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Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

In an appeal from a Patent Trial & Appeal Board finding of invalidity, the US Court of Appeals for the Federal Circuit held that the result-effective variable doctrine can apply even when there is no overlap between a claimed range and a prior art range. The Court also held that before denying a motion to amend, the Board must address every element of proposed claims, and that a party cannot challenge the US Patent & Trademark Office (PTO) Director Review procedure if it cannot show prejudice. Pfizer Inc. v. Sanofi Pasteur, Inc., Case No. 19-1871 (Fed. Cir. Mar. 5, 2024), (Lourie, Bryson, Stark, JJ.)

Sanofi filed five inter partes review (IPR) petitions targeting a patent owned by Pfizer and directed to immunogenic glycoconjugates of Streptococcus antigens (i.e., combinations of sugar molecules found on the surface of Streptococcus bacteria capable of provoking an immune response). The challenged independent claim recited conjugates having a sugar from the 22F Streptococcus serotype and a molecular weight falling within a claimed range. Dependent claims further limited the independent claim by requiring combinations of specific sugars.

Sanofi challenged the claims based on a combination of two references: GSK-711 and Merck-086. GSK-711 described vaccines using sugars from 22F, and Merck-086 described immunogenic compositions using Streptococcus sugar conjugates. While neither reference disclosed the molecular weight of a 22F conjugate, the Board found that the molecular weight of a conjugate was a “result-effective variable” – i.e., a variable that affected the efficacy of the result – and thus it would have been obvious for a person of ordinary skill in the art (POSITA) to optimize the molecular weight of a 22F-based conjugate to achieve the claimed molecular weight range. The Board also found that the dependent claims would have been obvious, as GSK-711 disclosed the additionally claimed sugars. Pfizer filed a motion to amend to add new claims, but the Board denied the motion. Pfizer also requested Director Review of the Board’s decision, but the Director denied the request.

Pfizer appealed to the Federal Circuit alleging that the Board improperly applied the result-effective variable doctrine, that the Board improperly denied Pfizer’s request to amend the claims, and that the Director’s denial of review violated the Administrative Procedure Act (APA). The Federal Circuit affirmed the Board’s finding of invalidity, affirmed in part and remanded in part the issue of the proposed claim amendment, and finally held that any violation of the APA was harmless.

The Federal Circuit started with an analysis of the result-effective variable doctrine. Pfizer argued that the result-effective variable doctrine could not apply when there was no disclosure of an effective range in the prior art. Therefore, because neither GSK-711 nor Merck-086 disclosed an effective molecular weight range for a 22F conjugate, and because the relationship between molecular weight and efficacy was unpredictable, the independent claim was not obvious. The Court disagreed.

The Federal Circuit explained that, when there is a gap between the prior art and the claims, the relevant [...]

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That’s So Metal: Narrow Limitation Doesn’t Contradict Broader One

The US Court of Appeals for the Federal Circuit reversed a district court’s indefiniteness determination, finding that two claim limitations – one broad and one narrow – were not contradictory since it was possible to meet the requirements of both. Maxell, Ltd. v. Amperex Technology Limited, Case No. 23-1194 (Fed. Cir. Mar. 6, 2024) (Prost, Taranto, Chen, JJ.)

Maxell owns a patent directed to a rechargeable lithium-ion battery. Maxell filed suit against Amperex alleging infringement. Following claim construction proceedings, the district court found the claims to be indefinite based on two limitations in the independent claim that recited the variable M1. The relevant claim limitations read:

1- wherein M1 represents at least one transition metal element selected from Co, Ni and Mn, [. . .]

2- wherein the content of Co in the transition metal M1 of the formulae (1) and (2) is from 30% by mole to 100% by mole[.]

The district court found that these two limitations contradicted each other because limitation 1 recited Co (cobalt) as an optional transition metal selected from a Markush group for M1, whereas limitation 2 recited a minimum Co content of 30% in M1. The district court reasoned that the claims were indefinite because limitation 1 did not require the presence of cobalt, whereas limitation 2 did. In its claim construction order, the district court stated that simultaneous recitation that a claim element is both optional and required is a “contradiction on its face.” Maxell appealed.

