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
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-4, drawn to a concentrated reconstitutable liquid composition comprising of: a. blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate, in the molar ratio of 1:2 and with solids content of minimum 40 %; b. cocamidopropyl betaine with solids content of minimum 40% ; c. 1.0% to 2.5% by weight of total composition, an antimicrobial preservative; d. 0.5% to 5% by weight of total composition, a cosmetically and pharmaceutically acceptable auxiliaries; and wherein, the blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate is synthesized using lauroyl chloride; wherein the ratio of a : b 5.0 to 6.0 : 3.5 to 4.5 by weight; and the said composition is without any additionally added fatty alcohol or fatty acid as a structurant; wherein the said composition when diluted 3 - 5 times, by weight with water to afford a liquid cleansing formulation with pH ranging from 5.0 to 6.0 and viscosity ranging from 2,000 to 10,000 cps at 25 °C, classified in A61K8/0204 and A61Q5/02.
II. Claim 5, drawn to a process for preparing a concentrated reconstitutable liquid composition comprising: a. an aqueous blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate; b. an aqueous solution of cocamidopropyl betaine; c. 1.0% to 2.5% by weight of total composition, an antimicrobial preservative; d. 0.5% to 5% by weight of total composition, a cosmetically and pharmaceutically acceptable auxiliaries; and wherein, the blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate is synthesized using lauroyl chloride in a single reaction vessel; wherein the ratio of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate is 1:2; wherein the solid content of the component a. and the component b. is greater than 40%; wherein the ratio of a : b 5.0 to 6.0 : 3.5 to 4.5 by weight; and wherein the said composition when diluted 3 - 5 times, by weight, with water, affords a liquid cleansing formulation with pH ranging from 5.0 to 6.0 and viscosity ranging from 2,000 to 10,000 cps at 25 °C. wherein the process comprises the steps of: i) preparing a 40% to 45% solid content blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate; ii) preparing cocamidopropyl betaine with solid content of 40% to 45%; and iii) mixing the components of step i) and step ii) along with an antimicrobial preservative and a cosmetically or pharmaceutically auxiliaries, classified in A61K2800/80 and A61K2800/ 805.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product can be made by using structuring agents which are not fatty acid or fatty alcohol and the surfactants (anionic and amphoteric/zwitterionic surfactants) and furthermore the process of mixing could be in any order.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
• the inventions have acquired a separate status in the art in view of their different classification
• the inventions have acquired a separate status in the art due to their recognized divergent subject matter
• the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Kristen L. Pursley on 11/13/25 a provisional election was made without traverse to prosecute the invention of group I, claims 1-4. Affirmation of this election must be made by applicant in replying to this Office action. Claim 5 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dai (US PG Pub. 2017/0172892 A1), in view of (JP 7169194 B2 ; JP’194), Koshti et al. (USP 9,308,156) and further in view of Nacharaju (USP 10,351,523 B2) and Wankhade (USP 10,376,456 B2).
Dai teaches a cleansing bar (Dai, abstract) wherein the composition comprises about 30-70% by weight of non-soap anionic surfactants based on the total weight of the composition (Dai, page 4, paragraph 0044), and teaches suitable non-soap anionic surfactants (Dai, page 2, paragraph 0015) to include sodium lauroyl methyl isethionate, see (page 2, paragraph 0016), sodium lauroyl glutamate, sodium cocoyl glutamate (Dai, page 4, paragraph 0037), sodium methyl cocoyl taurate (Dai, page 4, paragraph 0039), and sodium lauroyl sarcosinate (Dai, page 4, paragraph 0041).
Dai teaches antimicrobial agents (Dai, page 9, paragraph 0096) in 0-4% by weight (Dai, page 8, paragraph 0086) which overlaps the claimed range of 1-2.5%, and teaches additional ingredients can include preservatives in 0-1% by weight (i.e., cosmetically or pharmaceutically acceptable auxiliary; Dai, page 9, paragraph 0095) which overlaps the claimed range of 0.5-5%. Dai further teaches a pH of preferably 4-6 (Dai, page 9, paragraph 0098), which overlaps the 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(I). Dai teaches suitable zwitterionic surfactants (Dai, page 6, paragraph 0062) to include cocamidopropyl betaine and lauramidopropyl betaine (Dai, page 6, paragraph 0067). Dai teaches additional ingredients can include chelating agents, conditioning agents, fragrances and teaches these ingredients to be present in cleansing bars (Dai, page 8, paragraph 0086), suggesting the ingredients are cosmetically or pharmaceutically acceptable. Dai teaches the composition is preferably used in products such as shampoo, hand, face, and body soaps (Dai, page 10, paragraph 0105).
While Dai teaches use of sodium methyl cocoyl taurate, Dai does not teach the use of sodium lauroyl methyl taurate.
