Transcript Compliance with the Written Description Requirement

Compliance with the Written
Description Requirement
Raymond R. Mandra, Esq.
Partner
FITZPATRICK, CELLA, HARPER & SCINTO
30 Rockefeller Plaza
New York, NY
www.fitzpatrickcella.com
Compliance with the Written Description
Requirement
Look To:
35 U.S.C. §112, First Paragraph
•The Case Law
•The PTO Guidelines (And Training Materials)
2
www.fitzpatrickcella.com
Written Description Statute
“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.” (emphasis
added)
35 U.S.C. § 112, ¶ 1
3
www.fitzpatrickcella.com
Written Description Basics
• An adequate written description means describing the invention
in sufficient detail that one skilled in the art can conclude that
the inventor invented the claimed invention. Lockwood v.
American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
• An adequate written description means describing the invention
in sufficient detail so that one skilled in the art can conclude the
inventor had possession of the claimed invention. Purdue Pharma
L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
• Possession is shown by describing the invention with all its claim
limitations, even if they are obvious, and is measured as of the
filing date sought. Lockwood v. American Airlines, Inc., 107 F.3d
1565, 1571-72 (Fed. Cir. 1997).
4
www.fitzpatrickcella.com
Written Description Basics
•Fact question – reviewed for clear error
•Meaningful and adequate disclosure is quid pro quo to
public for being excluded from practicing the invention
for limited period
•An “application itself must describe an invention, and
do so in sufficient detail that one skilled in the art can
clearly conclude that the inventor invented the claimed
invention as of the filing date sought.”
Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41
U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997)
5
www.fitzpatrickcella.com
Written Description v. Enablement
•Written description means describing the invention in
sufficient detail that one skilled in the art can conclude
that the inventor invented the claimed invention
•Enablement means one skilled in the art is taught by
the patent how to make and use the invention, without
undue experimentation
6
www.fitzpatrickcella.com
Some Relevant Cases
•Written description
 In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967).
 The Regents of California v. Eli Lilly & Co., 119 F.3d
1559 (Fed. Cir. 1997)
 Gentry Gallery v. Berkline Corp., 134 F.3d 1473 (Fed.
Cir. 1998)
 Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013
(Fed. Cir. 2002)
 Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316
(Fed. Cir. 2002)
 University of Rochester v. G.D. Searle & Co., 2003 U.S.
Dist. LEXIS 3030 (W.D.N.Y. 2003)
 Moba, B.V. v. Diamond Automatic, 325 F.3d 1306
(Fed. Cir. 2003)
7
www.fitzpatrickcella.com
Written Description Basics
•Often applied to a priority situation, e.g., new matter
added
•However, the written description requirement also
applies to original claims.
The Regents of the University of California v. Eli Lilly and
Co., 119 F.3d 1559 (Fed. Cir. 1997)
8
www.fitzpatrickcella.com
Lilly Facts
•Patent specification disclosed:
– rat insulin cDNA sequences
– method for obtaining them
– amino acid sequences of human insulin
•Claims in dispute were to vertebrate, mammalian and
human insulin cDNA
9
www.fitzpatrickcella.com
Lilly Holdings
Court affirmed judgment that both human cDNA and
genus cDNA patent claims were invalid for lack of written
description:
Human cDNA claims:
• patent describes only general method for obtaining
human insulin-encoding cDNA, but not cDNA’s
relevant structural or physical characteristics
• description of human insulin amino acid sequences
does not describe cDNA that encodes them (because
of redundancy of genetic code)
10
www.fitzpatrickcella.com
Lilly Holdings (continued)
Genus cDNA claims:
•disclosure of rat cDNA sequences does not describe
structure of sufficient members of broad “functional”
classes of “vertebrate” or mammalian” insulin cDNA
•“A definition by function… does not suffice to define
the genus because it is only an indication of what the
gene does, rather than what it is”
Lilly, 119 F.3d at 1568
11
www.fitzpatrickcella.com
Lilly Consequences
How should one properly describe cDNA genus?
