Ex Parte Lipovsek et al

Patent Trial and Appeal Board

May 28, 2013

11890627 (P.T.A.B. May. 28, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DASA LIPOVSEK, RICHARD W. WAGNER,
and ROBERT G. KUIMELIS
__________

Appeal 2011-011350
Application 11/890,627
Technology Center 1600
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
isolated molecule comprising a tenth domain of fibronectin type III (
10
Fn3).
The Patent Examiner rejected the claims as failing to comply with the
written description requirement, as non-enabling, and as indefinite. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2011-011350
Application 11/890,627

2
STATEMENT OF THE CASE
Claims 1-2 and 5-12 are on appeal. Claim 1 is representative and
reads as follows:
1. An isolated molecule comprising i) a protein comprising a tenth
domain of fibronectin type III (
10
Fn3) domain, wherein the
10
Fn3 domain:
(a) has an amino acid sequence at least 50% identical to SEQ ID NO: 33;
(b) has at least one loop with a modified amino acid sequence relative to the
sequence of the corresponding loop of a human
10
Fn3 domain having the
sequence of SEQ ID NO: 33, wherein the loop is selected from the group
consisting of: the BC loop, corresponding to amino acids 21-30 of SEQ ID
NO: 33; the DE loop, corresponding to amino acids 51-56 of
SEQ ID NO: 33; and the FG loop, corresponding to amino acids 76-88 of
SEQ ID NO: 33; and (c) binds to a target compound that is not bound by
the corresponding human
10
Fn3 domain having the sequence of SEQ ID
NO: 33; and ii) a nucleic acid, wherein the protein is bonded through a
DNA-puromycin linker to the nucleic acid, and wherein the protein is
encoded by said nucleic acid.

The Examiner rejected the claims as follows:
• claims 1-2 and 5-12 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement;
• claims 1-2 and 5-12 under 35 U.S.C. § 112, first paragraph, as
lacking enablement;
• claims 1-2 and 5-12 under 35 U.S.C. § 112, second paragraph, as
being indefinite.

WRITTEN DESCRIPTION
The Examiner‟s position is that, according to the claims, any of the
loop binding regions of the
10
Fn3 domain, known in the art, “may be
modified (substituted) by any known amino acid, thereby conferring no
metes and bounds as to what applicant had possession of both in structure or
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Application 11/890,627

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function ….” (Ans. 4.) According to the Examiner, “[o]ne of skill in the art
would not recognize from the disclosure that the Applicant was in
possession of the genus, namely any protein comprising any „altered‟ Fn3
domain amino acids relative to the naturally occurring Fn3.” (Id. at 5
(emphasis omitted).)
Appellants contend that “[t]he application clearly provides relevant
structural and functional characteristics that are common to the claimed
conjugates as well as a correlation between such structural and functional
characteristics.” (App. Br. 7.) In particular, Appellants assert the claims are
directed to conjugates wherein the protein portion comprises a
10
Fn3 domain
having the structural and functional characteristics recited as claim elements
(a), (b) and (c). (Id. at 7-8.) Additionally, according to Appellants, “[t]he
specification provides extensive information about the structure of the
10
Fn3
domain such that one of skill in the art would clearly know how to modify
the sequence of the
10
Fn3 domain in order to change its binding specificity
while maintaining the overall three dimensional fold.” (Id. at 8.) Further,
Appellants assert that “the specification also provides a representative
number of working examples” by providing “the amino acid sequences for
108
10
Fn3 domains having modified BC, DE and FG loops that were isolated
based on their ability to bind to the exemplary target TNFα.” (Id. at 10.)
When an Applicant claims a class, the Applicant “must describe that
class in order to meet the description requirement of the statute.” In re
Lukach, 442 F.2d 967, 968 (CCPA 1971). “The adequate written description
requirement . . . serves „to ensure that the inventor had possession, as of the
filing date of the application relied on, of the specific subject matter later
claimed by him; how the specification accomplishes this is not material.‟”
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Application 11/890,627

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In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996) (citation omitted). The
amount of description needed to meet the requirement can vary with the
scientific and technologic knowledge already in existence. Capon v. Eshhar,
418 F.3d 1349, 1357 (Fed. Cir. 2005). “It is not necessary that every
permutation within a generally operable invention be effective in order for
an inventor to obtain a generic claim, provided that the effect is sufficiently
demonstrated to characterize a generic invention.” Id. at 1359.
Regardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor
cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing
compounds from non-infringing compounds, or infringing
methods from non-infringing methods.

Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir.
2004).
While we agree with Appellants that the claims describe the structure
of the protein portion of the claimed isolated molecule, it is evident that such
structure may also describe proteins that are beyond the scope of the
invention. Indeed, the functional language of the claim, i.e., wherein the
modified
10
Fn3 domain binds to a target compound that is not bound by the
corresponding human
10
Fn3 domain having the sequence of SEQ ID NO:33,
limits the genus of the claimed invention. However, what is missing from
the Specification is a description of what these “target compounds” are and
which proteins comprising modified
10
Fn3 domains will bind them.
Appellants assert that “the specification provides a representative number of
working examples” by providing “the amino acid sequences for 108
10
Fn3
domains having modified BC, DE and FG loops that were isolated based on
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Application 11/890,627

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their ability to bind to the exemplary target TNFα.” (App. Br. 10.) These
working examples, however, only represent a single species of the genus
claimed, that is, those proteins having modified
10
Fn3 domains that bind to
TNFα.
Thus, as in Rochester, we find here that a person of ordinary skill in
the art would not understand from reading the Specification what isolated
molecules having (a) an amino acid sequence at least 50% identical to SEQ
ID NO:33 and (b) at least one loop with a modified amino acid sequence
relative to the sequence of the corresponding loop of a human
10
Fn3 domain
having the sequence ID NO:33, wherein the loop is selected from the group
recited in claim 1 would (c) bind to a target compound that is not bound by
the corresponding human having the sequence of SEQ ID NO: 33. See Univ.
of Rochester, 358 F.3d at 925. Nor would the artisan know how to find
such a compound except through trial and error. (Id.) Apart from those
molecules comprising a protein wherein its
10
Fn3 domain binds to TNFα, the
Specification fails to establish that the inventors had either possession or
knowledge of compounds satisfying the limitations of the claimed invention.
Accordingly, we affirm the written description rejection of
independent claim 1. Claims 2 and 5-12 have not been argued separately
and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

ENABLEMENT
The Examiner‟s position is that the claims contain subject matter
which was not described in the Specification in such a way as to enable one
skilled in the art to which it pertains, or with which it is most nearly
connected, to make and/or use the invention. (Ans. 6.) According to the
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Examiner, “[t]he lack of specificity as to what amino acid(s) are to be
substituted and where in the modified FN3 10
th
domain, critical or essential
to the practice of the invention, but not included in the claim(s) is not
enabled by the disclosure.” (Id. at 7) (emphasis omitted) (citing In re
Mayhew, 527 F.2d 1229 (CCPA 1976)).
Appellants contend that the Examiner “merely asserts that the
specification fails to enable the pending claims without providing any
rationale or explanation for the basis of this assertion.” (App. Br. 15.) In
particular, regarding the Examiner‟s citation to Mayhew, Appellants assert
that the Examiner “has failed to point to any disclosure in the specification
which teaches that a particular element not included in the claims is critical
to the practice of the claimed invention.” (Id. at 17.)
We agree with Appellants that the Examiner has not set forth a
reasonable basis to question the enablement of the claimed invention. See In
re Wright, 999 F.2d 1557, 1562 (Fed. Cir. 1993). In particular, the
Examiner has not established that the Specification did not teach those
skilled in the art how to make and use the full scope of the claimed invention
without undue experimentation. Genentech, Inc. v. Novo Nordisk, A/S, 108
F.3d 1361, 1365 (Fed. Cir. 1997).
Accordingly, we reverse the enablement rejection.

INDEFINITENESS
The Examiner‟s position is that the claims are “incomplete for
omitting essential structural cooperative relationships of elements, such
omission amounting to a gap between the necessary structural connections.”
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(Ans. 7 (emphasis omitted).) According to the Examiner, “the primary
missing „element‟ is function.” (Id. at 12)(citing Mayhew.)
Appellants contend that the Specification does not omit any
information necessary for understanding the “structural cooperative
relationships” of the claimed conjugates. (App. Br. 18.) In particular,
Appellants assert the claims define the conjugates as having a protein
portion comprising the structural and functional characteristics recited as
claim elements (a), (b) and (c). (Id.)
We agree with Appellants that the claims clearly point out and
distinctly claim the subject matter of the invention in terms of structure and
function such that those skilled in the art would understand what is claimed.
See Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576
(Fed. Cir. 1986) (citations omitted).
Accordingly, we reverse the indefiniteness rejection.
SUMMARY
We affirm the written description rejection;
we reverse the enablement rejection;
we reverse the indefiniteness rejection.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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