DETAILED ACTION
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
The amendment filed 2026 January 6 containing newly amended claims 1-6, 41, 48-50, 55,. 56, 79, 82, 83, 88, 89, 102, and 103 is acknowledged. In applicants’ arguments, the following is stated:
Arguments
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Claims
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The statements are not reflected in the examined claims because it appears the second and third rows are underlined instead of struck through. The 35 U.S.C. 102 and non-statutory double rejections are maintained for this reason. Please see MPEP 714 (II)( C ) for the proper way to amend the claims.
The objections against claim 2-6 are overcome because the extraneous language is no longer present. The objection to claim 101 is overcome because claim 101 is cancelled. The 35 U.S.C. 112(b) rejections are overcome for the following reasons: formula I-A is recited in the preamble of claim 1; the proviso has antecedent basis; variables Z1-Z4 are C(H) in claim 41; and in claim 55, R3 can be present one to three times.
Claims 83, 88, and 89 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2025 May 16.
Claim Rejections - 35 USC § 112
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 1-6, 41, 48-50, 55. 56, 79, and 103 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. Variables na and nb are not defined in amended claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 2, and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PEPIN (US 5342835, issued 30 August 1994). Pepin describes compound 239 [column 56, lines 35-45; column 29, line 6, table (VI)]. In compound 239, the following examined definitions apply: variables Z1-Z3 are each CH; X1 is 4-oxo-piperidine; na and nb are each two; R2 is 3,4-dimethoxy-phenyl; and X2 is C(O)-morpholinyl.
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Claim(s) 1, 55, and 79 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by YANG (WO 2004106296, published 2004 December 9). Wang describes example 58 [column 29, line 6, table (VI)]. In example 58, the following examined definitions apply: variable Z1 is N; Z2 is N; Z3 is CH; X1 is N(Et)-CH2CH3; R1 Is Me; R2 is 2,4-dimethoxy-pyridyl; and X2 is C(O)-1,2,3,4-tetrahydroisoquinoline. Pharmaceutical compositions are described (claims 13-16, page 81).
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Claim(s) 1, 2, 55, and 79 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MARTINBOROUGH (WO 2006050476, published 2006 May 11). Martinborough describes the following compounds: 236; 252; 282; 304 and 306; 318; 343; and 351 (page 68; page 69; page 72; page 74; page 75; page 77; and page 78). In these compounds, the following examined definitions apply: variable Z1 is N; Z2 is N; Z3 is CH; X1 is selected from the group consisting of NH-meta-CF3-benzyl, NH-benzyl; NH-CH2-cyclohexane, NH-meta--Cl-benzyl, and N(Me)-Et; R1 Is Me; R2 is selected from the group consisting of ortho-F-phenyl or meta-Me-phenyl; and X2 is selected from the group consisting of C(O)-[morpholine, 1-Me-5-Et-piperidine, or 4-Me-piperidine]. Pharmaceutical compositions are described (page 81, paragraph [00194] to page 91, paragraph [00218]).
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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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 41, 48, 49, 55, and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13 , 75, 103, 122, and 123 of copending Application No. 18/645159 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because example 5 of 18/645159 is encompassed by the specified claims of the examined for the following reasons: X1 is NH-C(O)-cyclopropyl; Z1-Z3 are each H; X2 is a 2,6-dimethyltetrahydro-2H-thiopyran-4-carbonyl-1,1-dioxide group, in which each instance of R3 is Me, Y1 is N, and Y2 is SO2; and R2 is pyrrolidine.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1-6, 41, 48-50, 55. 56, 79, and 103 are not allowed.
Claim 102 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 following is a statement of reasons for the indication of allowable subject matter: YANG (WO 2004106296, published 2004 December 9) does not describe a compound in which variable X1 is C(O)NH-cyclopropyl.
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 NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699