Do not omit an “essential element” of the original invention in the reissue claims
| August 29, 2023
In Re: FloatʻN’Grill LLC
Decided: July 12, 2023
Before Linn (author), Prost, and Cunningham
Summary:
When FloatʻN’Grill LLC filed a reissue application, they deleted an essential part of the original disclosure from reissue claims. The PTAB rejected those claims for failure to satisfy the original patent requirement of § 251. The CAFC affirmed the PTAB’s decision.
Details:
FloatʻN’Grill LLC (“FNG”) appeals from the decision of the PTAB affirming the Examiner’s rejection under 35 U.S.C. §§112(b) and 251 of claims 4, 8, 10-14, and 17-22 of FNG’s application for reissue of its U.S. Patent No. 9,771,132 (“’132 patent”).
The ’132 patent
The ’132 patent is directed to a float designed to support a grill (76) so that a user can grill food in a body of water.
A floating apparatus (10) includes a float (20), a pair of grill supports (46 and 48), and an upper support (52). Each of the grill supports includes a plurality of magnets (60) disposed within a middle segment (58) of the upper support (52) of each grill support (46 and 48).
In particular, the specification states: “A flattened bottom side 74 of a portable outdoor grill 76 is removably securable to the plurality of magnets 60 and removably disposed immediately atop the upper support 52 of each” of the grill supports.” The specification does not disclose, suggest, or imply any other structures besides the plurality of magnets for removably securing the grill to the supports.
Independent claim 1 is a representative claim:
1. A floating apparatus for supporting a grill comprising. . .
. . .
a plurality of magnets disposed within the middle segment of the upper support of each of the right grill support and the left grill support . . .
. . .
wherein a flattened bottom side of a portable outdoor grill is removably securable to the plurality of magnets and removably disposed immediately atop the upper support of each of the right grill support and the left grill support.
Reissue Application
After the ’132 patent was issued, FNG filed a reissue application. However, none of the claims in the reissue application recites “the plurality of magnets” limitations. Rather, the claims recite the feature regarding the removable securing of a grill to the floating apparatus.
Independent claim 4 is a representative claim in the reissue application:
4. A floating grill support apparatus adapted to support a grill on water, the apparatus comprising:
a float having an outer rim wherein the float is buoyant and adapted to float in water and support a grill above the water; and
at least one base rod disposed within the outer rim wherein the base rod comprises a grill support member;
wherein the grill support member has an upper support portion;
wherein a bottom side of the grill is removably securable and removably disposed immediately atop the upper support portion of the grill support member.
The Examiner rejected the claims for failure to satisfy the reissue standard of 35 U.S.C. §251.
The Examiner indicated that the ’132 patent disclosed “a single embodiment of a floating apparatus for supporting a grill” using a “plurality of magnets” and did not disclose the plurality of magnets as being “an optional feature of the invention.” In addition, the Examiner indicated that the magnets are a critical element of the invention because the magnets alone are responsible for a safe and stable attachment between the floating apparatus and the grill.
The Examiner noted that since some claims in the reissue application do not require any magnets, require only a single magnet, and do not positively recite any magnets, they do not satisfy the original patent requirement of §251.
The PTAB
The PTAB maintained all the Examiner’s rejection.
The CAFC
The CAFC reviewed de novo.
The CAFC emphasized that for a reissue application, there is an additional statutory limitation in 35 U.S.C. §251 for a patentee seeking to change the scope of the claims through reissue – the “original patent” requirement of §251 (the reissue claims must be directed to “the invention disclosed in the original patent”).
The CAFC noted that the focus of the §251 analysis is on the invention disclosed in the original patent and whether that disclosure, on its face, explicitly and unequivocally described the invention as recited in the reissue claims.
The CAFC agreed with the PTAB that the reissue claims in this case are not directed to the invention disclosed in the original patent and, therefore, do not meet the original patent requirement of § 251.
The CAFC noted that the original specification describes a single embodiment of the invention characterized as a floating apparatus having a grill support including a plurality of magnets for safely and removably securing the grill to the float.
The CAFC held that the plurality of magnets component of the grill support structure are removed from the reissue claims, and that the original patent disclosure does not disclose these structures as optional. Also, the CAFC noted that the original patent disclosure does not provide any examples of alternative components or arrangements that might perform the functions of the plurality of magnets.
Therefore, the CAFC found that the plurality of magnets are essential parts of the invention because they are only disclosed structures for performing the task of removably and safely securing the grill to the float apparatus.
Accordingly, the CAFC held that the PTAB did not err in affirming the rejection of reissue claims for failure to satisfy the original patent requirement of § 251.
Takeaway:
- If Applicant would like to broaden the scope of the original invention, file a continuation or divisional application during the pendency of a parent application.
- Make sure that do not omit an “essential element” of the original invention in the reissue claims.
- Add more boilerplate statements and additional embodiments in the original application so that the broader reissue claims could be saved.
Tags: 35 U.S.C. § 251 > continuation application > divisional application > original patent requirement > Reissue application
Federal Circuit Affirms Alice Nix of Poll-Based Networking System
| August 10, 2023
Trinity Info Media v Covalent, Inc.
Decided: July 14, 2023
Before Stoll, Bryson and Cunningham.
Summary:
The Federal Circuit affirmed patent ineligibility of the Trinity’s poll-based networking system under Alice. The claims are directed to the abstract idea of matching based on questioning, something that a human can do. The additional features of a data processing system, computer system, web server, processor(s), memory, hand-held device, mobile phone, etc. are all generic components providing a technical environment for performing the abstract idea and do not detract from the focus of the claims being on the abstract idea. The specification also does not support a finding that the claims are directed to a technological improvement in computers, mobile phones, computer systems, etc.
Procedural History:
Trinity sued Covalent for infringing US Patent Nos. 9,087,321 and 10,936,685 in 2021. The district court granted Covalent’s 12(b)(6) motion to dismiss, concluding that the asserted claims are not patent eligible subject matter under 35 USC §101. Trinity appealed.
Decision:
Representative claim 1 from the ‘321 patent is as follows:
A poll-based networking system, comprising:
a data processing system having one or more processors and a memory, the memory being specifically encoded with instructions such that when executed, the instructions cause the one or more processors to perform operations of:
receiving user information from a user to generate a unique user profile for the user;
providing the user a first polling question, the first polling question having a finite set of answers and a unique identification;
receiving and storing a selected answer for the first polling question;
comparing the selected answer against the selected answers of other users, based on the unique identification, to generate a likelihood of match between the user and each of the other users; and
displaying to the user the user profiles of other users that have a likelihood of match within a predetermined threshold.
