Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Receipt of Applicants’ Response, filed 29 August 2025, is acknowledged. Applicants have amended claims 1, and 7 – 9, and added new claim 21. Accordingly, claims 1, 4 – 9, and 11 - 21 are available for substantive consideration.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 29 August 2025, which is now of record in the file.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejection pursuant to 35 U.S.C. § 112(d) set forth in the Action of 30 May 2025 is hereby withdrawn in light of Applicants’ amendment to claim 11.
Claim Issues
In the claim set filed 29 August 2025, Applicants made amendment to a number of claims. In claims where Applicants made changes, the claim set included the claim identifier, “Currently Amended,” to indicate the fact of the Amendment. However, the amendments for claims 1 and 7 did not comport with 37 C.F.R § 1.21(c)(2) in that Applicants did not provide “markings to indicate the changes that have been made relative to the immediate prior version of the claims,” as required. Appropriate correction is necessary.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected pursuant to 35 U.S.C. § 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7, dependent from claim 1, recites a limitation directed to the niacinamide present in the composition of the invention being present in an amount from 1 – 5% wgt. However, claim 1 recites that the niacinamide is present in the composition in an amount from 0.05 to 3.5% wgt. Consequently, the scope of claim 7, as defined by the amount of niacinamide in the composition, is broader than that of claim 1, in violation of § 112(d).
Applicants may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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, 3, 4, 7 – 9, 11, 12, 14, 16, 19, 20, and 21 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2008/0206169 A1 to Millikin, C. and D. Bissett, published 28 August 2008 (“Millikin ‘169”), as evidenced by CAS: 1115-47-5, obtained from the Internet at https://www.tcichemicals.com-/US/en/p/A0100, on 22 May 2025.
The Invention As Claimed
Applicants claim a topical personal care composition comprising (a) from 0.05 to 3.5% wgt of niacinamide (see Structural Formula 3), (b) from 0.01 to 6% wgt, or from 0.01 to 2% wgt, of N-acetylmethionine, and (c) a cosmetically acceptable carrier, wherein the composition is a skin cosmetic composition, wherein the composition further comprises stearic acid, hydroxystearic acid, or a combination thereof, wherein the composition further comprises a thickening agent, wherein the composition further comprises a cationic ammonium compound, wherein the composition further comprises hydroxyl urea, wherein the composition further comprises glycerol, and wherein the composition further comprises Vitamin A.
Applicants also claim a method for preventing mitochondrial fragmentation in the skin of an individual in need thereof by topically applying to the skin the composition comprising from 0.05 to 3.5% wgt of niacinamide, from 0.01 to 6% wgt, or from 0.01 to 2% wgt, of N-acetylmethionine, and a cosmetically acceptable carrier, wherein the composition comprises from 1 to 5% wgt of niacinamide, or from 0.05 to 3% wgt, and wherein the composition comprises from 0.01 to 3% wgt of N-acetylmethionine, or from 0.000001 to 10% wgt.
The Teachings of the Cited Art
Millikin ‘169 discloses personal care compositions comprising a skin care active, such as an acetyl methionine, and a dermatologically effective carrier (see Abstract), wherein the compositions comprise an additional skin care active, such as a vitamin B compound, a chelator, skin lightening compounds, and/or vitamins, among others (see ¶[0006]), wherein the compositions are used in methods to treat skin-related conditions by topically applying the compositions to the skin of a mammal needing such treatment (see ¶[0007]), wherein the compositions may be used in a variety of personal care products, including moisturizers, conditioners, cleansers, sunscreens, anti-aging compounds, cosmetics, and combinations thereof, the compositions being in a variety of forms, including an emulsion, lotion, milk, liquid, solid, cream, gel, mousse, ointment, paste, serum, stick, spray, tonic, aerosol, foam, pencil, etc. (see ¶[0011]), wherein the compositions comprise acetyl methionine (CAS 1115-47-5) which, as evidenced by CAS: 1115-47-5, is N-acetyl methionine (cf. claim 3), present at loadings of from about 0.01 to about 10% wgt (see ¶[0031]), wherein the compositions comprise at least one additional skin care active, useful for regulating and/or improving the condition of mammalian skin (see ¶[0037]), wherein the additional skin care actives, such as niacinamide (vitamin B3) and vitamin A, are present at loadings of from about 0.0001 to about 50% wgt (see ¶[0038]), wherein the niacinamide can also function as an oil control agent, at loadings of from about 0.0001 to about 15% wgt (see ¶[0043]), wherein the compositions can further comprise optional components, such as thickeners, at loadings from about 0.05 to about 5% wgt (see ¶[0061]), and wherein the compositions further comprise moisturizing/conditioning agents, such as glycerol, at loadings of from 0.01 to about 20% wgt (see ¶[0060]). The reference does not explicitly disclose compositions comprising niacinamide at from 0.05 to 3.5% wgt, and N-acetyl methionine at from 0.01 to 6% wgt with sufficient specificity to rise to the level of anticipation. Although “picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference . . . has no place in . . . a 102, anticipation rejection,” picking and choosing may be entirely proper in an obviousness rejection. In re Arkley, 455 F.2d 586, 587 (CCPA 1972).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare personal care compositions comprising a skin care active, such as an acetyl methionine which, as evidenced by CAS: 1115-47-5, is N-acetyl methionine, and a dermatologically effective carrier, wherein the compositions comprise an additional skin care active, such as a vitamin B compound, wherein the compositions comprise acetyl methionine, present at loadings of from about 0.01% to about 10% wgt, and additional skin care actives, such as niacinamide (vitamin B3), vitamin A, a chelator, and a sunscreen, at loadings of from about 0.0001 to about 50% wgt, wherein the compositions can further comprise optional components, such as thickeners, and wherein the compositions further comprise moisturizing/conditioning agents, such as glycerol, as disclosed by Millikin ‘169.