According to Lilly:
•One way is to recite the nucleotide sequences of a
representative number of cDNAs (silent as to what is
representative)
•Another way is to recite structural features common to
genus members, which features constitute a substantial
portion of genus
Lilly, 119 F.3d at 1569
12
www.fitzpatrickcella.com
Gentry Gallery
•The patent disclosed that recliner controls were located
on the console of a sectional sofa having two
independent recliner seats facing in the same direction
•Broadest claim covered control means mounted on the
double reclining seat sofa section
•The court concluded that the patent did not support
claims where the recliner controls were not located on
the console since that location was an essential element
of the invention when viewing the disclosure in its
entirety
13
www.fitzpatrickcella.com
Enzo Facts
• Detection of bacteria that causes gonorrhea difficult
because of high degree of homology between N.
gonorrhoeae and meningitidis
• Specification referred to ATCC deposit of three
sequences that preferentially hybridize to six common
strains of N. gonorrhoeae over six common strains of
N. meningitidis (also deposited)
Enzo Bichem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002)
14
www.fitzpatrickcella.com
Enzo Facts (continued)
• Patent claims nucleotide sequence that preferentially
hybridizes to N. gonorrhoeae over N. meningitidis by
ratio of greater than 5:1
• Dependent claims were drawn to the three deposited
probe sequences and discrete subsequences, mutations,
and mixtures
15
www.fitzpatrickcella.com
Enzo Procedural Background
Original panel decision (Lourie; Prost; Dyk, dissenting)
affirmed judgment claims were invalid for failure to meet
written description requirement of 35 U.S.C. § 112
• rejected argument that deposit inherently disclosed
inventors were in possession of claimed sequences
On rehearing, panel unanimously vacated that decision
and reversed and remanded
16
www.fitzpatrickcella.com
Enzo Holdings
On rehearing, Court faced with two main questions:
1. Whether Enzo’s deposits of claimed sequences of
dependent claims constituted an adequate written
description?
• Issue of first impression
• Reference in specification to a deposit in a public
depository, when it is not otherwise available in
written form, may constitute an adequate written
description
• Remanded - fact issue of whether subsequences,
mutations, and mixtures were described by
reference to the deposited sequences
Enzo, 296 F.3d at 1325
17
www.fitzpatrickcella.com
Enzo Holdings (cont’d.)
2. Whether written description requirement is met for all
claims on basis of functional ability of three deposited
probe sequences to hybridize to deposited strains of N.
gonorrhoeae?
• Depends on whether three deposited sequences are
representative of the scope of the genus under Lilly
• PTO written description Training Example 9
provides that nucleic acid genus claims may be
adequately described if nucleic acids hybridize under
highly stringent conditions to known sequences
• Remanded issue to be decided consistent with Lilly
and PTO’s written description Guidelines
Enzo, 296 F.3d at 1324, 1327-28
18
www.fitzpatrickcella.com
Enzo Additional Issues
1. Whether reference to deposit of six strains of N.
gonorrhoeae inherently describes claimed sequences
that hybridize to them (i.e., by showing
function/structure correlation) is a fact issue
2. Ipsis verbis inclusion of claim words in specification
does not necessarily satisfy the written description
requirement, e.g., an “anti-inflammatory steroid” or
an “antibiotic penicillin”
19
www.fitzpatrickcella.com
Enzo Additional Issues
3. Even if three deposited probe sequences indicated Enzo
“possessed” invention, “possession” may not be sufficient
to describe invention
— compare Lockwood, “One shows that one is ‘in
possession’ of the invention by describing the
invention, with all its claimed limitations, not that
which makes it obvious.”
Lockwood 107 F.3d at 1572, emphasis omitted
4. Reduction to practice without adequate description is
insufficient to describe invention
20
www.fitzpatrickcella.com
Enzo En Banc Rehearing Denial
•Only Rader, Gajarsa and Linn voted for rehearing (PTO
filed brief as amicus in favor of rehearing)
•Dyk, who voted against rehearing, nevertheless said
Court would benefit from “further percolation” of the
issues
Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed. Appx. 439 (Fed. Cir. 2002)
21
www.fitzpatrickcella.com
Enzo En Banc Rehearing Denial
Those for en banc rehearing:
• based on statute, there is no separate written
description requirement; only an enablement
requirement
• separate written description requirement
introduced by CCPA in 1967 only for determining
priority
• Lilly was first CAFC case to apply written
description outside of a priority context
• Lilly and Enzo result in heightened disclosure
requirement making enablement irrelevant
22
www.fitzpatrickcella.com
Enzo En Banc Rehearing Denial
Those against en banc rehearing:
• Written description is separate requirement from
enablement
• Statute says “and” between mentions of written
description and enablement
• Supreme Court in Festo said “patent application
must describe, enable and set forth the best mode of
carrying out the invention”
• Fact that prior written description cases may have
dealt only with priority is circumstantial
23
www.fitzpatrickcella.com
Post-Enzo Written Description Decisions
University of Rochester v. G.D. Searle & Co., 2003 U.S. Dist.
