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 1-10 and 13-22.
Previous Rejections
Applicants' arguments, filed 9/16/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 is withdrawn but appears to be inadvertently marked as “(Previously Presented)”. Appropriate correction is required.
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) 1-8, 10, and 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lazzeri-Vigouroux et al. (US 2009/0324526, Dec. 31, 2009) (hereinafter Lazzeri-Vigouroux) in view of Mahe et al. (US 2001/0044444, Nov. 22, 2001) (hereinafter Mahe).
Lazzeri-Vigouroux discloses cosmetic care compositions containing, in a physiologically acceptable medium, one or more compounds selected from among arginines and/or the organic or inorganic acid salts and/or derivatives thereof; and a compound or a mixture of compounds of formula (I), useful for treating human keratin fibers and/or the scalp, for inducing and/or stimulating the growth of these fibers and/or preventing the loss and/or increasing the density thereof (satisfies amino acid of claim 1-2) (Abstract). The arginine(s) and/or the salts thereof and/or the derivatives thereof in accordance with the invention will be present in the compositions in amounts preferably ranging from 0.01 % to 5% by weight (satisfies claim 3 & 13) (¶ [0037]). The compound(s) of formula (I) correspond to the formula below, in which R1= H or -CH3; R2= H or -CH3; R3 = -CH3, with the proviso that R1 and R2 are not being simultaneously H (satisfies claim 6 and 19-21) (¶ [0038-0039]).
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Further, the compounds of formula (I) can in particular be extracts of Centella asiatica (¶ [0041]). According to one preferred embodiment of the invention, a mixture of madecassoside and of terminoloside is formulated (satisfies claim 7) (¶ [0042]). The compound or the mixture of compounds of formula (I) described above may be present in the composition in an amount ranging from 0.001 % to 20% by weight (satisfies claim 8) (¶ [0045]). Suitable physiologically acceptable medium include dispersions of a fatty phase in an aqueous phase (O/W) or vice versa (W/O) and solid dispersions or emulsions (O/W) or (W/O) (satisfies phases of claim 1) (¶ [0050]). When the composition is an emulsion, the proportion of the fatty phase may range from 1 % to 80% by weight, relative to the total weight of the composition, while the aqueous phase is from 5% to 99.9% by weight (¶ [0057]). The fatty phase may contain oily compounds (satisfies oil of claim 1) (¶ [0058]). The composition may comprise additives preferably in amounts from 0.1 % to 10% by weight (¶ [0067]). Suitable additional active agents include hydroxy acids such as salicylic acid and fruit acids (satisfies salicylic acid of claim 1) (¶ [0074]).
Lazzeri-Vigouroux differs from the instant claim insofar as not disclosing wherein the composition comprises citric acid.
However, Mahe discloses hair growth/hair loss-affecting cosmetic/therapeutic compositions (Abstract). Suitable additional active agents for use include keratolytic agents such as hydroxy acids such as salicylic acid and citric acid (¶ [0162]).
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, Lazzeri-Vigouroux discloses wherein the composition may include additional actives such as hydroxy acids, which includes salicylic acid and fruit acids. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Lazzeri-Vigouroux to comprise citric acid as the fruit acid, since it is a known additional active agent for use in hair growth/hair loss-affecting cosmetic/therapeutic compositions as taught by Mahe.
In regards to the composition comprising both salicylic acid and citric acid, since the use of various hydroxy acids for use in hair growth/hair loss-affecting cosmetic/therapeutic compositions is known individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Therefore it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used a combination of salicylic acid and citric in the composition of Lazzeri-Vigouroux because they are known to be used for the same purpose, as supported by cited precedent.
Regarding the oily/ aqueous phase ratio recited in instant claim 1 (i.e., between 0.75 and 1.25), 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, Lazzeri-Vigouroux in view of Mahe discloses wherein the fatty phase may range from 1 % to 80% by weight, relative to the total weight of the composition, while the aqueous phase is from 5% to 99.9%. As such, when the fatty phase and the aqueous phase are each present in an amount of 50%, the resulting ratio would be 1. Therefore, the claimed ratios would have been obvious from one selecting amounts of the fatty/aqueous phases from the ranges disclosed by Lazzeri-Vigouroux and arriving at a weight ratio that overlaps with the claimed range.
