Technology Information Law Blog by Charles Gideon Korrell

Tag: CAFC

  • 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

  • Merck v. Aurobindo: Patent Term Extensions and Reissued Patents

    Merck v. Aurobindo: Patent Term Extensions and Reissued Patents

    Introduction

    The Federal Circuit recently issued a significant ruling in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., clarifying how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act. The court upheld the U.S. Patent and Trademark Office’s (PTO) decision to calculate the PTE for a reissued patent based on the original patent’s issue date, rather than the reissued patent’s date. This decision has major implications for pharmaceutical patents, regulatory review, and generic drug market entry.

    Background of the Case

    The case involved Merck’s reissued U.S. Patent No. RE44,733 (the “RE’733 patent”), which originated from U.S. Patent No. 6,670,340 (the “’340 patent”). The ’340 patent covered the active ingredient sugammadex, used in Merck’s BRIDION® drug. Due to the lengthy FDA approval process, Merck applied for a five-year PTE to compensate for the regulatory delay. The PTO granted the extension based on the ’340 patent’s original issue date, allowing the RE’733 patent to extend its exclusivity until 2026.

    Aurobindo and other generic manufacturers challenged this extension, arguing that the PTE should be calculated based on the reissued patent’s issue date, which would result in a significantly shorter extension. This dispute centered on the interpretation of 35 U.S.C. § 156(c) and whether “the patent” in the statute referred to the original or reissued patent.

    Key Legal Issues

    1. Interpretation of Patent Term Extensions for Reissued Patents
      • The primary legal issue was whether the term “the patent” in 35 U.S.C. § 156(c) refers to the original patent or the reissued patent when calculating a PTE.
      • The court affirmed that, for PTE purposes, the original patent’s issue date should be used, aligning with the intent of the Hatch-Waxman Act to compensate patent holders for lost market exclusivity during regulatory review.
    2. Statutory Construction and the Hatch-Waxman Act
      • The court emphasized that statutory interpretation should consider the broader context and purpose of the law, not just a plain-text reading.
      • It ruled that denying a PTE based on a reissued patent’s later issue date would undermine the Hatch-Waxman Act’s goal of incentivizing pharmaceutical innovation.
    3. Impact on Generic Drug Approvals and Litigation
      • The ruling affects how generic manufacturers time their Abbreviated New Drug Applications (ANDAs) and plan for Paragraph IV certifications.
      • By affirming the PTO’s method of calculating PTEs, the decision reinforces the stability of patent rights and regulatory protections for brand-name drug manufacturers.

    Court’s Conclusion

    The Federal Circuit affirmed the district court’s decision, holding that Merck’s RE’733 patent was entitled to a PTE based on the original ’340 patent’s issue date. This ruling ensures that reissued patents inheriting the original patent’s claims can benefit from the full term extension granted under the Hatch-Waxman Act.

    Implications for Patent Holders and Generic Drug Makers

    • For patent holders: This decision reinforces the strength of reissued patents and provides a clear precedent for how PTEs will be calculated moving forward.
    • For generic manufacturers: The ruling underscores the importance of carefully analyzing PTEs in litigation strategies, as challenges based on reissue dates are unlikely to succeed.

    The decision in Merck v. Aurobindo highlights the ongoing complexities in pharmaceutical patent law and the delicate balance between encouraging innovation and promoting generic drug competition. It sets a clear precedent for future PTE disputes and offers critical guidance to both patent holders and the generic drug industry.

    By Charles Gideon Korrell

  • Trademark Showdown: Bullshine Distillery v. Sazerac Brands and the FIREBALL Controversy

    Trademark Showdown: Bullshine Distillery v. Sazerac Brands and the FIREBALL Controversy

    On March 12, 2025, the Federal Circuit handed down its decision in Bullshine Distillery LLC v. Sazerac Brands, LLC, a case that highlights fundamental principles in trademark law, particularly the concepts of genericness and likelihood of confusion under the Lanham Act. The court affirmed the Trademark Trial and Appeal Board’s (TTAB) ruling that Sazerac’s FIREBALL trademark is not generic and that there is no likelihood of confusion between FIREBALL and Bullshine’s proposed BULLSHINE FIREBULL mark.

    Background of the Case

    The dispute arose when Bullshine Distillery applied to register the mark BULLSHINE FIREBULL for alcoholic beverages. Sazerac, the owner of the well-known FIREBALL mark for whiskey and liqueurs, opposed the registration, claiming that the mark would likely cause confusion among consumers. Bullshine responded with a counterclaim, arguing that “fireball” was a generic term for whiskey or liqueur-based drinks and, as such, should not have been registered as a trademark.