The Federal Circuit found no contradiction between the two limitations, explaining that “[i]t is perfectly possible for a selected [M1] to satisfy both of these limitations.” The Court reasoned that in the context of Maxell’s patent, it was of no import that the two requirements (i.e., that M1 must comprise cobalt, nickel (Ni) or manganese (Mn), and that M1 must comprise at least 30% cobalt) were recited in separate clauses. It was enough that both limitations could be simultaneously satisfied. The Court further reasoned that the inclusion of two requirements in a claim did not create an otherwise nonexistent contradiction because the claim language must be read as a whole and not merely on a limitation-by-limitation basis. The Court also looked to the prosecution history to provide context for the ordering of the claim limitations at issue and explained that limitation 2 was added during prosecution to overcome a prior art reference that primarily used nickel as a transition metal.

The Federal Circuit explained that contrary to the district court’s characterization, the subject claim limitations did not grant options. Instead, they stated requirements that must be met to fall within the scope of the claimed invention. The Court noted that, rather than contradicting limitation 1, limitation 2 narrowed it. If limitation 2 had been recited in a dependent claim, there would be no contradiction, notwithstanding that proper construction of a dependent claim requires importation of all limitations from the claims from which it depends. The same conclusion applied when both limitations were [...]

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I Hear Ya – No Intent to Deceive, No Inequitable Conduct

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the asserted patents were not unenforceable for inequitable conduct, determining that statements made by counsel to the US Patent & Trademark Office (PTO) to revive an abandoned application were not shown to have been made with deceptive intent. Freshub, Inc. v. Amazon.com, Inc., Case No. 2022-1391 (Fed. Cir. Feb. 26, 2024) (Reyna, Taranto, Chen, JJ.)

Freshub sued Amazon for infringement of patents directed to voice processing technology. Amazon denied infringement and defended on the basis that the patents should be declared unenforceable based on inequitable conduct by Freshub’s parent company, Ikan Holdings, during prosecution of the application at the PTO. Amazon alleged that Ikan improperly revived an earlier-abandoned parent application from which the asserted patents descend.

The predicate facts are as follows: In June 2011, the PTO issued a final office action rejecting the claims of the parent application. Ikan failed to respond to the office action, rendering the application abandoned in January 2012. In January 2017, Ikan petitioned the PTO to revive the application. In support of its revival petition, Ikan’s counsel asserted that “[t]he entire [five-year] delay in filing the required reply . . . was unintentional.” “[R]elying on petitioner’s duty of candor and good faith,” the PTO granted the petition, eventually resulting in issuance of the three patents-in-suit.

At trial, a jury found that Amazon did not infringe the asserted patents. The district court subsequently conducted a bench trial on inequitable conduct and found that Amazon had failed to prove inequitable conduct by clear and convincing evidence. Freshub appealed, arguing that it was entitled to judgment as a matter of law that Amazon infringed. Amazon cross-appealed, seeking reversal of the district court’s inequitable conduct ruling.

The Federal Circuit affirmed the district court’s determination of failure to prove inequitable conduct, finding that Amazon had not shown by clear and convincing evidence that Ikan misrepresented or omitted material information with the specific intent to deceive the PTO. The Court focused its analysis on deceptive intent, finding that the district court did not commit clear error in rejecting Amazon’s inequitable conduct defense.

The Federal Circuit noted that the record was minimal due to the passage of time and the limited testimonial and documentary evidence available, as well as the many unchallenged claims of attorney-client privilege. Nevertheless, both parties presented evidence concerning Ikan’s intent between 2012 and 2017.

To support its position, Freshub relied on the 2017 statement by Ikan’s counsel asserting that Ikan’s delay in filing its reply to the PTO’s final office action was unintentional. The Federal Circuit found this evidence probative, even without the presentation of additional evidence to further explain why the period of non-response was so long. On the other hand, Amazon presented specific evidence that it contended demonstrated deceptive intent. For example:

  • The 2017 statement to revive the parent application was made by the same counsel that prosecuted the application at the time of its 2012 abandonment.
  • Ikan’s counsel [...]