Regarding the citric/salicylic acid to amino acid ratio recited in instant claim 1 (i.e., between 0.90 and 1.10), 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, Lazzeri-Vigouroux in view of Mahe discloses wherein the arginine(s) will be present in amounts ranging from 0.01 % to 5% by weight, while actives such as hydroxy acids (i.e., citric/salicylic acid) may be present in an amount of 0.1 % to 10% by weight. As such, when the citric/salicylic acid are each present in an amount of 1% and the arginine(s) is present in an amount of 2%, the resulting ratio would be 1. Therefore, the claimed ratios would have been obvious from one selecting amounts of the citric/salicylic acid and amino acid from the ranges disclosed by Lazzeri-Vigouroux and arriving at a weight ratio that overlaps with the claimed range.
Regarding the amounts of citric/salicylic acid recited in claims 4-5 and 14-18 (i.e., between 0.01 % and 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(I). As discussed above, Lazzeri-Vigouroux in view of Mahe discloses wherein the hydroxy acids (i.e., citric/salicylic acid) may be present in an amount of 0.01 % to 50% by weight. Accordingly, because the amounts recited in the instant claims overlap with the range disclosed by Lazzeri-Vigouroux in view of Mahe, the range disclosed by Lazzeri-Vigouroux in view of Mahe meets the instantly recited limitations.
Regarding claim 10 reciting wherein the composition is substantially free of a monovalent/divalent inorganic salt, Lazzeri-Vigouroux does not require such salts be present in the composition. Lazzeri-Vigouroux merely requires a composition comprising arginines and/or the organic or inorganic acid salts and/or derivatives thereof; and a compound or a mixture of compounds of formula (I). As such, a composition free of monovalent/divalent inorganic salts would have been obvious.
Regarding claim 22 reciting a makeup removal cosmetic composition, this is merely a recitation of the intended use of the claimed composition. Since the composition of Lazzeri-Vigouroux in view of Mahe is substantially the same as the claimed composition, comprising substantially the same active agent, one amino acid; citric acid; salicylic acid; and a compound or a mixture of compounds of formula (I), one would reasonably conclude that the composition of Lazzeri-Vigouroux in view of Mahe would be suitable for removing makeup, whether the prior art discloses such use or not. One of ordinary skill in the art would also reasonably conclude that the composition of Lazzeri-Vigouroux in view of Mahe would
Therefore, the teachings of Lazzeri-Vigouroux in view of Mahe render obvious claims 1-8, 10, and 13-22.
2. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lazzeri-Vigouroux et al. (US 2009/0324526, Dec. 31, 2009) (hereinafter Lazzeri-Vigouroux) in view of Mahe et al. (US 2001/0044444, Nov. 22, 2001) (hereinafter Mahe) and further in view of Dias et al. (International Journal of Trichology, 2014 Jul-Sep;6(3):95–99) (hereinafter Dias).
The teachings of Lazzeri-Vigouroux in view of Mahe are discussed above.
The combined teachings of Lazzeri-Vigouroux in view of Mahe do not disclose wherein the composition has a pH of between 3.8 and 4.4.
However, Dias discloses that in the shampoo and conditioner formulas, the formula and ingredients must create a final pH no higher than 5.5 so not to damage the scalp via negative electric charges and static interactions which result in frizz (Conclusion).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of Lazzeri-Vigouroux in view of Mahe to have a pH of less than 5.5 motivated by the desire to achieve a composition that avoids hair damage via static interactions and frizz as taught by Dias.
Therefore, the combined teachings of Lazzeri-Vigouroux in view of Mahe and further in view of Dias render obvious claim 9.
Response to Arguments
Regarding the allegations of unexpected results (page 9 of Applicant’s response), any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02.
Applicant does not appear to have discussed same with respect to objective data. Furthermore, Applicant’s data does not appear to be unexpected. For example, regarding the Comparative Example C3 not guaranteeing good demixing and being an eye irritant, C3 did not contain arginine which was contained by all the other examples which passed stability testing. Furthermore, C3 contained sodium chloride which was not contained in any of the other compositions and which could be reasonably expected to materially affect composition stability. Finally, C3 had a significantly lower pH that was actually outside of the range recited by the instant claims. The other comparative example, C2, which was also an eye irritant also had a low pH compared to the two compositions which were not irritants. In view of these substantial changes to the composition, one of ordinary skill in the art cannot conclusively determine that the lack citric acid is the only factor that resulted in the composition not displaying satisfactory demixing and causing eye irritation. Accordingly, these findings do not appear to be “unexpected”.
