Recent Trends at the Patent Office: Strategies for Improving Your Outcome

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Recent Trends at the Patent OfficeStrategies
for Improving Your Outcome
Edwin V. Merkel Carissa R. Childs Ph.D.

• LeClairRyan
• 290 Linden Oaks, Suite 310
• Rochester, NY 14625 US
• 585.270.2100

• W W W . L E C L A I R R Y A N . C O M

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Overview

• Purpose of obtaining a patent
• Anatomy of a patent application
• Requirements of patentability
• What to expect during patent prosecution and
  strategies for successfully obtaining
  a patent

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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

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Anatomy of a Patent Application

• U.S. patents are obtained by filing a written
  application which includes the following
  components
• Specification 
• Background of the invention
• Summary of the invention
• Detailed description of invention
• Claims
• Drawings, if any

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Patentable Subject Matter

• A process or method
• e.g. Method of treating or diagnosing cancer

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Patentable Subject Matter
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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

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Patentable Subject Matter
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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

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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 description of the invention
• Enables one of skill in the art to make and use
  the invention
• Written Description that shows the applicant is
  in possession of the full scope of the claimed
  subject matter
• Best Mode for carrying out the invention

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Requirements of Patentability

• Claims
• Define the scope of the invention
• Broadly cover all commercial embodiments
• Focus of examination for patentability
• Example
• Your invention discover protein X is
  overexpressed in cancer cells and inhibition of X
  inhibits cell proliferation survival
• Method of treating a patient having cancer
  comprising
• Method of diagnosing cancer
• Pharmaceutical composition for treating cancer
  comprising.

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The Patent Process

• Filing  the application is submitted to the U.S.
  Patent and Trademark Office (PTO), along with a
  fee and an oath executed by the inventor stating
  certain required facts

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The Patent Process (cont.)

• Examination
• The application is reviewed by a patent examiner
• The examiner searches prior art patents and
  publications and decides either to allow claims
  or to reject them
• Written rejections are mailed out to the
  applicant
• Responses are filed by applicant

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The Patent Process (cont.)

• Issuance of a patent
• An allowed application issues as a patent once an
  issue fee is paid
• Maintenance fees must be paid during the fourth,
  eighth, and twelfth years of the patent term

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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, preferably before you submit a
  manuscript for publication

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Strategies for SuccessDisclose Invention to OTT
Early

• Invention disclosure should contain
• Complete description of the invention including
  various embodiments
• 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

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Example 1 Intervening Art

• Timeline
• Rush provisional filed in U.S. with minimal
  disclosure (covering use of ?-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 a2d
  subunit of a voltage-gated calcium channel
  (VGCC).

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Example 1 Intervening Art (cont.)

• Intervening publication problematic in Europe
• Intervening publication was cited against all
  claims that were not supported in the provisional
  (or immediately derivable therefrom)
• Use of a compound that is structurally related to
  GABA in the manufacture of a medicament for
  treating hot flashes.

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Strategies for Success
Review, Disclose, and Distinguish
Prior Art

• Perform a search of patent literature
• USPTO - http//patft.uspto.gov/
• WIPO - http//www.wipo.int/ipdl/en
• 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 disclose references materially relevant
  to the patentability of invention
• TIP Disclose to OTT all references that are even
  closely related to invention

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Strategies for Success
Overcoming Inherent Anticipation
Rejection

• Inherent anticipation is often seen in context of
  pursuing method of treatment claims for a known
  class of compounds
• Requires that the prior disclosure necessarily
  would have involved practicing the claimed
  subject matter
• Ways to overcome
• Define patient population
• Define mode, timing, or frequency of
  administration

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Example 2 Inherent Anticipation

• Claims directed to a method of treating or
  preventing atherosclerosis using Growth Hormone
  Releasing Peptides (GHRPs)
• Prior Art taught single administration of
  hexarelin (a GHRP) during by-pass surgery
• PTO asserted same class of patients, same class
  of drug, would inherently have treated
  atherosclerosis
• Overcame by specifying frequency of use (daily)
  in one set of claims and extent of use (for six
  or more weeks) in another set of claims

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Strategies for SuccessOvercoming an Obviousness
Rejection

• An invention is not patentable even if it is not
  identically disclosed or described in a prior art
  reference, if the differences between the
  invention to be patented and the prior art are
  such that the invention as a whole would have
  been obvious at the time the invention was made
  to a person having ordinary skill in the art
• Assessed based on number of factors

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Strategies for SuccessOvercoming an Obviousness
Rejection (cont.)

