[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32639-32645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15777]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. 980605148-8148-01]
Request for Comments on Interim Guidelines for Examination of
Patent Applications Under the 35 U.S.C. 112 para. 1 ``Written
Description'' Requirement
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Notice and request for public comments.
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SUMMARY: The Patent and Trademark Office (PTO) requests comments from
any interested member of the public on the following interim
guidelines. These guidelines will be used by PTO personnel in their
review of biotechnological patent applications for compliance with the
``written description'' requirement of 35 U.S.C. 112 para. 1. Although
the guidelines are directed primarily to written descriptions of
biotechnological inventions, they reflect the current understanding of
the PTO and apply across the board to all relevant technologies.
DATES: Written comments on the interim guidelines will be accepted by
the PTO until September 14, 1998.
ADDRESSES: Written comments should be addressed to Box 8, Commissioner
of Patents and Trademarks, Washington, D.C. 20231, marked to the
attention of Scott A. Chambers, Associate Solicitor or to Box Comments,
Assistant Commissioner for Patents, Washington, D.C. 20231 marked to
the attention of Linda S. Therkorn. Alternatively, comments may be
submitted to Scott Chambers via facsimile at (703) 305-9373 or by
electronic mail addressed to scott.chambers@uspto.gov'' or to Linda
Therkorn via facsimile at (703) 305-8825 or by electronic mail
addressed at linda.therkorn@uspto.gov.''
FOR FURTHER INFORMATION CONTACT: Scott Chambers by telephone at (703)
305-9035, by facsimile at (703) 305-9373, by mail to his attention
addressed to Box 8, Commissioner of Patents and Trademarks, Washington,
D.C. 20231, or by electronic mail at scott.chambers@uspto.gov'; or
Linda Therkorn by telephone at (703) 305-8800, by facsimile at (703)
305-8825, by mail addressed to Box Comments, Assistant Commissioner for
Patents, Washington, D.C. 20231, or by electronic mail at
linda.therkorn@uspto.gov.''
SUPPLEMENTARY INFORMATION: The PTO requests comments from any
interested member of the public on the following interim guidelines.
These guidelines will be used by PTO personnel in their review of
biotechnological patent applications for compliance with the ``written
description'' requirement of 35 U.S.C. 112 para. 1. Although the
guidelines are directed primarily to written descriptions of
biotechnological inventions, they reflect the current understanding of
the PTO and apply across the board to all relevant technologies.
Because these guidelines govern internal practices, they are exempt
from notice and comment rulemaking under 5 U.S.C. 553(b)(A).
Written comments should include the following information: (1) name
and affiliation of the individual responding; and (2) an indication of
whether the comments offered represent views of the respondent's
organization or are they respondent's personal views. The PTO is
particularly interested in comments relating to: (1) the accuracy of
the methodology; (2) relevant factors to consider in determining
whether the written description requirement of 35 U.S.C. 112 para. 1 is
satisfied; (3) whether the scope of these guidelines should be limited
to certain technologies, such as biotechnology, or even a particular
area of biotechnology such as nucleic acids, or encompass all
technologies generally; (4) whether the scope of these guidelines
should be expanded to include processes and/or product-by-process
claims; and (5) the impact these guidelines may have on currently
pending applications as well as future applications.
Parties presenting written comments are requested, where possible,
to provide their comments in machine-readable format in addition to a
paper copy. Such submissions may be provided by electronic mail
messages sent over the Internet, or on a 3.5'' floppy disk formatted
for use in either a Macintosh, Windows, Windows for Workgroups, Windows
95, Windows NT, or MS-DOS based computer.
Written comments will be available for public inspection on or
about September 14, 1998, in Suite 918, Crystal Park 2, 2121 Crystal
Drive, Arlington, Virginia. In addition, comments provided in machine-
readable format will be available through anonymous file transfer
protocol (ftp) via the Internet (address: comments.uspto.gov) and
through the World Wide Web (address: www.uspto.gov).
