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Patentability of Reach-Through Claims. Brian R. Stanton Practice Specialist Technology Center 1600 (703) 308-2801 Brian.stanton@uspto.gov. Exemplary Reach Through Situations.

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patentability of reach through claims

Patentability of Reach-Through Claims

Brian R. Stanton

Practice Specialist

Technology Center 1600

(703) 308-2801

Brian.stanton@uspto.gov

exemplary reach through situations
Exemplary Reach Through Situations
  • 1. Small molecule per se claim, where the molecule is defined as binding to target but not yet identified (e.g. "A receptor [X] agonist").
  • 2. Method of screening claim: how effectively does this claim protect a small molecule identified in the screen?
  • 3. "Functional use" claim: claim is to a method of treating a disease by a compound defined not by its structure but rather by its ability to bind to a target (e.g. "A method of treating disease [Y] by administering a compound which is a receptor [X] agonist."
major patentability issues
Major Patentability Issues
  • Utility (35 U.S.C. 101)
    • See Utility Examination Guidelines
      • 66 Fed. Reg. 1092 (Jan. 5, 2001)
  • Written Description (35 U.S.C. 112, 1st para.)
    • See Written Description Examination Guidelines
      • 66 Fed. Reg. 1099 ( Jan. 5, 2001)
  • Enablement (35 U.S.C. 112, 1st para.)
  • Novelty (35 U.S.C. 102)
  • Nonobviousness (35 U.S.C. 103)
receptor claims
Receptor Claims
  • Major Patentability Issue - Utility
    • If applicant shows at least one specific, substantial, and credible utility for the receptor, and other statutory requirements are met, applicant is entitled to a patent on the receptor per se.
receptor agonist claims
Receptor Agonist Claims
  • Types of claims at issue:
    • “A receptor [X] agonist.”
    • “A method of treating disease [Y] by administering a compound which is a receptor [X] agonist.”
receptor agonist claims6
Receptor Agonist Claims
  • Major Patentability Issue - Written Description
    • Generic claim to “A receptor [X] agonist.” unlikely to comply with written description requirement:
      • No description of structure of representative number of claimed compounds
      • No description of chemical or physical characteristics of representative number of claimed compounds or of function of representative number of claimed compounds (other than binding to identified receptor)
      • Analogous to Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997)(description of how to obtain compounds not sufficient without description of what the compounds are)
        • See also Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993); In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)
receptor agonist claims7
Receptor Agonist Claims
  • Major Patentability Issue - Enablement
    • Generic claim to “A receptor [X] agonist.” unlikely to comply with enablement requirement:
      • The specification does not usually teach how to make and use the full scope of agonists or antagonists within that genus without undue experimentation.
      • Specification usually teaches how to identify compounds, rather than how to make them; specification does not usually teach how to use the full scope of the compounds within the genus without undue experimentation.
receptor agonist claims8
Receptor Agonist Claims
  • Major Patentability Issue - Enablement
    • If a claim to “A receptor [X] agonist” meets the utility, enablement and written description requirements, a claim to “A method of treating disease [Y] by administering a compound which is a receptor [X] agonist” must still be supported by an enabling disclosure.
    • Will compound operate as intended without undue experimentation?
more examples
More Examples
  • Claims:
  • 1. An isolated and purified receptor the sequence of which consists of SEQ ID NO: 1.
  • 2. A method of identifying an agonist of the receptor of claim 1 comprising:
    • preparing a candidate compound,
    • contacting a cell which expresses said receptor on its surface with said candidate
    • compound, and
    • determining whether said candidate compound activates the receptor of claim 1,
      • wherein a compound that activates the receptor of claim 1 is an agonist of said re-ceptor.
  • 3. An isolated and purified receptor agonist identified by the method of claim 2.
another example
Another Example
  • 4. A method for the treatment of disease treatable by the agonist of claim 2,comprising administering to a host in need thereof a therapeutically effective amount of the agonist of claim 3.
  • 5. A method for treating a disease treatable by compound X comprising administering to a host in need thereof a therapeutically effective amount of compound X.
additional fact patterns
Additional Fact Patterns
  • Trilateral Web Site Case Studies
    • USPTO
    • EPO
    • JPO
  • http://www.uspto.gov/web/tws/sr-3.htm
combinatorial libraries13
Combinatorial libraries
  • Major Patentability Issue - Utility
    • Must have a specific, substantial and credible utility for the collection of elements making up the library (e.g., as an extrinsic research tool)
    • Individual members of the library may not have specific, substantial and credible utilities.
      • The utility that serves to meet the requirements of 35 U.S.C. §101 relates to the use of the library rather than to the individual members thereof (in the absence of a specific disclosure of a use for an individual member).
combinatorial libraries14
Combinatorial Libraries
  • Major Patentability Issue - Written Description
    • A disclosure of a collection of molecules does not necessarily provide support for a claim drawn to any particular individual member of the collection.
    • Possession of a genus does not imply possession of any particular member of genus.
      • See Fujikawa v. Wattanasin, 93 F.3d 1559, 39 USPQ2d 1895 (Fed. Cir. 1996) and In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967).
      • See also In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 29 USPQ2d 1550 (Fed. Cir. 1994).
combinatorial library
Combinatorial Library
  • Scope of protection
    • Right to exclude others from making, using, selling, offering for sale, or importing the library
      • Using a patented library in a screening method for compounds of interest may constitute infringement
    • Does a patented claim to a collection of components confer exclusionary rights to the individual members of the collection?
      • It is the collection of molecules, not the individual components, that is protected by a claim to a combinatorial library.
methods of screening combinatorial libraries receptors
Methods of Screening (Combinatorial Libraries; Receptors)
  • Major Patentability Issue - Utility
    • Requirement met if screening method identifies a ligand which acts upon a receptor so as to effect a specific, substantial, and credible use
    • Requirement met if the asserted utility for screening a combinatorial library is specific, substantial, and credible.
methods of screening combinatorial libraries receptors17
Methods of Screening (Combinatorial Libraries; Receptors)
  • Scope of Protection
    • Claim prevents others from making, using, selling, or offering for sale the claimed screening method.
    • A product identified by a screening method is not a product made by a patented process.
      • 35 U.S.C. 271(g) includes use, sale, or importation of a product made by a patented process as an act of infringement.