DETAILED ACTION
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 amended Claims 9 and 10 are directed to inventions which are independent or distinct from the invention originally claimed for the following reasons:
Claims 1-7 and Claims 9 and 10 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the composition of Claim 1 can be used in a materially different process of using the product, such as a Pueraria thunbergiana tea which is ingestible.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 9 and 10 are withdrawn from consideration as being directed to a non-elected invention.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.
Claim Status
Applicant’s remarks and amendments, filed 20 July 2026 in response to the non-final rejection mailed 21 April 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 20 July 2026 replaces all prior versions and listings of the claims.
Claims 1-7, 9, and 10 are pending. Claims 8 and 11-13 are canceled by Applicant’s amendment. Claims 1, 9, and 10 are amended. Claims 9 and 10 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 1-7 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on pages 6-7 of the reply filed 20 July 2026 with respect to the rejection of Claims 9 and 10 under 35 USC § 112(b) have been fully considered. The rejections of Claims 9 and 10 are withdrawn due to amendment of the claims.
Applicant’s arguments and amendments, on pages 7-9 of the reply filed 20 July 2026 with respect to the rejection of Claims 1-6, 9, and 10 under 35 USC § 101 have been fully considered. The rejections of Claims 1-6, 9, and 10 are withdrawn due to amendment of Claim 1.
Claim Rejections - 35 USC § 103
(grounds modified as 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 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.
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.
Claims 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (Arch Dermatol Res, 2015, 57-72) in view of Sook (KR 20120060313 A, machine translation, 11 pages).
The instant claims are as of record, drawn to a skin external composition comprising a honey water extract of Pueraria thunbergiana.
Han et al. teach that extracts of Pueraria thunbergiana comprising the isoflavones daidzein, gylcitein, genistin, daidzin, glycitin, and genistin (Han et al., Table 1, page 61) and applied topically to the skin of mice (skin external) in the form of a cream with 1-3% of the extract (Han et al., Animals, In vivo skin pigmentation determinations, page 62; as required for instant Claim 7) inhibits pigmentation, thereby lightening skin (Han et al., Discussion, page 71; as required for instant Claim 1). Isoflavone content was determined using HPLC with aqueous methanol and acetic acid as mobile phases, and wherein results were measured using a UV wavelength of 260 nm and confirmed comparing peaks to the standards (Han et al., High-performance liquid chromatography analysis, page 59).
Han et al. do not teach wherein the extraction solvent is honey water.
Sook, however, teaches that emerging active ingredients at 1-70% by weight of the natural product in 1 to 90% by weight of honey or honey solution (e.g., honey water; Sook, 3., page 5; as required for instant Claims 1, 2, and 4) provides a method for preparing active ingredients from various natural products. The weight ratio of the natural ingredient : honey could therefore be 1:1 (e.g., 50% of each) or 1:20 (e.g., 1% natural product and 20% honey; as required for instant Claim 6). The natural products may be aged in the honey (Sook, 2., page 4; as required for instant Claim 5). This enables preparation of cosmetic compositions and allows for long-term storage without necessitating preservatives or antiseptics (Sook, Abstract, page 1).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Han et al. and Sook to arrive at the instantly claimed invention. A skilled artisan would be motivated to provide Pueraria thunbergiana as a natural product because of its skin lightening effects and also to use a honey water solvent because it allows for long-term storage without necessitating preservatives or antiseptics. A skilled artisan could therefore use honey water as a solvent to provide an extract of Pueraria thunbergiana to arrive at a skin external composition with a reasonable expectation of success. It is additionally noted that the feature of the Pueraria thunbergiana honey water extract having an HPLC peak under the specific conditions of instant Claim 1 merely describes the extract; a skilled artisan motivated to use honey water as an extraction solvent due to its utility for long-term storage without necessitating preservatives for extraction of Pueraria thunbergiana due to is skin-positive effects would necessarily obtain an extract with the indicated peak when analyzed using HPLC with the specifically claimed parameters.
Han et al. and Sook are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to utilizing HPLC and effective amounts of Pueraria thunbergiana extract used in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable effective dose ranges (instant Claim 7) or optimizing specific HPLC parameters such as wavelength and mobile phase (instant Claim 1)) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (Arch Dermatol Res, 2015, 57-72) in view of Sook (KR 20120060313 A, machine translation, 11 pages) as applied to Claims 1 and 4-7 above, and further in view of Choung et al. (KR 20210003390 A, machine translation, 14 pages) and Venskutonis (J Food Bioact, 2018, 69-87).