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New PTO Guidance: Use KSR Flexible Approach to Obviousness

On February 27, 2024, the US Patent & Trademark Office (PTO) published updated guidance for examiners on how to make a proper determination of obviousness. The guidance expands upon and reinforces the legal framework for obviousness determinations discussed by the Supreme Court in KSR Int’l. v. Teleflex (2007) and Graham v. John Deere Co. (1966) through the lens of post-KSR precedential Federal Circuit cases. The guidance does not have the force and effect of law and is not intended by the PTO to convey any new practice or procedure.

Drawing from more than 30 Federal Circuit cases, the guidance addresses several themes. An overriding theme concerns the implementation of a flexible approach to obviousness and the need for a reasoned explanation when concluding that a claimed invention would have been obvious. In its discussion, the PTO characterizes the flexibility expressed by the KSR court and reiterated by subsequent Federal Circuit cases as mandating a proper understanding of the scope of the prior art and providing appropriate reasons to modify the prior art.

Regarding the scope and content of the prior art, the guidance draws attention to understanding the prior art and all that it may reasonably suggest to a person of ordinary skill in the art (POSITA) who would naturally apply common sense and glean suggestions from the art – even where such suggestions are not explicitly stated. Thus, the obviousness inquiry need not seek out precise teachings regarding a solution to a technological problem but can take account of the inferences, creative steps and common knowledge that a POSITA would employ. In one precedential example, the Federal Circuit held that a POSITA would have combined certain prior art elements based on common knowledge of an industry’s concern for rider stability when using water recreational devices. (Zup v. Nash Mfg. (2018).) The guidance also affirms the need for an evaluation of analogous prior art, which must be evaluated using a flexible approach when considering the “same field of endeavor” and “reasonably pertinent” tests in combination with evidence concerning the knowledge and perspective of a POSITA.

According to the guidance, a flexible approach to obviousness should provide a reasoned explanation with evidentiary support for modifying the prior art. To facilitate compact prosecution, the examiner should clearly articulate this explanation early in the prosecution. The PTO also cautions that wholesale use of “common sense” as a rationale is no substitute for reasoned analysis and evidentiary support. There should be an explanation of why common sense would have compelled a finding of obviousness, especially where limitations are not expressly disclosed in the prior art.

The guidance further emphasizes that decision-makers are not free to ignore relevant evidence before them, including Graham’s secondary considerations or other objective indicia of obviousness, to establish prima facie obviousness. At the same time, conclusory opinions by an expert in a declaration or attorney argument alone should not be accorded weight in the absence of factual support. The guidance notes that in keeping with the flexible approach to obviousness [...]

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Consider Invention When Assessing Support for Claimed Range

The US Court of Appeals for the Federal Circuit affirmed in part and vacated in part a Patent Trial & Appeal Board finding that the claims at issue were either invalid under 35 U.S.C. §112 as unsupported by written description or obvious under 35 U.S.C. §103. RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., Case No. 22-1862 (Fed. Cir. Feb. 9, 2024) (Chen, Stoll, Cunningham, JJ.)

RAI owns a patent with claims directed to “electrically powered smoking devices that provide an inhalable vapor by heating tobacco or other substances without significant combustion.” Philip Morris challenged the patent in a post-grant review (PGR).

The Board issued a final written decision concluding that two dependent claims, which recited limitations requiring a heating member with “a length of about 75% to about 85% of a length of the disposable aerosol forming substance,” lacked § 112 written description support. The specification disclosed ranges of 75% – 125%, 80% – 120%, 85% – 115% and 90% – 110%. The Board explained that written description support was lacking because “the claimed range is different from and substantially narrower than the specific ranges disclosed in the specification.”

The Board found that the remaining claims were unpatentable as obvious based on a combination of prior art references where the heater found in one reference, Robinson, was replaced with the heater from another, Greim. Robinson explained that its heating element could be altered and acknowledged design choices, thus inviting skilled artisans to select an alternate appropriate heating element. Greim disclosed certain advantages to its heater. Thus, the Board found that a skilled artisan would have been motivated to replace Robinson’s heater with that of Greim, rendering the claims obvious. RAI appealed.