Representative claim 2 from the ‘685 patent is as follows:
A computer-implemented method for creating a poll-based network, the method comprising an act of causing one or more processors having an associated memory specifically encoded with computer executable instruction means to execute the instruction means to cause the one or more processors to collectively perform operations of:
receiving user information from a user to generate a unique user profile for the user;
providing the user one or more polling questions, the one or more polling ques-tions having a finite set of answers and a unique identification;
receiving and storing a selected answer for the one or more polling questions;
comparing the selected answer against the selected answers of other users, based on the unique identification, to generate a likelihood of match between the user and each of the other users;
causing to be displayed to the user other users, that have a likelihood of match within a predetermined threshold;
wherein one or more of the operations are carried out on a hand-held device; and
wherein two or more results based on the likelihood of match are displayed in a list reviewable by swiping from one result to another.
Looking at the claims first, the claimed functions of (1) receiving user information; (2) providing a polling question; (3) receiving and storing an answer; (4) comparing that answer to generate a “likelihood of match” with other users; and (5) displaying certain user profiles based on that likelihood are all merely collecting information, analyzing it, and displaying certain results which fall in the “familiar class of claims ‘directed to’ a patent ineligible concept,” which a human mind could perform. The court agreed with the district court’s finding that these claims are directed to an abstract idea of matching based on questioning.
The ‘685 patent adds the further function of reviewing matches using swiping and a handheld device. These features did not alter the court’s decision. The dependent claims also added other functional variations, such as performing matching based on gender, varying the number of questions asked, displaying other users’ answers, etc. These are all trivial variations that are themselves abstract ideas. The further recitation of the hand-held device, processors, web servers, database, and a “match aggregator” did not change the “focus” of the asserted claims. Instead, such generic computer components were merely limitations to a particular environment, which did not make the claims any less abstract for the Alice/Mayo Step 1.
With regard to software-based inventions, the Alice/Mayo Step 1 inquiry “often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool.” In addressing this, the court looks at the specification’s description of the “problem facing the inventor.” Here, the specification framed the inventor’s problem as how to improve existing polling systems, not how to improve computer technology. As such, the specification confirms that the invention is not directed to specific technological solutions, but rather, is directed to how to perform the abstract idea of matching based on progressive polling.
Under Alice/Mayo Step 2, the claimed use of general-purpose processors, match servers, unique identifications and/or a match aggregator is merely to implement the underlying abstract idea. The specification describes use of “conventional” processors, web servers, the Internet, etc. The court has “ruled many times” that “invocations of computers and networks that are not even arguably inventive are insufficient to pass the test of an inventive concept in the application of an abstract idea.” And, no inventive concept is found where claims merely recite “generic features” or “routine functions” to implement an underlying abstract idea.
Trinity’s Argument 1
Claim construction and fact discovery was necessary, but not done, before analyzing the asserted claims under §101.
Federal Circuit’s Response 1
“A patentee must do more than invoke a generic need for claim construction or discovery to avoid grant of a motion to dismiss under § 101. Instead, the patentee must propose a specific claim construction or identify specific facts that need development and explain why those circumstances must be resolved before the scope of the claims can be understood for § 101 purposes.”
Trinity’s Argument 2
Under Alice/Mayo Step One, the claims included an “advance over the prior art” because the prior art did not carry out matching on mobile phones, did not employ “multiple match servers” and did not employ “match aggregators.”
Federal Circuit’s Response 2
A claim to a “new” abstract idea is still an abstract idea.
Trinity’s Argument 3
Humans cannot mentally engage in the claimed process because humans could not perform “nanosecond comparisons” and aggregate “result values with huge numbers of polls and members” nor could humans select criteria using “servers, storage, identifiers, and/or thresholds.”
Federal Circuit’s Response 3
The asserted claims do not require “nanosecond comparisons” nor “huge numbers of polls and members.”
Trinity’s claims can be directed to an abstract idea even if the claims require generic computer components or require operations that a human cannot perform as quickly as a computer. Compare, for example, with Electric Power Group, where the court held the claims to be directed to an abstract idea even though a human could not detect events on an interconnected electric power grid in real time over a wide area and automatically analyze the events on that grid. Likewise, in ChargePoint (electric car charging network system), claims directed to enabling “communication over a network” were abstract ideas even though a human could not communicate over a computer network without the use of a computer.
Trinity’s Argument 4
Claims are eligible inventions directed to improvements to the functionality of a computer or to a network platform itself.
Federal Circuit’s Response 4
As described in the specification, mere generic computer components, e.g., a conventional computer system, server, web server, data processing system, processors, memory, mobile phones, mobile apps, are used. Such generic computer components merely provide a generic technical environment for performing an abstract idea. The specification does not describe the invention of swiping or improving on mobile phones. Indeed, the ‘685 patent describes the “advent of the internet and mobile phones” as allowing the establishment of a “plethora” or “mobile apps.” As such, “the specification does not support a finding that the claims are directed to a technological improvement in computer or mobile phone functionality.”
Trinity’s Argument 5
The district court failed to properly consider the comparison of selected answers against other uses “based on the unique identification” which was a “non-traditional design” that allowed for “rapid comparison and aggregation of result values even with large numbers of polls and members.”
Federal Circuit’s Response 5
Use of a “unique identifier” does not render an abstract idea any less abstract.
On the other hand, the “non-traditional design” appears to be based on use of an “in-memory, two-dimensional array” that “provides for linear speed across multiple match servers” and permits “an immediate comparison to determine if the user had the same answer to that of another user.” However, the asserted claims do not require any such in-memory, two-dimensional array.
Trinity’s Argument 6
The district court failed to properly consider the generation of a likelihood of a match “within a predetermined threshold.” Without this consideration, “there would be no limit or logic associated with the volume or type of results a user would receive.”
Federal Circuit’s Response 6
This merely addresses the kind of data analysis that the abstract idea of matching would include, namely how many answers should be the same before declaring a match. This does not change the focus of the claimed invention from the abstract idea of matching based on questioning.
Trinity’s Argument 7
There is an inventive concept under Alice/Mayo Step 2 because the claims recite steps performed in a “non-traditional system” that can “rapidly connect multiple users using progressive polling that compare[s] answers in real time based on their unique identification (ID) (and in the case of the ’685 patent employ swiping)” which “represents a significant advance over the art.”
Federal Circuit’s Response 7
These conclusory assertions are insufficient to demonstrate an inventive concept. “We disregard conclusory statements when evaluating a complaint under Rule 12(b)(6).”
Takeaways:
The evisceration of software-related inventions as abstract ideas continues. Although the court looks at the “claimed advance over the prior art” in assessing the “directed to” inquiry under Alice Step 1, conclusory assertions of advances over the prior art are insufficient to demonstrate inventive concept under Alice Step 2, at least for a 12(b)(6) motion to dismiss. It remains to be seen what type of description of an “advance over the prior art” would not be “conclusory” and satisfy the “significantly more” inquiry to be an inventive concept under Alice Step 2.
