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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Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

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

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

2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult regulatory environment, elevated interest rates, and deflated valuations.Strategic buyers, private equity sponsors, and other MedTech participants entered 2025 with cautious optimism, encouraged by the potential for a pro-growth agenda and a deregulatory backdrop under a new presidential administration. Industry stakeholders hoped for renewed M&A momentum, particularly in sectors aligned with healthcare innovation and digital transformation.While this broader resurgence has yet to materialize across the M&A landscape, MedTech deal activity has begun to show meaningful momentum in 2025, as dealmakers seek to capitalize on innovations in artificial intelligence (AI), digital health platforms, and advanced surgical technologies.1. Fewer Transactions, Larger Dollar AmountsAlthough MedTech M&A activity decreased slightly from Q4 2024 (62 transactions, per J.P. Morgan) to Q1 2025 (57 transactions), the upfront value of these deals increased dramatically (from $2.7 billion to $9.2 billion). This uptick reflects both large-cap deals (such as the Stryker (NYSE: SYK) $4.9 billion acquisition of Inari Medical (NASDAQ: NARI) and the Zimmer Biomet (NYSE: ZBH) $1.2 billion acquisition of Paragon 28 (NYSE: FNA)) and broader valuation trends: median upfront payments rose from $14 million in Q4 2024 to $250 million in Q1 2025.These figures suggest that M&A participants are placing greater emphasis on high-value investments and acquisitions of more mature companies with deeper product pipelines or commercial traction. Additionally, buyers appear more willing to pursue singular strategic deals that align with core growth priorities rather than broad-based asset aggregation.This trend appears poised to continue throughout 2025. For example, Thermo Fisher Scientific recently announced that it will acquire Solventum’s purification and filtration business for $4.1 billion, with the deal expected to close by year-end.2. Innovations in Surgical Solutions and AI Are Driving Deal FlowThe rapid evolution of MedTech technologies—particularly those offering advanced surgical solutions, specialized capabilities, and real-world data analytics capabilities—has been a major driver of deal activity in 2025. Buyers are increasingly targeting companies with differentiated procedural capabilities that can be integrated into broader care platforms.One notable example is Stryker’s $4.9 billion acquisition of Inari Medical, which expanded Stryker’s presence in the cardiovascular and peripheral vascular markets. Inari’s proprietary thrombectomy devices generate real-time procedural and outcomes data, aligning with Stryker’s strategy of integrating procedural intelligence, clinical analytics, and AI-assisted technologies into its surgical platforms. The transaction builds on Stryker’s recent AI-focused acquisitions, including its 2024 purchase of care.ai.Other high-profile surgical technology deals in H1 2025 include: the Boston Scientific (NYSE: BSX) $900 million acquisition of Bolt Medical, Boston Scientific’s $540 million acquisition of SoniVie, Zydus Lifesciences’ $281 million acquisition of Amplitude Surgical, and Argon Medical’s purchase of SeQure and DraKon. These deals reflect a focus on expanding portfolios in niche, high-growth specialties such as renal denervation, peripheral vascular intervention, and orthopedic reconstruction.In parallel, digital health and AI-driven solutions have drawn increasing attention. Key transactions include: the Illumina (NASDAQ: ILMN) acquisition of SomaLogic from Standard BioTools (NASDAQ: LAB) (strengthening Illumina’s multi-omics and proteomics capabilities through algorithmic analysis), MoveUp’s acquisition of Deep Structure AI (adding advanced deep learning capabilities to MoveUp’s digital health platform), and SyntheticMR’s acquisition of Combinostics Oy (expanding its portfolio of AI-based diagnostics tools). Interest in companies with embedded, FDA-cleared AI functionality (especially those operating within regulated clinical workflows) will remain a key driver of MedTech M&A through the second half of 2025.These deals illustrate the growing importance of machine learning, patient-specific modeling, and predictive analytics in the future of MedTech. As reimbursement models increasingly emphasize outcomes, solutions that incorporate real-world data will be central to product differentiation.3. Portfolio Optimization and Specialty Consolidation Remain PrioritiesLarge-cap MedTech companies continue to restructure and realign their portfolios through strategic acquisitions and divestitures targeting high-growth, high-margin therapeutic areas. Companies are actively divesting non-core segments and reinvesting proceeds into platforms with long-term market leadership potential.For example, Zimmer’s acquisition of Paragon 28, a leader in foot and ankle implants, vertically enhanced Zimmer’s specialty surgical platform while addressing growing demographic demand for aging-related procedures. Similarly, Becton Dickinson (NYSE: BDX) recently announced its intent to separate its Biosciences & Diagnostic Solutions business into a standalone company. This move underscores BDX’s focus on streamlined operations and more concentrated R&D investment, while also reflecting a broader industry shift toward capital discipline and strategic prioritization.Looking AheadWhile analysts anticipate continued demand for AI-driven technologies—particularly those generating real-world data and clinical insights—broader macroeconomic factors may temper deal appetite in the near term. Risks such as tariff escalation, valuation volatility, and regulatory uncertainty remain as material headwinds. Persistent concerns around inflation, geopolitical tensions, and policy shifts may lead to prolonged deal timelines or heightened buyer caution.Nonetheless, the early trends in 2025 suggest that innovation-led dealmaking and focused capital deployment will continue to define the MedTech M&A landscape. Well-capitalized strategic buyers and sponsors with a clear digital health thesis are likely to continue pursuing targeted acquisitions that enhance long-term capabilities. As a result, dealmakers should remain focused on identifying assets with defensible intellectual property, scalable infrastructure, and regulatory clarity.

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Dustin represents clients in a variety of corporate and securities matters, including mergers and acquisitions, joint ventures, securities and capital transactions and complex corporate governance matters. 

Dustin K. McKenzie

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Shai Kalansky's practice focuses on corporate and transactional matters, including mergers and acquisitions (representing both buyers and sellers), venture capital financings, and a broad range of sec

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Recent Digital Health-Related FDA Announcements

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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 B. Sanders Ph.D.

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

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

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

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