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 . 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.
Priority
The instant application is a 371 of PCT/US19/33434 filed on 05/22/2019 and claims domestic benefit to US provisional application no. 62/678,347 filed on 05/31/2018.
Status of the Claims
The claim amendments and remarks filed on 07/25/2025 is acknowledged. Claim 8 is amended. Claims 1-7, 9-10, and 15 are cancelled. Claims 8, 11-12, 13-14, and 16-20 are pending.
Claims 13-14 and 16-20 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, in the office action dated 01/09/2024.
Accordingly, claims 8 and 11-12 are being examined on the merits herein.
Withdrawn Objections/Rejections
35 USC 112(b) for claims 1, 5-8, and 11-12 are withdrawn in view of claims 1 and 5 being cancelled and claim 8 being amended to recite at least one combination of compounds.
35 USC 103 rejection over Lanzalaco in view of Zawadzki, Ashida, and Cattuzzato for claims 1, 6-7, and 11-12 are withdrawn in view of claims 1 and 6-7 being cancelled and in favor of the rejection discussed below for claims 11-12.
Specification
The disclosure is objected to because of the following informalities:
Table 3 (pages 12-98) contain shading of cells to identify desired ratios, which is not permitted in tables of a specification. See CFR 1.52 and 1.58(a).
Appropriate correction is required.
Claim Objections
Claims 13-14 and 16-20 are objected to because of the following informalities:
Claims 13-14 and 16-20 are withdrawn, however the text for these claims is missing and should be included according to CFR 1.121(c), which states “Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application.”.
Appropriate correction is required.
Amended and New Rejections Not Necessitated by the Amendments filed on 07/25/2025
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the combinations “Tween 40 + Oxalic Acid + L-Alanine” and “Tween 40 + Pectin +L-Alanine”.
The compound “Tween 40” contains the trademark name “Tween”, and MPEP 2173.05(u) recites “if the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”.
Claim Rejections - 35 USC § 103
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.
Claim(s) 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ashida et al. (US 8637572 in PTO-892 dated 02/25/2025) in view of Berge et al. (US 10821060 in PTO-892 dated 02/25/2025).
Ashida et al. teaches a topical composition comprising of D-aspartic acid or D-alanine for suppressing or improving skin conditions such as photoaging or wrinkles (see Abstract). Ashida et al. teaches their composition can include a carrier solvent or water (see column 4, lines 32-63), and can be in a form of a cream (see column 5, lines 1-12). Ashida teaches that their compositions can include other optional formulated components such as an antioxidant and among others (see column 4 lines 47-53)
The difference between Ashida and the claimed invention is that Ashida does not disclose one of the combination of compounds recited in claim 8.
Berge et al. teaches topical compositions for improving the moisturization state of the stratum corneum of human skin epidermis (see Abstract). Berge et al. teaches their topical compositions can be used to improve skin conditions such as slowing down skin aging and/or slowing down wrinkles in the skin (see column 14, lines 21-34). Furthermore, Berge teaches their composition comprises at least one cosmetically acceptable excipient and a composition C1 consisting of 20-50% by weight of composition C2, which in turn includes from 3-25% by weight of a polyol, from 25-45% by weight anhydrides of the polyol, and from 30-72% by weight of polyol glycosides of the polyol, with the remainder of composition C2 to 100% by weight being made up of water (see Abstract). Berge et al. teaches that antioxidants can be combined with their composition for topical use and lists suitable antioxidants such as citric acid, tartaric acid, and oxalic acid (see column 22, lines 62-67).
It would have been prima facie obvious to combine Ashida and Berge before the effective filing date of claimed invention by selecting the oxalic acid disclosed in Berge as the antioxidant in the composition of Ashida comprising D-alanine to arrive at the recited combination “D-alanine + Oxalic Acid” (second combination) in instant claim 8. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because both Ashida and Berge disclose topical compositions useful for the same purpose of slowing down skin aging and/or slowing down wrinkles in the skin as well as further including antioxidants into their compositions. Therefore, an ordinary skilled artisan could have chosen from a finite number of identified, predictable solutions for the antioxidant such as the oxalic acid disclosed in Berge with a reasonable expectation of success.
Furthermore, under broadest reasonable interstation, the modified composition discussed above meets all the structural limitations of the recited composition of claim 8 and would be capable of the recited intended use “for providing or maintaining a healthy skin microbiota of a first desired ratio of Corynebacterium to Staphylococcus, a second desired ratio of Corynebacterium to Micrococcus, and a third desired ratio of Staphylococcus to Micrococcus, wherein the first desired ratio of Corynebacterium to Staphylococcus is 1.3, the second desired ratio of Corynebacterium to Micrococcus is 1.4, and the third desired ratio of Staphylococcus to Micrococcus is 1.1.” because the modified composition discussed above contains a recited combination of compounds that can be applied topically onto the skin.