Interim Guidelines for the Examination of Patent Applications Under
The 35 U.S.C. 112 para. 1 ``Written Description'' Requirement
These ``Written Description Guidelines'' are intended to assist
Office personnel in the examination of patent applications for
compliance with the written description requirement of 35 U.S.C. 112,
para. 1, in view of University of California v. Eli Lilly 1
and the earlier cases Fiers v. Revel 2 and Amgen, Inc. v.
Chugai Pharmaceutical Co. 3 These Interim Guidelines are
directed primarily to determining whether there is written description
support for product claims and are not intended to specifically address
the description necessary to support process or product-by-process
claims. Similarly, these Guidelines are not intended to directly
address the question of new matter, which is currently addressed in the
Manual of Patent Examining Procedure Secs. 2163.06-.07. The Final
Guidelines may address these additional issues if public comment
suggests they should be addressed. These guidelines are based on the
Office's current understanding of the law and are believed to be fully
consistent with binding precedent of the Supreme Court, the Federal
Circuit, and the Federal Circuit's predecessor courts.
These guidelines do not constitute substantive rulemaking and hence
do not have the force and effect of law. They are designed to assist
Office personnel in analyzing claimed subject matter for compliance
with substantive law. Rejections will be based upon the substantive
law, and it is these rejections which are appealable. Consequently, any
failure by Office personnel to follow the guidelines is neither
appealable nor petitionable.
[[Page 32640]]
These guidelines are intended to form part of the normal
examination process. Thus, where Office personnel establish a prima
facie case of lack of written description for a claim, a thorough
review of the prior art and examination on the merits for compliance
with the other statutory requirements, including those of 35 U.S.C.
101, 102, 103, and 112, is to be conducted prior to completing an
Office action which includes a rejection for lack of written
description.
Office personnel are to rely on these guidelines in the event of
any inconsistent treatment of issues involving the written description
requirement between these guidelines and any earlier guidance provided
from the Office. Although these guidelines address examples principally
drawn from the biotechnological arts, they are intended to be equally
applicable to all fields of invention.
I. General Principles Governing Compliance with the ``Written
Description'' Requirement for Applications
The first paragraph of 35 U.S.C. 112 requires that the
``specification shall contain a written description of the invention *
* *'' This requirement is separate and distinct from the enablement
requirement. 4 This written description requirement has
several policy objectives. ``[T]he ``essential goal'' of the
description of the invention requirement is to clearly convey the
information that an applicant has invented the subject matter which is
claimed.'' 5 Another objective is to put the public in
possession of what the applicant claims as the invention. The written
description requirement prevents an applicant from claiming subject
matter that was not described in the specification as filed, and the
proscription against the introduction of new matter in a patent
application 6 serves to prevent an applicant from adding
information that goes beyond the subject matter originally filed.
To satisfy the written description requirement, a patent
specification must describe the claimed invention in sufficient detail
that one skilled in the art can reasonably conclude that the inventor
had possession of the claimed invention. 7 This requirement
of the Patent Act promotes the progress of the useful arts by ensuring
that patentees adequately describe their inventions in their patent
specifications for the benefit of the public in exchange for the right
to exclude others from practicing the invention for the duration of the
patent's term. 8
II. Evaluate Whether The Application Complies With the ``Written
Description'' Requirement
The inquiry into whether the description requirement is met must be
determined on a case-by-case basis and is a question of fact.
9 The examiner has the initial burden of presenting evidence
or reasons why a person skilled in the art would not recognize in an
applicant's disclosure a description of the invention defined by the
claims. 10 Office personnel should adhere to the following
procedures when reviewing patent applications for compliance with the
written description requirement of 35 U.S.C. 112, para. 1.
A. Review the Entire Application To Determine What Applicant has
Invented, the Field of the Invention and the Level of Predictability in
the Art
Prior to determining whether the claims satisfy the written
description requirement, Office personnel should review the entire
specification, including the specific embodiments, figures, sequence
listings, and the claims, to understand what applicant has invented and
the correspondence between what applicant has described, i.e., has
possession of, and what applicant is claiming. Such a review should be
conducted from the standpoint of one of skill in the art at the time
the application was filed and should include a determination of the
field of the invention and, thus, the level of predictability in the
art. Predictability of the structure of a species can be premised upon:
(1) Whether the level of skill in the art leads to a predictability
of structure; and/or
(2) Whether teachings in the application or prior art lead to a
predictability of structure.
