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 .
Election/Restrictions
Applicant's election with traverse of (i) a single disclosed hydrophilic vitamin C derivative species-Bis-Glyceryl Ascorbate, (ii) a single disclosed lipophilic vitamin C derivative species-Tetrahexyldecyl Ascorbate, and (iii) a single disclosed amphiphilic vitamin C derivative species-Myristyl 3-Glyceryl Ascorbate in the reply filed on 07/13/2026 is acknowledged. The traversal is on the ground(s) that the Restriction Requirement is unclear. This is not found persuasive because first of all, the species election requirement was made based upon the scope of the claims pending at the time the requirement was entered. In particular, claim 1, prior to the present amendment, generically recited a hydrophilic vitamin C derivative, a lipophilic vitamin C derivative, and an amphiphilic vitamin C derivative without limiting each of those classes to the particular species now recited in the amended claim 1. Claims 13-15 further identified multiple discloses species falling within the respective hydrophilic, lipophilic, and amphiphilic classes. Accordingly, examination of the then-pending generic claims would have required consideration of materially different combinations of vitamin C derivative species having different chemical structures and associated physical and chemical properties.
The statement in the election requirement that “each compound is distinct” referred to the individual disclosed vitamin C derivative species with their respective hydrophilic, lipophilic, and amphiphilic classes, rather than merely to the three general classes of hydrophilic, lipophilic, and amphiphilic derivatives. The requirement therefore called for election of one disclosed species from each of the three classes so that a definite combination of species could be searched and examined on the merit.
Applicant further argues that the disclosed vitamin C derivatives possess certain common chemical or physical properties, including vitamin C-related properties, solubility characteristics, and stability. Such common characteristics do not, however, establish that the individual discloses species are patentably distinct from one another. The individual species differ in chemical structure and associated properties, and Applicant has not established that the nonelected species are obvious variants of the elected species or otherwise patentably indistinct therefrom.
Applicant subsequently elected (i) a single disclosed hydrophilic vitamin C derivative species-Bis-Glyceryl Ascorbate, (ii) a single disclosed lipophilic vitamin C derivative species-Tetrahexyldecyl Ascorbate, and (iii) a single disclosed amphiphilic vitamin C derivative species-Myristyl 3-Glyceryl Ascorbate and amended claim 1 to expressly recite those elected species. The subsequent amendment of claim 1 to the elected species does not render the species election requirement improper when made or require withdrawal of the requirement. Rather, the amendment limits the claims presently under examination to the elected combination species. The requirement is still deemed proper and is therefore made FINAL.
Priority
The effective filing date of this application is November 27, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/06/2025 has been considered by the examiner.
Status of Claims
Claims 1-12 and 16-18 are pending and examined in accordance to the elected species. Claims 13-15 are canceled.
Claim Objections
Claims 10-12 are objected to because of the following informalities: claims 10-12 recite that “the effective amount in the active vitamin C derivatives to form” a specified weight percentage of the skincare formulation. The recited language is grammatically inaccurate and unclear in form because an “amount” does not “combine to form” a weight percentage. Rather, it appears that Applicant intends to recite the combined amount of the active vitamin C derivatives as constituting the specific weight percentage of the skincare formulation. Appropriate correction is required. For example, claim 10 may be amended to recite: “wherein the active vitamin C derivatives are present in a combined amount of between 5-30 wt.% of the skincare formulation.” Claims 11 and 12 should be correspondingly amended.
Claim 10 recites “derivates” instead of “derivatives.” The proper language should be “derivatives.”
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.
Claims 1-12 and 16-18 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). In the present instance, claim 1 initially recites that “the active vitamin C derivatives include a hydrophilic vitamin C derivative, a lipophilic vitamin C derivative, and an amphiphilic vitamin C derivative,” thereby broadly defining the respective vitamin C derivatives by their hydrophilic, lipophilic, and amphiphilic characteristics. Claim 1 subsequently recites that the “the hydrophilic vitamin C derivative is bis-glyceryl ascorbate, the lipophilic vitamin C derivative is tetrahexyldecyl ascorbate, and the amphiphilic vitamin C derivative is myristyl 3-glyceryl ascorbate,” thereby more narrowly defining the previously recited derivatives as particular species. The claims 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 3 recites that “the lipophilic vitamin C derivative and the hydrophilic vitamin C derivative are included in approximately equal amounts.” The phrase “approximately equal amounts” constitutes a term of degree for which the specification does not provide an objective standard by which one of ordinary skill in the art could determine the scope of the limitation. Although the specification repeatedly describes the lipophilic and hydrophilic vitamin C derivatives as being present in “approximately equal amounts,” the specification does not define the permissible degree of variation between the respective amounts, provide a numerical tolerance or ratio corresponding to “approximately equal,” or otherwise establish an objective boundary for determining when two amounts cease to be approximately equal.
