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 . Claims included in prosecution are claims 43-48 and 50-52.
Previous Rejections
Applicants' arguments, filed 3/24/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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.
1. Claim(s) 43-45, 47-48, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leva (US 2022/0395437, Dec. 15, 2022) (hereinafter Leva).
Leva discloses a composition for the making of an emulsifiable triphasic formulation, which consists of a liquid biphasic composition and a powder solid phase, wherein said liquid biphasic composition consists of a hydrophilic phase and a lipophilic phase. The composition is particularly suitable for the use in the clinical dermatological and/or cosmetological fields (Abstract). Allowing skin fibroblasts to return to normal functioning by stimulating these cells directly (so-called bio-stimulation), or providing them with pre-formed substances (so-called bio-restructuring or bio-revitalization), means counteracting the signs of aging (¶ [0002]). The composition has a bio-stimulating and bio-restructuring activity, suitable for topical application (¶ [0011]). Leva further discloses that the hydrophilic phase of the composition it is characterized by comprising at least one organic acid (¶ [0018]). Pyruvic acid, lactic acid, and any combination thereof are suitable organic acids for use in the hydrophilic phase of the composition (¶ [0019]). Lactic acid belongs to the class of alpha-hydroxy acids and allows for a thinning of the corneum layer of the skin, resulting in faster exfoliation of surface dead cells, and greater production of collagen and elastin (¶ [0020]). Pyruvic acid is an alpha-ketoacid which, thanks to its low pH, is particularly suitable for the use thereof in dermatology as an exfoliating substance, in particular for its ability to eliminate pigmented corneocytes with a lightening effect, increasing skin brightness (¶ [0021]). In a preferred embodiment, the at least one organic acid is present in the hydrophilic phase of the composition in a total amount comprised between 0.1 % and 80% (¶ [0023]). In a preferred embodiment, the hydrophilic phase comprises the following in weight percentage with respect to the total weight of said hydrophilic phase: glycolic acid in an amount comprised between 1 % and 5% by weight (satisfies alpha hydroxy acid of claim 44); and salicylic acid in an amount less than or equal to 5% by weight (satisfies beta hydroxy acid of claim 45) (¶ [0029-0037]). In a preferred embodiment, the lipophilic phase comprises olive oil in an amount comprised between 6% and 25% by weight (satisfies fatty compound of claim 43 & 48) (¶ [0046 & 0049]). The solid powder phase of the composition is characterized by comprising hyaluronic acid and/or its salt, ferulic acid, creatine, at least one vitamin and at least one amino acid and/or one of the salts thereof (¶ [0051]). In a preferred embodiment, the solid powder phase comprises: hyaluronic acid and/or a salt thereof in a quantity comprised between 5% and 10% by weight; arginine in an amount between 0.1 % and 1 % by weight; glycine in an amount between 0.1 % and 1 % by weight; proline in an amount between 0.1 % and 1 % by weight; and valine in an amount between 0.1% and 1% by weight (satisfies polyol and amino acid of claim 43, 47, & 50) (¶ [0070-0081]).
Leva differs from the instant claims insofar as not explicitly disclosing wherein the ratio of the lactic acid to pyruvic acid is from about 9:1 to about 2:1.
However, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Leva discloses wherein a combination of lactic acid and pyruvic acid may be used in the hydrophilic phase and discloses that their total amount in the hydrophilic phase is between 0.1 % and 80%. Accordingly, the claimed weight ratio would have been obvious from one of ordinary skill in the art selecting an amount of lactic acid and an amount of pyruvic acid from the above range and the ratio thereof overlapping with the claimed ratio.
Alternatively, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, lactic acid affects corneum layer thickness, exfoliation, and collagen/elastin production while pyruvic acid affects exfoliation, skin pigmentation, and skin brightness. As such, amounts/ratios of lactic acid and pyruvic acid are result effect variables since amounts directly impact the dermatological (i.e., therapeutic) effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratio of lactic acid to pyruvic acid to yield the desired corneum layer thickness, exfoliation, collagen/elastin production. skin pigmentation, and/or skin brightness.
2. Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leva (US 2022/0395437, Dec. 15, 2022) (hereinafter Leva) in view of Deckers et al. (US 2002/0106337, Aug. 8, 2002) (hereinafter Deckers).
The teachings of Leva are discussed above.
Leva differs from the instant claims insofar as not disclosing wherein the composition comprises a polyhydroxy acid such as gluconolactone.
However, Deckers discloses emulsion formulations for topical application to the skin (Abstract). The oil body emulsions of the present invention also may be advantageously formulated with anti-wrinkle and anti-aging actives. Suitable anti-wrinkle and anti-aging actives include alpha-hydroxy acids such as lactic acid, beta hydroxy acids such as salicylic acid and polyhydroxy acids such as gluconolactone, and mixtures of these acids (¶ [0125]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Leva to comprise a polyhydroxy acid such as gluconolactone motivated by the desire to utilize its anti-wrinkle and anti-aging properties as taught by Deckers.
