Result-Effective-Ugh…a Bridge Too Far?
| April 25, 2024
Pfizer Inc. v. Sanofi Pasteur Inc.
Decided: March 5, 2024
Result-Effective Variable; Obviousness
Before LOURIE, BRYSON, and STARK, Circuit Judge. Opinion drafted by LOURIE.
Summary:
Pfizer appealed to the Federal Circuit following rulings from five inter partes review proceedings petitioned by Sanofi challenging all claims of Pfizer’s U.S. Patent No. 9492559 (‘559 Patent). The ‘559 Patent claims immunogenic compositions comprising glycoconjugates of various Streptococcus pneumoniae serotypes for use in pneumococcal vaccines. Independent claim 1 is as follows (emphasize added):
- An immunogenic composition comprising a Streptococcus pneumoniae serotype 22F glycoconjugate, wherein the glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa and comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a carrier protein, and wherein a ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2.
The Board instituted review based on each petition and issued final written decisions which, taken together, found all claims unpatentable. Pfizer raised four challenges on appeal. The first, which will be the only challenge discussed herein, alleged that the Board erred in determining that the ‘559 Patent was obvious based on prior art references PCT Patent Application Publication 2007/071711 (“GSK-711”) and U.S. Patent Application Publication 2011/0195086 (“Merck-086”).
The Board recognized that neither GSK-711 nor Merck-086 disclosed any molecular weight for a S. pneumoniae serotype 22F glycoconjugate, as required by claim 1 of the ’559 Patent, but nevertheless concluded that, based on the evidence of record, glycoconjugate molecular weight is a result-effective variable that a person of ordinary skill in the art would have been motivated to optimize to provide a conjugate having improved stability and good immune response. It is here that Pfizer argued the Board erred, because it is undisputed that the prior art does not disclose any molecular weight for the claimed serotype 22F glycoconjugate, there could be no presumption of obviousness. The CAFC disagreed.
The CAFC begin by stating that “the determination whether or not a claimed parameter is a result-effective variable is merely one aspect of a broader routine optimization analysis.”
The CAFC followed that “an overlap between a claimed range and a prior art range creates a presumption of obviousness that can be rebutted with evidence that the given parameter was not recognized as result-effective. See Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1341 (Fed. Cir. 2020) (citing E.I. DuPont, 904 F.3d at 1006); In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012).” However, they emphasized that this “does not mean that the determination whether or not a variable is result-effective is only appropriate when there is such an overlap.” Rather that “a routine optimization analysis generally requires consideration whether a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to bridge any gaps in the prior art to arrive at a claimed invention. Where that gap includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective. If so, then the optimization of that parameter is “normally obvious.” In re Antonie, 559 F.2d 618, 620 (CCPA 1977).”
Thus, the CAFC concluded that the Board did not err in considering, as part of its obviousness analysis, whether or not the claimed molecular weight of a S. pneumoniae serotype 22F glycoconjugate was a result-effective variable, dispute the cited references being silent thereon.
It was ultimately concluded that “substantial evidence supports the Board’s conclusion that the molecular weight recited in claim 1 would have been obvious over the references.” Such evidence included the fact that GSK-711 gave the molecular weights for fourteen other S. pneumoniae serotype glycoconjugates, and that Expert Testimony showed that, at the time of the invention, conjugation techniques and conditions were routine such that a person of ordinary skill in the art would have understood the claimed molecular weight to be “typical of immunogenic conjugates.”
Comments:
An argument against a Result-Effective Variable assertion may be weakened, even when the prior art is silent on said variable, if a PHOSITA can bridge the gaps in the teaching with a reasonable success based on the evidence overall. Thus, it may be necessary to demonstrate more than simply the variable not being recognized by the reference. That is, one may also have to show there is no reasonable expectation of success in said variable
Written Description Compliance Requires Lack of Different Inventions Achieved by Claimed and Disclosed Ranges
| April 19, 2024
RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A
Decided: February 9, 2024
Chen, Stoll, and Cunningham. Opinion by Stoll.
Summary
The CAFC addressed a question of written description compliance where a numerical range set forth in a patent claim is narrower than and encompassed by a disclosed range in the specification. The CAFC found that the written description requirement is met under fact-specific circumstances where substantial evidence indicates that a skilled artisan would see no different inventions resulting from the claimed range and the disclosed range.
Details
RAI appealed a final written decision by the Patent Trial and Appeal Board in a post-grant review (PGR) finding certain claims of RAI’s U.S. Patent No. 10,492,542 (“the ’542 patent”) unpatentable. RAI challenged, among other issues,[1] the Board’s finding that claims 10 and 27 of the ’542 patent lack adequate written description under 35 U.S.C. § 112.
The ’542 patent relates to electrically powered “smoking articles” which, as in e-cigarettes, use an electrical heating element to heat tobacco or like substance to form an inhalable vapor or aerosol. Claims 10 and 27—added by preliminary amendment in the underlying application which is a continuation from a former application having no such claims in the original filing—specify that the heating element has a certain range of length, which is not disclosed verbatim in the specification.
The written description requirement is a question of fact subject to substantial evidence review. The CAFC prefaced the written description analysis with the general threshold for compliance: the disclosure must “reasonably convey[ to a skilled artisan] that the inventor had possession of the claimed subject matter as of the filing date.” The CAFC then discussed precedents finding written description support, or lack thereof, for claimed ranges that are narrower than ranges described in specifications.
Courts finding adequate written description: Wertheim, Blaser, Kolmes[2]
In Wertheim, the parameter at issue was “solids content of the concentrated coffee extract.” The claimed range “between 35% and 60%” was found adequately supported by the specification disclosing a broader range of “25% to 60%” along with specific examples where the parameter was either “36% or 50%.” The Wertheim court held that presence of a clear indication that “the broad described range pertains to a different invention than the narrower (and subsumed) claimed range” (emphasis added) would negate adequacy of written description, whereas absence of such indication would support written description compliance.
Two subsequent courts followed Wertheim. InBlaser, the claimed range of temperature for heating a reaction blend for acylation, “80º to 200º C.” was found adequately supported by the disclosure of a broader range of “between 60º and 200º C.” In Kolmes, the claimed range of wrapping rate for cut-resistant yarn, “8–12 turns per inch,” was found adequately supported by the disclosure of a broader range of “4–12 turns per inch, with 8 turns per inch being preferred.”
Courts finding no adequate written description: Baird, Indivior[3]
Baird involved a patent application which included claims copied from an issued patent for an interference proceeding, i.e., the applicant was not the original author of the copied claims. The parameter at issue was a quench bath temperature in production of stretch-orienting polypropylene. The claimed range was “from about 40[º F] to … about 60 [º F].” While this range was explained in the issued patent as having certain criticality, the applicant’s specification disclosed a broader range of “between 32º F and 176º F,” while silent on the narrower range. Finding lack of adequate support, the Baird court reasoned that the copied claim pertained to a “different” invention from that disclosed in the specification.
In Indivior, the parameter at issue was a concentration of certain polymers in thin film formulation. Disputed claims recited two numerical ranges: (A) “about 40 wt % to about 60 wt %” and (B) “about 48.2 wt % to about 58.6 wt %.” The specification disclosed broader ranges—or lower bounds without express upper bounds—of “at least 25” and “at least 50,” as well as specific instances of “48.2” and “58.6” gleaned from data tables. The specification also stated that the parameter may be at “any desired level.” The claimed range (A) failed the written description requirement because the specification did not literally recite the range or the endpoints, while the “any desired level” statement obscured the scope of the invention. The claimed range (B) also failed the written description requirement because, although the endpoints were disclosed at least implicitly, it was unclear that the specification described the range bound by these endpoints.
