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 .
Status of the Application
Claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 and 44 are pending, of which claim 44 stands withdrawn.
Amendment necessitated new claim rejection as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1 is rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The subject matter of instant claim 1, is not properly described in the application as filed. In particular, there was no indication in original specification as filed that “Rc as halogen” and therefore raise doubt as to possession of the claimed invention at the time of filing.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
(I) Claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 14, 19, 23-30, 32-33, 39, 40, 48, 49, 53, 54, 56-58 of co-pending Application No. 18/018,245. Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘245 claims “A process for preparing a solid form of Compound 1:
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or a pharmaceutically acceptable salt thereof… to yield the solid form of Compound 1 or a pharmaceutically acceptable salt thereof” and A process for preparing a solid form of Compound 1:
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or a pharmaceutically acceptable salt thereof… to yield the solid form of Compound 2 or a pharmaceutically acceptable salt thereof”, in which the compound of Appl ‘245 read on claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(II) Claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 72, 74, 78, 80, 86 of copending Application No. 18036491. Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘491 claims “A method of identifying a patient with alpha-I antitrypsin deficiency (AATD) that has an increased likelihood of responding to treatment with an AAT modulator, wherein the method comprises measuring the concentration of circulating polymerized alpha-1 antitrypsin (AAT) in the patient (or wherein the patient has a Z mutation in the AAT protein and: i) is heterozygous for said Z mutation; or ii) is heterozygous for said Z mutation and has an additional AAT mutation associated with AATD; or wherein the AAT modulator is
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(compound 1))”, in which the compound and method of Appl ‘491 read on claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(III) Claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18463796. Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘796 claims “A compound of Formula I:
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… or The compound, tautomer, deuterated derivative, or pharmaceutically acceptable salt according to claim 2 wherein the compound of Formula Ia is selected from
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… and deuterated derivatives)” (claims 1-3), “A pharmaceutical composition comprising the compound, tautomer, deuterated derivative or pharmaceutically acceptable salt according to any one of claims 1 to 11 and a pharmaceutically acceptable carrier” (claim 12), and “A method of treating a patient suffering from alpha anti-trypsin deficiency (AATD), comprising administering a compound, tautomer, deuterated derivative or pharmaceutically acceptable salt according to any one of claims 1 to 4, or a pharmaceutical composition according to claim 5” (claim 15), in which the compound, composition, and method of Appl ‘796 read on claims 1-8, 11,14-18, 20, 22, 23, 26-35, 37, 39, 40 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s amendment and remarks, filed on 11/13/2025, have been fully considered but not found persuasive.
Applicant didn’t argue over ODP rejection and is maintained.
Rest of applicant’s argument is moot in view of new rejection as set forth above.
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.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623