Recent Trends at the Patent Office:
Strategies 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
WWW.LEC LAIR RYAN.COM
Overview




2
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
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
3
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
4
Patentable Subject Matter
 A process or method
• e.g. Method of treating or diagnosing cancer
5
Patentable Subject Matter
6
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
7
Patentable Subject Matter
8
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
9
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
10
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….
11
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
12
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
13
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
14
Strategies for Success:
Prevent Public Disclosure

Public disclosure of invention prior to filing patent
application = jeopardizes patent rights
•
•

Abstracts and manuscripts
•
•

15
Most foreign countries – absolute novelty
U.S. – one year grace period
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
Strategies for Success:
Disclose 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
16
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)….
17
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….
18
Strategies for Success:
Review, Disclose, and Distinguish Prior Art

Perform a search of patent literature
•
•

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
•
19
USPTO - http://patft.uspto.gov/
WIPO - http://www.wipo.int/ipdl/en
TIP: Disclose to OTT all references that are even closely related to
invention
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
20
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
21
Strategies for Success:
Overcoming 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
22
Strategies for Success:
Overcoming an Obviousness Rejection (cont.)





23
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)
PTO Guidelines
Rationale 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
24
PTO Guidelines
Rationale 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
25
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
26
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
27
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?
28
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
29
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.
30
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 art—before the filing date—as 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
31
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
32
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
33
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
• Inventor’s own work or work by others
34
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
35
Strategies for Success:
Summary

When designing experiments, keep in mind the need to
support the breadth of the invention
•
•




36
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
Thank You
37