to establish that it had suffered an injury in fact. Phigenix argued that the statutory estoppel provision of 35 U.S.C. 315(e) was an injury in that it would be prevented from asserting the same challenges if Immunogen asserted the claims against Phigenix in the future. The CAFC held that such would not be an injury in fact when Phigenix is not engaged in any activity that would give rise to a possible infringement suit. Phigenix did not manufacture any products that could be considered to infringe the patent in question. Phigenix argued that the mere existence of the patent in question encumbered its efforts to license its own patent directed to similar cancer treatments. Phigenix argued it suffered an economic injury in the form of lost licensing revenue due to competition presented by the existence of the patent involved in the IPR. The CAFC found such to be hypothetical and only supported by conclusory statements in the submitted declarations. There was no evidence of the risk of infringement.

JTEKT – No Standing

In JTEKT, the record was not sufficient to establish standing. JTEKT had argued competitive harm. JTEKT had not admitted to engaging in infringing activity because its product had not yet been finalized. The CAFC held that JTEKT had failed to show concrete plans for future potentially infringing activity, and therefore lacked standing to appeal (noting that “typically in order to demonstrate the requisite injury in an IPR appeal, the appellant/petitioner must show that it is engaged or will likely engage ‘in an[] activity that would give rise to a possible infringement suit,’. . . or has contractual rights that are affected by a determination of patent validity” (quoting Consumer Watchdog v. Wis. Alumni Research Found., 753 F.3d 1258, 1262 (Fed. Cir. 2014)).

AVX – No Standing

AVX addressed the “competitor standing doctrine” in IPR appeals. This doctrine, in non-patent contexts, recognized that government actions that “alter competitive conditions” may give rise to injuries that suffice for standing. Clinton v. City of New York, 524 U.S. 417, 433 (1998). AVX argued that the PTAB’s decision upholding claims in a patent injures AVX because the decision reduces AVX’s ability to compete with Presidio. The panel of the CAFC (Newman, O’Malley and Taranto, opinion by Taranto) rejected this argument, holding that “the rationale for finding standing in those cases does not carry over to support standing in the present context, where AVX has no present or nonspeculative interest in engaging in conduct even arguably covered by the patent claims at issue.”

The panel in AVX found that the government action of upholding specific patent claims is different in that they “do not address prices or introduce new competitors, but rather give exclusionary rights over precisely defined product features.”

General Electric Company (I) – No Standing

The first GE case held that the evidence of record did not support standing. In the decision before the panel of Reyna, Taranto and Hughes, the CAFC noted that the two declarations of record were the only evidence of standing before the court, but each declaration failed to show “a concrete and imminent injury to GE related to the ‘605 patent.”

The concurring opinion by Hughes is interesting in that he believed that AVX was incorrectly decided. Hughes stated that he does

“not believe that a Board decision erroneously upholding a competitor’s patent in an IPR is meaningfully different from the type of government actions held to invoke competitor standing in those cases. Thus, absent our holding in AVX Corp., I would conclude that GE possesses Article III standing in this appeal.”

Although Hughes believed that GE should be considered to have standing to appeal, he was bound by the precedent of the AVX decision indicating that the competitor standing doctrine does not apply in the patent context. Even when parties are direct competitors, Hughes noted that decisions of the CAFC have required an unsuccessful IPR appellant/petitioner to show concrete current or future plans to infringe the challenged patent. Hughes’ concurring opinion may have been instructive to GE in what is needed to show that it has suffered an injury-in-fact.

General Electric Company (II) –Standing

In the second GE decision (panel[1] of Lourie, Reyna and Hughes), GE was found to have standing. The decision specifically noted that GE had remedied the deficiencies in GE I. More specifically, the evidence submitted by GE has shown concrete plans raising a substantial risk of future infringement. In GE I, the CAFC had faulted GE for contending only that some unspecified amount of time and money was expended to consider engine designs that could potentially implicate the patent at issue in that case.GE also did not provide any evidence that it had designed a geared-fan engine covered by the patent at issue. Considered as a whole, the allegations “were not just speculative, but overtly theoretical.”

In GE II, however, these deficiencies were addressed and remedied in that:

(1) GE has alleged that it has conceived a geared turbofan engine design that Raytheon would likely argue falls within the scope of the asserted claims.

(2) GE has alleged specific ongoing expenditures to continue to develop and refine that design.

(3) GE provides that this geared turbofan engine design is its preferred design to offer its customers for the next-generation narrow body market segment.

(4) GE identifies an Airbus aircraft program where it intends to offer this design for sale to Airbus.

(5) GE supports the concreteness of its plans by showing that it in fact submitted the design to Airbus for the preliminary stage of the bidding process, and it has not yet submitted any other design.

(6) GE alleges that it believes Raytheon would accuse this specific design of infringement.

Where do we now stand on standing?

As can be seen, the current status for establishing standing in an IPR appeal is to almost admit to infringement. Of course, a competitor does not typically want to make such an admission. It remains to be seen whether there is any movement away from the rigid precedent set in AVX toward a recognition of the competitor standing doctrine in patent cases. This issue could quite possibly make its way to the Supreme Court.

