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 50-51.
Previous Rejections
Applicants' arguments in the Request for Continued Examination, filed 8/17/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
1. Claims 44-46 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
For example, in the present instance, claim 44 recites the broad recitation “alpha hydroxy acid(s) and/or a salt(s) thereof”, and the claim also recites “optionally, in an amount from about 0.1 to about 6 wt.%, based on the total weight of the personal care composition” which is the narrower statement of the range/limitation.
Claims 45-46 also contain similar recitations of the term “optionally”.
In the instant case, optionally is used in the same context, and with the same meaning, as the term "preferably."
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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, 47 and 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2021/0275419, Sep.9, 2021) (hereinafter Li) in view of Cardoso de Lima et al. (US 2021/0059917, Mar. 4, 2021) (hereinafter Cardoso de Lima).
Li discloses personal care compositions comprising a complex comprising a plurality of short chain fatty acids (Abstract). The composition provides benefits for maintaining skin
elasticity and firmness (¶ [0002-0003]). The compositions comprise a first short chain fatty acid and a second short chain fatty acid (¶ [0006]). The blend may further comprise a polyol (¶ [0047]). Suitable polyols include glycerol (i.e., glycerin) (¶ [0057]). In one embodiment, the short chain fatty acids are lactic acid and pyruvic acid (¶ [0066]). In Example 1, lactic acid and pyruvic acid were used at a ratio of 4:1 lactic acid to pyruvic acid (¶ [0095]) (Table 1). Additional ingredients for use include skin conditioning agents (¶ [0069]). The composition may include skin compatible oils such mineral oil (¶ [0075]). The composition may comprise organic acids (¶ [0076]).
Li differs from the instant claims insofar as not disclosing wherein the composition comprises amino acids.
However, Cardoso de Lima discloses a dermocosmetic composition for combating skin ageing (Abstract). The composition comprises skin conditioning agents (¶ [0024]). Suitable skin conditioning agents include amino acids such as arginine, alanine, glycine, histidine, proline threonine, and valine (¶ [0031]).
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, Li discloses wherein the composition may comprise skin conditioning agents. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Li to comprise amino acids such as arginine, alanine, glycine, histidine, proline threonine, and valine since they are known skin conditioning agents for use in skin compositions which combat skin ageing as taught by Cardoso de Lima.
Regarding the ratio of the lactic acid to pyruvic acid recited in instant claim 43 (i.e., about 4:1), 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, in the example of Li in view of Cardoso de Lima the ratio of lactic acid to pyruvic acid was 4:1. Accordingly, because the ratio recited in the instant claims overlaps with the ratio disclosed by of Li in view of Cardoso de Lima the ratio disclosed by of Li in view of Cardoso de Lima meets the instantly recited limitations.
Regarding claim 47, as discussed above, suitable polyols include glycerol. Accordingly, a composition comprising such a component would have been obvious.
Regarding claims 50-51, as discussed above, the composition of Li in view of Cardoso de Lima comprises amino acids such as histidine, threonine, and valine. Accordingly, a composition comprising such amino acids would have been obvious.
Accordingly, the combined teachings of Li in view of Cardoso de Lima render obvious claims 43, 47 and 50-51.
2. Claim(s) 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2021/0275419, Sep.9, 2021) (hereinafter Li) in view of Cardoso de Lima et al. (US 2021/0059917, Mar. 4, 2021) (hereinafter Cardoso de Lima) and further in view of Han et al. (KR 102383715, Apr. 8, 2022) (hereinafter Han).
The teachings of Li in view of Cardoso de Lima are discussed above.
The combined teachings of Li and Cardoso de Lima differ from the instant claims insofar as not disclosing wherein the composition comprises alpha, beta or poly hydroxy acids.
However, Han discloses a cosmetic composition which has the effect of controlling sebum and dead skin and moisturizing (Abstract). The composition utilizes organic acids selected from the group consisting of AHA (α-hydroxy acid), BHA (β-hydroxy acid) and PHA (polyhydroxy acid) (¶ [0011]).
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, Li in view of Cardoso de Lima discloses wherein the composition may comprise organic acids. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Li in view of Cardoso de Lima to comprise organic acids such as AHA (α-hydroxy acid), BHA (β-hydroxy acid) and PHA (polyhydroxy acid) since they are known organic acids for use in skin care compositions as taught by Han.
Accordingly, the combined teachings of Li, Cardoso de Lima, and Han render obvious claims 44-46.
3. Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2021/0275419, Sep.9, 2021) (hereinafter Li) in view of Cardoso de Lima et al. (US 2021/0059917, Mar. 4, 2021) (hereinafter Cardoso de Lima) and further in view of Rawlings et al. (International Journal of Cosmetic Science, 2012, 34, 511- 518) (hereinafter Rawlings).
The teachings of Li in view of Cardoso de Lima are discussed above.
The combined teachings of Li and Cardoso de Lima differ from the instant claims insofar as not disclosing the specific amount of skin compatible oil used.
However, Rawlings discloses that the barrier effects of mineral oil can also be observed in the skin's susceptibility to stinging from lactic acid. It has been reported that the increasing the concentration of mineral oil in formulations containing the same concentration of lactic acid tended to decrease the stinging effect thereof, as the concentration of mineral oil increased from 10% to 50% (Pg. 514).