With respect to the limitations recited in claims directed to the quantitative loadings (from 0.05 to 3.5% wgt) of niacinamide and N-acetyl methionine (from 0.01 – 6% wgt), the Examiner notes that the cited reference does not disclose loadings that are exactly congruent with the limitations at issue. However, it is the Examiner’s position that the reference teaches a range of loadings of these components that significantly overlaps with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1, 3, 4, 7 – 9, 11 – 12, 14, 16, 19, 20, and 21 would have been obvious within the meaning of 35 USC § 103.
Claims 13, 15, 17, and 18 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Millikin ‘169, as applied in the above rejection of claims 1, 3, 4, 7 – 9, 11 – 12, 14, 16, 19, 20, and 21, and further in view of US 2008/0299054 A1 to Chandar, P. and L. Yang, published 4 December 2008 (“Chandar ‘054”).
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicants claim a topical personal care composition comprising a ceramide , such as Ceramide 1, Ceramide 3, Ceramide 36, Ceramide 6, or combinations thereof, hydroxystearic or stearic acids, and wherein the composition further comprises at least one cationic ammonium compound, such as hydroxyethyl urea.
The Teachings of the Cited Art
The teachings of Millikin ‘169 are relied upon as set forth in the above rejection of claims 1, 3, 4, 7 – 9, 11 – 12, 14, 16, 19, 20, and 21. The reference does not disclose compositions comprising niacinamide and N-acetyl methionine that further comprise Ceramides, stearic or hydroxystearic acids, or hydroxyethyl urea. The teachings of Chandar ‘054 remedy those deficiencies.
Chandar ‘054 discloses personal care products that include a fragrance, a substituted urea, and a quaternary ammonium salt, and that are applied to the skin or hair (see Abstract), wherein the term, personal care composition, is meant any product applied to a human body for improving appearance, cleansing, odor control or general aesthetics, for example leave-on skin lotions and creams, shampoos, conditioners, shower gels, toilet bars, antiperspirants, deodorants, shave creams, depilatories, lipsticks, foundations, mascara, sunless tanners, and sunscreen lotions (see ¶[0015]), wherein the compositions comprise scent boosting components such hydroxyethyl urea (see ¶[0017]), in amounts ranging from about 0.01 to about 20% wgt (see ¶[0019]), wherein the compositions also include cosmetically acceptable carriers, such as fatty acids or fatty alcohols, in amounts of ranging from about 1 to about 99.9% wgt (see ¶[0121]), the fatty acids having from 10 to 30 carbon atoms, such as stearic and hydroxystearic acids (see ¶[0131]), and wherein the compositions comprise Ceramides, such as Ceramide 1, Ceramide 3, Ceramide 3B, Ceramide 6, and Ceramide 7) in amounts from about 0.000001 to about 10% (see ¶[0148), as well as opacifiers (see ¶[0149]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare personal care compositions comprising a skin care active, such as an acetyl methionine, and a dermatologically effective carrier, wherein the compositions comprise an additional skin care active, such as a vitamin B compound, wherein the compositions comprise acetyl methionine, present at loadings of from about 0.01% to about 10% wgt, and additional skin care actives, such as niacinamide (vitamin B3) and vitamin A, at loadings of from about 0.0001 to about 50% wgt, wherein the compositions can further comprise optional components, such as thickeners, at loadings from about 0.05 to about 5% wgt, and wherein the compositions further comprise moisturizing/conditioning agents, such as glycerol, as disclosed by Millikin ‘169, and wherein the personal care compositions that include a substituted urea, wherein the compositions comprise Ceramide 1, Ceramide 3, Ceramide 36, Ceramide 6, or combinations thereof, and hydroxyethyl urea, and wherein the compositions also include cosmetically acceptable carriers, such as fatty acids or fatty alcohols, in amounts of ranging from about 1 to about 99.9% wgt, the fatty acids having from 10 to 30 carbon atoms, such as stearic and hydroxystearic acids, as taught by Chandar ‘054. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of the reference to the effect that these components have utility in personal care compositions for application to the skin.
