Sect. 112 Indefiniteness in Chemical and Biotech Patent Claims

Drafting and Prosecuting Patent Claims That Will Hold Up Under Any Definiteness Standard

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Wednesday, February 14, 2018

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Program Materials

This CLE webinar will provide guidance to patent counsel on the impact of recent Federal Circuit and PTAB case law on daily patent practice. The panel will offer best practices to navigate pre- and post-issuance scrutiny for compliance with 35 U.S.C. §112(b).


In Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S._, 134 S. Ct. 2120 (2014), the Supreme Court held unanimously that the Federal Circuit’s “insolubly ambiguous” standard for indefiniteness “breed[s] lower court confusion.” In re Packard, 751 F.3d 1307 (Fed. Cir. 2014)(per curiam) and Ex parte McAward, Appeal No. 2015-006416 (precedential), show that the USPTO applies a different (lower) standard; a difference that stems from the different claim construction standard applied by the USPTO than the courts.

Where does that leave the chem/bio patent practitioner? Different standards for indefiniteness depending on whether the claim is pre-issuance in the PTO or post-issuance in the courts?

Post-Nautilus Federal Circuit caselaw continues to develop. The claims in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017), were upheld under the Nautilus standard (“a person of ordinary skill in the art would understand the scope of the claim term “vitamin B12” with reasonable certainty.”) In BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360 (Fed. Cir. Nov. 20, 2017), the Federal Circuit overturned a finding of indefiniteness of claims reciting a “composition . . . effective to catalyze,” holding that:

What is needed is a context-specific inquiry into whether particular functional language actually provides the required reasonable certainty.

MasterMine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 1316 (Fed. Cir. 2017), also reversed a district court holding of indefiniteness because “the claims merely use permissible functional language to describe the capabilities of the claimed system.” In Presidio Components, Inc. v. American Technical Ceramics Corp., 875 F.3d 1369, 1377 (Fed. Cir. 2017), the holding of no indefiniteness was affirmed because the claimed measurement required “was within the skill of a skilled artisan based on an established method.”

Does functional claiming language provide a path for life science claims struggling with §112 indefiniteness (and §101 subject matter eligibility)?

And what about PTAB proceedings? Section 112 arguments may arise as a ground of unpatentability in post-grant review (PGR) and in the context of priority date assertions in inter partes reviews (IPRs). IPRs and PGRs relate to issued claims, but so far, the ability to amend claims (a rationale for the appropriateness of the application of the broadest reasonable interpretation claim construction standard) has been almost nonexistent, although one eagerly awaits to see what difference, if any, results from Aqua Products.

Will there be more successful §112 arguments in IPRs/PGRs post-Packard/McAward?

Listen as our authoritative panel of patent attorneys discusses the impact of recent Federal Circuit and PTAB caselaw on your daily patent practice. The panel will offer best practices to navigate pre-and post-issuance scrutiny for compliance with 35 U.S.C. §112(b).



  1. Understanding 35 U.S.C. §112(b) ("indefiniteness")
  2. Post-Nautilus caselaw
  3. Post-Packard/McAward caselaw
  4. Best practices for drafting and prosecuting strong patent claims that will hold up in litigation and before PTAB under any of the definiteness standards


The panel will review these and other key issues:

  • How do the decisions distinguish the USPTO’s standard and the court’s standard for indefiniteness?
  • What are the implications of the post-Nautilus and post-Packard/McAward cases for patent counsel in drafting applications?
  • What steps can counsel take to increase the likelihood that patent claims will survive in litigation and under PTAB review?


Irving, Thomas
Thomas L. Irving

Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

Baur, Amelia
Amelia Feulner Baur, Ph.D

Founding Partner
McNeill Baur

Dr. Baur’s practice covers a broad spectrum of intellectual property issues, including patent preparation and...  |  Read More

Murphy, Amanda
Amanda K. Murphy, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

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