Ex Parte Vale et al

Board of Patent Appeals and Interferences

Apr 15, 2008

11214371 (B.P.A.I. Apr. 15, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte WYLIE W. JR. VALE, KATHY A. LEWIS,
MARILYN H. PERRIN, KOICHI S. KUNITAKE,
JEAN E. RIVIER, and JOZSEF GULYAS
____________

Appeal 2007-4128
Application 11/214,371
Technology Center 1600
____________

Decided: April 14, 2008
____________

Before DEMETRA J. MILLS, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 98 and 99.2 We have jurisdiction under
35 U.S.C. § 6(b). The appealed claims read as follows:

1 This Appeal was heard on March 11, 2008.
Appeal 2007-4128
Application 11/214,371

98. A method of reducing glucagon production in an individual
comprising administering to the individual an effective amount of
corticotropin releasing factor receptor 2 (“CRF R2”) antagonist.

99. The method of claim 98, wherein the CRF-R2 antagonist is a
Urocortin III analog, the analog comprising a Urocortin III protein with an
N-terminal deletion selected from the group consisting of the first five amino
acids, the first six amino acids, the first seven amino acids and the first eight
amino acids.

We reverse, but enter a new ground of rejection.

DISCUSSION
Claim 98 stands rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
According to the Examiner, “the genus of ‘CRF R2 antagonist’ has
not been adequately described, since only one species, Urocortin III analog
is disclosed.” (Ans. 4.) The Examiner, while noting that Rühmann3
discloses other CRF-R2 antagonists, argues that Rühmann teaches that there
are structural and functional similarities between CRF R2 and CRF R1, and
that as nonpeptidic antagonists of CRF R1 are known, there could be other,
nonpeptidic antagonists to CRF R2 (id. at 5-6.)
The Examiner concludes:
Thus, as the CRF R1 and CRF R2 are similar in structure,
it can reasonably be concluded that there are other peptidic and
2 Claims 102, 103, 106, and 107 are also pending and stand objected to as
depending from a rejected base claim but are otherwise free of rejection.
3 Rühmann et al., “Structural requirements for peptidic antagonists of the
corticotropin-releasing factor receptor (CRFR): Development of CRFR2β-
selective antisauvagine-30,” Proc. Nat’l Acad. Sci., USA, Vol. 95, pp.
15264-269 (1998).
2
Appeal 2007-4128
Application 11/214,371

nonpeptidic antagonist[s] CRF R2 and the small subset of these
antagonist family of urocortin III cannot be considered to be
representative of the entire genus of CRF R2 antagonists, and
therefore cannot be considered to be representative of the entire
genus of CRF R2 antagonists, and therefore cannot be evidence
of the possession of the entire genus of CRF R2 antagonists.
Therefore, written description is not satisfied because one
skilled in the art cannot predict other potential CRF R2
antagonists.

(Id. at 6.)
Appellants argue that the Specification “discloses . . ., in effect,
thousands of CRF-R2 antagonists, including a wide assortment of peptides
as well as antibodies.” (App. Br. 4.) Appellants argue further, citing
Rühmann, that “CRG-R2 antagonists are an ‘art recognized’ class of
agents.” (Id. at 5.)
“The burden of showing that the claimed invention is not described in
the application rests on the PTO in the first instance.” In re Edwards,, 568
F.2d 1349, 1354 (CCPA 1978). A written description of an invention
involving a chemical genus, like a description of a chemical genus, “requires
a precise definition, such as by structure, formula, [or] chemical name,” of
the claimed subject matter sufficient to distinguish it from other materials.
Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). While “examples
explicitly covering the full scope of the claim language” is not typically
required, a sufficient number of representative species must be included “to
demonstrate that the [applicant] possessed the full scope of the invention.”
LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345
(Fed. Cir. 2005). This requirement applies not only to compositions of
3
Appeal 2007-4128
Application 11/214,371

matter, but to methods as well. University of Rochester v. G.D. Searle &
Co., 358 F.3d 916, 926 (Fed. Cir. 2004). However,
the determination of what is needed to support generic claims to
biological subject matter depends on a variety of factors, such
as the existing knowledge in the particular field, the extent and
content of the prior art, the maturity of the science or
technology, the predictability of the aspect at issue, and other
considerations appropriate to the subject matter.

Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
In the case before us, contrary to the finding of the Examiner, CRF-R2
antagonists, other than urocortin III analogs, are described by the
Specification, and also known in the prior art, as evidenced by Rühmann.
First, as noted by Appellants, the Specification teaches a large number of
urocortin III analogs that can act as CRF-R2 antagonists (Spec. 7-8; see also
claims 106 and 107). In addition, the Specification also teaches the use of
urocortin III antibodies as the CRF-R2 antagonist (Spec. 9; see also claim
108).
Moreover, Rühmann teaches the development of CRF-R2 antagonists,
wherein truncated and conformationally constrained analogs of CRF based
on the amino acid sequences of h/rCRF, ovine CRF, rat urocortin, and
sauvagine (Rühmann, p. 15264, second column). The reference also teaches
the production of a specific antagonist to CRF-R2 (id. at 15267, second
column).
Thus, given the disclosure of the CRF-R2 antagonists in the
Specification, as well as the recognition of CRF-R2 antagonists as a class of
compounds in the prior art, as evidenced by Rühmann, we find that the
preponderance of the evidence supports a finding that claim 98 is supported
4
Appeal 2007-4128
Application 11/214,371

by an adequate written description. Thus, the rejection of the Examiner is
reversed.

Claims 98 and 99 stand rejected on the ground of nonstatutory
obviousness-type double patenting as being unpatentable as being
unpatentable over claim 1 of Vale Jr..4 According to the Examiner:
Although the conflicting claims are not identical, they are not
patentably distinct from each other because instant claims 98
and 99 refer to a method of reducing glucagons production in a
patient by administering CRF R2 antagonist (claim 98) and
where the antagonist is urocortin protein (claim 99), where the
claim 1 of U.S. Patent No. 6,953,838 refers to a method of
treating a pathophysiological state by administering of urocortin
III protein.

(Ans. 6)
Appellants argue that “the claim[s] at issue in the application claims a
species of the genus from the patent,” asserting “a genus neither anticipates a
species, nor does it render a species prima facie obvious on its own.” (App.
Br. 10.) Thus, Appellants assert that the Examiner has not met the burden of
establishing a prima facie case of obviousness. As we agree, we are
compelled to reverse the rejection.

We make the following new grounds of rejection using our authority
under 37 C.F.R. § 41.50(b).
Claims 98 and 99 are rejected on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1 and
5 of Vale Jr.

4 Vale Jr., US Patent No. 6,953,838 B2, issued October 11, 2005.
5
Appeal 2007-4128
Application 11/214,371

Claim 1 of Vale Jr. is drawn to:
A method of treating a pathophysiological state, comprising the
step of administering a pharmaceutical composition comprising
a urocortin III protein and a pharmaceutically acceptable carrier
to an individual in need of such treatment, the urocortin III
protein having the amino acid sequence of SEQ ID NO:5 with
an N-terminal deletion selected from the group consisting of the
first five amino acids, the first six amino acids, the first seven
amino acids and the first 8 amino acids.

Claim 5 of Vale Jr. adds the limitation that the pathophysiological state may
be diabetes mellitus. In addition, the Specification teaches that glucagon “is
a major hyperglycemic factor known to exacerbate diabetic glucose control.”
(Spec. 56, ll. 13-16.)
Instant claim 98 is drawn to a method of reducing glucagon
production by administering a CRF-R2 antagonist, and instant claim 99
defines the CRF-R2 antagonist as Urocortin III protein with an N-terminal
deletion selected from the group consisting of the first five amino acids, the
first six amino acids, the first seven amino acids and the first eight amino
acids.
Therefore, the agent required by claims 1 and 5 of Vale Jr. is
encompassed by the CRF-R2 antagonist as required by instant claim 99. In
addition, claim 5 of Vale Jr. is drawn to use of the agent to treat diabetes
mellitus. As taught by the Specification, glucagon is a major hyperglycemic
factor known to exacerbate diabetic glucose control. (Spec. 56, ll. 13-16.)
Thus, claims 1 and 5 of Vale Jr. administer an agent that is a CRF-R2
antagonist as required by instant claims 98 and 99 to the same patient
population—that is—patients with diabetes mellitus. The ability of the CRF
R2 antagonist to reduce glucagon production would be an inherent property
6
Appeal 2007-4128
Application 11/214,371

of the compound, and is the mechanism by which the antagonist treats the
pathophysiological state of diabetes mellitus. Thus, instant claims 98 and 99
are not patentably distinct from claims 1 and 5 of Vale Jr.

CONCLUSION
In summary, we reverse the rejections on Appeal, but institute a new
ground of rejection.
TIME PERIOD FOR RESPONSE

This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner . . . .

7
Appeal 2007-4128
Application 11/214,371

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record . . . .
REVERSED; 37 C.F.R. § 41.50(b)

lp

FULBRIGHT & JAWORSKI, L.L.P.
600 CONGRESS AVENUE
SUITE 2400
AUSTIN TX 78701

8