DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06 March 2026 has been entered.
This Office Action is in response to Applicant’s Amendment and Remarks filed on 06 March 2026 in which claims 7, 11 and 15 were canceled, claims 1 and 12 were amended to change the scope and breadth of the claims, and claim 17 was newly added.
Claims 1, 2, 5, 6, 8, 9, 10, 12, 13, 14, 16 and 17 are pending in the current application. Claims 6, 8, 9, 10, and 14 remain withdrawn as being drawn to a non-elected invention/species. Claims 1, 2, 5, 12, 13, 16, and 17 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 .
Withdrawn Rejections
Applicant’s amendment, filed 06 March 2026, with respect to the rejection of claims 12, 15 and 16 under 35 U.S.C. § 112, first paragraph, for scope of enablement, has been fully considered and is persuasive because claim 12 has been amended to delete “preventing onset or”; and claim 15 was canceled. The claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification. The rejection is hereby withdrawn.
Applicant’s amendment, filed 06 March 2026, with respect to the rejection of claims 1, 5, 7, 12, 15 and 16 under 35 U.S.C. § 112(b), second paragraph, for indefiniteness, has been fully considered and is persuasive because the claims have been amended to recite “enzyme-treated rutin”; “enzyme-treated hesperidin”; and “enzyme-treated naringin”. The claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification. The rejection is hereby withdrawn.
Applicant’s amendment, filed 06 March 2026, with respect to the rejection of claims 1, 5, 7, 12, 15 and 16 under 35 U.S.C. § 102(a)(1), as being anticipated by Hanaoka et al., has been fully considered and is persuasive because the claim has been amended to delete “any one or both of naringin and”. The claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification. The rejection is hereby withdrawn.
Election/Restrictions
To expedite prosecution of the present application, the species has been expanded to include a mixture of α-glucosylrutin and isoquercitrin. Thus, claims 2 and 13 are no longer withdrawn.
New Rejections & Modified Rejections
The following are new ground(s) or modified rejections.
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.
Claim(s) 1, 2, 5, 12, 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshizumi et al. (JP2004059522, original document and translation cited in PTO-892).
Yoshizumi et al. disclose a long-lasting rutin preparation comprising an enzyme-treated rutin, wherein the composition is a pharmaceutical composition (claims 1 and 6). Yoshizumi et al. disclose preparing the composition by treating α-glucosylrutin with glucoamylase and hesperidinase to produce monoglucosylrutin and isoquercitrin (para [0025]-[0026]). The mixture was analyzed by HPLC and determined to have a 5:1 weight ratio of α-monglucosylrutin to isoquercitrin (para [0026]). In example 1, rats were treated with the αG-rutin (para [0031]). The test substances were administered orally after being suspended in a 0.5% carboxymethylcellulose sodium (CMC-Na) aqueous solution (i.e. pharmaceutically acceptable carrier; para [0032]).
The recitation “collagenase activity inhibitor” in the preamble is an intended use of the composition. Yoshizumi et al. disclose a 5:1 weight ratio of α-monglucosylrutin to isoquercitrin, i.e. 83% by mass α-glucosylrutin, based on the total weight of the enzyme-treated rutin.
The recitation “wherein the collagenase activity inhibitor inhibits an activity for decomposition of Type I collagen” in claim 5 is a latent property of the composition.
Thus, the disclosure of Yoshizumi et al. anticipates claims 1, 2, 5, 12, 13 and 16 of the present application.
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, 5, 12, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanaoka et al. (US2023/0293416, cited in previous Office Action).
Hanoaka et al. teach glycosyl naringenin as an effective ingredient for stabilizing an emulsion, including a water-in oil type or oil-in-water type emulsion (i.e. a carrier, para [0002], [0023]).
Hanaoka et al. teach the glycosyl naringenins may be prepared enzymatically, including via the use of α-1,6-transglycosylation (para [0021]). Hanaoka et al. teach “depending on its production process, this glycosyl naringenin mixture usually comprises as a main ingredient one or more kinds selected from (1) naringin and α-glycosyl naringin (e.g., α-glucosyl naringin, etc.), which are the compounds having a naringenin skeleton” (para [0023]). It is also noted glucosyl naringenin includes prunin, 7-O-α-D-glucopyranosyl-naringin from a list of 6 glycosylated forms of naringin (chemical formula 6; para [0016]-[0018]). The composition may be an external dermal composition.
In Experiment 1-1, Hanoaka et al. teach treating naringin with cyclodextrin glucanotransferase (i.e. enzyme-treated naringin). Hanoaka et al. teach obtaining a glucosyl containing composition comprising 70% glucosyl naringin (3’’-α-glucosyl naringin) and 30% naringin. Hanoaka et al. disclose the 3’’-α-glucosyl naringin is preferably 3’’-α-monoglucosyl naringin (para [0024]). Hanoaka et al. teach the α-glucosyl naringin may be present in an amount of preferably 30% by mass or more and 100% by mass or less (para [0025]-[0026]).