Regarding Comparative Example C4 not displaying sufficient microbiological protection, while C4 had a (citric acid + salicylic acid) to arginine ratio that was outside the range recited by the instant claims, its ratio was indeed very close. Similarly, C2 also had a ratio that was outside the range recited by the instant claims, but was very close to said range, yet it somehow passed microbiological protection testing. Comparing other parameters of the compositions C1-C4, one of ordinary skill in the art would find that C4 had the highest pH of all of the compositions. Accordingly, in view of the aforementioned observations, it would be reasonable for one of ordinary skill in the art to conclude that microbiological protection of the composition could potentially have been affected by the composition pH instead of the (citric acid + salicylic acid) to arginine ratio. In other words, one of ordinary skill in the art, taking these findings into account, cannot definitively point to the (citric acid + salicylic acid) to arginine ratio as the only factor responsible for C4 failing the microbiological protection test. Accordingly, these findings do not appear to be “unexpected”.
Regarding Applicant’s argument that the prior art of record does not address the problems related to a composition intended for makeup removal, the Examiner submits that, as discussed above, reciting a makeup removal cosmetic composition is merely a recitation of the intended use of the claimed composition. Since the composition of Lazzeri-Vigouroux in view of Mahe is substantially the same as the claimed composition, comprising substantially the same active agents: one amino acid; citric acid; salicylic acid; and a compound or a mixture of compounds of formula (I), one would reasonably conclude that the composition of Lazzeri-Vigouroux in view of Mahe would be suitable for removing makeup, whether the prior art discloses such use or not.
Regarding the use of the Mahe reference, the Examiner submits that Mahe cures any alleged deficiencies of Lazzeri-Vigouroux where it discloses that suitable hydroxy acids include salicylic acid and citric acid. One of ordinary skill in the art would consider looking to the Mahe reference after Lazzeri-Vigouroux since they are both related to the same field. The intended use of the instant composition does not negate the fact that one of ordinary skill in the art would have been logically led to combine the teachings of the Lazzeri-Vigouroux and Mahe references.
Regarding Applicant’s arguments that the prior art of record does not disclose a biphasic system with distinct aqueous and oily phase and that such a system would be unsuitable, the Examiner submits that while the instant claims do require an aqueous phase and an oily phase which are separate, they do not require permanent visible separation. “Separate phases” denotes the presence of two immiscible phases, and does not necessarily imply that the two phases must remain visibly segregated at all times. Emulsions are, by definition, biphasic systems comprising immiscible aqueous and oily phases, even when one phase is dispersed within the other. Visible phase separation merely confirms the presence of distinct (i.e., separate) phases. Accordingly, an emulsion as disclosed by Lazzeri-Vigouroux in view of Mahe satisfies the claimed “biphasic” system and importing a requirement of permanent visible separation would improperly narrow the claims.
Regarding Applicant’s arguments that the cited references do not disclose any technical effects related to having a (citric acid + salicylic acid) to arginine ratio of 0.9 to 1.1, a reference need not disclose or recognize the technical effect or advantage attributed to a claimed component, amount, and/or ratio. It is sufficient for the reference to teach the presence of the claimed component, its relative concentration, and/or the resulting ratio, such that one of ordinary skill in the art would be motivated to arrive at the claimed composition.
Regarding Applicant’s arguments that routine optimization only applies to result effective variables with respect to the (citric acid + salicylic acid) to arginine ratio, the Examiner submits that the rejection is based on overlapping ranges. 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). The art discloses amounts whereby one of ordinary skill in the art would reasonably choose amounts within the overlap. This would result in an overlap in the claimed weight ratios. It is understood that a component must be a result effective variable in order to make a routine optimization argument. However, this is not the basis of the argument of record. The basis of the argument of record is that the claimed weight ratio would have been obvious from one selecting amounts of citric acid, salicylic acid, and arginine from the ranges disclosed by the prior art and arriving at a weight ratio range that overlaps with the claimed range.
Regarding Applicant’s argument that improper hindsight in combining the references, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). As discussed above, where Mahe discloses that suitable hydroxy acids for use in hair growth/hair loss-affecting cosmetic/therapeutic compositions include salicylic acid and citric acid, it would have been obvious for one of ordinary skill in the art to have used citric acid in the composition of Lazzeri-Vigouroux.
Regarding the use of the Dias reference, the Examiner submits that Dias cures any alleged deficiencies of Lazzeri-Vigouroux where it discloses that a pH of no higher than 5.5 is suitable for hair care products. One of ordinary skill in the art would consider looking to the Dias reference after the Lazzeri-Vigouroux reference since they are both related to the same field. The intended use of the instant composition does not negate the fact that one of ordinary skill in the art would have been logically led to combine the teachings of Lazzeri-Vigouroux and Dias.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 1-10 and 13-22 are rejected.
Claim 11 is withdrawn.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612