DETAILED ACTION
This Office Action is in response to Applicant’s Remarks filed on 06 March 2026.
Claims 1, 2, 5, 6, 8-10, 12-14, 16 and 17 are pending in the current application. Claims 6, 8-10 and 14 remain withdrawn as being drawn to a non-elected invention. Claims 1, 2, 5, 12, 13, 16 and 17 are examined on the merits herein.
The Declaration of Dr. Nakanishi (hereinafter the Declaration), submitted by Applicant on 23 July 2026 under 37 CFR §1.132 are acknowledged and will be further discussed 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 .
Response to Arguments
Applicant's arguments, and Declaration, filed 23 July 2026 have been fully considered but they are not persuasive.
According to the Declaration, the 5:1 ratio of α-monoglucosylrutin to isoquercetin disclosed by Yoshizumi et al. cannot be directly translated to the percent content of α-monoglucosylrutin and isoquercetin, because the enzymatic reaction produces additional impurities that are difficult to remove “e.g., α-maltosylrutin, α-maltotriosylrutin, α-monoglucosylrutin and isoquercetin”.
The above arguments have been considered, but are not found persuasive. While Applicant argues other impurities may be present in example 1 of the purified enzyme-treated rutin of Yoshizumi et al., α-monoglucosylrutin and isoquercetrin are the only two identified components in the mixture by Yoshizumi et al. Thus, it is clear these two compounds are the major components present.
Furthermore, there is evidence commercially available enzyme-treated rutin which Yoshizumi et al. references, contains “75 mass% of α-monoglucosylrutin and 15 mass% of isoquercetrin”. According to para [0014] of Yoshizumi et al., “commercially available enzyme-treated rutin can be used. Examples of commercially available products include αG-rutin PS or αG-rutin P manufactured by Toyo Sugar Refining Co., Ltd.”.
As evidenced by Applicant’s specification “Examples of the commercially available product of the enzyme-treated rutin include products “αG rutin PS”…”αG rutin PS is a composition containing 75 mass% of α-monoglucosylrutin and 15 mass% of isoquercetrin” (p.11, para [0024]). Incidentally, a 75:15 ratio simplifies to a 5:1 ratio.
Thus, the rejection over Yoshizumi et al. is maintained since the reference discloses “αG rutin PS” can be used as the form of enzymatically-treated rutin, and Applicant’s Specification discloses “αG rutin PS” contains “75 mass% of α-monoglucosylrutin and 15 mass% of isoquercetrin”. These concentrations lie in the range of claim 1, limitation (i).
The rejection is hereby maintained.
Maintained 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 previous Office Action).
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-monoglucosylrutin 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-monoglucosylrutin 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.
Response to Arguments
Applicant's arguments filed 23 July 2026 have been fully considered but they are not persuasive.
Applicant contends one of ordinary skill in the art would not have arrived at a mixture comprising 7-glucosyl naringenin and α-monoglucosyl naringin by treating naringin with an enzyme.
The above arguments have been carefully considered, but are not found persuasive, because Hanaoka et al. provide motivation to prepare a mixture comprising 70 mass% or more α-monoglucosyl naringin with additional naringin derivatives. Hanaoka et al. expressly teach “Furthermore, as shown in Table 7, when the mass ratio of 3’’-α-glucosyl naringin and naringin was in the range of 90:10 to 20:80, the relative separation degree was always less than 60%..., indicating the more remarkable improvement of the emulsion stability compared to when 3’’-α-glucosyl naringin was used alone (para [0069]).
Hanaoka et al. teach “The stabilizer of the present invention may be the one comprising only one kind of a compound that is within the scope of the glycosyl naringenin. However, from the viewpoint of synergistically enhancing the effect of stabilizing an emulsion composition shown by the glycosyl naringenin, the stabilizer of the present invention may preferably comprise two or more kinds of compounds that are within the scope of the glycosyl naringenin….Further preferably, the stabilizer of the present invention may comprise one or more selected from 3’’-α-monoglucosyl naringin” (para [0024]).
Hanaoka et al. teach preparing the mixtures by mixing purified 3’’-α-glucosyl naringin with purified naringin (see para [0065]). Thus, Hanaoka et al. do not require using an enzyme to arrive at the mixture of 3’’-α-glucosyl naringin and naringin. Rather, Hanaoka et al. teach preparing and purifying the naringin derivatives, and mixing them together in different ratios to identify optimal emulsion stabilizers.
As discussed in the previous Office Action, Hanaoka et al. teach additional glucosyl naringenin derivatives that can be incorporated in the mixture for emulsion stabilization include “prunin” a 7-glucopyranosyl-naringin from a list of 6 glycosylated forms of naringin. Thus, it would have been obvious to substitute the purified naringin with prunin or 7-glucosyl naringin as part of an external dermal composition.
Applicant contends Hanaoka does not provide an enzymatic treatment technique for producing 7-glucosyl naringenin.
Applicants arguments are not found persuasive, because the present claims are product-by-process claims. See MPEP 2113, “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
In the present claims, patentability is based on a composition comprising a mixture having 70% by mass or more α-monoglucosyl naringin, based on the total weight of the mixture, in combination with 7-glucosyl naringenin.
While the claims recite “based on a total weight of the enzyme-treated naringin”, this is interpreted as a mixture comprising “α-monoglucosyl naringin and 7-glucosyl naringenin”, because limitation (iii) of claim 1 defines “an enzyme-treated naringin” as “containing α-monoglucosyl naringin and 7-glucosyl naringenin”.
The rejection is hereby maintained.
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.
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.
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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
Prosecution Insights