Application to Claims 10 and 27 of the ’542 patent
After summarizing the precedents, the CAFC turned to the claims at issue. Claims 10 and 27 both recite that a heating member used in the smoking device has “a length of about 75% to about 85% of a length of the disposable aerosol forming substance.” The specification describes four progressively narrow, nested ranges for the parameter: “about 75% to about 125%,” “about 80% to about 120%,” “about 85% to about 115%,” and “about 90% to about 110%.” The Board’s finding of no written description was driven by the fact that the upper endpoint “85%” of the claimed range does not have a corresponding upper endpoint in any of the disclosed ranges.
The CAFC found that the written description requirement is met. To reach the conclusion, the CAFC centered its analysis on “different invention” test set forth in Wertheim, restating that “[t]he specification need not expressly recite the claimed range to provide written description support.” The factual inquiry looked to specific factors, including:
- Express disclosure in the specification: Although the claimed range itself is not literally disclosed, both of its endpoints are identified as part of the disclosed ranges.
- Predictability and complexity of the invention: Since the smoking device invention relates to a relatively predictable, electro-mechanical field, and the claim language is simple, the level of clarity or details required to satisfy the written description requirement is low.
- Lack of indication that the claimed parameter affects the invention: The specification nowhere indicates that “operability, effectiveness, or any other parameter” of the invention is impacted by changing the claimed parameter.
Based thereon, the CAFC found no “different invention” arising from the claimed range than that disclosed in the specification.
The CAFC distinguished Indivior and Baird relied upon by the Board. Unlike Indivior, the ’542 patent discloses the endpoints and contains no inconsistent statements regarding the range (e.g., that “any desired level” may work); plus the predictability of the electro-mechanical invention is higher than the chemical invention set forth in the Indivior claims. Also, unlike Baird where the claimed range was shown to have criticality over the boarder disclosed range, no evidence was presented in the present case that the broader disclosed range operates differently than the claimed range.
Additionally, the CAFC dismissed an expert testimony offered by Phillip Morris pointing to different center points of the disclosed range (100%) and the claimed range (80%). The expert evidence was not enough to overcome the intrinsic evidence and the case law supporting adequacy of the written description.
Takeaways
This case exemplifies one way in which a court may apply case-by-case analysis of written description compliance. Where the claimed range is narrower than and subsumed in the disclosed range, the “different invention” test may not only examine the express disclosure and the nature of the technology, but also may consider whether varying the parameter inside and outside the claimed range would make any difference.
While the test could be useful in establishing written description support—given that a patent specification typically describes numerical ranges in connection with one general inventive concept—caution should be used in asserting lack of different inventions emanating from different numerical ranges; such admission might be used by an opponent to support obviousness of the claimed range. The dilemma may be avoided, for example, by drafting an original disclosure to describe both commonalities and differences across broad and narrow ranges as well as specific values of a key parameter.
[1] RAI’s other argument challenged the Board’s obviousness finding of other claims of the ’542 patent, which was affirmed by the CAFC on appeal.
[2] In re Wertheim,541 F.2d 257 (C.C.P.A. 1976), In re Blaser, 556 F.2d 534 (C.C.P.A. 1977), and Kolmes v. World Fibers Corp., 107 F.3d 1534 (Fed. Cir. 1997).
[3] In re Baird,348 F.2d 974 (C.C.P.A. 1965), and Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323 (Fed. Cir. 2021).
Depends On How You Slice It: CAFC reverses PTAB on Weber v. Provisur IPR ruling
| April 5, 2024
Weber, Inc. v. Provisur Tech. Inc.
Decided: February 8, 2024
Before Reyna, Hughes and Stark. Authored by Reyna
Summary: The Court reversed the PTAB’s finding that Weber’s instruction manuals did not qualify as printed publications under 35 USC §102. The Court also reversed key claim construction taken by the PTAB in upholding Provisur’s patents.
Background:
Provisur sued Weber for patent infringement on two patents, USP 10,639,812 (“’812 patent”) and 10,625,436 (“’436 patent”) relate to high-speed mechanical slicers used in food-processing plants. Weber countered by filing IPR proceedings against both patents at the USPTO Patent Trial and Appeal Board (PTAB). The PTAB found both the ‘812 and the ‘436 patentable. During the PTAB proceeding, Weber had attempted to use their own instruction manual for the slicer they sold as a prior art publication under 35 U.S.C. §102. The Board found that the instruction manual was not a “printed publication” under §102 on the basis that the manuals were controlled in their circulation to only customers or potential customers by a strict copyright and confidentiality clause.
Further, the PTAB had construed three terms from the slicer components, (1) the “food article loading apparatus”; (2) the “food article feed apparatus”; and (3) the “food article stop gate” in a manner that maintained the patents’ validity while excluding the disclosures in Weber’s manuals.
Weber appealed the Board’s finding that their instruction manual was not a printed publication under §102 and the claim construction of the three terms.
Decision:
(a) Weber’s Instruction Manual as a “Printed Publication”
The Board had relied upon the CAFC’s prior holding in Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319 (Fed. Cir. 2009), in finding that Weber’s manuals were not “printed publications.” In Cordis, the references in question were two academic monographs describing an inventor’s work that were only distributed to a handful colleagues and two companies potentially interested in the technology.
The CAFC was quick to distinguish the current case from Cordis. First, the CAFC noted that the statutory phrase “printed publication” from § 102 has been defined to mean a reference that was “sufficiently accessible to the public interested in the art,” citing In re Klopfenstein, 380 F.3d 1345, 1348 (Fed. Cir. 2004) and that “public accessibility” was based on the relevant public being able to “locate the reference by reasonable diligence,” citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1376 (Fed. Cir. 2021). Next, the Court found that Weber’s operating manuals were created for dissemination to the interested public to provide instructions for Weber’s slicer. The Court stated the Weber manuals were in “stark contrast” to the confidential monographs in Cordis which were subject to “academic confidentiality norms.” The Court went on to describe that the evidence provided by employees of Weber, stating that the manuals were readily provided to potential buyers, clearly indicated that the manuals did in fact qualify as “printed publications” under §102.
The Court also found the Board’s reliance on the copyright and confidentiality of Weber’s manuals to be misplaced. The Board had keyed in on the copyright language restricting the reproduction or transfer of the manuals and Weber’s “terms and conditions” stating that documents related to a sale of a slicer “remain the property of” Weber. The CAFC was not convinced that these statements made the manuals confidential to the point of not being a “printed publication”, stating:
Weber’s assertion of copyright ownership does not negate its own ability to make the reference publicly accessible. Cf. Correge v. Murphy, 705 F.2d 1326, 1328–30 (Fed. Cir. 1983) (“A mere assertion of ownership cannot convert what was in fact a public disclosure and offer to sell to numerous potential customers into a non-disclosure.”). The intellectual property rights clause from Weber’s terms and conditions covering sales, likewise, has no dispositive bearing on Weber’s public dissemination of operating manuals to owners after a sale has been consummated.
The Court reversed the PTAB’s finding that Weber’s instruction manuals were not “printed publications” within the meaning of 35 U.S.C. §102.
(b) Claim Construction – “disposed over” and “stop gate”
The Court next addressed the PTAB’s claim construction as to the term “disposed over” as used in the claims. The Board had construed the term “disposed over” to require that the “feed apparatus and its conveyor belts and grippers are ‘positioned above and in vertical and lateral alignment with’ the food article loading apparatus and its lift tray assembly.” The Court rejected this interpretation asserting that it reads elements into the claim which are not present. The Court noted that the specification and prosecution history did not impart any limited meaning to the term “disposed over” and therefore there was no basis for including the additional aspect that the feed apparatus and loading apparatus were in alignment. Citing Cyntec Co. v. Chilisin Elecs. Corp., 84 F.4th 979, 986 (Fed. Cir. 2023), the Court held that “Had the patent drafter intended to limit the claims” to address the alignment of the conveyor belts and lift tray assembly between the apparatuses, “narrower language could have been used in the claim.”
