DETAILED ACTION
Claims 1-9, 11, 13, and 16-24, submitted 19 February 2026, are pending in the application. Claims 16-24 are withdrawn. Claims 1-9, 11, and 13 are rejected.
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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-9, 11, and 13, as well as the elected species,
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, in the reply filed on 19 February 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 16-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 February 2026.
The Examiner did not find prior art on the elected species, therefore, the elected species is free of the art. However, in the search of the claimed species, prior art which reads on the genus and subsequent compounds of the claimed invention was found. As detailed in the following art rejection, the generic claim encompassing the elected species was not found patentable.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-8, 11,and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hallberg et al. (WO 02/096883).
Hallberg teaches a genus, shown below, which reads on the limitations taught by claim 1 of the instant application. Hallberg teaches a similar compound to that of the Applicant when X1 = -C(R1)-, wherein R1 = H; X2 = -N-; X3 = -C(R2)-,wherein R2 = H; X4 = -C(R3)-, wherein R3 = H; Y1, Y2, Y3, and Y4 = -CH- or -CF-; Z1 = -CH=CH-, -CH-, -O-, -N-, or -S-; Z2 = -CH-, -O-, -S-, or -N-, provided that Z1 and Z2 are not the same and when Z1 = -CH=CH-, then Z2 must = -CH-; R4 = -S(O)2N(H)C(O)R6, wherein R6 = C1-6 alkyl, C1-6 alkoxy, or C1-6 alkoxy-C1-6 alkyl; and wherein R5 = C1-6 alkyl, C1-6 alkoxy, or C1-6 alkoxy-C1-6 alkyl (pg. 4 and 5, lines 10-23 and 1-19, respectively).
Formula I taught by Hallberg
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(pg. 4, Lines 10-15)
The Examiner acknowledges the proviso found in the prior art reference which teaches when X1 = -C(R1)-, X3 = -C(R2)- and X4 = -C(R3)-, R1 = H. However, it would have been prima facie obvious for a person having ordinary skill in the art to substitute the hydrogen of R1 with a methyl (i.e., methylation) to arrive at the instantly claimed invention. It is also noted that several decisions recognize the structural obviousness of compounds differing from the prior art merely in the addition of a methyl group (i.e. to replace a hydrogen substituent): In re Grunwell, 203 USPQ 1055; In re Magerlein, 202 USPQ 473; In re Wood, 199 USPQ 137; and In re Lohr, 137 USPQ 548.
With respect to claim 2, Hallberg teaches wherein the Z equivalent atom, when R4 is -S(O)2N(H)C(O)R6, is a C1-6 alkoxy or a C1-6 alkyoxy-C-1-6 alkyl (pg. 5, Lines 9-15) which would make the Z equivalent moiety an oxygen atom reading, in part, on the limitation of claim 2 wherein Z represents -O-. Additionally, the C1-4 alkoxy taught by Hallberg reads on the limitation of instant 5 when R4 is a C1-6 alkyl.
With respect to claim 3, as mentioned above, Hallberg teaches the X--1 moiety being -C(R1)- wherein R1 = H (pg. 4, Lines 15-21). Hallberg does not teach wherein the R1 equivalent could be a methyl. However, it would have been prima facie obvious to a person having ordinary skill in the art to substitute the hydrogen of R1 with a methyl through the known process of methylation.
Regarding claim 4, Hallberg teaches wherein the X3 and X4 moieties are -C(R2)- and -C(R3)-, respectively wherein R2 and R3 both = H (pg. 4, Lines 15-20).
Regarding claim 6, Hallberg teaches wherein the R5 moiety is either a C1-4 alkyl (pg. 5, Line 12) which reads on the limitation wherein R5 is methyl, ethyl, n-propyl, n-butyl, or isobutyl.
Regarding claim 7, Hallberg teaches wherein Z1 = -CH=CH-, -CH-, -O-, -N-, or -S-; Z2 = -CH-, -O-, -S-, or -N-, provided that Z1 and Z2 are not the same and when Z1 = -CH=CH-, then Z2 must = -CH- (pg. 4-5, Lines 23 and Lines 1-8, respectively). Which reads on the claim limitation wherein X = CH and Y = CH=CH or X = N and Y = S.
With respect to claim 8, Hallberg teaches wherein R5, the R6 equivalent moiety, represents a C1-4 alkyl (pg. 5, Line 12) which reads on the limitations of the instant claim wherein R6 is n-propyl, n-butyl, or isobutyl.
Regarding claim 11, while Hallberg does not exemplify or explicitly teach the compounds of the instantly claimed invention, a person having ordinary skill in the art would have at least arrived the 4 compounds of the instantly claimed invention through the simple substitution of hydrogen for a methyl. For example, the following 4 compounds of the instant claim could be achieved through nothing more than the teachings of Hallberg and methylation of the R1 hydrogen. Compound names have been converted to structures to better convey the teachings of Hallberg.
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With respect to claim 13, Hallberg teaches a pharmaceutical formulation comprising a compound of the invention and a pharmaceutically acceptable adjuvant, diluent or carrier (pg. 29, Lines 24-26).
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/912,284 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because independent claim 1 of App. No. 17/912,284 is drawn to a genus that renders obvious the instantly rejected claim. Independent claim 1 of ‘284 claims a compound of Formula I, shown below along with limitations, which are patentably indistinct from the genus taught by the Applicant.
Genus taught by ‘284
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The aforementioned claim of ‘284 obviates instant claim 1 because the genus and limitations taught but ‘284 have overlap and can teach identical compounds.
Allowable Subject Matter
Claim 9 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 closest prior art is Hallberg, which teaches a similar genus and compound to that of the Applicant. However, Hallberg does not teach the R1 moiety, much less an R1 moiety substituted by one or more fluorine atoms and/or with OR7 which would lead to a similar compound as that of the Applicants.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner, Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622