Ex Parte Hann

Board of Patent Appeals and Interferences

Jun 30, 2009

10997763 (B.P.A.I. Jun. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEPHEN R. HANN
__________

Appeal 2009-002068
Application 10/997,763
Technology Center 1600
__________

Decided:1 June 30, 2009
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and STEPHEN
WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
substance screening assay. The Patent Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2009-002068
Application 10/997,763

STATEMENT OF THE CASE
Claims 1-15, which are all the pending claims, are on appeal. Claim 1
is representative and reads as follows:
1. A method of screening a candidate substance comprising:

(a) providing an isolated c-Myc polypeptide;
(b) mixing said c-Myc polypeptide with a candidate substance;
(c) mixing the mixture of step (b) with p19Arf polypeptide; and
(d) measuring the binding of p19Arf and c-Myc polypeptides,

wherein a decrease in p19Arf polypeptide binding to c-Myc
polypeptide, as compared to the binding of p19Arf polypeptide to c-
Myc polypeptide in the absence of said candidate substance, identifies
said candidate substance as a p19Arf mimic.

The Examiner rejected the claims under 35 U.S.C. § 103(a) as obvious
over the combined teachings of Sherr,2 Matsumura3 and Eischen.4

OBVIOUSNESS
The Issue
The Examiner’s position is that Sherr disclosed the Arf polypeptide,
screening assays for mimics of Arf, and that Myc and Arf interact. (Ans. 4.)
The Examiner concluded “it would have been obvious to combine the ‘drug
screening’ method disclosed in Sherr et al. to identify candidate substances

2 U.S. Patent No. 6,586,203 B1, issued to Sherr et al., Jul. 1, 2003.
3 Itaru Matsumura et al., E2F1 and c-Myc in Cell Growth and Death, 2
CELL CYCLE 333-38 (2003).
4 Christine M. Eischen et al., Disruption of the ARF-Mdm2-p53 tumor
suppressor pathway in Myc-induced lymphomagenesis, 13 GENES &
DEVELOPMENT 2658-69 (1999).
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Application 10/997,763

that mimic p19Arf by measuring the interaction of p19Arf and c-Myc in the
presence/absence of candidate substances based on the teachings of
Matsumura et al. and Eischen et al.” (Id. at 5.)
Appellant disputes the Examiner’s finding that p19Arf and c-Myc
were known to “physically interact.” (App. Br. 4.) Appellant contends that
Sherr’s Fig. 25, on which the Examiner relied, “merely shows that MYC has
an effect on ARF-p19, not that there is any binding between these two
molecules.” (Id.) “If anything, Sherr suggests that MYC interacts with the
p19-ARF promoter, not p19-ARF itself.” (Id.) Further, according to
Appellant, neither Matsumura nor Eischen provides “the teaching clearly
missing from Sherr, namely, that p19-ARF and Myc physically interact.”
(Id.)
The issue with respect to this rejection is whether the evidence
supports the Examiner’s finding that Sherr taught interaction between
p19Arf polypeptide and c-Myc polypeptide.

Findings of Fact
Sherr
1. Sherr disclosed that “ARF is activated via MYC and E2F-1 and acts in
turn to trigger p53-dependent cell cycle arrest or apoptosis.” (Col. 16,
ll. 22-24.)
2. Sherr explained that “[a]ctivation of ARF by MYC and E2F-1 need
not be direct, although both transcription factors have been
demonstrated to increase ARF mRNA levels.” (Col. 16, ll. 28-32.)
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Application 10/997,763

3. Sherr further disclosed that “[o]verexpression of MYC induces the
accumulation of p19ARF, at least in part by increasing ARF gene
expression.” (Col. 81, ll. 49-51.)
4. Sherr stated that ARF protein binds mdm and p53 proteins. (Col. 68,
ll. 32-38.)

Matsumura
4. According Matsumura’s diagram on page 335, Myc has an effect on
ARF via transcriptional regulation.
5. Matsumura disclosed that c-Myc and E2F1 “induce p14/p19ARF that
inhibits MDM2-mediated degradation of p53.” (p. 335, right col.)
6. Matsumura further described the induction process: “[i]n this process,
c-Myc and E2F1 upregulate the protein expression level of DAP
kinase, a calcium-regulated serine/threonine kinase, which in turn
induces the expression of p14/p19ARF.” (p. 335, right col.)

Eischen
7. Eischen disclosed that “Myc rapidly induces p19ARF expression, but
without evidence that Myc transactivates the ARF promoter, its action
may be indirect.” (p. 2659, Fig. 1 legend.)
8. Eischen further disclosed that “p19ARF binds directly with Mdm2 to
neutralize its function.” (p. 2659, Fig. 1 legend.)

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Appeal 2009-002068
Application 10/997,763

Principles of Law
Obviousness is a question of law based on fact findings. The scope
and content of the prior art are determined; differences between the prior art
and the claims at issue are ascertained; the level of skill in the art is resolved;
and objective record evidence of nonobviousness is considered. Graham v.
John Deere Co., 383 U.S. 1, 17-18 (1966). A rejection for obviousness must
include “articulated reasoning with some rational underpinning to support
the legal conclusion.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007), quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).

Analysis
The claimed method of screening candidate substances includes a step
“measuring the binding of p19Arf and c-Myc polypeptides.” When a
candidate substance is being tested, a decrease from the standard amount of
binding between the p19Arf and c-Myc polypeptides will indicate that the
candidate substance is a p19Arf mimic.
In order for the claimed screening method to have been obvious to a
person having ordinary skill in the art at the time Appellant invented the
method, that person must have known that p19Arf polypeptide binds to c-
Myc polypeptide. The Examiner found the binding information disclosed in
Sherr. Appellant disputes the finding. We agree with Appellant.
The Examiner cited Sherr’s Fig. 25 as evidence that p19Arf and c-
Myc polypeptides interact, but Sherr’s explanation of Fig. 25 does not
support the Examiner’s inference that Sherr meant the polypeptides interact
by binding to each other. Instead, Sherr explained that Myc is a
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Application 10/997,763

transcription factor that induces Arf gene expression. (FF2, FF3.) In a
separate section on protein interactions, Sherr disclosed that p19Arf
polypeptide binds to the mdm and p53 proteins, but did not disclose that
p19Arf protein binds to the Myc protein. (FF4.) Matsumura and Eischen
repeated Sherr’s description of Myc as a transcription factor, but neither
disclosed that Myc polypeptide binds to p19Arf polypeptide. (FF4, FF7.)
Eischen repeated Sherr’s disclosure that p19Arf protein binds to Mdm
protein. (FF8.)
The portions of Sherr’s disclosure that the Examiner cited do not
support a finding that Sherr taught binding between p19Arf polypeptide and
c-Myc polypeptide. We agree with Appellant that the claimed method could
not have been obvious without the knowledge that p19Arf polypeptide and
c-Myc polypeptide bound to each other. (Reply Br. 3.) We conclude that
the evidence developed on this record under the first Graham factor is
insufficient to support a conclusion of obviousness.

CONCLUSIONS OF LAW
Appellant established that the evidence of record does not support the
Examiner’s finding that Sherr taught a binding interaction between p19Arf
polypeptide and c-Myc polypeptide.

SUMMARY
We reverse the rejection of claims 1-15 under 35 U.S.C. § 103(a) as
obvious over the combined teachings of Sherr, Matsumura and Eischen.

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Appeal 2009-002068
Application 10/997,763

REVERSED

cdc

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