Technology Information Law Blog by Charles Gideon Korrell

Author: 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

  • Navigating Antidumping Duties and International Trade: A Review of Vandewater v. United States

    On March 6, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Vandewater International Inc. v. United States, affirming the Department of Commerce’s determination that certain steel branch outlets imported by Vandewater fell within the scope of an existing antidumping duty (ADD) order. This ruling underscores the complex interplay between trade law and industry standards in determining the applicability of antidumping measures.

    Key Legal Issues

    The case revolved around whether Vandewater’s steel branch outlets qualified as “butt-weld pipe fittings” under a 1992 ADD order imposing duties on such fittings from China. The court addressed several major legal issues:

    1. Interpretation of Antidumping Duty Orders

    One of the central issues was the interpretation of the term “butt-weld pipe fittings” in the ADD order. Vandewater argued that its products were not traditional butt-weld pipe fittings as recognized by industry standards (such as ANSI B16.9). Commerce, however, found the language of the order ambiguous and conducted a multi-step scope analysis, concluding that the steel branch outlets fell within the order’s scope. The Federal Circuit upheld this finding, emphasizing that ambiguity in trade orders allows for a broader interpretation that may not strictly adhere to industry-defined categories.

    2. The Role of Industry Standards in Trade Disputes

    The appellants contended that industry standards should define what constitutes a butt-weld pipe fitting. However, the court found that conflicting evidence regarding industry usage prevented a definitive exclusion of Vandewater’s products. This ruling suggests that while industry standards can be persuasive, they are not necessarily dispositive in trade disputes.

    3. Commerce’s Discretion in Scope Determinations

    The court deferred to Commerce’s expertise in determining the scope of the ADD order. By affirming Commerce’s authority to use multiple sources, including prior rulings and trade investigations, the decision reinforces the agency’s broad discretion in enforcing trade laws. This has significant implications for companies navigating antidumping duties, as it signals that Commerce’s determinations will be given substantial weight in legal challenges.

    4. Retroactive Application and Trade Compliance

    Another point of contention was whether the ruling applied retroactively to past imports. While the court did not rule on this issue due to a lack of unliquidated entries before Commerce’s 2020 determination, the case highlights the uncertainty businesses face regarding past imports and potential liability under trade enforcement mechanisms.

    Implications for International Trade

    This decision has broader ramifications for businesses involved in international trade:

    • Trade Compliance for Manufacturers: Companies importing products subject to antidumping orders must be vigilant in assessing whether their products fall within the scope of existing orders. The broad interpretative authority granted to Commerce suggests that businesses should seek proactive rulings before importing goods that might be subject to duties.
    • Regulatory Uncertainty: The reliance on Commerce’s discretion underscores the challenges of navigating U.S. trade law, particularly for foreign manufacturers and importers. With industry standards playing a limited role in legal determinations, businesses may need to adapt compliance strategies beyond technical definitions.

    Conclusion

    The Federal Circuit’s decision in Vandewater v. United States serves as a critical reminder of the complexities involved in antidumping enforcement. While industry standards remain influential, Commerce’s broad discretion in trade classifications underscores the need for businesses to adopt proactive compliance strategies. As trade regulations continue to evolve, companies engaged in international commerce must carefully monitor legal developments to mitigate risks and ensure compliance with U.S. trade laws.ith U.S. trade laws.

    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

  • 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 Upholds Antidumping Enforcement in Xanthan Gum Transshipment Case

    On February 27, 2025, the United States Court of Appeals for the Federal Circuit issued a significant opinion in All One God Faith, Inc. v. United States, affirming the U.S. Court of International Trade’s decision that upheld Customs and Border Protection’s (CBP) enforcement actions under the Enforce and Protect Act (EAPA). The case revolved around allegations that several companies, including GLōB Energy Corp. and Ascension Chemicals LLC, engaged in transshipment to evade antidumping (AD) duties on xanthan gum originating from China.

    This case highlights two critical areas of law—international trade enforcement and intellectual property protection—as it relates to regulatory compliance, customs evasion, and the implications of foreign manufacturing claims.

    Key Legal Issues in the Case

    1. Transshipment and Antidumping Evasion

    The central issue before the Federal Circuit was whether the appellants had engaged in transshipment, a practice in which goods subject to antidumping or countervailing duties are routed through a third country to obscure their true origin. The U.S. Department of Commerce had previously imposed antidumping duties on xanthan gum from China under AD Order No. A-570-985, requiring importers to pay tariffs to offset unfair pricing advantages.

    Customs determined that the appellants imported xanthan gum produced in China but falsely declared India as the country of origin. This resulted in an unlawful avoidance of duties, which Customs deemed an act of evasion under 19 U.S.C. § 1517. The court upheld this determination, emphasizing that companies cannot circumvent trade laws by misrepresenting the origins of their goods.

    2. Customs’ Use of Adverse Inferences

    A pivotal issue in the case was CBP’s use of adverse inferences against the appellants and their foreign suppliers for failing to provide requested manufacturing documentation. The EAPA allows Customs to apply adverse inferences under 19 U.S.C. § 1517(c)(3)(A) when parties do not cooperate fully with investigations.

    The court upheld CBP’s approach, noting that the appellants’ suppliers did not adequately respond to inquiries, and therefore, Customs was justified in inferring that the xanthan gum was manufactured in China, not India. This ruling reinforces the importance of compliance with regulatory investigations, as failure to provide supporting documentation can lead to negative legal presumptions.

    3. Jurisdiction Over Finally Liquidated Entries

    A notable procedural question was whether the trial court had jurisdiction to review CBP’s evasion determinations regarding entries that had already been finally liquidated. Initially, the U.S. Court of International Trade ruled that it lacked jurisdiction over these entries, but the Federal Circuit clarified that judicial review remains available under 28 U.S.C. § 1581(c), which allows challenges to evasion determinations irrespective of liquidation status.

