Technology Information Law Blog by Charles Gideon Korrell

Tag: patent law

  • 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

  • Federal Circuit Upholds Patentability of Stem Cell Technology in Restem v. Jadi Cell

    The United States Court of Appeals for the Federal Circuit recently issued a significant ruling in Restem, LLC v. Jadi Cell, LLC, upholding the validity of Jadi Cell’s U.S. Patent No. 9,803,176. This case, which originated from an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB), revolved around whether Restem could prove that Jadi Cell’s patent claims were unpatentable due to anticipation or obviousness. The Federal Circuit affirmed the PTAB’s decision, reinforcing critical aspects of intellectual property law, particularly regarding claim construction, inherent anticipation, and obviousness in biotechnology patents.

    Key Legal Issues in the Case

    1. Claim Construction and the Definition of “Isolated Cell”

    One of the central disputes in the case was the proper construction of the term “isolated cell” in Jadi Cell’s patent. Restem argued that an “isolated cell” should be construed as a single cell derived from the subepithelial layer of mammalian umbilical cord tissue. However, the Federal Circuit agreed with the PTAB’s construction that “isolated cell” referred to a cell population, based on how cell marker expression was analyzed in the industry and throughout the patent prosecution history. This interpretation was critical because it influenced how prior art disclosures were evaluated for anticipation and obviousness.

    2. Inherent Anticipation and Prior Art

    Restem challenged the patent on the grounds that prior art (specifically, the Majore reference) inherently anticipated the claimed invention. To establish inherent anticipation, Restem needed to show that following Majore’s process would necessarily and inevitably result in the claimed isolated cells. The court, however, found that the prior art did not disclose the specific cell marker expression profile required by the ‘176 patent. Because cell marker expression can depend on multiple variables, including cell-to-cell interactions and culture conditions, the court concluded that inherency had not been established.

    This ruling reinforces a fundamental principle in patent law: inherency must be more than just a possible or likely result—it must be a guaranteed outcome of the prior art.

    3. Obviousness and the Influence of Culture Media

    Restem also argued that the patent was obvious based on a combination of prior art references, including Kita, Majore, and other secondary references. One of the dependent claims (claim 9) specified that the isolated cells were cultured in media free of animal components. The PTAB ruled that claim 9 was non-obvious for two reasons: (1) Restem failed to prove that the prior art inherently produced the claimed cells, and (2) the record evidence suggested that animal components were commonly used in culture media at the time, making the patented method distinct.

    The Federal Circuit’s decision underscores the importance of demonstrating a clear motivation to combine prior art references and a reasonable expectation of success—both key requirements in proving obviousness.

    Implications for Intellectual Property Law

    This case has several important takeaways for intellectual property practitioners and companies in the biotechnology space:

    1. Claim Scope Matters: How patent claims are constructed and interpreted can make or break a validity challenge. The court’s recognition of “isolated cell” as referring to a population of cells rather than a single cell highlights the importance of precision in drafting patent claims and prosecution history estoppel.
    2. Inherent Anticipation Requires Certainty: Simply arguing that a prior art process might result in the patented invention is not enough. The challenger must show that the patented invention necessarily results from the prior art.
    3. Obviousness Requires Stronger Evidence: In biotechnology patents, particularly those involving complex biological processes, showing that a claimed invention was obvious requires clear evidence of motivation to combine references and a reasonable expectation of success.

    Conclusion

    The Federal Circuit’s ruling in Restem v. Jadi Cell is a crucial win for patent holders in the biotech industry, reaffirming that patents must be carefully analyzed before they are invalidated. The decision reinforces the standards for claim construction, inherency, and obviousness, ensuring that patent rights remain robust where innovation is demonstrated.

    As biotechnology and stem cell research continue to evolve, this case will likely serve as a precedent in future disputes over similar intellectual property rights. Companies and practitioners should take note of the court’s reasoning when drafting patent applications and preparing for potential challenges.

    By Charles Gideon Korrell

  • Federal Circuit Weighs in on Gesture-Based Patent Dispute: Key Takeaways for IP Law

    The Federal Circuit’s recent decision in Apple Inc. v. Gesture Technology Partners, LLC (March 2025) provides important insights into patent law, particularly in the context of inter partes review (IPR) proceedings and obviousness determinations. This ruling builds on the court’s earlier January 2025 decision in another dispute involving Gesture Technology Partners, reinforcing key legal principles regarding patent validity and the scope of IPR challenges.

    Below, we explore the major legal issues addressed in this case, how they connect to the January ruling, and what they mean for the future of intellectual property law in the tech industry.

