Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

Need to FAST Track Your Patent? The USPTO increases the Annual Limit to 20,000

What Makes a Good Cell and Gene Therapy Application?

A Tip for Improving Your “Improved” Jepson Claim: Include Written Description Support

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

On June 30, 2025, the Federal Circuit issued a precedential decision in Eye Therapies, LLC v. Slayback Pharma, LLC,<a href="#_ftn1" target="_self">[1]</a> reversing the Patent Trial and Appeal Board’s (PTAB’s) claim construction of the phrase “consisting essentially of,” as recited in the claims of issued U.S. Patent No. 8,293,742 (hereafter, “the ’742 patent”).1. A Refresher: “Open” Versus “Closed” Claim LanguageUnder the conventional claim construction doctrine, the transitional phrase “comprising” signals that the claim is open to additional elements or steps beyond those explicitly recited in the claim, whereas “consisting of” signals that the claim is limited to the exact elements recited therein and nothing more. In contrast, “consisting essentially of” signals that a claim is partially open. Typically, when “consisting essentially of” is used, the claimed subject matter is primarily composed of the explicitly recited elements, but may also include other, minor elements that do not materially affect the claimed subject matter’s basic and novel characteristics.2. The “Consisting Essentially of” Language at Issue in the ’742 PatentThe ’742 patent is directed to methods for reducing eye redness using brimonidine. The claimed methods recite the “consisting essentially of” transitional phrase, such as in “[a] method for reducing eye redness consisting essentially of”<a href="#_ftn2" target="_self">[2]</a> (emphasis added) administering brimonidine to a patient having an ocular condition. Of note, the claims originally recited the open “comprising” language. During prosecution, the examiner rejected the claims as allegedly being anticipated by a reference that disclosed brimonidine in combination with another active agent for treating ocular conditions. In response, Applicant amended the claims to recite “consisting essentially of” in place of “comprising,” and argued that, in contrast to the cited reference that required brimonidine in combination with another active ingredient, the amended claims “do not require the use of any other active ingredients (emphasis added) in addition to brimonidine.”<a href="#_ftn3" target="_self">[3]</a> The examiner shortly thereafter allowed the claims, reiterating Applicant’s argument that the claims “do not require the use of any other active ingredients (emphasis added) in addition to brimonidine.”<a href="#_ftn4" target="_self">[4]</a>3. The PTAB’s Claim ConstructionSlayback challenged the patentability of the ’742 patent in an IPR, during which the parties disputed the scope of “consisting essentially of” as recited in the claims. The Patent Owner, Eye Therapies, argued that the phrase should be read in light of the prosecution history, meaning that “consisting essentially of” in this context refers to a method for administering brimonidine as the sole active ingredient. The PTAB rejected this argument, contending that in view of both the conventional meaning of the phrase and the prosecution history, the claimed method should be read as only being closed to additional active ingredients that are required to perform the claimed method. As such, the claimed method would be open to administering brimonidine in addition to other active ingredients as long as the other active ingredients are not required to perform the claimed method. Based on this claim construction, the PTAB concluded that the claims are obvious in view of the prior art and held all claims unpatentable.4. The Federal Circuit’s Claim Construction<ol class="li-text-orange"><ol class="li-text-orange"><li>Prosecution History Can Alter a Phrase’s Conventional Meaning The Federal Circuit sided with Eye Therapies in construing the claims. The court first acknowledged the conventional meaning of “consisting essentially of.” The court then explained that a patentee can alter the phrase’s conventional meaning by redefining it in the specification or disclaiming an alternative meaning during prosecution. Quoting Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005), the court expounded that statements made during prosecution can “inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.”