DETAILED ACTION
Claims 1-26 were pending. Claims 1, 4, 6-8, have been amended; claims 12-26 have been canceled; and claims 27-30 are newly added per the Reply of 2/25/2026.
Claims 1-11 and 27-30 are pending and the subject of the Office Action below.
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
The instant application, filed 5/20/2022 Claims Priority from Provisional Applications 63191753, filed 5/21/2021, and Provisional Application 63196524 , filed 6/3/2021.
Claim Objections
Claim7 is objected to because of the following informalities: Applicant left “mg” off the first series of amounts. Appropriate correction is required.
Claim Rejections - 35 USC § 112
(NEW Rejection necessitated by Amendment)
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 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 has several sets of combinations which cannot be derived from claim 1. Claim 1 requires a choline compound and at least two active agents selected from: a cholinergic agonist; a cholinesterase inhibitor; and a carnitine. Claim 6 then has sets that repeat a choline compound.as an active agent. For example, “wherein the two active agents are selected from: the choline compound and the cholinergic agonist. This cannot be derived from claim 1 which limits the actives to “active agents selected from: a cholinergic agonist; a cholinesterase inhibitor; and a carnitine.” Therefore, there is insufficient antecedent basis for this limitation in the claim.
Claim 27 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 requires 3 active agents, based on claim 1 the 3 agents would have to be to “selected from: a cholinergic agonist; a cholinesterase inhibitor; and a carnitine.” Therefore, claim 27 cannot require a new list without antecedent basis from claim 1. For example, “the choline compound, the cholinesterase inhibitor and the cholinergic agonist,” is not supported as choline is not in the list of claim 1.
Claim 28 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 requires 3 active agents or 4 active agents, based on claim 1 the 3 agents would have to be to “selected from: a cholinergic agonist; a cholinesterase inhibitor; and a carnitine,” and four active agents cannot be derived from a list of 34. Therefore, claim 28 cannot require a new list without antecedent basis from claim 1.
Claim Rejections - 35 USC § 102
(NEW Rejection necessitated by Amendment)
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.
Claims 1-3, 5-11, and 27-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Genius Consciousness Supplement, Webpage (https://web.archive.org/web/20200404071108/https://thegeniusbrand.com/products/genius-consciousness) provided by the Way Back Machine for 4/4/2020.
Claims 1-3, 5-11, and 27-32 read on a composition of matter comprising a choline compound, a cholinesterase inhibitor, and a carnitine.
Genius Consciousness Supplement contains 150 mg of L-Alpha Glycerylphosphorylcholine (Alpha GPC) as a choline compound; Huperzine A, 50 mcg (1% of 5 mg); as a cholinergic agonist: 150 mg (50% of AlphaSize); and a carnitine: Acetyl-l-carnitine, 500 mg. as an orally dosed supplement.
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Claims 1-3, 5-11, and 27-32 are anticipated.
Claim Rejections - 35 USC § 102
(NEW Rejection necessitated by Amendment)
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.
Claims 1-11 and 27-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Driscoll US 9,271,953 issued March 1, 2016.
Claims 1-11 read on a composition of matter comprising a choline compound, a cholinesterase inhibitor, and a carnitine.
Driscoll teaching in claim 3, using a composition of matter, “the composition comprises:
a choline compound selected from at least one of choline at 100 mg to 1,000 mg, lecithin at 100 mg to 3 grams, or L-alpha glycerylphosphorylcholine at 30 mg to 2,400 mg; 75 mcg to 300 mcg of a cholinesterase inhibitor is huperzine A; and 50 mg to 600 mg of Acetyl-L-Carnitine.”
Instant claim 4, requires the composition of claim 1, wherein the cholinergic agonist is selected from cevimeline, carbamoylcholine, bethanechol, pilocarpine, varenicline, acetylcholine, arecoline, lobeline, GTS-21, or is provided as a nicotine patch.
Driscoll states, “Nicotine, e.g., 3 to 21 mg nicotine patch can be used alone, for short periods of time (if the patients do not exhibit skin irritation, skin welting and/or dermatographia) to test the viability of the post-ganglionic nicotinic acetylcholinergic receptors and/or effector organs, or for short-term treatment, especially useful in ileocecal valve dysfunction and gastroparesis.”
Claims 1-11 and 27-32 are anticipated.
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 1-2 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/738,665 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to compositions of the same components. Given the reference (‘665) is a method of using the composition, it is a species that anticipates the instant composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-24 of copending Application No. 17/749,887 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to compositions of the same components. Given the reference (‘887) is a method of using the composition, it is a species that anticipates the instant composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims 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 MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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