    Background of the Case

    The dispute centers around U.S. Patent No. 7,933,431 (the ’431 patent), which relates to gesture-based input methods using cameras and optical sensors. Gesture Technology Partners, LLC (Gesture) sued Apple, LG Electronics, and Google for alleged infringement of the ’431 patent. Apple and its co-appellees petitioned for inter partes review (IPR), challenging the patent’s validity based on prior art.

    The Patent Trial and Appeal Board (PTAB) ruled that most claims were unpatentable but upheld claims 11 and 13. Apple appealed this decision, while Gesture cross-appealed, arguing that additional claims should remain valid.

    The Federal Circuit ultimately affirmed the PTAB’s findings, ruling that claims 1–10, 12, and 14–31 were unpatentable, while upholding claims 11 and 13.

    Connection to the January 2025 CAFC Decision

    This decision follows and reinforces the January 2025 ruling in Gesture Technology Partners, LLC v. Unified Patents LLC, another Federal Circuit case involving Gesture’s ’431 patent. In that case:

    • The Federal Circuit affirmed the PTAB’s finding that claims 7–9 and 12 were unpatentable, relying heavily on prior art disclosures in the Numazaki reference.
    • However, the court also upheld the PTAB’s ruling that claims 10, 11, and 13 were not unpatentable, which became a key point of contention in Apple’s subsequent appeal.

    The March 2025 ruling effectively follows the logic of the January 2025 decision, particularly in two major ways:

    1. Reaffirming PTAB’s Findings on Patent Validity:
      • Both cases emphasized that Numazaki disclosed fundamental aspects of gesture-based control, making most of Gesture’s claims obvious under 35 U.S.C. § 103.
      • The Federal Circuit consistently deferred to the PTAB’s factual findings regarding how Numazaki rendered certain claims unpatentable.
    2. Consistently Upholding Claims 11 and 13:
      • The January 2025 case upheld claims 10, 11, and 13, creating a foundation for Apple’s subsequent challenge.
      • In the March 2025 decision, Apple sought to overturn the PTAB’s finding on claims 11 and 13, arguing that the Board misapplied the obviousness standard—but the Federal Circuit again upheld these claims, reinforcing its prior stance.

    Together, these two decisions establish a strong precedent for how courts evaluate IPR outcomes, particularly in disputes involving expired patents and prior art analysis.

    Key Legal Issues Addressed by the Court

    1. Obviousness and Prior Art

    The primary legal issue in both cases was whether the patent claims were invalid due to obviousness under 35 U.S.C. § 103. The court ruled that most of the patent’s claims were obvious in light of prior art—particularly U.S. Patent No. 6,144,366 (Numazaki).

    • Apple argued that Numazaki disclosed similar technology and that a person of ordinary skill in the art would have found the claimed invention obvious.
    • Gesture countered that Numazaki did not sufficiently teach key elements of the ’431 patent, particularly its sensing and image-processing functionalities.

    In both cases, the court upheld the PTAB’s determinations, reaffirming that Numazaki was sufficient prior art to invalidate most claims.

    2. Inter Partes Review (IPR) Estoppel and Standing

    Apple faced a procedural challenge regarding IPR estoppel under 35 U.S.C. § 315(e)(1), which bars petitioners from re-litigating arguments that were (or could have been) raised in an earlier IPR.

    • Gesture argued that Apple should be estopped from challenging claims 11 and 13 because it was allegedly a real party in interest or privy of Unified Patents, the petitioner in the earlier January 2025 case.
    • The court rejected this argument, holding that Gesture had forfeited this claim by not raising it before the PTAB.

    This ruling aligns with the January 2025 decision, where the court emphasized that procedural challenges must be properly raised at the PTAB stage, not on appeal.

    3. Means-Plus-Function Claims and Claim Construction

    Another major issue was the interpretation of means-plus-function claims under 35 U.S.C. § 112, ¶ 6.

    • The March 2025 decision reaffirmed that Numazaki adequately disclosed structures corresponding to the claimed “sensing means” and “computer means” in the ’431 patent.
    • Gesture’s arguments that the Numazaki reference did not sufficiently disclose tracking and image analysis were rejected—just as they were in the January 2025 case.

    4. PTAB’s Jurisdiction Over Expired Patents

    Gesture made a broader challenge, arguing that the PTAB lacks jurisdiction over expired patents—a claim it also raised unsuccessfully in the January case.

    • The March 2025 ruling definitively rejected this argument, reaffirming the Federal Circuit’s prior holding that expired patents remain subject to IPR challenges.
    • This decision aligns with the court’s reasoning in January 2025, reinforcing that patent expiration does not shield invalid claims from IPR proceedings.

