Ex Parte Coutre

Patent Trial and Appeal Board

Mar 22, 2013

10560669 (P.T.A.B. Mar. 22, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte STEVEN COUTRE
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Appeal 2011-004719
Application 10/560,669
Technology Center 1600
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Before RICHARD M. LEBOVITZ, MELANIE L. McCOLLUM, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant has requested rehearing of the Decision entered January 2,
2013. The Decision affirmed the obviousness rejections of claims 20-33 and
35-39, but reversed the obviousness rejection of claim 34 (Decision 11). We
deny the request.
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STATEMENT OF THE CASE
The Examiner rejected claim 20 as obvious over Longley1 in view of
Goekjian2; rejected claims 30 and 34 as obvious over Longley in view of
Goekjian and Ma3; rejected claims 21-28, 31-33, and 35-38 as obvious over
Longley in view of Goekjian, Ma, and Caravatti4; and rejected claims 29 and
39 as obvious over Longley in view of Goekjian, Ma, Caravatti, and
Matthews5 (Ans. 5-12). In reversing the rejection of claim 34, we concluded
“that the Examiner has not adequately explained why Appellant’s evidence
[of an alleged unexpected benefit] is not persuasive” (Decision 9-10).
However, we concluded that “Appellant has not adequately explained why
this evidence is commensurate with the scope of claims 20 and 30” (id. at
10). In requesting rehearing, Appellant argues “that evidence of
nonobviousness [that] is commensurate in scope with all of claims of the
present invention, including claims 20 and 30, has been presented and is of
record” (Reh’g Req. 2).

1 B. J. Longley et al., New Approaches to Therapy for Mastocytosis: A Case
for Treatment with kit Kinase Inhibitors, 14 HEMATOLOGY/ONCOLOGY
CLINICS OF N. AM. 689-695 (2000).
2 Peter G. Goekjian & Michael R. Jirousek, Protein kinase C inhibitors as
novel anticancer drugs, 10 EXPERT OPIN. INVESTIG. DRUGS 2117-2140
(2001).
3 Yongsheng Ma et al., The c-KIT mutation causing human mastocytosis is
resistant to STI571 and other KIT kinase inhibitors; kinases with enzymatic
site mutations show different inhibitor sensitivity profiles than wild-type
kinases and those with regulatory-type mutations, 99 BLOOD 1741-1744
(2002).
4 Caravatti et al., US 5,093,330, Mar. 3, 1992.
5 Matthews et al., US 2002/0061873 A1, May 23, 2002.
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ISSUE
Has Appellant shown that we misapprehended or overlooked any
point in rendering the Decision?
PRINCIPLES OF LAW
“The evidence presented to rebut a prima facie case of obviousness
must be commensurate in scope with the claims to which it pertains.” In re
Dill, 604 F.2d 1356, 1361 (CCPA 1979). “Commensurate in scope” means
that the evidence provides a reasonable basis for concluding that the untested
embodiments encompassed by the claims would behave in the same manner
as the tested embodiment(s). See In re Lindner, 457 F.2d 506, 508 (CCPA
1972) (“we have to agree with the Patent Office that there is no ‘adequate
basis for reasonably concluding that the great number and variety of
compositions included by the claims would behave in the same manner as
the [single] tested composition’”) (bracketed material in original).
ANALYSIS
We understand that the Specification states that the “term
‘mastocytosis’ . . . relates to systemic mastocytosis” (Spec. 38).6 We also
understand that Appellant has provided evidence indicating that the KIT
point mutation D816V is detectable in a majority of patients with systemic

6 With regard to claim 30, which, unlike claim 20, does not specifically
recite that the patient is “human,” we note that the definition of
“mastocytosis” in Appellant’s Specification includes “canine mast cell
neoplasms” (Spec. 38).
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mastocytosis (Gleixner7 752 & Gotlib8 2865). However, Appellant has not
provided adequate basis to reasonably conclude that the claimed compound
would provide unexpectedly superior results in the treatment of systemic
mastocytosis in those patients that do not have this mutation. We recognize
that the claimed compound may be effective in the treatment of systemic
mastocytosis in patients that do not have this mutation (Gleixner 755).
However, Appellant has not provided sufficient evidence that this is
unexpected. In fact, Gleixner states that “all 3 TK inhibitors counteracted
SCF-dependent growth of doxycycline-exposed (KIT-expressing)
Ton.Kit.wt cells with IC50 values of 3 to 30 nM for PKC412, 30 to 300 nM
for AMN107, and 3 to 30 nM for imatinib” (id.), suggesting that the claimed
compound, PKC412, is not unexpectedly superior to imatinib in patients
having wild type KIT.
With regard to claim 30, we also understand that Appellant has
provided evidence indicating that the “D816V KIT mutation of [systemic
mastocytosis] has been shown to be resistant to the tyrosine kinase inhibitor
imatinib mesylate (Gleevec) both in vitro and in vivo” (Gotlib 2866).
However, given the presumption of claim differentiation, we assume that
there are mastocytosis patients with a resistance to imatinib that do not have
the mutation of claim 34. In addition, Appellant has not provided adequate

7 Karoline V. Gleixner et al., PKC412 inhibits in vitro growth of neoplastic
human mast cells expressing the D816V-mutated variant of KIT:
comparison with AMN107, imatinib, and cladribine (2CdA) and evaluation
of cooperative drug effects, 107 BLOOD 752-759 (2006).
8 Jason Gotlib et al., Activity of the tyrosine kinase inhibitor PKC412 in a
patient with mast cell leukemia with the D816V KIT mutation, 106 BLOOD
2865-2870 (2005).
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basis to reasonably conclude that the claimed compound would provide
unexpectedly superior results in the treatment of those patients.
CONCLUSION
Appellant has not shown that we misapprehended or overlooked any
point in rendering the Decision. We therefore deny the request for
rehearing.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

REHEARING DENIED

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