Technology Information Law Blog by Charles Gideon Korrell

Tag: claim construction

  • Optis Cellular Technology v. Apple Inc.: Federal Circuit Orders New Trial on Infringement and Damages Due to Unanimity Violation and Improper Evidence

    Optis Cellular Technology v. Apple Inc.: Federal Circuit Orders New Trial on Infringement and Damages Due to Unanimity Violation and Improper Evidence

    The Federal Circuit’s June 16, 2025, decision in Optis Cellular Technology, LLC v. Apple Inc., Nos. 2022-1904, 2022-1925, vacates a $300 million damages judgment in a high-stakes standard-essential patent (SEP) case and mandates a new trial on both infringement and damages. The court found that the Eastern District of Texas violated Apple’s constitutional right to a unanimous jury verdict and improperly admitted prejudicial evidence, including a large Apple-Qualcomm settlement. The ruling also carries broader implications for the treatment of abstract claims under § 101 and functional claim limitations under § 112 ¶ 6.

    Key Takeaway

    The Federal Circuit vacated both the infringement and damages verdicts because the jury verdict form failed to ensure unanimity on specific claims, and because the district court improperly admitted a high-dollar Apple-Qualcomm settlement agreement. The court also held two of the asserted claims invalid under § 101, reversed a § 112 ¶ 6 ruling, and rejected the patentee’s request to reinstate a previously set-aside $506 million award.

    Background

    Optis, asserting a suite of five LTE standard-essential patents, sued Apple in the Eastern District of Texas in 2019. After an initial trial in 2020, the jury awarded Optis $506.2 million in damages, finding infringement and willfulness. However, the trial court granted Apple a new trial on damages due to improper exclusion of FRAND evidence. A second trial in 2021 resulted in a $300 million lump-sum verdict.

    Apple appealed, challenging liability, damages, claim construction, and admissibility of certain evidence. Optis cross-appealed, seeking reinstatement of the original damages verdict.

    The Verdict Form and Jury Unanimity Violation

    The Federal Circuit held that the district court erred by using a single verdict question that asked whether Apple infringed “ANY of the asserted claims” without distinguishing between the five asserted patents. This structure permitted a finding of liability even if jurors disagreed on which patents were infringed, violating Apple’s right to a unanimous verdict under the Seventh Amendment and Federal Rule of Civil Procedure 48(b):

    “The verdict form instructed the jury to find Apple liable for infringement regardless of whether all jurors agreed that Apple was infringing the same patent.” (Slip op. at 15)

    Despite the parties’ joint request for patent-by-patent questions, the district court rejected that format. The Federal Circuit deemed this a clear legal error warranting vacatur of the liability judgment and a new trial.

    Damages Verdict Also Vacated

    Because liability was vacated, the court also vacated the $300 million damages verdict. Notably, the district court had instructed the jury to assume all five patents were infringed for purposes of damages—an instruction that now lacks any valid liability finding to support it.

    Further, the court held that the district court abused its discretion under FRE 403 by admitting a high-value Apple-Qualcomm settlement agreement and allowing Optis’s expert to rely on it:

    “[T]he probative value of the Apple-Qualcomm settlement agreement and Mr. Kennedy’s testimony concerning the same is substantially outweighed by the risk of unfair prejudice.” (Slip op. at 36)

    This agreement, which settled global disputes unrelated to the patents-in-suit, was deemed minimally probative and highly prejudicial.

    Patent Eligibility Under § 101

    The court reversed the district court’s denial of Apple’s § 101 motion on claims 6 and 7 of U.S. Patent No. 8,019,332, finding them directed to an abstract mathematical formula:

    “We conclude that the claims are directed to the abstract idea—a mathematical formula.” (Slip op. at 24)

    Charles Gideon Korrell notes that the Federal Circuit found the claims failed Alice step one and remanded for further proceedings on step two.

    Means-Plus-Function and § 112 ¶ 6

    In another reversal, the Federal Circuit held that the term “selecting unit” in claim 1 of U.S. Patent No. 8,411,557 invoked § 112 ¶ 6. It found “unit” to be a nonce term that fails to connote sufficient structure:

    “‘Selecting unit’ in the claim at issue here invokes § 112 ¶ 6.” (Slip op. at 31)

    The district court had relied on a prior Eastern District ruling, but the Federal Circuit found that opinion unpersuasive, particularly in light of Optis’s own assertion that the “unit” could be implemented in hardware or software. The matter was remanded to determine if the specification provides sufficient structure.

    Claim Construction Affirmed

    The court affirmed the construction of a key term in claim 8 of U.S. Patent No. 8,102,833, rejecting Apple’s argument that the mapping of ACK/NACK control signals required a specific start position.

    Optis’s Cross-Appeal Rejected

    Optis had sought reinstatement of the original $506.2 million award from the first trial, but the Federal Circuit dismissed the cross-appeal, concluding that:

    “[T]he first damages judgment presented the same verdict form issue… and thus cannot be reinstated.” (Slip op. at 36)

    Practical Implications

    This decision reinforces several critical points for SEP litigation and patent damages trials:

    1. Verdict Form Precision Matters: Patent plaintiffs must ensure verdict forms distinguish each asserted patent or claim to avoid violating the defendant’s right to unanimity.
    2. Evidence of Other Settlements Is Risky: Courts will scrutinize the use of large dollar-value settlements, especially when they involve different technologies or were driven by non-comparable litigation pressure.
    3. FRAND Damages Must Align with Liability: Damages awards must correspond to actual findings of infringement, particularly in FRAND cases.
    4. § 101 and § 112 Scrutiny Continues: The court’s reversals on patent eligibility and means-plus-function interpretation signal a continued willingness to invalidate improperly drafted claims—even in complex SEP disputes.