    Key Legal Issues and the Court’s Analysis

    1. Genericness – When Is a Trademark Too Common to Register?

    Bullshine’s primary argument on appeal was that “fireball” had been used generically before Sazerac registered its mark. Under trademark law, a generic term cannot function as a trademark because it refers to the general category of goods rather than a specific brand.

    However, the Federal Circuit rejected Bullshine’s argument, clarifying that the proper time to assess genericness is at the time of trademark registration, not based on historical usage.

    The Weiss Noodle Argument: “Once Generic, Always Generic”

    To support its case, Bullshine relied on the 1961 decision in Weiss Noodle Co. v. Golden Cracknell & Specialty Co., which had denied trademark registration for “haluska”, the Hungarian word for noodles. The court in Weiss Noodle held that a common name for a product can never gain trademark protection, no matter how strongly it becomes associated with a specific brand.

    Bullshine argued that if “fireball” had ever been used generically for an alcoholic drink, it should be forever barred from trademark protection under this principle.

    However, the Federal Circuit rejected this rigid approach, explaining that:

    • Genericness must be assessed at the time of registration, not based on historical use. Even if a word had once been generic, it could later acquire distinctiveness as a brand name.
    • Consumer perception controls – A term’s meaning can evolve, and what matters is how consumers understood the term when Sazerac registered it in 2001 and 2008.
    • The Lanham Act allows for cancellation of trademarks that later become generic (15 U.S.C. § 1064(3)), but it does not impose a “once generic, always generic” rule.

    Thus, because there was no strong evidence that “fireball” was understood as generic in 2001 or 2008, the court upheld Sazerac’s trademark rights. This aligns with recent Supreme Court precedent in Booking.com v. USPTO, which rejected rigid rules in favor of evaluating actual consumer perception.

    2. Likelihood of Confusion – Can FIREBALL and FIREBULL Coexist?

    Sazerac also cross-appealed, arguing that the TTAB erred in finding that BULLSHINE FIREBULL was not likely to cause confusion with FIREBALL.

    The likelihood of confusion analysis is based on the DuPont factors, which consider various elements such as the similarity of the marks, the strength of the senior mark, and the nature of the goods.

    The court found:

    • FIREBALL is commercially strong but conceptually weak – While FIREBALL is widely recognized, the term is suggestive of a product’s cinnamon flavor, making it less distinctive.
    • The marks are dissimilar in overall impression – The addition of “BULLSHINE” and the reversal of word order made BULLSHINE FIREBULL visually and phonetically distinct from FIREBALL.
    • No evidence of actual confusion – There was no significant evidence that consumers would confuse the two brands in the marketplace.

    Thus, the court affirmed the TTAB’s ruling that there was no likelihood of confusion.

    Key Takeaways from the Decision

    1. Genericness is assessed at the time of registration – A term’s prior usage does not automatically make it generic for all time.
    2. The “once generic, always generic” rule was rejected – The court refused to apply the rigid approach from Weiss Noodle and instead focused on consumer perception at the time of registration.
    3. Strength of a trademark depends on commercial and conceptual distinctiveness – Even a well-known mark like FIREBALL can be conceptually weak if it is descriptive of a product’s attributes.
    4. Trademark disputes require a careful likelihood of confusion analysis – Minor differences in a mark’s wording, order, and overall impression can be enough to distinguish it from an established brand.

    Final Thoughts

    This case serves as a reminder that trademark law is about consumer perception, not just historical technicalities. The decision ensures that while brand owners can enforce their rights, competitors still have room to create new branding without unnecessary restrictions. It also reinforces a modern, flexible approach to trademark law, ensuring that consumer understanding at the time of registration—not outdated historical use—controls the validity of a trademark.ictions.

    By Charles Gideon Korrell

  • Sierra Wireless v. Sisvel: (Dis)Qualification of Expert Witnesses in the PTAB

    Sierra Wireless v. Sisvel: (Dis)Qualification of Expert Witnesses in the PTAB

    In its March 10, 2025 decision in Sierra Wireless, ULC v. Sisvel S.p.A., the Federal Circuit vacated a Patent Trial and Appeal Board (PTAB) decision due, in part, to the improper reliance on an expert witness who was not shown to possess the qualifications of a person of ordinary skill in the art (POSITA). For patent litigators and practitioners navigating IPR proceedings, the court’s analysis serves as a reminder of the evidentiary standards governing expert testimony.

    Background

    Sisvel’s U.S. Patent No. 7,869,396 covers an ARQ method in wireless communications. The appellants—Sierra Wireless, Honeywell, and Telit Cinterion—challenged all claims in IPR, asserting anticipation and obviousness based on a prior international application (“Sachs”).

    The PTAB held the independent claims (1, 2, and 6–8) unpatentable but upheld the dependent claims (3–5, 9, 10). Both parties appealed. On appeal, the Federal Circuit took particular issue with how the Board assessed expert testimony from Sisvel’s declarant, Regis Bates.

