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 .
This is a Final Office Action.
Election/Restrictions
Applicant's election without traverse of Group II in the reply filed on October 2, 2025 is acknowledged. Group II, drawn to compounds of formula III, thieno[2,3-d][1,3]thiazoles, embraced by claims 59, 60, 62, 63, 65, 67, 68, 71, 72, 74, 75, 79, 80, 82, 85, 87, 90 and 93-96 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant indicates claims 98-100, 103, 105, 108-110, and 120 are amended to be drawn to compounds of Formula (III); said claims and dependent claims 106, 111, 114, and 121 also read on this election of Group (II).
Applicant elects the following species on page 109 of the specification, 2-
(7-fluoro-2-methyl-2H-indazol-5-yl)-5-(piperidin-4-yl)thieno[2,3-d]thiazole:
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178
570
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, and indicated claims 59, 60, 62, 63, 65, 71, 72, 74, 79, 80, 82, 85, 87, 90, 93, 94, 96, 98-100, 103, 105, 106, 108-111, 114, 120, and 121 read on said species. Claims 67 and 68 also read upon the elected species. However, claims 105, 106, 108-111, 114, 120 and 121, drawn to methods of intended use and are found in Groups IV, V, VI and VIII of the restriction requirement, and are withdrawn.
The elected species was searched and not found. Thus, the search was expanded to compounds of formula III, wherein 1) L1 and L2 are bonds; and 2) A and B are either indazole and/or piperidine rings.
Claims 75 and 95 are rejoined based on the search results.
Claims 1, 2, 4, 6, 9-11, 13-15, 17-19, 21, 23, 24, 28, 30-32, 35-37, 39, 42, 44, 45, 50, 51, 54, 56, 58-60, 62, 63, 65, 67, 68, 71, 72, 74, 75, 79, 80, 82, 85, 87, 90, 93-100, 103, 105, 106, 108-111, 114, 120 and 121 are pending. Claims 59, 60, 62, 63, 65, 67, 68, 71, 72, 74, 75, 79, 80, 82, 85, 87, 90, 93-96, 98-100 and 103 are under examination.
Claims 1, 2, 4, 6, 9-11, 13-15, 17-19, 21, 23, 24, 28, 30-32, 35-37, 39, 42, 44, 45, 50, 51, 54, 56, 58, 97 105, 106, 108-111, 114, 120, and 121 are withdrawn based on the lack of unity.
Specification
The objection to the disclosure because of the compliance for the sequence listing is withdrawn based on the amendments and statements received by the Office.
The substitute specification filed January 22, 2026 has been entered because it does conform to 37 CFR 1.125(b) and (c).
Claim Objections
The objection to claim 67 because of R7 should be replaced with R6, is withdrawn based on the amendments.
Claim Rejections - 35 USC § 112
The rejection of claim 1 (should have been claim 59) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the “arylene and heteroarylene” in the wherein clause in the definition of L1 and L2, is withdrawn based on the amendments.
The rejection of claims 59, 60, 62, 63, 65, 67, 68, 71, 72, 74, 79, 80, 82, 85, 87, 90, 93, 94, 96, 98-100 and 103 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term “absent” is in the definition of L1 and L2, is withdrawn.
The rejection of claim 98 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the improper reference to the specification, is withdrawn based on the amendments.
The rejection of claim 90 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the limitation "C6-C12-arylene" in the definition of L1 and L2, is withdrawn based on the amendments.
The rejection of claim 103 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase "for example", is withdrawn based on the amendments.
The rejection of claims 59, 60, 62, 63, 65, 67, 68, 71, 72, 74, 79, 80, 82, 85, 87, 90, 93, 94, 96, 98-100 and 103 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn based on the amendments.
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.
Claim 100 is 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 pre-AIA the applicant regards as the invention.
In claim 100, the phrase, “alters the target nucleic acid” and “stabilizes a target nucleic acid” is vague. How is it altered or stabilized? How is it measured?
Applicant states, “A person of ordinary skill in the art familiar with making and using small molecule splicing modulators would understand how to assess whether a compound is capable of altering and/or stabilizing a target nucleic acid based on their personal knowledge, or with a quick search of the available scientific literature.”
This is not persuasive. There are many ways a nucleic acid can be altered or stabilized and the specification does not provide sufficient guidance as to the metes and bounds of the claim. Therefore, the rejection is maintained.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 95 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The phenyl ring defined for L2 is no longer embraced by claim 59. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 98 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. There are species that are not embraced by claim 59, e.g. 124 and 125. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 59, 60, 62, 79, 80, 90, 93, 94 and 96, 100 and 103 under 35 U.S.C. 102(a)(1) as being anticipated by the supplier Ukrorgsyntez Ltd. (Chemical Abstracts Registry numbers entered on July 21, 2016 and downloaded on October 17, 2025), is withdrawn based on the amendments.
The reference teaches the following species:
The rejection of claim(s) 59, 60, 62, 63, 65, 71, 79, 80, 82, 85, 90, 93, 94, 96, 98, 99, 100 and 103 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kim et al. (US 20170121349), is withdrawn based on the amendments.
Claim Rejections - 35 USC § 103
The rejection of claims 59, 60, 62, 63, 65, 67, 68, 71, 72, 74, 79, 80, 82, 85, 87, 90, 93, 94, 96, 98, 99, 100 and 103 under AIA 35 U.S.C. 103(a) as being unpatentable over Kim et al. (US 20170121349), is withdrawn based on the amendments.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 59, 60, 62, 63, 65, 67, 68, 71, 72, 74, 75, 79, 80, 82, 85, 87, 90, 93-96, 98-100 and 103 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 59, 60 and 94 of copending Application No. 18726003. Although the conflicting claims are not identical, they are not patentably distinct from each other because compound 112 on page 109 is embraced by both claim sets. This is just one species in the ‘003 application that is embraced by both claim sets, there are more.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant requests “that the double patenting rejections be held in abeyance until an indication of allowable claim scope is acknowledged by the Office.”
Thus, the rejection is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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