Running Provisur through the figurative slicer, the Court noted that Provisur did not dispute that Weber’s manuals satisfy the limitation under Weber’s proposed construction (i.e. that alignment is not required between the feed and loading apparatus). Hence, they concluded that their review of the Board’s claim construction is dispositive of the issue and that the Weber manuals do disclose the “disposed over” limitation.
As to the “stop gate” term in the claims, Weber asserted that the Board erred in determining that the “product bed conveyer” disclosed in Weber’s operating manuals (as shown in Figures 10 and 227 thereof), does not disclose the “stop gate” limitation.
After analyzing the figures, the Court only commented that given these disclosures of the Weber manuals there was no substantial evidentiary support for the Board’s finding. Thus, the Court again reversed on the “stop gate” determinations.
Take aways:
- The Court clarifies the meaning of “printed publication” in 35 U.S.C. §102 by further defining the line between documents primarily intended to be confidential, such as the monographs in Cordis, and those primarily intended to be disseminated to the interested public, such as Weber’s manuals.
- By reversing the PTAB’s claim interpretation that had read a required alignment of parts into the claim where no such requirement was present, the Court also reiterates the standing law of claim construction that claim terms have their ordinary meaning unless intrinsic evidence demonstrates otherwise.
THE DOMESTIC INDUSTRY REQUIREMENT FOR AN ITC COMPLAINT CAN BE SATISFIED BASED ON A SUBSET OF A PRODUCT IF THE IP INVOLVES ONLY THAT SUBSET
| March 22, 2024
Roku, Inc. v. ITC
Decided: January 19, 2024
Before Dyk, Hughes, and Stoll. Opinion by Hughes.
Summary:
Universal Electronics, Inc. (“Universal”) filed a complaint against Roku in the International Trade Commission (ITC) for importing certain TV products that infringe U.S. Patent No. 10,593,196. The issues on appeal include whether the final determination of the ITC is proper in finding that (1) Universal had ownership rights to assert the ‘196 patent in the complaint; (2) Universal satisfied the economic prong of the domestic industry requirement under 19 U.S.C. § 1337(a)(3)(C) to bring a complaint at the ITC; and (3) Roku failed to demonstrate that the ‘196 patent was obvious over the prior art. The CAFC affirmed the ITC’s findings.
Details:
The ‘196 patent is to a device for allowing communication between various devices such as smart TVs and DVD players that may use different communication protocols such as wired connections (e.g., HDMI) or wireless communication (Wi-Fi or Bluetooth) that may be incompatible with each other. The ‘196 patent discloses a universal control engine (referred to as a “first media device” in the claims) that can scan various target devices (referred to as “second media devices” in the claims). The first media device receives wireless signals from various devices such as a remote control or an app on a tablet computer and can transmit commands using wired or IR signals to controllable devices such as TVs, DVRs or a DVD player.
Claim 1 is provided:
1. [pre] A first media device, comprising:
[a] a processing device;
[b] a high-definition multimedia interface communications port, coupled to the processing device, for communicatively connecting the first media device to a second media device;
[c] a transmitter, coupled to the processing device, for communicatively coupling the first media device to a remote control device; and
[d] a memory device, coupled to the processing device, having stored thereon processor executable instruction;
[e] wherein the instructions, when executed by the processing device,
[i] cause the first media device to be configured to transmit a first command directly to the second media device, via use of the high-definition multimedia communications port, to control an operational function of the second media device when a first data provided to the first media device indicates that the second media device will be responsive to the first command, and
[ii] cause the first media device to be configured to transmit a second data to a remote control device, via use of the transmitter, for use in configuring the remote control device to transmit a second command directly to the second media device, via use of a communicative connection between the remote control device and the second media device, to control the operational function of the second media device when the first data provided to the first media device indicates that the second media device will be unresponsive to the first command.
1. Ownership Issue
After filing its complaint, Universal filed a petition for correction of inventorship to add an inventor (Mr. Barnett) to the patent. Roku had filed a motion for summary determination before the ALJ that Universal lacked standing to assert the ‘196 patent because at the time Universal filed its complaint, it did not own all rights to the ‘196 patent. Roku argued that a 2004 agreement between Mr. Barnett and Universal did not constitute an assignment of rights.
The ALJ agreed stating that the 2004 agreement was a “mere promise to assign rights in the future, not an immediate transfer of expectant rights,” and thus, the 2004 agreement “did not automatically assign any of Mr. Barnett’s rights to the Provisional Applications of the ‘196 patent that eventually issued from the priority chain.”
The Commission reversed stating that there was a separate agreement in 2012 in which Mr. Barnett assigned all his rights to a series of provisional applications including the provisional which led to the ‘196 patent. The language of the assignment states that Mr. Barnett “hereby sell[s] and assign[s] … [his] entire right, title, and interest in and to the invention,” including “all divisions and continuations thereof, including the subject-matter of any and all claims which may be obtained in every such patent.” The Commission further found that Mr. Barnett did not contribute any new or inventive matter to the ‘196 patent after filing the provisional applications. The Commission found that the 2012 agreement constituted a “present conveyance” of Mr. Barnett’s rights in the ‘196 patent. The CAFC agreed with the Commission that the agreement constitutes a “present conveyance,” and thus, Universal had ownership rights to assert the ‘196 patent.
2. Domestic Industry Requirement – Economic Prong
To bring complaint at the ITC under Section 337, the complainant must possess a domestic industry in the United States. Domestic industry can be satisfied by showing “substantial investment in [a patent’s] exploitation, including engineering, research and development, or licensing.” 19 U.S.C. § 1337(a)(3)(C).
The Commission found that Universal had substantial investments in domestic engineering and R&D related to a platform called QuickSet which is incorporated into multiple smart TVs. The Commission found that the QuickSet platform involves software and software updates that result in practice of the asserted claims when implemented on the Samsung DI products and that Universal’s asserted expenditures are attributable to its domestic investments in R&D and engineering. The Commission further found that Universal’s investments go directly to the functionality necessary to practice many claimed elements of the ‘196 patent. The CAFC held that the Commission’s findings are supported by substantial evidence.
Roku attempted to frame the argument with regard to the TV as a whole rather than the QuickSet technology that is installed on those TVs to argue that Universal has not satisfied the domestic industry requirement. However, the CAFC stated that the domestic industry requirement “does not require expenditures in whole products themselves, but rather, sufficiently substantial investment in the exploitation of the intellectual property.” The CAFC further stated “a complainant can satisfy the economic prong of the domestic industry requirement based on expenditures related to a subset of a product, if the patent(s) at issue only involve that subset.” The CAFC held that the IP at issue in this case is practiced by QuickSet and the related QuickSet technologies, which is a subset of the entire TV.
3. Obviousness
Roku argued obviousness of the claims based on prior art references Chardon and Mishra. The parties agreed that Chardon disclosed all of the limitations of claim 1 except for limitation 1[e][ii]. Roku cited Mishra for teaching this feature. The ALJ found that Universal had presented evidence of secondary considerations showing that QuickSet satisfied a long-felt but unmet need that outweighed Roku’s obviousness case. The Commission went further regarding non-obviousness finding that the combination of Chardon and Mishra does not disclose a system that automatically configures two different control devices to transmit commands over different pathways. The Commission further found that Roku failed to present clear and convincing evidence of a motivation to combine the references.
On appeal, Roku merely argued that the Commission erred by accepting Universal’s evidence of secondary considerations. Roku argued that the Commission erred in finding a nexus between the secondary considerations of non-obviousness and the claims because some of the news articles presented by Universal discuss features in addition to QuickSet. The CAFC held that this argument is meritless because Roku did not dispute that QuickSet is discussed in the references that the Commission relied on.
The CAFC further stated that Roku did not challenge the actual findings that the combination of Chardon and Mishra does not disclose limitation 1[e], i.e., allowing for a choice between different second media devices. Thus, the Commission’s obviousness determination was affirmed.