[1] Note that Taranto, the author of the AVX decision, and a panel member of GE I was not on this panel.

Category: Case Summary
Tags: Standing

STANDING FOR A SUBSTITUTED PARTY IS NOT A CROCK

| April 26, 2021

MOJAVE DESERT HOLDINGS, LLC, v. CROCS, INC.

Decided February 11, 2021

NEWMAN, DYK, and O’MALLEY (Opinion by Dyk)

This precedential decision further clarifies that article III standing exists for a successor in interest. Article III standing had also been an issue in another recent decision from the CAFC in General Electric Company v. Raytheon Technologies Corporation decided on December 23, 2020 as reported by Miki Motohashi. The issue arises in the present case due to a change in the real party in interest while an appeal was pending in an inter partes reexamination.

The following timeline illustrates how this issue arose.

August 6, 2012 – Crocs sued U.S.A. Dawgs, Inc. for patent infringement of U.S. Design No. D517,789. Many should be familiar with this design:

August 24, 2012 – U.S.A. Dawgs filed a third-party request for inter partes reexamination.

November 19, 2012 – The USPTO orders reexamination. The district court stays the infringement proceedings in light of the reexamination.

2012 – 2018 – Reexamination proceeds with an anticipation rejection under 35 U.S.C. 102(b), which is appealed by Crocs.

January 31, 2018 – U.S.A. Dawgs files for Chapter 11 bankruptcy.

July 20, 2018 – The bankruptcy court approves the sale of all of U.S.A. Dawgs’s assets to Dawgs Holdings. The bankruptcy court stated that the sale was not free and clear of any claims Crocs may hold for patent infringement post-closing date.

August 15, 2018 – Dawgs Holdings assigns all rights, including explicitly the claims asserted by U.S.A. Dawgs in the infringement action and the inter partes reexamination, to Mojave Desert Holdings.

October 23, 2018 – U.S.A. Dawgs dissolves but continues to exist for limited purposes including “prosecuting and defending suits.”

July 18, 2019 – Mojave files a petition with the Board to change the real party in interest from U.S.A. Dawgs to Mojave.

August 19, 2019 – The Board dismisses and expunges the petition based on three reasons: (1) the initial transfer of assets from U.S.A. Dawgs to U.S.A. Dawgs Holdings appears to be silent about rights to the reexamination, (2) based on its interpretation of the transfer of assets, Mojave was not a party to the reexamination and did not have standing to update the real party in interest[1], and (3) Mojave did not file its submission within 20 days of any change of the real party-in-interest as required by 37 C.F.R. § 41.8(a), making it untimely.

September 10, 2019 – The Board reverses the Examiner’s rejection; U.S.A. Dawgs appeals to the CAFC sometime after.

December 13, 2019 – U.S.A. Dawgs and Mojave file a motion to substitute (under Federal Rule of Appellate Procedure 43(b)).

The CAFC addresses the motion to substitute in its decision. Although Crocs asserts that the motion should be denied for several reasons, the CAFC disagrees. The decision addresses why five different reasons for denial fail.

I. Crocs asserts the bankruptcy sale did not transfer U.S.A. Dawgs interest as a requester to Dawgs Holdings. This argument fails because the assignment was comprehensive in transferring all the “right, title and interest in, to and under all of the assets, properties and rights of every kind and nature, whether real, personal or mixed, tangible or intangible …”. Crocs had argued that this case was like Agilent Technologies, Inc. v. Waters Technology Corp., 811 F.3d 1326 (Fed. Cir. 2016). In Agilent, however, “substantially all” of the assets were transferred such that it was unclear whether Agilent was the successor in interest, unlike the present case which clearly conveyed all.

II. Crocs asserts that the substitution was not timely in that Mojave did not seek substitution for almost a year after it acquired the interest, well beyond the 20 days required by 37 C.F.R. § 41.8(a). In addressing this issue, the CAFC did not read 37 C.F.R. § 41.8(a) as permitting the Board to ignore a transfer of interest, pointing out that the rule is intended to detect conflicts of interest and to enable enforcement of estoppel provisions. The CAFC also pointed out that the rule is not directly related to substitution where in federal courts there is no time limit for a party moving for substitution. In addition, the CAFC pointed out that the Board has permitted parties to continue appeals after a change in the real party-in-interest despite the parties not filing the notices. Thus, the Board erred by not substituting Mojave as the third-party requester while the inter partes reexamination was pending before the Board.

