percent identity and the written description requirement of 35 u s c 112 first paragraph n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph PowerPoint Presentation
Download Presentation
Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph

Loading in 2 Seconds...

play fullscreen
1 / 40

Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph - PowerPoint PPT Presentation


  • 244 Views
  • Uploaded on

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) 272-0781 irem.yucel@uspto.gov. 35 U.S.C. 112 Specification, first paragraph.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Percent Identity and the Written Description Requirement of 35 U.S.C. 112, first paragraph' - lerato


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
percent identity and the written description requirement of 35 u s c 112 first paragraph
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) 272-0781

irem.yucel@uspto.gov

35 u s c 112 specification first paragraph
35 U.S.C. 112 Specification, first paragraph
  • The specification shall contain a written descriptionof the invention, and of the manner and process of making and usingit, 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.
written description notice and materials
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
      • http://www.uspto.gov/web/patents/guides.htm
written description coverage
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)
written description coverage1
Written Description- Coverage
  • Products, Processes, Products by process
written description coverage2
Written Description- Coverage
  • Original claims
  • New claims and amended claims
  • Claims asserting benefit of an earlier priority or filing date
general principles
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.
general principles1
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 714.02 and 2163.06).
foundation for examiner s analysis
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
foundation for examiner s analysis1
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))
foundation for examiner s analysis2
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
analysis
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.
how to determine possession
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
how to determine possession1
How to Determine Possession?
  • Particularly troublesome when possession of species does not equate with possession of genus
evidence of possession
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
evidence of possession1
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)
evidence of possession2
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
evidence of possession3
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.
evidence of possession4
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
new or amended claims or claims asserting entitlement to earlier filing date
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
new or amended claims or claims asserting entitlement to earlier filing date1
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)
written description analysis of percent identity claims
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.
examiner s burden of proof
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
examiner s burden of proof1
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.
example 1 a new restrictase family member
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.
example 1 a new restrictase family member1
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.
example 1 a new restrictase family member2
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?
example 1 a new restrictase family member3
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.
example 2 a novel polypeptide
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.
example 2 a novel polypeptide1
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?
example 2 a novel polypeptide2
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.
example 2 a novel polypeptide3
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.
example 3 a novel inducible promoter
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)
example 3 a novel inducible promoter1
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.
example 3 a novel inducible promoter2
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?
example 3 a novel inducible promoter3
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.
example 3 a novel inducible promoter4
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.
example 3 a novel inducible promoter5
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.
example 3 a novel inducible promoter6
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.
thank you
Thank You

Remy Yucel, Ph.D.

Supervisory Patent Examiner

TC1600

(571) 272-0781