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
Response to Amendment
1. Claims 1, 10-13, 17, 20-23, 29, 31 and 33 have been amended and claims 30 and 32 canceled as requested in the amendment filed on July 27, 2026. Following the amendment, claims 1, 10-23, 27-29, 31 and 33 are pending in the instant application.
2. Claims 1, 10-23, 27-29, 31 and 33 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on July 27, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
5. Claim(s) 33 stands rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 7,232,798, for reasons of record in section 8 of Paper mailed on February 27, 2025, section 11 of Paper mailed on September 17, 2025, and in section 16 of Paper mailed on March 25, 2026.
At pp. 8-11 of the Response, Applicant traverses the rejection on premises that Alzheimer’s disease, Alzheimer’s disease psychosis and psychosis associated with Alzheimer’s disease represent different pathologies, and therefore treatment of one is different from, not related to, and not obvious over the other(s). These arguments have been presented before and answered before. The Examiner maintains the same position. Briefly, all the recited pathologies have one thing in common—Alzheimer’s disease—and as such, treatment of Alzheimer’s disease psychosis and psychosis associated with Alzheimer’s disease encompass treatment of the population of patients first and foremost suffering from Alzheimer’s disease. The cited art fully teaches treatment of AD by administration of cPG. The symptoms of the disease are inseparable from the disease itself; thus, the cited art fully anticipates the instant claim, and the rejection is maintained.
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.
7. Claims 1, 10-23, 27-29, 31 and 33 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 7,232,798, and claims 31-76 of U.S. Patent No. 11,090,303 for reasons of record in sections 9 and 10 of Paper mailed on February 27, 2025, section 12 of Paper mailed on August 17, 2025, and section 17 of Paper mailed on March 25, 2026.
Applicant traverses the rejection at pp. 11-19 of the Response. In essence, Applicant argues that administration of the same compound to the same population of subjects to treat various symptoms of the same pathology is neither anticipatory nor obvious. While this has been fully considered, the Examiner disagrees. The claims of the ‘798 patent encompass a method of protecting neurons and glia otherwise destined to die as a result of a disease (such as Alzheimer’s disease, which is characterized by neuronal and glial death), and claims of the ‘303 encompass prevention of the symptoms of depression, all by following the same protocol of administering the same compound, by the same routes and using the same doses to the population of patients either suffering from AD or benefitting from the preventive measures. Thus, the issued claims fully anticipate the instant claims.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
August 6, 2026
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