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Advanced Patent Prosecution Topics 2019: Ethics, Patent Eligibility, PTAB and Roundtable Discussions


Speaker(s): Ann M. McCrackin, Jay P. Lessler, Keith D. MacMillan, Mercedes K. Meyer, Ph.D., Michael P. Dunnam, Rebecca Goldman Rudich, Robert D. Schaffer, W. Todd Baker
Recorded on: Sep. 2, 2019
PLI Program #: 279210

Ann McCrackin is the President and Chief Business Development Officer for Black Hills IP as well as a patent prosecution process expert and a highly accomplished patent attorney with extensive experience in both U.S. and international patent prosecution.  Before becoming President of Black Hills IP Ann was a Professor of Law and the Director of the nationally recognized Patent Prosecution and Procedure Program at Franklin Pierce Law Center (now the University of New Hampshire School of Law).  At Franklin Pierce, Ann directed the program and taught courses in advanced aspects of practice before the United States Patent and Trademark Office (USPTO).  Ann has also taught dozens of continuing legal education courses and seminars on various aspects of patent process and prosecution and has edited and authored a number of legal texts on patent law.  Ann is also attorney of record for several Amicus Briefs filed in patent cases before the U.S. Supreme Court and the Court of Appeals for the Federal Circuit.  Ann was a Shareholder at the Minneapolis patent firm Schwegman, Lundberg & Woessner, P.A. for eight years.  Ann has an undergraduate degree from Iowa State University and a law degree from Franklin Pierce Law Center.


Jay Lessler concentrates his practice in domestic and foreign patent procurement, transactions involving intellectual property, client counseling, and patent litigation, primarily in the chemical, pharmaceutical, and computer software arts.

Working closely with inventors and in-house counsel, Jay devises effective strategies to build and protect intellectual property assets, from initial drafting of patent applications to post-grant proceedings. His experience includes:

  • all areas of patent prosecution involving domestic and foreign patents
  • reissues
  • reexaminations
  • patent term extension proceedings
  • inter partes reviews
  • licensing and joint development agreements
  • conducting due diligence investigations
  • conducting validity and freedom-to-operate studies
  • counseling clients in connection with the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act 
  • preparation of Paragraph IV Notice letters and Offers for Confidential Access pursuant to the Hatch-Waxman Act
  • counseling regarding the listability of patents in the FDA Orange Book

He also has significant ANDA and biotech litigation experience.

Jay has been the co-chair of Practising Law Institute’s (“PLI’s”) annual Advanced Patent Prosecution Workshop since 2006. He was also a speaker at PLI’s Patent Boot Camp Workshop from 2002 to 2006, and in 2016 and 2017.

Jay has co-authored numerous chapters on Patent Law and the Hatch-Waxman Act, including the “Generic Drug-Approval Process: Hatch-Waxman Update” chapter in The Pharmaceutical Regulatory Process, Second Edition (edited by I. Berry) (2008), and the "Non-Obviousness, Regulatory Exclusivities for Pharmaceutical Products, Post-Grant Procedures," and "How to Prosecute a Biopharma Patent Application" chapters in Biotechnology And Pharmaceutical Patents (2007) (Aspen).


Mercedes K. Meyer, Ph.D. collaborates with her life sciences clients from start-up to Fortune 500 companies on their patent portfolio strategy and manages an extensive biotechnology and pharmaceutical patent prosecution practice. She drafts, prosecutes, opines and oversees global patent portfolio management, development, investment and acquisition. She works with Boards of Directors on start-ups for innovation monetization. She has experience in due diligence, patent interferences, reexamination, litigation, drug pricing and bioethics issues.

With a Ph.D. in virology and A.B. in chemistry, Mercedes has an intimate understanding of complex biotechnology and chemical subjects and their interplay. She helps clients protect innovations in areas covering antibodies, enzymes, viral vectors, genomics, vaccines, stem cell research, gene therapy, drug screening and identification, protein and tissue arrays, cancer therapeutics, cancer diagnostics, X-ray protein crystallography, food and beverages, animal health products, and industrial enzymes for biofuels and cosmetics. Her doctoral background provides practical research experience in the area of retroviruses, including HIV-1, virology, molecular biology, cancer biology, immunology and protein chemistry.

Mercedes is Co-Chair of the firm’s Intellectual Property Life Sciences Team, and an active member of the American Intellectual Property Law Association (AIPLA), the Intellectual Property Owner’s Organization (IPO) and Federal Circuit Bar Association (FCBA). She co-authored Patent Ethics – Prosecution (20016, 4th ed.) with David Hricik for LexisNexis.


Michael Dunnam is an attorney with the law firm of Schwegman, Lundberg, and Woessner.  Mr. Dunnam is a past chair of the Electronic and Computer Law Committee of the AIPLA, a past coordinator of the Electronic and Computer Law Committee’s Partnering in Patents Program, Road Shows and Patent Law Summit, and a member of several AIPLA delegations to Japan. Mr. Dunnam also was a recent member of the AIPLA’s 101 Task Force.  Locally, Mr. Dunnam is a former Board Member and Chair of the Computer Practice Committee of the Philadelphia Intellectual Property Law Association. 

