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 .
Claims 21 and 25 have undergone amendments. Thus, Claims 20-28, submitted on 20 August 2026 represent all claims currently under consideration.
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.
Response to Arguments
The objection to Claim 25 is withdrawn. Applicant has amended the claim to recite “wherein the method”.
The 35 U.S.C. § 112(b) rejection of Claims 25-28 is withdrawn. Applicant has amended the claims to replace “and/or” with “or”, obviating the indefiniteness.
The provisional statutory patenting rejection of Claims 20-28 over Claims 20-28 of co-pending application No. 18/948,926 (‘926) is withdrawn as applicant has cancelled co-pending Claims 20-28. However, the newly added claims 29-48 of the ‘926 necessitate a new provisional non-statutory double patenting rejection. The co-pending application claims the compound
PNG
media_image1.png
231
465
media_image1.png
Greyscale
, which differs from the claimed compound by the length of the alkyl chain
PNG
media_image2.png
73
87
media_image2.png
Greyscale
versus
PNG
media_image3.png
88
90
media_image3.png
Greyscale
in the examined application, and also claims the compound
PNG
media_image4.png
274
468
media_image4.png
Greyscale
, which has a single methyl group present in the same position, and thus there is an embodiment of the compounds of the co-pending application which embraces the compound claimed in the examined application, and thus, the genus of the co-pending application embraces the compound claimed (See provisional non-statutory double patenting rejection, below).
Double Patenting- NEW GROUNDS OF REJECTION NECESSITATED BY CO-PENDING APPLICATION AMENDMENT
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 20-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29 and 45 of copending Application No. 18/948,926 (Amended Claims of 24 July 2026) (‘926).
Claim 29 of ‘926 claims a compound of Formula (D):
PNG
media_image5.png
584
735
media_image5.png
Greyscale
or a pharmaceutically acceptable salt thereof, wherein:
PNG
media_image6.png
311
944
media_image6.png
Greyscale
PNG
media_image7.png
478
950
media_image7.png
Greyscale
. Claim 45 of ‘926 claims several specific compounds of Formula (D), including
PNG
media_image1.png
231
465
media_image1.png
Greyscale
and
PNG
media_image4.png
274
468
media_image4.png
Greyscale
.
Although the claims at issue are not identical, they are not patentably distinct from each other because the genus of ‘926 meets the limitations of the compound claimed in the examined application. The claimed compound differs from what is specifically disclosed in ‘926 by the length of the alkyl linker found in
PNG
media_image1.png
231
465
media_image1.png
Greyscale
. ‘926 discloses an embodiment where in this alkyl linker is a methylene group (
PNG
media_image4.png
274
468
media_image4.png
Greyscale
), and thus, the compound of the examined application meets the limitations of what is claimed. Moreover, the artisan would not expect the compound claimed in the examined application to have significantly different properties from the compound
PNG
media_image1.png
231
465
media_image1.png
Greyscale
due to the close chemical structure (See MPEP § 2144.09 I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 25-28 are 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 an examiner’s statement of reasons for allowance: There is no prior art which teaches, suggests, or provides motivation for a method of treating the claimed conditions using the compound of the examined application. The closest prior art is co-pending application No. 18/948,926 (Published as US 2025/0170955; Publication Date: 5 June 2025). As described above, the co-pending application discloses a genus of compounds which embraces the compound claimed in the examined application, as well as compounds which are obvious variations of the claimed compound. However, the co-pending application does not disclose methods of treatment comprising administering these compounds to a patient in need thereof.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 20-24 are rejected.
Claims 25-28 are 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.
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 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 PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights