Transcript USPTO GUIDELINES ON WRITTEN DESCRIPTION & ESTs

Percent Identity and the Written
Description Requirement of
35 U.S.C. 112, first paragraph
Remy Yucel, Ph.D.
Supervisory Patent Examiner
Technology Center 1600
(571) 272-0781
[email protected]
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35 U.S.C. 112 Specification, first
paragraph

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, or with which it
is most nearly connected, to make and use the
same, and shall set forth the best mode
contemplated by the inventor of carrying out his
invention.
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Written Description- Notice and
Materials

Written Description Guidelines (66 FR
1099 (Jan. 5, 2001); 1242 O.G. 168
(Jan. 30, 2001)
– http://www.uspto.gov/web/menu/current.html#register

Training Materials
• http://www.uspto.gov/web/patents/guides.htm
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Written Description- Coverage

Written in technology neutral manner since recent
decisions of the Federal Circuit have written
description implications in a broad range of
technologies
– In re Curtis (dental floss)
– Noelle v. Lederman (antibodies)
– Univ. of Rochester v. Searle (pharmaceutical treatment)
– In re Wallach (DNA)
– Bilstad v. Wakalopulos (sterilizing apparatus)
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Written Description- Coverage

Products, Processes, Products by
process
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Written Description- Coverage

Original claims

New claims and amended claims

Claims asserting benefit of an earlier
priority or filing date
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General Principles

Basic inquiry: Can one skilled in the art
reasonably conclude that the inventor
had possession of the claimed invention
at the time the application was filed?

Written description requirement is
separate and distinct from the
enablement requirement.
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General Principles

Strong presumption that an adequate written
description is present in the application as
filed.

Initial burden is on examiner to present prima
facie case of lack of written description.

Applicant should show support for new or
amended claims (MPEP 714.02 and
2163.06).
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Foundation for Examiner’s
Analysis

Determine what each claim as a whole
covers
– Broadest reasonable interpretation in light of
and consistent with written description - In re
Morris, 127 F.3d 1048, 44 USPQ2d 1023
(Fed. Cir. 1997).
– Preamble and transition phrases
treated under common usage
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Foundation for Examiner’s
Analysis

Transition phrases
– Open: “comprising”, “having”
– Closed: “consisting of”
– “Consisting essentially of”
• Necessarily includes listed ingredients
• Open to unlisted ingredients that do not
materially affect the basic and novel
properties of the invention (PPG Industries
Inc. v. Guardian Industries Corp., 156 F.3d
1351, 48 USPQ2d 1351 (Fed. Cir. 1998))
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Foundation for Examiner’s
Analysis

Review entire application to understand
what applicant has described as the
essential features of the claimed invention
– Review conducted from standpoint of one of
skill in the art at the time the application
was filed
– Includes determining field of invention and
level of skill and knowledge in the art
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Analysis

If a skilled artisan would have understood
the inventor to be in possession of the
claimed invention at the time of filing,
even if every nuance of the claim is not
explicitly described in the specification,
then the requirement for an adequate
written description is met.
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How to Determine Possession?

Federal Circuit has not directly set
forth a “possession test”

Extrapolate from decisions in various
technologies
» e.g., Pfaff v. Wells Electronics, Vas-Cath v.
Mahurkar, Fiers v. Revel
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How to Determine Possession?

Particularly troublesome when
possession of species does not
equate with possession of genus
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Evidence of Possession

Actual reduction to practice
– Reduction to practice normally not
required
• cf.: Amgen Inc. v. Chugai Pharmaceutical
Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed.
Cir. 1991)
– Deposit of biological materials
• Not a substitute for written description
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Evidence of Possession

Clear depiction of the claimed
invention in detailed drawings
– Pfaff v. Wells Electronics, Inc., 525
U.S. 55, 48 USPQ2d 1641 (1998)

