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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Partner

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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Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated guidelines to add a framework for analysis of antibody patentability. Although not all countries have written guidelines, this framework generally aligns with standards in other countries.New sections 8.192-8.193 were introduced to the <a href="https://www.ipos.gov.sg/docs/default-source/resources-library/patents/guidelines-and-useful-information/examination-guidelines-for-patent-applications.pdf" target="_blank" dir="ltr">Examination Guidelines</a> by the Intellectual Property Office of Singapore (IPOS) and set out an examination framework for assessing novelty and inventive step of antibody inventions. In particular, the guidance states that “for an antibody binding the same antigen as known antibodies, inventive step is not acknowledged based solely on its characterization by its CDR sequences.” Instead, the IPOS guidelines require that the specific amino acid sequence of an antibody must impart an additional surprising property compared to known antibodies binding the same antigen for it to be non-obvious. Description in the specification of a surprising technical effect associated with the claimed antibody is helpful to finding an antibody sequence inventive.The new guidelines issued in Singapore reflects a trend seen in other jurisdictions.In the United States, although there is no specific issued guidance for consistent examination of antibody claims, some examiners find claims obvious if the only difference from the prior art is the sequence, in which case data showing a superior activity may be helpful. Other examiners may consider sequence difference sufficient to confer non-obviousness. In contrast to the lack of standards for assessing non‑obviousness of antibodies in the United States, there is a more consistent and higher standard for written support for antibodies, making it challenging to obtain claims broader than exact sequences. For instance, claiming sequence identity (for example, to CDRs or the variable regions) is unlikely to be patentable unless the application discloses a sufficient number of examples that can support the breadth of the claims.To establish inventive step of novel antibody sequences, the European Patent Office (EPO) requires a surprising technical effect is shown by the application, or that there is no reasonable expectation of success of obtaining antibodies having the required properties (Section G-II.5.6.2 of Guidelines for Examination). In contrast to the United States, standards for establishing support for antibody claims are generally not as strict at the EPO. Nevertheless, it is generally required to define the antibodies by reference to the CDRs, but often examiners will also ask for full variable sequences to be included (e.g., if binding affinity is the technical effect).In China, the applicant needs to show that the claimed antibody has beneficial technical effects (rather than unexpected technical effects) compared to the known antibody. This may mean that it is not necessarily required to show that there is a special technical effect (e.g., binding affinity) and/or to have comparative data over the known antibody. Regarding the level of disclosure required for obtaining a genus claim, an antibody claim is required to be defined by at least the sequences of the six CDRs of the antibody. It is difficult to obtain a genus claim (e.g., antibodies defined by an epitope or only some CDRs of the heavy chain and/or light chain), and it is nearly impossible to obtain functional claims that are not limited to specific antibody sequences.Similar to all the jurisdictions above, applicants in Japan can rely on unexpected superior properties to overcome an obviousness rejection. Such unexpected superior property can be shown by the demonstrative data in the application as filed. The written description and enablement requirements in Japan generally align with those in the United States and China, in that a sufficient number of embodiments needs to be described in order to pursue a genus claim. Notably, the presence of any negative data in an application in Japan can evidence inoperative embodiments and—if such is within the scope of the claim—may also limit the ability to claim a broad genus.While the standard to inventiveness and written support for antibodies vary across jurisdictions, the trend toward tightening patentability standards is clear, making it even more important to have data characterizing the antibody of interest in the specification. The data in the specification can do double duty—providing both fodder for inventive step (especially if data comparing to the prior art are available) and evidence to support enablement and written description.

Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions

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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

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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Scientific Analyst

Dr. Paige Zhang focuses on patent preparation and prosecution, with an emphasis on cellular and molecular biology, antibody therapeutics, and gene therapy.
Prior to joining the firm, Paige was a Life 

Paige Zhang Ph.D.

Paige Zhang

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Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions

Transforming the U.S. Healthcare Industry with Blockchain Technology

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Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents.