Mr. Dunnam has an electrical engineering degree from Brown University and a JD from George Washington University.  Mr. Dunnam started his career as a patent examiner in the U.S. Patent and Trademark Office in the color television arts and was a patent agent with Cushman Darby & Cushman before joining Woodcock Washburn LLP, which merged with Baker Hostetler LLP in January, 2014.  Mr. Dunnam joined the Schwegman firm in August, 2017.

Michael has taught a course entitled Intellectual Property in Business at Temple University Law School and taught in the Intellectual Property Law Clinic at the University of Pennsylvania School of Law.  Michael is active in startup and angel network organizations and is a frequent speaker on topics of intellectual property law, especially patent eligibility.  Michael has lectured for the last several years at PLI’s Advanced Patent Prosecution Workshop in New York City. 

Michael's work primarily focuses on counseling and prosecution of patent applications in the areas of electronics, computer software, cloud computing applications, business methods, telephony, video, lasers, inductive power, autonomous vehicles, medical devices, and medical electronics, such as magnetic resonance imaging technology.


Rebecca Goldman Rudich is a patent attorney with diverse experience in electrical and mechanical technologies. Bolstered by her previous experience as an electrical engineer with the U.S. Air Force, Rebecca is uniquely able to understand the needs of clients within the electronics space.

Rebecca has over 20 years of experience counseling clients in intellectual property matters, including procurement, licensing and enforcement of patents and trademarks. Her prosecution practice is focused in the electrical and mechanical arts, including liquid crystal display devices, home appliances, software inventions, Internet systems, semiconductor devices, cellular telephone systems, cable television systems, audio amplifiers, computer memory devices, laser devices, flooring systems and injection molding.

She is a member of the firm’s Post Grant Proceedings practice, with extensive experience in reexamination proceedings at the U.S. Patent and Trademark Office.

In addition, Rebecca counsels clients in portfolio management, technology transfer and licensing matters. She has engaged in a wide variety of enforcement actions in the areas of liquid crystal displays, optical discs, microprocessors, memory devices and computer hard disks, and has participated in administrative hearings before the United States International Trade Commission. She has prepared numerous infringement, validity and freedom-to-operate opinions in a variety of technologies.


W. Todd Baker is Chair of the firm’s Post-Grant patent practice group and a member of the firm’s Management Committee.  He has significant experience handling patent prosecution and post-grant proceedings at the USPTO, including all aspects of reissue applications, ex parte reexamination, IPR proceedings and appeals to the USPTO’s Patent Trial and Appeal Board (PTAB).  Mr. Baker frequently advises his clients on alternatives to traditional litigation-based patent validity challenges, issues of priority, patentability, derivation, inventorship, and licensing related to patent interference matters before the PTAB.

Mr. Baker prepares and prosecutes patent applications in diversified electrical and mechanical technologies, including artificial intelligence (AI), automotive related technologies – such as autonomous vehicles, clean technologies, dynamic control systems, medical devices and wireless innovation. 


Keith D. MacMillan serves as Director – Patent Counsel in the Intellectual Property Group of Merck & Co., Inc.  His practice includes strategic counseling, drafting patent applications and prosecuting them worldwide, developing patent portfolios and conducting freedom-to-operate analysis for drug molecules, and performing due diligence on potential acquisitions and in-licensing drug candidates. He recently served as Chair of Merck’s internal U.S. patent practice committee.

Keith’s patent law experience spans government, law firm and corporate settings.  He began his career as a patent examiner in the Chemical/Biotechnology Group of the U.S. Patent and Trademark Office, where he held several leadership roles, including those of Acting Supervisory Examiner and Patent Academy Instructor. After leaving government service, he served as an associate in the Washington, D.C. office of a leading global law firm.  He then served as in-house patent counsel for a small biopharmaceutical company on the West Coast before joining Schering-Plough Corp. as Senior Patent Counsel.  He joined Merck when it acquired Schering. Keith enjoys teaching and has been an invited guest lecturer and contributor to the subcommittees of several IP professional organizations.  Keith holds a J.D. from the National Law Center of The George Washington University and a B.A. (Dean’s Scholar) in chemistry from the University of Delaware.  He is licensed to practice before the USPTO. 


Rob Schaffer has written and prosecuted several hundred patent applications before the United States Patent and Trademark Office (PTO), including applications in optics, aerodynamics, semi-conductor manufacturing, encryption, turbines, financial products, surgical devices, and textile machines. He has also written scores of opinions on these technologies. He has experience in a wide range of litigation matters and has personally argued summary judgments and Markman hearings.

Mr. Schaffer earned a BS in Engineering from Cornell University and a JD cum laude from New York Law School. He has served as a lecturer for PLI’s Patent Bar Review Course, PLI’s Fundamentals of Patent Prosecution Course, PLI’s Advanced Prosecution seminar since 1991, and as a visiting lecturer at the College of Engineering, University of Illinois.

Prior to becoming an attorney, Mr. Schaffer worked for twelve years as a consultant engineer, primarily in mechanical equipment and hydraulic analysis.

He is a member of the Bar in Connecticut, New York, and Washington and a member of the American Intellectual Property Law Association. Mr. Schaffer is admitted to practice in the Courts of New York State (1989), the United States District Court for the Southern District of New York (1989) the Court of Appeals for the Federal District (1989), and before the PTO.