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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/09/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 09/09/2026 is acknowledged. Claim 1 is amended and claims 3-4 and 13-19 are canceled. Claims 8-12 remain withdrawn as being directed to a non-elected invention. Claims 1-2 and 5-7 are examined on the merits herein.
Priority
The instant application filed 04/11/2023, claims benefit to Provisional Application No. 63/329,749, filed 04/11/2022.
Withdrawn Rejections
Claims 1-2 and 4-7 were rejected under 35 U.S.C. 103 as being unpatentable over Brandt, K. D., et al. (US 20210371773 A1). In view of Applicant’s remarks and upon further consideration the rejection is withdrawn.
Claims 1-2 and 4-7 were rejected under 35 U.S.C. 103 as being unpatentable over Allef, P., et al. (US 9271908 B2). In view of Applicant’s remarks and upon further consideration the rejection is withdrawn.
Claims 1-2 and 4-7 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/137,818 in view of Brandt, K. D., et al. In view of Applicant’s amendments and upon further consideration the rejection is withdrawn.
Claims 1-2 and 4-7 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/422,765 in view of Brandt, K. D., et al. In view of Applicant’s amendments and upon further consideration the rejection is withdrawn.
All prior rejections of claim 4 are moot due to its cancellation.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Durkee, B., et al. (US 20170273894 A1, 09/28/2017, on record), hereinafter Durkee, in view of Liang, J., et al. (WO 2023129710 A1, 07/06/2023, priority to 12/31/2021, PTO-892), hereinafter Liang, and Rhodia (2012). Macham® 2C Product Information Sheet (PTO-892), hereinafter Rhodia.
Durkee discloses a topical composition comprising Hylocereus undatus fruit extract, Aloe barbadensis leaf extract, and a dermatologically acceptable vehicle (claim 1).
Regarding claim 1: The compositions are used to cleanse skin, by applying any of the disclosed compositions to skin ([0021]; [0032], Embodiment 67), thereby reading a method of cleansing skin comprising applying a cosmetic composition. The topical composition includes cocamidopropyl betaine, glycerin, PEG-120 methyl glycose dioleate, sodium chloride, sodium C14-16 olefin sulfonate, cocoamphodiacetate, and PEG-80 sorbitan laurate ([0019]; Table 6). The topical composition may further comprise sodium methyl cocoyl taurate ([0015]; claim 9). The composition of Table 6 comprises (by weight) 20% of C14-16 olefin sulfonate, while the broader teachings disclose that that composition contains 10 to 30% w/w of sodium C14-16 olefin sulfonate ([0019]), which overlaps with the instantly claimed amount (i.e., 5-12%). The composition of Table 6 comprises 6% of cocoamphodiacetate, while the broader teachings disclose that the composition comprises 1 to 10% w/w of cocoamphodiacetate ([0019]), which overlaps with the instantly claimed amount (i.e., 1-5%). The composition of Table 6 comprises 0.9% of PEG-80 sorbitan laurate, which falls within the instantly claimed amount (i.e., 0.2-1.5%). When the topical composition comprises sodium methyl cocoyl taurate, it is included at 1 to 10% w/w ([0015]), which overlaps with the instantly claimed amount (i.e., 0.5-3%).
Regarding claim 2: The composition of Table 6 comprises (by weight) 8% of cocamidopropyl betaine, which falls within the instantly claimed range (i.e., 2-8%). In the same composition, glycerin is present at 2%, which falls within the instantly claimed range (i.e., 1-5%), and PEG-120 methyl glucose dioleate is present at 2%, which falls within the instantly claimed range (i.e., 0.5-3%). The composition of Table 6 comprises 0.3% of sodium chloride, while the broader teachings disclose that that composition contains 0.05 to 3% w/w of sodium chloride ([0019]), which overlaps with the instantly claimed amount (i.e., 0.4-2%).
Regarding claim 7: The topical skin composition may be an emulsion ([0012]; [0020]; [0055]; claims 4 and 15).
The teachings of Durkee differ from that of the instantly claimed invention in that Durkee does not explicitly teach an embodiment wherein sodium methyl cocoyl taurate is present in combination with the other recited ingredients of claim 1, nor does Durkee explicitly teach amounts of C14-16 olefin sulfonate, cocoamphodiacetate, sodium methyl cocoyl taurate, or sodium chloride falling within the ranges of claims 1 and 2. Durkee also fails to explicitly teach wherein the cocoamphodiacetate is disodium cocoamphodiacetate, as defined in claim 1, and wherein the composition further comprises the ingredients of claims 5 and 6.
