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1 Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph Remy Yucel, Ph.D. Supervisory Patent Examiner Technology Center.

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Presentation on theme: "1 Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph Remy Yucel, Ph.D. Supervisory Patent Examiner Technology Center."— Presentation transcript:

1 1 Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph Remy Yucel, Ph.D. Supervisory Patent Examiner Technology Center 1600 (571)

2 2 35 U.S.C. 112 Specification, first paragraph The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

3 3 Written Description- Notice and Materials Written Description Guidelines (66 FR 1099 (Jan. 5, 2001); 1242 O.G. 168 (Jan. 30, 2001) –http://www.uspto.gov/web/menu/current.html#register Training Materials

4 4 Written Description- Coverage Written in technology neutral manner since recent decisions of the Federal Circuit have written description implications in a broad range of technologies –In re Curtis (dental floss) –Noelle v. Lederman (antibodies) –Univ. of Rochester v. Searle (pharmaceutical treatment) –In re Wallach (DNA) –Bilstad v. Wakalopulos (sterilizing apparatus)

5 5 Written Description- Coverage Products, Processes, Products by process

6 6 Written Description- Coverage Original claims New claims and amended claims Claims asserting benefit of an earlier priority or filing date

7 7 General Principles Basic inquiry: Can one skilled in the art reasonably conclude that the inventor had possession of the claimed invention at the time the application was filed? Written description requirement is separate and distinct from the enablement requirement.

8 8 General Principles Strong presumption that an adequate written description is present in the application as filed. Initial burden is on examiner to present prima facie case of lack of written description. Applicant should show support for new or amended claims (MPEP and ).

9 9 Foundation for Examiner’s Analysis Determine what each claim as a whole covers –Broadest reasonable interpretation in light of and consistent with written description - In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). –Preamble and transition phrases treated under common usage

10 10 Foundation for Examiner’s Analysis Transition phrases –Open: “comprising”, “having” –Closed: “consisting of” –“Consisting essentially of” Necessarily includes listed ingredients Open to unlisted ingredients that do not materially affect the basic and novel properties of the invention (PPG Industries Inc. v. Guardian Industries Corp., 156 F.3d 1351, 48 USPQ2d 1351 (Fed. Cir. 1998))

11 11 Foundation for Examiner’s Analysis Review entire application to understand what applicant has described as the essential features of the claimed invention –Review conducted from standpoint of one of skill in the art at the time the application was filed –Includes determining field of invention and level of skill and knowledge in the art

12 12 Analysis If a skilled artisan would have understood the inventor to be in possession of the claimed invention at the time of filing, even if every nuance of the claim is not explicitly described in the specification, then the requirement for an adequate written description is met.

13 13 How to Determine Possession? Federal Circuit has not directly set forth a “possession test” Extrapolate from decisions in various technologies »e.g., Pfaff v. Wells Electronics, Vas-Cath v. Mahurkar, Fiers v. Revel

14 14 How to Determine Possession? Particularly troublesome when possession of species does not equate with possession of genus

15 15 Evidence of Possession Actual reduction to practice –Reduction to practice normally not required cf.: Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) –Deposit of biological materials Not a substitute for written description

16 16 Evidence of Possession Clear depiction of the claimed invention in detailed drawings –Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 48 USPQ2d 1641 (1998) What is conventional or well known to one skilled in the art need not be disclosed in detail –Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991)

17 17 Evidence of Possession Written description describing sufficient relevant identifying characteristics –Weigh factual considerations including: Level of skill and knowledge in the art Complete or partial structure Physical and/or chemical properties Functional characteristics Correlation between structure and function Method of making

18 18 Evidence of Possession Written description describing sufficient relevant identifying characteristics –The less mature the technology, the heavier the burden on the disclosure to demonstrate possession. –Because the level of skill and knowledge in the art increases over time, it is essential to determine possession as of the effective filing date.

19 19 Evidence of Possession Possession analyzed for each claim drawn to a species, and thereafter for each claim drawn to a genus –Legal definitions of genus and species recognized in patent law, not taxonomic definitions Written description for claimed genus may be satisfied through sufficient description of a representative number of species –Species must be adequately described and must fairly represent the variation within the entire genus

20 20 New or Amended Claims, or Claims Asserting Entitlement to Earlier Filing Date Each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure –Hyatt v. Boone, 146 F.3d 1348, 47 USPQ2d 1128 (Fed. Cir. 1998) In some situations, minor errors in sequence information may be corrected by reliance on a deposited biological material

21 21 New or Amended Claims, or Claims Asserting Entitlement to Earlier Filing Date Each claim must include all elements which applicant has described as essential or critical –Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998) –Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) –Johnson Worldwide Associates Inc. v. Zebco Corp., 175 F.3d 985, 50 USPQ2d 1607 (Fed. Cir. 1999)

22 22 Written Description: Analysis of Percent Identity Claims The following three examples illustrate analysis and determination of written description for claims reciting percent identity –Example 1: Percent Identity and a well-known family of polypeptides. –Example 2: Percent Identity and a novel polypeptide. –Example 3: Percent Identity and a novel, inducible promoter region.

