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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/EP2022/066422, filed 06/15/2022, which claims the priority benefit of PRO Application No. 63/211,478, filed 06/16/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/12/2023, 08/13/2024, and 02/07/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Upon further consideration the restriction requirement mailed 2/26/26 is withdrawn and all claims are rejoined and examined herein. Claims 1-11 and 13-15 are pending and under consideration.
Status of the Application
Claims 1-11 and 13-15 are pending. Claim 12 has been cancelled without prejudice or disclaimer.
Claim Objections
Claim 1, page 5, lines 12-13 are objected to because of the following informalities: the limitation “–NC(O)R10-” as an option for W1 or W2, which appears to be a misspelling of -N(Rl0)C(O)- since the structure generated when the Markush group R10 is oxo would create an unstable 5 bonded carbon. Appropriate correction is required.
Claim 1, page 7, line 4 is objected to because of the following informalities: the Markush definitions of R11 contains the limitation of “C4-C7 alkycycloalkyl” which examiner believes applicant intends as --C4-C7 alkylcycloalkyl--. Appropriate correction is required.
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 1-9, 11 and 13-15 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.
Claims 1-9, 11 and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are:
Claim 1, page 5, proviso (i) which cites the limitation “not more than two of W1, W2, W3 and W4 are nil”. This renders the claim indefinite because the definitions of W1 and W2 are silent in regards to the limitation nil, and is therefore indefinite as to whether W1 and W2 were intended to include nil while this embodiment is being implied by proviso (i).
Claim 1, page 5, proviso (ii) which cites the limitation “not more than two of W1, W2, W3, and W4 are -O-, -S-, -S(O)-, -S(O2)-, -NR9, or -C(O)-“. This proviso fails to distinctly claim the invention because the definitions of W1 and W2 as written do not encompass the limitations of -S(O)- and -S(O2)-. It is therefore unclear whether W1 and W2 were intended to include the embodiments -S(O)- and -S(O2)- when the proviso is attempting to exclude them under certain conditions.
Claim 1, proviso (iii), which recites the limitation “if two of W1, W2, W3, and W4 are -O- and/or -S- then at least one carbon atom is present between them”. This renders the claim indefinite because the provisos at lines 12-13 exclude the possibility of W1 and W2 being -O- and/or -S- at the same time. Furthermore, the definition of WI and W2 do not allow for the option of a carbon atom in between WI and W2. Therefore, the scope of WI and W2 is unclear as the claim is currently written.
Claim 1, proviso (iv) recites the limitation “the ring formed by W1, W2, W3, and W4” in claim 1, page 6, lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
A ring structure containing W1, W2, W3, and W4 simultaneously does not exist in the Q subgroup.
Claims 2-9, 11 and 13-15 are rejected for containing the indefiniteness of claim 1 as explained above. These rejections may be overcome by amending the language of the claim limitations to clearly address the indefiniteness described above.
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, 6-7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, and 10 of U.S. Patent No. US 12,497,370 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosed compound of 2-methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-4-[(5R)-5-[3-bromo-2-fluoro-5-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-4H-isoxazol-3-yl] benzamide in reference claim 7 would anticipate and satisfies the structural limitations of instant claims 1-4, 6-7, 9, and 11 where A1 and R2 is CF3, A2 is O, R1, R3, R11, A4, A5, and A6 are H, R4 is Br, R5 is F, Q is
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, wherein (R6)q is CH3, X is
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wherein W is CH2C(O)NHCH2CF3.
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Claims 1-4, 6-7, 9, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, 9-10, 12-13, and 16-18 of copending Application No. 19/389,577 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosed compound of 2-methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-4-[(5R)-5-[3-bromo-2-fluoro-5-(trifluoromethyl) phenyl]-5-(trifluoromethyl)-4H-isoxazol-3-yl] benzamide in reference claim 16 would anticipate the structural limitations of instant claims 1-4, 6-7, 9, and 11 where A1 and R2 is CF3, A2 is O, R1, R3, R11, A4, A5, and A6 are H, R4 is Br, R5 is F, Q is
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, wherein (R6)q is CH3, X is
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115
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wherein W is CH2C(O)NHCH2CF3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 10 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.
Conclusion
Claims 1-9, 11 and 13-15 are rejected, claim 10 is objected to.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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