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 .
Restriction/Election
Requirement for Restriction/Election was mailed 04 December 2025.
Applicant’s Response to Requirement for Restriction/Election was received 04 February 2026.
Applicant’s election without traverse of a single species of aqueous surfactant, a single species of an oil phase surfactant, and one of Cu-peptide, gamma-PGA, or hyaluronic acid in the Response filed 04 February 2026 is acknowledged.
Applicant indicated the elected claims (i.e., the claims which read on the elected species) are claims 1-4, 7-9, and 12. Accordingly, the non-elected claims 5-6, 10-11, and 13-14 are withdrawn (Response, p. 2, Identification of Elected Claims).
Status of the Claims
The listing of claims filed 01 February 2026 has been examined.
Claims 1-14 are pending.
Claims 1, 3-4, 6, 9, and 11 are amended.
Claims 5-6, 10-11, and 13-14 are withdrawn.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 08 April 2023 is acknowledged and has been considered.
Benefit of Earlier Filing Date
The instant application, filed 08 April 2023, is a national stage application of PCT/US21/54075, filed 08 October 2021, which claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/089,035, filed 08 October 2020. Acknowledgment is made of Applicant’s claim.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied, specifically the phrases “Disclosed herein…” and “Also disclosed here are…” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 3, 5, 8, and 10 are objected to because of the following informalities:
Claim 3 recites, “…said composition further comprises: about 0.05% to about 2.0% of NiSOD stock solution; about 1% to about 20% of polyoxyethane series or polyethylene oxide.” The word “and” appears to be missing. Examiner suggests amending to, “…NiSOD stock solution; and about 1% to about 20% of polyoxyethane series…” [Emphasis added.]
Claim 5 recites, “…about 0.05% to about 2.0% of NiSOD stock solution; about 5% to about 18% of Surfactant…” The word “and” appears to be missing. Examiner suggests amending to, “…about 0.05% to about 2.0% of NiSOD stock solution; and about 5% to about 18% of Surfactant…” [Emphasis added.]
Claim 8 recites, “…about 0.05% to about 2.0% of NiSOD stock solution; about 7% to about 16% oil-soluble Polyol fatty acid ester.” The word “and” appears to be missing. Examiner suggests amending to, “…about 0.05% to about 2.0% of NiSOD stock solution; and about 7% to about 16% oil-soluble Polyol fatty acid ester.” [Emphasis added.]
Claim 10 recites, “…about 0.05% to about 2.0% of NiSOD stock solution; about 10% to about 25% Multi-surfactant polyoxyethylene-polyoxypropylene series nonionic surfactant.” The word “and” appears to be missing. Examiner suggests amending to, “…about 0.05% to about 2.0% of NiSOD stock solution; and about 10% to about 25% Multi-surfactant polyoxyethylene-polyoxypropylene series nonionic surfactant.” [Emphasis added.]
Appropriate correction is requested.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 12 recites the instantly claimed composition comprises “Cu-peptide.” This is a broad genus and, according to its broadest reasonable interpretation, includes any Cu-containing peptide. For example, “Cu-peptide” could include GHK-Cu as well as other copper peptides used in skincare, such as copper lysinate. However, the Specification mentions only one Cu-peptide, GHK-Cu (p. 3, ¶ [0017]). Thus, the instant application lacks sufficient variety in the disclosed species to reflect the variance within the genus which is encompassed by the term “Cu-peptide.” Furthermore, based on the single example provided for the claimed genera, a representative number of examples to support the claimed genera is lacking and a person having ordinary skill in the art (PHOSITA) would conclude that Applicant is not in possession of the claims, as currently recited. Examiner suggests amending to replace “Cu-peptide” with “GHK-Cu.”
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-4, 7-9, and 12 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.
Claim 1 recites the limitation, “…NiSOD or a derivative thereof…” This is a broad genus which includes many SOD derivatives. A “derivative” could include innumerable additional enzymes, including those lacking substantial structural similarity to NiSOD. Furthermore, it is unclear how much structural variance is permitted by the term, “NiSOD or a derivative thereof,” and Examiner interprets this phrase broadly according to its broadest reasonable interpretation, which is NiSOD and other compounds recognized in the art as either structural or functional analogs. While the Specification indicates SOD mimetics which are disclosed by U.S. Patent No. 9,358,239 are “preferrable” (p. 1, ¶ 0006]) and discloses exemplary derivatives (p. 8, ¶ [0042]), the term “derivative” itself is not defined by the Specification, which leads to this term having multiple interpretations. Examiner suggests amending claim 1 to recite only the NiSOD derivatives which are supported by the disclosure.
Claims 3, 8, and 12 recite the limitation, “NiSOD stock solution.” While the Specification provides exemplary embodiments of “NiSOD stock solution,” the claim language renders the meaning of “NiSOD stock solution” unclear because a “NiSOD stock solution” could include a solution containing any amount of NiSOD and, potentially, other components such as polyethylene oxide. Accordingly, Examiner interprets “NiSOD stock solution” as a solution containing at least NiSOD. Additionally, claims 3, 8, and 12 indicate the composition “further comprises” the NiSOD stock solution. It is unclear whether the NiSOD stock solution is in addition to the original amount of NiSOD recited by claim 1 or if the NiSOD stock solution contains the original amount of NiSOD recited by claim 1. Examiner suggests amending “NiSOD stock solution” to “NiSOD”, or similar.