III. Crocs argues that the interest of a requester cannot be assigned under 35 U.S.C § 141. The CAFC pointed out that it has previously concluded that “mere privies” cannot appeal a reexamination due to lacking a cause of action. Furthermore, the CAFC had observed in Agilent that “[w]hile the language of the statute does not explicitly forbid a change in the identity of the third-party requester over the course of the proceeding or on appeal, … it similarly does not appear to address whether and under what circumstances a change of the identity of the third-party requester can occur.” The CAFC noted two lines of Supreme Court cases related to assigning causes of action. Both lines of cases rely on a policy against separating the right to exclude from the right to sue for infringement. Notably, the CAFC states:

But we are aware of no case that suggests that a federal claim is lost when it is transferred together with the assignor’s entire business. Where, as here, the requester’s right has been transferred together with all other assets, there is no reason that the requester’s right to challenge the Board’s decision cannot be effectively transferred. To refuse to recognize such a transfer where the other assets remain subject to infringement liability would create a situation in which the assets remained potentially liable for infringement, but the transferee would have lost the right to challenge patent validity.

Thus, the requester’s right (including its right to appeal) may be transferred at least when it occurs as part of the transfer of the requester’s entire business or assets.

The CAFC also noted that Vaillancourt v. Becton Dickenson & Co., 749 F.3d 1368 (Fed. Cir. 2014) is not contrary. In that case, the inventor had assigned his rights to a company while an inter partes reexamination was pending and before a decision on appeal. When the Board affirmed the examiner’s rejection, the individual could not appeal as the assignee was indisputably the owner when the individual had filed the appeal.

IV. Crocs argues that Mojave lacks standing because it does not face a potential suit for infringement. The CAFC pointed out that Article III of the Constitution limits judicial power to cases and controversies. Standing has three elements of injury in fact, causation and redressability, and these requirements apply on appeal, and with equal force to appeals from administrative agencies to the federal courts.

To establish an Article III injury on appeal from an inter partes reexamination, we have previously held that it is sufficient for an appellant to show that it has engaged in “activity that would give rise to a possible infringement suit.”

The sale agreement specifically provided that the transferred assets were not free and clear of any claims made by Crocs, so that the acquired assets face potential patent infringement claims, and Mojave could also face potential infringement liability because of activities after the bankruptcy sale. In addition, Mojave’s injury is traceable to the challenged patent and would be redressed by a favorable ruling by the CAFC reversing the patentability of the patent, meeting all elements of standing. In a footnote, the CAFC also noted that Mojave may also suffer an Article III injury as a result of false advertising counterclaims.

V. Lastly, Crocs argues that Mojave failed to file a notice of appeal from the Board’s decision. Mojave could not file a notice of appeal because it had not been added as a party. Under Nevada law, however, U.S.A. Dawgs had retained the ability to file a protective notice of appeal which was sufficient to confer jurisdiction to the CAFC.

Since the CAFC held that Mojave is the successor-in-interest, it has standing, and the Board had erred in not substituting Mojave as the third-party requester. Furthermore, the CAFC thought that there is no useful purpose served by remanding such that the appropriate course is to proceed with granting the motion to substitute while also updating the official caption of the decision to reflect Mojave.

Takeaways

Standing to continue as a successor-in-interest is established if it is clear all assets are transferred (a federal claim is not lost when it is transferred together with the assignor’s entire business).

Notice of a change in a real party in interest under 37 C.F.R. 41.8(a) differs from a motion to substitute under Federal Rule of Appellate Procedure 43(b) in that the former has a time limit (20 days) whereas the latter does not have a time limit. There is no apparent penalty for failure to comply with 37 C.F.R. 41.8(a) although this section is entitled “Mandatory notices.”

Full Opinion Download

[1] For patent owners, an assignment is recorded to show that a party is the real party in interest. In this case, since Mojave was not a patent owner but instead a third-party requester.

Category: Case Summary

Who has Standing to Appeal of IPR Decision? And What is Teaching Away?

| April 21, 2021

General Electric Company v. Raytheon Technologies Corporation, No. 2019-1319.

Decided on December 23, 2020

Before Lourie, Reyna and Hughes (Opinion by Hughes).

Summary

Raytheon had ’920 patent which was related to a gas turbine engine. GE filed IPR and PTAB reviewed the claim and found the patent is non-obvious. GE filed a request for rehearing challenging the PTAB’s application of the legal standard for both teaching away and motivation to combine. The PTAB denied the request for rehearing and GE appealed to the CAFC. Raytheon claimed that GE does not have standing to appeal because GE did not have the injury in fact. At the appeal, GE showed a concrete business plan as evidence of injury in fact, and the CAFC found that GE has a substantial risk of future infringement and has standing. Then, the CAFC reviewed the PTAB’s decision on obviousness issue. Upon review, the CAFC found that the PTAB correctly set forth the standard for teaching away, however, applied it erroneously. The CAFC also found that the PTAB lacked substantial evidence for its conclusion that GE did not establish a motivation to combine the prior arts. Therefore, the CAFC vacated the PTAB’s decision and remanded the case to the PTAB.

Details

Background

Raytheon Technologies Corporation (“Raytheon”[1]) filed US Patent No.8,695,920 (“’920 patent”) in 2011 and the patent was issued in April 2014.