    Implications for Patent Holders and Tech Companies

    The two 2025 Federal Circuit rulings offer several key lessons for companies engaged in patent litigation, particularly in the tech sector:

    1. Strengthen Patent Drafting & Prosecution – Ensure patents are clearly distinct from prior art to withstand obviousness challenges.
    2. Raise Procedural Challenges Early – Issues like IPR estoppel and standing must be raised at the PTAB stage, not for the first time on appeal.
    3. Be Strategic About IPRs – Defendants should carefully assess prior art before filing an IPR to maximize their chances of invalidation.

    With the continued expansion of gesture-based and optical-sensing technology, these cases serve as important precedents in software and hardware patent disputes.

    Final Thoughts: A Consistent Approach to Patent Challenges

    The January and March 2025 decisions together paint a clear picture:

    • The Federal Circuit remains deferential to PTAB findings, particularly in IPR proceedings.
    • Courts continue to take a rigorous approach to obviousness analysis, ensuring that patents covering well-known technologies do not survive merely due to clever claim drafting.
    • Expired patents remain vulnerable to challenges under IPR, reinforcing the importance of early and thorough patent prosecution strategies.

    As the tech industry continues to develop new gesture-based and camera-driven input systems, these rulings may have far-reaching consequences for how such patents are drafted, enforced, and challenged in the future.

    By Charles Gideon Korrell

  • Federal Circuit Overturns ITC’s Patent Ineligibility Ruling in US Synthetic v. ITC

    On February 13, 2025, the United States Court of Appeals for the Federal Circuit issued its opinion in US Synthetic Corp. v. International Trade Commission, a case involving key issues in intellectual property law, particularly the eligibility of patent claims under 35 U.S.C. § 101 and the requirements for enablement under § 112. The Federal Circuit reversed the ITC’s conclusion that certain patent claims were directed to an abstract idea and, therefore, ineligible for patent protection, marking a significant decision for patent law concerning material compositions.

    Case Background

    US Synthetic Corp. (USS) filed a complaint with the International Trade Commission (ITC) alleging that several companies had violated Section 337 of the Tariff Act (19 U.S.C. § 1337) by importing and selling products that infringed its U.S. Patent No. 10,508,502 (the ’502 patent). The patent in question covers a polycrystalline diamond compact (PDC), a material used in drilling and machining applications.

    After an investigation, the ITC determined that the asserted claims of the ’502 patent were directed to an abstract idea and were thus patent-ineligible under § 101. The ITC’s ruling was based on its conclusion that the patent claims were primarily focused on certain magnetic properties of the PDCs, which it considered to be merely the result of the manufacturing process rather than structural limitations of the claimed composition.

    USS appealed this determination, arguing that the ITC had misapplied the Supreme Court’s Alice test and that the patent claims were not abstract but instead directed to a specific, novel composition of matter.

    Federal Circuit’s Analysis and Ruling

    The Federal Circuit reversed the ITC’s finding of patent ineligibility and ruled in favor of USS. The court applied the Alice two-step test for determining patent eligibility:

    1. Step One: Are the Claims Directed to an Abstract Idea? The Federal Circuit found that the claims were not directed to an abstract idea but rather to a specific composition of matter. The court emphasized that the patent defines the PDC by its material composition, including diamond grains, catalyst properties, grain size, and certain magnetic properties. Because these characteristics inform a skilled artisan about the structure and physical properties of the PDC, the claims were not abstract.
    2. Step Two: Do the Claims Contain an Inventive Concept? Since the claims were not abstract under step one, the court did not need to proceed to step two. However, it noted that even if step two had been necessary, the claimed composition involved specific manufacturing parameters that resulted in improved material properties, which could qualify as an inventive concept.

    Enablement Under § 112

    In addition to patent eligibility, the intervenors argued that the claims were not enabled under § 112 because the patent did not adequately describe how to achieve the claimed properties without undue experimentation. However, the Federal Circuit upheld the ITC’s conclusion that the claims were enabled. The court found that the patent specification contained sufficient details on the manufacturing process and provided working examples that a skilled artisan could follow without undue experimentation.

    Key Takeaways for Intellectual Property Law

    1. Clarification on Patent Eligibility for Material Compositions
      • The ruling reinforces that claims defining specific material compositions—especially when tied to measurable properties—are not abstract ideas under § 101.
      • The decision pushes back against an overly restrictive view of patent eligibility that might otherwise exclude innovations in material science.
    2. Reaffirmation of the Enablement Standard
      • The Federal Circuit reiterated that the burden of proving non-enablement is on the party challenging the patent.
      • The court emphasized that some level of experimentation is permissible as long as it is not unduly extensive.

