DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 26 February 2026 in which claims 2, 11, 15 and 16 were canceled, claims 1, 3 and 12-14 were amended to change the scope and breadth of the claims, and claim 17 was newly added.
Claims 1, 3-10, 12-14 and 17 are pending in the current application. Claim 17 is withdrawn as being due to original presentation, see below. Claims 1, 3-10 and 12-14 are examined on the merits herein.
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
Newly submitted claim 17 is directed to an invention that lacks unity with the invention originally claimed for the following reasons: claim 17 is directed towards a method for activating autophagy, comprising administering the autophagy activator according to claim 1 to a target.
Unity of Invention
A group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature. The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art. For example, a corresponding technical feature is exemplified by a key defined by certain claimed structural characteristics which correspond to the claimed features of a lock to be used with the claimed key.
A process is "specially adapted" for the manufacture of a product if the claimed process inherently produces the claimed product with the technical relationship being present between the claimed process and the claimed product. The expression "specially adapted" does not imply that the product could not also be manufactured by a different process.
As set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), the international application shaft relate to one invention only or to a group of inventions. Moreover, as stated in PCT Rule 13.2, the requirement of unity of invention referred to in PCT Rule 13.1 shall be fulfilled where a group of inventions is claimed in one and the same international application only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression special technical features shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art, so linked, as to form a general inventive concept.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
The technical feature among all groups is “an autophagy activator comprising methyl hesperidin and an inositol derivative”. The inventions listed as Groups I - II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Kato et al. (JP2014114290, cited in previous Office Action) teaches methyl hesperidin of Formula (1) or (2), as a glycation reaction inhibitor, further comprising a moisturizer and an anti-inflammatory agent including inositol hexanicotinate. Aoki et al. (US Patent Application Publication No. 2007/0219158, cited in previous Office Action) teaches a skin preparation comprising an inositol derivative that when applied gives a moist and smooth feeling. While the combination of methyl hesperidin and inositol derivative is novel, the combination is not considered an inventive step, because each compound has been taught by the prior art as useful for the same purpose of providing a topical cosmetic composition with moisturizer. Accordingly, it would have been obvious to combine the two together in the same composition. As such, the shared technical feature does not make a contribution over the prior art with respect to an inventive step in view of Kato et al. and Aoki et al. Consequently, the product lacks a special technical feature as defined by PCT Rule 13.2 as it does not possess an inventive step over the teachings of the prior art.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Since applicant has received an action on the merits for the originally presented invention (i.e. an autophagy activator, which is a product), this invention has been constructively elected by original presentation for prosecution on the merits.
Accordingly, claim 17 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Terminal Disclaimer
The terminal disclaimer filed on 26 February 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on US Application No. 18/026,057 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
Applicant’s amendment, filed 26 February 2026, with respect to the rejections of claims 1-14 under 35 U.S.C. § 102(a)(1)/(a)(2), as being anticipated by Kato et al., has been fully considered and is persuasive because claim 1 has been amended to require the limitations from previously presented claim 15, i.e. an inositol derivative in combination with the methyl hesperidin claimed. The rejection is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 26 February 2026 have been fully considered but they are not persuasive.
Applicant contends the data presented in the Specification show the combination of methyl hesperidin and inositol derivatives exhibits superior autophagy activating effect as compared to methyl hesperidin alone.
The data presented in Tables 6-9 of the Specification have been reviewed, however, it is unclear if the increased expression levels of LC3 gene, AT5 gene, and ATG7 gene, the decreased expression level of mTOR gene, and the decreased proportion of apoptotic cells, were statistically significant.
See MPEP 716.02(b)(I), “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” And MPEP 716.02(b)(II), “"[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness."”.
Furthermore, the data presented in the Specification is limited to a single species of methyl hesperidin and a single species of inositol derivative. It is unclear if the results are commensurate in scope with the data presented in the Specification.
See MPEP 716.02(d)(I), “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.”.
Thus, the rejection is hereby maintained.
Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 26 February 2026, where the limitations in pending claims 1, 3 and 12-14 as amended now have been changed. Therefore, rejections from the previous Office Action, dated 26 November 2025, have been modified and are listed below.
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.
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) 1, 3-10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al. (JP 2014114290, hereinafter the ‘290 Publication, cited in the previous Office Action) in view of Aoki et al. (US Patent Application Publication No. 2007/0219158, cited in the previous Office Action).
The ‘290 Publication disclose methyl hesperidin as a glycation reaction inhibitor (abstract; para [0002]; claim 1). It can exist in the chalcone form of general formula (1), or flavanone form of general formula (2):
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(p.2, original document). Each of R1 to R19 independently represents a methyl group or hydrogen atom. The inhibitor is preferably a chalcone form of general formula (3), or flavanone form of general formula (4):
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(p.3, original document). In table 1, the ‘290 Publication disclose chalcone-1 is defined where R20 to R23 are CH3; chalcone-2 is defined where R20 and R23 are H, and R21 and R22 are CH3; chalcone-3 is defined where R20, R22 and R23 are H, and R21 is CH3 (p.3, original). In table 2, the ‘290 Publication disclose the flavanone methyl hesperidin of general formula (4) is defined as flavanone forms 1-4. Flavanone-1 is defined where R24 and R25 are CH3; flavanone-2 is defined where R24 is CH3 and R25 is H; flavanone-3 is defined where R24 and R25 are H; and flavanone-4 is defined where R24 is H and R25 is CH3 (p.4, original). The ‘290 Publication disclose a composition comprising 0.01-5% by mass hesperidin relative to a total amount of the composition (p.7, para [0023] translation). The composition preferably comprises 0.5% to 2.0% by mass of methyl hesperidin, relative to the total mass of the formulation. The inhibitor may be formulated as a dispersion in water or alcohol, and used as a pharmaceutical composition (p.7, translation). The composition may further comprise whitening agents including ascorbic acid phosphate salts, ascorbic acid fatty acid esters, and tocopherol phosphate (claim 17). The composition may further comprise an anti-inflammatory agent, including inositol hexanicotinate (claim 19). The composition may further include moisturizers (claims 1, 42, 58, 60).
The ‘290 Publication does not expressly disclose inositol derivative in which a saccharide is bound to inositol, wherein the saccharide is glucose or an oligosaccharide containing glucose as a constituent unit (present claim 1).
Aoki et al. teach an external skin preparation which contains an inositol derivative (abstract). The inositol derivative is advantageous in that it the topical composition can be applied to give a moist and smooth feeling (“without causing grain feeling”), (abstract). The saccharide is glucose (e.g. para [0022], [0026]-[0028]). Unlike inositol containing rice-brain extract, pure inositol has no odor (para [0015]-[0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine methyl hesperidin with glucosyl-inositol.
According to MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Both the ‘290 Publication and Aoki et al. are concerned with preparing cosmetic and external skin preparations. One having ordinary skill in the art would have been motivated to combine methyl hesperidin with glucosyl-inositol, because the ‘290 Publication teaches incorporating moisturizers with methyl hesperidin, and Aoki et al. teach glucosyl-inositol is a known moisturizer. Glucosyl inositol is particularly advantageous in that it functions as a moisturizer with no odor, and has a smooth feeling upon application.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, 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 BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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