23 23 Examiner’s Burden of Proof Description as filed presumed adequate No per se rules Allegation of unpredictability in the art is insufficient Need reasonable basis to challenge –Evidence –Technical reasoning

24 24 Examiner’s Burden of Proof Evidence and technical reasoning that indicates unpredictability may support a prima facie case for lack of written description. –In In re Curtis, the court held that there was sufficient evidence to indicate that ordinary artisans could not predict the operability of other species other than the single one disclosed in the specification.

25 25 Example 1: A New Restrictase Family Member The specification discloses SEQ ID NO: 1 which encodes a polypeptide. –The polypeptide is identified as a new restrictase family member based on a high level of homology to other restrictases. –The amino acid sequence is identified as SEQ ID NO: 2. –The specification does not disclose any other sequences, including any sequence with less than 100% identity to SEQ ID NO: 1 that encodes a polypeptide with restrictase activity.

26 26 Example 1: A New Restrictase Family Member The field recognizes that the restrictase family is well-characterized. The art teaches several domains and motifs shared by all family members that are required for restrictase activity.

27 27 Example 1: A New Restrictase Family Member Consider the following claim: An isolated nucleic acid sequence that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has restrictase activity. Is there written description?

28 28 Example 1: A New Restrictase Family Member An isolated nucleic acid sequence that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has restrictase activity. Weigh factual considerations such as: Level of skill and knowledge in the art Complete or partial structure Physical and/or chemical properties Functional characteristics Correlation between structure and function Analyze claim against the backdrop of a well-developed field and conclude that the written-description requirement is met for the claim above.

29 29 Example 2: A novel polypeptide The specification discloses SEQ ID NO: 1 which encodes a polypeptide. –The polypeptide is novel and does not share significant sequence identity with any known polypeptide or polypeptide family but the polypeptide has a novel activity X. –The amino acid sequence is identified as SEQ ID NO: 2. –The specification does not disclose any other sequences, including any sequence with less than 100% identity to SEQ ID NO: 1 that encodes a polypeptide with activity X.

30 30 Example 2: A novel polypeptide Consider the following claim: An isolated nucleic acid sequence that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has activity X. Is there written description?

31 31 Example 2: A novel polypeptide An isolated nucleic acid sequence that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has activity X. Weigh factual considerations In this situation, there is no well-developed field of prior art because the polypeptide and its activity are novel. The specification teaches a single, reference sequence and does not provide any information as to relevant characteristics or even partial structure/function information.

32 32 Example 2: A novel polypeptide Conclusion: The above claim does not meet the written description requirement, consistent with the reasoning in Curtis. Under In re Alton, 37 USPQ2d 1578 (Fed. Cir. 1998), USPTO bears the burden of presenting evidence or reasons why persons skilled in the art would not find the disclosure of a species to be a description of the genus defined in the claims. –The Office Action would present evidence and reasons to support a prima facie case.

33 33 Example 3: A novel inducible promoter The specification discloses: –a single nucleic acid sequence SEQ ID NO: 1 which is a novel, inducible promoter –promoter activity is induced by Y –location of sequences common to all promoters (e.g. CAAT-box)

34 34 Example 3: A novel inducible promoter The specification does not disclose: –other promoters that are inducible by Y –sequences or motifs responsible for induction by Y. The prior art does not teach promoters inducible by Y.

35 35 Example 3: A novel inducible promoter Consider the following claim: An isolated promoter with at least 85% sequence identity to SEQ ID NO: 1; wherein the promoter is inducible by Y. Is there written description?

36 36 Example 3: A novel inducible promoter An isolated promoter with at least 85% sequence identity to SEQ ID NO: 1; wherein the promoter is inducible by Y. In this situation we have some structure- function information from the prior art. However neither the prior art nor the specification teach the structure(s) required for induction by Y.

37 37 Example 3: A novel inducible promoter An isolated promoter with at least 85% sequence identity to SEQ ID NO: 1; wherein the promoter is inducible by Y. The structure-function information in the prior art is of a general nature because it describes promoter elements that are common to all promoters. Presence of these common elements does not address the question of what structure(s) are required for specific induction by Y. Conclusion: Because the specification does not disclose a single sequence with less than 100% identity to SEQ ID NO: 1 with promoter activity that is inducible by Y and because the prior art is silent with respect to promoters that are inducible by Y, disclosure of general promoter motifs alone is not sufficient to fulfill the written description requirement.

38 38 Example 3: A novel inducible promoter An isolated promoter with at least 85% sequence identity to SEQ ID NO: 1; wherein the promoter is inducible by Y. Conclusion: –because the specification does not disclose a single sequence with less than 100% identity to SEQ ID NO: 1 with promoter activity that is inducible by Y; and –because the prior art is silent with respect to promoter structure(s) that are inducible by Y, disclosure of general promoter elements alone is not sufficient to fulfill the written description requirement.

39 39 Example 3: A novel inducible promoter The Office action would present evidence and reasons to support a prima facie case for lack of written description based on the reasoning in Curtis.

40 40 Thank You Remy Yucel, Ph.D. Supervisory Patent Examiner TC1600 (571)


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