Success at the Patent Office Strategies to Consider Before by osq14347


									        Success at the Patent Office:
Strategies to Consider Before Filing a Patent

            Edwin V. Merkel Esq.
            Carissa R. Childs Ph.D.
                 Nixon Peabody LLP
                     1100 Clinton Square
                 Rochester, New York 14604
         Phone: (585) 263-1128 • Fax: (585) 263-1600

• Purpose of Obtaining a Patent
• Requirements of Patentability
• What to Expect During Patent Prosecution and Strategies for
  Successfully Obtaining a Patent
           Purpose of Obtaining a Patent

• Patent System Designed to Incentivize Innovation
   – Patent Grants Rights to Inventor – Exclude, But Not Use
• Bayh-Dole Encourages Technology Commercialization of
  Government Funded Inventions
   – Provide a Means to Commercialize Inventions, i.e. Bridge the
     Transition from Bench-to-Bedside
• Why Is This Relevant?
   – Not all Good Science is Patentable
   – The Value of a Patent Depends on its Commercial Utility
             Patentable Subject Matter
• A Process or Method
   – e.g. Method of Treating or Diagnosing Cancer

• A Machine
   – e.g. Devices, Gadgets

• An Article of Manufacture
   – e.g. Gene Array, Antibodies, Genetically Altered Cell Line

• Composition of Matter
   – e.g. Pharmaceutical Composition, Chemical Compound

• An Improvement of any of the Above
            Requirements for Patentability
• Utility – Specific Substantial Utility; Must Be Credible
• Novel - No Public Knowledge or Use that Predates Your Date
  of Invention
• Non-Obvious – The Invention as a Whole Cannot be Obvious to
  One of Skill in the Art at the Time it was Made
• Complete Written Description of the Invention
   – Enables One of Skill in the Art to Make and Use the Invention
   – Best Mode for Carrying Out the Invention

• One or More Claims Defining the Invention
            Requirements of Patentability
• Claims
   – Define the Scope of the Invention
   – Broadly Cover all Commercial Embodiments
   – Focus of Examination for Patentability

• Example: Your Invention = Discover that Aβ is a Pharmacological
  Target for Alzheimer’s Disease
   – Method of Treating a Patient having Alzheimer’s Disease comprising…
   – An Antibody that Binds to Amyloid-β…
   – Pharmaceutical Composition for Treating Alzheimer’s Comprising….
             Strategies for Success:
        Keep a Good Laboratory Notebook
• Evidence to Establish Date of Invention
   – Overcome Novelty Rejections
   – Win an Interference – U.S. is a First to Invent System
• Evidence to Resolve Inventorship Issues
• Evidence for Establishing Unexpected Results
• Keys to Good Record Keeping
   – Thorough and Detailed Record of Experiments
   – Date Every Entry
   – Review and Signature by a Non-Inventor Witness
                 Strategies for Success:
                Prevent Public Disclosure
•   Public Disclosure of Invention Prior to Filing Patent
    Application = Jeopardizes Patent Rights
    –   Most Foreign Countries – Absolute Novelty
    –   U.S. – One Year Grace Period
•   Abstracts and Manuscripts
    –   Be Aware of Early Online Publications
    –   Be Conscientious of “Future-Aim” Statements When Discussing
        the Implications of Research Findings
•   TIP: Contact Tech Transfer Office Before You Publish
               Strategies for Success:
          Disclose Invention to OTT Early
• Invention Disclosure Should Contain:
   – Complete Description of the Invention – Including Various
   – Experimental Data and Figures
   – Expected Dates of Public Disclosure

• Late Disclosure  Last Minute Filing May Impact Rights
   – Lose Benefit of Filing Date - Provisional Application May Fail to
     Support Claimed Invention, Prior Art References Published During the
     Pendency of Provisional Application Can Be Prior Art
             Strategies for Success:
    Review, Disclose, and Distinguish Prior Art
•   Perform a Search of Patent Literature
    –   USPTO -
    –   WIPO -
•   Novelty and Non-Obviousness
    –   Allows for Drafting Claims of Appropriate Scope
    –   Ensures that Distinguishing Characteristics are Emphasized
    –   Identify Problems or Deficiencies in Prior Art
•   Duty to Disclosure References Materially Relevant to the
    Patentability of Invention
    –   TIP: Disclose to OTT all References That Are Even Closely Related to
             Example 1 – Intervening Art

• Timeline
   – Rush Provisional Filed in U.S. with Minimal Disclosure (covering
     use of γ-aminobutyric acid (GABA) analogs in treating hot flashes;
     two compounds disclosed)
   – Publication Occurs After Provisional Filing Date
   – One Year Later, File Formal Applications in U.S. and PCT
• Intervening Publication Not Problematic in U.S.
   – One Year Grace Period in U.S.
   – Method of treating hot flashes in a patient by administering a
     compound which binds an α2δ subunit of a voltage-gated calcium
     channel (VGCC)….
                Example 1 – Continued
• Intervening Publication Problematic in Europe
   – Intervening Publication Was Cited Against All Claims That Were
     Not Supported in the Provisional (or Immediately Derivable
   – Use of a compound that is structurally related to GABA in the
     manufacture of a medicament for treating hot flashes….
            Strategies for Success:
   Provide an Enabling Written Description
• What Constitutes a “Complete Written Description”
   – 35 U.S.C. § 112 requires a “that 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 . . . to
     make and use the same . . .”