LEXIS (W.D.N.Y. 2003).
Moba B.V. v. Diamond Automatic, 325 F.3d 1306 (Fed. Cir.
2003).
24
www.fitzpatrickcella.com
Searle Facts
•Cox-1 helps protect stomach lining
•Cox-2 associated with inflammation stimuli
•Prior art drugs (NSAID’s) inhibited both Cox-2 and
Cox-1
25
www.fitzpatrickcella.com
University of Rochester claim 1:
1. A method for selecting inhibiting PgHS-2 activity in a
human host, comprising administering a non-steroidal
compound that selectively inhibits activity of the
PGHS-2 gene product to a human host in need of
such treatment.
26
www.fitzpatrickcella.com
Searle Facts (continued)
•Patent describes screening assays useful for development
of drugs that selectively inhibit inflammation without
producing side effects due to inhibition of Cox-1
•Patent says assays are for screening compounds
including peptides, polynucleotides and small organic
molecules
•Patent claims method of administering to humans a
non-steroidal compound that selectively inhibits Cox-2
activity and has minimal effect on Cox-1 activity
27
www.fitzpatrickcella.com
Searle Holding
Court held (Larimer, J.) patent failed to provide written
description of claimed invention:
• patent only describes the function of compound called for
but no showing of correlation between function and
structure (relying on PTO written description Guidelines)
• inventors did not identify even one suitable compound
• patent is merely “research plan” that describes tests to run
on wide spectrum of compounds in hope at least one will
work
Court rejected plaintiff’s contention that Enzo and Lilly limited to
claims directed to nucleic acid sequences:
• Lilly’s holding that the inventors must adequately describe
invention is not limited to genetic material
28
www.fitzpatrickcella.com
Searle Additional Issues
Court rejected plaintiff’s argument that written
description requirement doesn’t apply to method of
treatment claims:
• claimed method depends upon finding a
compound that selectively inhibits COX-2
• “It means little to invent a method if one does not
have possession of the substance that is essential to
practicing that method”
University of Rochester, 2003 U.S. Dist. LEXIS 3030 at *31.
29
www.fitzpatrickcella.com
Moba
• Patent claimed a method of processing eggs
• The alleged infringer argued that since the court
had construed the patent claim at issue to
encompass lifting eggs from a moving conveyor,
then the claim must be invalid for lack of written
description because the specification did not
disclose any such conveyor mechanisms
30
www.fitzpatrickcella.com
Moba (continued)
• Per curium (Judges Rader, Schall and Bryson)
• “The test for compliance with § 112 has always
required sufficient information in the original
disclosure to show that the inventor possessed the
invention at the time of the original filing.”
31
www.fitzpatrickcella.com
Moba Holdings
• Gentry Gallery was not controlling because there
was no allegation that the patent disclosure did
not show possession of a later-filed claim.
• The “Lilly disclosure rule” was not applicable
because one skilled in the art could determine
from the as-filed specification that the inventor
possessed the invention.
32
www.fitzpatrickcella.com
Moba (Judge Rader concurring)
• it is a mistake to apply the written description
doctrine beyond priority
• The “Lilly rule” requires the nucleotide by
nucleotide recitation of an entire sequence and
this rule unnecessarily increases the cost and time
required to prepare and prosecute a biotech
application
• to enable is to show possession and to show
possession is to enable
• the Lilly rule requires en banc correction.
33
www.fitzpatrickcella.com
Moba (Judge Bryson concurring)
• Does not believe you can separate Lilly from In re
Ruschig based on priority because § 112, first
paragraph, makes no such distinction.
• Are the Ruschig line of cases based on a flawed
construction of 35 USC § 112, first paragraph?