The claims and teachings of Han et al. and Sook are as of record.
Neither Han et al. nor Sook teach wherein the skin external composition further comprises Crataegus pinnatifida honey water extract or Dioscorea opposita honey water extract.
Choung et al. teach a cosmetic composition for skin moisturizing comprising Dioscorea japonica (Dioscorea opposita, see instant specification pg. 8, ln. 3-4), which has the effects of moisturizing the skin, strengthening the skin barrier, and acts as an antioxidant and anti-inflammatory (Choung et al., page 4; as required for instant Claims 2 and 3).
Venskutonis teaches that Crataegus pinnatifida has traditionally been used in Chinese and European herbal medicines, and that extracts increase procollagen type I expression, reduce matrix metalloproteinase-1 secretion, improve various other human skin values associated with aging, wrinkle formation and moisture, and can be used as a skin whitening agent (Venskutonis, 7., page 80; as required for instant Claims 2 and 3).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine Dioscorea opposite and Crataegus pinnatifida as taught by Choung et al. and Venskutonis with the Pueraria thunbergiana of Han et al. into a skin external composition, and to provide the ingredients as honey water extracts as taught by Sook. A honey water solvent allows for long-term storage without necessitating preservatives or antiseptics, motivating a skilled artisan to utilize this solvent, and a skilled artisan would further be motivated to provide Pueraria thunbergiana, Dioscorea opposite, and Crataegus pinnatifida for a skin external composition because of the skin beneficial effects of skin lightening, moisturizing the skin, strengthening the skin barrier, antioxidant and anti-inflammatory effects, increasing procollagen type I expression, reducing matrix metalloproteinase-1 secretion, and improving various other human skin values associated with aging, wrinkle formation and moisture. A skilled artisan could therefore provide Pueraria thunbergiana, Dioscorea opposite, and Crataegus pinnatifida as honey water extracts in a skin external composition with a reasonable expectation of success.
Han et al., Sook, Choung et al., and Venskutonis are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to skin beneficial effects disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable weight ratios (instant Claim 3) with which to provide such a composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 20 July 2026 have been fully considered but they are not persuasive.
Applicant argues that because Han et al. do not teach the specific HPLC peak under the specific conditions of instant Claim 1, the characteristic of a 15-25 minute peak of 0.20 A.U. or more under the claimed conditions is not established. The instant specification, however, does establish that a peak corresponding to the same unidentified compound is found in the water extract of Pueraria thunbergiana (e.g., Figure 1 and pg. 20, ln. 24-25 - pg. 21, ln. 1-5). The water extract of Han et al. would therefore comprise the same compound and necessarily have a peak corresponding to said unidentified compound. The specific peak parameters, however, cannot be determined because neither the instant specification or instant claims disclose which compound said peak correlates with. Without evidence to the contrary, the water extract of Pueraria thunbergiana as disclosed by Han et al. not only contains the unidentified compound, but also because a skilled artisan would be motivated to use honey water as a solvent due to the positive results of using such as solvent as disclosed above, the resulting extract would necessarily have the same peak when analyzed using the same HPLC parameters. It is additionally noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant goes on to argue that the honey water extract of Pueraria thunbergiana produces the unexpected result of an HPLC peak corresponding to a higher amount of an unidentified compound relative to a water extract of Pueraria thunbergiana. While neither Han et al. nor Sook contemplate an increased amount of a completely unidentified compound, the teachings of Sook regarding the utility of honey water as a solvent and the teachings of Han et al. regarding the utility of Pueraria thunbergiana as a skin care agent provide motivation and a reasonable expectation of success for a skilled artisan to use honey water as an extraction solvent for Pueraria thunbergiana, which would necessarily result in the same HPLC peak when analyzed using the same conditions. 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). Additionally, While applicant also argues that HPLC parameters are not merely routine optimization, it is still maintained that due to the motivation to combine Han et al. and Sook as discussed in the rejections and response to arguments above, the same peak as claimed would still be present when the extract is analyzed using the claimed HPLC parameters.
Conclusion
No claims are currently 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 5:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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