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 .
DETAILED ACTION
Claims 1, 3-5, 7, 8, 10, 12, 13, 15, 17, 20, 23, 26-36, 39, 41, 42, 44-47 and 50 are pending in the application. Claims 1, 3-5, 7, 8, 10, 12, 15, 17, 20, 23, 26-28, 30, 31, 34, 35, 36 and 39 are rejected. Claims 13, 29, 32, 33, 41, 42, 44-47 and 50 are withdrawn from further consideration.
Response to Amendment / Argument
Objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims. Therefore, arguments pertaining to these objections and rejections will not be addressed.
On page 32 of the response filed October 29th, 2025, Applicant requests that the double patenting rejection be held in abeyance. Until such time as the instant claims are allowable or the rejection is otherwise overcome, the provisional rejection below is maintained.
Election/Restrictions
In view of Applicant’s amendments, the search and examination of the instant claims has been extended according to MPEP 803.02 to include the scopes of instant claims 3-5, 7, 8, 10, 15, 28, 31 and 34, which are free of the prior art, and further expanded to include the prior art cited below under 35 USC 102.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-5, 7, 8, 10, 12, 15, 17, 20, 23, 26-28, 30, 31, 35, 36 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected as indefinite since claim 1 provides a definition for the variable R5 where the variable R5 is not otherwise required by the claimed structure. Dependent claims 3-5, 7, 8, 10, 12, 15, 17, 20, 23, 26-28, 30, 31, 35, 36 and 39 are rejected as indefinite for the same reason since they do not resolve the issue.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 12, 17, 20, 23, 26, 27, 30, 35, 36 and 39 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2012/068234 A2 by Bacon et al.
The prior art teaches the following compound on page 616:
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The compound is embraced by formula (I) where L is a absent, A is monocyclic 5-membered heterocyclyl substituted by four instances of R1 that are C1 alkyl, Z1-Z6 are each C(R6) where R6 is hydrogen, n and m are each 1, X is C(R7a)(R7b) where R7a and R7b are hydrogen, Y is O, and B is heteroaryl substituted by R1 which is heterocyclyl substituted by one instance of R8 that is -C(O)ORD where RD is C4 alkyl. The compound is embraced by instant claims 1, 12, 17, 20, 23 (second option), 26, 27 and 30.
Regarding instant claim 35, the prior art teaches subsequent reaction of the compound in ethanol, which is a pharmaceutically acceptable excipient. Regarding instant claims 36 and 39, the prior art is silent on the properties of the cited compounds; however, MPEP 2112.01(II) states: ‘"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. Id.’
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-5, 7, 8, 10, 12, 15, 17, 20, 23, 26-28, 30, 31, 34, 35, 36 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 13, 20, 22, 28, 35, 43, 47, 49, 52, 57, 60, 64, 68-71, 75, 77, 80, 82, 87, 88, 94 and 95 of copending Application No. 18/688,081 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite compounds that anticipate the instant claims. For instance, claim 70 of the copending case recites compounds found in instant claim 34 where Applicant’s instant elected species is disclosed in Table 1 of the copending case (page 90). Since examination has been limited to claims embracing the elected species, the compound of the copending is embraced by each of claims 1, 3-5, 7, 8, 10, 12, 15, 17, 20, 23, 26-28, 30, 31, 35, 36 and 39. Regarding instant claims 34, claim 71 of the copending case recites analogous compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626