Comments
When filing a patent infringement suit, make sure inventorship and ownership are clear, and make any necessary corrections before filing suit. When filing a complaint at the ITC, keep in mind that the domestic industry requirement does not require showing expenditures on whole products if the patent at issue only involves a subset of the product.
Inventor declaration not related to what is claimed or discussed in the patent would not help the patent to survive from patent eligibility attack in the pleading stage
| March 8, 2024
INTERNATIONAL BUSINESS MACHINES CORPORATION v. ZILLOW GROUP, INC., ZILLOW, INC.
Decided: January 9, 2024
Hughes (author), Prost, and Stoll
Summary:
The Federal Circuit affirmed the district court’s decision holding that the claims of two IBM’s patents are directed to patent ineligible subject matter under §101, and properly granting Zillow’s motion to dismiss under FRCP 12(b)(6).
Details:
IBM appealed a decision from the Western District of Washington, where the district court granted Zillow’s motion to dismiss under FRCP 12(b)(6). The district court held that all patent claims asserted against Zillow by IBM were directed to ineligible subject matter under 35 U.S.C. §101.
At issue in this appeal were IBM’s two patents – U.S. Patent Nos. 6,778,193 and 6,785,676.
The ’193 patent
The ’193 patent is directed to a “graphical user interface for a customer self-service system that performs resource search and selection.”
This patent is directed to improving how search results are displayed to a user by providing three visual workspaces: (1) a user begins by entering their search query into a “Context Selection Workspace”; (2) a user can further specify the details of their search in a “Detail Specification Workspace”; and (3) a user can view the results of their search in a “Results Display Workspace.”
Independent claim 1 is a representative claim:
1. A graphical user interface for a customer self service system that performs resource search and selection comprising:
a first visual workspace comprising entry field enabling entry of a query for a resource and, one or more selectable graphical user context elements, each element representing a context associated with the current user state and having context attributes and attribute values associated therewith;
a second visual workspace for visualizing the set of resources that the customer self service system has determined to match the user’s query, said system indicating a degree of fit of said determined resources with said query;
a third visual workspace for enabling said user to select and modify context attribute values to enable increased specificity and accuracy of a query’s search parameters, said third visual workspace further enabling said user to specify resource selection parameters and relevant resource evaluation criteria utilized by a search mechanism in said system, said degree of fit indication based on said user’s context, and said associated resource selection parameters and relevant resource evaluation criteria; and,
a mechanism enabling said user to navigate among said first, second and third visual workspaces to thereby identify and improve selection logic and response sets fitted to said query.
The ’676 patent
The ’676 patent is directed to enhancing how search results are displayed to users by disclosing a four-step process of annotating resource results obtained in a customer self service system that performs resource search and selection.”
Independent claim 14 is a representative claim:
14. A method for annotating resource results obtained in a customer self service system that performs resource search and selection, said method comprising the steps of:
a) receiving a resource response set of results obtained in response to a current user query;
b) receiving a user context vector associated with said current user query, said user context vector comprising data associating an interaction state with said user and including context that is a function of the user;
c) applying an ordering and annotation function for mapping the user context vector with the resource response set to generate an annotated response set having one or more annotations; and,
d) controlling the presentation of the resource response set to the user according to said annotations, wherein the ordering and annotation function is executed interactively at the time of each user query.
The District Court
Initially, IBM sued Zillow in the Western District of Washington for allegedly infringing five patents. The claims for two patents were dismissed, and Zillow filed a motion to dismiss under FRCP 12(b)(6) for the remaining three patents.
As for the ’676 patent, the district court found that the claims were merely directed to offering a user ‘the most beneficial and meaningful way’ to view the results of a query… and not advancing computer capabilities per se.”
The district court noted that four steps could be performed with a pen and paper, and that the claims were merely result-oriented.
Therefore, the district court found the asserted claims of the ’676 patent ineligible under §101.
As for the ’193 patent, the district court found that the claims were directed to the abstract idea of “more precisely tailoring the outcome of a query by guiding users (via icons, pull-down menus, dialogue boxes, and the like) to make choices about specific context variables, rather than requiring them to formulate and enter detailed search criteria.”
The district court did not find user context icons, separate workstations, and iterative navigation to be inventive concepts and held that they were well-understood, routine, or conventional at the time of the invention.
Therefore, the district court similarly found the asserted claims of the ’193 patent ineligible under §101.
The CAFC
The CAFC reviewed de novo.
As for the ’193 patent, the CAFC agreed with the district court that the claims do nothing more than improving a user’s experience while using a computer application.
Here, the CAFC noted that IBM failed to explain how the claims do anything more than identify, analyze, and present certain data to a user and that the claims did not disclose any technical improvement to how computer applications are used.
Furthermore, the CAFC agreed with the district court that IBM’s allegations of inventiveness “do[] not . . . concern the computer’s or graphical user interface’s capability or functionality, [but] relate[] merely to the user’s experience and satisfaction with the search process and results.”
Finally, the CAFC noted that the inventor declaration (“one of the key innovative aspects of the invention of the ’193 patent was not just the multiple visual workspaces alone, but how these various visual workspaces build upon each other and interact with each other,” as well as “the use of one visual workspace to affect the others in a closed-loop feedback system.”) did not cite the patent at all, and that neither the claims nor the specification include any such information. Therefore, the CAFC held that simply including allegations of inventiveness in a complaint with the inventor declaration did not make the complaint survive at the pleading stage.
Accordingly, the CAFC affirmed the district court’s decision holding that the ’193 patent is directed to ineligible subject matter under §101 and granting Zillow’s motion to dismiss as to the ’193 patent.
As for the ’676 patent, the CAFC agreed with the district court that the claims are directed to an abstract idea of displaying and organizing information because the representative claims use results-oriented language without mentioning any specific mechanism to perform the claimed steps.
In addition, the CAFC agreed with the district court that IBM failed to plausibly allege any inventive concept that would render the abstract claims patent-eligible.
IBM argued that the district court erred by failing to consider a supposed claim construction dispute regarding the term “user context vector”.
However, the CAFC noted that Zillow adapted IBM’s construction and did not propose an alternate construction. Therefore, the CAFC found that there was no claim construction dispute for the district court to resolve.
Accordingly, the CAFC affirmed the district court’s decision holding that the ’676 patent claimed ineligible subject matter under §101 and granting Zillow’s motion to dismiss as to the ’676 patent.
Dissenting opinion by Stoll
Stoll would vacate the district court’s holding of ineligibility of the claims of the ’676 patent because the majority, like the district court, did not meaningfully address IBM’s proposed construction of “user context vector.”
Takeaway:
- Conclusionary allegations of inventiveness in the inventor declaration would not help the patent to survive from patent eligibility attack in the pleading stage.
- The inventor declaration should be closely tied to the claims and the specification to help the patent to survive from patent eligibility attack.
Tags: 35 U.S.C. § 101 > declaration > Motion to Dismiss > patent eligible subject matter
The Twists and Turns of Claim Construction Issues in an IPR
| February 2, 2024
Parkervision v. Vidal
Decided: December 20, 2023
Summary:
Although patent owner ParkerVision’s claim construction was adopted in multiple district court litigations, it was not adopted by the PTAB in the IPR of the same patent. The Federal Circuit, reviewing claim construction de novo, affirmed the Board’s final decision. ParkerVision introduced the claim construction issue in its patent owner response, arguing that the claimed “storage element” should be construed as “an element of an energy transfer system that stores non-negligible amounts of energy from an input EM signal” and that the cited prior art did not teach the claimed “storage element” because its allegedly corresponding capacitors were not part of any energy transfer system. Intel filed a reply asserting that the interpretation of a “storage element” does not require it to be part of an energy transfer system. The Board and the Federal Circuit agreed. ParkerVision did not further argue in its patent owner response that the cited prior art’s capacitors failed the requirement that it store “non-negligible” amounts of energy from the input EM signal. ParkerVision included in its sur-reply that the cited prior art’s capacitors stored only a negligible amount of energy because “non-negligible” must be measured relative to the available energy of the input EM signal. The Board granted Intel’s motion to strike this part of ParkerVision’s sur-reply. The court affirmed, noting that there was no abuse of discretion when the Board refused to consider a new theory of patentability raised for the first time in a sur-reply.