Citing its expert, RAI argued that the ranges disclosed in the specification all centered around 100%, so that a person of ordinary skill in the art (POSITA) would not “conclude that the inventors possessed a range that went no higher than 85%[.]” The Federal Circuit began by summarizing a line of numerical range cases, including:

  • In re Wertheim (CCPA 1976), which found that a described range of 25% – 60%, with examples of 36% and 50%, supported a claim directed to a range of 35% – 60%.
  • In re Blaser (CCPA 1977), which found that a described range of 60° – 200° C supported a claim reciting a range of 80° – 200° C.
  • Kolmes v. World Fibers Corp. (Fed. Cir. 1997), which found that a described range of 4 – 12 turns per inch, and preference for 8 turns per inch, supported claims directed to 8 – 12 turns per inch.
  • In re Baird (CCPA 1965), which found that a relatively unexplained disclosure of 32 – 176° F did not support claims directed to a range from 40° to “at least as low as” 60° F.
  • Indivior UK v. Dr. Reddy’s Laboratories (Fed. Cir. 2021), which found that:
    • Disclosure of ranges of at least 25%, at least 50% and “any” value [...]

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I Hear Ya: Claim Terms Not as Narrow as Features in Specification

The US Court of Appeals for the Federal Circuit vacated a district court’s final judgment of noninfringement, finding that the district court improperly narrowed the constructions of certain claim terms to particular features recited in the specification. Promptu Sys. Corp. v. Comcast Corp., Case No. 22-1939 (Fed. Cir. Feb. 16, 2024) (Moore, Prost, Taranto, JJ.)

Promptu filed a lawsuit against Comcast alleging infringement of two patents. The patents describe and claim subject matter generally related to voice recognition but have materially different specifications. The first patent describes using remote voice recognition systems to deliver content in response to a user’s speech request (content delivery patent), while the second patent describes using remote voice recognition systems to control a user’s television set based on a user’s speech command (control patent).

The content delivery patent’s representative claim recites a method for using a “back channel containing a multiplicity of identified speech channels from a multiplicity of user sites presented to a speech processing system at a wireline node in a network supporting at least one of cable television delivery and video delivery” as well as a “method of operating at least part of a speech recognition system coupled to a wireline node in a network [for] processing a multiplicity of received identified speech channels to create a multiplicity of identified speech content.” Meanwhile, the claim of the control patent recites “a centralized multi-user voice operated television control system, comprising . . . a centralized processing station configured to receive and process second output from a multitude of television set top boxes by applying voice recognition.”

During the underlying district court proceeding, the district court adopted claim constructions proposed by Comcast. Based on those claim constructions, Promptu stipulated to and moved for entry of a final judgment of no infringement. After the district court granted Promptu’s motion, Promptu appealed.

Promptu challenged the district court’s construction of three claim limitations from the content delivery patent (“back channel,” “multiplicity of received identified speech channels” and “speech recognition system coupled to a wireline node”) and one claim limitation from the control patent (“centralized processing station”). In accordance with long-standing precedent, the Federal Circuit reviewed claim construction by affording the words of the claims their ordinary meaning in the context of the claims and specification.

The Federal Circuit concluded that the district court erred by narrowly construing “back channel” in the content delivery patent as being limited to a “fixed band of frequencies or time slot(s) for transmitting signals to a speech processing system or engine” because nothing in the claim language or the specification required limitation to a “fixed band of frequencies or time slot.” To the contrary, the specification of the patent disclosed the back channel broadly while recognizing the possibility of using different protocols and formats along different subsections of the path or route from user site to speech recognition system. Given the breadth of the techniques for the back channel disclosed in the specification, the Court found no reason to narrow the claims [...]

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Uncle Sam Can March In: Government Licenses Under Bayh-Dole Aren’t Subject to “Strict Timing Requirements”

In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the government for federally funded research based on work that occurred prior to the effective date of a funding agreement. University of South Fl. Board of Trustees v. United States, Case No. 22-2248 (Fed. Cir. Feb. 9, 2024) (Reyna, Taranto, Stoll, JJ.)

University of South Florida (USF) owns a now-expired patent directed to transgenic mice expressing a certain gene causing an accelerated pathology for Alzheimer’s disease. The patent’s subject matter was conceived while the two named inventors worked at USF, but both inventors transitioned their work to the Mayo Clinic prior to the first actual reduction to practice of the claimed invention. The mice remained at USF, under the care of USF professors, while the named inventors continued to oversee the project from Mayo. The first actual reduction to practice occurred while the inventors were at Mayo.

