DETAILED ACTION
Claims 1-19 are currently pending in the instant application. Claims 1-7, 9, 10, 12, and 17-19 are rejected. Claims 8, 11, and 13-16 are withdrawn from consideration as being for non-elected subject matter. Claim 12 is objected
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 .
Election/Restrictions
Applicant’s election without traverse of group I and the species of compound 28, see example 6:
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in the reply filed on 15 May 2025 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species does not appear allowable (see the following non-statutory double patenting rejection and provisional non-statutory double patenting rejection). However, in order to expedite prosecution, the search and examination has now been extended to the compound:
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which is not allowable. Claims 1-7, 9, 10, 12, and 17-19 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compound. Claims 8, 11 and 13 of elected group I do not read on the elected embodiment and are therefore withdrawn.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 10 June 2026 have been fully considered and entered into the instant application.
In regards to the Provisional Nonstatutory Double patenting rejections over US Application No. 18/264,189 and US Application No. 18/689,680, Applicant requests withdraw of these rejections as US Application No. 18/264,189 and US Application no. 18/689,680 are later filed applications and there would not be an unwarranted extension of patent term in view of the claims of the copending applications. Firstly, it is noted that the method claims of the conflicting applications provide the elected species as in the instant claims. Conflicting claims to methods of use provide anticipation of claims to the product utilized. Additionally, as seen in MPEP 804 I.B. and 804 I.B.1.(b).(i)
B. Between Copending Applications—Provisional Rejections
An examiner may become aware of two or more copending applications which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee, or that claim an invention resulting from activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) and (3), that would raise an issue of double patenting if one of the applications became a patent. Where this issue can be addressed without violating the confidential status of applications (35 U.S.C. 122 ), the courts have sanctioned the practice of making applicant aware of the potential double patenting problem if one of the applications became a patent by permitting the examiner to make a provisional rejection on the ground of double patenting. In re Mott, 539 F.2d 1291, 190 USPQ 536 (CCPA 1976); In re Wetterau, 356 F.2d 556, 148 USPQ 499 (CCPA 1966). An application that was published under 35 U.S.C. 122(b) without redactions can be utilized as a double patenting reference without violating the confidential status required by 35 U.S.C. 122. An unpublished application, or an application that has been published as redacted, can be utilized as a double patenting reference without violating the confidential status required by 35 U.S.C. 122 when it has at least one common (joint) inventor, applicant, assignee, or owner, or is deemed commonly owned (35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) ) with the application under examination. See MPEP §§ 2136.01 and 2154.01(d) for information on provisional rejections based on prior art. The merits of such a provisional rejection can be addressed by both the applicant and the examiner without waiting for the first patent to issue.
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A provisional double patenting rejection should be made and maintained by the examiner until the rejection has been obviated or is no longer applicable except as noted below.
(i) Application under examination has the earlier patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
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As the provisional nonstatutory double patenting rejection over Application 18/689,680 is proper and is not the only rejections remaining, the rejection are maintained. US Application No. 18/264,189 is now US Patent No. 12,723,049, therefore a nonstatutory double patenting rejection is now proper.
Applicant’s amendment to claim 2 has overcome the 35 USC 112(d) rejection of claim 2.
Applicant’s amendment to claims 1 and 2 has overcome the 35 USC 102(a)(1) rejection of claim 2.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12 has the status identifier of (Previously Presented) but has an “_” in the second line between “is” and “selected”. Appropriate correction is required.
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, 3-7, 9, 10, 12, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 and 9-16 of U.S. Patent No. 12,723,049. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of inhibiting or ameliorating spinocerebellar ataxia type 3 with compounds of the formula (I) (conflicting claim 1), wherein R1 is thiophenyl (conflicting claims 3), wherein R2 is C1-3 alkyl, such as propyl, wherein the C1-6alkyl contains a chiral carbon in the (S) configuration (conflicting claims 6, 7 and 9), with conflicting claims 10 and 11 claiming methods utilizing the elected species:
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, and with conflicting claims 12 and 13 claiming methods utilizing salts of the elected species. Conflicting method of use claims anticipate the product utilized in the methods.
Claims 1, 3-7, 9, 10, 12, and 17-19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-7, and 9-17 of copending Application No. 18/689,680 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods for treating a neurodegenerative disease characterized by the accumulation of aberrant forms of the microtubule associated protein Tau (MAPT) with compounds of the formula (I) (conflicting claim 1), wherein R1 is thiophenyl (conflicting claims 3-5), wherein R2 is C1-3 alkyl, such as propyl, wherein the C1-6alkyl contains a chiral carbon in the (S) configuration (conflicting claims 6, 7 and 9), with conflicting claims 10 and 11 claiming methods utilizing the elected species:
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, and with conflicting claims 12 and 13 claiming methods utilizing salts of the elected species. Conflicting method of use claims anticipate the product utilized in the methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) s 1, 2, and 17 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2019/0345157.
Determining the scope and contents of the prior art.
US Pre-Grant Publication 2019/0345157 discloses compound of the formula II: page 21:
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wherein:
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and R2 can be hydrogen. Page 28 provides:
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. Pharmaceutical compositions are disclosed on page 36. Page 64 provides the compound 99:
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. Entry 99 on table 2 has in vitro anti-Wolbachia activity on page 141.
Ascertaining the differences between the prior art and the claims at issue
The difference between the prior art compound 99 and the instant claims is one of hydrogen versus methyl. For example, the compound
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is a compound of the instant application within formula (I):
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of instant claims 1 and 2 wherein R1 is aryl, specifically phenyl, substituted with one R1a substituent which is halo-C1-6alkyl; R3 is hydrogen; R4 is hydrogen; and R2 is C3-cycloalkyl.
Resolving the level of ordinary skill in the pertinent art and considering objective evidence present in the application indicating obviousness or nonobviousness
However, minus a showing of unobvious results, it would have been obvious to prepare compounds of applicant’s instantly claimed formula (I) of the formula:
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when faced with the prior art compound formula (II) and the compound 99 as the compound 99 differs only by a hydrogen versus a methyl. Additionally, R7 and R7’ of formula (II) of the prior art are preferred to be hydrogen or methyl. It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity.
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 REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 3 September 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Prosecution Insights