    Charles Gideon Korrell notes that the Federal Circuit’s opinion emphasizes procedural fairness as much as substantive patent doctrine. Charles Gideon Korrell also observes that the court’s insistence on clarity in verdict forms may drive future litigants to pay closer attention to the architecture of jury questions.

    Conclusion

    The Federal Circuit’s decision in Optis v. Apple is a comprehensive rebuke of multiple aspects of the trial court’s handling of a major SEP case. By ordering a new trial on both liability and damages and reversing several key legal rulings, the opinion sets important precedent for how SEP litigation should be conducted and how damages should be assessed.

    By Charles Gideon Korrell

  • Ancora Technologies, Inc. v. Roku, Inc.: Federal Circuit Vacates PTAB Decision on Licensing Nexus in Obviousness Analysis

    Ancora Technologies, Inc. v. Roku, Inc.: Federal Circuit Vacates PTAB Decision on Licensing Nexus in Obviousness Analysis

    In the June 16, 2025 decision of Ancora Technologies, Inc. v. Roku, Inc., the Federal Circuit vacated and remanded two inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB) that had found claims of U.S. Patent No. 6,411,941—owned by Ancora Technologies, Inc.—to be unpatentable as obvious. While the Federal Circuit affirmed the Board’s construction of the key term “agent” and upheld its prima facie case of obviousness based on prior art, it held that the PTAB legally erred in dismissing Ancora’s license evidence as lacking a sufficient nexus to the claimed invention. This case offers important guidance on the evidentiary treatment of licenses as objective indicia of nonobviousness.

    The Patent at Issue: Software Licensing and BIOS Security

    Ancora’s ’941 patent addresses software license enforcement mechanisms by embedding license verification structures in the erasable, non-volatile memory of a computer’s BIOS. This technique is intended to secure software against unauthorized use without relying on more volatile or easily altered memory. The method described in claim 1 includes:

    1. Selecting a program in volatile memory (e.g., RAM),
    2. Using an “agent” to set up a verification structure (including at least one license record) in the erasable, non-volatile BIOS memory (e.g., EEPROM),
    3. Verifying the program using the verification structure, and
    4. Acting on the program based on the verification result.

    Claims 1–3, 6–14, and 16 were challenged and ultimately invalidated in IPRs filed by Nintendo, Roku, and VIZIO.

    The PTAB’s Decision: Obviousness Based on Hellman and Chou

    The PTAB found that the challenged claims were obvious over a combination of two prior art references:

    • Hellman (U.S. Patent No. 4,658,093): Discloses a system using hash functions and non-volatile memory to control software use based on allowed instances.
    • Chou (U.S. Patent No. 5,892,906): Describes BIOS-based security methods for verifying passwords and controlling hardware access.

    The Board determined that Hellman provided the base mechanism for license enforcement and that Chou taught the use of BIOS memory for secure storage. Ancora argued that this combination was inoperable and lacked a motivation to combine, but the Board found otherwise and rejected Ancora’s claims as obvious.

    The Board construed the term “agent” in the claims as “a software program or routine,” declining Ancora’s argument that the term should be limited to software running at the OS level. Relying on intrinsic evidence and dictionaries, the Board found no disavowal or redefinition requiring a narrower construction.

    Charles Gideon Korrell notes that the Federal Circuit gave deference to the Board’s reliance on extrinsic evidence, including industry definitions and expert declarations, and determined that “agent” was not limited to software-only or OS-level implementations. The court found substantial evidence supported the Board’s construction.

    Secondary Considerations: Licensing and the Nexus Requirement

    The Federal Circuit’s principal disagreement with the Board lay in its treatment of Ancora’s license agreements as objective indicia of nonobviousness.

    Ancora had presented multiple licenses entered into after extended litigation, many just before trial and with substantial royalty payments. The PTAB found that Ancora failed to show a nexus between these licenses and the specific claims of the ’941 patent, concluding that they could reflect business decisions to avoid litigation rather than recognition of the patent’s strength.

    The Federal Circuit sharply criticized this reasoning:

    “Licenses to the challenged patent then, unlike products or other forms of objective evidence of nonobviousness, do not require a nexus with respect to the specific claims at issue…”

    Citing LaserDynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51 (Fed. Cir. 2012) and Institut Pasteur v. Focarino, 738 F.3d 1337 (Fed. Cir. 2013), the court emphasized that actual licenses to the patented technology are highly probative of nonobviousness and should not be subject to the same parsing applied to commercial product evidence.

    In the court’s view, according to Charles Gideon Korrell, the Board erred by demanding a higher evidentiary burden than the law requires. Even if the licenses also referenced related patents or included redacted sections, that did not undermine the fact that they expressly covered the ’941 patent. The Board’s approach “too finely parsed” the record and ignored the licensing context: settlements reached after years of litigation and near trial dates, with substantial consideration paid.