• Scope and content of the prior art
• Level of ordinary skill in the art
• Differences between the claimed invention and the
  prior art
• Objective evidence of non-obviousness
• commercial success
• long-felt but unsolved needs and
• failure of others
• Explain in application itself why the invention
  would not have been obvious (unexpected results
  failure of others, if aware)

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PTO GuidelinesRationale for Finding of
Obviousness

• There is a teaching, suggestion, or motivation to
  combine prior art elements
• Combining prior art elements to yield predictable
  results
• Simple substitution of one known element for
  another to obtain predictable results
• Use of a known technique to improve similar
  devices, methods, products in the same way

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PTO GuidelinesRationale for Finding of
Obviousness

• Obvious to try choosing from a finite number of
  identified, predictable solutions, with a
  reasonable expectation of success
• Known work in one field of endeavor may prompt
  variation of it for use in either the same field
  or a different one based on design incentives or
  other market forces

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Example 3 - Obviousness

• Claims directed to method of analyzing blood/bone
  marrow using flow cytometry and three reagents to
  identify subpopulation
• Obvious in view of the combination of
• First reference, same purpose as claimed method,
  but only using two reagents
• Second reference, taught use of third reagent to
  identify specific population of cells
• PTO asserted combining prior art elements to
  yield predictable results

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Example 3 Obviousness (cont.)

• Rebuttal
• References provided no reason to modify method of
  1st reference, there was no recognized problem to
  be solved
• Persons of skill would have expected that there
  would have been no problem in absence of third
  reagent
• Incorporating the third reagent provided
  unexpected improvements over the prior method
• Presented evidence of commercial success

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Strategies for Success Providing a Sufficient
Written Description

• What constitutes a complete written description
• Patent law requires 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
  determined?

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Strategies for Success Providing a Sufficient
Written Description

• Determine scope of the claimed invention
• Determine whether claim scope is supported by
  application
• 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
• Biological deposits (ATCC) for cell lines,
  hybridomas

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Example 4 Written Description

• Claims directed to method of enhancing plant
  growth using class of plant pathogen proteins
  that cause a particular plant response
  (designated as hypersensitive response elicitor
  proteins).
• Specification identified four specific proteins
  and indicated that others were known to exist
  (they just had not been isolated and sequenced).
• PTO asserted that the four specific proteins and
  demonstrated results with only two of them did
  not show that applicants were in possession of
  the full scope of claimed subject matter.

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Example 4 Written Description (cont.)

• Overcame rejection by presenting evidence that
  persons of skill in the art appreciated that the
  protein elicitors were recognized in the
  artbefore the filing dateas having structural
  diversity at the amino acid level, but sharing
  conserved structural features and properties
• Isolated from bacterial plant pathogen
• Contain structural domains that share some
  homology even though overall homology may be low
• High glycine content, low (or no) cysteine
  content
• Heat stable
• Induces same plant response

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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 use the invention
• Biotechnology patents particularly prone to
  enablement rejections because of the gap between
  experimental data and claimed invention

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Example 5 - Enablement

• Claims directed to a method of treating a
  condition mediated by a deficiency or loss of
  myelin involving the administration of
  oligonucleotide progenitor cells
• Specification showed myelination of dysmyelinated
  axons in the hypomyelinated shiverer mouse model
  upon intraventricular administration of
  progenitor cells
• PTO asserted that remyelination alone was not
  indicative of therapeutic benefit

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Example 5 Enablement (cont.)

• To overcome the rejection submitted evidence
  showing that progenitor cell transplantation into
  the hypomyelinated shiverer mice achieved not
  only whole neuroaxis myelination, but also
  prolonged the survival of the mice and resolved
  their neurological deficits
• Strategy
• To the extent possible
• Validate initial in vitro findings in vivo
• Consider using different classes of therapeutic
  agents (RNAi, small molecules, antibodies, etc.)
  when designing experiments
• Submission of post-filing evidence
• Inventors own work or work by others

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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 filing
• Do not hesitate to provide comments
• Ask questions

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Strategies for Success Summary

• 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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Thank You