Notice of Pre-AIA or 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 .
Response to Amendment and Argument.
Applicant’s election without traverse of Group I (claims 1-9 and 11-20) in the reply filed on 9/3/25 is acknowledged.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/3/25. The restriction election is made final.
Species Election: Applicant elected Cligosiban.
The examination has withdrawn claims 5-6 as the elected species does not fall within the Markush group a nucleic acid. Claims 5-6 remain withdrawn.
Status of Claims
Claims 1-4, 7-9, 11-18 and 21-22 are under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 2/12/26 and 9/25/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-8, 11-18, 22 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Weinstein et al. (WO 2018/022668).
With regards to instant claim 1, Weinstein teaches treating malignant mesothelioma (see pg 7, lines 7-10) administering a compound that targets an oxytocin receptor (see pg 7, lines 30) wherein the compound is an oxytocin inhibitor (see pg 78, i., L368,899, as required by instant claim 2-3) and retosiban (see same as required by instant claim 4) and that the treatment comprises an anticancer agent cisplatin (as required by instant claims 7-8, 11-20 see Fig. 3). With regards to instant claim 22, it is anticipated that that the listed compounds in claim 3 will have the characteristics as an antagonist.
Applicant argues that Weinstein fails to teach “wherein the compound inhibits or knock down the oxyticin receptor”
In response applicant should note that It is noted that the recitation of “wherein the compound inhibits or knock down the oxyticin receptor” must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instance case since Weinstein teaches treating malignant mesothelioma (see pg 7, lines 7-10) administering a compound that targets an oxytocin receptor (see pg 7, lines 30) wherein the compound is an oxytocin inhibitor (see pg 78, i., L368,899, as required by instant claim 2-3) and retosiban (see same as required by instant claim 4) and that the treatment comprises an anticancer agent cisplatin (as required by instant claims 7-8, 11-20 see Fig. 3), therefore it meets the claim limitation. Under such circumstances, where the disease seems to be identical and the treatment method identical, then the burden shifts to applicant to provide evidence that the prior art would neither anticipate nor render obvious the claimed invention. Note the case law of In re Best 195 USPQ 430, 433 (CCPA 1977). Additionally, as stated in the MPEP 2112.01"Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658
(Fed. Cir. 1990), “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not."
With respect to the argument that Weinstein recites a plethora of cancers is found unpersuasive because a reference that clearly names the claimed species anticipates the claim no matter how many other species are named.
Also a 35 USC 102 cannot be overcome by an affidavit as the effect will necessarily occur upon the administering the claimed drug..
Maintained 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-4, 7-8, 11-18 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein et al. (WO 2018/022668) in view of Ryan (US 2011/0160159). Weinstein is applied here as above.
However Weinstein fails to teach that the anticancer agent comprises cisplatin and pemetrexed as required by instant claim 9.
Ryan teaches treating mesothelioma (see 0681) administering cisplatin in combination with pemetrexed (see 0047).
Therefore one of ordinary skill in the art would have expanded the teachings of Weinstein to include Ryan for the treatment of malignant mesothelioma with a reasonable expectation of success because one would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Applicant argument is addressed above.
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The affidavit under 37 CFR 1.132 filed on 1/5/26 is insufficient to overcome the rejection of claims 1-4, 7-8, 11-18 and 22 based upon the rejection as set forth in the last Office action because: a 35 USC 102 cannot be overcome by an affidavit as the effect will necessarily occur upon the administering the claimed drug.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 2/25/26