    Expert Qualifications: The Core of the Dispute

    Appellants argued the PTAB improperly relied on Bates’ declarations despite his failure to meet the Board’s own definition of a POSITA. Specifically, the Board had defined a POSITA as someone with:

    • A degree in electrical engineering or a similar discipline, and
    • At least three years of relevant industry or research experience in wireless radio systems for data transmission and retransmission.

    Bates lacked a technical degree and had no clear experience designing transmission/retransmission methods in cellular networks. Nonetheless, his testimony was repeatedly cited by the Board in support of its obviousness and anticipation findings.

    The Federal Circuit agreed with the appellants, citing Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369 (Fed. Cir. 2022), to reaffirm that a witness must possess at least the ordinary skill in the art to opine on claim construction, anticipation, and obviousness. The Board’s reliance on Bates, without addressing whether his decades of telecommunications experience could substitute for formal qualifications, was deemed an abuse of discretion.

    Practical Takeaways

    • POSITA matters: A witness’s qualifications must align with the Board’s (or court’s) definition of a skilled artisan. Practitioners should be prepared to establish this alignment explicitly—especially in PTAB proceedings, where the evidentiary record is often limited to declarations and cross-examination.
    • Challenge early and clearly: Raise challenges to expert qualifications as early as possible. In this case, the issue was preserved and ultimately reversed a PTAB finding.
    • Substance over longevity: Even decades of experience in a general field may not suffice if it doesn’t map to the specific technical area required under the POSITA standard.

    Final Thoughts

    As patent practitioners continue to leverage expert declarations in IPRs and litigation, Sierra Wireless underscores the importance of tightly linking an expert’s credentials to the POSITA definition. Courts will not hesitate to vacate Board decisions that rest on testimony from unqualified experts—regardless of the expert’s experience or the PTAB’s apparent confidence.

    By Charles Gideon Korrell

  • Federal Circuit Vacates PTAB Decision in CQV Co. v. Merck Patent GmbH, Raising Key Issues in Patent Infringement and Prior Art Analysis

    The United States Court of Appeals for the Federal Circuit recently issued an opinion in CQV Co., Ltd. v. Merck Patent GmbH, vacating and remanding the Patent Trial and Appeal Board (PTAB) decision regarding U.S. Patent No. 10,647,861. The ruling focuses on key legal issues related to patent infringement, prior art determination, and procedural fairness in PTAB proceedings.

    Background of the Case

    Merck Patent GmbH owns U.S. Patent No. 10,647,861, which claims α-Al2O3 (“alpha-alumina”) flakes used in industrial coatings, automotive coatings, printing inks, and cosmetic formulations. The patent purports that these flakes provide improved optical properties compared to prior art.

    CQV Co., Ltd. petitioned the PTAB for post-grant review, arguing that claims 1–22 of the ’861 patent were unpatentable as obvious in light of prior art, including the commercial product Xirallic®. The PTAB, however, found that CQV failed to prove by a preponderance of the evidence that the cited prior art (Xirallic®) was publicly available before the patent’s critical date and rejected CQV’s invalidity challenge. CQV appealed to the Federal Circuit.

    Key Legal Issues Addressed by the Court

    1. Prior Art and the Burden of Proof

    A central issue in the appeal was whether CQV sufficiently established that Xirallic® was prior art before the patent’s critical date. Under patent law, a reference must be publicly available before the critical date to qualify as prior art. The court scrutinized the PTAB’s analysis and found that the Board improperly disregarded unrebutted evidence from CQV indicating that the product was available to the public.

    The Federal Circuit emphasized that, while petitioners bear the burden of proving prior art status, they need only meet the preponderance of the evidence standard. The Board, in rejecting CQV’s argument, failed to fully consider critical evidence that supported Xirallic®’s availability, including testimony on quality control procedures and sales records.

    2. Standing in Post-Grant Review Appeals

    Merck challenged CQV’s standing to appeal the PTAB decision, arguing that CQV had not suffered a concrete injury. The Federal Circuit rejected this argument, holding that CQV had demonstrated a sufficient injury-in-fact based on Merck’s communications with CQV’s customers alleging infringement of the ’861 patent. Because CQV was contractually obligated to indemnify one of its customers against infringement claims, the court found that CQV had standing under Arris Grp., Inc. v. British Telecomms. PLC, which recognizes standing for suppliers who face indirect threats of litigation.

    3. Failure to Consider the Entirety of the Record

    The court criticized the PTAB for failing to consider all relevant evidence regarding the availability of Xirallic® as prior art. Specifically, it noted that the Board omitted testimony from CQV’s expert that contradicted the Board’s conclusion. The Federal Circuit reiterated that the Administrative Procedure Act (APA) requires the Board to fully explain its decisions and consider all material evidence. The failure to do so necessitated vacating and remanding the decision for reconsideration.