</li><li class="li-text-orange">The Prosecution History Leading to the ’742 Patent Informs an Atypical Meaning of “Consisting Essentially Of” The Federal Circuit explained that the prosecution history informs an atypical meaning of “consisting essentially of” in the ’742 patent. As described above, during prosecution, Applicant amended the claims to recite “consisting essentially of” to distinguish over the cited art. According to the Federal Circuit, this prosecution history supports a “more restrictive interpretation” of the transitional phrase than its conventional meaning.<a href="#_ftn5" target="_self">[5]</a> The court noted: “[w]hereas an interpretation applying the standard meaning might permit additional unlisted active ingredients, the applicant persuaded the examiner of the novelty of the claims by underscoring the absence of other active ingredients in the claimed methods.”<a href="#_ftn6" target="_self">[6] </a>The Federal Circuit also examined additional arguments made during prosecution. In one example, Applicant argued that the cited reference “does not teach any methods of treating any conditions by administering a pharmaceutical composition consisting essentially of brimonidine (i.e., a pharmaceutical composition which does not include any other active agents)” (emphasis added).<a href="#_ftn7" target="_self">[7]</a> The court analyzed Applicant’s use of “i.e.,” noting that its usage in the intrinsic record is often definitional. The Federal Circuit reasoned that in this context, “i.e.” indicates “methods which do not include administering other active agents.”<a href="#_ftn8" target="_self">[8]</a> In view of this definition, the court noted that the conventional meaning of “consisting essentially of” is incompatible with the more restrictive meaning that Applicant intended.</li><li class="li-text-orange">Application of Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009) In the PTAB’s decision, the Board analogized the facts of this case to Ecolab, which concerned a patent directed to a method for sanitizing fowl with a solution which “consists essentially of . . . peracetic acid.”<a href="#_ftn9" target="_self">[9]</a> In Ecolab, the Federal Circuit rejected a more restrictive interpretation of “consisting essentially of” that would have limited the claim scope to solutions containing peracetic acid as the only antimicrobial agent. The Federal Circuit found this narrower claim construction irreconcilable in view of the patent’s specification, which disclosed exemplary solutions containing antimicrobial agents other than peracetic acid. The Federal Circuit acknowledged that the ’742 patent’s specification describes compositions containing active ingredients other than brimonidine, in addition to embodiments that describe brimonidine as the only active ingredient. The Federal Circuit viewed these alternative embodiments as making sense in view of the “comprising” language that the claims originally recited. Even with these alternative disclosures, however, the court reasoned that Applicant’s amendments and arguments, particularly the definitional use of “i.e.,” require a more restrictive construction of “consisting essentially of.” In this regard, the court concluded that the appropriate interpretation of the issued claims precludes the use of agents other than brimonidine.</li></ol></ol>5. TakeawaysThis case underscores the weight that prosecution history can have on post-issuance claim construction. Although certain transitional phrases may often take on a traditional meaning, this case demonstrates that the intrinsic record (e.g., prosecution history and/or application specification) can alter such traditional definitions. To avoid potential uncertainty, applicants may want to consider using a traditional transitional term or phrase in their claims that corresponds with the scope of their arguments. Regardless, this case is a good reminder that whatever is stated in the record may have unintended consequences in post-grant proceedings and litigation.<hr class="divider"><a href="#_ftnref1" target="_self">[1]</a> Eye Therapies, LLC v. Slayback Pharma, LLC, No. 2023-2173 (Fed. Cir. June 30, 2025).<a href="#_ftnref2" target="_self">[2]</a> See claims 1 and 3 of U.S. 8,293,742.<a href="#_ftnref3" target="_self">[3]</a> Page 6, July 19, 2011 Office Action Response dated October 19, 2011 in Pat. App. No. 12/460,941.<a href="#_ftnref4" target="_self">[4]</a> Page 3, Notice of Allowance dated January 30, 2012 in Pat. App. No. 12/460,941.<a href="#_ftnref5" target="_self">[5]</a> Eye Therapies, LLC v. Slayback Pharma, LLC, p. 8.<a href="#_ftnref6" target="_self">[6]</a> Id. at 8–9.<a href="#_ftnref7" target="_self">[7]</a> Page 8, July 19, 2011 Office Action Response dated October 19, 2011 in Pat. App. No. 12/460,941.<a href="#_ftnref8" target="_self">[8]</a> Eye Therapies, LLC v. Slayback Pharma, LLC, p. 9.<a href="#_ftnref9" target="_self">[9]</a> See U.S. Pat. No. 5,632,676.