The Examiner notes that the preamble of claim 1 is directed to a composition “for improving cellular energy efficiency.” It is the Examiner’s position that such recitation is nothing more than a statement of intended purpose and, as such, is not accorded patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 13, 15, 17, and 18 would have been obvious within the meaning of 35 USC § 103.
Claims 5 and 6 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Millikin ‘169, in view of Chandar ‘054, as applied to the above rejection of claims 1, 3, 4, 7 – 9, 11 – 12, 14, 16, 19, 20, and 21, and further in view of Mellem, D., et al., PLoS ONE 12(6): e0174469 [https://doi.org/-10.1371/journal.pone.0174469 (2017) (“Mellem (2017)”).
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicants claim a method for preventing mitochondrial fragmentation in the skin of an individual in need thereof by topically applying to the skin the composition according to claim 1, and wherein the method improves cellular energy efficiency by protecting the skin of an aging individual in need thereof from mitochondrial fragmentation.
The Teachings of the Cited Art
The teachings of Millikin ‘169 and Chandar ‘054 are relied upon as applied in the above rejection of claims 1, 3, 4, 7 – 9, 11 – 12, 14, 16, 19, 20, and 21. The reference does not explicitly disclose the use of compositions comprising niacinamide and N-acetylmethionine for preventing mitochondrial fragmentation in the skin. The teachings of Mellem (2017) remedy that deficiency.
Mellem (2017) discloses investigations into mitochondrial morphologies during aging in human skin in vivo by exploring variations of the mitochondrial network in epidermal keratinocytes of young and old volunteers, wherein mitochondria form dynamic networks which adapt to the environmental requirements of the cell, wherein the studies on the age-dependency of the mitochondrial network in young and old volunteers revealed that keratinocytes in old skin establish a significantly more fragmented network with smaller and more compact mitochondrial clusters than keratinocytes in young skin (see Abstract), wherein a fragmentation of the mitochondrial network with age was observed in vitro (see p. 1, Introduction), wherein granular epidermal keratinocytes in young skin have fewer clusters in total than keratinocytes in old skin, and clusters in granular keratinocytes of young volunteers are bigger in size and less circular in shape, revealing a high connectivity among mitochondria in the stratum granulosum in young skin and a fragmented mitochondrial network in the stratum granulosum of old skin (see p. 4, 4th para.), and wherein mitochondrial aging processes lead to a quality decay of mitochondria, which process correlates well with age-related decrease in mitochondrial membrane potentials (MMP) (see p. 7, 3rd. para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a composition according to the teachings of Millikin ‘169 and Chandar ‘054 for topical application to the skin, wherein application of the compositions counters the effects of extrinsic and intrinsic factors on the skin that leads to, or inherently occurs with aging, which processes are characterized by a significantly more fragmented network of keratinocytes with smaller and more compact mitochondrial clusters than demonstrated by keratinocytes in young skin, as taught by Mellem (2017). One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Mellem (2017) establishing a correlation between fragmentation of keratinocytes and conditions associated with aging and skin damage.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 5 and 6 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants in their Response filed August 2025 but does not find them fully persuasive. Applicants first argue that “the cited references lack any indication that if the presently claimed components were chosen, the resulting composition would be able to achieve the technical advantages described in the present application,” and further that the cited art “does not provide the motivation to select the required components within the presently claimed ranges and does not provide any indication that, if the instantly claimed components in the claimed ranges were chosen, the resulting composition would provide the advantages of the present invention.” In this regard, it is the Examiner’s position that the fact that Applicants have 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). In this regard, Applicants are reminded that the invention as claimed is directed to a composition of matter, and that, as a consequence, the reasons for combining the teachings of cited references, are not necessarily controlling to the patentability of the compositions, as claimed. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
More specifically, Applicants argue that the invention as claimed “is simply not taught or even suggested by the cited prior art.” The Examiner respectfully disagrees. First of all, with respect to claims 1, 3, 4, 7 – 9, 11 – 12, 14, 16, 19, 20, and 21, Millikin ‘169, the primary obviousness reference, discloses all of the components of Applicants’ composition, except for Ceramides, hydroxystearic acids, and hydroxyethyl urea. These deficiencies are supplied by the teachings of Chandar ‘054, which reference discloses personal care products that are applied to the skin or hair including any product applied to a human body for improving appearance, cleansing, odor control, or general aesthetics, including leave-on skin lotions and creams, shampoos, conditioners, shower gels, toilet bars, antiperspirants, deodorants, shave creams, depilatories, lipsticks, foundations, mascara, sunless tanners, and sunscreen lotions (see ¶[0015]). Furthermore, the reference explicitly discloses that the Ceramides, hydroxystearic acids, and hydroxyethyl urea demonstrate utility in skin care compositions. In light of that, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron).
Furthermore, Applicants claim the Ceramides, chelator, opacifier, and sunscreen active as “optional additional skin benefit agent.” Consequently, as addressed in the above rejection, the cited art does not need to read on these optional components to read on the invention as claimed.
Consequently, Applicants’ arguments are unpersuasive, and claims 1, 4 – 9, and 11 - 21 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS 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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619