    Charles Gideon Korrell explains that the Federal Circuit’s holding here confirms that the economic behavior of parties—especially sophisticated technology companies licensing patents to avoid trial—is relevant and weighty evidence of the patent’s nonobviousness, even where the license bundles multiple rights.

    Remedy and Remand

    Although the Federal Circuit affirmed the PTAB’s claim construction and the Board’s finding of a prima facie case of obviousness, it vacated the Board’s decision due to legal error in the analysis of secondary considerations. On remand, the PTAB must:

    1. Re-evaluate the nexus between the challenged claims and Ancora’s licenses under the proper legal standard,
    2. Weigh this licensing evidence, including both high- and low-value settlements, as part of its overall nonobviousness analysis.

    This remand could potentially alter the outcome if the Board concludes that the licenses provide significant objective evidence supporting the validity of the challenged claims.

    Conclusion

    The Federal Circuit’s decision in Ancora Technologies, Inc. v. Roku, Inc. underscores the importance of properly evaluating licensing evidence in an obviousness analysis. While upholding a broad construction of “agent” and affirming the prima facie obviousness of the claims, the court found fault with the PTAB’s overly narrow view of what constitutes a nexus between a patent and license agreements. The decision reinforces that real-world licensing behavior—especially in litigation contexts—can and should play a meaningful role in the nonobviousness inquiry.

    Charles Gideon Korrell believes this decision will have broad implications for how PTAB and district courts assess secondary considerations in IPR and invalidity proceedings. In particular, it may offer patent holders new avenues to bolster the validity of their claims with well-supported licensing histories.

    By Charles Gideon Korrell

  • Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope

    Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope

    In Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., No. 23-2357 (Fed. Cir. June 4, 2025), the Federal Circuit affirmed a claim construction that doomed Alnylam’s infringement case against Moderna’s COVID-19 vaccine. The decision reinforces the primacy of clear definitional language in a patent’s specification—even when it narrows claim scope beyond what a patentee may have intended.

    Background: The mRNA Lipid Dispute

    Alnylam sued Moderna, asserting that the SM-102 lipid in Moderna’s SPIKEVAX® vaccine infringed U.S. Patent Nos. 11,246,933 and 11,382,979. The patents concern cationic lipids used for delivering nucleic acids into cells, particularly formulations where the hydrophobic “tail” includes a “branched alkyl” group.

    The litigation hinged on the meaning of the claim term “branched alkyl.” Moderna prevailed on a noninfringement stipulation after the district court adopted a narrow construction based on a definitional sentence in the patents’ shared specification.

    The Disputed Definition

    The critical passage appeared in the “Definitions” section:

    “Unless otherwise specified, the term ‘branched alkyl’ … refer[s] to an alkyl … group in which one carbon atom in the group (1) is bound to at least three other carbon atoms and (2) is not a ring atom of a cyclic group.”

    The district court treated this as lexicography and rejected Alnylam’s attempt to use a broader “plain and ordinary meaning” interpretation. Because Moderna’s lipid did not include a carbon atom meeting the “bound to at least three other carbon atoms” requirement, the court granted judgment of noninfringement.

    Federal Circuit Analysis

    The Federal Circuit affirmed, holding that the passage was definitional under the standards set out in Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) and its progeny:

    • The term was in quotation marks, signaling definition.
    • It was introduced with “refer to,” which courts have consistently viewed as definitional (ParkerVision, Inc. v. Vidal, 88 F.4th 969 (Fed. Cir. 2023)).
    • It was placed in a section titled “Definitions,” supporting the lexicographic reading.
    • The specification used permissive phrasing elsewhere (“e.g.,” “include”), contrasting with the precise language used for “branched alkyl.”

    The panel also rejected Alnylam’s fallback argument that its claims fell under the “unless otherwise specified” exception. The court held that this clause required a clear, specific departure—and nothing in the claims, specification, or prosecution history met that bar. References to secondary carbon structures in dependent claims and the prosecution record did not rise to the level of an explicit override of the express definition.

    Key Cases Cited

    Takeaway

    This case is a strong reminder that express definitions in a patent’s specification—especially when found in a “Definitions” section and marked with formal language—will bind the claim scope unless there is a clear and unmistakable reason to depart. Practitioners should be cautious with language like “unless otherwise specified” unless they can point to explicit exceptions elsewhere in the specification or prosecution history. Ambiguities or broader examples won’t suffice to override precise definitions.

    By Charles Gideon Korrell

  • Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc.: Inherent Anticipation Requires Full Scope of the Claim

    Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc.: Inherent Anticipation Requires Full Scope of the Claim

    In a decision clarifying the boundaries between claim construction and factual findings of inherency, the Federal Circuit in Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc., No. 23-2211 (Fed. Cir. May 23, 2025), reversed the PTAB’s determination that certain claims of U.S. Patent No. 7,400,704 were not anticipated by the prior art. The court concluded that the Board had improperly narrowed the scope of the claims through implicit construction and that, under the correct claim scope, the prior art reference Jorgensen inherently disclosed the disputed limitation.