Procedural History:
Intel petitioned for inter partes review (IPR) of claim 3 of Parkervision’s USP 7,110,444 (the ‘444 patent). There are related district court litigations involving the ‘444 patent and other related patents, which adopted a claim construction of a “storage element” aligned with Parkervision’s proposed claim construction. The Patent Trial and Appeal Board (the Board) adopted Intel’s claim construction of a “storage element” and issued a final decision that the ‘444 patent was obvious over cited prior art. Parkervision appealed. In issuing its final decision, the Board recognized that several district court cases involving the ‘444 patent adopted claim constructions inconsistent with Intel’s proposed construction. See, ParkerVision, Inc. v. Intel Corp., Nos. 6:20-cv-108-ADA, 6:20-cv-562-ADA (W.D. Tex.); ParkerVision, Inc. v. Hisense Co., Nos. 6:20-cv-870-ADA, 6:21-cv-562-ADA (W.D. Tex.); ParkerVision, Inc. v. TCL Indus. Holdings Co., No. 6:20-cv-945-ADA (W.D. Tex.); ParkerVision, Inc. v. LG Elecs. Inc., No. 6:21-cv-520-ADA (W.D. Tex.).
Decision:
Claim 3 of the ‘444 patent is as follows:
A wireless modem apparatus, comprising:
a receiver for frequency down-converting an input signal including,
a first frequency down-conversion module to down-convert the input signal, wherein said first frequency down-conversion module down-converts said input signal according to a first control signal and outputs a first down-converted signal;
a second frequency down-conversion module to down-convert said input signal, wherein said second frequency down-conversion module down-converts said input signal according to a second control signal and outputs a second down-converted signal; and
a subtractor module that subtracts said second down-converted signal from said first down-con-verted signal and outputs a down-converted signal;
wherein said first and said second frequency down-conversion modules each comprise a switch and a storage element.
The ‘444 patent relates to wireless local area networks (WLANs) that use frequency translation technology. In a two-device network using frequency translation, the first device receives a low-frequency baseband signal (audible voice signal) and up-converts it to a high-frequency electromagnetic (EM) signal before wireless transmission to the second device. The second device receives the EM signal, down-converts it back to a low-frequency baseband signal, and outputs an audible signal. The ‘444 patent is directed to down-converting EM signals using down-converter modules that include a switch and a storage element (also called a storage module).
The main issue in this case is the claim construction for a “storage element.”
ParkerVision contends that a “storage element” is an element of an energy transfer system that stores non-negligible amounts of energy from an input EM signal. A magistrate judge’s claim construction order in ParkerVision v. LG and a special master’s recommendation in ParkerVision v. Hisense and in ParkerVision v. TCL adopted ParkerVision’s proposed claim construction.
Intel contends that a “storage element” is “an element of a system that stores non-negligible amounts of energy from an input EM signal” – which does not require that the element be part of an energy transfer system. The Board adopted Intel’s claim construction. The Federal Circuit agreed. This is dispositive in the obviousness holding because ParkerVision’s patent owner response in the IPR focused exclusively on the prior art’s lack of an energy transfer system.
The ‘444 patent incorporated by reference USP 6,061,551 (the ‘551 patent) which provided the following disclosure critical to the meaning of a “storage element”:
1 FIG. 82A illustrates an exemplary energy transfer system 8202 for down-converting an input EM signal 8204. 2 The energy transfer system 8202 includes a switching module 8206 and a storage module illustrated as a storage capacitance 8208. 3 The terms storage module and storage capacitance, as used herein, are distinguishable from the terms holding module and holding capacitance, respectively. 4 Holding modules and holding capacitances, as used above, identify systems that store negligible amounts of energy from an under-sampled input EM signal with the intent of “holding” a voltage value. 5 Storage modules and storage capacitances, on the other hand, refer to systems that store non-negligible amounts of energy from an input EM signal.
(bracketed numbers identifying referenced sentences)
This is deemed “lexicographic” because “as used herein” in sentence #3 refers to the use of these terms (contained throughout the drawings and specification) in general, and not to specific embodiments, and “refer to” in sentence #5 links “storage modules” (parties agreed this is synonymous with “storage element”) to “systems that store non-negligible amounts of energy from an input EM signal.”
ParkerVision’s argued that the ‘551 paragraph was addressing examples in which storage modules are used in energy transfer systems in which holding modules, by contrast, are used in under-sampling systems. The court dismissed this because the comparative nature of the paragraph does not prevent it from being definitional. And, the court refused to incorporate an entire “energy transfer system” into the claim just because a single component (storage element) can be a part of such a system. The court also stated that the district court claim constructions by the magistrate judge and special masters do not alter its conclusion that the Board arrived at the correct construction.
Another, procedural, issue on appeal is whether (1) the Board erred in relying on Intel’s reply (raising this claim construction issue that “storage element” is not limited to being part of an “energy transfer system”) and (2) the Board erred in striking parts of ParkerVision’s sur-reply.
First, ParkerVision asserted that the Board erred in relying on Intel’s arguments allegedly raised for the first time in Intel’s reply. The presumed contention is that the Board deprived ParkerVision of its procedural rights under the Administrative Procedure Act (APA) and failed to comply with the USPTO’s rule that a reply “may only respond to arguments raised in the … patent owner response…” 37 C.F.R. § 42.23(b). The court reviews the Board’s compliance with the APA de novo, and the Board’s determination that a party violated USPTO rules for abuse of discretion. Under the APA, the Board must:
“timely inform[]” the patent owner of “the matters of fact and law asserted,” 5 U.S.C. § 554(b)(3), must provide “all interested parties opportunity for the submission and consideration of facts [and] arguments . . . [and] hearing and decision on notice,” id. § 554(c), and must allow “a party . . . to submit rebuttal evidence . . . as may be required for a full and true disclosure of the facts,” id. § 556(d).
Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016).
Neither petitioner nor patent owner expressly proposed any pre-institution claim construction. Post-institution, ParkerVision first proposed a new claim construction position in its patent owner response wherein “storage element” was construed as “an element of an energy transfer system that stores non-negligible amounts of energy from an input electromagnetic signal.” The APA required the Board to give Intel “adequate notice and an opportunity to respond under the new construction” proffered in ParkerVision’s patent owner response. As in Axonics, Inc. v. Medtronic, Inc., 75 F.4th 1374 (Fed. Cir. 2023), the court held that “where a patent owner in an IPR first proposes a claim construction in a patent owner response, a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction….” Id. at 1384. Intel did just that. Intel’s reply countered that ParkerVision’s non-obviousness position that the cited prior art did not disclose the claimed “storage element” because it was not in an energy transfer system is misplaced because that term is not restricted to be an element of an energy transfer system.
Pursuant to the APA, the Board may not change theories mid-stream without giving the parties reasonable notice of its change. The Board’s adopting of Intel’s claim construction did not “change theories midstream without giving the parties reasonable notice of its change.” “Once ParkerVision introduced a claim construction argument into the proceeding through its patent owner response, Intel was entitled in its reply to respond to that argument and explain why that construction should not be adopted.” And, ParkerVision had an opportunity to respond to Intel’s proposed construction by filing its sur-reply, which continued to press for its own claim construction.
However, with regard to patentability (non-obviousness), ParkerVision added in its sur-reply, for the first time, that the cited prior art’s capacitors stored only a negligible amount of energy because “non-negligible” must be measured relative to the available energy of the input EM signal. This part of ParkerVision’s sur-reply was stricken by the Board. ParkerVision’s patent owner response asserted that the cited prior art capacitors must store non-negligible amounts of energy, but did not assert that the reference failed to meet that requirement (instead, merely arguing the capacitors are not part of an energy transfer system). Accordingly, its sur-reply offered a new theory of patentability. There is no abuse of discretion in declining to consider a new theory of patentability raised for the first time in sur-reply.