The one glimmer of hope for the patentee might have been the use of an “in-memory, two-dimensional array” that “provides for linear speed across multiple match servers.” An example of patent eligibility based on use of such logical structures can be found in Enfish. However, if the specification does not describe this use of an in-memory two-dimensional array and the “technological” improvement resulting therefrom to be the “focus” of the invention, even this feature might not be enough to survive § 101.
Claim Construction Should be Well-Grounded in Intrinsic Evidence
| August 3, 2023
MEDYTOX, INC. v. GALDERMA S.A.
Decided: June 27, 2023
Before DYK, REYNA, and STARK, Circuit Judges.
Summary
The CAFC upheld a decision by the PTAB in a post-grant review involving a patent for a botulinum toxin treatment. The patent owner attempted to replace original claims with substitute claims was rejected by the Board, leading to the cancellation of the original claims and the finding that the substitute claims were unpatentable. The court affirmed the Board’s decision, emphasizing the challenges of amending claims in post-grant proceedings.
Background
Medytox owns U.S. Patent No. 10,143,728 (‘728 patent), issued in December 2018, which is directed to a method that uses an animal-protein-free botulinum toxin composition for cosmetic and non-cosmetic applications. Galderma filed a petition for post-grant review (PGR) proceedings at the PTAB to challenge the validity of ‘728 patent claims.
During the PGR proceedings, Medytox attempted to modify all 10 claims of its ‘728 patent and obtained initial feedback on proposed substitute claims under the PTAB’s amendment motion pilot program. The PTAB’s preliminary guidance revealed that Medytox did not meet the statutory requirements for submitting an amendment motion. However, the board acknowledged that the new phrase claiming “a responder rate at 16 weeks after the first treatment of 50% or greater” neither introduced new matter nor suggested a range of responder rates. Despite this, Galderma opposed Medytox’s substitute claims, arguing that the ‘728 patent’s specification only revealed responder rates up to 62% in clinical trials, whereas Medytox’s claim language encompassed a range of responder rates from 50% to 100%.
Contrary to its initial guidance, the PTAB issued a final written decision in the PGR proceedings, ruling that the substitute claims introduced new matter regarding to the responder rate limitation. Medytox asserted that the 50% responder rate was claimed as a minimum threshold and not a range. Nevertheless, the PTAB found the substitute claim language to be invalid for indefiniteness after reviewing the complete record, as “a skilled artisan would not have been able to achieve higher responder rates under the guidance provided in the specification without undue experimentation.” Ultimately, the Board cancelled the original claims 1-5 and 7-10 and also found that the substitute claims to be unpatentable.
Below, substitute claim 19 is provided as a representative of the substitute claims.
19. A method for treating glabellar lines
a conditionin a patient in need thereof, comprising:locally administering a first treatment of
therapeutically effective amount ofa botulinum toxin composition comprising a serotype A botulinum toxin in an amount pre-sent in about 20 units of MT10109L, a first stabilizer comprising a polysorbate, and at least one additional stabilizer, and that does not comprise an animal-derived product or recombinant human albumin;locally administering a second treatment of the botulinum toxin composition at a time interval after the first treatment;
wherein said time interval is the length of effect of the serotype A botulinum toxin composition as determined by physician’s live assessment at maximum frown;
wherein said botulinum toxin composition has a greater length of effect compared to about 20 units of BOTOX®, when
whereby the botulinum toxin composition exhibits a longer lasting effect in the patient when com-pared to treatment of the same condition with a botulinum toxin composition that contains an animal-derived product or recombinant human albumin dosed at a comparable amount andadministered in the same manner for the treatment of glabellar linesand to the same locations(s)as that of the botulinum toxin composition; andwherein said greater length of effect is determined by physician’s live assessment at maximum frown and requires a responder rate at 16 weeks after the first treatment of 50% or greater.
that does not comprise an animal-derived product or recombinant human albumin, wherein the condition is selected from the group consisting of glabellar lines, marionette lines, brow furrows, lateral canthal lines, and any combination thereof.
Discussion
The key issues in the case were the responder rate limitation and whether the substitute claims contained new matter not found in the patent specification. The responder rate limitation referred to the proportion of patients who responded favorably to the treatment with Medytox’s animal-protein-free botulinum toxin composition. In the appeal, Medytox contested the Board’s findings on claim construction, new matter, written description, and enablement, as well as the Board’s Pilot Program on amending practice and procedure under the Administrative Procedure Act.
The Board’s interpretation of the responder rate limitation as a range was the first issue addressed. Medytox argued that the responder rate limitation should be viewed as a binary (“yes-or-no”) inquiry, serving as a “threshold” for determining whether the animal protein-free composition has a more extended effect than BOTOX®.
According to Galderma, Medytox failed to cite intrinsic evidence supporting its suggested claim construction. Galderma also asserts that Medytox did not propose its “minimum threshold” interpretation of the responder rate limitation until after the Preliminary Guidance was released. Medytox did not substantively counter Galderma’s claim but instead insisted that extrinsic evidence supports their claim construction.
The court upheld the Board’s decision and noted that it is typically considered that intrinsic evidence, such as the specification and the prosecution history, is the most crucial consideration in a claim construction analysis. The court cited the U.S. Supreme Court’s recent landmark decision in Amgen v. Sanofi (2023) when nixing Medytox’s challenge to the PTAB’s lack of enablement determination. Under Amgen, “[t]he more one claims, the more one must enable,” and the court noted that data tables included with the ‘728 patent’s specification only disclosed responder rates of 52%, 61% and 62%. While the parties do not substantially dispute the responder rate limitation as a “threshold” or “range,” the Board’s construction of the responder rate limitation as a range in the substitute claims was ultimately affirmed.
Furthermore, the court concluded that the Board’s change in claim construction between its Preliminary Guidance and final written decision was not arbitrary and capricious and did not violate due process or the Administrative Procedure Act (APA). The court emphasized that the Board’s Preliminary Guidance, as indicated in its statement, is “initial, preliminary, [and] non-binding”, and only provides initial views on whether the patent owner has demonstrated a reasonable likelihood of meeting the requirements for filing an amendment motion. The court cited previous rulings which state that the Board must reevaluate matters based on the full record, especially when the standard changes, and that it is encouraged to modify its viewpoint if further development of the record necessitates such a change. Therefore, the Board’s decision to alter its claim construction for the responder rate limitation was not deemed arbitrary and capricious.
Takeaway
- The evolution of the record over the course of a proceeding can significantly impact the outcome, necessitating adjustments in views and decisions as the evidence develops.