It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At the end of August, the current German Government agreed on two concrete legislative projects.The Act to Accelerate the Digitization of Healthcare aims to integrate more digital solutions into everyday healthcare in Germany (so-called “Digital-Gesetz”; see the <a href="https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/D/Kabinettvorlage_Digital-Gesetz-DigiG.pdf" target="_blank">German draft version</a>). The Health Data Utilization Act aims to improve the exchange and use of health data in order to advance research in this field (so-called “Gesundheitsdatennutzungsgesetz”; see the <a href="https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/detail/gesundheitsdatennutzungsgesetz.html" target="_blank">German draft version</a>).Three key regulations for stakeholders in the e-health sectorThe two draft laws contain three key takeaways that are of particular interest to providers and manufacturers of e-health solutions:1. Medical apps move into the spotlightThere are currently 48 digital health applications (so-called “digitale Gesundheitsanwendungen” or “DiGA”) listed on the so-called <a href="https://www.diga-verzeichnis.de/" target="_blank" dir="ltr">DiGA register</a> that can be prescribed by a doctor and are reimbursed by German healthcare insurance. According to the proposed draft law, digital health applications shall be integrated more effectively into healthcare processes and their use will be made more transparent. As of now, only low-risk medical device software (MDR risk class IIa and lower) is suitable for being accepted as a reimbursable DiGA. Hence, the majority of these digital health applications are focusing on mental health issues. With the extension of such applications to medical devices of risk class IIb, it will be possible to get digital health applications for more complex treatment processes like telemonitoring admitted.2. Telemedicine to be expandedTelemedicine is set to become an integral part of healthcare. In particular, video consultations with doctors are to be used more extensively and more easily. For a long time, the German medical professional laws assumed that medical treatment for the insured person had to take place in the same place at the same time. In 2018, the laws that set out the professional legal framework for doctors in Germany were amended by the German Medical Association to allow remote treatment. However, German medical professional law continues to be based on the principle that doctors generally must treat patients in person, whereas communication media can be used to support this. Exclusive counselling or treatment via communication media is only permitted in individual cases if this is medically justifiable and the necessary medical care is maintained. To foster video consultation, the draft proposal of the Digital Act is supposed to lift these current restrictions on video consultations and to make patient treatment exclusively over video consultation more accessible to the public.3. Use of health data will be simplifiedThe legislative initiative also aims to simplify the use of health data and remove any hurdles or ambiguities that might currently exist. The draft Health Data Utilization Act will establish a decentralized health data infrastructure with a central data access and coordination office. An independent body will be set up at the Federal Institute for Drugs and Medical Devices (“BfArM”) for this purpose. The statutory health and long-term care insurance funds will be enabled to make greater use of their data if this serves to improve care, for example, by verifying the safety of drug therapies or facilitating the detection of cancer or rare diseases.The statutory health insurance funds’ billing data available at the Health Research Data Center (“Forschungsdatenzentrum Gesundheit,” “FDZ”) at the BfArM will be made more widely and quickly available for use by third parties. There are also plans to link data from the FDZ with data from the clinical cancer registries of the federal states.In an effort to make the data from the electronic patient file (for more information, see below) more usable for research purposes, it is foreseen that patients would have to opt out if they wish to object to such uses. To facilitate this, the draft bill requires an easy-to-use objection management system to be set up.Further regulationsAnother important step towards a digital healthcare system is the introduction of the electronic patient file (“ePA”). From the beginning of 2025, all people with statutory health insurance will have such an ePA and will be able to access online, for example, diagnoses and information on current medication, which they may decide to share with the practitioners of their choice. In addition, from January 2024, it will be mandatory for doctors to make prescriptions for medicines available online.OutlookThe two draft laws still need to be passed by the German Parliament. As the Government has agreed on the drafts, the laws have a sufficient majority to be passed. It is expected that the laws will come into force in 2024. In addition, the German Federal Ministry of Health plans to present a Medical Research Act later this year to comprehensively accelerate clinical trials. Watch this spot for more information on the ongoing legislative process and don’t miss our blog post on “<a href="https://lifesciences.mofo.com/topics/key-considerations-for-sponsors-of-clinical-trials-under-the-eu-clinical-trial-regulation?_gl=1*18lbuqo*_ga*NDAwMjk0NDUyLjE2ODU2MzIwNjM.*_ga_3HVRG7GH76*MTY5OTM4MDM5Ni41NC4wLjE2OTkzODA0MDUuMC4wLjA." target="_blank">Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation</a>,” if you are interested in this topic.MoFo Research Assistant Tim Stripling has contributed to this article.