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Marisa Sanders

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Of Counsel

Mark D. McBriar focuses his practice on patent drafting and prosecution, IP due diligence, freedom to operate, patentability evaluations, re-examinations, and litigation support. Dr. McBriar works wit

Mark D. McBriar Ph.D.

Mark McBriar

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Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

Recent Digital Health-Related FDA Announcements

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Effective July 8, 2025, the U.S. Patent and Trademark Office (USPTO) expanded the availability of prioritized examination, increasing the limit on the number of requests from 15,000 to 20,000 in a fiscal year. The 20,000 limit applies to the sum of all granted requests for prioritized examination, including Track One requests for new applications and requests for prioritized examination in pending applications where a request for continued examination (RCE) has been filed. This change was adopted in a final rule<a href="#_ftn1" target="_self">[1]</a> implemented immediately by the USPTO without prior notice or opportunity for comment, as an effort to continue to accommodate the number of applicants wishing to utilize this program. Prioritized examination is a tool used by many companies, including life sciences companies, to expedite issuance of key patents.Prioritized examination is a procedure for expedited examination of a patent application for an additional fee, allowing patent applicants to receive a final disposition within 12 months of prioritized status being granted. Prioritized examination is available for original nonprovisional utility and plant patent applications filed under 35 U.S.C. § 111(a), known as the Track One program. Original applications include both first filings and continuing applications,<a href="#_ftn2" target="_self">[2]</a> and thus, continuation, continuation-in-part, and divisional applications are eligible for prioritized examination.  A request for prioritized examination may also be filed in a pending application with or after an RCE but before the mailing of the first Office action subsequent to the RCE. Among other requirements, patent applications must contain, or be amended to contain, no more than four independent claims, 30 total claims, and no multiple dependent claims to be eligible for prioritized examination.This expansion in prioritized examination came after the recent termination and expiration of a number of pilot programs that permitted certain patent applications to be advanced out of turn for examination, including the discontinuation of the Accelerated Examination program for utility patent applications as of July 10, 2025.<a href="#_ftn3" target="_self">[3]</a> The additional availability of prioritized examination is expected to have a positive or at least net neutral effect on overall pendency across all applications. Based on the Patents Dashboard provided by the USPTO, the current average total pendency of a patent application (excluding applications in which an RCE has been filed) is about 26.2 months, whereas the average pendency of a Track One application is about 4.5 months, from the Track One petition grant date to the date a Final Rejection, a Notice of Abandonment, or a Notice of Allowance is mailed.Due to the benefit of expedited examination, the number of requests for prioritized examination has been increasing steadily over the years. In fiscal year 2024, the USPTO received more than 15,000 requests for prioritized examination.  In fiscal year 2025 (October 1, 2024 through September 30, 2025), a total of 10,921 Track One applications had been received as of May, on track to exceed the prior 15,000 limit. For those wishing to obtain a patent quickly, the announcement by the USPTO is a welcome change as we approach the end of the fiscal year.<hr class="divider"><a href="#_ftnref1" target="_self">[1]</a> <a href="https://www.federalregister.gov/documents/2025/07/08/2025-12644/2025-increase-of-the-annual-limit-on-accepted-requests-for-prioritized-examination" target="_blank">Federal Register: 2025 Increase of the Annual Limit on Accepted Requests for Prioritized Examination</a>.<a href="#_ftnref2" target="_self">[2]</a> See MPEP 201.02.<a href="#_ftnref3" target="_self">[3]</a> <a href="https://www.uspto.gov/about-us/news-updates/uspto-discontinuing-accelerated-examination-program-utility-applications" target="_blank">USPTO discontinuing Accelerated Examination program for utility applications | USPTO</a>.

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Dr. Qiwen Zhong focuses on patent prosecution, freedom-to-operate analyses, and IP due diligence, with an emphasis on chemistry and pharmaceuticals.
Qiwen obtained her J.D. from UCLA School of Law whe

Qiwen Zhong Ph.D.

Qiwen Zhong

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With over 20 years of experience, Shannon excels in IP strategy for a wide range of life sciences technologies, including pre-clinical and clinical stage therapeutics, drug delivery systems and diagnostics. 

Shannon Reaney Ph.D.