There is an inverse correlation between the level of predictability
in the art and the amount of disclosure necessary to satisfy the
written description requirement. For example, if there is a well-
established correlation between structure and function in the art, one
skilled in the art will be able to reasonably predict the complete
structure of the claimed invention from its function. Thus, in some
factual situations, the written description requirement may be
satisfied through disclosure of function alone when there is a well-
established correlation between structure and function. In contrast,
without such a correlation, prediction of structure from function is
highly unlikely. In this latter case, disclosure of function alone will
not satisfy the written description requirement. 11
B. For Each Claim, Determine What the Claim as a Whole Covers
Each claim must be separately analyzed and given its broadest
reasonable interpretation. 12 The entire claim, including
its preamble language and transitional phrase, must be considered.
``Preamble language'' is that language in a claim appearing before a
transitional phase, e.g., before ``comprising,'' ``consisting
essentially of,'' or ``consisting of''. The transitional term
``comprising'' (and other comparable terms, e.g., ``containing'' and
``including'') is ``open-ended''--it covers the expressly recited
subject matter alone or in combination with other unstated subject
matter. 13 There must be adequate written description to
support the claimed invention including the preamble. 14 The
claim as a whole, including all limitations found in the preamble, the
transitional phrase, and the body of the claim, must be described
sufficiently to satisfy the written description requirement.
15 For claims of the form ``A [structure] comprising SEQ ID
NO: 1'' there may be a written description problem if the claim as a
whole, including its preamble and transitional phrase, is directed to
an invention of unpredictable structure that is not fully described.
For example, when the term ``gene,'' ``mRNA,'' or ``cDNA'' is
recited in the preamble, it implies a specific structure (or a small
genus of specific structures) when used in the traditional sense, i.e.,
to mean the structure having the naturally occurring sequence. Thus,
``A gene comprising SEQ ID NO: 1''; ``A mRNA comprising SEQ ID NO: 1'';
and ``A cDNA comprising SEQ ID NO: 1'' implicitly recite specific
structures such as promoters, enhancers, coding regions, and other
regulatory elements in the preamble which must be sufficiently
described in the specification so as to show the applicant was in
possession of the claimed inventions.
In contrast, use of less specific, generic preamble language, such
as ``composition,'' ``nucleic acid,'' ``DNA,'' and ``RNA,'' does not
typically present a written description problem. These terms are
sufficiently general that one skilled in the art can readily envision a
sufficient number of members of the claimed genus to provide written
description support for the genus.
A claim such as ``A gene comprising SEQ ID NO: 1,'' can be viewed
as a species claim in which the preamble recites a combination and the
body of the claim recites a subcombination: The ``gene'' is the
combination and ``SEQ ID
[[Page 32641]]
NO: 1'' (which is a fragment of the gene) is the subcombination.
Written description of only the subcombination (in this example the
fragment SEQ ID NO: 1) normally does not put one in possession of the
combination (in this example the gene).
Likewise, generic claims to sequences can be viewed as a genus of
such combination-subcombination claims. For example, a claim such as
``A nucleic acid comprising SEQ ID NO: 1'' can be viewed as a genus
claim in which each member of the genus (each species) is itself a
combination-subcombination: Each member of the genus ``nucleic acid''
is a combination containing the subcombination ``SEQ ID NO: 1'' (which
is a fragment of the nucleic acid). Again, the generic term ``nucleic
acid'' does not typically present a written description problem because
one skilled in the art can readily envision a sufficient number of
members of the claimed genus to provide written description support for
the genus. 16
C. For Each Claimed Species, Determine Whether There is Sufficient
Written Description To Inform a Skilled Artisan That Applicant was in
Possession of the Claimed Invention at the Time the Application was
Filed
Written description may be satisfied through disclosure of relevant
identifying characteristics, i.e., structure, other physical and/or
chemical characteristics, functional characteristics when coupled with
a known or disclosed correlation between function and structure, or
some combination of such characteristics. What is well known to one
skilled in the art need not be disclosed. 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 claims is
not explicitly described in the specification, then the adequate
description requirement is met.