Digitalization of German Healthcare System to Receive Legislative Boost in 2024

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Counsel

Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Digitalization of German Healthcare System to Receive Legislative Boost in 2024

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It is no secret that the healthcare system in Germany is not sufficiently digitized.

The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the opportunity to influence government policy regarding federal and international biotechnology regulations that will affect anyone sourcing or manipulating genetic material. We expect these policies to be particularly salient for developers in the food, agriculture, and pharmaceutical industries. Read the full<a href="https://www.mofo.com/resources/insights/231115-comment-morphing-us-biotechnology-regs" dir="ltr" target="_blank"> client alert</a>.

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Associate

Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Owen counsels clients in the life sciences, healthcare, food, and agriculture industries on cross-cutting issues involving regulatory compliance, intellectual property, and litigation.

Owen Grayson Hosseinzadeh

Owen Hosseinzadeh

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The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks.

Comment on Morphing U.S. Biotechnology Regulations

On October 26, 2023, the U.S. Court of Appeals for the Federal Circuit in Monterey Research, LLC v. STMicroelectronics, Inc.[1] affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB)[2] that invalidated challenged patent claims owned by Monterey Research (“Monterey”) covering an “improved Static Random Access Memory (SRAM) cell design and method of manufacture”[3] for computer memory.U.S. Patent No. 6,534,805 (“U.S. Pat. No. ’805”)Monterey’s U.S. Pat. No. ’805 protects a memory cell having multiple layers of circuit components.[4]  A conventional semiconductor memory device stores information digitally, in the form of bits (e.g., binary digits).  The memory is typically organized as a matrix of memory cells, each of which is capable of storing one bit.  The cells of the memory matrix are accessed by wordlines (that are typically associated with the rows of the memory matrix) and bitlines (that are typically associated with the columns of the memory matrix).[5]  Figure 3 of U.S. Pat. No. ’805 depicts local interconnects that correspond to bitlines (38 and 39) or a global wordline (43 and 44), each of which is associated with a single contact region (15c, 16c, 17c1, and 17c4) within the circuit.[6]<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt2ae0f4d67cb35854/6554028c4d28592649afb1f1/231114-patent-prosecution-trategies.jpg?format=auto&amp;quality=60" alt="Patent Prosecution Strategies to Avoid Pitfalls in Post-grant Proceedings"/></div>Inter Partes ReviewPetitions for Inter Partes Review of U.S. Pat. No. ’805 were brought by Advanced Micro Devices, Inc. and STMicroelectronics, Inc.[7] and by Qualcomm Inc., Advanced Micro Devices, Inc., and STMicroelectronics, Inc.[8]  The dispute concerned, inter alia, claim 8, which reads:<blockquote dir="ltr">8. A memory cell comprising a plurality of substantially oblong active regions formed in a semiconductor substrate and arranged substantially in parallel with one another, and a plurality of substantially oblong local interconnects above said substrate that extend only partially across the memory cell and are arranged substantially in parallel with one another and substantially perpendicular to said active regions.</blockquote>Petitioners argued that neither the claim language nor the Specification supported Patent Owner’s proposed claim construction that a single local interconnect layer required lateral routing of signals along the interconnect layer because the word “routing” wasn’t present in the application, and Figure 3 did not illustrate any routing along the local interconnect layer, let alone specific positions that would demonstrate routing.[9]To oppose Petitioners’ assertion, Patent Owner Monterey referenced the underlying prosecution history to support its position that the disputed limitation was limited to the embodiment in Figure 3 showing the type of lateral routing of signals being discussed.  Specifically, Monterey argued that the limitation “single local interconnect layer comprising local interconnects corresponding to bitlines and a global wordline” was added to claim 8 during reexamination to distinguish over a cited prior art reference.