- Arguments related to claim construction should be well-grounded in the intrinsic evidence, which includes the specification and the prosecution history, as these are typically the most important considerations in claim construction.
- Claims should be well-grounded in the specification.
UNEXPECTED RESULTS VERSUS UNEXPECTED MECHANISM
| July 28, 2023
In Re: John L Couvaras
Decided June 14, 2023
Before Lourie, Dyk and Stoll.
Summary
This precedential decision serves as a good lesson on what is necessary to overcome an obviousness rejection based on unexpected results. The applicant in this decision, however, failed to overcome the rejection due to arguing an unexpected mechanism instead of unexpected results.
Background
The applicant appeals a decision from the Patent Trial and Appeal Board (PTAB) affirming the Examiner’s rejection of the pending claims as obvious over prior art. Representative claim 11 recites:
11. A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:
providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;
providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;
delivering the composition to the human individual’s circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;
synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and
activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and
relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release. (emphasis added).
The applicant had conceded during prosecution that GABA-a agonists and ARBs had been known as essential hypertension treatments for many decades. The Examiner agreed and found that the claimed results (increased release of prostacyclin; activating the uninhibited GABA-a receptors; relaxing smooth muscle of the systemic blood vessels) were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.
On appeal to the PTAB, the applicant asserted that the prostacyclin increase was unexpected and that objective indicia had overcome any existing prima facie case of obviousness. The PTAB affirmed the rejection, holding that the claimed result of an increased prostacyclin release was inherent, and that the objective indicia arguments did not overcome the rejection because no evidence existed to support a finding of objective indicium.
Discussion
The PTAB’s legal determination is reviewed de novo, and the factual findings are reviewed for substantial evidence.
Couvaras asserts that (1) the Board erred in affirming that motivation to combine the art applied by the Examiner, (2) that the claimed mechanism of action was unexpected in that the Board erred in discounting its patentable weight by deeming it inherent, and (3) that the Board erred in weighing objective indicia of nonobviousness.
1. Motivation to Combine
As explained by the Examiner and affirmed by the Board, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” Couvaras asserted that the Board’s reasoning was too generic. However, it is undisputed that the antihypertensive agents recited in the claims existed and were known to treat hypertension.
Couvaras also asserted that even if there had been a motivation to combine, such motivation would fail to identify a finite number of identified, predicted solutions. The CAFC dismissed this argument because (1) it was made in a footnote and thus waived, (2) there was no evidence presented regarding a “substantial number of hypertension treatment agent classes”, and (3) the Board’s conclusion was supported by substantial evidence.
Regarding a reasonable expectation of success, Couvaras did not present any arguments against the Examiner’s findings when the rejection was appealed.
2. Unexpected Mechanism of Action
Couvaras contends that because the increased prostacyclin release was unexpected, it cannot be dismissed as having no patentable weight due to inherency, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A.,865 F.3d 1348, 1355 (FED. Cir. 2017). This decision, however, held that unexpected properties may cause what may appear to be an obvious composition to be nonobvious, not that the unexpected mechanisms of action must be found to make the known use of known compounds nonobvious. As stated in the opinion:
We have previously held that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) (citation omitted); see also In re Huai-Hung Kao, 639 F.3d 1057, 1070–71 (Fed. Cir. 2011) (holding that a “food effect” was obvious because the effect was an inherent property of the composition). While mechanisms of action may not always meet the most rigid standards for inherency, they are still simply results that naturally flow from the administration of a given compound or mixture of compounds. Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.”
3. Weighing objective indicia of nonobviousness
To establish unexpected results, Couvaras needed to show that the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages. The CAFC agreed with the Board that no such benefits have been shown, and therefore no evidence of unexpected results exists.
Takeaways
- Evidence needs to be presented to rebut a prima facie rejection. It seems that the applicant was attempting to assert that the combined use of the 2 agents provided unexpected results (better than what would be expected) based on synergy. As set forth in MPEP 716.02, greater than expected results are evidence of nonobviousness.
MPEP 716.02(a)
Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating “synergism”). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).
It seems that no evidence was presented to support the applicant’s argument of synergy. In reviewing the prosecution history, there were two interviews with the primary Examiner, one of which also included the Supervisory Examiner (SPE)[1]. In the interview summary, the Examiners indicated that the claims were too broad in that there were no amounts recited, no dose regime and/or no specific agents recited. It seems that a successful outcome could have been possible if evidence had been presented which was commensurate in scope with the claims.
- Once an Examiner establishes a prima facie rejection, the burden shifts to the applicant to prove otherwise.
[1] It is never a good idea to call on the SPE to attend an interview with a Primary Examiner. This not only angers a Primary Examiner but also the SPE.
THE MORE YOU CLAIM, THE MORE YOU MUST ENABLE
| July 12, 2023
Amgen Inc. v. Sanofi
Decided: May 18, 2023
Supreme Court of the United States. Opinion by Justice Gorsuch
Summary:
Amgen owns patents covering antibodies that help reduce levels of low-density lipoprotein (LDL) cholesterol. Amgen sued Sanofi for infringement of its patents in district court. Sanofi raised the defense of invalidity for lack of enablement because while Amgen provided amino acid sequences for 26 antibodies, the claims cover potentially millions more undisclosed antibodies. The district court granted a motion for JMOL for invalidity due to lack of enablement, the CAFC affirmed, and the Supreme Court affirmed.
Details:
Amgen’s patents are to PCSK9 inhibitors. PCSK9 is a naturally occurring protein that binds to and degrades LDL receptors. PCSK9 causes problems due to degradation of LDL receptors because LDL receptors extract LDL cholesterol from the bloodstream. A method used to inhibit PCSK9 is to create antibodies that bind to a particular region of PCSK9 referred to as the “sweet spot” which is a sequence of 15 amino acids out of PCSK9’s 692 total amino acids. An antibody that binds to the sweet spot can prevent PCSK9 from binding to and degrading LDL receptors. Amgen developed a drug named REPATHA and Sanofi developed a drug named PRALUENT, both of which provide a distinct antibody with its own unique amino acid sequence. In 2011, Amgen and Sanofi received patents covering the antibody used in their respective drugs.
The patents at issue are U.S. Patent Nos. 8,829,165 and 8,859,741 issued in 2014 which relate back to Amgen’s 2011 patent. These patents are different from the 2011 patents in that they claim the entire genus of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to LDL receptors.” The relevant claims are provided:
Claims of the ‘165 patent:
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.
19. The isolated monoclonal antibody of claim 1 wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3.
29. A pharmaceutical composition comprising an isolated monoclonal antibody, wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO: 3 and blocks the binding of PCSK9 to LDLR by at least 80%.