34
www.fitzpatrickcella.com
Status of Written Description
Requirement
•Genus may be adequately described by identifying
sufficient number of species or structural features
common to substantial portion of genus (Lilly)
•Functional descriptions are not enough unless there is
shown a clear correlation between function and
structure (Enzo)
•Written description requirement applies to
pharmaceuticals, nucleic acids, methods of treatment,
and compositions (Searle)
•PTO Written Description Guidelines are important
reference for prosecutors, opinion givers and litigators
(Enzo/Searle)
35
www.fitzpatrickcella.com
The PTO Written Description Guidelines
– 66 Fed. Reg. 1099, 1104 (Jan. 5, 2001)
– Purpose is to assist the PTO in the examination of patent
applications for compliance with the written description
requirement
– Do not constitute substantive rulemaking (perceived
failure to follow neither appealable or petitionable)
– Synopsis of Application of Written Description
Guidelines available at
http://www.uspto.gov/web/patents/guides.htm
36
www.fitzpatrickcella.com
Written Description Guidelines
I.
General Principals
“The written description requirement of the Patent Act
promotes the progress of the useful arts by ensuring that
patentees adequately describe their inventions in their patent
specifications in exchange for the right to exclude others
from practicing the invention for the duration of the patent
term.”
66 Fed. Reg. at 1104
37
www.fitzpatrickcella.com
Written Description Guidelines
I.
General Principals (continued)
•
An applicant shows possession of the claimed invention by
describing the claimed invention with all of its limitations
using such descriptive means as words, structures, figures,
diagrams, and formulas that fully set forth the claimed
invention. Possession may be shown in a variety of ways
including description of an actual reduction to practice, or by
showing that the invention was “ready for patenting” such as
by the disclosure of drawings or structural chemical formulas
that show that the invention was complete, or by describing
distinguishing identifying characteristics sufficient to show
that the applicant was in possession of the claimed invention.
66 Fed. Reg. at 1104
38
www.fitzpatrickcella.com
Written Description Guidelines
I.
General Principals (continued)
The issue of an adequate written description may arise when
–
an original claim is not described sufficiently
–
a new or amended claim which adds or removes a
limitation
–
a claim to benefit of an earlier priority date or effective
filing date
66 Fed. Reg. at 1104
39
www.fitzpatrickcella.com
Written Description Guidelines
I.A. Original Claims
–
strong presumption of adequate written
description for an original claim
–
but, originally claimed invention “may not be
adequately described if the claims require an
essential or critical feature which is not
adequately described in the specification and
which is not conventional in the art or known to
one of ordinary skill in the art.” (emphasis
added)
66 Fed. Reg. at 1105
40
www.fitzpatrickcella.com
Written Description Guidelines
I.B. New or Amended Claims
– “New or amended claims which introduce
elements or limitations which are not supported
by the as-filed disclosure violate the written
description requirement.”
– Support must be either express, implicit or
inherent
66 Fed. Reg. at 1105
41
www.fitzpatrickcella.com
Written Description Guidelines
I.B. New or Amended Claims (continued)
– obvious errors may be corrected if one skilled in the
art recognizes
(i) the existence of the error and (ii) the
appropriate correction
– deposits made after the filing date cannot support
additions to or correction of information in the asfiled application.
66 Fed. Reg. at 1105
42
www.fitzpatrickcella.com
Written Description Guidelines
I.B. New or Amended Claims (continued)
– omission of a limitation may raise an issue; did the
inventor have possession of a broader, more generic
invention?
– a claim that omits an element which applicant
describes as an essential or critical feature of the
invention originally disclosed does not comply with
the written description requirement.
66 Fed. Reg.at 1105
43
www.fitzpatrickcella.com
Written Description Guidelines
II.
A.
Methodology
Read and Analyze the Specification (question of fact
determined on a case-by-case basis)
1. For each claim determine what the claim as a
whole covers.
2. Review the entire application to understand how
applicant provides support for the claimed
invention including each element and/or step.
3. Determine whether there is sufficient written
description to inform a skilled artisan that
applicant was in possession of the claimed
invention as a whole at the time the application
was filed.
66 Fed. Reg. at 1105
44
www.fitzpatrickcella.com
Written Description Guidelines
II.
a)
Methodology (continued)
Original Claims – possession may be shown by:
i. actual reduction to practice (but see Enzo);
ii. detailed drawings;
iii. structural chemical formula; or
iv. sufficient relevant, identifying characteristics
from which a person skilled in the art would
recognize that the inventor had possession.
66 Fed. Reg. at 1105-06
45
www.fitzpatrickcella.com
Written Description Guidelines
II. Methodology (continued)
For a single species or embodiment, the Examiner is
to determine if an actual reduction to practice,
detailed drawings or structural chemical formula
shows possession of the claimed invention. If not, are
there sufficient relevant, identifying characteristics?
– if the complete structure (or acts of a process) is
disclosed then adequate description.