MPEP 2111.02 II recites “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.”
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ashida et al. (US 8637572 in PTO-892 dated 02/25/2025) in view of Berge et al. (US 10821060 in PTO-892 dated 02/25/2025), as applied to claim 8 above, and further in view of Cruse et al. (US20060182737 in PTO-892).
The combined teachings of Ashida and Berge disclose the composition of claim 8 as discussed above.
The difference between the combined teachings of Ashida and Berge and the claimed invention is that the combined teachings of Ashida and Berge do not disclose the composition is applied to a component of an absorbent article or to a wipe.
Cruse discloses wet wipes comprising a composition for reducing and preventing wrinkles on the skin (see Abstract). Crus discloses that the wet wipe compromises an aqueous composition comprising papain, urea, boric acid, preservatives, the sodium salt of 2-pyrrolidone-5-carboxylic acid, and almond extract (see Abstract). Crus discloses that the wet wipe is fabricated from any suitable combination of materials and components known in the art for desired wiping or skin topical application properties and may include components may include water, emollients, surfactants, fragrances, preservatives, chelating agents, pH buffers or combinations thereof as are well known to those skilled in the art (see paragraph 0030). Crus discloses that the liquid may also contain lotions and/or medicaments (see paragraph 0030).
It would have been prima facie obvious to combine Ashida and Berge with Cruse before the effective filing date of the claimed invention by including the composition as disclosed by the combined teachings of Ashida and Berge described above into a wet wipe such as disclosed in Cruse to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Ashida, Berge, and Cruse all teach topical compositions useful for the same purpose of treating for the same purpose of slowing down skin aging and/or slowing down wrinkles, and Cruse provides further guidance that various combination of components can be added to a wet wipe to achieve this purpose. Therefore, an ordinary skilled artisan could have chosen from a finite number of identified, predictable solutions for applying the composition as disclosed by the combined teachings of Ashida and Berge into a wet wipe as disclosed in Cruse with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments filed on 07/25/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that there is no reasonable expectation of success that the combination of D-alanine from Ashida and Oxalic Acid from Berge would provide the recited intended use of maintaining the desired health skin microbiota ratios recited in claim 8 because Ashida is directed to compositions that promote production of collagen, and Berge is directed to compositions that improve moisturization state of the skin epidermis. Applicant states there is no disclosure in either reference related to the skin microbiota balance effect of these compounds and thus no reasonable expectation of success would provide the three desired ratios.
In response to this argument, the instant rejection is based on both Ashida and Berge disclosing that their topical compositions are useful for the same purpose of slowing down skin aging and/or slowing down wrinkles in the skin as well as further including antioxidants into their compositions with Berge providing additional guidance of oxalic acid as an antioxidant that can be included. Furthermore, as discussed above, the combined teachings of Ashida and Berge meet all the structural limitations of the recited composition of claim 8 and would be capable of the recited intended use of providing the desired ratios of skin bacteria because the modified composition discussed above contains a recited combination of compounds that can be applied topically onto the skin. MPEP 2111.02 II recites “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.” Furthermore, in response to Applicant's argument that there is no disclosure in either reference related to the skin microbiota balance effect of these compounds, 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).
Applicant further states an unexpected result that only 32 combinations out of the 2532 combinations tested provided all the desired ratios of commensal bacteria. Applicant shows each combination tested on Table 3, pages 12-98 in the instant specification.
In response to this argument, the evidence of an unexpected result must compare the claimed invention with the closest prior art as stated in MPEP 816.02(e). Here, the closest prior art is Ashida.
Ashida discloses topical compositions comprising either D-aspartic acid or D-alanine. While Applicant has tested an extensive combination of compounds and identified 32 combinations that provide all three of the desired ratios of skin bacteria, Applicant has not provided a comparison to D-alanine alone, making it difficult to ascertain if the combination of compounds provides the recited ratios or if it is one of the individual components in the combination. Furthermore, Ashida also discloses the combination of D-alanine and an antioxidant, in which Berge provides guidance to use oxalic acid as an antioxidant described above. Therefore, Applicant also has not provided a proper comparison of the recited combination of D-alanine and oxalic acid against other combinations of D-alanine and other antioxidants such as those disclosed in Berge.
Conclusion
No claim is found allowable.
This action is made non-final in view of the newly added and amended rejections that were not necessitated by Applicant’s amendments.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693