In December 2016, General Electric Company (“GE”), a competitor of Raytheon in the industry of commercial aviation, petitioned to the Patent Trial and Appeal Board (“PTAB”) for reviewing the 920 patent’s claims 1-4, 7-14, and 19. GE explained that the claims were obvious based on two prior art references, Wendus and Moxon.

Before the IPR institution Raytheon disclaimed claims 1-4, 7, 8, 17, and 19. The PTAB reviewed only claims 9 -14. After the IPR institution, Raytheon disclaimed 9 and the PTAB only ruled on claims 10-14.

The disputed claims 10-14 were depended on independent claim 9.

9. A method of designing a gas turbine engine comprising:
providing a core nacelle defined about an engine centerline axis;
providing a fan nacelle mounted at least partially around said core nacelle to define a fan bypass flow path for a fan bypass air-flow;
providing a gear train within said core nacelle;
providing a first spool along said engine centerline axis within said core nacelle to
drive said gear train, said first spool includes a first turbine section including be-tween three–six (3–6) stages, and a first compressor section;
providing a second spool along said engine centerline axis within said core nacelle, said second spool includes a second turbine section including at least two (2) stages and a second compressor section;
providing a fan including a plurality of fan blades to be driven through the gear train by the first spool, wherein the bypass flow path is configured to provide a bypass ratio of airflow through the bypass flow path di-vided by airflow through the core nacelle that is greater than about six (6) during engine operation.
10. The method as recited in claim 9, wherein said first turbine section defines a pressure ratio that is greater than about five (5.0).
11. The method as recited in claim 10, wherein a fan pressure ratio across the plurality of fan blades is less than about 1.45.
12. The method as recited in claim 11, wherein the gear train is configured to provide a speed reduction ratio greater than about 2.5:1.
13. The method as recited in claim 12, wherein the plurality of fan blades are configured to rotate at a fan tip speed of less than about 1150 feet/second during engine operation.
14. The method as recited in claim 13, wherein the second turbine section includes two (2) stages.

The PTAB concluded that Wendus taught away from combination with Moxon and GE did not establish the obviousness of claim 10 when considered as a whole. Therefore, the PTAB found claims 10-14 are nonobvious. GE filed a request for rehearing challenging the PTAB’s application of the legal standard for both teaching away and motivation to combine. The PTAB denied the request for rehearing and GE timely appealed to the Federal Circuit (“CAFC”).

Standing

Raytheon moved to dismiss this appeal for lack of standing because GE has never “sued or threatened to sue” for infringing the ’920 patent. Raytheon also mentioned that GE “had never alleged that an engine exists that presents a concrete and substantial risk of infringing the ’920 patent,”

In JTEKT[2], the CAFC found that when the appellant does not currently engage in infringing activity and “relies on potential infringement liability as a basis for injury in fact”, the appellant must show that “it has concrete plans for future activity that creates a substantial risk of future infringement or would likely cause the patentee to assert a claim of infringement.”

In prior lawsuit between the same parties GE v. UTC[3], GE failed to show the evidence. However, the CAFC shows some guideline of what kind of evidence do we need to have a standing to appeal IPR decision to CAFC. GE responds that it has alleged facts that show it “is currently undertaking activities” likely to lead Raytheon to sue it for infringement.

Here, GE has shown concrete plans for future activities:

GE spent $10–12 million in 2019 developing a geared turbofan architecture and design;
GE intends to keep developing its geared turbofan engine design;
The design is GE’s technologically preferred design for the next-generation narrow body market;
GE has offered this preferred geared turbofan design to Airbus;
GE has also established that such a sale would raise a substantial risk of an infringement suit; and
GE believes its preferred design raises a substantial risk of infringement.

GE explicitly stated that “this preferred geared turbofan design includes a gear train driven by the low-pressure spool and a two-stage high-pressure turbine.” The CAFC found that this GE’s declaration “plausibly establish that its preferred next-generation engine design substantially risks infringing the ’920 patent.” With these concrete plans, the CAFC found that GE has shown concrete plans raising a substantial risk of future infringement.

Obviousness

The CAFC reviewed the PTAB’s decision on Obviousness. The patent at issue is related to “turbofan gas turbine engines used to propel commercial airliners.” Typically, a turbofan engine has four main components, (1) the fan, (2) compressor, (3) combustor, and (4) turbine[4]. In a turbofan engine, there are two ways airflow, “bypass flow” and “core flow.” The bypass ratio is a ratio of bypass flow to core flow and it was known that a “higher bypass ratio increases fuel efficiency.”

In the industry, the high-pressure compressor and high-pressure turbine are referred to as the “high spool” and the low-pressure compressor and low-pressure turbine are referred to as the “low spool.” Ordinary, “direct-drive” turbofan engine has a low spool and all connected to the same shaft and rotate at the same speed. On the other hand, a high bypass ratio (fuel-efficient) turbofan, the difference of the diameter of the fan and the engine creates the difference of the rotational speed and the rotational speed is ideal compared to the low-pressure turbine.