ParkerVision further asserted that its sur-reply arguments addressed allegedly new arguments in Intel’s reply. But, the Board noted:
[I]f [ParkerVision] believed [Intel’s] Reply raised an issue that was inappropriate for a reply brief or that [ParkerVision] needed a greater opportunity to respond beyond that provided by our Rules (e.g., to include new argument and evidence in its Sur-reply), it was incumbent upon [ParkerVision] to contact [the Board] and request authorization for an exception to the Rules. [ParkerVision] did not do so. [ParkerVision] did not request that its Sur-reply be permitted to include arguments and evidence that would otherwise be impermissible in a sur-reply.
The court faulted ParkerVision for not availing itself of the available procedural mechanisms. For these reasons, the court found no abuse of discretion in the Board’s exclusion of part of ParkerVision’s sur-reply.
Takeaways:
The existence of district court claim construction positions do not guarantee the same claim constructions being adopted by the Board. And, the Federal Circuit reviews claim construction issues de novo.
For the patent owner’s sur-reply, be wary of potentially “new” patentability positions being advanced that were not originally raised in the patent owner response. If any such “new” patentability positions are taken, be cognizant of the procedural mechanism to contact the Board and request authorization for an exception to the Rules to include arguments and/or evidence that may otherwise be impermissible in a sur-reply.
Claim Construction Should Be Well-Grounded in Both Intrinsic and Extrinsic Evidence
| January 15, 2024
ACTELION PHARMACEUTICALS LTD v. MYLAN PHARMACEUTICALS INC.
Decided: November 6, 2023
Before REYNA, STOLL, and STARK, Circuit Judges.
Summary
The Federal Circuit ruled that the patent claim term “a pH of 13 or higher” could not be interpreted solely based on the patent’s intrinsic evidence. The court remanded the case to the district court, instructing it to consider extrinsic evidence to determine the proper construction of this claim limitation.
Background
The case of Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc. involves a dispute over patent infringement related to epoprostenol, a drug used for treating hypertension. Actelion Pharmaceuticals, the patent holder, owns two patents of the drug: U.S. Patent Nos. 8318802 and 8598227. These patents disclose a pharmaceutical breakthrough in stabilizing epoprostenol using a high pH solution, which is otherwise unstable and difficult to handle in medical applications.
Mylan Pharmaceuticals, aiming to enter the market with a generic version of epoprostenol, filed an Abbreviated New Drug Application (ANDA). In this process, Mylan certified under Paragraph IV that the patents held by Actelion were either invalid or would not be infringed by Mylan’s manufacture, use, or sale of the generic drug. In response, Actelion asserted these patents against Mylan, claiming infringement.
The key issue in the dispute revolves around the interpretation of the phrase “a pH of 13 or higher” in the patent claims. This particular claim is crucial because the stability of epoprostenol is significantly impacted by the pH level of its solution. Actelion’s patents suggest that the epoprostenol bulk solutions should preferably have a pH adjusted to about 12.5 to 13.5 to achieve the desired stability. However, in the claims, Actelion’s patents only set the limitation as “a pH 13 or higher” as shown in claim 11 of the ’802 patent, a representative of the asserted claims:
11. A lyophilisate formed from a bulk solution comprising:
(a) epoprostenol or a salt thereof;
(b) arginine;
(c) sodium hydroxide; and
(d) water,
wherein the bulk solution has a pH of 13 or higher, and wherein said lyophilisate is capable of being reconstituted for intravenous administration with an intravenous fluid.
The dispute centered on the interpretation of the pH value specified in the patent claims. Actelion contended that the claim should encompass pH values that effectively round up to 13, including values like 12.5. Conversely, Mylan argued for a narrower interpretation, asserting that the claim should only cover pH values strictly at 13 or higher, thus excluding anything below this threshold, such as 12.5.
This interpretation was critical in determining whether Mylan’s generic version of epoprostenol would infringe upon Actelion’s patents. The district court initially adopted Actelion’s interpretation, which led to a stipulated judgment of infringement against Mylan.
Discussion
The Federal Circuit’s analysis began with a de novo review of the district court’s decision. The central question was whether the district court’s adoption of Actelion’s interpretation, which included pH values that could round up to 13 (such as 12.5), was appropriate. This broader interpretation affected the scope of the patent and the potential infringement by Mylan’s generic version of the drug. In scientific and technical contexts, the practice of rounding pH levels, such as rounding 12.5 to 13, depends on the specific requirements of the situation and the level of precision needed. pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution, and even small changes can represent significant differences in acidity or basicity.
Mylan Pharmaceuticals argued for a narrower interpretation of the term. They insisted that “a pH of 13” sets a definitive lower limit, suggesting that any pH value below 13, even those marginally lower like 12.995, would not fall within the scope of the patent. Mylan suggested that if a margin of error was considered necessary for a pH of 13, it should be minimal, encompassing a range only from 12.995 to 13.004. This interpretation was grounded in the belief that precision was implicit in the claim term, as the absence of approximation language like “about” in the claim suggested an exact value.
In contrast, Actelion Pharmaceuticals argued for a broader interpretation. They argued that the term should include values that round up to 13, thus potentially including values such as 12.5. Actelion’s argument was based on the principle that a numerical value in a patent claim includes rounding, dictated by the inventor’s selection of significant figures, unless the intrinsic record explicitly indicates a different intention. Actelion maintained that rounding was a common practice in scientific measurements and that the absence of specific approximation language did not necessarily dictate a precise value.
One of the key findings of the Federal Circuit was the inadequacy of intrinsic evidence to resolve the dispute conclusively. Intrinsic evidence, which includes the original patent claim language, specification, and prosecution history, is generally the primary resource for interpreting patent claims. However, in this case, these sources did not clearly define the precision of the pH value in question. The specification stated that, “the pH of the bulk solution is preferably adjusted to about 12.5-13.5, most preferably 13.” This language suggested that while the inventor recognized a preferred range (about 12.5-13.5), they specifically highlighted a most preferred value (13). The Federal Circuit also noted that the specification uses both “13” and “13.0” and various degrees of precision for pH values generally throughout the specification. Moreover, the prosecution history shows that the Examiner drew a distinction between the stability of a composition with a pH of 13 and that of 12. However, such distinction does not clarify the narrower issue of whether a pH of 13 could encompass values that round to 13, in particular 12.5.
The specifications and prosecution history left ambiguous whether the term referred exclusively to a pH of 13.0 or could include values that round up to 13. Recognizing this ambiguity, the Federal Circuit emphasized the need for extrinsic evidence to properly interpret the term. This approach is aligned with the Supreme Court’s guidance in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., which acknowledged the importance of considering such evidence in certain contexts of patent claim interpretation. The Federal Circuit decided to vacate the district court’s ruling and remand the case for further consideration of extrinsic evidence.
Takeaway
- Precise and specific wording in patent claims is crucial, especially in technical fields, as it defines the scope and protection of the invention.
- Although intrinsic evidence (claim language, specifications, and prosecution history) is primary in patent interpretation, it may not always be sufficient. In cases where intrinsic evidence is ambiguous or lacks clarity, extrinsic evidence such as expert testimonies, scientific literature, and other technical documents becomes crucial for a comprehensive understanding of the claim.
FUNCTIONAL CLAIMS REQUIRE MORE THAN JUST TRIAL-AND-ERROR INSTRUCTIONS FOR SATISFYING THE ENABLEMENT REQUIREMENT
| January 5, 2024
Baxalta Inc. v. Genentech, Inc.
