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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated June 15, 2026 is acknowledged.
Claims 1-8 and 10-13 are pending.
Claim 9 is cancelled.
Claims 1, 12 and 13 are currently amended.
Claims 12 and 13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-8, 10 and 11 as filed on June 15, 2026 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim rejections under 35 USC 103 are withdrawn.
Applicant’s arguments 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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 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(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 1-8, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Pinzon et al. (US 6,159,479, published December 12, 2000, of record) in view of Piljac et al. (WO 93/14767, published August 5, 1993, of record) and Allef et al. (US 2014/0349902, published November 27, 2014).
Pinzon teaches hydrous (aqueous) salicylic acid solutions comprising a salicylic acid derivative:
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in which R is a linear, branched or cyclic saturated aliphatic group or an aliphatic unsaturated group containing one or a number of double bonds, which may or may not be conjugated, these groups containing from 2 to 22 carbon atoms and being able to be substituted and R' is a hydroxyl group or an ester functional group and a method of use thereof for treating skin (title; abstract; claims, in particular 1-3, 16; column 1, lines 5-10; column 1, line 48 through column 2, line 40), as required by instant claims 3-5, 11. The solutions comprise 0.1 to 65 wt% of the salicylic acid derivative and 1 to 94.8 wt% water (claim 7), as required by instant claims 7, 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. The pH of the solutions is adjusted to a final level of from 0.5 to 11, preferably 2 to 8 (column 4, lines 58-67). The compositions may further comprise other ingredients inclusive of active agents (column 5, lines 1-16). The compositions may treat acne (column 1, lines 37-43).
Pinzon does not teach 0.1 to 10 wt% of at least one glycolipid, and at least 1 wt% of at least one amphoteric surfactant as required by claim 1.
Pinzon does not teach rhamnolipids or sophorolipids as required by claim 2.
Pinzon does not teach 0.2 to 7 wt% glycolipid as required by claim 6.
Pinzon does not teach the weight ratio glycolipid to salicylic acid derivative is 1 or more as required by claim 8.
These deficiencies are made up for in the teachings of Piljac and Allef.
Piljac teaches rhamnolipids (glycolipids) as treatments against dermatological diseases inclusive of Acnae vulgaris (title; abstract; claims; paragraph bridging pages 3-4; page 10, lines 8-14), as required by instant claim 2. The compositions comprise 0.05 to 10 wt% of the rhamnolipid (page 7, lines 26-34), as required by instant claim 6. The compositions may be solutions (page 7, lines 22-26).
Allef teaches aqueous cleansing compositions comprising 0.1 to 30 wt% biosurfactants, understood as meaning all glycolipids produced by fermentation, inclusive of rhamnolipids and exemplifies an embodiment of an oil-free acne cleanser further comprising salicylic acid (title; abstract; claims, in particular 1, 12; paragraphs [0024]-[0025], [0028], [0072]; Table 66), as required by instant claims 2, 6. The compositions may further comprise at least one surfactant which is not a biosurfactant inclusive of amphoteric surfactants; the weight ratio of biosurfactants to surfactants which are not biosurfactants can be >1:1 or ≤1:1 (claims 5-7; paragraphs [0031], [0033]-[0034], [0037], [0076]). The acne cleanser comprises 3 wt% cocaminopropyl betaine (amphoteric surfactant) (Table 66). The compositions may have a pH from 5 to 8 (paragraph [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrous salicylic acid solutions of Pinzon having a pH of from 0.5 to 11, preferably 2 to 8 to further comprise 0.05 to 10 wt% rhamnolipid as taught by Piljac in order to treat dermatological diseases inclusive of acne. There would be a reasonable expectation of success because the compositions of Pinzon may further comprise active ingredients and because the compositions of Pinzon are intended to treat acne.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrous salicylic acid solutions of Pinzon in view of Piljac to comprise the rhamnolipids and to further comprise additional surfactants inclusive of amphoteric surfactants in a weight ratio of for example 1:1 rhamnolipid to amphoteric surfactant as taught by Allef in order to provide a cleansing preparation suitable for treating acne.
Regarding claim 8, the combined teachings of Pinzon, Piljac and Allef render obvious compositions comprising 0.1 to 65 wt% salicylic acid derivative and 0.05 to 10 wt% rhamnolipid, the ratio of these ranges ranging up to 10/0.1.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant's arguments have been considered but are moot in light of the new / modified grounds of rejection over Pinzon necessitated by Applicant’s amendments. Allef as newly applied discloses and renders obvious amounts of amphoteric surfactant as newly claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-11, 14 and 15 of copending Application No. 17/618,204; (2) claims 1-9 and 11-19 of copending Application No. 18/216,943; and (3) claims 1-14 of copending Application No. 19/492,651 in view of Pinzon et al. (US 6,159,479, published December 12, 2000, of record), Piljac et al. (WO 93/14767, published August 5, 1993, of record) and Allef et al. (US 2014/0349902, published November 27, 2014).