For each claimed species:
(1) Determine whether a complete structure is disclosed. The
complete structure of a species typically satisfies the requirement
that the description be set forth in ``such full, clear, concise and
exact terms'' to show possession of the claimed invention. If a
complete structure is disclosed, the written description requirement is
satisfied for that species, and a rejection under 35 U.S.C. 112 para. 1
for lack of written description must not be made.
For example, consider the following claim:
A probe for use in detecting nucleic acid sequences coding for
enzyme Q from the genus Bacillus consisting of SEQ ID NO: 16.
Considering the claim as a whole, it is a species claim covering
the probe SEQ ID NO: 16. The specification discloses the complete
sequence for SEQ ID NO: 16. Thus, this claim falls into the ``safe
harbor'' described under C(1).
(2) If the complete structure is not disclosed, determine whether
the specification discloses other relevant identifying characteristics,
i.e., physical and/or chemical characteristics and/or functional
characteristics coupled with a known or disclosed correlation between
function and structure, sufficient to describe the claimed invention in
such full, clear, concise and exact terms that a skilled artisan would
recognize applicant was in possession of the claimed invention.
Disclosure of any combination of such identifying characteristics that
would lead one of skill in the art to the conclusion that the applicant
was in possession of the claimed species is sufficient. In such a case,
a rejection for lack of written description under 35 U.S.C. 112 para. 1
must not be made.
For example, consider the following claim:
An isolated double-stranded DNA consisting of (1) a single-
stranded DNA which has a molecular size of 2.57 Kb and is derived
from golden mosaic virus, and (2) a DNA complementary to said
single-stranded DNA, giving the restriction endonuclease cleavage
map shown in FIG.2(a) and having no Mbo I restriction endonuclease
site.
Although the specification does not disclose the complete structure
for the claimed DNA, it does disclose sufficient identifying
characteristics, i.e., size, cleavage map, and source from which the
DNA is derived. Thus, while this claim does not meet the C(1) criteria
because the complete sequence is not disclosed, it does meet the C(2)
criteria because one skilled in the art would recognize from the
characteristics, e.g., size, map, source, that applicant was in
possession of the claimed material at the time of filing.
The following protein claim also falls within the C(2) criteria:
An isolated alginate lyase enzyme wherein said enzyme lyses
alginate in the mucous substance produced in a patient with cystic
fibrosis and wherein said enzyme has the N-terminal amino acid
sequence SEQ ID No. 1, obtained from Flavobacterium pepermentium and
has the following physicochemical properties: (1) Activity: lyses
alginate to saccharides having a non-reducing end C4-
C5 double bond and ultimately to 4-deoxy-5-ketouronic
acid; (2) Molecular weight: 60,000 daltons; (3) Optimal pH: 8.0; (4)
Stable pH: 6.0-8.0; (5) Optimal temperature: 70 degrees C; and (6)
Substrate specificity: alginate.
In this example, the specification discloses the molecular weight,
origin, activity, and specificity but does not disclose the complete
structure for the claimed enzyme. Thus, this claim would not meet the
C(1) criteria because the complete sequence is not disclosed. However,
the claim meets the C(2) criteria because, although the complete
structure is not disclosed, one skilled in the art would recognize from
the disclosed physical characteristics--e.g., molecular weight, origin,
activity, and specificity--that applicant was in possession of the
claimed material at the time of filing.
In contrast, consider the following claim:
An isolated nucleotide sequence consisting of the sequence of the
reverse transcript of a human mRNA, which mRNA encodes insulin.