Claims of the ‘741 patent:
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.
2. The isolated monoclonal antibody of claim 1, wherein the isolated monoclonal antibody is a neutralizing antibody.
7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.
In its application, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. Amgen provided two methods to make other antibodies that perform the described binding and blocking functions. Amgen refers to the first method as the “roadmap,” which provides instructions to:
(1) generate a range of antibodies in the lab; (2) test those antibodies to determine whether any bind to PCSK9; (3) test those antibodies that bind to PCSK9 to determine whether any bind to the sweet spot as described in the claims; and (4) test those antibodies that bind to the sweet spot as described in the claims to determine whether any block PCSK9 from binding to LDL receptors.
Amgen refers to the second method as “conservative substitution” which provides instructions to:
(1) start with an antibody known to perform the described functions; (2) replace select amino acids in the antibody with other amino acids known to have similar properties; and (3) test the resulting antibody to see if it also performs the described functions.
Amgen sued Sanofi for infringement of claims 19 and 29 of the ‘165 patent and claim 7 of the ‘741 patent. Sanofi raised the defense of invalidity because Amgen had not enabled a person skilled in the art to make and use all of the antibodies that perform the two functions Amgen described in the claims. Sanofi argued that Amgen’s claims cover potentially millions more undisclosed antibodies that perform the same two functions than the 26 antibodies identified in the patent.
The court provided an explanation of the law and policy regarding the enablement requirement. 35 U.S.C. § 112 requires that a specification include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art … to make and use the same.” The court stated:
the law secures for the public its benefit of the patent bargain by ensuring that, upon the expiration of [the patent], the knowledge of the invention [i]nures to the people, who are thus enabled without restriction to practice it.
The court stated that “the specification must enable the full scope of the invention as defined by its claims.” Specifically, the court stated:
If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.
The court emphasized that the enablement requirement does not always require a description of how to make and use every single embodiment within a claimed class. A few examples may suffice if the specification also provides “some general quality … running through” the class. A specification may also not be inadequate just because it leaves a skilled artisan to engage in some measure of adaptation or testing, i.e., a specification may call for a reasonable amount of experimentation to make and use a patented invention. “What is reasonable in any case will depend on the nature of the invention and the underlying art.”
Regarding this case, the court stated that while the 26 exemplary antibodies provided by Amgen are enabled by the specification, the claims are much broader than the specific 26 antibodies. And even allowing for a reasonable degree of experimentation, Amgen has failed to enable the full scope of the claims.
The court stated that Amgen seeks to monopolize an entire class of things defined by their function and that this class includes a vast number of antibodies in addition to the 26 that Amgen has described by their amino acid sequences. “[T]he more a party claims, the broader the monopoly it demands, the more it must enable.”
Amgen argued that the claims are enabled because scientists can make and use every undisclosed but functional antibody if they simply follow Amgen’s “roadmap” or its proposal for “conservative substitution.” The court stated that these instructions amount to two research assignments and that they leave scientists “forced to engage in painstaking experimentation to see what works.” The court referred to Amgent’s two methods as “a hunting license.”
Comments
The key takeaway from this case is that the broader your claims are, the more your specification must enable. If it is difficult to show enablement for every embodiment claimed, then make sure your specification describes some general quality throughout the class or genus. A reasonable amount of experimentation is permissible for enablement, but reasonableness will depend on the nature of the invention and the underlying art.
Joint Inventorship Gone Up In Smoke For Want of Significant Contribution
| June 16, 2023
HIP, INC. v. HORMEL FOODS CORPORATION
Decided: May 2, 2023
Before Lourie, Clevenger, and Taranto. Opinion by Lourie.
Summary
The CAFC held that an alleged inventor did not make a contribution sufficiently significant in quality to establish joint inventorship to an issued patent, where the alleged contributed concept was only minimally mentioned throughout the entirety of the patent document including the specification, drawings and claims.
Details
Hormel Foods Corporation (“Hormel”) owns U.S. Patent 9,980,498 (the “’498 patent”) relating to production of precooked bacon. While a traditional bacon producer would “precook” or prepare the bacon prior to sale by a certain type of oven, such as microwave or steam oven, the invention uses a two-step, hybrid oven system to improve the precooking process. FIG. 1, reproduced below, depicts a principle embodiment where a microwave oven 40 initially heats bacon so as to form a coating of melted fat around the meat piece, followed by a super heated steam oven 60 equipped with external steam source 61 for further cooking to a finishing temperature:
Per the ‘498 patent, the first step of forming the “fat barrier” protects the underlying meat from condensation and resulting dilution of flavor, whereas the second step using the external gas source prevents the oven’s internal surfaces from becoming hotter than the smoke point of bacon fat, which would otherwise cause off flavor of the resulting product.
The ’498 patent includes independent claims 1, 5 and 13, defining the inventive method using slightly different languages from each other. As relevant on appeal, claims 1 and 13 both recite a particular mode of cooking in the first step of the hybrid system as “preheating … with a microwave oven,” whereas claim 5 recites three alternative preheating techniques using a Markush language, “selected from the group consisting of a microwave oven, an infrared oven, and hot air.”
As part of its R&D efforts toward the improved precooking process, Hormel contacted Unitherm Food Systems, Inc. (“Unitherm”), now HIP, a manufacturer of cooking machinery such as industrial ovens. The parties jointly agreed to develop an oven to be used in a two-step cooking process. The alleged inventor in question, David Howard of Unitherm, was involved in those meetings and testing process where he allegedly disclosed an infrared heating concept to Hormel. As Hormel’s further R&D—including testing with their own facility instead of Unitherm’s facility—eventually led to the discovery of the inventive two-step process, Hormel filed for a patent. The resulting ’498 patent named four inventors, which did not include Howard.
HIP sued Hormel in the District Court for the District of Delaware, alleging that Howard was either the sole inventor or a joint inventor of the ’498 patent. HIP argued, among other things, that Howard contributed to preheating with an infrared oven, the concept recited in independent claim 5. The district court held that although Howard was not the sole inventor, his contribution of the infrared oven concept made him a joint inventor of the ’498 patent. Hormel appealed.
On appeal, Hormel argued, among other things,[1] that Howard was not a joint inventor because the infrared oven concept was well known, and his alleged contribution was insignificant in quality relative to the extent of the full invention.
Specifically, the joint inventorship issue was argued based on the three-part test set forth in Pannu v. Iolab Corp., 155 F.3d 1344, 1351. Under Pannu, to qualify as an additional joint inventor, one must have:
(1) contributed in some significant manner to the conception of the invention;
(2) made a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention; and
(3) did more than merely explain to the real inventors well-known concepts and/or the current state of the art.