Withdrawn copending claims are included in these rejections because withdrawn claims are still pending
The instant claims are drawn to solutions having a pH of 5 to 9 comprising 0.1 to 10 wt% of at least one glycolipid, 0.01 to 1 wt% of at least one salicylic acid derivative of formula (I), and at least 1 wt% of at least one amphoteric surfactant. The glycolipids may be rhamnolipids or sophorolipids or may be present from 0.2 to 7 wt%. The derivative may be present from 0.05 to 0.5 wt%. The weight ratio of glycolipids to the derivative may be 1 or more. The compositions may comprise at least 60 wt% water. The compositions may be used for caring for, conditioning or cleansing keratinous substances.
The copending ‘204 claims are drawn to compositions comprising 0.01 to 15 wt% of at least one glycolipid biosurfactant selected from rhamnolipids or/and sophorolipids and 0.001 to 5 wt% of at least one carboxybetaine polymer. The compositions may further comprise amphoteric surfactants or may comprise at least 60 wt% water. The compositions may be used for cleansing or conditioning keratinous substances.
The copending ‘943 claims are drawn to aqueous compositions comprising at least one amphoteric surfactant and at least one anionic surfactant. The amphoteric surfactant may be present from about 1 to 20 wt%. The compositions may comprise about 40 to 90 wt% water. The compositions may further comprise glycolipids selected from inter alia rhamnolipids or/and sophorolipids.
The copending ‘651 claims are drawn to compositions comprising at least one polylysine and at least one glycolipid. The glycolipid may be a rhamnolipid or may be present from 0.1 to 20 wt%. The compositions may further comprise at least one amphoteric surfactant. The pH of the composition may be from 4 to 8 (implies aqueous). The composition may be a cleanser.
The instant claims primarily differ from the conflicting, copending claims with respect to the salicylic acid derivative of formula (I) and the amount / ratio thereof and the express recitation of a solution. The ‘204 and ‘943 claims also differ with respect to the recitation of the pH. The ‘651 claims also differ with respect to the amount of water. The ‘204 and ‘651 claims also differ with respect to the amount of amphoteric surfactant. However, Piljac teaches rhamnolipids and solutions thereof as acne treatments and Pinzon teaches acne treatments to include hydrous (aqueous) solutions having a pH of 0.5 to 11, preferably 2 to 8 comprising 0.1 to 65 wt% of a salicylic acid derivative of formula (I) and 1 to 94.8 wt% water as elaborated supra. Therefore, it would have been obvious to one of ordinary skill in the art that the aqueous rhamnolipid compositions of the copending claims encompass solutions because Piljac teaches overlapping amounts of rhamnolipids formulated as solutions and it would have been obvious to modify the aqueous rhamnolipid solutions of the copending claims to further comprise 0.1 to 65 wt% solubilized salicylic acid derivatives of formula (1) because it is prima facie obvious to combine two compositions useful for the same purpose. See MPEP 2144.06. The ratio of glycolipids to the derivative of formula (1) is also met as the individual numerator and denominator are met. Regarding the pH, it would have been obvious to modify the solutions of the ‘204 and ‘943 claims in view of Piljac and Pinzon to have a pH of 0.5 to 11, preferably 2 to 8 as taught by Pinzon or/and to have a pH of 5 to 8 as taught by Allef because these pH ranges are suitable for acne treatments and/or for glycolipid-containing cleansing compositions. Regarding the amount of water, it would have been obvious to modify the solutions of the ‘651 claims to comprise 1 to 94.8 wt% water as taught by Pinzon because this amount is suitable for acne treatments. Regarding the amount of amphoteric surfactant, it would have been obvious to modify the amphoteric surfactant of the ‘204 and ‘651 claims to have a greater than or lesser than 1:1 ratio with the glycolipid as taught by Allef because this range is suitable for cleansing applications. The ‘943 claims also differ with respect to the express recitations of the utility of the compositions, however, recitations of intended use are not limiting. See MPEP 2111.02.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,673,016 (Application No. 18/525,456) in view of Pinzon et al. (US 6,159,479, published December 12, 2000, of record), Piljac et al. (WO 93/14767, published August 5, 1993, of record) and Allef et al. (US 2014/0349902, published November 27, 2014).
The instant claims have been described supra.
The patent claims are drawn to cleansing compositions having a pH of 4 to 8 comprising at least one amphoteric surfactant, at least one glycolipid, about 0.05 to 0.2 wt% of at least one cationic polymer, and at least one solvent or water. The glycolipid may be rhamnolipids or sophorolipids or may be present from 2 to 7%. The amphoteric surfactant may be present from about 3 to 8 wt%. The compositions may comprise at least one additional cosmetic ingredient.