    Implications for Patent Litigation and PTAB Proceedings

    This decision highlights several important aspects of patent law:

    • Patent challengers must present compelling evidence to establish prior art status, but the PTAB must also fairly weigh all available evidence when making its determinations.
    • Standing in post-grant review appeals may be established through indemnity obligations, reinforcing the ability of suppliers to challenge patents that may indirectly affect them.
    • The Federal Circuit continues to hold PTAB accountable for failing to properly consider the record, signaling that procedural fairness remains a key concern in administrative patent proceedings.

    Conclusion

    The Federal Circuit’s ruling in CQV Co. v. Merck Patent GmbH serves as a significant reminder of the evidentiary and procedural standards that govern PTAB proceedings. By vacating the PTAB’s decision, the court reinforced the importance of a thorough and fair assessment of prior art claims and set a precedent for future disputes involving commercial products as prior art. As the case returns to the Board for further consideration, patent litigators and stakeholders will be watching closely to see how the PTAB reevaluates the evidence in light of the Federal Circuit’s guidance.

    By Charles Gideon Korrell

  • Federal Circuit Revives Patent Infringement Case Over Quick-Release Tactical Vest System

    In a recent decision, the United States Court of Appeals for the Federal Circuit vacated a district court’s summary judgment ruling of noninfringement in IQRIS Technologies LLC v. Point Blank Enterprises, Inc., and National Molding, Inc. The ruling focuses on a dispute over the proper interpretation of the term “pull cord” in IQRIS Technologies’ patents for quick-release systems used in tactical vests. The decision addresses key issues in patent law, including claim construction, literal infringement, and the doctrine of equivalents.

    Background of the Case

    IQRIS Technologies LLC (“IQRIS”) sued Point Blank Enterprises and National Molding (collectively, “Defendants”) for allegedly infringing U.S. Patent Nos. 7,814,567 and 8,256,020. These patents cover quick-release mechanisms for tactical vests, designed to allow soldiers and first responders to rapidly remove their vests in emergency situations. The accused products, Point Blank’s tactical vests using National Molding’s “Quad Release” and “Evil Twin” quick-release systems, were alleged to infringe on these patents.

    Defendants moved for summary judgment, arguing that their products did not infringe because they lacked a “pull cord” as required by the claims. The district court agreed, construing the term “pull cord” to mean a “cord that can be directly pulled by a user to disengage a releasable fastener or hook.” Because Defendants’ products used Bowden cables—flexible, sheathed cables actuated by a trigger—the district court held they did not meet the patent claim requirements and granted summary judgment of noninfringement.

    Issues of Law Addressed by the Court

    1. Claim Construction – What Constitutes a “Pull Cord”?

    One of the most critical aspects of the case was the interpretation of the term “pull cord.” The district court had narrowly construed “pull cord” as requiring direct pulling by the user, excluding designs incorporating triggers or handles. The Federal Circuit, however, found this construction too restrictive, emphasizing that the patent claims did not explicitly require direct pulling and that nothing in the specification clearly disavowed the inclusion of a handle or intermediary mechanism.

    This ruling aligns with longstanding Federal Circuit precedent cautioning against importing limitations from preferred embodiments into the claims unless the patentee has expressly redefined the term or disavowed broader interpretations. By overturning the district court’s construction, the Federal Circuit ensured that IQRIS could argue that the accused products’ mechanisms fell within the scope of the asserted patent claims.

    2. Literal Infringement and the Doctrine of Equivalents

    Given its narrow construction of “pull cord,” the district court concluded that the accused products did not literally infringe because their Bowden cable system was indirectly actuated by a trigger rather than being directly pulled. It also found no infringement under the doctrine of equivalents, reasoning that the accused system provided a “mechanical advantage” over the claimed invention and that a finding of equivalency would ensnare prior art.

    The Federal Circuit disagreed, ruling that the lower court’s reasoning improperly relied on an overly restrictive claim interpretation. The appellate court emphasized that while prior art considerations are relevant to the doctrine of equivalents, the patent specification did not criticize handles per se, only the tedious reassembly process associated with certain prior art systems. Because the district court’s ruling was based on an erroneous claim construction, the Federal Circuit vacated the summary judgment and remanded the case for further proceedings.

    Implications for Patent Law and Intellectual Property

    This case highlights several important principles in patent law:

    • Claim Scope and Construction: Courts must be careful not to limit claim terms to specific embodiments unless there is a clear disavowal or redefinition in the specification.
    • Doctrine of Equivalents: When determining infringement under the doctrine of equivalents, courts must avoid improperly excluding systems that achieve substantially the same function, in the same way, to achieve the same result.
    • Impact on Future Litigation: The decision underscores the importance of precise claim drafting and the risks associated with overly narrow claim constructions. Patent owners must ensure their claims are drafted broadly enough to cover alternative implementations while avoiding prior art limitations.

