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 371 of PCT/EP2022/056551, filed Mar. 14, 2022, and claims foreign priority to EP21162515.7 and EP21217278.7, filed Mar. 15, 2021, and Dec. 23, 2021, respectively, with the European Patent Office.
Information Disclosure Statement
The information disclosure statement (IDS) filed Sept. 14, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the information disclosure statement/ transmittal letter does not have a certification statement specifying (1) or (2) under 37 CFR 1.97(e). The transmittal letter has both statements under 37 CFR 1.97(e), but does not check the boxes next to either statements. It must specify only one of the statements because they are mutually exclusive. The IDS has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Status
Claims 1-8 and 10-11 are currently pending and subject to examination.
Claim Rejections – 35 USC § 112(b)
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 1-4, 6-8 and 10-11 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.
Claim 1 is directed towards a compound of formula I:
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and specifies that “R2 and R3 when present are independently selected from the group consisting of H, (C1-C6)alkyl and a group of formula J.” One of ordinary skill in the art cannot determine the metes and bounds of the claim because the phrase “when present” creates uncertainty about whether R2 and R3 are required structural elements. The chemical formula explicitly shows these substituents, suggesting that they must be present in the structure, but the phrase “when present” implies they might be optional or absent in some embodiments. This creates a conflict because if these substituents can be absent, what occupies those positions in the formula, particularly because H is already specified, and because if they are always present, why say “when present”? Therefore, one of ordinary skill in the art cannot determine with reasonable certainty which compounds fall within the scope of the claim.
Claims 2-4, 6-8 and 10-11 depend from claim 1 and do not resolve this ambiguity and are also indefinite.
Nonstatutory 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 1-8 and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-12 of copending Application No. 18/282,096 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compounds of formula I, compositions and combinations thereof and methods of treating a subject in need of treatment with compounds of formula I. The difference between claim 1 of the instant application and the copending application No. 18/282,096 is that claim 1 of the copending application lists one additional allowed group for optional substituents off the R1 ring in the compound of formula I. The dependent claims of both applications further limiting the compound of formula I are directed towards overlapping subgenera and similar species.
The species claimed by the reference application fall within the claimed formula I of claim 1 as well as the subgenera of claims 2-4. and therefore these claims are anticipated. The claimed species, while not identical, are obvious variants because the modifications necessary to arrive at the claimed compounds are suggested by the genera of the reference application.
For example, the instant application claims the compound: N-(3-methoxy-4-(3-methyl-6-(pyrazolo[1,5-a]pyrimidin-3-yl)-1H-pyrazolo[4,3-c]pyridin-1-yl)phenyl)methanesulfonamide (claim 5), which has the following structure:
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(drawn by examiner).
The reference application claims the largely similar compound: 4-methoxy-N-methyl-3-(3-methyl-6-(pyrazolo[1,5-a]pyrimidin-3-yl)-1H- pyrazolo[4,3-c]pyridin-1-yl)benzenesulfonamide (reference application, claim 6), which has the following structure:
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(drawn by examiner).
While these compounds differ in the K substituent off R1, one of ordinary skill in the art would have a reasonable expectation of success to substitute N(R6)S(O)2 for S(O)2N(R6) because claim 1 of the reference application teaches that L (part of K) can be N(R6)S(O)2 and S(O)2N(R6).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629