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 .
DETAILED ACTION
Claims 1-18 are pending in the application. Claims 1-18 are rejected.
Priority
This application is a continuation of International Application No. PCT/EP2022/054586, filed February 24th, 2022, which claims priority under 35 U.S.C. 119(a-d) to EP21159452.8, filed February 26th, 2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on August 26th, 2025.
Claim Objections
The term “cyanyalkoxy” in the definition of R5 in claim 1 should be changed to “cyanoalkoxy”.
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 1-7 and 15-18 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 1-7 and 15-18 are rejected as indefinite based on the option for R5 to be “N-alkyl” in claim 1. The moiety appears to contain a dangling valence and it is unclear if the option should be considered -NH-alkyl or where the nitrogen can have an additional substituent besides alkyl. It is suggested that Applicant replace “N-alkyl” with “-NH-alkyl” since the specification does not appear to suggest the possibility of additional nitrogen substitution on the noted option. Dependent claims 1-7 and 15-18 are rejected as indefinite since they do not obviate the issue.
Claim 15 is rejected as indefinite since it recites that variables are “as defined above” but where there are multiple different definitions for these variables “above” claim 15, i.e. in claim 2-12. It is suggested that Applicant replace “above” with “in claim 1”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitations “conditions resulting from direct damage to myelin sheaths,” “demyelinating disorders,” “CNS disorders associated with myelin loss,” and “inflammation in the CNS” and the claim also recites (following each category) a list of diseases included with the generic terms, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15, 21 and 22 of copending Application No. 19/059,580 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite compounds embraced by the instant claims. For instance, claim 10 of the copending case recites 6-chloro-7-fluoro-N-[4-methoxy-5-(1,1,2,2-tetradeuterio-2-fluoro-ethoxy)pyrimidin-2-yl]-1H-indole-3-sulfonamide, which has the following structure:
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The compound is embraced by formula I where R1 is alkoxy, R2 is haloalkoxy, R3 is H (or where the definitions of R1 and R3 are switched), X2 is NH, X1 is CR5, R4 is halo and R5 is halo. The compound is embraced by instant claims 1-12, 13 (as the second compound recited in the claim) and 14 (as the first compound recited in the claim). Regarding the claims of the copending case reciting deuterium containing compounds, the instant claims do not exclude the presence of deuterium and since deuterium occurs at natural abundance, the broadest reasonable interpretation of the instant claims is considered to include isotopes. Regarding instant claims 15-18, claims 12, 15, 17 and 18 of the copending case recite analogous methods or compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art
The closest prior art appears to be U.S. Patent PGPub No. 2023/0373935 A1 by McCartney et al., which discloses compounds of the following general formula (abstract):
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The prior art discloses the following species on page 795 that appears to be the closest structurally to the instant claims (support can be found on page 912 of the prior art’s provisional application No. 63/089,000):
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The closest prior art structure has several differences relative to the instant claims including that the instant claims do not provide for R2 to be hydrogen and do not provide for R1/R3 to be aryl or aryloxy. The prior art provides insufficient guidance or motivation to choose the compound above and make at least three structural changes to arrive at a compound instantly claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626