Claim 3 recites the limitation, “…polyoxyethane series or polyethylene oxide.” The phrase “polyoxyethane series” is not defined by or contained within the Specification. Thus, the compounds which Applicant intends to be encompassed by this phrase is unclear. While claim 4 indicates this phrase encompasses Polyethylene glycol, Polypropylene glycol, and alkoxy polyethylene glycol/Polypropylene glycol copolymer, the other structures which are included in the series are undefined. Accordingly, Examiner suggests amending claim 3 to remove the phrase “polyoxyethane series” and replacing this phrase with only the polyethylene glycols which are supported by the disclosure.
Dependent claims which do not rectify indefiniteness issues are included in this rejection.
Claims 4 and 9 are rejected under 35 USC 112(b) on the basis that these claims contain improper Markush groups. Claims 4 recites the phrase, “…wherein said polyoxyethane includes Polyethylene glycol, Polypropylene glycol, and alkoxy polyethylene glycol/Polypropylene glycol copolymer.” [Emphasis added.] The phrase “wherein… includes…” suggests a Markush group, which includes alternative components. However, the word “and” suggests all of the alternatives are required. Thus, it is unclear whether the claim requires any one of Polyethylene glycol, Polypropylene glycol, or alkoxy polyethylene glycol/Polypropylene glycol copolymer or if the claims require all three of Polyethylene glycol, Polypropylene glycol, or alkoxy polyethylene glycol/Polypropylene glycol copolymer. Similarly, claim 9 recites the phrase, “…wherein said Oil-soluble polyol fatty acid ester includes Propylene Glycol Monostearate, Ethylene glycol fatty acid ester, Sorbitan Monostearate, and Propylene Glycol Monolaurate.” [Emphasis added.] Thus, it is unclear whether the claim requires all the listed components, only one component, or at least one component. Examiner interprets the lists recited by claims 4 and 9 as Markush groupings with the species elected in the Response dated 04 February 2026. Examiner suggests amending “and” to “or”, or similar. See MPEP 2173.05(h).
Dependent claims which do not rectify indefiniteness issues are included in this rejection.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (WO 2004/010958 A2) in view of Bafana (Bafana et al., “Superoxide dismutase: an industrial perspective”, Critical Reviews in Biotechnology, 2011, 31(1), p. 66-76.; IDS dated 08 April 2023, Cite No. 2).
Regarding claims 1-2, Siddiqui teaches cosmetic hair care products which are intended to improve hair quality (p. 1, Lines 11-16). Siddiqui indicates hair growth depends on keeping hair nourished, conditioned, and moisturized (p. 3, Lines 24-25). The hair care compositions disclosed by Siddiqui include an antioxidant, which can be superoxide dismutase (SOD) (p. 4, Lines 28-30; p. 8, Line 28), which can help protect the scalp from the damaging free radicals produced by ultraviolet light and environmental pollutants (p. 10, Lines 9-13). Furthermore, Siddiqui discloses an exemplary scalp serum formulation comprising 0.00001-7.0000% (w/w) SOD and 0.0001-25.0000% (w/w) Polysorbate 80 (p. 12, Line 35 – p. 13), which a skilled artisan would recognize as an aqueous phase surfactant.
Siddiqui does not explicitly teach NiSOD.
Bafana teaches SODs can have four different types of metal centers, including Ni (p. 65, ¶ 2). Bafana states SOD is widely used in cosmetic products to reduce free radical damage and promote general health of the body and SODs have been shown to offer protection against UV rays, prevent hair graying, and promote hair growth (p. 67, Col. 2).
Bafana does not explicitly teach an exemplary hair care formulation containing SOD.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Siddiqui would have found it prima facie obvious to prepare a composition for treating hair follicle degeneration and/or hair graying based on the teachings of Bafana because Bafana teaches Ni can be the metal center in SOD and suggests SODs are useful in promoting hair growth and preventing hair graying and Siddiqui discloses an exemplary hair serum composition containing 0.00001-7.0000% (w/w) SOD and 0.0001-25.0000% (w/w) Polysorbate 80. Thus, a PHOSITA would have been motivated to prepare a composition containing SOD and an aqueous phase surfactant according to Siddiqui’s teachings because Bafana indicates SODs like NiSOD are useful in supporting hair growth. Furthermore, based on the ranges provided by Siddiqui, a PHOSITA would have been motivated to optimize the amount of NiSOD in the composition based on the desired effect on hair growth and/or graying via routine optimization (MPEP 2144.05(II)).
Claims 3-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (WO 2004/010958 A2) in view of Bafana (Bafana et al., “Superoxide dismutase: an industrial perspective”, Critical Reviews in Biotechnology, 2011, 31(1), p. 66-76.; IDS dated 08 April 2023, Cite No. 2) and Joerger (US 2015/0125403 A1).