    Conclusion

    The Federal Circuit’s ruling revives IQRIS’s infringement claims and provides an opportunity for further fact-finding on remand. This case serves as a reminder that claim construction disputes can significantly impact infringement determinations and that patentees should carefully define their terms to avoid unnecessary limitations on claim scope. As the case returns to the district court, the parties will now litigate under a broader interpretation of “pull cord,” which could ultimately affect the outcome on infringement and potential damages.

    Patent litigants should take note of this decision, as it reinforces the importance of claim language and how courts interpret key patent terms in infringement disputes.

    By Charles Gideon Korrell

  • Patent Battles in Wearable Tech: AliveCor v. Apple and the Fight Over Arrhythmia Detection

    Patent Battles in Wearable Tech: AliveCor v. Apple and the Fight Over Arrhythmia Detection

    On March 7, 2025, the Federal Circuit issued its decision in AliveCor, Inc. v. Apple Inc., upholding the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling that invalidated AliveCor’s patents on heart rate monitoring technology. The case has significant implications for the wearable technology industry, particularly in the areas of patentability, obviousness, and the interplay between patent litigation and administrative patent challenges.

    Background of the Case

    AliveCor, a medical technology company, held patents covering systems and methods for detecting cardiac arrhythmias using wearable devices. The key patents in dispute—U.S. Patent Nos. 9,572,499, 10,595,731, and 10,638,941—described a technology involving smartwatches equipped with photoplethysmography (PPG) sensors to monitor heart rate, notify users of irregularities, and prompt them to conduct electrocardiogram (ECG) recordings for further analysis.

    Apple challenged these patents through inter partes review (IPR) at the PTAB, arguing that the claims were obvious in light of prior art references. The Board ruled in Apple’s favor, finding that the claims lacked novelty. AliveCor appealed to the Federal Circuit, arguing that the PTAB’s conclusions on obviousness were incorrect and that Apple had withheld evidence relevant to secondary considerations of non-obviousness.

    Key Legal Issues

    1. Obviousness of Machine Learning-Based Arrhythmia Detection

    AliveCor’s patents included claims requiring the use of machine learning algorithms to detect arrhythmias based on heart rate data. The court affirmed the PTAB’s determination that this approach was obvious in view of prior art references, particularly:

    • Hu 1997: A study describing a patient-adaptable ECG classifier that employed machine learning to detect cardiac conditions.
    • Li 2012: A research paper discussing the use of machine learning to reduce false arrhythmia alarms by integrating multiple physiological signals.
    • Shmueli Patent Application (2012): A prior patent application disclosing a wrist-mounted heart monitoring device that used both PPG and ECG data to detect and confirm irregular heart activity.

    The Federal Circuit concluded that a person of ordinary skill in the art would have been motivated to combine these techniques, reinforcing the Board’s finding that AliveCor’s claimed use of machine learning was not sufficiently novel.

    2. “Confirmation” Step in Arrhythmia Detection

    Another key issue was whether the requirement to confirm an arrhythmia using ECG data was patentable. AliveCor argued that its method—detecting arrhythmia using PPG data and then confirming it using an ECG—was unique. However, Apple successfully argued that Shmueli already disclosed this concept. The PTAB and the Federal Circuit both found that a skilled artisan would have found it obvious to confirm PPG-based arrhythmia detection with ECG, leading to the invalidation of the relevant claims.

    3. Failure to Produce Secondary Consideration Evidence

    AliveCor also contended that Apple failed to disclose evidence from a parallel International Trade Commission (ITC) investigation, which had considered secondary indicators of non-obviousness, such as commercial success and industry praise. AliveCor claimed that Apple’s withholding of this evidence violated discovery obligations.

    However, the Federal Circuit found that AliveCor had forfeited this argument by failing to raise the issue before the PTAB. The court emphasized that procedural diligence is essential in IPR proceedings and that issues must be timely presented to be considered on appeal.

    Implications for Intellectual Property Law

    This decision underscores several critical points in patent law and intellectual property strategy:

    • Obviousness in Emerging Technologies: Courts and the PTAB continue to scrutinize patents in fast-evolving fields like machine learning and wearable tech, often finding that incremental improvements fail to meet the non-obviousness requirement.
    • Interplay Between Patent Litigation and IPRs: The case highlights the increasing role of inter partes reviews in invalidating patents that might otherwise survive district court litigation.
    • Procedural Rigor in Patent Challenges: Parties must be meticulous in raising all relevant issues during PTAB proceedings; failure to do so may result in forfeiture on appeal.