What is conventional or well known to
one skilled in the art need not be
disclosed in detail
– Vas-Cath, Inc. v. Mahurkar, 935 F.2d
1555, 19 USPQ2d 1111 (Fed. Cir. 1991)
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Evidence of Possession

Written description describing sufficient
relevant identifying characteristics
– Weigh factual considerations including:
•
•
•
•
•
•
Level of skill and knowledge in the art
Complete or partial structure
Physical and/or chemical properties
Functional characteristics
Correlation between structure and function
Method of making
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Evidence of Possession

Written description describing sufficient
relevant identifying characteristics
– The less mature the technology, the heavier the
burden on the disclosure to demonstrate
possession.
– Because the level of skill and knowledge in the
art increases over time, it is essential to
determine possession as of the effective filing
date.
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Evidence of Possession

Possession analyzed for each claim drawn
to a species, and thereafter for each claim
drawn to a genus
– Legal definitions of genus and species
recognized in patent law, not taxonomic
definitions

Written description for claimed genus may
be satisfied through sufficient description of
a representative number of species
– Species must be adequately described and must
fairly represent the variation within the entire
genus
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New or Amended Claims, or Claims
Asserting Entitlement to Earlier
Filing Date

Each claim limitation must be expressly,
implicitly, or inherently supported in the
originally filed disclosure
– Hyatt v. Boone, 146 F.3d 1348, 47 USPQ2d
1128 (Fed. Cir. 1998)

In some situations, minor errors in sequence
information may be corrected by reliance on a
deposited biological material
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New or Amended Claims, or Claims
Asserting Entitlement to Earlier
Filing Date

Each claim must include all elements which
applicant has described as essential or
critical
– Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d
1829 (Fed. Cir. 1998)
– Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d
1473, 45 USPQ2d 1498 (Fed. Cir. 1998)
– Johnson Worldwide Associates Inc. v. Zebco
Corp.,
175 F.3d 985, 50 USPQ2d 1607 (Fed. Cir. 1999)
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Written Description: Analysis of
Percent Identity Claims

The following three examples illustrate analysis
and determination of written description for
claims reciting percent identity
– Example 1: Percent Identity and a well-known
family of polypeptides.
– Example 2: Percent Identity and a novel
polypeptide.
– Example 3: Percent Identity and a novel, inducible
promoter region.
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Examiner’s Burden of Proof
Description as filed presumed
adequate
 No per se rules
 Allegation of unpredictability in the
art is insufficient
 Need reasonable basis to challenge

– Evidence
– Technical reasoning
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Examiner’s Burden of Proof

Evidence and technical reasoning that
indicates unpredictability may support a
prima facie case for lack of written
description.
– In In re Curtis, the court held that there was
sufficient evidence to indicate that ordinary
artisans could not predict the operability of
other species other than the single one
disclosed in the specification.
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Example 1: A New Restrictase
Family Member

The specification discloses SEQ ID NO: 1
which encodes a polypeptide.
– The polypeptide is identified as a new restrictase family
member based on a high level of homology to other
restrictases.
– The amino acid sequence is identified as SEQ ID NO: 2.
– The specification does not disclose any other sequences,
including any sequence with less than 100% identity to SEQ
ID NO: 1 that encodes a polypeptide with restrictase activity.
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Example 1: A New Restrictase
Family Member

The field recognizes that the restrictase
family is well-characterized.

The art teaches several domains and
motifs shared by all family members
that are required for restrictase activity.
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Example 1: A New Restrictase
Family Member
Consider the following claim:

An isolated nucleic acid sequence that
encodes a polypeptide with at least 85%
amino acid sequence identity to SEQ ID NO:
2; wherein the polypeptide has restrictase
activity.

Is there written description?
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Example 1: A New Restrictase
Family Member

An isolated nucleic acid sequence that encodes a polypeptide with at least 85% amino acid
sequence identity to SEQ ID NO: 2; wherein the polypeptide has restrictase activity.