Regarding claims 3-4, Siddiqui in view of Bafana teaches all of the claimed elements as stated above.
With respect to claims 3-4, the combination fails to explicitly teach a composition comprising about 1-20% of a polyoxyethane series compound or polyethylene oxide.
Joerger teaches personal care and cosmetic compositions including hair products such as conditioner and hair treatment cream (p. 6, ¶ [0075]). Joerger’s compositions may include anti-oxidants/radical scavengers, like superoxide dismutase, in amounts from about 0.1-10% of the composition (p. 9-11, ¶ [140-141]). The compositions may also comprise various sensory modifiers, like humectants and emollients, in amounts up to 20% by weight of the composition (p. 12, ¶ [0173]). Joerger notes humectants provide desirable moisturizing properties to the composition and lists exemplary humectants including polyols, like polypropylene glycols and polyethylene glycols, as well as polyhydric alcohols, like 1,2-propanediol (p. 12, ¶ [0170]).
Joerger does not explicitly teach an exemplary hair care composition containing NiSOD.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Siddiqui would have found it prima facie obvious to prepare a composition comprising about 0.05-2.0% NiSOD and 5-20% polyoxyethane based on the teachings of Bafana and Joerger because the instantly recited NiSOD amount is within the SOD range disclosed by Siddiqui and Joerger suggests including a similar SOD amount as well as up to 20% of a sensory modifier, which could be humectants like polyethylene glycols and/or polypropylene glycols. Furthermore, a skilled artisan would have been motivated to include polyethylene glycols and/or polypropylene glycols in the composition because Joerger indicates such components provide additional benefit to the composition as moisturizers.
Regarding claims 7-9, Siddiqui in view of Bafana and Joerger teaches all of the claimed elements as stated above. Furthermore, Siddiqui discloses a hair conditioner formulation comprising 0.001-15.00% (w/w) glyceryl stearate (p. 15), which a skilled artisan would recognize as an oil phase surfactant.
Additionally, Joerger teaches esters made using 1,3-propanediol and other biologically-derived glycols, such esters including propanediol monostearate and propanediol monolaurate, can also be included as emollients in the disclosed compositions (p. 10, ¶ [0145] and [150]). A skilled artisan would recognize 1,2-propanediol monostearate and 1,2-propanediol monolaurate can also be referred to as Propylene Glycol Monostearate and Propylene Glycol Monolaurate, respectively. Furthermore, as stated above, Joerger indicates the compositions may also comprise various sensory modifiers, like emollients, in amounts up to 20% by weight of the composition (p. 12, ¶ [0173]).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Siddiqui would have found it prima facie obvious to prepare a composition comprising about 7-16% of an oil phase surfactant based on the teachings of Bafana and Joerger because Siddiqui and Joerger both disclose oil phase surfactants, with Joerger specifically indicating propanediol monostearate or propanediol monolaurate can be included in the composition.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (WO 2004/010958 A2) in view of Bafana (Bafana et al., “Superoxide dismutase: an industrial perspective”, Critical Reviews in Biotechnology, 2011, 31(1), p. 66-76.; IDS dated 08 April 2023, Cite No. 2), Joerger (US 2015/0125403 A1), and Ding (CN 105106028 A).
Regarding claim 12, Siddiqui in view of Bafana and Joerger teaches all of the claimed elements as stated above. Furthermore, in Siddiqui’s exemplary scalp serum formulation suggests including 5.0000-96.0000% (w/w) water (p. 13).
However, the combination of Siddiqui, Bafana, and Joerger does not explicitly teach including about 0.5-1.5% of a Cu-peptide.
Ding teaches cosmetic compositions for promoting hair growth which include polypeptides (p. 1, Technical Field). Ding indicates copper peptides have been known to stimulate hair follicles to grow hair since the 1980s (p. 2, 4. Polypeptide is used to promote the condition of hair growth). Thus, Ding’s compositions include a collagen-stimulating protein, which can be copper peptide (GHK-Cu) and Ding indicates, “…the concentration of each polypeptide component is 0.01-5% (w/w) and the solvent is water.” (p. 2, SUMMARY OF THE INVENTION, b.).
Ding does not explicitly teach SOD.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Siddiqui would have found it prima facie obvious to prepare a composition comprising about 0.5-1.5% Cu-peptide and about 76.3-84.1% water based on the teachings of Bafana, Joerger, and Ding because Siddiqui and Ding both disclose hair care compositions and specifically mention promoting hair growth. Thus, a PHOSITA would have had a reasonable expectation of success in preparing a composition for promoting hair growth by including multiple ingredients in the composition which have been identified in the art for their ability to support hair growth, specifically Cu-peptide as noted by Ding and superoxide dismutase as indicated by the combination of Siddiqui and Bafana. Additionally, because Joerger indicates components like polyols are useful as humectants in cosmetic compositions in amounts up to 20% by weight (¶ [0170] and [0173] ), a skilled artisan would have known to optimize the humectant amount in the composition in relation to the other components based on the desired moisturizing effect (MPEP 2144.05(II)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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