Decided: September 20, 2023
Moore, Clevenger and Chen. Opinion by Moore
Summary:
Baxalta sued Genentech alleging that Genentech’s Hemlibra product infringes US Patent No. 7,033,590 (the ‘590 patent). Genentech moved for summary judgment of invalidity of the claims for lack of enablement. The district court granted summary judgment of invalidity. Upon appeal to the CAFC, the CAFC affirmed invalidity for lack of enablement citing the recent Supreme Court case Amgen v. Sanofi.
Details:
Baxalta’s patent is to a treatment for Hemophilia A. Blood clots are formed by a series of enzymatic activations known as the coagulation cascade. In a step of the cascade, enzyme activated Factor VIII (Factor VIIIa) complexes with enzyme activated Factor IX (Factor IXa) to activate Factor X. Hemophilia A causes the activity of Factor VIII to be functionally absent which impedes the coagulation cascade and the body’s ability to form blood clots. Traditional treatment includes administering Factor VIII intravenously. But this treatment does not work for about 20-30% of patients.
The ‘590 patent provides an alternative treatment. The treatment includes antibodies that bind to Factor IX/IXa to increase the procoagulant activity of Factor IXa which allows Factor IXa to activate Factor X in the absence of Factor VIII/VIIIa. Claim 1 of the ‘590 patent is provided:
1. An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.
The ‘590 patent describes that the inventors performed four hybridoma fusion experiments using a prior art method. And using routine techniques, the inventors screened the candidate antibodies from the four fusion experiments to determine whether the antibodies bind to Factor IX/IXa and increase procoagulant activity as claimed. Only 1.6% of the thousands of screened antibodies increased the procoagulant activity of Factor IXa. The ‘590 patent discloses the amino acid sequences of eleven antibodies that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa.
Citing Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the CAFC stated that “the specification must enable the full scope of the invention as defined by its claims, allowing for a reasonable amount of experimentation. Citing additional cases, the CAFC stated “in other words, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.”
Baxalta argued that one of ordinary skill in the art can obtain the full scope of the claimed antibodies without undue experimentation because the patent describes the routine hybridoma-and-screening process. However, the CAFC stated that the facts of this case are indistinguishable from the Amgen case in which the patent at issue provided two methods for determining antibodies within the scope of the claims. In Amgen, the Supreme Court stated that the two disclosed methods were “little more than two research assignments,” and thus, the claims fail the enablement requirement.
The CAFC described the claims in this case as covering all antibodies that (1) bind to Factor IX/IXa; and (2) increase the procoagulant activity of Factor IXa, and that “there are millions of potential candidate antibodies.” The specification only discloses amino acid sequences for eleven antibodies within the scope of the claims. Regarding the method for obtaining the claimed antibodies, the specification describes the following steps:
(1) immunize mice with human Factor IX/IXa;
(2) form hybridomas from the antibody-secreting spleen cells of those mice;
(3) test those antibodies to determine whether they bind to Factor IX/IXa; and
(4) test those antibodies that bind to Factor IX/IXa to determine whether any increase procoagulant activity.
The CAFC stated that similar to Amgen, this process “simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the eleven antibodies they elected to disclose.”
The Supreme Court in Amgen also stated that the methods for determining antibodies within the scope of the claims might be sufficient to enable the claims if the specification discloses “a quality common to every functional embodiment.” However, no such common quality was found in the ‘590 patent that would allow a skilled artisan to predict which antibodies will perform the claimed functions. Thus, the CAFC concluded that the disclosed instructions for obtaining claimed antibodies, without more, “is not enough to enable the broad functional genus claims at issue here.”
Baxalta further argued that its process disclosed in the ‘590 patent does not require trial-and-error because the process predictably and reliably generates new claimed antibodies every time it is performed. The CAFC stated that even if a skilled artisan will generate at least one claimed antibody each time they follow the disclosed process, “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.” “Under Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).”
Baxalta also argued that the district court’s enablement determination is inconsistent with In re Wands. The CAFC disagreed stating that the facts of this case are more analogous to the facts in Amgen, and the Amgen case did not disturb prior enablement case law including In re Wands and its factors.
Comments
When claiming a product functionally, make sure your specification includes something more than just trial-and-error instructions. The CAFC suggested in this case that the enablement requirement may be satisfied if the patent discloses a common structural or other feature delineating products that satisfy the claims from products that will not. The CAFC also suggested that a description about why the actual disclosed products perform the claimed functions or why other products do not perform the claimed function would be helpful for satisfying the enablement requirement.
Ramification of Silence in Prosecution History and Reminder on Formulating Effective Obviousness Arguments
| November 17, 2023
ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.
Decided: September 21, 2023
Before Reyna, Stoll, and Stark. Opinion by Reyna.
Summary
The CAFC held that motivation to combine references is supported by substantial evidence including the patent prosecution history where relevancy of certain prior art, similar to an asserted reference in the IPR, was not contested by the applicant. The CAFC also rejected the patent owner’s arguments on lack of requisite findings on reasonable expectation of success, where such findings can be implied from express findings on motivation to combine as the two issues are interrelated to each other.
Details
Elekta’s U.S. Patent No. 7,295,648 (the “’648 patent”) pertains to ionizing radiation treatment. The technology is designed to deliver therapeutic radiation, such as one created by a linear accelerator or “linac,” to a target area of a patient such as brain tumors for treatment purposes. The ‘648 patent discloses that the linac, because of its great weight, requires a suitable structure to support the device while allowing a wide range of movement to focus the radiation precisely, leading to a challenge in implementing the linac-based system for treating highly sensitive, complex areas as with neurosurgery.
Representative claim 1 of the ‘648 patent recites:
A device for treating a patient with ionising radiation comprising:
a ring-shaped support, on which is provided a mount,
a radiation source attached to the mount;
the support being rotateable about an axis coincident with the centre of the ring;
the source being attached to the mount via a rotateable union having a an axis of rotation axis which is non-parallel to the support axis;
wherein the rotation axis of the mount passes through the support axis of the support and the radiation source is collimated so as to produce a beam which passes through the co-incidence of the rotation and support axes.
In the underlying inter partes review, the final written decision concluded, among other things, that claim 1 of the ’648 patent is obvious over a combination of Grady and Ruchala. In essence, Grady teaches an X-ray imaging device having a sophisticated rotatable support structure similar to that recited in the body of claim 1, whereas Ruchala teaches a linac-based radiation device for treating tumors, which may correspond to “treating a patient with ionising radiation” of claim 1.
On appeal, the CAFC addressed Elekta’s three main arguments regarding obviousness of claim 1: (1) “the Board’s findings on a motivation to combine are unsupported by substantial evidence”; (2) “the Board failed to make any findings, explicit or implicit, on a reasonable expectation of success”; and (3) “even had the Board made such findings, those findings are not supported by substantial evidence.” The CAFC reviewed the Board’s legal conclusions de novo and its factual findings for substantial evidence.
- Substantial evidence for the motivation to combine
Elekta argued that substantial evidence was lacking with the Board’s finding of a motivation to combine the references. In particular, Elekta asserted that no motivation would have existed for a skilled artisan to combine Grady and Ruchala, one disclosing “radiation imagery” and the other for “radiation therapy,” where incorporating Ruchala’s linac radiation into Grady’s imaging system would not improve its imagery function in any aspect, whilst the linac’s heavy weight would hamper precision and control, thereby “render[ing] the device essentially inoperable.”
The Board’s obviousness conclusion relies on, among other findings, its review of the prosecution of the ’648 patent, wherein “patents directed to imaging devices were cited, and were not distinguished based on an argument that imaging devices were not relevant art,” along with the pertinent field being framed in the IPR as one that “includes the engineering design of sturdy mechanical apparatus[es] capable of rotationally manipulating heavy devices in three dimensions oriented in a variety of approach angles with high geometrical accuracy, in the context of the radiation imaging and radiation therapy environment.”
The CAFC held that there was substantial evidence for the motivation to combine. Specifically, the CAFC noted that such evidence includes the prosecution history of the ’648 patent, in which Elekta “notably did not argue that prior art references directed to imaging devices were not relevant art.” The CAFC concluded that such failure to distinguish imaging radiation prior art during the patent prosecution, along with the asserted references and an expert testimony pointing to benefits of combining imagery and therapeutic radiation functions, substantially support the motivation to combine.