The specification in this example provides the coding sequence for
rat insulin but not that for human insulin. The description for the
reverse transcript of human mRNA is limited to its function, encoding
human insulin, and to a method for isolating the claimed sequence from
its natural source. A sequence described only by a purely functional
characteristic, without any known or disclosed correlation between that
function and the structure of the sequence, normally is not a
sufficient identifying characteristic for written description purposes,
even when accompanied by a method of obtaining the claimed species. In
this case, even though a genetic code table would correlate a known
insulin amino acid sequence with a genus of coding nucleic acids, the
same table cannot predict the native, naturally occurring nucleic acid
sequence of human mRNA or its corresponding cDNA. Thus, the
specification in this example does not provide adequate written
description, either under the C(1) or C(2) criteria.
Any claim to a species that does not meet the test described under
C(1) or C(2)must be rejected as lacking adequate written description
under 35 U.S.C. 112 para. 1.
[[Page 32642]]
D. For Each Claimed Genus, Determine Whether There is Sufficient
Written Description to Inform a Skilled Artisan That Applicant was in
Possession of the Claimed Genus at the Time the Application was Filed
The written description requirement for a claimed genus may be
satisfied through sufficient description of a representative number of
species by relevant identifying characteristics, i.e., structure or
other physical and/or chemical characteristics, by functional
characteristics coupled with a known or disclosed correlation between
function and structure, or by a combination of such identifying
characteristics, sufficient to show the applicant was in possession of
the claimed genus. A ``representative number of species'' requires that
the species which are expressly described be representative of the
entire genus. Thus, when there is substantial variation within the
genus, it may require a description of the various species which
reflect the variation within the genus. For example, a broadly drawn
claim to a specific gene from ruminant mammals may require a
representative species from cattle, buffalo, bison, goat, deer,
antelope, camel, giraffe and llama.
What constitutes a ``representative number'' is an inverse function
of the predictability of the art, as determined in IIA above. The
number must be sufficient to reasonably identify the other members of
genus. In an unpredictable art, adequate written description of a genus
cannot be achieved by disclosing only one species within the genus. In
fact, if the members of the genus are expected to vary widely in their
identifying characteristics, such as structure and activity, written
description for each member within the genus may be necessary.
Generalized descriptions alone, such as ``vertebrate insulin cDNA''
or ``mammalian insulin cDNA,'' fail to satisfy the written description
requirement because they do not describe any members of the genus
except by function without any known or disclosed correlation between
function and structure.24 If the correlation between
structure and function in the art would not have been known to one
skilled in the art and the specification does not describe the
correlation, the written descriptive support cannot depend on that
correlation.
For each claim to a genus:
(1) Determine whether a representative number of species have been
described by complete structure as in C(1) above. If a representative
number have been so described, then the applicant has written
description support for the claimed genus and a rejection under 112
para. 1 for lack of written description must not be made.
For example, consider the following claim to a genus:
An isolated DNA probe for detecting HIV-X, wherein said DNA
probe hybridizes to the nucleotide sequence set forth in SEQ ID NO:1
under the following conditions: hybridization in 7% sodium dodecyl
sulfate (SDS), 0.5M NaPO 4 pH 7.0, 1mM EDTA at 50 deg.
C.; and washing with 1% SDS at 42 deg. C.
In this case, the specification discloses the sequence of the
isolated DNA molecule consisting of SEQ ID NO: 1 and discloses several
sequences that hybridize to SEQ ID NO: 1. Hybridization under the
stringent conditions specified here requires that the claimed nucleic
acid probes be structurally similar to the complement of the nucleic
acid sequence disclosed as SEQ ID NO: 1. In this case, the description
as a whole is sufficient to evidence possession of the claimed genus
because the genus is defined by relation to the structure of the
sequence provided as SEQ ID NO: 1, and because several species are
disclosed that possess the hybridization property which further defines
the genus. Thus, this claim to a genus meets the D(1) criteria.
(2) For each claim to a genus not supported as described under
D(1), determine whether there is a representative number of adequately
described species, as analyzed under C(2). The representative number
must permit one skilled in the art to reasonably identify the remaining
members of the genus. If a representative number are so described, then
the written description requirement is satisfied and, again, a
rejection under 112 para. 1 for lack of written description must not be
made.
For example, consider the following claim to a genus:
A monoclonal antibody which specifically binds to the novel
cancer associated TAG-31 antigen but which does not substantially
bind normal adult human tissues, wherein said monoclonal antibody
has a binding affinity of greater than 3 times 10 \9\ M-
-\1\ for TAG-31.
