DETAILED ACTION
Notice of AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-9 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bich Ho et al (J Immunother Cancer 8:e001367, 12 pages, published 11/13/2020) in view of Hanks et al (US 2021/0077582).
Claim 1 is drawn to a method of treating pancreatic cancer (more specifically, pancreatic ductal adenocarcinoma (claim 2)) comprising the step of:
administering to a subject suffering from pancreatic cancer an effective amount of dapansutrile, or a pharmaceutically acceptable solvate thereof;
wherein, as recited by claims 7-8, the method further comprises administering gemcitabine to the subject.
Bich Ho et al – recognizing that “[p]ancreatic ductal adenocarcinoma (PDAC) is among the most dreadful of malignancies with an extremely poor diagnosis” and, “[t]hus, novel effective treatments for advanced patients with PDAC should be developed to improve their prognosis” (Page 1, Column 2) – teach that “gemcitabine hydrochloride (GEM), which is one of the most standard chemotherapeutic drug treatments, in combination with anti-programmed cell death 1 (anti-PD-1) antibody (Ab) treatment... induced a prominent anticancer immune response” and “prolonged survival in the murine model of PDAC liver metastasis” (Page 1, Column 2 to Page 2, Column 1).
As such, Bich Ho et al teach a method of pancreatic ductal adenocarcinoma comprising administering anti-PD-1 antibody along with gemcitabine. However, Bich Ho et al do not teach administration of dapansutrile.
Yet, Hanks et al teach “a method of increasing the efficacy of anti-PD-1... antibody immunotherapy comprising... administering to the subject a therapeutically effective amount of an NLRP3 inhibitor together with an... anti-PD-1 antibody... such that the cancer is treated in the subject” (Paragraph 0013), wherein the cancer is “any cancer... including, but not limited to... pancreatic cancer” (Paragraph 0042) and the NLRP3 inhibitor is dapansutrile (Page 61, Compound 66). And, as further taught by Hanks et al, “[i]n another embodiment, the method further comprises administering another anti-cancer therapy [which]... may include... chemotherapy” (Paragraph 0050).
Accordingly, in view of Hanks et al, it would have been prima facie obvious to further administer dapansutrile in the method of Bich Ho et al (comprising the administration of anti-PD-1 antibody and gemcitabine) for the treatment of pancreatic cancer. It would have been obvious to do so in an effort to further increase “the efficacy of the anti-PD-1... antibody immunotherapy” administered according to the method of Bich Ho et al, with a reasonable expectation of success.
As such, claims 1-2 and 7-8 are rejected as prima facie obvious.
Claims 3-4 are drawn to the method of claim 1, wherein dapansutrile is administered by systemic administration (claim 3), more specifically by oral administration (claim 4).
As taught by Hanks et al, “[p]harmaceutical compositions may take a form suitable for virtually any mode of administration, including, for example... oral” (Paragraph 0058).
As such, claims 3-4 are also rejected as prima facie obvious.
Claim 5 is drawn to the method of claim 1, wherein the method reduces tumor volume or tumor weight.
As indicated in Hoffer v. Microsoft Corp., 405 F.3d 1326 (Fed. Cir. 2005), a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003)).
As such, claim 5 is also rejected as prima facie obvious.
Claim 6 is drawn to the method of claim 1, wherein the patient is not administered with cytokine induced killer.
Neither Bich Ho et al nor Hanks et al teach administering cytokine induced killer.
As such, claim 6 is also rejected as prima facie obvious.
Claim 9 is drawn to the method of claim 8, wherein gemcitabine is administered intravenously.
Bich Ho et al teach administration of “50 mg/kg GEM (G0367; TCI, Tokyo, Japan) by tail vein injection” (Page 2, Column 1).
As such, claim 9 is also rejected as prima facie obvious.
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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