Shannon Reaney is head of the firm’s Chemistry Patent Practice Group. She counsels companies in the life science, agricultural, and materials science industries. Shannon develops and manages global patent portfolios to align with specific business needs. Her practice specializes in patent matters in the areas of organic chemistry, with a particular technical emphasis on small molecule pharmaceuticals, polymers, formulations, and agricultural products. With 15 years of experience in the patent field, Shannon has a keen understanding of how to build and strengthen a patent portfolio and how to assess and manage third party intellectual property assets. She develops and manages large patent portfolios for mid-size to large companies and provides strategic advice on lifecycle management. She assists smaller clients with securing foundation intellectual property and with strategic positioning for investment or partnering opportunities. Shannon also facilitates business transactions and in-licensing opportunities through investor side and defensive due diligence.

Shannon Reaney

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Need to FAST Track Your Patent? The USPTO increases the Annual Limit to 20,000

241114-cell-and-gene-therapies

Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations requires a carefully crafted patent application. A strong application not only protects the product but also anticipates challenges during prosecution and potential competitor workarounds. This post explores three critical components of a robust cell and gene therapy patent application: claims, examples, and detailed description.Claims: The Foundation of ProtectionThe claims define the scope of protection for a cell or gene therapy invention. Well-drafted claims are essential to ensure the application covers the product while remaining defensible and adaptable.1. Do the Claims Cover the Product?Claims must clearly encompass the therapeutic product, whether it’s a specific cell type, a genetically modified construct, or a method of treatment. For example, in a gene therapy application, claims should cover specific vectors, the therapeutic gene, protein, its delivery method, and method of treatment. One particular challenge with cell and gene therapy, is the variety of delivery methods that necessitate different claiming strategies. For example, a claim directed to a viral vector comprising a gene would not cover delivery of the protein in a lipid nanoparticle. It’s important to think through how the therapy will be delivered as well as any likely design-arounds. Failing to align claims with the product creates risks by leaving critical aspects unprotected, potentially allowing competitors to exploit gaps.2. Do They Provide Backup Positions?A strong application includes fallback positions to mitigate risks during examination or litigation. This can involve dependent claims that narrow the scope by specifying particular cell types, promoters, or delivery systems. For instance, if a broad claim to a CAR T-cell therapy is challenged, dependent claims covering specific recombinant receptors or vector designs can preserve protection.3. Can Claims Be Framed to Avoid Design-Arounds?Competitors often seek to design around patents by developing alternative approaches. To counter this, claims should anticipate potential workarounds. For example, including a range of equivalents (e.g., different viral vectors with similar transduction efficiencies) may make it harder for competitors to sidestep the patent. Strategic use of functional language, where appropriate, can also broaden protection without overreaching.4. Do They Have an Appropriate Scope?Claims must strike a balance between breadth and defensibility. Overly broad claims are more vulnerable to be rejected for lack of support (e.g., insufficient enablement or written description in the U.S.). Conversely, overly narrow claims may limit commercial value. The scope should be supported by the specification and tailored to the invention’s novelty and inventiveness, ensuring it captures the product’s unique features while remaining enforceable.Examples: Demonstrating Feasibility and AdvantageWorking examples provide concrete evidence of the invention’s utility and advantage, which are critical for patentability in cell and gene therapies.1. Are There Working Examples?In recent years, Patent Offices in many jurisdictions have taken a stricter stance, requiring at least some evidence that the invention works as claimed. For cell and gene therapies, this often involves in vitro or in vivo data demonstrating efficacy or advantage. For instance, it may be crucial to include in a CAR T-cell therapy application data showing tumor reduction in animal models. Preferably, the examples should align with the candidate product and claims. If claims cover a specific gene-edited cell line, the examples should demonstrate how it can be produced and its therapeutic effect. Misalignment—such as providing data for a different cell type—can weaken the application by raising enablement concerns.In cases where concrete data is not available at the time of filing, one should consider adding prophetic examples that may provide a hook in the future to present post-filing data to support patentability of the invention.2. Do They Lay the Foundation for Unexpected Results?Examples can highlight the invention’s inventiveness by demonstrating unexpectedly advantageous results. For instance, data showing superior efficacy of a novel gene delivery system compared to existing methods can bolster patentability. Including negative data, such as failed attempts with alternative approaches, can further underscore the invention’s uniqueness, provided it supports the conclusion of unexpected advantage.Detailed Description: Balancing Disclosure and StrategyThe detailed description supports the claims and examples while navigating the delicate balance between enabling the invention and preserving future IP opportunities.Balancing Alternatives vs. Creating Prior ArtA robust description provides enough detail to enable the invention across its claimed scope, including alternative embodiments. However, excessive disclosure of alternatives can create prior art that hinders later applications. For example, describing a broad range of non-enabled cell therapy (e.g., cell therapies for treating non-enabled diseases) might hurt applicant’s own future IP opportunities, especially in view of the importance of experimental data for cell and gene therapy applications. Strategic drafting focuses on enabling the claimed invention while reserving unclaimed alternatives for future filings.Ensuring Enablement Without Over-DisclosureThe description must enable a skilled artisan to practice the invention without undue experimentation. For cell and gene therapies, this often requires detailed protocols for cell modification, vector construction, or delivery methods if such methods are not readily accessible to the public. However, proprietary details (e.g., specific manufacturing conditions) can sometimes be omitted, if they are not essential to enablement, to preserve trade secrets while meeting patent requirements.ConclusionA well-crafted cell and gene therapy patent application requires robust and strategic drafting of claims, examples, and detailed description. Claims should comprehensively cover the product, provide fallback positions, and anticipate competitor workarounds while maintaining an appropriate scope. Working examples must demonstrate feasibility, align with the claims, and highlight unexpected advantages. The detailed description should enable the invention without creating unnecessary prior art. By addressing these elements strategically, innovators can secure robust IP protection, safeguarding their contributions to this rapidly evolving field.