- Findings on the reasonable expectation of success
Elekta argued that the Board’s obviousness determination was devoid of any findings on reasonable expectation of success.
The CAFC disagreed, finding that a sufficient, implicit finding was made as to the reasonable expectation of success. The CAFC contrasted findings of reasonable expectation of success, which “can be implicit,” with those of motivation to combine, which must be “explicit.” Although an explicit finding would be usually required to support determinations made by the Board, the CAFC points to its precedent where the Board’s rejection of a patent owner’s motivation to combine argument based on teaching away constituted an implicit finding of a reasonable expectation of success, as the latter could be “reasonably discern[ed]” in the Board’s findings on “other, intertwined arguments.”
The CAFC noted that Elekta’s own arguments on the motivation to combine and the reasonable expectation of success presented before the Board were “blended”: Elekta essentially asserted that the suggested combination, lacking precision and control due to the device’s heavy weight, would fail to serve its intended purposes so as to negate motivation to combine, and consequently, would also negate reasonable expectation of success. As such, the CAFC held that by making express findings on the motivation to combine, the Board adequately made an implicit finding on Elekta’s argument on reasonable expectation of success.
- Substantial evidence for the reasonable expectation of success
Elekta argued that substantial evidence was lacking in the Board’s findings, if any, on reasonable expectation of success.
The CAFC succinctly rejected the argument. The CAFC noted that the evidence establishing a motivation to combine may—but not always—establish a finding of reasonable expectation of success. And that was the case with the present appeal, where “the arguments and evidence of reasonable expectation of success are the same for motivation to combine.”
Takeaways
This case presents an interesting situation pointing to one potential ramification of prosecution history made by silence: A failure to object to the scope of pertinent art during patent prosecution undercuts the patent owner’s argument in attacking the motivation to combine, where the asserted prior art is arguably from a disparate field. It is important to consider potential benefits and downsides of presenting or not presenting certain arguments during prosecution.
Another takeaway is the importance of formulating non-obviousness arguments on an issue-by-issue basis even if interrelated issues are involved; doing so would help keep the analysis of reasonable expectation of success from being comingled with the issues of motivation to combine.
Tags: motivation to combine > prosecution history > Reasonable Expectation of Success
IPR Amendments: Broader is Broader (even narrowly so).
| September 15, 2023
Sisvel International S.A. v. Sierra Wireless, Inc, Telit Cinterion Deuschland GMBH
Decided: September 1, 2023
Before Prost, Reyna and Stark. Authored by Stark.
Summary: Sisvel appealed a PTAB IPR decision based on claim construction and denial of entry of a claim amendment for broadening the claim. The CAFC affirmed the Board on both counts, noting that broad disclosures in the specification will lead to a broad interpretation of the claims, and that claim amendments which encompass embodiments that would come within the scope of the amended claim but would not have infringed the original claim will be considered broadening.
Background:
In an IPR involving Sisvel’s patent claims 10, 11, 13, 17, and 24 of U.S. Patent No. 7,433,698 (the “’698 patent”) and claims 1, 2, 4, and 13-18 of U.S. Patent No. 8,364,196 (the “’196 patent”), the PTAB had found all claims unpatentable as anticipated and/or obvious in view of certain prior art.
The issues centered on the phraseology in the claims regarding the “connection rejection message” being used to direct a mobile communication means to attempt a new connection with certain parameter values such as a certain carrier frequency.
Claim 10, reproduced below, was the primary representative claim used by the CAFC:
10. A channel reselection method in a mobile communication means of a cellular telecommunication system, the method comprising the steps of:
receiving a connection rejection message;
observing at least one parameter of said connection rejection message; and
setting a value of at least one parameter for a new connection setup attempt based at least in part on information in at least one frequency parameter of said connection rejection message.
On appeal, Sisvel challenged the Board’s construction of the single claim term, “connection rejection message.”
Sisvel also challenged the Board’s denial of their motion to amend the claims on the basis that the amendment enlarged their scope.
Decision:
(a) Claim construction of “connection rejection message”
Sisvel appealed the Board’s construction of giving “connection rejection message” its plain and ordinary meaning of “a message that rejects a connection.” Sisvel’s purported a construction of “a message from a GSM or UMTS telecommunications network rejecting a connection request from a mobile station.” However, the PTAB found that such a construction would improperly limit the claims to embodiments using a Global System for Mobile Communication (“GSM”) or Universal Mobile Telecommunications System (“UMTS”) network.
Sisvel argued that UMTS and GSM “are the only specific networks identified by [the] ’698 and ’196 patents that actually send connection rejection messages” provided for in their specification.
The CAFC, in required fashion, reiterated the Phillips claim-construction standard – whereby “[t]he words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history,” citing Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc)) 669 F.3d at 1365.
After reviewing, the Court found that the intrinsic evidence provided no persuasive basis to limit the claims to any particular cellular networks. They noted that the specification, while only expressly disclosing embodiments in a UMTS or GSM network, in fact still included broad teachings directed to any network. The CAFC affirmed the Board, noting that a person of ordinary skill in the art would not read the broad claim language, accompanied by the broad specification statement to be limited to GSM and UMTS networks.
(b) IPR Amendment
The Court also considered Sisvel’s contention that the Board erred during the IPR by denying its motion to amend the claims of the ’698 patent. The Board had denied Sisvel’s motion, concluding that the amendments to original claim 10 would have impermissibly enlarged claim scope. Original claim 10 and substitute amended claim 36 read as follows:
The Court first noted that broadening claims are not allowable during an IPR in the same fashion as in a Reissue or Reexamination proceeding at the USPTO. They further delved into the law of what constitutes a broadening of a claim noting that a claim “is broader in scope than the original claim if it contains within its scope any conceivable apparatus or process which would not have infringed the original patent” citing Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 74 (Fed. Cir. 1999).
The Court further remarked that it is Sisvel’s burden, as the patent owner, to show that the proposed amendment complies with relevant regulatory and statutory requirements, citing to 37 C.F.R. § 42.121(d)(1) (“A patent owner bears the burden of persuasion to show, by a preponderance of the evidence, that the motion to amend complies with the [applicable] requirements . . . .”).
The PTAB’s denial had focused on the last (“setting a value”) limitation, comparing the original claim’s requirement that the value be set “based at least in part on information in at least one frequency parameter” of the connection rejection message, while in the substitute claims the value may be set merely by “using the frequency parameter” contained within the connection rejection message. The Board had concluded that “[i]n proposed substitute claim 36, the value that is set need not be based, in whole or in part, on information in the connection rejection message and, thus, claim 36 is broader in this respect than claim 10.” J.A. 73.
The Court agreed with the PTAB’s reasoning that, in the context of these claims, “using” is broader than “based on” and that whereas the original claim language required that the value in a new connection setup attempt be at least in some respect impacted by (i.e., “based” on) the frequency parameter, the substitute claim removes this requirement. They concluded that this removal of a claim requirement can broaden the resulting amended claim, because it is conceivable there could be embodiments that would come within the scope of substitute claim 36 but would not have infringed original claim 10, citing Pannu v. Storz Instruments, Inc., 258 F.3d 1366, 1371 (Fed. Cir. 2001) (“A reissue claim that does not include a limitation present in the original patent claims is broader in that respect.”).
Take aways:
- The Phillips standard is reiterated with the Court finding that even general disclosures within a specification (i.e. not supported by any embodiments) will provide sufficient intrinsic evidence that a skilled artisan will be considered to interpret the claim language to encompass the general disclosures.
- Drafting claim amendments in a post-grant proceeding at the USPTO must be done with extreme care. Any logically conceivable interpretation of the amendment whereby embodiments would come within the scope of substitute claim but would not have infringed the original claim will be considered broadening.