[10]The PTAB found that neither the specification nor the prosecution history limited the claim scope to lateral routing[11] because Figure 3 only showed a single contact point on each relevant interconnect, rather than contacts on both ends that would impose lateral routing, and the underlying prosecution history did not disclaim any specific routing.[12]  The challenged claims were found unpatentable as obvious[13] and Monterey appealed.[14]Federal CircuitOn appeal, the Federal Circuit affirmed the PTAB’s conclusion that Monterey’s representations made during prosecution did not restrict the claim limitation to lateral routing because those statements did not require that the local interconnects provide connections between “laterally displaced” components such that signals would have to be horizontally routed.[15]  Even if the disputed “single local interconnect layer” claim term were limited to Figure 3, the majority held that Figure 3 did not restrict the claim as argued by Monterey because Figure 3 only depicts a single contact region for each of the relevant local interconnects required by the disputed limitations,[16] leaving it ambiguous as to whether the second contact region associated with the local interconnects (about which Figure 3 is silent) required lateral and not vertical routing.  As such, the Federal Circuit agreed with the PTAB’s claim construction.Interestingly, in dissenting in part, Judge Dyk disagreed with the majority’s holding that Figure 3 was not limited to the lateral routing construction because the PTAB concluded that “the embodiment shown in Figure 3 of the ’805 patent illustrate[d] routing . . . signals along an interconnect layer to connect laterally displaced bitlines and wordlines.”[17]  Thus, according to Judge Dyk, the PTAB determined that the rest of the claim language and specification did not limit the claim scope to the embodiment disclosed by Figure 3, not that Figure 3 was so limited.[18]  Therefore, under the PTAB’s determination, limiting the scope of the disputed claim term to the embodiment in Figure 3 would limit the claim’s scope to an embodiment connecting laterally displaced components.[19]Practical Tips for ProsecutionTypically, to maintain flexibility for a broad claim construction, patent practitioners seek to put fewer statements and declarations on the record during prosecution.  Patent practitioners may engage in a balancing act and apply a minimalistic approach, placing just enough on the record to support the Applicant’s position, while not placing too much on the record to result in unintentional repudiations of claim scope.  However, this decision emphasizes how this approach may have unintended consequences during post-grant proceedings.Patent practitioners should consider pursuing claims of varying scope during prosecution to protect diverse embodiments of the invention as an alternative to narrowing the claims during prosecution, which could create estoppel issues when attempting to argue for broader claim construction in post-grant proceedings at the PTAB or during litigation.References[1] Monterey Research, LLC v. STMicroelectronics, Inc., No. 2022-1411, 2022-1770 (Fed. Cir. 2023) (“Fed. Cir. Decision”).[2] Advanced Micro Devices, Inc. and STMicroelectronics, Inc. v. Monterey Research, LLC, IPR2020-00990, 2021 WL 6339618 (P.T.A.B. Nov. 23, 2021) (“0990 Decision”); Qualcomm Inc. v. Monterey Research, LLC, No. IPR2020-01491, 2022 WL 682743 (P.T.A.B. Mar. 4, 2022) (“1491 Decision”).[3] U.S. Patent No. 6,534,805 (“U.S. Pat. No. ’805”), 1:7–10.[4] See 1491 Decision, at *2.[5] See U.S. Pat. No. ’805, 1:32–43.[6] See id. at 11:18–21, 13:12–13, 31.[7] See 0990 Decision, at *4 (challenging claims 8, 10, 12, 16, 18, 22, and 23 under 35 U.S.C. § 103(a) in view of U.S. Patent No. 6,417,549 (“Oh”) individually and Oh in view of R. Jacob Baker, et al., CMOS Circuit Design, Layout and Simulation (2011) (“Baker”)).[8] See 1491 Decision, at *4–5 (challenging several claims under 35 U.S.C. § 103(a) in view of U.S. Patent Nos. 6,347,062, 5,702,982, 5,930,163, Oh, and/or Baker).[9] See 1491 Decision, at *17.[10] See id. at *7 and *17.[11] See id. at *8 (“although Figure 3 shows bitline signals can be routed horizontally . . . neither the Specification nor the claims require such routing.”).[12] See id. at *8.[13] See id. at *80–81. See also 0990 Decision, at *45.[14] See Fed. Cir. Decision, at *5.[15] See id. at *18.[16] See id.[17] See id. at *3 (quoting 1491 Decision, at *17) (Dyk, J., dissenting in part, concurring in part).[18] See id. at *3.[19] See id. at *3 and *4.

Patent Prosecution Strategies to Avoid Pitfalls in Post-grant Proceedings