    Background

    Zeiss’s patent claims an X-ray imaging system incorporating “projection magnification,” with the key limitation being that the magnification of the projection stage is “between 1 and 10 times.” Sigray petitioned for inter partes review, arguing that a 1998 paper by Jorgensen disclosed all limitations of the claims, including this magnification range.

    The Board acknowledged that Jorgensen disclosed nearly all elements of the claims but found no anticipation because it concluded that the reference did not disclose “enough” beam divergence to result in the required projection magnification. Sigray appealed, arguing that this conclusion was based on an implicit and erroneous narrowing of the claim scope.

    Implicit Claim Construction

    The Federal Circuit found that the Board had implicitly construed the phrase “between 1 and 10 times” in a way that excluded very small—indeed undetectable—levels of magnification. The Board’s repeated focus on whether Jorgensen’s beam diverged “enough” and whether it created a “meaningful” amount of magnification revealed that it was assessing not just whether any magnification was present, but whether the magnification was perceptible or functionally significant.

    As the court explained, “[t]he Board’s use of the word ‘enough’ reflects that it considered a certain level of divergence as outside the claim. Narrowing the claim scope in this way is in fact claim construction.” The court emphasized that claim construction had occurred even though the Board disclaimed doing so—relying on its precedent in Google LLC v. EcoFactor, Inc., 92 F.4th 1049 (Fed. Cir. 2024), to look at the Board’s analysis and outcome rather than its labels.

    Inherent Disclosure and Physical Geometry

    After correcting the Board’s construction, the court held that Jorgensen inherently disclosed the disputed magnification limitation. Charles Gideon Korrell sees that the opinion stresses that under the geometric optics formula (M = (Ls + Ld)/Ls), any system with a diverging X-ray beam and a nonzero sample-to-detector distance (Ld > 0) necessarily results in magnification greater than 1.

    Since perfect collimation—i.e., zero divergence—is physically impossible in real-world systems, the court found that Jorgensen’s setup, which necessarily included some divergence, inherently satisfied the “between 1 and 10 times” magnification requirement. As stated in the opinion: “Here, it is undisputed that Jorgenson’s X-ray beams are not completely parallel and naturally must result in some magnification. That miniscule amount of magnification disclosed by the prior art definitionally achieves a magnification within the claimed range of 1 to 10.”

    Charles Gideon Korrell notes that the court relied heavily on SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005), in concluding that inherent anticipation does not require recognition or intention by the prior art. Rather, it is sufficient that the claimed feature necessarily results from practicing the prior art reference, regardless of whether it was appreciated at the time.

    Reversal and Remand

    • Claims 1, 3, and 4: Reversed. The court found that these claims were inherently anticipated by Jorgensen.
    • Claims 2, 5, and 6: Vacated and remanded. Sigray had argued these claims were obvious, not anticipated, so the Board must evaluate obviousness in light of the Federal Circuit’s clarified claim scope.

    Takeaway

    Charles Gideon Korrell thinks that this decision illustrates the Federal Circuit’s firm stance on the plain meaning of claim terms. The phrase “between 1 and 10 times” includes any magnification over 1, no matter how small, and the Board erred by requiring a “meaningful” or “detectable” amount. The ruling reinforces the principle from SmithKline that inherent disclosure encompasses all inevitable consequences of prior art, even if imperceptible.

    It also underscores how implicit claim construction—especially when it narrows the scope based on technical judgments about magnitude or significance—can fundamentally alter the outcome of IPR proceedings. Courts and the PTAB alike must be careful not to impose unstated thresholds that conflict with the express language of the claims.

    Finally, Charles Gideon Korrell believes that the opinion serves as a reminder that physical realities of system design (such as the impossibility of true parallel beams) can be decisive in proving inherent anticipation. The court’s analysis—rooted in the inevitability of divergence and magnification in Jorgensen’s geometry—shows that anticipation can rest not only on what’s disclosed, but also on what must unavoidably occur.

    By Charles Gideon Korrell

  • In re Kostic: Broadened Reissue Claims Rejected Due to Statutory Bar

    In re Kostic: Broadened Reissue Claims Rejected Due to Statutory Bar

    In In re Kostic, the Federal Circuit recently reinforced the statutory bar against broadening reissue applications filed beyond the two-year limit, emphasizing that claims must be construed based on their actual language rather than an inventor’s subjective intent.

    Background:
    Appellants Kostic and Vandevelde sought reissue of U.S. Patent No. 8,494,950, covering methods for buying and selling click-through internet traffic via an intermediary website. Original dependent claim 3 allowed a direct traffic exchange without a trial process but explicitly depended on independent claim 1, which required a trial process. Arguing that original claim 3 was invalid under 35 U.S.C. § 112 for inconsistency, appellants attempted to rewrite it in independent form, providing optional pathways either with or without a trial process.

    Federal Circuit Decision:
    The Federal Circuit affirmed the PTAB’s rejection, holding the reissue claim was impermissibly broader than the original. The Court applied the principle established in Medtronic, Inc. v. Guidant Corp. that any claim containing at least one conceivable process not infringing the original claims is broader in scope.