–
if not, are there other relevant identifying
characteristics sufficient to adequately describe
the invention?
66 Fed. Reg. at 1106
46
www.fitzpatrickcella.com
Written Description Guidelines
II. Methodology (continued)
– Features for determining if other relevant
identifying characteristics are sufficient
*
level of skill and knowledge in the art
*
partial structure
*
physical and/or chemical properties
*
functional characteristics alone or
coupled with a known or disclosed
correlation between structure and
functions
*
method of making the claimed invention
66 Fed. Reg. at 1106
47
www.fitzpatrickcella.com
Written Description Guidelines
II. Methodology (continued)
–
if the technology is mature and the level of skill
is high then disclosure even of only a method
of making and a function should be adequate
to support a product claim
– if the technology is emerging or unpredictable
greater evidence is needed to show possession
66 Fed. Reg. at 1106
48
www.fitzpatrickcella.com
Written Description Guidelines
II.
Methodology (continued)
– The written description requirement for a claimed
genus may be satisfied through sufficient description
of a representative number of species, i.e., the species
which are adequately described are representative of
the entire genus.
– the higher the skill and the knowledge in the art the
smaller the representative number of species needed.
– the more unpredictable the art the greater the
representative number of species needed.
66 Fed. Reg. at 1106
49
www.fitzpatrickcella.com
Written Description Guidelines
II. Methodology (continued)
– New claims, amended claims or claims asserting a
priority benefit must be expressly, implicitly, or
inherently supported by the original application.
– If the original application does not support the new
claim limitation or if element described as essential
or critical is missing from the claim, then lack of
adequate written description.
66 Fed. Reg. at 1107
50
www.fitzpatrickcella.com
Some Suggestions
•
•
•
•
•
Avoid unsupported provisos to obtain allowance
If an element of the invention is described as critical
or essential then it should be included in the claims
When drafting an application be certain that the
elements of your invention are accurately described
Consider describing an alternative embodiment with
the phrase “consisting essentially of” in the
specification
When drafting a provisional remember that the
disclosure must meet the requirements of 35 U.S.C.
§ 112, first paragraph
51
www.fitzpatrickcella.com
Suggestions For Biotech Claims
•
•
•
CLAIM THE HUMAN SEQUENCES (cDNA,
GENOMIC, AMINO ACID) SPECIFICALLY FOR
EXAMPLE
SEQ ID NO: 1 = cDNA
SEQ ID NO: 2 = GENOMIC
SEQ ID NO: 3 = AMINO ACID (Perhaps active
fragments of this protein)
CLAIM cDNA (SEQ ID NO: 1) OPERABLY LINKED TO
AN EXPRESSION CONTROL SEQUENCE
CLAIM HOST CELL CONTAINING “OPERABLY
LINKED” cDNA
52
www.fitzpatrickcella.com
Suggestions For Biotech Claims
(continued)
•
CLAIM NUCLEIC ACIDS THAT SPECIFICALLY
HYBRIDIZE TO SEQ ID NOs: 1 AND 2 UNDER
HIGHLY STRIGENT CONDITIONS [and identify highly
stringent conditions in specification or claim]
•
CLAIM ANTISENSE NUCLEOTIDES THAT INHIBIT
THE EXPRESSION OF SEQ ID NOs: 1 AND 2
•
CLAIM ANTIBODIES THAT BIND TO THE PROTEIN
(SEQ ID NO: 3)
•
CLAIM TRANSGENIC and/or KNOCKOUT ANIMALS
(based on SEQ ID NOs: 1 AND 2)
53
www.fitzpatrickcella.com
Suggestions For Biotech Claims
(continued)
• IF AWARE OF PARTICULAR FUNCTIONAL
DOMAINS OR CONSERVED SEQUENCES, CLAIM
THEM SPECIFICALLY [Amino Acid and Nucleotide
sequence]
•
CLAIM ANALOGS (SHOULD BE TIED TO
FUNCTION OR OTHER DISTINGUISHING
ATTRIBUTES, e.g., degeneracy of condons for SEQ ID
NO: 3)
•
CLAIM ALLELIC VARIANTS -- as possible support,
discuss single nucleotide polymorphisms (SNPs) - (identify
fact that some particular number of SNPs within the gene
is known (e.g., in the public SNP database(s)); specifically
identify those SNPs present within the coding sequence)
54
www.fitzpatrickcella.com
Thank You
www.fitzpatrickcella.com