Contrary to the ordinary “low spool” turbofan, Raytheon’s patent was a “‘geared’ turbofan which uses a gearbox mounted between the low-pressure compressor and the fan to reduce the rotational speed of the fan compared to the” low spool turbine. When the gearbox is used, “the fan to rotate more slowly than the rest of the low spool.” Therefore, each part can rotate at an optimal speed and create many benefits. Such as reducing engine fuel consumption, improving aerodynamic efficiency with less costly design, reducing the mechanical stress on the fan and improving safety, reducing torque on the low spool shaft and allowing to design smaller diameter shaft, and reducing engine noise.

During the IPR, GE explained that “Wendus discloses all elements of claims 9–14 except that it teaches a one-stage high-pressure turbine instead of the “at-least-two-stage” high-pressure turbine taught in claim 9 and narrowed to two stages in claim 14” and “Moxon concludes that because of increased performance demands on the high-pressure turbine required to improve fuel efficiency, “a move to one instead of two high pressure turbine stages is thought unlikely, although designs have been carried out and demonstrations have been run.”

However, the PTAB found that Wendus taught away from combination with Moxon “despite the PTAB’s prior findings of the benefits of the two-stage high-pressure turbine” and concluded “GE did “not establish the obviousness of claim 10 when considered as a whole.” Therefore, the PTAB found claims 10-14 are nonobvious.

Therefore, GE pointed the errors of the Board’s decision on three issues before the CAFC. As to the first issue, teaching away, GE asserted that “the PTAB errored by misreading Wendus to find that it disparages or discourages the use of a two-stage high pressure turbine, and therefore erred in finding that Wendus taught away from a two-stage high-pressure turbine.” For the second issue, artisan’s motivation to combine references, GE also argues that the PTAB “applied an overly rigorous requirement for motivation to combine the Wendus and Moxon references.” Lastly, GE argues that the PTAB also erred by requiring GE to show that an artisan would be motivated to retain the claimed performance parameters taught in Wendus in combining Wendus and Moxon.

Raytheon counter-argued that the CAFC must affirm the PTAB’s decision if there is substantial evidence of “(1) Wendus teaches away from modifying its advanced engine to add a two-stage high-pressure turbine; (2) no matter if Wendus teaches away, Wendus discloses a strong preference for a one-stage high-pressure turbine, undermining GE’s motivation-to-combine arguments; or (3) GE failed to establish a motivation for modifying the Wendus advanced engine to achieve the invention of claim 10, ‘as a whole.’”

CAFC stated that the PTAB correctly set forth the standard for teaching away.

“[a] reference does not teach away ‘if it merely expresses a general preference for an alternative invention but does not “criticize, discredit, or otherwise discourage” investigation into the invention claimed.’”

The PTAB found that criticism of the use of a two-stage high-pressure turbine in the prior art suggests a general preference for a one-stage high-pressure turbine.

By referencing Table 16 of Wendus[5], the PTAB concluded that “Wendus discourages the useof a two-stage high-pressure turbine rather than merely suggesting a general preference for a one-stage high-pressure turbine because…A person of ordinary skill in the art would have known that modifying the Wendus [advanced] engine to include a two-stage turbine would have increased the weight and cost of the engine which Wendus criticizes, discredits, or otherwise discourages.”

However, the CAFC found that the PTAB misleads Table 16 in the full context of Wendus because “Wendus itself only weakly supports that a one-stage high-pressure turbine has weight and cost advantages over a two-stage high pressure turbine.” Also, the CAFC mentioned that “Wendus itself does not criticize the use of a two-stage turbine for weight or cost reasons” and “Wendus references neither efficiency nor number of parts in comparison to any other high-pressure turbine design.”

The CAFC also explained that “even if an artisan recognized that a one-stage turbine would have led to reduced engine weight and lower engine cost than a two-stage turbine, Wendus is hardly consistent in indicating that weight and cost concerns alone mandate the correct design choices of an improved engine, compared to other factors like fuel efficiency or reliability.”

“Wendus ‘expressly weigh[ed] the tradeoffs [between a one-stage and two-stage turbine] and cho[se] the one-stage option’ cannot withstand scrutiny.” Therefore, the CAFC conclude that “Wendus does not criticize, credit, or discourage the use of a two-stage high-pressure turbine” and there is no substantial evidence to support the PTAB’s conclusion of teaching away.

Secondly, the CAFC concluded that the PTAB lacks substantial evidence for its conclusion that GE did not establish a motivation to combine Wendus and Moxon. By referring the PharmaStem Therapeutics[6], the CAFC confirmed the standard of obviousness is that “a person of ordinary skill in the art would have had reason to attempt to make the composition or device, or carry out the claimed process, and would have had a reasonable expectation of success in doing so.”

The CAFC found that the PTAB again misread Wendus and applied “its faulty findings that Wendus described ‘the one-stage turbine as a critical and enabling technology providing significant advantages over a prior art engine having a two-stage turbine,’ and that ‘other [Wendus] engine components [being] specifically designed to accommodate the [one-stage] turbine[7].”