    Key Points of Law:

    • Claim Construction: The Court clarified that the determination of claim scope for broadening reissues under 35 U.S.C. § 251(d) depends strictly on the claims as originally written, rather than on the patentees’ intended scope or subjective understanding. Citing Chef America, Inc. v. Lamb-Weston, Inc. and Superior Fireplace Co. v. Majestic Prods. Co., the Court underscored the importance of objective claim interpretation.
    • Broadened Scope Analysis: Reissue claim 3 introduced optional pathways (with or without a trial process), whereas original claims mandated a trial process. Thus, the reissue claim was broader, capturing methods that would not infringe original claims. Since this broadened claim was sought beyond the two-year statutory limit, it violated 35 U.S.C. § 251(d).

    Implications:
    This decision reiterates the importance of careful drafting and review during patent prosecution. Inventors and practitioners must ensure that dependent claims clearly align with independent claims and avoid ambiguous constructions. Once the two-year period for broadening reissues passes, any attempts to retroactively broaden claims are statutorily barred, emphasizing the critical nature of claim precision at the outset.

    Conclusion:
    In re Kostic serves as a reminder of the rigorous statutory limitations surrounding reissue applications. Patent holders must rely on the explicit language of their claims rather than intentions or interpretations developed post-issuance. Clarity in original claim drafting remains paramount.

    By Charles Gideon Korrell

  • Azurity Pharmaceuticals v. Alkem Labs: Prosecution Disclaimer and “Consisting Of” Language Bar Infringement Finding

    Azurity Pharmaceuticals v. Alkem Labs: Prosecution Disclaimer and “Consisting Of” Language Bar Infringement Finding

    In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 23-1977 (Fed. Cir. Apr. 8, 2025), the Federal Circuit affirmed the District of Delaware’s ruling that Alkem’s Abbreviated New Drug Application (ANDA) product did not infringe Azurity’s U.S. Patent No. 10,959,948 (“’948 patent”) due to a clear and unmistakable prosecution disclaimer of propylene glycol.

    Background

    Azurity’s ’948 patent claims drinkable, non-sterile liquid formulations of vancomycin, tailored to pediatric and geriatric patients. The asserted claims used a “consisting of” transition, listing specific ingredients but omitting propylene glycol. During prosecution, Azurity’s predecessor application had been repeatedly rejected over Palepu (U.S. Pat. App. Pub. No. 2016/0101147), which disclosed vancomycin formulations including propylene glycol.

    To overcome these rejections, Azurity amended its claims to include the “consisting of” transition and repeatedly emphasized the absence of propylene glycol. The examiner’s notice of allowance explicitly cited this absence as the basis for allowance. Although a later sibling application (not in the same line of priority) included a statement purporting to reserve the right to claim propylene glycol, the Federal Circuit found this late-stage statement irrelevant and ineffective to undo the earlier disclaimer.

    Key Legal Holdings

    1. Clear Prosecution Disclaimer
      The court held that Azurity “clearly and unmistakably” disclaimed propylene glycol to distinguish its claims from Palepu, citing Data Engine Techs. LLC v. Google LLC, 10 F.4th 1375 (Fed. Cir. 2021), and TriVascular, Inc. v. Samuels, 812 F.3d 1056 (Fed. Cir. 2016). The disclaimer applied broadly across all claim limitations due to Azurity’s sweeping and repeated statements.
    2. Effect of “Consisting Of” Language
      Use of the closed “consisting of” transition further limited the claims to exclude unlisted components like propylene glycol. Citing Norian Corp. v. Stryker Corp., 363 F.3d 1321 (Fed. Cir. 2004), and AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239 (Fed. Cir. 2001), the court emphasized that such transitions typically exclude any additional components.
    3. Ineffectiveness of Later Statement in Related Prosecution
      A disclaimer made in a parent application binds later continuations (Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973 (Fed. Cir. 1999)), but a later, unilateral attempt to retract that disclaimer in a grand-nephew application (filed in parallel) did not negate the clear disclaimer made during the original prosecution.
    4. Interpretation of Pretrial Stipulation
      Azurity’s reliance on a discovery stipulation—that flavoring agents may contain or omit propylene glycol—did not undo the prosecution disclaimer. The court, citing Akamai Techs., Inc. v. Limelight Networks, Inc., 805 F.3d 1368 (Fed. Cir. 2015), found the stipulation did not equate to a concession on infringement or override the prosecution record.
    5. Non-Infringement Finding Supported by ANDA Content
      Since Alkem’s ANDA product contains propylene glycol, and the patented formulation disclaimed that compound, the Federal Circuit affirmed the finding of non-infringement. The case underscores the principle, restated from Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d 1401 (Fed. Cir. 2014), that an ANDA’s defined composition controls the infringement analysis under Hatch-Waxman.

    Takeaways

    This decision reinforces the enduring power of prosecution disclaimer, especially when paired with the “consisting of” claim transition. Practitioners should be mindful that:

    • Statements made to overcome prior art will likely limit claim scope—even if arguably broader than necessary.
    • Subsequent clarifying or contradictory statements in sibling applications cannot override earlier disclaimers.
    • Closed claim language (“consisting of”) combined with clear disclaimer can preclude infringement where additional components are present.

    Careful claim drafting and prosecution strategy remain essential tools in preserving enforceable patent scope.

