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 .
Priority
This application is a U.S. national phase of International Application No. PCT/US2022/033122, filed on 06/10/2022, which claims domestic benefit to US provision application 63/321,598, filed 03/18/2022; 63/289,081, filed 12/13/2021; and 63/209,929, filed 06/11/2021.
Claim Status
The Amendment, filed on 08/04/2026, is acknowledged in which:
Claims 2-5, 7-12, and 14-100 are canceled.
Claims 1 and 6 are currently amended.
Claim 13 is previously presented.
Claims 1, 6, and 13 are pending in the instant application and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement filed 08/04/2026 has been considered by the examiner.
Withdrawn Objections and Rejections
In the office action dated 05/04/2026,
The specification was objected to for tradenames or marks used in commerce without appropriate symbols. Applicant’s submission of an amendment of the specification with appropriate corrections has overcome the objection and the objection are withdrawn.
Claims 1 and 6 were objected to for a typographical error. Applicant’s amendments to the claims to add “or” between limitations has overcome the objections and the objections are withdrawn.
All previous rejections regarding claims 37, 51, and 52-54 are rendered moot in view of claim cancellations.
Claims 1 and 6 were rejected under 35 USC 102(a)(1) as being anticipated by Supernus as evidenced by AMA; and Claim 13 was rejected under 35 USC 103 as being unpatentable over Supernus as evidenced by AMA and in further view of Koenig and Huang. Applicant’s arguments regarding the priority date of evidentiary reference AMA are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 11,104,701 B2 and Sheppard and Coleman as discussed below.
Claims 1 and 6 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 22 of U.S. Patent No. 11,104,701. Applicant’s amendments to the claims has overcome the rejections, and the rejections (as previously stated) are withdrawn. However, upon further consideration, a modified ground(s) of rejection is made in view of Sheppard and Coleman as discussed below.
The following grounds of objections and/or rejections are either maintained or necessitated by applicant’s amendment to the claims. Please note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
New Claim Rejections - 35 USC § 103
Claims 1, 6, and 13 are rejected under 35 U.S.C. 103 as being obvious over US 11,104,701 B2 (herein US’701; filed 12/20/2018, with priority to provisional application 61/779,735, filed 03/13/2013) and Sheppard and Coleman (Alzheimer’s Disease: Drug Discovery. Exon Publications; 2020:1-21).
The applied reference has a common applicant and joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claims 1 and 6, US’701 teaches a method for treating a CNS-related condition in a subject using a compound selected from a group that includes compound “3-5” (shown below), which is identical to instant compound 1, wherein the CNS-related condition includes Alzheimer’s disease (AD) (Claims 1 and 22). Martinez Botella defines treatment to be within scope of reducing the severity of the disease, disorder or condition, or to slowing disease progression (column 22, ¶ 4).
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While US’701 teaches a method for AD treatment, it does not explicitly teach improving executive function, working memory, or learning in a subject having mild cognitive impairment (MCI) associated with AD as instantly claimed.
Sheppard and Coleman teach AD is an irreversible neurodegenerative disorder involving a decline in memory and executive function, and that these features are considered primary signs of the disease (pg 2, lines 2-3 and 20-21). Sheppard and Coleman further teach that people with AD have severely impaired episodic, sematic and working memory, functions (pg 2, lines 22-23) within scope of “learning” as defined in the instant specification to include processes of the brain involved in the acquisition of skill, knowledge and information (¶ [0135]).
One of ordinary skill in the art would recognize that a method of reducing the severity of AD as taught by Martinez Botella would broadly encompass improving primary symptoms of the disease including executive function, working memory, and learning as taught by Sheppard and Coleman. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that the instantly claimed Compound 1 as taught by Martinez Botella for reducing the severity of AD would implicitly have a reasonable expectation of success in improving executive function, working memory, and learning in subjects having MCI associated with AD as these are primary symptoms and indicators of disease progression as taught by Sheppard and Coleman (See MPEP 2144.01).
Regarding claim 13, Martinez Botella and Sheppard and Coleman teach claim 1 as discussed above.
Martinez Botella further teaches that in treatment of long-term conditions that stretches over many months or years, oral dosing is preferred for patient convenience and tolerance (column 53, lines 37-40). Martinez Botella further teaches 1-5 oral doses per day at 0.01-20 mg/kg of the disclosed compounds (i.e. instant Compound 1) (column 53, lines 40-46).
The office maintains that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Moreover, a change in form, proportions, or degree "will not sustain a patent" (In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05 (II). Therefore, it would be prima facie obvious that routine optimization of a method as taught by Martinez Botella would lead a skilled artisan to the optimum or workable ranges for oral dosages of taught compound 3-5 (identical to instant Compound 1).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Response to Arguments – 35 USC 103
Applicant’s arguments with respect to claim(s) 1, 6, and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Modified 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.
US 11,104,701 B2
Claims 1 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 22 of U.S. Patent No. 11,104,701 (herein US’701) in view of Sheppard and Coleman (cited above).
Claim 1 of US’701 claims a method for treating a CNS-related condition in a subject using a compound selected from a group that includes compound “3-5” (shown below), which is identical to instant compound 1, wherein the CNS-related condition is selected from a group including a cognitive disorder including dementia or AD. Claim 22 of US’701 further claims the method of claim 1, wherein the CNS-related condition is AD. US’701 defines treatment to be drawn to reducing the severity of the disease, disorder or condition, or to slowing disease progression (e.g. the development of MCI or dementia).
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While US’701 teaches a method for AD treatment, it does not explicitly teach improving executive function, working memory, or learning in a subject having mild cognitive impairment (MCI) associated with AD as instantly claimed.
Sheppard and Coleman teach AD is an irreversible neurodegenerative disorder involving a decline in memory and executive function, and that these features are considered primary signs of the disease (pg 2, lines 2-3 and 20-21). Sheppard and Coleman further teach that people with AD have severely impaired episodic, sematic and working memory, functions (pg 2, lines 22-23) within scope of “learning” as defined in the instant specification to include processes of the brain involved in the acquisition of skill, knowledge and information (¶ [0135]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that the instantly claimed Compound 1 as taught by US’701 for reducing the severity of AD would implicitly have a reasonable expectation of success in improving executive function, working memory, and learning in subjects having MCI associated with AD as these are primary symptoms and indicators of disease progression as taught by Sheppard and Coleman (See MPEP 2144.01), and therefore the claims are patentably indistinct
Response to Arguments - NSDP
Applicant’s arguments, see Remarks (pg 9-10; Section 5), filed 08/04/2026, with respect to the rejection(s) of claim(s) 1 and 6 under non-statutory double patenting have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sheppard and Coleman as discussed above.
Conclusion
No claims are currently allowed.
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 HANNAH SUNSHINE whose telephone number is (571)270-7417. The examiner can normally be reached M-Th & Second Friday 8:30am-5pm EST.
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, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANNAH SUNSHINE/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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