Hormel asserted that Howard met none of the three factors, and HIP countered that each and every factor was met so as to establish joint inventorship.
The CAFC ultimately sided with Hormel. The CAFC focused its analysis on the second Pannu factor, noting specific circumstances:
- Small # of times mentioned in the specification: The alleged contribution, preheating with an infrared oven, is “mentioned only once in the … specification as an alternative heating method to a microwave oven.”
- Small # of times mentioned in the claims: The alleged contribution is “recited only once in a single claim” whereas the two other independent claims recite preheating with a microwave oven, with no mention of an infrared oven.
- Presence of a more significant alternative in the disclosure: The alternative to the alleged contribution, preheating with a microwave oven, “feature[s] prominently throughout the specification, claims, and figures.”
- Specification focused on the alternative: All the specific examples disclosed in the specification are limited to embodiments using preheating with a microwave oven.
- Drawings focused on the alternative: All the figures, including Figure 1 primarily depicting the operating principles of the claimed invention, are limited to embodiments based on preheating with a microwave oven.
Noting that the entirety of the ’498 patent disclosure supports insignificance in quality of the alleged contribution per the second part of Pannu test, the CAFC concluded that Howard did not qualify as a joint inventor. Lastly, the CAFC noted that there was no need to address the other Pannu factors “as the failure to meet any one factor is dispositive on the question of inventorship.”
Takeaway
This case provides a reminder of the role a patent disclosure may play in determining the question of joint inventorship. In particular, although the second Pannu factor requires the inventor’s contribution to be “not insignificant in quality” (emphasis added), in certain circumstances, the amount of mentions made of the alleged contributed concept in the patent, along with other considerations such as the primary focus of the patent as discerned from the entire disclosure, may influence the determination of joint inventorship.
[1] Hormel’s second main argument challenges insufficiency of corroboration of Howard’s testimony, the question rendered moot due to the decision on the significance of the alleged contribution.
CAFC upheld ITC’s ruling under the ‘Infrequently Applied’ Anderson two-step test regarding the enablement of open-ended ranges
| June 8, 2023
FS.com Inc. v. ITC and Corning Optical Corp.
Decided: April 20, 2023
Before Moore, Prost and Hughes. Opinion by Moore.
Summary:
Corning filed a complaint with the ITC alleging FS was violating §337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), (a.k.a ‘unfair import’) by importing high-density fiber optic equipment that infringed several of their patents – U.S. Patent Nos. 9,020,320; 10,444,456; 10,120,153; and 8,712,206. The patents relate to fiber optic technology commonly used in data centers.
The Commission ultimately determined that FS’ importation of the high-density fiber optic equipment violated §337 and issued a general exclusion order prohibiting the importation of infringing high-density fiber optic equipment and components thereof and a cease-and-desist order directed to FS.
Subsequently, FS appealed the Commission’s determination that the claims of the ’320 and ’456 patents are enabled and its claim construction of “a front opening” in the ’206 patent.
ISSUE 1: ENABLEMENT
FS challenges the Commission’s determination that claims 1 and 3 of the ’320 patent and claims 11, 12, 15, 16, and 21 of the ’456 patent are enabled. These claims recite, in part, “a fiber optic connection density of at least ninety-eight (98) fiber optic connections per U space” or “a fiber optic connection of at least one hundred forty-four (144) fiber optic connections per U space.” FS argued these open-ended density ranges are not enabled because the specification only enables up to 144 fiber optic connections per U space.
A patent’s specification must describe the invention and “the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same.” 35 U.S.C. § 112(a). To enable, “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.”
In determining enablement, the Commission applied the two-part standard set forth in Anderson Corp. v. Fiber Composites, LLC, 474 F.3d 1361 (Fed. Cir. 2007):
[O]pen-ended claims are not inherently improper; as for all claims their appropriateness depends on the particular facts of the invention, the disclosure, and the prior art. They may be supported if there is an inherent, albeit not precisely known, upper limit and the specification enables one of skill in the art to approach that limit.
Although the CAFC acknowledged that the Anderson test is infrequently applied, both FS and Corning agreed that the test governed their legal dispute. In applying this standard, the Commission determined the challenged claims were enabled because skilled artisans would understand the claims to have an inherent upper limit and that the specification enables skilled artisans to approach that limit.
The CAFC agreed, understanding the Commission’s opinion as determining there is an inherent upper limit of about 144 connections per U space. See Appellant’s Opening Br. at 51 (“The only potential finding by the Commission of an inherent upper limit to the open-ended claims is approximately 144 connections per 1U space.”). Specifically, that determination was based on the Commission’s finding that skilled artisans would have understood, as of the ’320 and ’456 patent’s shared priority date (August 2008), that densities substantially above 144 connections per U space were technologically infeasible. This was supported by expert testimony.
ISSUE 2: CLAIM CONSTRUCTION
The Commission construed “a front opening” in claim 14 of the ’206 patent as encompassing one or more openings. FS argued the proper construction of “a front opening” is limited to a single front opening and therefore its modules, which contain multiple openings separated by material or dividers, do not infringe claims 22 and 23. The CAFC disagreed.
The CAFC held that, generally, the terms “a” or “an” in a patent claim mean “one or more,” unless the patentee evinces a clear intent to limit “a” or “an” to “one.” 01 Communique Lab’y, Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012). The CAFC concluded here that the claim language and written description did not demonstrate a clear intent to depart from this general rule.
Comments:
- Open-end ranges are not automatically improper. If such a range is required/desired during prosecution, apply the two-part standard set forth in Anderson: (1) is there inherent, albeit not precisely known, support for an upper limit and (2) does the specification enables one of skill in the art to approach that limit.
- The terms “a” or “an” in a patent claim remain to mean “one or more,” unless the patentee evinces a clear intent to limit “a” or “an” to “one.”
File your patent application before attending a trade show to showcase your products
| May 26, 2023
Minerva Surgical, Inc. v. Hologic, Inc., Cytyc Surgical Products, LLC
Decided: February 15, 2023
Summary:
Minerva Surgical, Inc. sued Hologic, Inc. and Cytyc Surgical Products, LLC in the District of Delaware for infringement of U.S. Patent No. 9,186,208 (“the ’208 patent”). Hologic moved for summary judgment of invalidity, arguing that the ’208 patent claims were anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). The district court granted summary judgment that the asserted claims are anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b) because the patented technology was “in public use,” and the technology was “ready for patenting.” The Federal Circuit held that the district court correctly determined that Minerva’s disclosure of their constituted the invention being “in public use,” and that the device was “ready for patenting.” Therefore, the Federal Circuit affirmed the district court’s grant of summary judgment.
Details:
Minerva Surgical, Inc. sued Hologic, Inc. and Cytyc Surgical Products, LLC in the District of Delaware for infringement of U.S. Patent No. 9,186,208 (“the ’208 patent”).