    By Charles Gideon Korrell

  • Wash World v. Belanger: CAFC Reins in Claim Construction and Remits Damages Based on Improper Convoyed Sales

    Wash World v. Belanger: CAFC Reins in Claim Construction and Remits Damages Based on Improper Convoyed Sales

    The Federal Circuit issued a split ruling in Wash World Inc. v. Belanger Inc., affirming the district court’s judgment of infringement but vacating the lost profits damages award due to improper inclusion of convoyed sales.

    The case presents key takeaways on claim construction waiver, convoyed sales damages, and preserving post-trial remedies, with important implications for managing patent risks and damages strategies.

    Background

    Belanger Inc., holder of U.S. Patent No. 8,602,041 covering a lighted spray arm in an automated car wash system, accused Wash World’s “Razor EDGE” system of infringement. Wash World responded with a declaratory judgment action and was found liable for infringement of independent claim 7 and several dependent claims. A jury awarded over $10 million in damages, primarily as lost profits.

    Claim Construction: Know Your Limits on Appeal

    Wash World appealed on the basis that the district court improperly failed to construe three key claim terms:

    • “Outer cushioning sleeve”
    • “Predefined wash area”
    • “Dependingly mounted from”

    The Federal Circuit, applying a strict forfeiture rule, found that Wash World had waived its proposed constructions on the first two terms by not clearly presenting them to the district court.

    Wash World’s pivot from its trial construction (“thick sleeve of extruded foam plastic”) to a new appellate construction (“soft and resilient…can spring back into shape”) was deemed materially different and untimely. Similarly, its appellate interpretation of “predefined wash area” as requiring invariant dimensions and pre-wash definition was new and forfeited.

    Only the “dependingly mounted from” issue was properly preserved. The court affirmed that both direct and indirect mounting satisfied the claim, rejecting Wash World’s noninfringement theory based on the use of an intermediate trolley.

    This opinion underscores the importance of framing claim construction disputes early and clearly. Implicit arguments or vague references to functional limitations may be insufficient. The Federal Circuit will enforce waiver unless “exceptional circumstances” are shown.

    Damages: The Limits of Convoyed Sales

    While Wash World’s claim construction arguments were mostly waived, it succeeded on appeal in challenging a significant portion of the jury’s $9.8 million lost profits award — approximately $2.58 million tied to convoyed (i.e., unpatented) components sold alongside the patented system.

    The legal standard for convoyed sales is exacting. Under Rite-Hite v. Kelley Co., to recover lost profits on unpatented components sold with a patented item, a patentee must prove that the items together constitute a functional unit — that is, components that are physically and functionally interrelated in such a way that they operate together as part of the patented invention.

    What the patentee cannot do is claim lost profits on items that are merely sold together as a matter of customer convenience or commercial packaging. This is a critical line — and one Belanger crossed, according to the Federal Circuit.

    At trial, Belanger’s damages expert, Dr. McDuff, offered lost profit calculations based on sales of the entire car wash system, including dryers and other components not covered by the asserted patent claims. His per-unit lost profit number — $53,866 — incorporated profits from those unpatented components. Critically, the jury awarded damages that exactly matched his bottom-line estimate, making it clear that convoyed sales were part of the jury’s calculation.

    Belanger attempted to defend the inclusion by arguing that the products were “typically” sold as a package and that dryers were installed in roughly 75% of Belanger’s IBA systems. But the Federal Circuit found that this testimony — emphasizing sales custom rather than functional integration — fell short of establishing the required functional relationship. As the court put it, “selling the products together as a package is the exact sort of ‘matter of convenience or business advantage’ that does not, in and of itself, give rise to damages liability.”

    The Federal Circuit was also unmoved by Belanger’s argument that the general verdict form precluded remittitur. Although the jury did not specify how much of its award was attributable to convoyed sales, Belanger had repeatedly told the district court that the jury adopted Dr. McDuff’s model — a point that judicially estopped it from arguing otherwise on appeal.

    In light of the above, the court ordered remittitur of $2,577,848 and directed the district court to enter a reduced damages award.

    By Charles Gideon Korrell

  • Maquet v. Abiomed: Scope of Prosecution Disclaimer

    Maquet v. Abiomed: Scope of Prosecution Disclaimer

    On March 21, 2025, the Federal Circuit vacated a district court judgment of non-infringement and remanded the case for further proceedings in Maquet Cardiovascular LLC v. Abiomed Inc. (No. 23-2045). The opinion focuses on the claim construction of U.S. Patent No. 10,238,783 (the “’783 patent”), specifically the proper application of the prosecution disclaimer doctrine and the relevance of related patents’ histories in claim construction.

    Background and Claims at Issue

    Maquet’s ’783 patent relates to intravascular blood pump systems that include integrated guide mechanisms for positioning the pump inside the circulatory system. At issue were three claim terms from claims 1 and 24:

    1. “Guide mechanism comprising a lumen” (claim 1)
    2. “Guide mechanism is configured to allow for a guide wire to slideably advance therealong” (claim 1)
    3. “Guide wire does not pass through the rotor hub or the catheter” (claim 24)

    The district court construed each of these to include negative limitations—e.g., that the lumen is not distal to the cannula or that the guide wire does not pass through the free space between rotor blades—based on prosecution history from related patents. Maquet stipulated to non-infringement under these constructions and appealed.