• How is the Adequacy of Written Description and Enablement
              Strategies for Success:
     Provide an Enabling Written Description
• Determine Scope of the Claimed Invention
• Determine Whether the Scope of the Claimed Invention is
  Supported by an Enabling Written Description
   – Detailed Description of the Invention
       • Sets Forth all Possible Embodiments of Claimed Invention
           – Different classes of agents to be used (therapeutic/diagnostic)
           – Different uses (indications/diagnostics)
   – Examples
       • Experimental Data Supporting Claimed Invention
             Strategies for Success:
    Provide an Enabling Written Description
• In Biotechnology/Pharmaceutical Patent Applications – Early
  Experimental Data Rarely Supports the Full Scope of the
• Result: Patent Office Rejects Claims for Failure to Meet the
  Written Description Requirements
• TIPS :
   – Acquire Animal Data for Therapeutic Treatments
   – Consider Using Different Classes of Therapeutic Agents (RNAi,
     Small Molecules, Antibodies, etc.) when Designing Experiments
         Example 2 – Written Description
Claimed Invention:
A method for selectively inhibiting PGHS-2 activity in a human
  host, comprising:
administering a non-steriodal compound that selectively inhibits
  activity of the PGH-2 gene product to a human host in need of
  such treatment.
Written Descriptive Support:
   – Isolation/Cloning/Sequencing of Murine/Human PGHS-2
   – Characterization of Cyclooxygenase Activity
   – Dexamethasone Reduces Expression of PGHS-2, not PGHS-2
   – Screening Assays for Identifying Selective PGHS-2 Inhibitors
                Example 2- Continued

• Problem: Specification Had No Examples of Non-Steriodal
  Compounds that Could be Used to Carry out the Claimed
  Invention and No Description of How to Make Compounds
• Result: Patent, Upon Challenge, Found Invalid for Failure to
  Meet the Written Description Requirement.
• Strategy: Consider and Fully Describe All Types of Reagents,
  Compounds, etc. that are Applicable to Carrying out Invention
   – Only a CONSTRUCTIVE, and Not ACTUAL, Reduction to
     Practice is Necessary.
          Example 3 – Written Description
Claimed Invention:
A method of treating neurofibrosarcoma in a human by administering an
  effective amount of monoclonal antibody idiotypic to the
  neurofibrosarcoma of said human, wherein said monoclonal antibody is
  secreted from a human-human hybridoma derived the
  neurofibrosarcoma cell line.

Written Descriptive Support
    – Preparation of Tumor Cell Suspension From Patient and
      Subsequent Sensitization of Human Spleen Cells – Development of
    – Isolation of Antibodies and Successful Treatment of Patient Having
                 Example 3 – Continued

• Problem: Specification Lacked Adequate Descriptive Support
  for the Broad Genus of Antibodies Encompassed by the Claim
   – Only One Antibody Had Been Described and No Description of the
     Antigen had been Provided

• Strategy:
   – Complete Description of a “Genus” Includes
      • A Representative Number of Species in the Genus; or
      • Description of Relevant Identifying Structural, Physical, or Chemical
        Properties (Not Functional Properties)
           The Enablement Requirement

• Purpose: Allow One of Skill in the Art to Make and Use
             the Invention
• “Test” of Enablement: Whether Undue Experimentation is
  Required for One of Skill in the Art to Make or Use the
• Biotechnology Patents Particularly Prone to Enablement
  Rejections Because of the Gap Between Experimental Data
  and Claimed Invention
   – In vivo Data?
   – How Many Different Therapeutic Agents are Shown?
               Example 4 - Enablement
A method of inducing neuronal cell differentiation in a
  population of neuronal progenitor cells, said method
administering to the cells an antagonist of receptor Y under
  conditions effective for inducing neuronal cell differentiation
  in the progenitor cells

Supporting Written Description:
• Specification Enumerates Various Receptor Y Antagonists
• Examples Show Experimental Data for Only One Receptor Y
                Example 4 - Continued

• Failure to Enable the Use of Any Receptor Y Antagonist
• To the Extent Possible, Validate Initial Findings Using
  Additional Reagents Which Support the Scope of the Claimed
•   Submission of Post-Filing Evidence
    – Inventor’s Own Work or Work by Others
                  Example 5 - Enablement
Claimed Invention:
A method of producing a protein of interest, comprising:
(i) Providing a transgenic silkworm whose genome comprises the following
    (a) A first DNA …
    (b) A second DNA encoding the protein of interest … wherein the transgenic
        silkworm secretes the protein of interest; and
(ii) Recovering the secreted protein of interest produced by the transgenic
Written Descriptive Support:
•   Demonstrated the Production of Transgenic Silkworm that Secreted
    GFAP and the Secreted Protein was Recovered From the Silk Gland
                   Example 5 - Continued

• Problem:
   •   Specification Failed to Enable the Production of Any Protein of
       Interest (Limited to a Protein that Contains a Secretory Signal) and
       Fails to Enable the Recovery of Secreted Protein From Any Tissue
• Result:
   •   Overcame Rejection with the Submission of Post-Filing Evidence
            Strategies for Success:
Participate in Patent Application Preparation

•   Read Drafts of Application for Accuracy and Thoroughness
    –   New Material Cannot Be Added to Specification After Formal

•   Do Not Hesitate to Provide Comments
•   Ask Questions
                   Strategies for Success:
•   When Designing Experiments, Keep in Mind the Need to
    Support the Breadth of the Invention
    –   Preferably Obtain Some In Vivo Data During Your Initial
        Experimental Work
    –   Consider Using Different Classes of Reagents in Parallel

•   Keep Good Records – We May Need Them
•   Contact OTT Before You Disclose and Keep Them Updated
•   Conduct Your Own Literature and Patent Searches
•   Be Involved in the Claim and Application Drafting Processes

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