The instant claims primarily differ from the conflicting patent claims with respect to the salicylic acid derivative of formula (I) and the amount / ratio thereof and the express recitation of a solution. The patent claims also differ with respect to the amount of water. However, Piljac teaches rhamnolipids and solutions thereof as acne treatments and Pinzon teaches acne treatments to include hydrous (aqueous) solutions comprising 0.1 to 65 wt% of a salicylic acid derivative of formula (I) and 1 to 94.8 wt% water as elaborated supra. Therefore, it would have been obvious to one of ordinary skill in the art that the aqueous rhamnolipid compositions of the patent claims encompass solutions because Piljac teaches overlapping amounts of rhamnolipids formulated as solutions and it would have been obvious to modify the aqueous rhamnolipid solutions of the patent claims to further comprise 0.1 to 65 wt% solubilized salicylic acid derivatives of formula (1) because it is prima facie obvious to combine two compositions useful for the same purpose. See MPEP 2144.06. The ratio of glycolipids to the derivative of formula (1) is also met as the individual numerator and denominator are met. Regarding the amount of water, it would have been obvious to modify the solutions of the patent claims to comprise 1 to 94.8 wt% water as taught by Pinzon because this amount is suitable for acne treatments.
Claims 1-8, 10 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-16, 18 and 19 of copending Application No. 18/591,178; and (2) claims 1-18 of copending Application No. 18/756,678 in view of Pinzon et al. (US 6,159,479, published December 12, 2000, of record), Piljac et al. (WO 93/14767, published August 5, 1993, of record) and Allef et al. (US 2014/0349902, published November 27, 2014).
Although a Notice of Allowance has been mailed in the ‘178 Application, the rejection remains provisional because the Application has not yet issued as a patent
The instant claims have been described supra.
The copending ‘178 claims are drawn to compositions comprising at least one glycolipid and at least one salicylic acid or derivative thereof of formula (I). The glycolipid may be a rhamnolipid or sophorolipid and may be present from 0.1 to 10 wt%. The at least one salicylic acid or derivative thereof may be present from 0.1 to 5 wt%. The weight ratio of glycolipid to the salicylic acid or derivative thereof may be 3:1 to 1:3. The compositions may comprise 20 to 70 wt% water. The compositions may be used for treating, hydrating and/or cleansing acne-prone skin.
The copending ‘678 claims are drawn to compositions having a pH of 4 to 8 comprising at least one amphoteric surfactant, at least one glycolipid, about 0.05 to 2 wt% of at least one cationic polymer, at least one acne treatment agent, and at least one solvent or water. The amphoteric surfactant may be present from about 3 to 8 wt%. The glycolipid may be a rhamnolipid or sophorolipid or may be present from about 2 to 7%. The acne treatment agent may be a salicylic acid derivative or capryloyl salicylic acid (derivative of formula (I)) and may be present from about 0.1 to 5 wt%.
The instant claims primarily differ from the conflicting, copending claims with respect to the express recitation of a solution. The ‘178 claims also differ with respect to the amphoteric surfactant and the pH. The ‘678 claims also differ with respect to the amount of water. However, Piljac teaches rhamnolipids and solutions thereof as acne treatments and Pinzon teaches acne treatments to include hydrous (aqueous) solutions having a pH of 0.5 to 11, preferably 2 to 8 comprising 0.1 to 65 wt% of a salicylic acid derivative of formula (I) and 1 to 94.8 wt% water as elaborated supra. Therefore, it would have been obvious to one of ordinary skill in the art that the aqueous rhamnolipid compositions of the copending claims encompass solutions because Piljac teaches overlapping amounts of rhamnolipids formulated as solutions Regarding the pH, it would have been obvious to modify the solutions of the ‘178 claims in view of Piljac to have a pH of 0.5 to 11, preferably 2 to 8 as taught by Pinzon because these pH ranges are suitable for acne treatments and/or for glycolipid-containing cleansing compositions. Regarding the amphoteric surfactant of the ‘178 claims, it would have been obvious to modify the solutions of the ‘178 claims in view of Piljac to further comprise additional surfactants inclusive of amphoteric surfactants as taught by Allef because it is prima facie obvious to combine two compositions useful for the same purpose and it would have been obvious to include the additional amphoteric surfactants within the ranges taught by Allef inclusive of 1:1 with respect to the amount of glycolipid biosurfactants. See MPEP 2144.06. Regarding the amount of water, it would have been obvious to modify the solutions of the ‘678 claims to comprise 1 to 94.8 wt% water as taught by Pinzon because this amount is suitable for acne treatments. The ’678 claims also differ with respect to the express recitation of the utility of the compositions, however, recitations of intended use are not limiting. See MPEP 2111.02.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments: Double Patenting
Applicant’s repeated request to hold the provisional double patenting rejections in abeyance at page 16 of the Remarks is acknowledged but is denied because Applicant has already been advised that rejections cannot be held in abeyance and because Applicant has already been advised at to what actions constitute a complete response to a nonstatutory double patenting rejection. Because Applicant’s Remarks are non-responsive to the rejections, the rejections are properly maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
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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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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