    While the appellate court found that the lower court erred in dismissing these claims on jurisdictional grounds, it nonetheless affirmed the trial court’s decision because CBP’s evasion determinations were supported by substantial evidence.

    4. Intersection with Intellectual Property and Trade Laws

    Beyond trade enforcement, this case underscores broader implications for intellectual property (IP) protection. Many antidumping and countervailing duty cases involve industries where intellectual property plays a key role in market competitiveness. The production of xanthan gum, a specialty polysaccharide used in food and industrial applications, involves proprietary manufacturing processes that companies seek to protect through patent and trade regulations.

    When companies engage in transshipment to evade duties, it can undermine domestic producers who invest in IP and R&D. The enforcement of antidumping duties thus serves a dual purpose—preventing unfair trade practices and ensuring that companies adhering to U.S. intellectual property and trade laws are not undercut by competitors evading tariffs.

    Implications of the Ruling

    The Federal Circuit’s decision reinforces the U.S. government’s commitment to strict enforcement of antidumping and countervailing duty laws. Key takeaways from the ruling include:

    • Companies must accurately report the origin of their imports or face significant penalties, including back duties and additional enforcement actions.
    • Failure to cooperate with trade investigations can lead to adverse inferences, increasing financial and legal risks for importers.
    • Judicial review of trade enforcement actions remains available even for liquidated entries, providing clarity on the scope of federal court oversight in trade disputes.
    • This case highlights the ongoing tension between international trade laws and intellectual property protections, particularly where proprietary manufacturing processes and trade secrets are implicated.

    As global supply chains grow more complex, businesses engaged in international trade must remain vigilant in compliance efforts, particularly when sourcing materials from countries subject to trade restrictions. The ruling in All One God Faith, Inc. v. United States serves as a cautionary tale for importers seeking to circumvent trade laws and a reminder of the legal tools available to combat customs evasion.

    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

  • Federal Circuit Weighs in on Gesture-Controlled Camera Patent Dispute

    In a significant ruling on patent validity and inter partes review (IPR) jurisdiction, the Federal Circuit recently decided Apple Inc. v. Gesture Technology Partners, LLC, a case addressing the patentability of gesture-based camera control technology. The decision clarifies key issues surrounding the obviousness of patents, the scope of IPR proceedings, and the ability of the Patent Trial and Appeal Board (PTAB) to review expired patents.

    Background of the Case

    Gesture Technology Partners, LLC (“Gesture”) owns U.S. Patent No. 8,878,949 (“the ’949 patent”), which describes a portable device incorporating an electro-optical sensor that detects gestures and controls a digital camera accordingly. Apple, alongside LG Electronics and Google, challenged the patent through an IPR, arguing that multiple claims were unpatentable due to obviousness over prior art references.

    The PTAB ruled that claims 1–3, 5–10, and 12–17 were unpatentable but upheld the validity of claims 4, 11, and 18. Both parties appealed: Apple contested the decision upholding claim 4, while Gesture cross-appealed the unpatentability findings against claims 1–3 and 5–7.

    Key Legal Issues Addressed

    1. PTAB’s Authority to Review Expired Patents

    One of the central issues in Gesture’s cross-appeal was whether the PTAB had jurisdiction over the IPR, given that the ’949 patent had expired before Apple filed its petition. Gesture argued that an expired patent ceases to be a public franchise and is thus outside the PTAB’s purview.

    The Federal Circuit rejected this argument, reaffirming that expired patents can still be subject to IPR because they retain enforceable rights, such as claims for past damages. The court emphasized that IPR proceedings serve as a “second look” at the initial patent grant, aligning with the Supreme Court’s reasoning in Oil States Energy Services v. Greene’s Energy Group (2018).

    2. Obviousness and Prior Art Considerations

    The Federal Circuit upheld the PTAB’s finding that claims 1–3 and 5–7 were unpatentable as obvious in light of prior art, particularly U.S. Patent No. 6,144,366 (Numazaki) and Japanese Patent Application No. H4-73631 (Nonaka). The court found that:

    • Numazaki’s light extraction unit, which detects user interactions, corresponds to the electro-optical sensor claimed in the ’949 patent.
    • A skilled person would have been motivated to combine Numazaki’s different embodiments and Nonaka’s remote-control functionality to create a device that captures images based on gesture recognition.
    • Gesture’s expert failed to provide sufficient technical reasoning to dispute the Board’s obviousness findings.

    3. Reversal of PTAB’s Decision on Claim 4

    Apple successfully challenged the PTAB’s ruling on claim 4, which required the electro-optical sensor to be “fixed” in relation to the digital camera. The Federal Circuit found that the PTAB improperly disregarded Apple’s expert testimony, which demonstrated that fixing these components was an obvious design choice for maintaining overlapping fields of view. As a result, the court reversed the PTAB’s finding, declaring claim 4 unpatentable.

    Implications for Intellectual Property Law

    This ruling underscores the Federal Circuit’s approach to obviousness analyses and reinforces the PTAB’s authority over expired patents. The decision also highlights the importance of expert testimony in IPR proceedings—both in establishing obviousness and in defending against it.

    For patent holders, the case serves as a cautionary tale about the vulnerabilities of broad, technology-based claims in the face of prior art. For challengers, it confirms that IPR remains a powerful tool for invalidating weak patents, even post-expiration.

    Conclusion

    The Apple v. Gesture decision provides important clarity on the role of IPR in expired patents and the standards for proving obviousness in technology-related patents. With the court’s ruling, Apple, LG, and Google have successfully invalidated additional claims of the ’949 patent, reinforcing the competitive landscape in the field of gesture-based camera technology.

    By Charles Gideon Korrell