The disclosure of particular embodiments containing equal or specified amounts does not resolve the ambiguity because such embodiment provides examples falling within the limitation but do not establish the outer boundary of what constitutes “approximately equal.”
Accordingly, it is unclear, for example, amounts differing by 5%, 10%, 25%, 40%, or some other amounts would satisfy the recited limitation. One of ordinary skill in the art therefore would not be reasonably apprised of the metes and bounds of “approximately equal amounts.”
Claim 4 recites that “the lipophilic vitamin C derivative and the hydrophilic vitamin C derivative are included in amounts that differ by less than 50.” This imitation is indefinite because neither the claim nor the specification identifies the reference amount of calculation methodology from which the recited percentage difference is to be determined. For example, where the respective derivatives are present at 6 wt.% and 9 wt.%, the absolute difference is 3 percentage points; however, the percentage difference may be calculated as 50% relative to the 6 wt.% amount, approximately 33% relative to 6 wt.% amount, or 40% relative to the average of the two amounts. These calculations do not necessarily result in the same determination as to whether the “less than 50%” limitation is satisfied.
Although the specification repeats the “differ by less than 50% terminology, it does not identify which of the respective amounts, or what other quantity, constitutes the denominator/reference value for calculating the percentage difference. Accordingly, one of ordinary skill would not be apprised of the metes and bounds of the claimed limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-12 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Foss et al. (US2021/0186840 A1) in view of Kim (KR20160068177A). The machine English translation of Kim is provided as Kim is already cited in the IDS filed 03/06/2025.
Foss teaches topical composition comprising stabilized vitamin C derivatives for application to human skin. In particular, Foss teaches aqueous compositions comprising stabilized ascorbates, especially oil-soluble ascorbates, and expressly identifies tetrahexyldecyl ascorbate (THA) and bisglyceryl ascorbate (BGA) as suitable ascorbate derivatives for use in human skin, hair and/or nails. (See paragraph [0022].) Foss further teaches that its composition may contain conventional care additives, including surfactants, thickening agents, fragrances, moisturizers, and other conventional components, and may take conventional topical forms, including cream, gels, and emulsion. (See paragraphs [0026], [0027] & {0040].) Thus, Foss teaches the claimed skincare formulation and carrier-base environment.
Foss additionally teaches that salts and/or derivatives of ascorbates may be used “in place of, or in addition to” the preferred bisglyceryl ascorbate and expressly teaches that such derivatives of the oil-soluble compounds “would function similarly” in the disclosed compositions and methods. (See paragraph [0035].) Thus, Foss expressly contemplates compositions containing BGA together with additional ascorbate derivatives. In view of Foss’s express identification of THA as a suitable stabilized ascorbate derivative, one of ordinary skill in the art would have understood THA to be among the ascorbate derivatives suitable for incorporation with BGA in Foss’s formulation.
Although Foss does not expressly characterize BGA as “hydrophilic” and THA as “lipophilic,” foss expressly teaches the same chemical compounds required by the claims. The hydrophilic and the lipophilic character of compounds are intrinsic physiochemical property of the compound and is not dependent upon whether the property is expressly recognized or described in the prior art reference. Therefore, Foss expressly disclosed compounds inherently possess those respective properties.
Foss further teaches the “effective amount” of ascorbate ant teaches aqueous compositions containing about 0.05-25 wt%, alternatively 0.5-20 wt%, and alternatively 1-15 wt% oils-soluble ascorbate. Foss explains that the effective amount is an amount sufficient to provide the disclosed ascorbate function. (See paragraph [0037].) Foss also teaches the compositions having pH values within the claimed range. In particular, Foss teaches pH 6.0-7.5 and ascorbate solutions, dispersion, suspensions, emulsions having pH about 5-8, including about 5-7.5 and about 6-7. (See paragraphs [0042] & [0043].) Thus, Foss teaches a pH greater than 3.5.
Foss does not expressly teach incorporating myristyl 3-glyceryl ascorbate (MGA) as the claimed amphiphilic vitamin C derivative in the BGA/THA-containing formulation.
Kim remedies this deficiency. Kim teaches a cosmetic composition comprising myristyl 3-glyceryl ascorbate, which Kim identifies as a vitamin C derivative having skin-aging, whitening, and moisturizer effects. Kim teaches MGA in an amount of 0.01-10 wt% of the cosmetic composition. Sigificantly, Kim teaches MGA possesses both hydrophobic and hydrophilic properties. (See paragraphs 21-24 of page 2.). This corresponds to the claimed amphiphilic character, and that MGA thereby performs as emulsification/barrier-forming function in Kim’s cosmetic formulation. (See page 2.) Kim further teaches that MGA provides antioxidant, skin-whitening, and moisturizing effects. (See paragraph next to the last paragraph of page 3.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the myristyl 3-glyceryl ascorbate (MGA) taught by Kim as an additional ascorbate derivative in the topical ascorbate composition of Foss. Foss expressly teaches that additional ascorbate derivatives may be used in addition to BGA and teaches that such derivatives would function similarly in its compositions. Kim identifies MGA as a vitamin C derivative suitable for cosmetic compositions and teaches that MGA possesses both hydrophilic and hydrophobic properties and provides desirable antioxidant, whitening, and moisturizing skin effects.