3. Claim(s) 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leva (US 2022/0395437, Dec. 15, 2022) (hereinafter Leva) in view of Taniguchi et al. (US 2018/0116940, May 3, 2018) (hereinafter Taniguchi).
The teachings of Leva are discussed above.
Leva differs from the instant claims insofar as not disclosing wherein the composition comprises 6 amino acids including histidine, threonine, and/or alanine.
However, Taniguchi discloses an external dermal agent that tightens the skin, lifts up sagging skin, has no stickiness to the skin, and has a satisfactory compatibility with the skin, without giving any unfavorable feeling to users (Abstract). Sagging skin and skin wrinkling are skin changes associated with ageing (¶ [0002]). The agent may comprise amino acids (¶ [0025]). Suitable amino acids include glycine, alanine, valine, threonine, praline, arginine, histidine (¶ [0035]). The external dermal agent may be in the form of an oil/water/powder triphasic emulsion system (¶ [0038]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Leva discloses wherein the composition may comprise at least one amino acid in the solid powder phase. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Leva to comprise alanine, threonine, and histidine, since it they are known amino acids for use in triphasic anti-ageing dermatological compositions as taught by Taniguchi.
Response to Arguments
Applicant’s arguments filed 3/24/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments with respect to the lactic acid/pyruvic acid ratio, as a threshold matter, the Examiner points to the fact that the rejection was not only made on the basis that it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratio of lactic acid to pyruvic acid. The rejection of record was also made on the basis of overlapping ranges. As discussed above, Leva discloses wherein a combination of lactic acid and pyruvic acid may be used in the hydrophilic phase and discloses that their total amount in the hydrophilic phase is between 0.1 % and 80%. A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art". See MPEP 2144.05(A). Accordingly, the claimed weight ratio would have been obvious from one of ordinary skill in the art selecting an amount of lactic acid and an amount of pyruvic acid from the above range and the ratio thereof overlapping with the claimed ratio.
Regarding Applicant’s argument that the Office has not established this ratio as a result effective variable, the Examiner submits that, as discussed above, Leva discloses that lactic acid affects corneum layer thickness, exfoliation, and collagen/elastin production while pyruvic acid affects exfoliation, skin pigmentation, and skin brightness. As such, amounts and subsequent ratios of those components would be result effective variables. where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). Specifically, since these components affect the skin in a dermatological composition their effect would be therapeutic and their amounts and resulting ratios would affect said therapeutic effect, making said amounts and ratios a result effective variable. As such, while it is understood that Leva does not explicitly disclose an inventive embodiment with the claimed ratio, routine experimentation to arrive at the effective ratio of the lactic/pyruvic acid disclosed by Leva would have been well within the capabilities of one of ordinary skill in the art prior to the filing of the instant application.
Regarding Applicant’s argument that it would not have been obvious to try and adjust/select these ratios, the Examiner submits that it indeed would have been obvious for one of ordinary skill in the art to try and select the claimed ratio based on Leva’s disclosure where Leva discloses that a combination of lactic acid and pyruvic acid may be used in the hydrophilic phase and discloses that their total amount in the hydrophilic phase is between 0.1 % and 80%. Accordingly, the claimed weight ratio would have been obvious from one of ordinary skill in the art selecting an amount of lactic acid and an amount of pyruvic acid from the above range and the ratio thereof overlapping with the claimed ratio.
Regarding Applicant’s argument that Deckers fails to rectify the alleged deficiencies of Leva, the Examiner submits that Deckers cures any alleged deficiencies of Leva where Deckers discloses that gluconolactone comprises anti-wrinkle and anti-aging properties.
Regarding Applicant’s argument that Taniguchi fails to rectify the alleged deficiencies of Leva, the Examiner submits that Taniguchi cures any alleged deficiencies of Leva where Taniguchi discloses that alanine, threonine, and histidine are known amino acids for use in triphasic anti-ageing dermatological compositions.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejections are 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.
1. Claims 43-48 and 50-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/985,915 in view of Lemke et al. (US 2009/0324693, Dec. 31, 2009) (hereinafter Lemke).
Both the instant claims and the copending claims recite a personal care composition comprising a post biotic system comprising lactic acid and pyruvic acid. The copending claims differ insofar as further disclosing wherein the post biotic system further comprises saccharide isomerate.