Considering the claim as a whole, it is drawn to a genus of
monoclonal antibodies. Although the specification does not disclose the
complete structure of a representative number of species to support the
claimed genus of antibodies, it does disclose multiple monoclonal
antibodies which have the isotype claimed as well as the binding
specificity and binding affinity characteristics recited in the claims.
In this well-developed art, additional identifying characteristics for
a substantial portion of the genus are well-known (e.g., number of
chains, disulfide bonds, constant and variable regions, etc.). Thus,
applicant's disclosure combined with what was known in the art are
sufficient to describe the claimed genus of monoclonal antibodies in
such full, clear, concise and exact terms to show applicant was in
possession of the claimed antibodies. Thus, the claim meets the D(2)
criteria.
As another example, consider the following claim to a genus:
An isolated mutanase enzyme produced by Bacillus having the
following physicochemical properties (1) to (9): (1) action: an
ability to cleave alpha-1,3-glucosidic links of mutan; (2) substrate
specificity: an ability to effectively decompose mutan; (3) optimum
pH: pH 4 to 4.5 when reacting on a mutan substrate at 35 degrees C
for 10 minutes; (4) pH range for stability: pH 4 to 10 when kept at
25 degrees C for 24 hours; (5) optimum temperature: 50 degrees to 65
degrees C when reacted at pH 5 with mutan as a substrate; (6)
thermal stability: enzyme activity remains stable below 50 degrees C
after incubation at pH 5 for 10 minutes; (7) effect of metal ions:
mercury and silver show inhibitory effect on a mutan substrate; (8)
effect of inhibitors: p-chloromercurybenzoic acid shows inhibitory
effect on a mutan substrate; and (9) molecular weight: about 140,000
to about 160,000 as determined by SDS-polyacrylamide gel
electrophoresis.
Considering the claim as a whole, it covers a genus of mutanase
enzymes. Although the specification does not disclose the complete
structure of a representative number of species to support the claimed
genus of enzyme compositions, it does disclose 3 mutanase species
produced by different strains of Bacillus (mutanases A, B and C) which
are identified by multiple relevant identifying characteristics, i.e.,
molecular weight, substrate specificity, optimum and ranges of
temperature and pH for mutan cleavage activity, etc. In this well-
developed art, these identifying characteristics are sufficient for a
skilled artisan to recognize applicant had possession of the species
from the identifying characteristics of the three mutanase species, to
reasonably predict sufficient identifying characteristics of the other
members of the genus and, thus, establish possession of the genus.
Thus, the claim meets the D(2) criteria.
As another example, consider the following claim to a genus:
[[Page 32643]]
A DNA comprising a novel DF3 enhancer and DNA encoding a
heterologous gene but not encoding DF3 wherein said DF3 enhancer
consists of SEQ ID NO: 1.
Considering the claim as a whole, it covers a genus of DNA. The
specification does not describe a representative number of members of
the genus by complete structure. Thus, the claim does not meet the D(1)
criteria. However, there is sufficient disclosure of identifying
characteristics common to the members of the genus, i.e., DF3 enhancer,
to meet the D(2) criteria. Because of the nature of the generic term
``DNA,'' one skilled in the art could envision a sufficient number of
the members of the genus to describe the invention in such full, clear
and concise terms as to show possession of the invention at the time of
filing.
In contrast, consider the claim:
An isolated nucleic acid comprising the structure of the reverse
transcript of a mammalian mRNA, which mRNA encodes insulin.
Considering the claim as a whole, the claim covers the genus of
nucleotide sequences encoding mammalian insulin. The specification only
provides the coding sequence for rat insulin cDNA and a method to
isolate the coding sequence from its natural source.25 This
description does not meet the criteria of D(1) or D(2) and thus does
not satisfy the written description requirement.
Also contrast the claim ``A gene comprising SEQ ID NO: 1.''