The ’208 patent is directed to surgical devices for a procedure called “endometrial ablation” for stopping or reducing abnormal uterine bleeding. This procedure includes inserting a device having an energy-delivery surface into a patient’s uterus, expanding the surface, energizing the surface to “ablate” or destroy the endometrial lining of the patient’s uterus, and removing the surface.
The application for the’208 patent was filed on November 2, 2021 and claims a priority date of November 7, 2011. Therefore, the critical date for the ’208 patent is November 7, 2010.
The ’208 patent
Independent claim 13 is a representative claim:
A system for endometrial ablation comprising:
an elongated shaft with a working end having an axis and comprising a compliant energy-delivery surface actuatable by an interior expandable-contractable frame;
the surface expandable to a selected planar triangular shape configured for deployment to engage the walls of a patient’s uterine cavity;
wherein the frame has flexible outer elements in lateral contact with the compliant surface and flexible inner elements not in said lateral contact, wherein the inner and outer elements have substantially dissimilar material properties.
The appeal focused on the claim term, “the inner and outer elements have substantially dissimilar material properties” (“SDMP” term”).
District Court
After discovery, Hologic moved for summary judgment of invalidity, arguing that the ’208 patent claims were anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b).
The district court granted summary judgment that the asserted claims are anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b) because of the following reasons:
First, the patented technology was “in public use” because Minerva disclosed fifteen devices (“Aurora”) at an event, where Minerva showcased them at a booth, in meeting with interested parties, and in a technical presentation. Also, Minerva did not disclose them under any confidentiality obligations.
Second, the technology was “ready for patenting” because Minerva created working prototypes and enabling technical documents.
Federal Circuit
The Federal Circuit reviewed a district court’s grant of summary judgment under the law of the regional circuit (Third Circuit).
The Federal Circuit held that “the public use bar is triggered ‘where, before the critical date, the invention is [(1)] in public use and [(2)] ready for patenting.’”
The “in public use” element is satisfied if the invention “was accessible to the public or was commercially exploited” by the invention.
“Ready for patenting” requirement can be shown in two ways – “by proof of reduction to practice before the critical date” and “by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.”
The Federal Circuit held that disclosing the Aurora device at the event (American Association of Gynecologic Laparoscopists (“AAGL 2009”)) constituted the invention being “in public use” because this event included attendees who were critical to Minerva’s business, and Minerva’s disclosure of their devices included showcasing them at a booth, in meeting with interested parties, and in a technical presentation.
The Federal Circuit noted that AAGL 2009 was the “Super Bowl” of the industry and was open to the public, and that Minerva had incentives to showcase their products to the attendees. Also, Minerva sponsored a presentation by one of their board members to highlight their products and pitched their products to industry members, who were able to see how they operate.
The Federal Circuit also noted that there were no “confidentiality obligations imposed upon” those who observed Minerva’s devices, and that the attendees were not required to sign non-disclosure agreements.
The Federal Circuit also held that Minerva’s Aurora devices at the event disclosed the SDMP term because Minerva’s documentation about this device from before and shortly after the event disclosed this device having the SDMP terms or praises benefits derived from this device having the SDMP technology.
The Federal Circuit held that the record clearly showed that Minerva reduced the invention to practice by creating working prototypes that embodied the claim and worked for the intended purpose.
The Federal Circuit noted that there was documentation “sufficiently specific to enable a person skilled in the art to practice the invention” of the disputed SDMP term. Here, the documentation included the drawings and detailed descriptions in the lab notebook pages disclosing a device with the SDMP term.
Therefore, the Federal Circuit held that the district court correctly determined that Minerva’s disclosure of the Aurora device constituted the invention being “in public use” and that the device was “ready for patenting.”
Accordingly, the Federal Circuit affirmed the district court’s grant of summary judgment because there are no genuine factual disputes, and Hologic is entitled to judgment as a matter of law that the ’208 patent is anticipated under the public use bar of § 102(b).
Takeaway:
- File your patent application before attending a trade show to showcase your products.
- Have the attendees of the trade show sign non-disclosure agreements, if necessary.
Tags: 35 U.S.C. § 102(b) > confidentiality > critical date > enablement > pre-AIA > prototype > public use > reduction to practice > summary judgment
Common Sense Still Applies In Claim Construction
| May 13, 2023
Alterwan, Inc. v Amazon.com Inc
Decided: March 13, 2023
Before Lourie, Dyk, Stoll (Opinion by Dyk)
Summary:
For a claim term “non-blocking bandwidth,” the district court accepted the applicant-as-his-own-lexicographer definition set forth in the specification to mean “a bandwidth that will always be available and will always be sufficient.” This meant that bandwidth must be available even when the Internet is down – which is impossible (and hence, the parties’ agreed-upon stipulation of non-infringement with this claim interpretation). Courts will not rewrite “unambiguous” claim language to cure such absurd positions or to sustain validity. But, when the claim language is “not unambiguous” concerning the disputed interpretation, common sense applies in claim construction, especially in view of the proper context for the source of the applicant-as-his-own-lexicographer definition.
Procedural History:
Alterwan sued Amazon for patent infringement. After a Markman hearing and motions for summary judgment by both parties, the district court changed the claim construction for “cooperating service provider” at a summary judgment hearing to be a “service provider that agrees to provide non-blocking bandwidth.” The district court construed “non-blocking bandwidth” to be “a bandwidth that will always be available and will always be sufficient” which meant that the bandwidth will be available even if the Internet is down. With this updated construction, the parties filed a stipulation and order of non-infringement of the patents-in-suit. Amazon argued, and the patentee agreed, that if the claim required bandwidth provision even when the Internet is down, Amazon could not possibly infringe. The district court entered the stipulated judgment of non-infringement and the parties appealed.
Decision:
Representative claim 1 is as follows:
An apparatus, comprising:
an interface to receive packets;
circuitry to identify those packets of the received packets corresponding to a set of one or more predetermined addresses, to identify a set of one or more transmission paths associated with the set of one or more predetermined addresses, and to select a specific transmission path from the set of one or more transmission paths; and
an interface to transmit the packets corresponding to the set of one or more predetermined addresses using the specific transmission path;
wherein
each transmission path of the set of one or more transmission paths is associated with a reserved, non-blocking bandwidth, and
the circuitry is to select the specific transmission path to be a transmission path from the [sic] set of one or more transmission paths that corresponds to a minimum link cost relative to each other transmission path in the set of one or more transmission paths.