Finally, the CAFC concluded that the PTAB’s holding that GE did not establish the obviousness of claim 10 “as a whole” lacks substantial evidence. The CAFC pointed that “Wendus meets all the elements of claim 10 except for the two-stage high-pressure turbine, which Moxon discloses” and “GE does not merely identify each claim element as present in Wendus and Moxon. Instead, GE’s obviousness theory combines the elements disclosed in Wendus’s advanced engine with Moxon’s teaching of a two-stage high-pressure turbine to attain better turbine reliability and efficiency.”

Therefore, the CAFC vacated the PTAB’s decision and remand the case to the PTAB.

Takeaway

As to the standing requirement “injury in fact”, this case shows what degree the appellee needs to prove the concrete plans in the future and what type of evidence is appropriate. 35 U.S.C §319 states that “Any party to the inter partes review shall have the right to be a party to the appeal.” The law did not specifically state the minimum standing requirement to appeal of IPR decision.
An appellant’s declaration that it believes the preferred design raises a substantial risk of infringement is also plausible only if the declaration was supported by the other evidence.
When determining the obviousness by teaching away from the prior art references, the meaning must be interpreted by the entire reference, not the partial words in the reference.
Teaching away argument needs “criticize” more than “preference.”

Full Opinion Download

[1] During the appeal, Raytheon was known as United Technologies Corporation.

[2] JTEKT Corp. v. GKN Auto. LTD., 898 F.3d 1217, 1221 (Fed. Cir. 2018), cert. denied, 139 S. Ct. 2713 (2019).

[3] Gen. Elec. Co. v. United Techs. Corp., 928 F.3d 1349 (Fed. Cir. 2019).

[4] The compressor pressurized the air come into the core flow. Then, the combustor mixed the compressed air and fuel and ignite and generates hot gas. The hot gas expands in the turbine and create power to rotate the blades in turbine.

[5] Wendus, See page 52 of https://ntrs.nasa.gov/api/citations/20030067946/downloads/20030067946.pdf

[6] PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007).

[7] Final Written Decision at *13 (citations omitted).

Category: Case Summary
Tags: obviousness > Standing > teaching away

Broad functional limitations in claims “raise the bar for enablement”

| April 13, 2021

Amgen Inc. v. Sanofi

February 11, 2021

Before Prost, Lourie, and Hughes (Opinion by Lourie).

Summary

The Federal Circuit invalidates genus claims with functional limitations for lacking enablement. The Federal Circuit focuses the enablement analysis on the broad scope of structures covered by the claims and the lack of guidance in the specification on how to identify those structures that exhibit the claimed functionalities.

Details

Low-density lipoprotein (LDL) cholesterol is often called the “bad” cholesterol. An elevated LDL level leads to fatty buildups (or plaques) in arteries and contributes to heart disease. LDL receptors remove LDL cholesterol from the bloodstream and regulates the amount of LDL cholesterol in circulation.

The proprotein convertase subtilisin/kexin type 9 (PCSK9) enzyme has for years been an important cholesterol-lowering target. The PCSK9 enzyme degrades LDL receptors and can interfere with the regulation of circulating LDL cholesterol levels. It has been found that loss-of-function mutations in the PCSK9 enzyme lead to higher levels of the LDL receptor, lower circulating LDL cholesterol levels, and protection from heart disease.

U.S. Patent Nos. 8,829,165 and 8,859,741, owned by Amgen Inc., relate to antibodies that bind to and block PCSK9 to inhibit PCSK9-LDL receptor interactions.

The relevant claims in the 165 and 741 are all directed to an antibody, and all define the antibody in terms of two specific functions: first, the antibody “binds to” a combination of amino acid residues on the PCSK9 protein, and second, the antibody “blocks” binding of PCSK9 to LDL receptor.

For example, independent claim 1 of the 165 patent recites:

1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.

Independent claim 29 of the 165 patent specifically requires that the antibody blocks the binding of PCSK9 to LDL receptor by at least 80%.

Independent claim 1 of the 741 patent recites:

1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.

The 165 and 741 patents share a common written description. The specifications disclose 26 specific antibodies, including their production, screening, and amino acid sequences. For only 2 of those antibodies, the specifications disclose the 3D structures showing the binding of the antibodies to specific PCSK9 residues. The examples test the binding of only 3 antibodies to PCSK9.

Another one of Amgen’s patents, not at issue in this case, claims Repatha®, which is a PCSK9 inhibitor that Amgen currently markets as a prescription injection therapy for treating adults with high cholesterol. Amgen used to sell Repatha® for $14,520, but to stay “competitive” with other drug makers’ PCSK9 inhibitors, Amgen lowered the price tag to $5,850 in 2020. Amgen still made nearly $900 million from Repatha® in 2020.

Repatha® is exemplified in the 165 and 741 patents, but not claimed. And whereas Amgen’s Repatha patent claims the amino acid sequence of the antibody, the 165 and 741 patents at issue in this case do not define the antibodies in terms of their amino acid sequences. Rather, the 165 and 741 patent claims use functional language to recite an entire genus of antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding to LDL receptors.