Although all genes encompassed by this claim share the characteristic
of comprising SEQ ID NO: 1, and as such might appear to meet the D(2)
criteria, there is insufficient description of the characteristics
(e.g., promoters, enhancers, coding regions, and other regulatory
elements) which identify the genes, as opposed to any DNA comprising
SEQ ID NO: 1.
If sufficient identifying characteristics are not disclosed for a
given genus, as described in D(1) or D(2), the claim to that genus must
be rejected as lacking adequate written description under 35 U.S.C. 112
para. 1.
III. Complete Patentability Determination Under All Statutory
Requirements and Clearly Communicate Findings, Conclusions and
Their Bases
The above only describes how to determine whether the written
description requirement of 35 U.S.C. 112 para. 1 is satisfied.
Regardless of the outcome of that determination, Office personnel must
complete the patentability determination under all the relevant
statutory provisions of the Patent Act.
Once Office personnel have concluded analysis of the claimed
invention under all the statutory provisions, including 35 U.S.C. 101,
112, 102 and 103, they should review all the proposed rejections and
their bases to confirm their correctness. Only then should any
rejection be imposed in an Office action. The Office action should
clearly communicate the findings, conclusions and reasons which support
them.
Specific to these guidelines:
A. For Each Claim Lacking Written Description Support, Reject the Claim
Under Section 112, para. 1, for Lack of Adequate Written Description
In rejecting a claim, set forth express findings of fact regarding
the above analysis which support the lack of written description
conclusion. These findings should:
(1) identify the claim limitation not described; and
(2) provide reasons why a person skilled in the art at the time the
application was filed would not have recognized the description of this
limitation in view of the disclosure of the application as filed.
When appropriate, suggest amendments to the claims which would
bring the claims into compliance with the written description in the
specification, bearing in mind the prohibition against new matter in
the claims and corresponding description set forth in 35 U.S.C. 112 and
132.
B. Upon Reply by Applicant, Again Determine the Patentability of the
Claimed Invention, Including Whether the Written Description
Requirement is Satisfied by Performing the Analysis Described Above in
View of the Whole Record
Upon reply by applicant, before repeating any rejection under
Section 112 para. 1 for lack of written descriptive basis, review the
basis for the rejection in view of the record as a whole, including
amendments, arguments and any evidence submitted by applicant. If the
whole record now demonstrates that the written description requirement
is satisfied, do not repeat the rejection in the next Office action. If
the record still does not demonstrate that written description is
adequate to support the claim(s), repeat the rejection under 35 U.S.C.
112 para. 1, fully respond to applicant's rebuttal arguments, and
properly treat any further showings submitted by applicant in the
reply. Any affidavits, including those relevant to the 112 para. 1
written description requirement, must be thoroughly analyzed and
discussed in the Office action.
Endnotes
1. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).
2. 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993).
3. 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
4. E.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19
USPQ2d 1111, 1115 (Fed. Cir. 1991).
5. In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4
(CCPA 1977).
6. 35 U.S.C. Secs. 132 & 251.
7. E.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19
USPQ2d 1111, 1116 (Fed. Cir. 1991). Much of the written description
case law addresses whether the specification as originally filed
supports claims not originally in the application. The issue raised
in the cases is most often phrased as whether the original
application provides ``adequate support'' for the claims at issue or
whether the material added to the specification incorporates ``new
matter'' in violation of 35 U.S.C. Sec. 132. The ``written
description'' question similarly arises in the interference context,
where the issue is whether the specification of one party to the
interference can support the newly added claims corresponding to the
count at issue, i.e., whether that party can ``make the claim''
corresponding to the interference count. E.g., see Martin v. Mayer,
823 F.2d 500, 502, 3 USPQ2d 1333, 1335 (Fed. Cir. 1987).
In addition, early opinions suggest the Patent and Trademark
Office was unwilling to find written descriptive support when the
only description was found in the claims; however, this viewpoint
was rejected. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA
1980) (original claims constitute their own description); In re
Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973) (accord); In re
Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (accord). It is now
well-accepted that a satisfactory description can be mined from the
claims or any other portion of the originally filed specification.
These early opinions did not address the quality or specificity
of particularity that was required in the description, i.e., how
much description is enough.