    Federal Circuit Analysis

    1. Prosecution Disclaimer Must Involve Similar Claim Language

    The Federal Circuit vacated the district court’s construction of the term “guide mechanism comprising a lumen”, holding that the court erred in relying on amendments to different claim language in a parent patent (U.S. Patent No. 9,789,238). The court reiterated that prosecution disclaimer generally does not apply when the claim term at issue in the descendant patent uses different language from that in the ancestor patent.

    The court cited:

    • Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294 (Fed. Cir. 2001): emphasizing that the prosecution history of a related patent is only relevant when it addresses a limitation in common.
    • Regents of Univ. of Minn. v. AGA Med. Corp., 717 F.3d 929 (Fed. Cir. 2013): reaffirming that prosecution disclaimer does not apply when there is no parity between claim limitations.
    • Ventana Med. Sys., Inc. v. Biogenex Lab’ys, Inc., 473 F.3d 1173 (Fed. Cir. 2006): noting that different claim language generally precludes the application of disclaimer.

    2. Silence in Response to Examiner Statements Is Not a Disavowal

    On the issue of whether the guide wire could pass through the space between rotor blades, the court reversed the district court’s reliance on statements in the prosecution of U.S. Patent No. 8,888,728 (a great-great-grandparent of the ’783 patent). The district court had found a disclaimer based on the applicant’s failure to contest an examiner’s notice of allowance distinguishing prior art.

    The Federal Circuit rejected that approach, citing:

    • Salazar v. Procter & Gamble Co., 414 F.3d 1342 (Fed. Cir. 2005): holding that an applicant’s silence in response to an examiner’s characterization does not constitute a clear and unmistakable disavowal.
    • Avid Tech., Inc. v. Harmonic, Inc., 812 F.3d 1040 (Fed. Cir. 2016): emphasizing the high standard required to find prosecution disclaimer based solely on prosecution history—namely, a “clear and unmistakable” disavowal.
    • Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc): confirming that claim terms are to be given their ordinary meaning in light of the intrinsic record, absent a clear disclaimer.

    The court also held that general statements Maquet made during an inter partes review proceeding were too vague to constitute a disclaimer under Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353 (Fed. Cir. 2017).

    3. Specification Did Not Require Limitation on Guide Wire Path

    Finally, the court rejected Abiomed’s argument that the patent specification limited the guide wire’s path. The court found no “manifest exclusion or restriction” in the specification that would justify reading in a limitation that the guide wire cannot pass through the rotor blade area, citing:

    • Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004): noting that limiting a claim based on the specification is only appropriate when the patentee clearly expresses such a limitation.

    Conclusion

    The Federal Circuit vacated the judgment of non-infringement as to the ’783 patent and remanded the case for further proceedings under corrected claim constructions. The court left undisturbed the separate judgment of non-infringement as to U.S. Patent No. 9,789,238, which Maquet did not challenge on appeal.

    The opinion provides guidance on the limits of prosecution disclaimer and underscores the need for clear, consistent claim language across related patents when relying on prosecution history to construe claims.

    Post by Charles Gideon Korrell

  • Regeneron v. Amgen: Patent Infringement and Biologic Formulations

    Regeneron v. Amgen: Patent Infringement and Biologic Formulations

    On March 14, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., affirming the district court’s denial of a preliminary injunction sought by Regeneron. This ruling is significant in the realm of the biologic pharmaceutical industry, as it centers on claim construction and the principles governing patent infringement.

    Background of the Case

    Regeneron sued Amgen, alleging that Amgen’s biosimilar product, ABP 938 (Pavblu), infringed its U.S. Patent 11,084,865 (the ’865 patent). This patent claims a pharmaceutical formulation for an ophthalmic drug, Eylea, which contains a vascular endothelial growth factor (VEGF) antagonist, a buffer, an organic co-solvent, and a stabilizing agent.

    Amgen developed ABP 938 as a biosimilar to Eylea but with a key difference: it eliminated the need for a separate buffer component by utilizing a self-buffering VEGF antagonist. Regeneron argued that Amgen’s formulation still fell within the scope of its patent, while Amgen maintained that its approach did not infringe because it lacked a distinct buffer component.

    Key Legal Issues

    The central legal question in this case revolved around claim construction—specifically, whether the language of the ’865 patent required the VEGF antagonist and the buffer to be separate components. The court’s analysis focused on the following issues:

    1. Claim Construction and the Becton Doctrine

    The court applied the principle established in Becton, Dickinson & Co. v. Tyco Healthcare Grp., which states that where a patent claim lists components separately, there is a presumption that they are distinct. Since the ’865 patent separately lists the VEGF antagonist and the buffer, the Federal Circuit found that the presumption of distinctness applied.

    Regeneron argued that the buffer requirement could be satisfied by the VEGF antagonist itself, given its buffering capacity. However, the court rejected this argument, emphasizing that the claim structure and specification reinforced the requirement that the buffer must be a separate component.

    2. The Role of Intrinsic and Extrinsic Evidence

    The court reviewed both intrinsic evidence (the patent claims and specification) and extrinsic evidence (expert testimony and scientific literature) to determine the meaning of the disputed claim terms. The specification described formulations where a VEGF antagonist was always accompanied by a separate buffer. Moreover, the examples and embodiments consistently treated the buffer as a distinct component.