The use of functional limitations is central to the Federal Circuit’s affirmance of the district court’s determination that the 165 and 741 patent claims lack enablement.

The Federal Circuit begins with the usual reiteration of the Wands factor for evaluating enablement:

the quantity of experimentation necessary;
the amount of direction or guidance presented;
the presence or absence of working examples;
the nature of the invention;
the state of the prior art;
the relative skill of those in the art;
the predictability or unpredictability of the art; and
the breadth of the claims.

The Federal Circuit then compares the facts of the case to several precedents:

Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013);
Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and
Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 2019).

In each of those precedents, the claims required both a particular structure and functionality. And in each case, the Federal Circuit found that the claims were not enabled, because the large number of embodiments within the scope of the claims and the specification’s lack of guidance on the structure/function correlation would have required undue experimentation to determine which embodiments would exhibit the required functionality.

None of these precedents are favorable to Amgen. The precedents, together with Sanofi’s argument that the binding limitation in Amgen’s claims alone encompasses “millions” of antibodies, effectively focuses the Federal Circuit’s attention on the breadth of Amgen’s patent claims:

While functional claim limitations are not necessarily precluded in claims that meet the enablement requirement, such limitations pose high hurdles in fulfilling the enablement requirements for claims with broad functional language…
Turning to the specific Wands factors, we agree with the district court that the scope of the claims is broad. While in and of itself this does not close the analysis, the district court properly considered that these claims were indisputably broad… However, we are not concerned simply with the number of embodiments but also with their functional breadth. Regardless of the exact number of embodiments, it is clear that the claims are far broader in functional diversity than the disclosed examples. If the genus is analogized to a plot of land, the disclosed species and guidance “only abide in a corner of the genus.” Further, the use of broad functional claim limitations raises the bar for enablement, a bar that the district court found was not met.

Amgen argues that the specifications provide “roadmap” for making the claimed antibodies, but the problem, as the Federal Circuit sees it, is that even after the antibodies are made, identifying those specific antibodies that exhibit the claimed functionalities of binding and blocking PCSK9 is only possible through laborious “trial and error” requiring “substantial time and effort”.

Amgen is not helped by seemingly undisputed expert testimony on the unpredictability of the art. There appears to be agreement between the two sides’ experts that a small modification in an antibody’s sequence can result in big changes in structure and functions. Further, there is evidence that translating an antibody’s amino acid sequence into a known 3D structure is still not possible, so that it is difficult to visualize and evaluate the binding of an antibody to PCSK9. As the Federal Circuit articulates, “the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.”

There are some interesting observations.

First, while the patents at issue clearly claim a biotech invention, the Federal Circuit’s decision cites frequently to McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091 (Fed. Cir. 2020)—a computer case—for its discussion on the enablement of a claimed range. However, in McRO, the Federal Circuit did not even address the question of whether the disputed claims were enabled. The Federal Circuit held only that the enablement analysis required first delineating the precise scope of the claimed invention, and having failed to make that delineation, the district court’s summary determination of non-enablement must be vacated.

Second, at first glance, the Federal Circuit appears to have articulated a “heightened” standard of enablement for claims reciting functional limitations. But really, the “heightened” bar seems to be no more than a proposition that the broader the claim, the more guidance the specification may need to provide to satisfy the enablement requirement.

Third, during prosecution of the 165 patent, the Examiner rejected the claims as lacking enablement. However, Amgen overcame the rejection by arguing, without any Rule 132 declarations, that “various antibodies” and “crystal structures” provided in the specification explained how antibodies bound to PCSK9 to achieve the claimed functionalities.

Takeaway

The use of functional limitations, while desirable for imparting breadth to a claim, remains rife with pitfalls. For certain types of claims, such as claims directed to biologics, functional limitations are almost unavoidable because claiming the invention strictly in structural terms would be unduly narrow. For those claims, details in the specification are especially important.
Where a claim requires both a particular structure and functionality, the specification should preferably describe some correlation between the structure and the claimed functionality.
Where a claim recites a broad genus of structures for achieving a specific function, it is important for the specification to exemplify more than one species within that genus. Ideally the specification should also describe structural characteristics common to the species of the genus.

Full Opinion Download

Category: Case Summary
Tags: enablement

THE PTAB’S IPR INSTITUTION DECISION IS FINAL AND NONAPPEALABLE

| April 6, 2021

CyWee Group LTD. v. Google LLC

Summary:

CyWee appealed the PTAB’s final decision on three grounds. First, CyWee argued that the PTAB erred in concluding that Google disclosed all real parties in interest. However, the CAFC noted that the CAFC is precluded from reviewing this challenge because the PTAB’s determination on this issue is final and nonappealable. Second, CyWee argued that the CAFC should terminate and dismiss the IPR proceedings because the APJs were appointed in violation of the Appointments Clause. The CAFC rejected this challenge because the APJs were constitutionally appointed as of the date that the Arthrex decision was issued. Finally, a prior cited by Google (Bachmann) is not an analogous art. However, the CAFC held that Bachmann is reasonably pertinent to the particular problem with which the inventor is involved, and that this reference does not have to be reasonably pertinent to every problem facing a field to be analogous prior art. Therefore, the CAFC affirmed that the PTAB’s determination that the challenged claims would have been obvious in view of Bachmann.