    Conclusion

    The Federal Circuit’s decision in AliveCor v. Apple represents a significant win for Apple and a cautionary tale for patent holders in the medical technology space. As courts and administrative bodies continue to apply strict standards for patent validity, companies seeking to protect their innovations must ensure their patents contain clear, non-obvious advancements over existing technology. Moreover, maintaining procedural diligence in parallel patent litigation and administrative proceedings is crucial to avoiding unfavorable rulings on appeal.

    As wearable health technology continues to advance, the legal battles over patentability will shape the competitive landscape, influencing which companies can dominate the market with their innovations.

    By Charles Gideon Korrell

  • Patent Law and Drug Innovation: Federal Circuit Upholds Rejection of ImmunoGen’s Patent Application

    On March 6, 2025, the Federal Circuit issued its opinion in ImmunoGen, Inc. v. Stewart, affirming the district court’s ruling that denied ImmunoGen’s patent application for a dosing regimen of its antibody drug conjugate (ADC), IMGN853. The court’s decision, rooted in key principles of intellectual property law, particularly focused on the doctrines of indefiniteness and obviousness. This case highlights ongoing challenges in securing patents for pharmaceutical dosing regimens and underscores the high bar for patentability in the biotechnology sector.

    Background of the Case

    ImmunoGen sought a patent for a specific dosing regimen of IMGN853, a drug used to treat ovarian and peritoneal cancers. The key claim at issue involved administering IMGN853 at a dose of 6 milligrams per kilogram (mg/kg) of adjusted ideal body weight (AIBW). The U.S. Patent and Trademark Office (USPTO) rejected the application, a decision that was subsequently affirmed by the Patent Trial and Appeal Board (PTAB). ImmunoGen then pursued relief in the Eastern District of Virginia under 35 U.S.C. § 145, which allows applicants to challenge USPTO decisions in district court.

    Following a bench trial, the district court ruled against ImmunoGen, determining that the claimed invention was fatally indefinite, obvious in light of prior art, and unpatentable under the doctrine of obviousness-type double patenting. ImmunoGen appealed to the Federal Circuit, which affirmed the lower court’s ruling based on obviousness.

    Key Legal Issues

    1. Obviousness Under 35 U.S.C. § 103

    The Federal Circuit upheld the rejection of ImmunoGen’s patent claims on the grounds that they were obvious in light of prior art. The court applied the well-established Graham v. John Deere Co. framework, which requires assessing:

    • The scope and content of the prior art
    • Differences between the prior art and the claims at issue
    • The level of ordinary skill in the art
    • Any secondary considerations (such as commercial success or unexpected results)

    The court found that a person of ordinary skill in the art would have been motivated to try the claimed dosing regimen based on existing knowledge of ocular toxicity risks associated with ADCs, prior dosing methodologies, and available clinical data. The decision emphasized that AIBW was a known dosing methodology in the prior art, and adjusting dosage to reduce toxicity was a routine optimization.

    2. The Role of Prior Art in Determining Obviousness

    The court found that:

    • Existing literature disclosed IMGN853 and its dosing regimens based on total body weight (TBW).
    • Previous studies had explored adjusted dosing strategies (including AIBW) to reduce toxicity in related drug classes.
    • A person of ordinary skill in the art would have been able to transition from TBW to AIBW dosing as an obvious variation, especially since AIBW dosing had been previously used to reduce ocular toxicity for other drugs.

    Ultimately, because the claimed dose of 6 mg/kg AIBW was within the range of known effective doses, the court determined that the invention was a predictable result of routine experimentation rather than an unexpected innovation.

    3. Indefiniteness Under 35 U.S.C. § 112

    While the Federal Circuit did not rule on indefiniteness, the district court’s decision noted that the application failed to define AIBW adequately, leaving ambiguity in the claim’s scope. Courts require patent claims to be sufficiently clear so that a person of ordinary skill in the art can ascertain the precise bounds of the invention.

    The district court found that multiple formulas for AIBW existed, creating uncertainty about which formula applied to ImmunoGen’s claims. This contributed to the court’s ruling that the patent claims were fatally indefinite, making them unenforceable.

    4. Obviousness-Type Double Patenting

    The government also argued that the claims were unpatentable under the doctrine of obviousness-type double patenting, which prevents an inventor from obtaining multiple patents on obvious variations of the same invention. The district court found that ImmunoGen’s claims were largely duplicative of its previous patents, reinforcing the determination of obviousness. However, on appeal, both parties agreed that the double patenting issue rose and fell with the obviousness analysis, making further discussion unnecessary.

    Implications for the Biotechnology and Pharmaceutical Industries

    This decision underscores the high threshold for patentability in pharmaceutical dosing regimens. Courts have consistently ruled that dosing adjustments—particularly those based on well-known methodologies—are often seen as routine optimizations rather than true inventions. This presents significant challenges for drug developers seeking patent protection for new dosing strategies.