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

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Dr. Kate You is a member of the firm’s Patent  Group and focuses her practice on patent prosecution and counseling, including  domestic and international patent preparation and prosecution, and litiga

Yuying (Kate) You Ph.D.

Yuying (Kate) You

What Makes a Good Cell and Gene Therapy Application?

The Federal Circuit issued a precedential opinion in In re: Xencor, Inc.<a href="#_ftn1">[1]</a> concerning written support for Jepson claims. The decision affirms the decision of the Appeals Review Panel (ARP) of the USPTO, which held that the pending claims at issue in U.S. Patent Application No. 16/803,690 are unpatentable for lacking written description. Although there were two different claims on appeal in In re: Xencor (a “Jepson claim” and a “method claim”), this blog post will focus only on the Jepson claim.1. Refresher: What is a Jepson Claim?A Jepson claim is a type of patent claim that describes an improvement over the prior art.In sum, a Jepson claim has a certain structure: (i) a preamble that describes known features of the subject matter; (ii) a transitional phrase such as “wherein the improvement comprises”; and (iii) a recitation of the new or improved features of the subject matter.2. The Jepson Claim at Issue in XencorThe Jepson claim at issue in Xencor, claim 8, was directed to a method of treating a patient by administering a modified antibody. The method had the purported beneficial effect of enhancing serum half-lives while reducing treatment frequency. The claim is recited below:<blockquote>8. In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising said Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.</blockquote>3. The Preamble of a Jepson Claim Requires Written DescriptionThe issue on appeal regarding Xencor’s claim 8 was whether the preamble—specifically, the reference to an anti-C5 antibody—needed written description, and if so, whether Xencor satisfied this requirement.Xencor argued that the specification need only provide written support for the improvement recited in the Jepson claim, and hence not the preamble itself. The ARP disagreed, and argued that Jepson claim preambles are part of the invention and therefore require written description.After analyzing the requirements of written description under 35 U.S.C. 112 and assessing relevant case law, the Federal Circuit agreed with the ARP that a Jepson claim preamble requires written description. As the Federal Circuit reasoned, the preamble in a Jepson claim defines the claimed invention and therefore limits the claim scope. The court continued: “[t]he invention is not only the claimed improvement, but the claimed improvement as applied to the prior art, so the inventor must provide written description sufficient to show possession of the claimed improvement to what was known in the prior art.”<a href="#_ftn2">[2]</a>The Federal Circuit analogized Xencor’s Jepson claim to a Jepson claim directed to a time machine:<blockquote>A patentee cannot be permitted to use a Jepson claim to avoid the requirement that she be in possession of the claimed invention simply by asserting something is well-known  in the art. For example, a patentee cannot obtain a Jepson claim with a preamble that says that a time machine is well-known in the art without describing a time machine, in sufficient detail to make clear to a person of ordinary skill in the art that the inventor is in possession of such a time machine.<a href="#_ftn3">[3]</a></blockquote>4. The Jepson Claim in Xencor Did Not Satisfy the Written Description RequirementAs the Federal Circuit noted, in order to provide sufficient written description for a Jepson claim, the applicant must establish that what is well-known in the prior art is indeed well-known. Both the Federal Circuit and the PTAB agreed that Xencor failed to demonstrate that the anti-C5 antibody limitation recited in the Jepson preamble was in fact well-known. In making this determination, the Board examined, among other things, the few examples of anti-C5 antibodies in the prior art and the large number of possible antibodies in the genus. 5. TakeawaysThe Federal Circuit’s holding requires that Jepson claims have full written support to demonstrate that the inventor had possession of the invention as applied to the prior art. As a result, applicants should consider sufficiently describing the prior art recited in the preamble of a Jepson claim or demonstrate that the prior art is “well-known” to a person of ordinary skill in the art. As the court recognized, the amount and content of the disclosure necessary to confer adequate written description will vary, depending on several factors (e.g., how new the technology is, the unpredictability of the art, and the level of knowledge of the person of ordinary skill in the art). For example, for a Jepson claim directed to an improved front-loading washing machine, simply using the term, “front-loading washing machine,” would have likely been insufficient in the 1800s without more explanation. Today, however, the term, “front-loading washing machine,” is likely well-known and probably needs no further explanation.           <a href="#_ftnref1">[1]</a> In re Xencor Inc., No. 2024-1870 (Fed. Cir. Mar. 13, 2025).<a href="#_ftnref2">[2]</a>  Id. at 17 (emphasis in original).<a href="#_ftnref3">[3]</a> Id. at 17-18.