    While Regeneron presented extrinsic evidence suggesting that proteins like aflibercept could function as buffers, the court found this insufficient to override the intrinsic evidence. The ruling underscored the principle that claim construction must align with the patent’s written description rather than rely on broad interpretations supported by external sources.

    3. Implications for Biosimilar Litigation

    A key takeaway from this case is how courts interpret claims involving biosimilars. The ruling reinforces that companies developing biosimilars can avoid infringement if they modify formulations in a way that eliminates explicitly claimed components. Amgen’s strategy of using a self-buffering formulation proved successful in distinguishing ABP 938 from Eylea in a legally meaningful way.

    Conclusion

    The Federal Circuit’s decision in Regeneron v. Amgen sets an important precedent for biologic patent disputes. It highlights the significance of precise claim drafting and underscores the challenges in asserting broad interpretations of patent scope. For companies engaged in biosimilar development, this ruling provides a roadmap for designing around existing patents by focusing on structural distinctions in formulation components.

    This case serves as a reminder that in patent litigation, the wording of claims and the clarity of specifications are critical. While Regeneron’s patent remains valid, its enforceability against biosimilars like Amgen’s ABP 938 has been significantly weakened. As the biosimilar market continues to grow, expect more litigation focused on claim construction and the interpretation of formulation patents.

    By Charles Gideon Korrell

  • In re Xencor: Written Description and Preamble Limitations

    In re Xencor: Written Description and Preamble Limitations

    On March 13, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in In re Xencor, Inc., affirming the rejection of Xencor’s patent application for failing to meet the written description requirement under 35 U.S.C. § 112. This case raises important considerations regarding patent claim construction, particularly the treatment of Jepson claims and the role of preamble language in determining the scope of an invention.

    Background of the Case

    Xencor, Inc. filed U.S. Patent Application No. 16/803,690, seeking protection for modified anti-C5 antibodies with increased in vivo half-life, which could potentially improve treatments for autoimmune diseases. The Patent Trial and Appeal Board (PTAB) rejected Xencor’s claims on the grounds that they lacked sufficient written description. Xencor appealed the decision, leading to a review by the Appeals Review Panel (ARP) and ultimately by the Federal Circuit.

    Key Legal Issues

    1. Written Description Requirement

    Under 35 U.S.C. § 112, a patent’s specification must provide a clear and precise written description of the claimed invention. The court found that Xencor’s application failed to demonstrate that the company had possession of the full scope of its claimed invention at the time of filing. Specifically:

    • The application disclosed only one anti-C5 antibody (5G1.1), which the court found insufficient to support a broad genus claim covering all anti-C5 antibodies.
    • The specification lacked data or examples demonstrating the treatment of any disease using an anti-C5 antibody with the claimed modifications.

    The court emphasized that for claims involving biological inventions, written description sufficiency depends on the predictability of the field. Since antibodies have varying specificities and epitopes, a broader disclosure was necessary.

    2. Role of Preamble Language in Claim Construction

    A major point of contention was whether the preamble in Xencor’s method claim was limiting. The claim preamble recited, “A method of treating a patient by administering an anti-C5 antibody…” Xencor argued that “treating a patient” was merely a statement of purpose and should not require written description. However, the court held that:

    • The preamble was necessary to give meaning to the claim, particularly in relation to the claimed “increased in vivo half-life.”
    • The phrase “treating a patient” could not be separated from “administering an anti-C5 antibody,” making it an essential part of the invention.
    • Since the specification failed to provide examples or data supporting the therapeutic effect of the modified antibodies, the claim lacked sufficient written description.

    This ruling underscores that patentees cannot rely on preamble language to define the scope of an invention while avoiding corresponding disclosure requirements.

    3. Jepson Claims and Their Written Description Requirement

    The case also addressed whether Jepson claims—which define an invention as an improvement over prior art—require written description for both the improvement and the prior art elements. The court ruled that:

    • A Jepson claim’s preamble is part of the invention and, therefore, requires written description support.
    • Xencor failed to establish that anti-C5 antibodies were well-known in the prior art, meaning additional written description was needed.
    • Simply asserting that something is conventional does not relieve the applicant of the obligation to provide sufficient disclosure.

    This clarification is significant for applicants using Jepson claims, as it reinforces that both the improvement and the prior art must be supported by adequate written description.

    Implications for Patent Applicants

    The In re Xencor decision serves as a cautionary tale for patent applicants in the biotechnology and pharmaceutical fields:

    1. Broad Genus Claims Require Broad Support – Disclosing a single species within a broad genus may not be sufficient if the field is unpredictable.
    2. Preambles Can Be Limiting – If preamble language gives life and meaning to a claim, it will be treated as a limitation requiring written description support.
    3. Jepson Claims Require Complete Written Description – If using a Jepson claim, applicants must provide written support for both the claimed improvement and the elements stated to be prior art.

    Conclusion

    The Federal Circuit’s decision in In re Xencor, Inc. reaffirms the importance of the written description requirement, particularly for complex biological inventions. Patent applicants should ensure that their specifications provide sufficient disclosure to support the full scope of their claims, especially when using Jepson claim structures or asserting broad genus claims in unpredictable fields. This case highlights the necessity of careful patent drafting to avoid claim rejections based on insufficient written description.

    By Charles Gideon Korrell