While the named inventors were still at USF, one inventor submitted a grant application to the National Institutes of Health (NIH). The NIH awarded the inventors (while they were still at USF) a grant covering the mouse project. After the inventors moved to Mayo but prior to the award grant, the designated grantee changed from USF to Mayo. In November 1997, Mayo and USF entered into a subcontract whereby Mayo would pay USF for grant-covered work occurring at USF.

USF sued the United States alleging infringement of the mouse patent by a third party with the government’s authorization and consent. The third party was producing and using mice covered by the patent for the government. The US asserted a license defense under the Bayh-Dole Act, which gives the government a license to practice certain federally funded inventions. The Claims Court granted judgment to the US under its license defense, determining that USF operated pursuant to an implied contract with Mayo based on the understanding that Mayo would use funding from the NIH grant to pay USF for work done there. The Claims Court therefore determined that USF was a contactor with an implied subcontract that was a funding agreement under Bayh-Dole. Since the invention was therefore invented by a government contractor operating under a funding agreement, it was a “subject invention” that was first actually reduced to practice under a government contract. Therefore, under Bayh-Dole, the government was entitled to a license. USF appealed, arguing that the invention was not a “subject invention” within the meaning of § 202(c)(4) of Bayh-Dole.

USF argued that to trigger § 202(c)(4), a funding agreement must be in place at the time of the relevant work and there was no implied agreement in April 1997, the time the work that led to the reduction to practice commenced. The Federal Circuit determined that the November 1997 subcontract was adequate to support entitlement to claim a government license under § [...]

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No Home Away From Home: Federal Circuit Confirms PTO Domicile Requirements

The US Court of Appeals for the Federal Circuit confirmed the US Patent & Trademark Office’s (PTO) refusal to register a trademark based on the applicant’s failure to comply with the domicile address requirement of 37 C.F.R. §§ 2.32(a)(2) and 2.189. In re Chestek PLLC, Case No. 22-1843 (Fed. Cir. Feb. 13. 2024) (Lourie, Chen, Stoll, JJ.)

Chestek included only a PO box for its domicile address in its trademark application. The PTO found this information noncompliant with the domicile address rule, which requires trademark applicants to either have a domicile within the United States or be represented by US counsel. The PTO implemented the requirement in 2019 following a notice-and-comment period. Chestek appealed the PTO’s refusal to register based on the Administrative Procedure Act (APA) and challenged the processes surrounding implementation of the domicile address requirement.

Chestek first argued that the requirement was improperly instituted because the PTO failed to comply with the notice-and-comment rulemaking requirement under 5 U.S.C. § 533 by failing to provide notice of the domicile address requirement adopted in the final rule. However, the Federal Circuit held that the formalities of the notice-and-comment were not required under § 533(b)(A) because the rule was procedural, not substantive (i.e., effecting a change in existing law or policy that affects individual rights and obligations). As the Court explained, the rule did not affect the substantive trademark standards used during examination to evaluate applications but was simply an applicant information requirement.

Chestek next argued that the domicile address requirement was arbitrary and capricious because in implementing the final rule, the PTO “offered an insufficient justification for the domicile address requirement” and failed to consider important repercussions of the requirement, such as its effects on privacy. The Federal Circuit rebuffed that argument, explaining that the domicile requirement and the explanations given for it (determining whether the US attorney requirement applied) were “at least reasonably discernable.” The Court stated that as long as an agency does not give “almost no reason at all” for a new policy, the change is sufficiently justified and not arbitrary or capricious. The Court also noted that the APA does not require an agency to consider and respond to every impact of a proposed policy change.




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Trademark Trial & Appeal Board Gets a DuPont 101 Lesson

Addressing errors in the Trademark Trial & Appeal Board’s likelihood of confusion analysis in a cancellation action, the US Court of Appeals for the Federal Circuit vacated and remanded, holding that the Board erred by failing to give sufficient weight to the first DuPont factor (similarity of the marks) and failing to consider the relevant evidence for the third (similarity of established trade channels). Naterra International, Inc. v. Samah Bensalem, Case No. 22-1872 (Fed. Cir. Feb. 15, 2024) (Moore, Stoll, Cunningham, JJ.)