Liang discloses compositions for cleansing keratin materials, e.g., skin, hair, etc., comprising (a) at least one amphoteric surfactant; (b) at least one anionic surfactant system comprising (i) at least one acyl taurate, (ii) at least one acyl isethionate, and (iii) at least one additional anionic surfactant; (c) at least one nonionic surfactant chosen from alkyl(poly)glycosides; (d) optionally, at least one cationic compound; and (e) sodium chloride (abstract; [0010]; [0025]-[0027]; claim 1). Such a combination allows for a skin or hair cleansing composition that is free or substantially free of sulfate- based surfactants and minimizes the use of silicones, can be prepared wherein the resulting cleansing composition requires lower amount of surfactant to produce excellent abundant and creamy foaming and cleansing properties, as well as good wet and dry cosmetic properties such as detangling and smoothness, and is environmentally friendly ([0008]).
The amphoteric surfactant (a) is preferably chosen from cocamidopropyl betaine ([0014]; [0021]; [0025]-[0027]; [0036]; Table 1; claims 9 and 24). The anionic surfactant system (b) comprises (i) sodium methyl cocoyl taurate, which reads on that of claim 1, and (ii) sodium cocoyl isethionate, which reads on that of claim 5 ([0021]; [0025]-[0027]; Table 1; claim 24). The sodium methyl cocoyl taurate is present in an amount of 0.75 to 3%, which overlaps with the range of claim 1, and the sodium cocoyl isethionate is present in an amount of 3 to 8%, which overlaps with the range of claim 6 ([0021]; [0026]-[0027]; claim 24). The nonionic surfactant (c) comprises at least one poly alkylglucoside chosen from decyl glucoside, caprylyl/capryl glucoside, or mixtures thereof ([0018]; [0025]-[0027]; [0066]; claim 20), which reads on that of claim 5. The total amount of the nonionic surfactant is 1.5% to about 3% by weight ([0018]; [0025]-[0027]; [0067]; claim 21), which overlaps with the total amount of glucosides defined in claim 6.
Rhodia discloses Mackam 2C, INCI name: disodium cocoamphodiacetate, which reads on that of claim 1. Mackam 2C is one of the mildest amphoteric surfactants of its class and is suggested for personal care applications. In personal care formulations such as shampoos, bubble baths, and body cleansers, Mackam 2C provides a moderate lather and cleans without defatting the skin to give a rich, conditioning effect (p. 1, Product Description).
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add sodium methyl cocoyl taurate to the composition of Durkee comprising cocamidopropyl betaine, glycerin, etc., since sodium methyl cocoyl taurate is a known and routine surfactant in skin cleansers as taught by Durkee and Liang. One of ordinary skill in the art could have combined the composition of Durkee disclosed in Table 6 with the sodium methyl cocoyl taurate of Durkee or Liang using known methods to predictably yield the instant invention. One of ordinary skill in the art would have been especially motivated to include sodium methyl cocoyl taurate since Liang teaches that skin cleansers comprising sodium methyl taurate in combination with cocamidopropyl betaine and sodium chloride are environmentally friendly and require lower amounts of surfactant to produce excellent abundant and creamy foaming and cleansing properties.
Regarding the cocoamphodiacetate of claim 1, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to use the disodium cocoamphodiacetate of Rhodia as the cocoamphodiacetate in the composition of Durkee since disodium cocoamphodiacetate is known and routine in the art as taught by Rhodia. One of ordinary skill in the art could have performed simple substitution of one known cocoamphodiacetate for another to predictably yield the instant invention.
Regarding the amounts of C14-16 olefin sulfonate, disodium cocoamphodiacetate, and sodium methyl cocoyl taurate, as recited in claim 1, and the amount of sodium chloride, as recited in claim 2, Durkee discloses ranges for each of these ingredients which overlap with the instantly claimed ranges. Liang also teaches an amount of sodium methyl cocoyl taurate which overlaps with the instantly claimed range. 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. Furthermore, it is well within the abilities of an ordinary artisan to optimize the amount of each ingredient in the composition depending on the desired properties of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of claims 1 and 2 through no more than routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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).