Thus, Hanaoka et al. teach naringin containing α-glucosyl naringin and naringin, and wherein a content of α-glucosyl naringin in the mixture is 70% by mass or more based on a total weight of the mixture. And the 3’’-α-glucosyl naringin is preferably 3’’-α-monoglucosyl naringin.
While Hanaoka et al. do not expressly disclose a mixture of the 3”-α-monoglucosyl naringin with 7-O-α-D-glucopyranosyl-naringin, it would have been obvious to combine them together where the 3”-α-monoglucosyl naringin is present in an amount of 70% by weight of the composition, or 80-90% by mass.
The skilled artisan would have been motivated to combine 3”-α-monoglucosyl naringin with 7-O-α-D-glucopyranosyl-naringin because they are both recognized as emulsion stabilizers for cosmetic compositions. The ordinary artisan would have been motivated to include 70% by weight of 3”-α-monoglucosyl naringin as part of the composition because Hanaoka et al. expressly exemplify preparing and testing compositions having 70% by weight of 3”-α-monoglucosyl naringin, with any amount of 7-O-α-D-glucopyranosyl-naringin. Furthermore, the ordinary artisan would have been motivated to use 80-90% by mass of the 3”-α-monoglucosyl naringin, because Hanoaka et al. expressly teach the upper limit can range up to 100% by mass of the α-glucosyl naringin.
Alternatively, one having ordinary skill in the art would have been motivated to substitute the naringin in the mixture of 3’’-α-monoglucosyl naringin of Example I-1 with 7-O-α-D-glucopyranosyl-naringin to provide a mixture of 7-O-α-D-glucopyranosyl-naringin with 70% by weight 3’’-α-monoglucosyl naringin, because Hanoaka et al. teach naringin and 7-O-α-D-glucopyranosyl-naringin as alternative forms of glycosyl naringenins for stabilizing an emulsion.
The recitation “collagenase activity inhibitor” in the preamble of present claim 1 is interpreted as an intended use or property of the mixtures claimed. It is not necessary for the prior art to teach or recognize this property, since it is inherent to the mixture.
The recitation “wherein the collagenase activity inhibitor inhibits an activity for decomposition of Type I collagen” in claim 5 is a latent property of the composition.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Response to Arguments
Applicant's arguments filed 06 March 2026 have been fully considered but they are not persuasive.
Applicant contends one of ordinary skill in the art would not have been motivated to optimize enzyme treatment conditions or by-product ratios from the viewpoint of collagenase inhibition.
In response to applicant's argument that the prior art do not teach the use of the combination of naringin derivatives for inhibiting collagenase, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Furthermore, the claims only require 70% by weight or more of α-monoglucosyl naringin (or 80-90% by weight, per present claim 17), and any amount of 7-glucosyl naringenin. As discussed above, Hanoaka et al. provide an express teaching of using a composition having 70% by weight or more of α-monoglucosyl naringin (or up to 100% by weight), with the rest being naringin.
The rejection is hereby 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.
Claims 1, 5, 12, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 17/773,599 (reference application) in view of Hanaoka et al. (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application recite “the α-glucosyl naringin comprises 80 weight percent (wt.%) or more of 3’’-α-monoglucosyl naringin, based on a total weight of the α-glucosyl naringin”.
The claims of the reference application do not expressly disclose a mixture of the α-glucosyl naringin with 7-O-glucosyl naringenin (present claims 1 and 12).
Hanaoka et al. teach as discussed above.
It would have been obvious before the effective filing date of the claimed invention to mix the α-glucosyl naringin with 7-O-glucosyl naringenin because the mixture has been shown to stabilize emulsions for cosmetic applications.
Claims 1, 5, 12, 16 and 17 are prima facie obvious over the claims of the reference application in view of the combined teaching of the prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 12, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/573,549 (reference application) in view of Hanaoka et al. (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are directed towards an inhibitor comprising at least one component selected from α-glucosylnaringin. The content of the component (A) is 65 mass% or more.
The claims of the reference application do not expressly disclose a mixture of the α-glucosyl naringin with 7-O-glucosyl naringenin (present claims 1 and 12).
Hanaoka et al. teach as discussed above.
It would have been obvious before the effective filing date of the claimed invention to mix the α-glucosyl naringin with 7-O-glucosyl naringenin because the mixture has been shown to stabilize emulsions for cosmetic applications.
It would have been obvious before the effective filing date of the claimed invention to increase the amount of α-monoglucosyl naringin because 65 mass% or more significantly encompasses the range of 70 mass% or more, and 80-90%.
Claims 1, 5, 12, 16 and 17 are prima facie obvious over the claims of the reference application in view of the combined teaching of the prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
Prosecution Insights