Ex Parte OdenikeDownload PDFBoard of Patent Appeals and InterferencesMar 17, 201111281666 (B.P.A.I. Mar. 17, 2011) Copy Citation 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 3 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] Appeal 2010-007068 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 Appeal 2010-007068 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 6 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 Copy with citationCopy as parenthetical citation