    Conclusion

    The US Synthetic v. ITC decision is a significant win for patent holders in the field of material science. It demonstrates that courts are willing to take a nuanced approach when assessing whether a patent is directed to an abstract idea, particularly in cases involving compositions of matter. Moreover, the ruling affirms that patents must provide enough information to enable a skilled artisan to practice the invention without undue experimentation, but they do not need to be exhaustive in their disclosures. This decision is likely to influence future litigation involving patent eligibility and enablement in the chemical and material sciences industries.

    By Charles Gideon Korrell

  • Patent Litigation and Expert Testimony: Lessons from Trudell v. D R Burton

    The recent decision in Trudell Medical International Inc. v. D R Burton Healthcare, LLC by the United States Court of Appeals for the Federal Circuit highlights significant issues in intellectual property law, particularly in the realm of patent litigation. This case, which revolves around the infringement of U.S. Patent No. 9,808,588, serves as a critical reminder of the procedural and evidentiary requirements in patent disputes.

    Background of the Case

    Trudell Medical International Inc. (“Trudell”) sued D R Burton Healthcare, LLC (“D R Burton”) for infringement of its patent covering oscillatory positive expiratory pressure (OPEP) therapy devices. Trudell alleged that D R Burton’s vPEP®, iPEP®, PocketPEP®, and related products infringed claims 1–7, 9, and 18 of its patent. After a three-day trial, the jury found the asserted claims valid but not infringed.

    Trudell appealed on multiple grounds, including the improper admission of expert testimony by Dr. John Collins, an expert retained by D R Burton. The Federal Circuit ultimately reversed the district court’s decision allowing Dr. Collins’ testimony, granted a new trial on infringement, and ordered the case to be reassigned to a different judge.

    Key Legal Issues in the Case

    1. Expert Testimony and Compliance with Federal Rules

    One of the most significant issues in the case was the admission of expert testimony. Under Federal Rule of Civil Procedure 26(a)(2), expert reports must include a complete statement of opinions, the basis and reasons for those opinions, supporting data, and a list of prior cases where the expert has testified. Additionally, under Rule 37(c)(1), failure to disclose expert information as required by Rule 26 results in automatic exclusion unless the failure is substantially justified or harmless.

    The court found that D R Burton failed to comply with these disclosure requirements, as Dr. Collins did not submit a timely expert report on noninfringement. His testimony was introduced at trial despite not being disclosed during discovery, depriving Trudell of an opportunity to challenge or cross-examine his findings adequately. The court held that this failure was neither substantially justified nor harmless, leading to the exclusion of his testimony and the ordering of a new trial.

    2. Claim Construction and Expert Reliability

    The Federal Circuit also addressed issues with the methodology of Dr. Collins’ testimony. The district court had construed specific claim terms, including the definition of “a vane” and “rotate relative to the opening.” Despite this, Dr. Collins provided testimony that contradicted the court’s construction, effectively redefining key claim terms. His approach was deemed unreliable under Federal Rule of Evidence 702, which requires that expert opinions be based on reliable principles and methodologies.

    This aspect of the decision underscores the importance of ensuring that expert witnesses adhere to judicial claim constructions rather than reinterpreting patent terms in a manner inconsistent with the court’s ruling.

    3. The Impact of Procedural Missteps on Patent Trials

    Another crucial takeaway from this case is the procedural mismanagement at the district court level. The judge overseeing the case made multiple contradictory rulings regarding Dr. Collins’ testimony, initially excluding it, then allowing it, then reversing again. Additionally, comments made by the judge suggested a predisposition toward resolving the case quickly, rather than ensuring a fair trial. These concerns led the Federal Circuit to order a reassignment of the case to a different judge on remand—a rare but important corrective measure to preserve judicial impartiality.

    Implications for Patent Law and Litigation Strategy

    This decision has several important takeaways for patent litigants:

    • Strict Compliance with Expert Disclosure Rules: Failure to provide timely and complete expert reports can lead to exclusion of testimony, which can be case-dispositive in patent disputes.
    • Adherence to Claim Construction: Experts must base their testimony on the court’s claim construction and avoid introducing conflicting interpretations.
    • The Role of Judicial Conduct in Patent Trials: The reassignment of this case underscores the importance of judicial impartiality and procedural fairness in complex intellectual property disputes.

    Conclusion

    The Trudell v. D R Burton case highlights the complexities of patent litigation, particularly in the areas of expert testimony and claim construction. For attorneys and companies engaged in intellectual property disputes, this ruling reinforces the necessity of procedural diligence, expert reliability, and fair trial practices. As the case moves forward on remand, it will be interesting to see how the new trial unfolds without the tainted expert testimony that influenced the first jury’s verdict.

    By Charles Gideon Korrell