Weigh factual considerations such as:
•
•
•
•
•

Level of skill and knowledge in the art
Complete or partial structure
Physical and/or chemical properties
Functional characteristics
Correlation between structure and function
Analyze claim against the backdrop of a well-developed field
and conclude that the written-description requirement is met for
the claim above.
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Example 2: A novel polypeptide

The specification discloses SEQ ID NO: 1
which encodes a polypeptide.
– The polypeptide is novel and does not share significant
sequence identity with any known polypeptide or polypeptide
family but the polypeptide has a novel activity X.
– The amino acid sequence is identified as SEQ ID NO: 2.
– The specification does not disclose any other sequences,
including any sequence with less than 100% identity to SEQ
ID NO: 1 that encodes a polypeptide with activity X.
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Example 2: A novel polypeptide
Consider the following claim:

An isolated nucleic acid sequence that
encodes a polypeptide with at least 85%
amino acid sequence identity to SEQ ID NO:
2; wherein the polypeptide has activity X.

Is there written description?
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Example 2: A novel polypeptide

An isolated nucleic acid sequence that encodes a polypeptide with at least 85% amino acid
sequence identity to SEQ ID NO: 2; wherein the polypeptide has activity X.

Weigh factual considerations

In this situation, there is no well-developed field of
prior art because the polypeptide and its activity are
novel.

The specification teaches a single, reference
sequence and does not provide any information as to
relevant characteristics or even partial
structure/function information.
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Example 2: A novel polypeptide

Conclusion: The above claim does not meet the
written description requirement, consistent with the
reasoning in Curtis.

Under In re Alton, 37 USPQ2d 1578 (Fed. Cir. 1998),
USPTO bears the burden of presenting evidence or
reasons why persons skilled in the art would not find
the disclosure of a species to be a description of the
genus defined in the claims.
– The Office Action would present evidence and reasons to
support a prima facie case.
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Example 3: A novel inducible
promoter

The specification discloses:
– a single nucleic acid sequence SEQ ID
NO: 1 which is a novel, inducible promoter
– promoter activity is induced by Y
– location of sequences common to all
promoters (e.g. CAAT-box)
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Example 3: A novel inducible
promoter

The specification does not disclose:
– other promoters that are inducible by Y
– sequences or motifs responsible for
induction by Y.

The prior art does not teach promoters
inducible by Y.
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Example 3: A novel inducible
promoter
Consider the following claim:

An isolated promoter with at least 85%
sequence identity to SEQ ID NO: 1; wherein
the promoter is inducible by Y.

Is there written description?
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Example 3: A novel inducible
promoter

An isolated promoter with at least 85% sequence identity to SEQ ID
NO: 1; wherein the promoter is inducible by Y.

In this situation we have some structurefunction information from the prior art.

However neither the prior art nor the
specification teach the structure(s) required
for induction by Y.
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Example 3: A novel inducible
promoter

An isolated promoter with at least 85% sequence identity to SEQ ID
NO: 1; wherein the promoter is inducible by Y.

The structure-function information in the prior
art is of a general nature because it describes
promoter elements that are common to all
promoters.

Presence of these common elements does
not address the question of what structure(s)
are required for specific induction by Y.
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Example 3: A novel inducible
promoter

An isolated promoter with at least 85% sequence identity to SEQ ID
NO: 1; wherein the promoter is inducible by Y.

Conclusion:
– because the specification does not disclose a
single sequence with less than 100% identity to
SEQ ID NO: 1 with promoter activity that is
inducible by Y; and
– because the prior art is silent with respect to
promoter structure(s) that are inducible by Y,
disclosure of general promoter elements alone is
not sufficient to fulfill the written description
requirement.
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Example 3: A novel inducible
promoter

The Office action would present
evidence and reasons to support a
prima facie case for lack of written
description based on the reasoning in
Curtis.
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Thank You
Remy Yucel, Ph.D.
Supervisory Patent Examiner
TC1600
(571) 272-0781
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