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 Li in view of Cardoso de Lima to comprise a skin compatible oil such as mineral oil in an amount ranging from 10-50% or in the same amount as the lactic acid used motivated by the desire to achieve the barrier effects of mineral oil as it relates to reducing the stinging effect of lactic acid as taught by Rawlings.
Accordingly, the combined teachings of Li, Cardoso de Lima, and Rawlings render obvious claim 48.
4. Claim(s) 43-48 and 50-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro et al. (US 6,649,176, Nov. 18, 2003) (hereinafter Shapiro) in view of Waldmann-Laue et al. (WO 2013/092080, Jun. 27, 2013) (hereinafter Waldmann-Laue).
Shapiro discloses a cosmetic composition comprising a mineral water and a compound such as pyruvic acid (Abstract). Cosmetic compositions containing mineral water, have been reported for the purpose of hydrating the skin (col 1, line 13-15). In one embodiment, the composition further comprises at least one nutrient or a skin-conditioning agent selected from the group consisting of an emollient and a humectant (col 1, line 30-32). Suitable nutrients include essential amino acids (col 3, line 56-60). Suitable amino acids include, but are not limited to, arginine, histidine, threonine, and valine (col 4, line 1-4). Suitable emollients include plant, nut, and vegetable oils (col 4, line 15-23). Suitable humectants include glycerin (col 4, line 25-30). The composition typically comprises from about 0.001 % to about 10% by weight of pyruvic acid (col 4, line 40-45). In one embodiment, the composition further comprises another cosmetically active agent such as hydroxy acids (col 4, line 46-51). These are typically present in an amount of from about 0.001 % to about 20% by weight of the composition (col 4, line 62-63). Suitable hydroxy acids include (i) alpha-hydroxy acids such as lactic acid, malic acid, citric acid, and tartaric acid; (ii) beta-hydroxy acids; and/or (iii) polyhydroxy acids (col 4, line 65-67 – col 5, line 1). Avocado oil was used in an amount of 0.1-5 wt. % in Example 4 (Table IV).
Shapiro differs from the instant claims insofar as not disclosing wherein the composition comprises glycine and alanine.
However, Waldmann-Laue discloses a composition for skin care which increases skin moisture comprising, among other components, lactic acid and at least one amino acid (Abstract). Suitable amino acids include alanine, glycine, histidine, proline threonine, and valine (Description, Pg. 2). The composition preferably further comprises pyruvic acid (Description, Pg. 29).
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, Shapiro discloses wherein the composition may comprise amino acids. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Shapiro to comprise glycine and alanine since they are known amino acids for use in skin moisturizing compositions which comprise lactic acid and pyruvic acid as taught by Waldmann-Laue.
Regarding the ratio of the lactic acid to pyruvic acid recited in instant claim 43 (i.e., about 4:1), 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, Shapiro in view of Waldmann-Laue discloses wherein the pyruvic acid may be contained in an amount of from about 0.001 % to about 10% by weight while additional actives such as lactic acid may be contained in an amount of from about 0.001 % to about 20% by weight of the composition. 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 ranges and the ratio thereof overlapping with the claimed ratio.
Regarding claim 44, as discussed above, the composition of Shapiro in view of Waldmann-Laue comprises alpha-hydroxy acids. Accordingly, a composition comprising such acids would have been obvious.
Regarding claim 45, as discussed above, the composition of Shapiro in view of Waldmann-Laue comprises beta-hydroxy acids. Accordingly, a composition comprising such acids would have been obvious.
Regarding claim 46, as discussed above, the composition of Shapiro in view of Waldmann-Laue comprises poly-hydroxy acids. Accordingly, a composition comprising such acids would have been obvious.
Regarding claim 47, as discussed above, suitable humectants include glycerin. Accordingly, a composition comprising such a component would have been obvious.
Regarding claim 48, 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, suitable emollients include plant oils and avocado oil was used in an example in an amount of 0.1-5 wt. %. Accordingly, because the range recited in the instant claims overlaps with the range disclosed by Shapiro in view of Waldmann-Laue, the range disclosed by Shapiro in view of Waldmann-Laue meets the instantly recited limitations.
Regarding claims 50-51, as discussed above, the composition of Shapiro in view of Waldmann-Laue comprises amino acids such as histidine, threonine, and valine. Accordingly, a composition comprising such amino acids would have been obvious.
Accordingly, the combined teachings of Shapiro and Waldmann-Laue render obvious claims 43-48 and 50-51.
Response to Arguments
Applicant’s arguments filed 8/17/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments with respect to the previous rejections in view Leva and the ratio of lactic acid to pyruvic acid, upon further search, the Examiner found Li which discloses the exact combination of lactic acid and pyruvic acid in the exact ratio claimed and found Shapiro which discloses cosmetic compositions with specified amounts of each of lactic acid and pyruvic acid that would result in a ratio that overlaps with the instantly claimed ratio.
Accordingly, and while not agreeing, Applicant’s arguments with respect to the previous rejection are moot at this time.
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 50-51 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 50-51 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 50-51 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 50-51 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 50-51 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 50-51 are rejected.
No claims are allowed.
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.
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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
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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