Section 112(a) Enablement and Written Description: Leveraging CCPA and Federal Circuit Decisions

Capitalizing on Past Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability

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


Conducted on Tuesday, September 18, 2018

Recorded event now available

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Program Materials

This CLE webinar will provide guidance to patent counsel on leveraging decisions by the CCPA and the Federal Circuit regarding application of §112 written description and enablement requirements. The panel will examine lessons learned from these decisions, and offer strategies to overcome the challenges of §112.

Description

Practitioners face §112(a) issues all the time, in examiner rejections during prosecution, patentability challenges in post-grant reviews (PGRs) before PTAB, and validity challenges before the courts. In addition, §112(a) written description support is required for entitlement to priority date, so practitioners may find themselves facing §112(a) issues in inter partes reviews (IPRs) to either defend a priority date assertion of a patent claim or attack a priority date assertion of a reference raised by a petitioner. Furthermore, in motions to amend in post-grant proceedings, 37 C.F.R. §42.121/42.221 requires patent owners to show support for any proposed substitute claims.

Potential written description support issues include:

  • Result without means of achieving it (just a hope or plan);
  • Broad claim with little support in specification such as a genus claim with few or no species described in the specification;
  • Unsupported claim limitations;
  • Attempts to cherry pick the original disclosure to claim narrow subject matter later discovered to be valuable;
  • Substantial claim amendments made during prosecution;
  • Priority chain support; and
  • Could a POSITA conclude with “reasonable certainty” that patentee had “possession” of claimed invention?

Potential enablement issues include:

  • Are claims objectively enabled?
  • Routine vs. undue experimentation;
  • Proper/improper use of post-filing evidence? (can only reflect state of art at the time of filing);
  • Priority date assertions;
  • Claims enabled throughout scope?
  • Any incorporation by reference issues?

The CCPA developed a rich body of §112 jurisprudence, which the Federal Circuit adopted as binding precedent, providing a treasure trove of arguments for practitioners. Counsel can draw on these CCPA cases, as well as PTAB and Federal Circuit cases for guidance in presenting evidence and arguments of written description support and enablement.

Listen as our authoritative panel of U.S. patent attorneys examines the lessons from select CCPA, PTAB and Federal Circuit decisions to avoid repeating past mistakes and to truly promote the progress of the useful arts and sciences as mandated by the Constitution.

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Outline

  1. Lessons from the CCPA and early Federal Circuit decisions that reversed §112 rejections/invalidity holdings
    1. In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953) (claim rejected as improper Markush; reversed)
    2. In re Robins, 429 F.2d 452, 166 USPQ 552 (CCPA 1970) (examples not required)
    3. In re Borkowski, 422 F.2d 904, 164 USPQ 642 (CCPA 1970) (“magical relation between the number of representative examples and the breadth of the claims”)
    4. In re Brower, 433 F.2d 813, 167 USPQ 684 (CCPA 1970) (patent application found enabled for priority date benefit)
    5. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971) (correcting obvious error not new matter)
    6. In re Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA 1971) (“first paragraph of § 112 requires nothing more than objective enablement. How such a teaching is set forth, either by the use of illustrative examples or by broad terminology, is of no importance.”)
    7. In re Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971) [analyze 112(b) first (rejection at issue is one for indefiniteness)]
    8. In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973) (meeting “how-to-use” requirement)
    9. In re Smythe, 480 F.2d 1376, 178 USPQ 279 (CCPA 1973) (liquids and gases other than air)
    10. In re Angstadt, 537 F.2d 498, 190 USPQ 214 (CCPA 1976) (not required to test every species covered by a claim)
    11. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (range)
    12. In re Johnson, 558 F.2d 1008, 194 USPQ 187 (CCPA 1977) (proviso)
    13. In re Hogan, 559 F.2d 595, 194 USPQ 527 (CCPA 1977) (date benefit)
    14. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980) (improper Markush groups)
    15. In re Breslow, 616 F.2d 516, 205 USPQ 221 (CCPA 1980) (enabled)
    16. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981) (claim may be broader than the specific embodiment disclosed in a specification)
    17. In re Bundy, 642 F.2d 430, 209 USPQ 48 (CCPA 1981) (how-to-use requirement of the first paragraph of §112 has been adequately complied with)
    18. In re Marosi, 710 F.2d 799, 218 USPQ 289 (CCPA 1983) (sufficiently enabled; “appellants’ invention does not reside in such a number”)
    19. Gore & Associates Inc. v. Garlock Inc., 721 F.2d 1540 (Fed. Cir 1983) (“no evidence and no finding that those skilled in the art would have found the specification non-enabling”)
    20. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. 1984) (“Even if some of the claimed combinations were inoperative, the claims are not necessarily invalid”)
    21. Cross v. Iizuka, 753 F.2d 1040 (Fed. Cir. 1985) (“how-to-use” requirement met)
    22. Spectra-Physics Inc. v. Coherent Inc., 3 USPQ2d 1737 (Fed. Cir. 1987), cert. denied, 484 U.S. 954 (1987) (enabled but failed to disclose best mode)
    23. In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) (some experimentation okay)
    24. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991)
    25. In re Brana, 51 F.2d 1560, 34 USPQ2d 1437 (Fed. Cir. 1995) (PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure)
  2. Recent §112 Federal Circuit decisions
    1. Univ. of Rochester
    2. Ariad

Benefits

Our panel will review these and other important issues:

  • What steps can counsel for patentees take to meet the written description and enablement requirements and withstand invalidity/unpatentability challenges based on written description and enablement?
  • What steps can be taken to fix written description and enablement problems?
  • What steps should patent counsel take going forward to avoid repeating mistakes of the past?

Faculty

Irving, Thomas
Thomas L. Irving

Partner
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

Burgy, Adriana
Adriana L. Burgy

Partner
Finnegan Henderson Farabow Garrett & Dunner

Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the...  |  Read More

O’Connor, Steven
Steven P. O'Connor, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. O’Connor leads the firm’s biotechnology and pharmaceutical practice group. He provides IP counseling...  |  Read More

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