8. See Eli Lilly, 119 F.3d at 1566, 43 USPQ2d at 1404.
9. See In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA
1972) (``Precisely how close [to the claimed invention] the
description must come to comply with Sec. 112 must be left to a
case-by-case development.''); In re Wertheim, 541 F.2d 257, 262, 191
USPQ 90, 96 (CCPA 1976) (inquiry is primarily factual and depends on
the nature of the invention and the amount of knowledge imparted to
those skilled in the art by the disclosure).
10. Wertheim, 541 F.2d at 262, 191 USPQ at 96.
11. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written
description requirement not satisfied by merely providing ``a result
that one might achieve if one made that invention''); In re Wilder,
736 F.2d 1516, 1521, 222 USPQ 369, 372-73
[[Page 32644]]
(Fed. Cir. 1984) (affirming a rejection for lack of written
description because the specification does ``little more than
outline goals appellants hope the claimed invention achieves and the
problems the invention will hopefully ameliorate'').
12. See, e.g., In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d
1023, 1027 (Fed. Cir. 1997).
13. See, e.g., Ex parte Davis, 80 USPQ 448, 450 (1948)
(``comprising'' leaves the ``claim open for the inclusion of
unspecified ingredients even in major amounts''.), quoted with
approval in Moleculon Research Corp v. CBS, Inc., 793 F.2d 1261,
1271, 229 USPQ 805, 812 (Fed. Cir. 1986).
14. See Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, 14
USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that preamble
language that constitutes a structural limitation is actually part
of the claimed invention).
15. An applicant shows possession of the claimed invention by
describing the claimed invention with all of its limitations.
Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d
1961, 1966 (Fed. Cir. 1997).
16. E.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06.
17. A ``relevant identifying characteristic'' is one that would
provide evidence that applicant was in possession of what is
claimed. For example, the presence of a restriction enzyme map of a
gene may be relevant to a statement that the gene has been isolated.
One skilled in the art could determine whether the gene disclosed
was the same as or different than a gene isolated by another by
comparing the restriction enzyme map. In contrast, evidence that the
gene could be digested with a nuclease would not normally represent
a relevant characteristic since any gene would be digested with a
nuclease.
Examples of identifying characteristics include a sequence,
structure, binding affinity, binding specificity, molecular weight
and length. Although structural formulas provide a convenient method
of demonstrating possession of specific molecules, other identifying
characteristics can demonstrate the requisite possession. For
example, unique cleavage by particular enzymes, isoelectric points
of fragments, detailed restriction enzyme maps, a comparison of
enzymatic activities, or antibody cross reactivity may be sufficient
to show possession of the claimed invention to one of skill in the
art. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572,
41 USPQ2d 1961, 1966 (1997) (``written description'' requirement may
be satisfied by using ``such descriptive means as words, structures,
figures, diagrams, formulas, etc. that fully set forth the claimed
invention'').
However, a definition by function alone ``does not suffice'' to
sufficiently describe a coding sequence ``because it is only an
indication of what the gene does, rather than what it is.'' Eli
Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d
at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen).
18. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d
1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).
19. See, e.g., Vas-Cath, 935 F.2d at 1563, 19 USPQ2d at 1116;
Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ 391, 395 (CCPA 1972)
(stating ``the description need not be in ipsis verbis to be
sufficient'').
20. 35 U.S.C. Sec. 112 para. 1. Cf. Fields v. Conover, 443 F.2d
1386, 1392, 170 USPQ 276, 280 (CCPA 1971) (finding a lack of written
description because the specification lacked the ``full, clear,
concise, and exact written description'' which is necessary to
support the claimed invention).
21. The examples contained within these guidelines are not
intended to represent the minimum requirements necessary to comply
with 35 U.S.C. Sec. 112 para. 1.
22. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
23. See id. at 1568, 43 USPQ2d at 1406.
24. Cf. Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at 1405 (stating
that ``The name cDNA is not itself a written description of that
DNA; it conveys no distinguishing information concerning itself.'').
25. See id. 1568, 43 USPQ2d at 1406.
Dated: June 9, 1998.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
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