On June 10, 2025, the United States Patent and Trademark Office (USPTO) announced that, after nearly 20 years, it will be discontinuing its Accelerated Examination Program for utility applications on July 10, 2025.The USPTO’s Accelerated Examination Program was implemented in 2006 as a way for Applicants to petition for an accelerated examination procedure that would lead to a patentability decision within 12 months or less. This provided a meaningful acceleration since the overall pendency to receive a first Office Action was approximately 20 months for fiscal year 2024, for instance.While initially popular, the number of petitions for the Accelerated Examination Program has declined substantially following the introduction of the USPTO’s Prioritized Patent Examination Program, also known as “Track One.” A contributing factor is that a petition under Track One can accelerate examination without having to meet several requirements of the Accelerated Examination Program, including performing a pre-examination search and providing an examination support document. Further, the additional requirements under the Accelerated Examination Program have led to approximately one-third of its requests being denied.As a result, fewer than 100 Applicants have taken advantage of the Accelerated Examination Program in each of fiscal years 2014 through 2024, as compared to nearly 10,000 Track One petitions being filed during the first seven months of the current fiscal year.The USPTO noted that, as opposed to the more straightforward Track One program, the resource demands of the Accelerated Examination Program are also in tension with its broader efforts to reduce overall pendency.Thus, the USPTO ultimately decided that “the Accelerated Examination Program does not provide a sufficient benefit to the public or the patent system to justify the cost of continuing the program for utility applications,” in view of the availability of the largely redundant and far more popular Track One program, which is better equipped to achieve the objective of accelerating examination and reducing overall pendency of applications. The Accelerated Examination Program will, however, remain in effect for design patent applications.This discontinuation follows soon after the expiration of the Cancer Moonshot Expedited Examination Pilot Program, which allowed for the acceleration of pendency to a first Office Action for certain applications in the field of oncology or smoking cessation.Importantly, Applicants of utility applications still have options available for accelerating examination. This includes the popular Track One program, for which the USPTO anticipates further increasing the annual limit from 15,000 requests to 20,000 requests in 2025. Like the Accelerated Examination Program, the goal of the Track One program is to have a final disposition within 12 months. Latest statistics show that, under Track One, a first Office Action is issued approximately three months after filing the request, and a final disposition is reached approximately six months after the request. Another option for accelerating examination is to file a “petition to make special,” which is available if an inventor or joint inventor is at least 65 years of age or has a state of health such that the inventor “might not be available to assist in the prosecution of the application if it were to run its normal course.”