Regarding the additional ingredients of claim 5, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to further include decyl glucoside, sodium cocoyl isethionate, and caprylyl/capryl glucoside in the combined composition since each of these ingredients are known and routine in the art as taught by Liang. Liang teaches that surfactant combinations including cocamidopropyl betaine, sodium methyl cocoyl taurate, sodium cocoyl isethionate, and alkyl glycosides, such as decyl and caprylyl/capryl glucoside, are especially useful in skin cleanser compositions. One of ordinary skill in the art could have added the decyl glucoside, sodium cocoyl isethionate, and caprylyl/capryl glucoside taught by Liang into the combined composition above via known methods to predictably yield the instant invention. One of ordinary skill in the art would have been especially motivated to add these surfactants since their combination with cocamidopropyl betaine, sodium methyl cocoyl taurate, and sodium chloride (already present in the combined composition) yields environmentally friendly compositions that require lower amounts of surfactant to produce excellent abundant and creamy foaming and cleansing properties.
Regarding the amount of decyl glucoside, sodium cocoyl isethionate, and caprylyl/capryl glucoside as recited in claim 6, Liang teaches amounts which overlap with the instantly claimed 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. Furthermore, it is well within the abilities of an ordinary artisan to optimize the amount of each ingredient, specifically a surfactant, in the composition depending on the desired properties (i.e., foaming, cleansing, lathering) of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of claim 6 through no more than routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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).
As such, the prior art teaches all the components of the composition as claimed with amounts within or overlapping the instantly claimed ranges. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Durkee, Liang, and Rhodia teach the claimed ingredients as desirable components in skin cleansers.
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.
1. Claims 1-2 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 17-18 of U.S. Patent No. 10,912,956 in view of Brandt, K. D., et al. (US 20210371773 A1, on record). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Brandt.
The conflicting claims recite a method of reducing oxidative damage and reducing TNF-a expression in skin, the method comprising topically applying to inflamed skin a composition (conflicting claim 1), wherein the composition comprises glycerin and a pH adjuster (conflicting claim 6). The composition further comprises sodium C14-16 olefin sulfonate, cocamidopropyl betaine, cocoamphodiacetate, PEG-120 methyl glucose dioleate, and PEG-80 sorbitan laurate (conflicting claim 17). The composition further comprises sodium methyl cocoyl taurate (conflicting claim 8). The composition is further formulated as a facial cleansing gel (conflicting claim 18). Thus, the method inherently includes a method of cleansing skin since the composition is a facial cleansing gel.
The conflicting claims differ from the instant claims in that they do not explicitly define the composition to comprise sodium chloride nor the amount of sodium C14-15 olefin sulfonate, cocoamphodiacetate, sodium methyl cocoyl taurate, and PEG-80 sorbitan laurate, as recited in instant claim 1.
Brandt discloses cosmetic compositions which comprise cocamidopropyl betaine, sodium methyl cocoyl taurate at 4%, sodium chloride, sodium C14-16 olefin sulfonate at 1%, and PEG-120 methyl glucose dioleate ([0136], Example 38). A composition comprising 2% of disodium cocoamphodiacetate with cocamidopropyl betaine and sodium chloride is also taught ([0131]; Example 33), as well as a composition comprising 4% of PEG-80 sorbitan laurate with cocamidopropyl betaine and sodium chloride ([0196], Example 98). Such compositions have a good ability to wash off skin and hair and that they provide a good skin feel during and after washing ([0015]-[0019]).
It would have therefore been prima facie obvious to add the sodium chloride of Brandt into the composition of the copending claims since sodium chloride is known and routine in combination with the ingredients of the copending claims, as taught by Brandt. One of ordinary skill in the art could have added sodium chloride by known methods with no change in its function to predictably yield the instant invention. Regarding the amounts of claim 1, Brandt teaches each of these ingredients at varying amounts in different compositions. While such amounts do not fall within the instantly claimed ranges it is well within the abilities of an ordinary artisan to optimize the amount of each ingredient in the composition depending on the desired properties of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of claim 1 through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Response to Arguments
Applicant’s arguments with respect to the 35 USC 103 rejections over Brandt or Allef have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 9-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