Details:

Google LLC (“Google”) petitioned for IPR of claims 1 and 3-5 of U.S. Patent No. 8,441,438 and claims 10 and 12 of U.S. Patent No. 8,552,978, asserting that those claims are unpatentable as obvious in view of U.S. Patent No. 7,089,148 (“Bachmann”).

The PTAB instituted IPR and found that those claims would have been obvious. CyWee appeals.

CyWee’s first argument

CyWee argues that the PTAB erred in concluding that Google disclosed all real parties in interest, as required by 35 U.S.C. §312(a)(2)[1].

The CAFC found that the CAFC is precluded from reviewing this challenge because the PTAB’s determination on this issue is final and nonappealable under 35 U.S.C. §314(d)[2] because this issue “raises an ordinary dispute about the application of an institution-related statute.”

CyWee argued that CyWee attempts to challenge the PTAB’s denial of CyWee’s post-institution motion to terminate the proceedings in view of newly found evidence.

However, the CAFC found that CyWee’s request is nothing more than a request for the PTAB to reconsider its institution decision, which is final and nonappealable.

CyWee’s second argument

CyWee argues that the CAFC should terminate and dismiss the IPR proceedings because the APJs were appointed in violation of the Appointments Clause.

However, the CAFC rejected this challenge because the APJs were constitutionally appointed as of the date that the Arthrex decision[3] was issued, and because the Arthrex decision was issued before the final decisions in this case. Therefore, the CAFC found that those final decisions were rendered by constitutional panels.

CyWee’s third argument

CyWee argues that Bachmann is not an analogous art.

However, the CAFC found that the PTAB’s conclusion is supported by substantial evidence because the PTAB determined that (1) “improving error compensation with an enhanced comparison method” was of “central importance” to the inventors, and that (2) Bachmann was reasonably pertinent to this problem because Bachmann “illustrates collection of data from the same kinds of sensors” and “correct[s] for the same kinds of errors that were of concern to the inventor[s].”

Therefore, the CAFC found that Bachmann is reasonably pertinent to the particular problem with which the inventor is involved.

Furthermore, the CAFC noted that a reference need not be reasonably pertinent to every problem facing a field to be analogous prior art, but rather need only be “reasonably pertinent to one or more of the particular problems to which the claimed inventions relate.” Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1361 (Fed. Cir. 2020).

Finally, the CAFC noted that “a reference can be analogous art with respect to a patent even if there are significant differences between the two references.” Donner, 979 F.3d at 1361.

Takeaway:

The PTAB’s decision on whether to institute an IPR proceeding is final and nonappealable.
The Supreme Court heard the oral argument in the Arthrex case on March 1, 2021. Two questions before the Court are (1) whether APJs are properly appointed, and (2) if they are not properly appointed, whether removing employment protections corrects the defect.
A reference need not be reasonably pertinent to every problem facing a field to be analogous prior art, but rather need only be “reasonably pertinent to one or more of the particular problems to which the claimed inventions relate.” A reference can be analogous art with respect to a patent even if there are significant differences between the two references.

Full Opinion Download

[1] 35 U.S. Code § 312 – Petitions

(a) Requirements of Petition. – A petition filed under section 311 may be considered only if –

(2) the petition identifies all real parties in interest;

[2] 35 U.S. Code § 314 – Institution of inter partes review

(d) No Appeal. – The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.

[3] Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019): “The APJs were actually “principal officers” under the Appointments Clause, and that the APJ appointment provisions of the AIA creating the PTAB were unconstitutional because the APJs were not appointed by the President and confirmed by the Senate, as is required for “principal officers.””

Category: Case Summary
Tags: administrative patent judge > Analogous Art > appointment clause > inter partes review > real party in interest

« Previous Page — Next Page »

CAFC Alert

Lessons on Claim & Specification Drafting, Litigation Strategies and more

Search

Favorite Blogs

Making DJ Jurisdiction Easier to Maintain

Lying in a Deposition – Never a Good Policy

Inventors’ Agreements will not protect a former employer from the inventors’ future related work

An Improvement in Computational Accuracy Is Not a Technological Improvement

If it cannot be made, it does not exist!

UNDERSTANDING STANDING IN AN IPR

STANDING FOR A SUBSTITUTED PARTY IS NOT A CROCK

Who has Standing to Appeal of IPR Decision? And What is Teaching Away?

Broad functional limitations in claims “raise the bar for enablement”

THE PTAB’S IPR INSTITUTION DECISION IS FINAL AND NONAPPEALABLE

Subscribe | 登録

Archives

Tags

英語から日本語