Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Patents
  • Published:

Analyzing the USPTO's revised utility guidelines

Nature Biotechnology volume 18, pages 349–350 (2000)Cite this article

Under the new guidelines, Section 101 “utility” rejections may make a comeback.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. 35 USC §101.

  2. 35 USC §112, first paragraph.

  3. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991).

  4. See In re Cortright, 49 USPQ2d 1464 (Fed. Cir. 1999).

  5. See Maximizing AIDS Drug Research by the Biotechnology Industry: Presentations of the Biotechnology Industry Organization to the Joint Meeting of the Public/Private Issues and Drug Development Subcommittees of the National Task Force on AIDS Drug Development (April 25, 1995); Cf. BIO News 12/95, Looking Ahead (“The new Patent and Trademark Office Utility Guidelines, adopted by the PTO this year, are expected to save millions in legal fees”). Citing the 234-page agenda of reforms entitled Critical Synergy: the Biotechnology Industry and Intellectual Property Protection presented at an October 17, 1994, hearing regarding patent issues of concern to the biotechnology industry as identifying as one of the “key issues as the consideration by the PTO of the ‘utility’ of a biotechnology invention,” noting “an unfortunate trend at the PTO toward requiring human clinical data to demonstrate utility" and damage resulting therefrom to “the small biotechnology company because it often must find corporate partners to fund clinical development which is very expensive" but “[w]ithout a clear patent position it can be difficult to recruit a partner.”

  6. 60 FR 36,263; 1177 OG 146 (July 14, 1995).

  7. See 64 FR 71,428 (December 21, 1999) (The USPTO, with respect to the Interim Written Description Guidelines, 63 FR 32,639 (June 15, 1998), issued “The Extension of Comment Period and Notice of Hearing,” 63 FR 50887 (September 23, 1998) and 1214 O.G. 180 (September 29, 1998), asking for comments regarding the patentability of ESTs); many respondents asserted that ESTs lacked the requisite utility to satisfy the US Patent Law; and, “[i]n view of comments and testimony with respect to ESTs and the enablement and utility requirements, the [USPTO]…revis[ed] the Utility Guidelines as published at 60 FR 36263 (July 14, 1995)"; see also Letter of Carl Feldbaum, President, BIO, to The Honorable Bruce Lehman, Commissioner, USPTO (January 26, 1998) (Stating: “We understand some EST applications will…provide the barest minimal disclosure that merely speculates EST utilities that would be true of most or all ESTs….[W]e request the PTO to publish for comment the examination guidelines regarding the patenting of ESTs, preferably with clear examples of the types of disclosure that will be sufficient for particular claim scope.” And, “anticipat[ing] a similar convergence of opinion will occur in regard to single nucleotide polymorphisms (SNPs).”).

  8. 383 US 519-534-35, 148 USPQ 689-95 (1966). Accord In re Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1603 (Fed. Cir. 1996) (requiring disclosure of specific and substantial or practical utility as a condition for satisfying requirement of §101).

  9. 153 USPQ 48 (CCPA 1967).

  10. See, e.g., 35 USC §§119, 120.

Download references

Acknowledgements

The opinions expressed herein are personal opinions of the author, and are not to be considered opinions of Frommer Lawrence & Haug LLP or any of the firm's clients. The author gratefully acknowledges the assistance of Elizabeth Pearce.

Author information

Authors and Affiliations

  1. Partner at Frommer Lawrence & Haug LLP, 745 Fifth Avenue, New York, 10151, NY

    Thomas J. Kowalski

Authors
  1. Thomas J. Kowalski
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Thomas J. Kowalski.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kowalski, T. Analyzing the USPTO's revised utility guidelines. Nat Biotechnol 18, 349–350 (2000). https://doi.org/10.1038/73820

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/73820

This article is cited by

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing