Ex Parte Odenike

Board of Patent Appeals and Interferences

Mar 17, 2011

11281666 (B.P.A.I. Mar. 17, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/281,666 11/17/2005 Olatoyosi Odenike 5666-00055 9672
26753 7590 03/17/2011
ANDRUS, SCEALES, STARKE & SAWALL, LLP
100 EAST WISCONSIN AVENUE, SUITE 1100
MILWAUKEE, WI 53202
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
03/17/2011 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte OLATOYOSI ODENIKE
__________

Appeal 2010-007068
Application 11/281,666
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL1

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2010-007068
Application 11/281,666

2
STATEMENT OF THE CASE
The following claim is representative and reads as follows:
1. A method for treating a patient with acute myeloid leukemia comprising
administering to the patient a histone deacetylase inhibitor in an amount
effective to reduce bone marrow blasts relative to pretreatment bone marrow
blasts, the patient having a chromosomal aberration correlated with
increased deacetylation of histones and the chromosomal aberration
disrupting AMLl function.

Cited References
The Examiner relies on the following prior art references:
Klisovic et al., Depsipeptide (FR 901228) promotes histone acetylation,
gene transcription, apoptosis and its activity is enhanced by DNA
methyltransferase inhibitors in AML1/ETO-positive leukemic cells, 17
Leukemia 350-358 (2003).

Bruner et al., A phase 1 study to determine minimally effective
pharmacologic dose of depsipeptide (FR901228) in selected hematologic
malignancies, 21 Proc Am Soc Clin Oncol (abstr 1059)(2002).

Öhler et al., Semi-solid Colony Growth in Acute Myeloid, 21
Leukemia and its Relation to Cytogenetic Risk Groups, 43 (9) Leukemia and
Lymphoma 1743-1747 (2002).

Grounds of Rejection
Claims 1-4, 6-13 and 15 are rejected under 35 U.S.C. § 103(a) for
obviousness over Klisovic in view of Bruner2 and Öhler.

2 Appellant refers to this reference as Byrd in the Appeal Brief and Reply
Brief.
Appeal 2010-007068
Application 11/281,666

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FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
4-7.

Discussion
ISSUE
The Examiner finds that “Bruner et. al. teach a method for treating
AML patients with the histone deacetylase (HDAC) inhibitor: depsipetide
(FK228 or FR901228) in Phase I clinical trials (see abstract). Bruner does
not explicitly teach the treatment of AML with Depsipeptide in the AML
subpopulation that has chromosomal aberrations like t(8;21) or (invl6).”
(Ans. 4.)
However, the Examiner finds that Klisovic teaches that “[a]lthough
the experiments of this study were conducted mostly in cell lines, taken
together our results suggests that depsipeptide has a significant activity in
AML1/ETO and other molecular subgroups of AML” (Klisovic, pg. 357, last
paragraph). Klisovic further teaches that the “t(8;21) (q22;q22) [mutations
are] found in approximately 7 to 10% of patients with AML” (Klisovic, p.
350, col. 1).
Appellant argues that Bruner “fails to teach treating AML patients
having ‘the chromosomal aberration disrupting AML1 function.’” (App. Br.
12; bold font omitted.) Appellant further argues that Bruner “fails to teach
‘reduc[ing] bone marrow blasts relative to pretreatment bone marrow
blasts.’” (App. Br. 14; bold font omitted.)
The issue is: Does the prior art teach “treating AML patients having
the ‘chromosomal aberration disrupting AML1 function’”, and ‘reduc[ing]
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Application 11/281,666

4
bone marrow blasts relative to pretreatment bone marrow blasts’ (App. Br.
pp. 12 & 14) , as claimed?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.

ANALYSIS
Appellant argues that Bruner “fails to teach treating AML patients
having ‘the chromosomal aberration disrupting AML1 function.’” (App. Br.
12; bold font omitted.) Appellant further argues that Bruner “fails to teach
reduc[ing] bone marrow blasts relative to pretreatment bone marrow
blasts.’” (App. Br. 14; bold font omitted.) We are not persuaded by
Appellant’s argument.
With respect to treating AML patients having the chromosomal
aberration disrupting AML1 function, Bruner teaches treating AML patients
generally with depsipeptide and Klisovic further teaches that the “t(8;21)
(q22;q22) [mutations are] found in approximately 7 to 10% of patients with
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Application 11/281,666

5
AML” and are associated with AML1 (Klisovic, pg. 350, col. 1.) Klisovic
teaches that “[a]lthough the experiments of their study were conducted
mostly in cell lines, taken together our results suggest that depsipeptide has a
significant activity in AML1/ETO and other molecular subgroups of AML”
(Klisovic, pg. 357, last paragraph). Klisovic hypothesized and confirmed
that depsipeptide restores gene transcription and cell differentiation in
AML1/ETO cells. (See Abstract.)
We find that the evidence before us supports a prima facie case of
obviousness. Appellant has not presented any evidence that one of ordinary
skill in the art would have had a reason to believe that the AML1 t(8;21)
form would not have been responsive to depsipeptide in view of the fact that
such a mutation was known to be found in approximately 7 to 10% of
patients with AML and Klisovic teaches treating AML1 t(8;21) patients and
cell lines with depsipeptide. (Klisovic abstract.)
With respect to the reducing bone marrow blasts relative to
pretreatment bone marrow blasts claim limitation, we find that the
Specification teaches that dosages of 1 to 1000 mg/day/m2 (See Spec. 5) of
depsipeptide are dosages sufficient to reduce bone marrow blasts. (See
Spec. 7.) Bruner suggests a dosage of 17 mg/m2 of depsipeptide to treat
AML. (Bruner Abstract.) Thus, the dosage suggested by Bruner, according
to the Specification, would have inherently been sufficient to reduce bone
marrow blasts in a patient with AML1. Appellant has presented no evidence
to the contrary. Moreover, Öhler teaches that in AML there is an “excess
production of blast cells” (Öhler, pg. 1743, right column) and corroborates
that a measure of successful treatment of AML is a reduction in the level of
bone marrow blasts. (Öhler, Fig. 2.)
Appeal 2010-007068
Application 11/281,666

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Thus, we find that the Examiner has established a prima facie case of
obviousness on the evidence before us, which has not been rebutted by
Appellant with sufficient argument or evidence.
CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection.

TIME PERIOD
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

alw

ANDRUS, SCEALES, STARKE & SAWALL, LLP
100 EAST WISCONSIN AVENUE, SUITE 1100
MILWAUKEE, WI 53202