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 .
Amendment after Non final office action filed on February 19, 2026 is acknowledged.
Claims 17-20 have been cancelled.
Claims 1-16 are pending in this application.
Applicant elected with traverse of Group 1 (claims 1-4) and elected the species of an immune boosting agent as the additional gent, a capsule as the dose form, and cognitive function as the symptom or disorder to be treated in the reply filed on June 16, 2025. The traversal was not found persuasive and the restriction requirement was deemed to be proper and was made FINAL in the previous office action. Claims 5-16 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-4 are examined on the merits in this office action.
This application contains claims 5-16, drawn to an invention nonelected with traverse in the paper of 6/16/2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Withdrawn Objections and Rejections
Objection to claim 19 as being substantial duplicate is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejections of claims 1-4 and 19-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claim 20 on the basis that it contains an improper Markush grouping of alternatives, is hereby withdrawn in view of Applicant cancelling claim 20.
Rejection of claims 1-4 and 19-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 1-4 and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by Underwood reference (WO 2009/114597, filed with IDS), is hereby withdrawn in view of Applicant’s amendment to the claims.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
New Rejection
35 U.S.C. 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.
Claims 1-4 is/are rejected under 35 U.S.C. 103 as being obvious over Underwood reference (WO 2009/114597, filed with IDS) in view of Pop et al (US 2021/0032210) and Boutry et al (WO 2020/094555).
The applied reference has a common Inventor and Applicant 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).
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.
Underwood reference teaches a composition comprising (a0 an effective amount of apoaequorin in combination with acceptable carriers for administration to a subject by a variety of routes…directed to nutraceutical composition including effective amounts of apoaequorin in combination with an acceptable carrier (see paragraphs [0008]-[0009]). Underwood reference teaches nutraceutical composition include, in addition to apoaequorin, at least one other component recognized as providing nutraceutical benefit such as, an immune boosting agent, anti-inflammatory agent…anti-viral agents…in a unit dosage form selected from a tablet, a capsule, a solution, a suspension, a syrup, a beverage, an oral or ophthalmic formulation or injection (see paragraph [0009]). Underwood reference further teaches the use of apoaequorin for treating a symptom or disorder associated with calcium imbalance in a subject…exemplary symptoms or disorders treated by such compositions include those associated with sleep, energy, mood, pain, or memory (see paragraph [0012]). Underwood reference teaches that the apoaequorin is formulated with at least one acceptable carrier at a dosage of approximately 10 mg/dose, a dose preferably in capsule form, with recommended dosage for a subject approximately 10 mg/day (i.e., one capsule per day) (see paragraph [0031]). Underwood reference teaches that anti-inflammatory herbal supplements and anti-inflammatory compounds derived from plants or herbs may also be used as anti-inflammatory agents in the composition. These include bromolain, a proteolytic enzyme found in pineapple; teas and extracts of stinging nettle; turmeric, extracts of turmeric, or curcumin, a yellow pigment isolated from turmeric (see paragraph [0054]).
With respect to the limitation “treating a mental symptom or disorder associated with calcium imbalance” in instant claims 1-4, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art..
Similarly, with respect to the limitation in the preamble of claim 1, “A composition for treating a mental symptom or disorder associated with a calcium imbalance”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Additionally, instant claims do not define the patient population. Thus, anybody being administered a composition comprising apoaequorin, curcumin and an acceptable carrier would have the inherent property of treating a mental symptom or disorder associated with calcium imbalance recited in claims 1-4.
Since the Underwood reference teaches ALL of the active components of instant claims, the reference anticipates instant claims 1-4.
The difference between the Underwood reference and the instant claims is that the reference does not teach the amount of curcumin.
However, Pop et al teach that “Curcumin has also been shown to have beneficial effect on the heart and to support and protect cognitive processes in the brain” (see paragraph [0008], for example).
Boutry et al further teach a composition comprising curcumin and omega-3 fatty acid, wherein the curcumin may be present in amount of about 0.01 mg to about 2.0 g per serving, preferably from about 0.1 mg to about 2.0 g per serving, even more preferably from about 10.0 mg to about 1.0 g per serving (see paragraph [0002], for example). Boutry et al teach a composition in a unit dosage form comprising an amount of a combination of curcumin and an omega-3 fatty acid effective for at least one of…(iii) improving or maintaining cognitive function, (iv) enhancing mental performance…(see claim 29); a method of enhancing at least one of mental performance or muscle performance, the method comprising orally administering an effective amount of curcumin and an omega-3 fatty acid (see claim 24); …wherein the combination is administering an amount providing about 0.01 mg to about 2.0 gram of the curcumin per day (see claim 3).
Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Underwood reference, Pop et al and Boutry et al, since all references teach compositions for treating a mental symptom, e.g., cognitive processes in the brain. One of ordinary skill in the art would be motivated to combine and optimize with a reasonable expectation of success, since all of the references teach the activity of the each component in treating mental symptoms, mental disorders and so on, since Pop et al teach that “Curcumin has also been shown to have beneficial effect on the heart and to support and protect cognitive processes in the brain” and Boutry et al teach that the curcumin may be present in amount of about 0.01 mg to about 2.0 g per serving. The MPEP states that “Generally, 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated to optimize the amount of curcumin in the composition with a reasonable expectation of success, since from 0.01 mg to about 2.0 g per serving is used in a composition for improving or maintaining cognitive function and/or enhancing mental performance. Therefore, the combined art is prima facie obvious over instant claims 1-4.
Art of Interest
Pond reference (US 2023/0346873, cited in the previous office action) teaches the following:
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(see claims 1, 3, 6 and 17). Pond reference is a CIP of application No. 17/567751, filed on Jan. 3, 2022 (issued as US Patent No. 11752188). US Patent No. 11752188 does not disclose the compound apoaequorin.
CONCLUSION
No claim is 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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
5/13/2026
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