    Key takeaways from this case include:

    • Drug manufacturers must provide clear evidence of unexpected results to differentiate dosing regimen patents from routine experimentation.
    • Precision in claim drafting is critical to avoid indefiniteness challenges.
    • Applicants should consider alternative strategies, such as method-of-use claims tied to specific patient populations or therapeutic effects, to enhance patentability.

    Conclusion

    The Federal Circuit’s ruling in ImmunoGen, Inc. v. Stewart reinforces longstanding principles in patent law regarding obviousness and claim definiteness. While pharmaceutical innovators continue to seek patent protection for dosing regimens, this case demonstrates the difficulties of overcoming obviousness rejections, particularly where prior art provides clear guidance on dosage adjustments. Moving forward, companies seeking similar patents will need to present strong, non-obvious justifications to withstand legal scrutiny and secure valuable intellectual property protections.

    By Charles Gideon Korrell

  • Navigating Patent Law After Arthrex: The Federal Circuit’s Decision in Odyssey Logistics v. Stewart

    The Federal Circuit’s recent decision in Odyssey Logistics & Technology Corp. v. Stewart (No. 23-2077) highlights the ongoing implications of the Supreme Court’s Arthrex decision on the United States Patent and Trademark Office (USPTO) and its review processes. This case revolves around a long-disputed patent application, constitutional challenges under the Appointments Clause, and the procedural limitations of post-judgment review in intellectual property cases.

    Case Background

    Odyssey Logistics & Technology Corporation filed U.S. Patent Application No. 11/678,021 in 2007 for a “Web Service Interface for Transit Time Calculation,” which proposed an online logistics system for real-time freight shipment tracking. The patent examiner rejected claims 3–21 of the application in 2015, concluding that they were directed to an abstract idea—simply looking up transit times using conventional computer functions. The Patent Trial and Appeal Board (PTAB) affirmed this rejection in 2018, and the Federal Circuit upheld that decision in In re Tarasenko (2020).

    However, after the Supreme Court’s 2021 decision in United States v. Arthrex, Inc., which found that the unreviewable authority of PTAB administrative patent judges violated the Appointments Clause, Odyssey attempted to invoke Arthrex to request post-judgment Director review of its rejected claims. When the USPTO denied this request, Odyssey turned to the courts, arguing that it was entitled to such a review. The Eastern District of Virginia dismissed Odyssey’s claim, and the Federal Circuit has now affirmed that dismissal.

    Key Legal Issues

    1. Appointments Clause Challenges in Patent Law

    The primary issue in this case was whether the Arthrex decision retroactively entitled Odyssey to Director review of a final PTAB decision. The Supreme Court’s Arthrex ruling established that PTAB administrative judges must operate under the oversight of the USPTO Director, but it did not automatically reopen previously decided cases. The Federal Circuit ruled that Odyssey forfeited its Appointments Clause challenge by failing to raise it during its direct appeal in Tarasenko, despite having ample notice of the Arthrex argument while its appeal was still pending.

    This decision underscores the importance of preserving constitutional arguments at the earliest opportunity. The Federal Circuit has consistently held that failure to raise an Appointments Clause challenge in a timely manner constitutes forfeiture. Odyssey’s delay of more than a year after the Federal Circuit’s mandate in Tarasenko led the court to deny its request.

    2. Limits on Agency Reconsideration of Final Decisions

    Odyssey argued that the USPTO should have reopened its case based on Arthrex, but the court rejected this claim. The Federal Circuit reiterated that administrative agencies possess inherent authority to reconsider their decisions within a reasonable timeframe but are not required to do so. In this case, the USPTO reasonably declined to revisit a case that had been fully adjudicated and closed.

    The court drew analogies to Rule 60(b) of the Federal Rules of Civil Procedure, which allows reconsideration of judgments under extraordinary circumstances. However, it noted that an intervening change in law (such as Arthrex) does not automatically justify reopening a final decision—especially when a party had the opportunity to raise the issue earlier but failed to do so.

    3. Finality in Patent Proceedings

    A key takeaway from this case is the court’s emphasis on finality in patent proceedings. Once the Federal Circuit has affirmed a PTAB decision and issued its mandate, the case is considered terminated. The Manual of Patent Examining Procedure (MPEP) § 1216.01 makes it clear that a rejected application cannot be reopened merely because of a subsequent change in law unless explicitly authorized. Odyssey’s attempt to revive its case was therefore seen as an improper collateral challenge.

    Implications for Patent Applicants and Practitioners

    This decision has significant implications for patent applicants navigating post-Arthrex challenges:

    • Timeliness is crucial: Constitutional challenges, including Appointments Clause objections, must be raised during direct review, not as an afterthought.
    • Finality in PTAB decisions remains strong: The Federal Circuit has reaffirmed that once an appeal has been decided, reopening proceedings is rare and requires compelling justification.
    • Limited scope of Director review: While Arthrex expanded the USPTO Director’s oversight, it did not create a blanket right to retroactive review of prior PTAB decisions.