In 2020, Naterra International filed a petition to cancel Samah Bensalem’s registration for BABIES’ MAGIC TEA for use in connection with “medicated tea for babies that treats colic and gas and helps babies sleep better” based on a likelihood of confusion with Naterra’s multiple registrations for BABY MAGIC for use in connection with infant toiletry products such as lotion and baby shampoo. The Board denied Naterra’s petition, finding that Naterra failed to prove a likelihood of confusion. The Board found that while the first DuPont likelihood of confusion factor (similarity of the marks) weighed in favor of a likelihood of confusion, factors two (similarity of the goods) and three (similarity of established trade channels) did not, and Naterra’s BABY MAGIC mark “fell somewhere in the middle” for factor five (fame of the prior mark). The Board found that factors four (conditions of purchasing), six (number and nature of similar marks in use on similar goods), eight (length of time and conditions of concurrent use without evidence of actual confusion), 10 (market interface between applicant and owner of a prior mark) and 12 (extent of potential confusion) were neutral. Naterra appealed.

Naterra argued “that substantial evidence does not support the Board’s finding that the similarity and nature of the goods (DuPont factor two) and trade channels (DuPont factor three) disfavor a likelihood of confusion,” and that the Board did not properly weigh the first (similarity of the marks) and fifth (fame of the prior mark) DuPont factors.

DuPont Factor Two – Relatedness of the Goods

The Board rejected Naterra’s expert testimony that other so-called “umbrella” baby brands offered both infant skincare products and ingestible products, calling it “unsupported by underlying evidence.” The Federal Circuit disagreed, stating that “testimony that third-party companies sell both types of goods is pertinent to the relatedness of the goods.” Nonetheless, because the Court could not determine whether the Board rejected the expert testimony for other reasons, it remanded the case for further consideration and explanation of its analysis on this point.

DuPont Factor Three – Similarity of Trade Channels

The Board found that the third factor weighed against a likelihood of confusion, stating that it lacked the “persuasive evidence” necessary to “conclude that the trade channels are the same.” The Federal Circuit found that the Board erred by not addressing relevant evidence, namely Bensalem’s admission that the parties’ goods were sold in similar trade channels. The Court also noted that the Board “did not identify in its decision any evidence showing a lack of [...]

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We Meant It – No Incorporation by Reference

The US Court of Appeals for the Federal Circuit issued a sua sponte order regarding the impermissibility of incorporating by reference arguments from one brief into another, especially when doing so causes the brief to exceed the permitted word count. Promptu Sys. Corp. v. Comcast Cable Commc’ns, LLC, Case No. 22-1093 (Fed. Cir. Feb. 16, 2024) (Moore, CJ; Prost, Taranto, JJ.) (per curiam).

On January 11, 2024, the Federal Circuit heard oral arguments in four related cases involving Promptu and Comcast. During oral argument, the Court asked counsel for the appellee to submit a brief within 10 days, totaling no more than 10 pages, to show why he should not be sanctioned for attempting to incorporate by reference multiple pages – almost 2,000 words – of argument from the brief in one case into another, thereby causing the brief to exceed the word limit.

The Federal Circuit recounted that it has “repeatedly held” that incorporating by reference to exceed word count is not permitted, citing its holdings on this issue in Microsoft v. DataTern (2014) and more recently in Medtronic v. Teleflex Life Sciences (2023). Appellee counsel responded that he was unaware of the Microsoft decision until the appellant’s reply brief had already been filed. The Court accepted his assertion but noted with disapproval that the precedential Microsoft decision admonished “the exact same law firm before us now for the exact same behavior,” and that once made aware of the Microsoft decision, counsel did nothing to remedy the impropriety.

Practice Note: The Federal Circuit did not award sanctions against appellate counsel but sternly warned future litigants that it is improper to incorporate by reference arguments from one brief into another unless in compliance with Fed. R. App. P. 28, and that such incorporation is never permitted if it results in exceeding the applicable word limit. The Court stated that going forward, such a violation “will likely result in [an award of] sanctions.”




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