However, Lemke discloses a skin composition and delivery product for it (Abstract). In one embodiment, the topical skin composition may be for moisturizing the skin and may contain a humectant. Humectants are typically cosmetic ingredients used to increase the water content of the top layers of the skin or mucous membrane, by helping control the moisture exchange between the product, the skin, and the atmosphere. Suitable humectants include saccharide isomerate (¶ [0048]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain saccharide isomerate to arrive at the composition of the copending claims motivated by the desire to utilize the skin moisture control properties that humectants such as saccharide isomerate provide as taught by Lemke.
This is a provisional nonstatutory double patenting rejection.
2. Claims 43-48 and 50-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/458,702 in view of Lemke et al. (US 2009/0324693, Dec. 31, 2009) (hereinafter Lemke).
Both the instant claims and the copending claims recite a personal care composition comprising a post biotic system comprising lactic acid and pyruvic acid. The copending claims differ insofar as further disclosing wherein the composition further comprises a polysaccharide.
However, Lemke discloses a skin composition and delivery product for it (Abstract). In one embodiment, the topical skin composition may be for moisturizing the skin and may contain a humectant. Humectants are typically cosmetic ingredients used to increase the water content of the top layers of the skin or mucous membrane, by helping control the moisture exchange between the product, the skin, and the atmosphere. Suitable humectants include polysaccharides (¶ [0048]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain polysaccharides to arrive at the composition of the copending claims motivated by the desire to utilize the skin moisture control properties that humectants such as polysaccharides provide as taught by Lemke.
This is a provisional nonstatutory double patenting rejection.
3. Claims 43-48 and 50-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, 13-19, 23, 25, and 27 of copending Application No. 18/240,795 in view of Lemke et al. (US 2009/0324693, Dec. 31, 2009) (hereinafter Lemke).
Both the instant claims and the copending claims recite a personal care composition comprising a post biotic system comprising lactic acid and pyruvic acid. The copending claims differ insofar as further disclosing wherein the composition further comprises a polysaccharide.
However, Lemke discloses a skin composition and delivery product for it (Abstract). In one embodiment, the topical skin composition may be for moisturizing the skin and may contain a humectant. Humectants are typically cosmetic ingredients used to increase the water content of the top layers of the skin or mucous membrane, by helping control the moisture exchange between the product, the skin, and the atmosphere. Suitable humectants include polysaccharides (¶ [0048]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain polysaccharides to arrive at the composition of the copending claims motivated by the desire to utilize the skin moisture control properties that humectants such as polysaccharides provide as taught by Lemke.
This is a provisional nonstatutory double patenting rejection.
4. Claims 43-48 and 50-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/977,205 in view of Lemke et al. (US 2009/0324693, Dec. 31, 2009) (hereinafter Lemke).
Both the instant claims and the copending claims recite a personal care composition comprising a post biotic system comprising lactic acid and pyruvic acid. The copending claims differ insofar as further disclosing wherein the composition further comprises a polysaccharide.
However, Lemke discloses a skin composition and delivery product for it (Abstract). In one embodiment, the topical skin composition may be for moisturizing the skin and may contain a humectant. Humectants are typically cosmetic ingredients used to increase the water content of the top layers of the skin or mucous membrane, by helping control the moisture exchange between the product, the skin, and the atmosphere. Suitable humectants include polysaccharides (¶ [0048]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain polysaccharides to arrive at the composition of the copending claims motivated by the desire to utilize the skin moisture control properties that humectants such as polysaccharides provide as taught by Lemke.
This is a provisional nonstatutory double patenting rejection.
5. Claims 43-48 and 50-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,201,713 in view of Lemke et al. (US 2009/0324693, Dec. 31, 2009) (hereinafter Lemke).
Both the instant claims and the patented claims recite a personal care composition comprising a post biotic system comprising lactic acid and pyruvic acid. The patented claims differ insofar as further disclosing wherein the composition further comprises a polysaccharide.
However, Lemke discloses a skin composition and delivery product for it (Abstract). In one embodiment, the topical skin composition may be for moisturizing the skin and may contain a humectant. Humectants are typically cosmetic ingredients used to increase the water content of the top layers of the skin or mucous membrane, by helping control the moisture exchange between the product, the skin, and the atmosphere. Suitable humectants include polysaccharides (¶ [0048]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain polysaccharides to arrive at the composition of the patented claims motivated by the desire to utilize the skin moisture control properties that humectants such as polysaccharides provide as taught by Lemke.
Response to Arguments
Applicant’s arguments are the same as above.
The Examiner’s response above is repeated as above. Furthermore, Applicant has not submitted documentation (i.e. terminal disclaimer) in response to the double patenting rejection(s).
Therefore, the previous rejections of non-statutory double patenting are maintained.
Conclusion
Claims 33-42 are withdrawn. Claims 43-48 and 50-52 are rejected.
No claims are 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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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