Detailed Action
The present office action is in response to the amendments filed 05 Sep 2025.
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 .
Status
Claims 1, 4, 6, 8-13, 15-16, and 18-30 of the pending application have been examined on the merits. Claims 5, 7, 14, 31, and 33-35 remain withdrawn. Acknowledgement is made of the amendments filed 05 Sep 2025. Acknowledgement is made of the cancelation of claims 2-3, 17, and 32.
Priority
Applicant identifies the instant application, Serial #: 17/632,330 filed February 2, 2022, as a National Stage Entry of International Patent Application #: PCT/US2020/044797, filed August 3, 2020, which claims priority from U.S. Provisional Application #: 62/882,255, filed August 2, 2019.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05 Sep 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Arguments:
The anticipatory-type nonstatutory double patenting rejection of claims 1, 4, 6, 8-13, 15-16, and 18-30 over U.S. Application No. 17/632,334, hereinafter ‘334, has been rendered moot following amendments to ‘334. A new grounds of rejection for claims 1, 4, 6, 8-13, 15-16, and 18-30 under obviousness-type nonstatutory double patenting rejection has been made due to the reference application amendments.
Regarding the obviousness-type nonstatutory double-patenting rejection of claims 1, 4, 6, 8-13, 15-16, and 18-30 over Application No. 17/416,411, hereinafter ‘411, and Barillari et al. (Bioisosteres in Medicinal Chemistry, 2012, Ch. 2; provided in the office action mailed 13 Mar 2025), hereinafter Barillari, applicant's arguments filed 05 Sep 2025 have been fully considered but they are not persuasive.
Applicant argues on pgs. 18-19 of the remarks filed 05 Sep 2025 that Barillari’s general view that any phenyl and pyridine are interchangeable overlooks the choices of location of the pyridine’s nitrogen atom and the nitrogen position affects the ring’s electronics, dipole, and hydrogen-bonding in ways that cannot be foreseen. Applicant further argues that even if a person of ordinary skill in the art tried to substitute one of the phenyl rings with a pyridinyl ring based on the teaching of Barillari, the artisan would not be motivated to pick the correct phenyl ring having the nitrogen atom at the claimed position. Applicant argues that without hindsight and undue experimentation, the artisan would not have arrived at the presently claimed compounds based on the teachings of ‘411 and Barillari.
This is not considered persuasive because arguments do not take the place of evidence. See MPEP 2145(I).
In light of the discussion above, the rejection of claims 1, 4, 6, 8-13, 15-16, and 18-30 under obviousness-type nonstatutory double-patenting over ‘411 and Barillari is maintained for the reasons of record and restated below. Since the previous office action was mailed on 13 Mar 2025, ‘411 was issued a Notice of Allowance and is now U.S. Patent No. 12,459,932. The rejection is now directed to the patent and not the application and is no longer a provisional rejection.
Regarding the obviousness-type nonstatutory double-patenting rejection of claims 1, 4, 6, 8-13, 15-16, and 18-30 over Application No. 17/416,410, hereinafter ‘410, and Barillari, applicants arguments have been fully considered but are not persuasive.
Applicant argues on pgs. 19-20 of the remarks filed 05 Sep 2025 that Barillari’s general view that any phenyl and pyridine are interchangeable overlooks the choices of location of the pyridine’s nitrogen atom and the nitrogen position affects the ring’s electronics, dipole, and hydrogen-bonding in ways that cannot be foreseen. Applicant further argues that even if a person of ordinary skill in the art tried to substitute one of the phenyl rings with a pyridinyl ring based on the teaching of Barillari, the artisan would not be motivated to pick the correct phenyl ring having the nitrogen atom at the claimed position. Applicant argues that without hindsight and undue experimentation, the artisan would not have arrived at the presently claimed compounds based on the teachings of ‘411 and Barillari.
This is not considered persuasive because arguments do not take the place of evidence. See MPEP 2145(I).
In light of the discussion above, the rejection of claims 1, 4, 6, 8-13, 15-16, and 18-30 under obviousness-type nonstatutory double-patenting over ‘410 and Barillari is maintained for the reasons of record and restated below. Since the previous office action was mailed on 13 Mar 2025, ‘410 was issued a Notice of Allowance and is now U.S. Patent No. 12,441,736. The rejection is now directed to the patent and not the application and is no longer a provisional rejection.
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, 4, 6, 8-13, 15-16, and 18-30 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/632,334, hereinafter ‘334, further in view of Barillari. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 has the following generic formula which has overlap to the generic formula of instant claim 1.
Instant Formula (I)
Reference Formula (Ia)
PNG
media_image1.png
173
221
media_image1.png
Greyscale
PNG
media_image2.png
202
302
media_image2.png
Greyscale
However, in reference claim 1, there is an N instead of a C as in the instant generic formula (see circled position above).
Barillari teaches that the substitution of phenyl ring with pyridine is widely used to improve metabolic stability (pg. 19, final paragraph).
It would be obvious for a person having ordinary skill in the art to modify the reference generic formula (I) to create a phenyl ring in order to test the metabolic stability of the compounds covered by generic formula (I).
This is a provisional nonstatutory double patenting rejection. This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 6, 8-13, 15-16, and 18-30 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,459,932, hereinafter ‘932, in view of Barillari et al. (Bioisosteres in Medicinal Chemistry, 2012, Ch. 2), hereinafter Barillari.
Reference claim 1 has the following generic formula which has overlap to the generic formula of instant claim 1.
Instant Formula (I)
Reference Formula (I)
PNG
media_image3.png
190
245
media_image3.png
Greyscale
PNG
media_image4.png
104
181
media_image4.png
Greyscale
However, in reference claim 1, there is an N instead of a C as in the instant generic formula (see circled position above).
Barillari teaches that the substitution of phenyl ring with pyridine is widely used to improve metabolic stability (pg. 19, final paragraph).
It would be obvious for a person having ordinary skill in the art to modify the reference generic formula (I) to create a phenyl ring in order to test the metabolic stability of the compounds covered by generic formula (I).
Claims 1, 4, 6, 8-13, 15-16, and 18-30 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,441,736, hereinafter ‘736, in view of Barillari.
Reference claim 1 has the following generic formula which has overlap to the generic formula of instant claim 1:
Instant Formula (I)
Reference Formula (I)
PNG
media_image3.png
190
245
media_image3.png
Greyscale
PNG
media_image4.png
104
181
media_image4.png
Greyscale
However, in reference claim 1, there is an N where there is a C in the instant generic formula (see circled position above).
Barillari teaches that the substitution of phenyl ring with pyridine is widely used to improve metabolic stability (pg. 19, final paragraph).
It would be obvious for a person having ordinary skill in the art to modify the reference generic formula (I) to create a phenyl ring in order to test the metabolic stability of the compounds covered by generic formula (I).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625