Accordingly, one of ordinary skill would have been motivated to select Kim’s MGA as an additional ascorbate derivative for incorporation into Foss’s topical ascorbate formulation to obtain the known amphiphilic properties and skin-beneficial properties of MGA in addition to the properties provided by Foss’s stabilized ascorbate derivatives. The rationale is supported by the references themselves rather than Applicant’s disclosure. Foss supplies an express reason to employ additional ascorbate derivatives with NGA, and Kim identifies MGA as a cosmetic ascorbate derivative and teaches the properties that would have made its inclusion desirable.
One of ordinary skill in the art would have had a reasonable expectation of successfully making and using the modified composition because Foss expressly teaches that additional ascorbate derivative may be incorporated with BGA and teaches that such derivatives would function similarly in its composition, while Kim demonstrates successful incorporation of MGA into cosmetic compositions in amounts of 0.01-10 wt%. Moreover, both references employ vitamin C derivatives in topical/cosmetic formulations, and nothing in either reference indicates that incorporation of Kim’s MGA into Foss’s formulations would prevent BGA and THA, or MGA from performing their known functions. Rather, Kim expressly demonstrates that MGA is compatible with cosmetic formulations.
Accordingly, the proposed modification represents the combination of known cosmetic formulation components according to known methods, with the components retaining their known functions, and yielding predictable results.
With respect to claim 2, Foss teaches broad workable concentrations of its ascorbate derivative, including ranges of 0.05-25 wt%, 0.5-20 wt%, and 1-18 wt%, while Kim teaches MGA at 0.01-10 wt%. Kim further teaches that there is no significant improvement when the amount of MGA exceeds its disclosed range (see paragraph before the last paragraph of page), thereby providing a reason to maintain MGA within the disclosed amount. Thus, the prior art expressly recognizes the respective concentrations of the ascorbate derivatives as formulation variables and provides overlapping ranges encompassing compositions in which the concentrations of BGA and THA are individually greater than the concentration of MGA.
Upon incorporating Kim’s MGA into BGA and THA-containing composition of Foss for the reasons discussed above with respect to claim 1, it would have been obvious to one of ordinary skill in the art to select the respective amounts of the known ascorbate components from within their disclosed workable concentration ranges according to the desired contribution of each component to the formulation. Selection of BGA and THA concentration greater than the MGA concentration would have constituted a routine selection from the expressly taught ranges, particularly, in view of Kim’s teaching that MGA is effective within its disclosed 0.01-10 wt% range and that increasing its concentration beyond the disclosed range provides not significant additional improvement. One of ordinary skill in the art therefore would have had a reason to employ MGA at a relatively lower concentration, while employing BGA and THA at a higher convention within the ranges taught by Foss, thereby arriving at the relative concentration relationship recited in claim 2.
One of ordinary skill in the art would have had a reasonable expectation of success because Foss and Kim expressly teach workable concentration ranges for their perspective ascorbate derivatives, Forss teaches that additional ascorbate derivatives may be used with BGA and would function similarly, and Kim demonstrates that MGA performs its intended cosmetic and amphiphilic functions within the disclosed concentration range. Accordingly, selection of concentrations within the expressly taught ranges would have been expected to preserve the known functions of the respective derivatives.
Claim 2 does not require any particular degree by which the concentrations of BGA and THA must exceed that of MGA. Thus, the claim encompasses any selection from the prior-art concentration ranges in which each of the BGA and THA is present at a concentration even minimally greater than MGA.
The art identifies concentrations as a result-effective formulation variable →provides workable ranges →those ranges expressly encompass the claimed relative relationship →POSITA selecting concentrations according to the known functions would have arrived at the claimed relationship through routine optimization.
Claims 3 and 4 are additionally rejected under 112(b), as discussed above separately. For purpose of examination, claim 3’s “approximately equal amounts” is reasonably construed to encompass equal amounts, and claim 4’s “differ by less than 50%” likewise encompasses equal amounts because equal amounts differ by zero. Foss teaches overlapping concentration of BGA/THA ascorbate derivatives. It would have been obvious to employ equal concentrations of BGA and THA components as one of the readily apparent concentration selections within Foss’s same disclosed workable concentration ranges, particularly where Foss teaches that the derivatives function similarly.
