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

LeClairRyan290 Linden Oaks, Suite 310

Rochester, NY 14625 US 585.270.2100

Edwin V. MerkelCarissa R. Childs Ph.D.

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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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….

Requirements of Patentability

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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 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

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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)….

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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….

Example 1 – Intervening Art (cont.)

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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 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

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Strategies for Success:Overcoming 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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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?

Strategies for Success: Providing a Sufficient Written Description

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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 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

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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

• Inventor’s 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