Effective Tools & Techniques to Minimize Section 101 Rejection in a Patent Prosecution Minefield
Determining the eligibility of a claim in a patent or patent application under 35 U.S.C. § 101 has become a challenging task, particularly in the fields of business methods, computer software, and biotechnology. In 2014, the U.S. Patent and Trademark Office (USPTO) issued guidance for use in evaluating the eligibility of claimed subject matter based on the Supreme Court’s decision in Alice Corp v. CLS Bank.
Despite these guidelines, and despite many hypothetical examples provided by the United States Patent and Trademark Office since Alice, there is wide-spread disagreement and confusion over application of the Supreme Court’s decision. As a result, patentees and patent applicants must have a thorough understanding of patent eligibility doctrine.
The panel will discuss the examination guidelines and some examples published by the U.S. Patent Office, a short history of the current state of subject matter eligibility, and briefly summarize and critique proposals for amending the governing statute, 35 U.S.C. § 101, announced by three major American intellectual property associations. The panel will also introduce a proposed alternative and offer some related practical guidance for prosecution before the Patent Office.
Key topics include:
- Two-Step Analysis
- Recent Case Law
- Risks and Pitfalls
- Proposed Amendments to the Current Statute and Implications
- Alternative to Amendments to the Current Statute
- Practical Guidance
Taft Stettinius & Hollister LLP
The PTO Guidelines
- Where are We and Why?
- Myriad and Post Myriad Minefield
- Patent Eligible Flow Chart
- PTO Life Sciences Examples
- Vaccine Example
- PTO Life Sciences Examples
- Diagnosing & Treating
- Dietary Sweeteners
- Screening for Gene Alterations “Myriad”
- Hydrolysis of Fat
- No recitation of law of nature in claim
- Post Myriad Life Sciences Patent Eligiblity Cases
- Cleveland Clinic Foundation v. True Health Diagnostics, LLC
- Genetic Tech. Ltd. v. Merial LLC
- Ariosa Diagnostics, Inc. v. Sequenom, Inc.
- Univ. of Utah Research Found. v. Ambry Genetics Corp. (Myriad again)
- In re Roslin Institute (Edinburgh)
- SmartGene, Inc. v Advanced Biological Labs.
- Rapid Litigation Management v. Cellzdirect
- Prosecution Tips
Hamilton, Brook, Smith & Reynolds, P.C.
- “Roundtable 2” - Overview of the July 2017 Report on a roundtable conducted at Stanford University by the USPTO on Dec. 6, 2016, entitled “Patent Eligible Subject Matter: Report on Views and Recommendations From the Public”
- Public Views from the Roundtable, as reported by the Patent Office
- Intellectual Property Owners Association (IPO), American Bar Association (ABA) and American Intellectual Property Law Association (AIPLA) Proposals to Amend § 101
- Replace two-part test
- Expressly define exceptions to patentability
- Distinguish eligibility from other patentability requirements
- Establish research exemption to infringement
Hamilton, Brook, Smith & Reynolds, P.C.
- Preemption doctrine: Where did it start?
- We have been here before:
- New Use
- Why now?
- What now?
- A critique of some recent proposals
- An alternative
Who Should Attend:
- IP Attorneys & Consultants
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Litigators
- Patent Owners
- Patent Counsel
- In-house Counsel
- General Counsel
- Other Related and Interested Professionals
DR. ADELAIDE K. LEITZEL, a registered patent agent, holds a Ph.D. in genetics and molecular biology from the University of North Carolina and received her undergraduate degree in biology and history from Davidson College in Davidson, North Carolina. She has extensive experience in drafting and prosecuting patent applications for inventions from diverse areas including genetics, transgenic animals, immunology, bacteriology, cardiology, nephrology, pulmonology, diagnostic methods, transgenic plants, plant pathology, and plant development. Her research was published in the journal Yeast. Dr. Leitzel is a registered patent agent with the U.S. Patent and Trademark Office. She practices in the area of Patent Prosecution with a focus on Life Sciences. Dr. Leitzel has published multiple articles on the unique aspects of life sciences patent prosecution, especially the Myriad decisions.
DR. ADELAIDE K. LEITZEL, a registered patent agent, holds a Ph.D. in genetics and molecular biology from the University of …
DR. MARY K. MURRAY has an extensive scientific background and has been a patent attorney for over twenty years. She was elected to the Board of Mass MEDIC, where she served for six years, and as an officer for three years. Prior to becoming a patent attorney, Mary participated in grant review panels for the U.S. Department of Agriculture, National Institutes of Health and the National Science Foundation. She also authored or co-authored over fifty peer-reviewed scientific publications.
An alumnus of Suffolk University Law School, Mary is also the Chairperson of the law school’s Intellectual Property Advisory Board, which is dedicated to advancing the legal and professional training of law students and the intellectual property community. Mary is an active speaker, moderator, and author on issues relating to intellectual property, recently speaking at MassBio on the topic “Innovation in Life Sciences: Demystifying Patent Eligibility.”
DR. MARY K. MURRAY has an extensive scientific background and has been a patent attorney for over twenty years. She …
MR. N. SCOTT PIERCE is a patent prosecutor with almost thirty years of experience at Hamilton, Brook, Smith & Reynolds, P.C. He also serves on the Firm’s Management Committee.
Scott is an adjunct professor at Suffolk University Law School teaching biotechnology patent law and the author of numerous published academic articles. Recent articles on patent eligibility include “Three Patent Eligibility Statute Proposals – And An Alternative,” (Law360 July 31, 2017); “Patent Eligibility as a Function of New Use, Aggregation, and Preemption Through Application of Principle,” 23 Rich. J. L. & Tech 11 (2017); and “A Great Invisible Crashing: The Rise and Fall of Patent Eligibility through Mayo v. Prometheus” 23 Fordham Intellectual Prop., Media & Ent. L. 186 (2012).
MR. N. SCOTT PIERCE is a patent prosecutor with almost thirty years of experience at Hamilton, Brook, Smith & Reynolds, …
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About Taft Stettinius & Hollister LLP
In a world where Intellectual Property (IP) may well be a client's most valuable asset, Taft’s IP practice group focuses on providing comprehensive services designed to develop legal strategies and achieve legal solutions to meet our clients' business goals.
Taft’s IP group consist of more than 60 attorneys, including 32 registered patent attorneys, who are experienced in identifying, protecting and enforcing our clients' IP rights. Our attorneys are well-positioned to address our clients' business and IP needs because of our diverse industry experience, including banking and financial services, gaming, software development and licensing, real estate, e-commerce, telecommunications, electronics, automotive, agricultural, candy and confectionery, food manufacturing and distribution, restaurants and food service, distilled spirits, coffee, sports and entertainment, medical and dental products, clothing and jewelry, manufacturing, metal working and woodworking machinery, hospitals and health care institutions, life sciences, universities, and advertising and marketing.
About Hamilton, Brook, Smith & Reynolds, P.C.
Hamilton Brook Smith Reynolds is among New England's largest law firms devoted to the practice of intellectual property law. The firm specializes in patents, trademarks, intellectual property litigation, copyrights, licensing, due diligence, trade secrets, and intellectual property counseling. The firm provides intellectual property legal expertise in biotechnology, chemistry, computer hardware and software, telecommunications, medical devices, pharmaceuticals, physics, optics, nanotechnology, electrical, chemical and mechanical engineering. bout Hamilton, Brook, Smith & Reynolds, P.C.