The specification states “the quality of service problem that has plagued prior attempts is solved by providing non-blocking bandwidth (bandwidth that will always be available and will always be sufficient)…” (USP 8,595,478, col. 4, line 66 to col. 5, line 2). Accordingly, “non-blocking bandwidth” was defined by the applicant, acting as his own lexicographer, to mean “a bandwidth that will always be available and will always be sufficient.”
Normally, “[c]ourts may not redraft claims, whether to make them operable or to sustain validity” (citing, Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004)). In Chef America, the claim limitation “heating the resulting batter-coated dough to a temperature in the range of about 400°F to 850°F” would lead to an absurd result in that the dough would be burnt. Instead, the limitation would be made operable if it recited heating the dough “at” a temperature in the range of about 400°F to 850°F. However, since the limitation at issue was unambiguous, the court declined to rewrite the claim to replace the term “to” with “at.”
However, the court noted that, “[h]ere, the claim language itself does not unambiguously require bandwidth to be available even when the Internet is inoperable.” So, “Chef America does not require us to depart from common sense in claim construction.” Without “unambiguous” claim language requiring the disputed interpretation (“a bandwidth that will always be available and will always be sufficient”), the court proceeded to check the context for the support for the disputed interpretation. That “context” included specification discussion of wide area network technology that uses the internet as a backbone, and several “quality of service” problems that arise from the use of the internet as a backbone, including latency problems in the delays for critical transmission packets getting from a source to a destination over that internet backbone. The patent’s solution was to provide “preplanned high bandwidth, low hop-count routing paths” between sites that are geographically separated. These preplanned routing paths are a “key characteristic that all species within the genus of the invention will share.” It is after this discussion that the specification then concludes “[i]n other words, the quality of service problem that has plagued prior attempts is solved by providing non-blocking bandwidth (bandwidth that will always be available and will always be sufficient) and predefining routes for the ’private tunnel’ paths between points on the internet…”
Providing bandwidth even with the Internet being down is an impossibility. The specification describes operability and transmission over the Internet as a backbone and is completely silent about provision of bandwidth when the Internet is unavailable. In context, the definitional sentence for “non-blocking bandwidth” is addressing the problem of latency (when the Internet is operational), rather than providing for bandwidth even when there is no Internet. The court’s decision does not opine on what the meaning of non-blocking bandwidth is, but holds that “it does not require bandwidth when the Internet is down.”
Takeaways:
The court will not redraft claim language during claim construction to maintain operability or sustain validity when the claim language is unambiguous. But, when the claim language is “not unambiguous,” common sense applies, especially when looking at any source of the disputed interpretation in context.
What’s the Problem? CAFC reverses PTAB for identifying the problem to be solved in finding combined references analogous when the burden was properly on the Petitioner
| May 11, 2023
Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc.
Decided: May 9, 2023
Before Reyna, Mayer and Cunningham. Opinion by Cunningham.
Summary:
The Court reverses a PTAB final written decision finding all challenged claims of Safoni’s patent unpatentable as obvious over prior art. The Court held that Mylan improperly argued a first prior art reference is analogous to another prior art reference and not the challenged patent. Therefore Mylan failed to meet its burden to establish obviousness premised on the first reference since the Board’s factual finding that the first reference is analogous to the patent-in-suit is unsupported by substantial evidence.
Background:
Mylan filed an IPR against Sanofi’s RE47,614 (“the ‘614 patent”) alleging its unpatentability in light of a combination of three prior art references: (1) U.S. Patent Application No. 2007/0021718 (“Burren”); (2) U.S. Patent No. 2,882,901 (“Venezia”); and (3) U.S. Patent No. 4,144,957 (“de Gennes”). Claim 1 of the ‘614 patent is directed to a drug delivery device with a spring washer arranged within a housing so as to exert a force on a drug carrying cartridge and to secure the cartridge against movement with respect to a cartridge retaining member, the spring washer has at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.
Mylan asserted that Burren with Venezia taught the use of spring washers within drug-delivery devices and relied on de Gennes to add “snap-fit engagement grips” to secure the spring washer. Burren and Venezia were both within the field of a drug delivery system. However, de Gennes was non-analogous art being directed to a clutch bearing in the automotive field. Sanofi argued that the combination was improper because de Gennes was non-analogous art. Mylan responded that de Gennes was analogous in that it was relevant to the pertinent problem in the drug delivery art and cited to Burren as providing a problem which a skilled artisan may look to extraneous art to solve.
The PTAB found that Burren in combination with Venezia and de Gennes does render the challenged claims unpatentable relying on the “snap-fit connection” of de Gennes as equivalent to the “fixing elements” of the ’614 patent. Sanofi appealed.
Discussion:
In its appeal, Sanofi argued that the PTAB “altered and extended Mylan’s deficient showing” by analyzing whether de Gennes constitutes analogous art to the ’614 patent when Mylan, the petitioner, only presented its arguments with respect to Burren (i.e. other prior art). Mylan countered that the Board had found de Gennes as analogous art because there was “no functional difference between the problem of Burren and the problem of the ‘614 patent.”
In its review of the law governing whether prior art is analogous, the CAFC noted that “we have consistently held that a patent challenger must compare the reference to the challenged patent” and, citing precedent, noted that the proper test is whether prior art is “reasonably pertinent to the particular problem with which the inventor is involved.” The CAFC expanded thereon stating:
Mylan’s arguments would allow a challenger to focus on the problems of alleged prior art references while ignoring the problems of the challenged patent. Even if a reference is analogous to one problem considered in another reference, it does not necessarily follow that the reference would be analogous to the problems of the challenged patent…[broad construction of analogous art]… does not allow a fact finder to focus on the problems contained in other prior art references to the exclusion of the problem of the challenged patent.
The Court re-emphasized that the petitioner has the burden of proving unpatentability and that they have reversed the Board’s patentability determination where a petitioner did not adequately present a motivation to combine.
Conclusion:
The CAFC concluded that the Board’s decision did not interpret Mylan’s obviousness argument as asserting de Gennes was analogous to the ’614 patent, but rather improperly relied on de Gennes being analogous to the primary reference, Burren. As such, Mylan did not meet its burden to establish obviousness premised on de Gennes; and therefore, the Board’s factual finding that de Gennes is analogous to the ’614 patent is unsupported by substantial evidence. The Court reversed the finding of obviousness.
Take away:
- Relying on non-analogous art to support an obviousness contention requires looking at the problems the inventor of the patent-in-issue would find pertinent not those set forth in other relied upon prior art. Arguments that a problem solved by non-analogous art should focus on the inventor of the patent-in-issue as recognizing the problem to be solved not generally problems recognized in the art.
- Petitioner’s in IPRs should be cautious relying on the PTAB formulating an argument outside of those clearly set forth in their filings. Extrapolation of Petitioner’s arguments by the PTAB can open the possibility of a reversal based on lack of substantial evidence.