Regarding claim 5, Foss teaches ascorbate concentrations encompassing amount no greater than 10 wt%, including 0.05-25 wt%, 0.5-20 wt%, and 1-18 wt%, and Kim expressly teaches MGA within 0.01-10 wt%. It would have been obvious to select amounts of respective ascorbate derivatives at or below 10 wt% in preparing the modified composition because such amounts fall within the workable concentration ranges expressly taught for the respective known components.
Regarding claims 6-8, the respective claimed ranges are:
Claim BGA THA MGA
6 3-15% 3-15% 010-10%
7 4-12% 4-12% 0.25-8%
8 5-10% 5-10% about 0.5-5%.
Foss teaches broad ascorbate concentration ranges encompassing the claimed BGA and THA concentrations, including 0.5-20% and 1-18%. Kim teaches MGA at 0.01-10 wt%, encompassing the claimed MGA ranges. Once BGA, THA, and MGA were selected for the reasons set forth above, it would have been obvious to select workable amounts of the respective components from within concentration ranges taught by Foss and Kim. The claimed concentration ranges fall within or substantially overlap the respective prior-art ranges. Where the claimed range overlaps or lies within a range disclosed by the prior art, a prima facie case of obviousness ordinarily exists. MPEP 2144.05, In re Werheim; In re Woodruff.
The optimization is not based merely on a generalized assertion that concentrations are routinely optimized. Rahter, Foss expressly identifies ascorbate concentration as a formulation parameter and provides multiple workable concentration ranges, while Kim likewise expressly identifies the amount of MGA as a formulation parameter and teaches a workable concentration range for MGA. Thus, the prior art itself recognizes the amounts of the respective ascorbate components as variables available for selection in formulating the respective compositions.
Regarding claim 9, Foss teaches BGA, THA and MGA components were selected for incorporation for the reasons discussed above, selection of about 7 wt% BGA, about 7 wt% THA, and about 1 wt% MGA would have constituted selection of concentration falling within the respective prior-art ranges. Absent evidence establishing criticality or unexpected results associated with the specifically claimed concentrations, selection of the recited amounts within the workable concentration ranges taught for the respective known components would have been within the ordinary formulation skill in the art and would have yielded the predictable result of a topical formulation containing the known vitamin C derivatives at concentrations within their taught workable ranges.
Regarding claims 10-12, the claims recite combined active-vitamin C-derivative amounts of:
Claim 10: 5-30 wt%;
Claim 11: 8-25 wt%; and
Claim 12: 10-20 wt%. Foss expressly teaches compositional amounts of ascorbate of about 0.05-25 wt%, alternatively 0.5-20 wt%, and alternatively 1-18 wt%. These prior-art
ranges overlap substantially with the claimed ranges. It would have been obvious to select the overall loading of vitamin C derivatives in the modified multi-ascorbate formulation within the overlapping ranges taught by Foss, because Foss expressly recognizes the amount of ascorbate in its topical composition as a variable land provides workable ranges therefor. The overlap of the claimed prior-art ranges supports a prima facie conclusion of obviousness. MPEP2144.05.
Regarding claim 16, Foss teaches composition having pH 6.0-7.5 and additionally teaches ascorbate solutions, dispersions, suspensions, or emulsions having pH about 5-8, including pH 5-7.5 and about 6-7. Thus, Foss’s disclosed pH ranges overlap the claimed range of greater than 3.5 and less than 7, rendering the claimed pH prima facie obvious. MPEP 2144.05.
Regarding claim 17, Applicant’s specification provides that “skin neutral” corresponds to approximately pH 4.0-6.0, and more specifically, pH 5. Foss teaches composition having pH 6.0-7.5 and additionally teaches ascorbate solutions, dispersions, suspensions, or emulsions having pH about 5-8, including pH 5-7.5 and about 6-7, thereby expressly teaching pH values falling within the scope of the claimed “skin neutral pH.” Accordingly, the limitation of claim 7 would have been obvious from Foss’s expressly disclosed pH values.
Regarding claim 18, Foss further teaches that the disclosed topical ascorbate compositions may be formulated as emulsions (See paragraph [0040]) and exemplifies composition containing BGA, water, and an emulsifying agent (e.g., Example 4, paragraph [0071], and Example 6, paragraph [0074]). Thus, Foss expressly contemplates the ascorbate-containing carrier composition in emulsion form. Kim further teaches that MGA possesses both hydrophilic and hydrophobic properties and function in forming an emulsified cosmetic system. Accordingly, the modified Foss composition comprising BGA, THA, and the MGA of Kim, as set forth above with respect to claim 1, would have been obvious to formulate as an emulsion, as expressly taught by Foss and further supported by the known amphiphilic/emulsifying properties of MGA taught by Kim.
Conclusion
Claims 1-12 and 16-18 are not allowed.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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