    Conclusion

    The Federal Circuit’s ruling in Odyssey Logistics v. Stewart reinforces the principle that litigants must be diligent in preserving constitutional arguments and underscores the limited avenues for post-judgment reconsideration in patent law. Patent applicants seeking to challenge PTAB decisions must ensure they raise all possible claims during the appellate process or risk losing them permanently. As Arthrex continues to reshape aspects of patent litigation, this case serves as a cautionary tale about procedural timing and the doctrine of finality in administrative law.

    By Charles Gideon Korrell

  • Court of Appeals Decision in Lashify, Inc. v. International Trade Commission: Key Takeaways

    On March 5, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Lashify, Inc. v. International Trade Commission, a case concerning intellectual property rights in the context of international trade and the domestic industry requirement under Section 337 of the Tariff Act of 1930. The ruling has significant implications for patent enforcement at the U.S. International Trade Commission (ITC) and the interpretation of what constitutes a “domestic industry.”

    Background of the Case

    Lashify, Inc., a U.S.-based company, filed a complaint with the ITC alleging that several importers were violating Section 337 by importing and selling artificial eyelash extension products that infringed its patents. The patents at issue included:

    • U.S. Patent No. 10,721,984 (a utility patent related to lash extensions and their application process), and
    • U.S. Design Patent Nos. D877,416 and D867,664 (design patents covering a lash applicator and storage cartridge).

    To succeed under Section 337, Lashify had to demonstrate both patent infringement and the existence of a domestic industry relating to the patented products. The ITC ruled against Lashify, finding that it failed to satisfy the “economic prong” of the domestic industry requirement and that its own products did not practice the claimed invention of the ’984 patent.

    Key Legal Issues Addressed

    1. Domestic Industry Requirement Under Section 337

    One of the central legal issues was the interpretation of the “economic prong” of the domestic industry requirement under Section 337(a)(3), which requires a complainant to show:

    • (A) Significant investment in plant and equipment;
    • (B) Significant employment of labor or capital; or
    • (C) Substantial investment in the exploitation of the patent, including engineering, research and development, or licensing.

    The ITC found that Lashify’s domestic activities—sales, marketing, warehousing, quality control, and distribution—did not qualify as “significant employment of labor or capital” under subsection (B). The Federal Circuit rejected this interpretation, ruling that the ITC had applied an overly restrictive reading of the statute. The court held that Section 337 does not categorically exclude expenditures on sales, marketing, warehousing, quality control, and distribution. Instead, it directed the ITC to reassess Lashify’s expenditures under the correct legal framework.

    2. Claim Construction and the “Heat Fused” Limitation

    Another key issue was whether Lashify’s own lash extension products met the “heat fused” requirement in its ’984 patent. The ITC had determined that Lashify’s products did not satisfy the technical prong of the domestic industry test because they did not form a “single entity” as required by the claim construction.

    Lashify challenged this finding, arguing that “heat fused” should be interpreted more broadly. The Federal Circuit upheld the ITC’s construction, emphasizing that the claim language and specification supported the requirement that the fused fibers form a “single entity,” excluding methods that merely use glue as a binding agent. This ruling underscores the importance of precise claim drafting in patent applications and litigation.

    Implications for Intellectual Property Law

    This decision has several notable implications:

    1. Expanded Scope of Domestic Industry: The ruling clarifies that non-manufacturing activities, such as warehousing and marketing, can contribute to a domestic industry analysis under Section 337. This makes it easier for companies that primarily engage in sales and distribution to seek ITC protection against infringing imports.
    2. Stricter Standards for Proving Patent Practice: The court’s affirmation of the ITC’s claim construction reinforces the importance of clear patent drafting and claim scope. Patent holders must ensure that their claims are not so narrowly construed that their own products fail to qualify.
    3. Stronger ITC Jurisdiction Over Design Patents: Since the Federal Circuit vacated the ITC’s decision regarding the economic prong for the design patents, the case may lead to stronger ITC enforcement of design patents, which are often easier to enforce than utility patents due to their lack of technical-prong requirements.

    Conclusion

    The Lashify, Inc. v. ITC decision is a pivotal case in ITC intellectual property enforcement. It reinforces a broader interpretation of the domestic industry requirement, making it more accessible for U.S.-based companies relying on intellectual property protection. At the same time, it highlights the critical importance of robust patent claim drafting and the need to ensure that a company’s own products meet the claimed invention’s requirements. As the case heads back to the ITC on remand, the industry will be watching closely to see how these legal principles are applied in practice.

    By Charles Gideon Korrell