JP’194 discloses mild cleansing composition with make-up removing properties, see title. JP teaches that surfactants are widely used in aqueous personal care, household and industrial products. They are typically used as wetting agents, detergents and emulsifiers. In personal care cleansing products (e.g. shampoos, body washes, facial cleansers, liquid hand soaps, etc.) surfactants are often the most important ingredients as they provide many of the cleansing attributes of the composition, see first paragraph. The cleaning composition comprises (a) a taurate surfactant; (b) an isethionate surfactant; (c) betaine and/or another amphoteric surfactant; and (d) nonionic emulsifiers. The reference teaches use of surfactants wherein taurate surfactants include sodium lauroyl methyl taurate, sodium myristoyl methyl taurate, potassium myristoyl methyl taurate, sodium cocoyl methyl taurate, sodium oleoyl methyl taurate, calcium lauroyl methyl taurate, potassium lauroyl methyl taurate, and potassium lauroyl methyl taurate, see description, see section under (“description of embodiments”). The taurate surfactant is from 0.1 to 15 wt. % and in some cases, the (b) surfactant is sodium lauroyl methyl isethionate and additional ingredient includes cocoamidopropylbetaine, see decription, 6th paragraph. The cleansing compositions disclosed are particularly useful in methods for cleansing the body, particularly skin, particularly facial skin, wherein the method comprises using the compositions disclosed herein. This includes applying to the body, skin and/or face and rinsing off the cleansing composition or wiping the composition from the face. In addition, the cleansing compositions disclosed herein are useful in methods for removing makeup from skin, particularly facial skin. The composition can be applied to the skin and washed away from the skin. The composition can then be used in a method for gently moisturizing the skin comprising applying the composition to the skin, see description of translation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized sodium lauroyl methyl taurate in place of sodium methyl cocoyl taurate as taught by Dai et al. One of ordinary skill would have been motivated to do so because JP’194 teaches that surfactants like sodium lauroyl methyl taurate, sodium myristoyl methyl taurate, potassium myristoyl methyl taurate, sodium cocoyl methyl taurate, sodium oleoyl methyl taurate and an isethionate surfactant can be used in a cleansing composition and further provides equivalency between various laurate surfactants such as sodium lauroyl methyl taurate and the surfactant taught by Dai et al., sodium cocoyl methyl taurate. Thus, simple substitution of one taurate surfactant with another would have provided predictable surface active results.
Koshti et al. discloses blend of O-acyl-isethionates and N-acyl amino acid surfactants, see title. Koshti et al. teaches a process for preparing blends of O-acyl isethionates and N-acyl amino acid surfactants using common fatty acid chlorides, in quantitative yields. The blends are in liquid form or can be spray dried to obtain solid dried form, see abstract. Koshti teaches in Example 2, (To a stirred lauroyl chloride (228 g, 1.04 gmol) under slow purging of nitrogen at room temperature, sodium isethionate (52.0 g, 0.35 gmol) was added and the slurry was stirred at 65-70° C. for 4 h. The HCl gas generated was absorbed in alkali solution and the progress of reaction was monitored by IR spectrum analysis. The FTIR spectrum of the intermediate showed the presence of unreacted lauroyl chloride (carbonyl stretch at 1800 cm.sup.−1), sodium lauroyl isethionate (carbonyl of ester at 1734 cm.sup.−1) and disappearance of hydroxyl stretch (3323 cm.sup.−1) of sodium isethionate, see column 13, Example 2, third paragraph.
Therefore, based on the teachings of Koshti et al. disclosing blending of O-acyl isethionates and N-acyl amino acid surfactants using common fatty acid chlorides, it would have been obvious to one of ordinary skill to have followed the process of blending method comprising O-acyl isethionates and N-acyl amino acid surfactants by using lauroyl chloride as the reference teaches use of such in preparation.
Dai does not teach the composition as a reconstitutable powder which can be in a liquid form.
Nacharaju teaches a skin care product which can be in the form of a reconstitutable product, a liquid, a powder, or flakes (Nacharaju, column 20, lines 3-5). Nacharaju teaches similar ingredients, including suitable anionic surfactants as isethionates and taurates (Nacharaju, column 29, lines 43-44) and suitable zwitterionic surfactants as betaines (Nacharaju, column 30, lines 10-11). Dai and Nacharaju are considered to be analogous to the claimed invention, because both are in the same field of skin cleansing compositions comprising surfactants.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flake composition taught by Dai (Dai, page 10, paragraph 0103) to be formulated as a reconstitutable powder or in liquid form because Nacharaju teaches flakes and powders and liquids as reasonable alternatives (Nacharaju, column 20, lines 3-5) and teaches such skin care products can be useful in a variety of skin and sun care products (Nacharaju, column 20, lines 12-13).
Dai further teaches suitable zwitterionic surfactants (Dai, page 6, paragraph 0062) to include cocamidopropyl betaine (i.e., an alkylamidopropyl betaine; Dai, page 6, paragraph 0067), but does not teach the cocamidopropyl betaine in the claimed amount.
Wankhade teaches a concentrated surfactant composition of a blend of O-acyl isethionates of formula I and N-acyl glutamate of formula II as shown below, wherein R1 can be a methyl group (i.e., resulting in an O-acyl methyl isethionate), which is prepared by reacting a fatty acid chloride to prepare the O-acyl isethionate in a first step, then reacting that product to form the N-acyl glutamate (i.e., prepared sequentially from the same fatty acid chloride; Wankhade, claim 1) wherein the molar ratio of O-acyl isethionate to N-acyl glutamate is exemplified to be 1:2 (i.e., a molar ratio within the claimed range; Wankhade, column 11, line 1). Wankhade teaches that the term ‘GLI’ refers to ‘O-acyl isethionate (Formula I), see column 5, lines 1-35. Wankhade further teaches a weight ratio of the amount of the blend of O-acyl isethionate and N-acyl glutamate to the amount of cocamidopropyl betaine of 12% (GLI of Example 1 contains 45% of the solid surfactants and example 7A contains 26.5% of GLI) to 10% (Wankhade, column 16, example 7A), suggesting a weight ratio of 1.2:1 would result in a formulation with the desired properties. Based on the amount of anionic surfactant (i.e., GLI The term ‘GLI’ refers to ‘O-acyl isethionate (Formula I as taught by Wankhade) of 30-70% taught by Dai (Dai, page 4, paragraph 0044), this would result in a possible range of 36-84% of the cocamidopropyl betaine.
The recitation of “wherein the said composition when diluted 3 - 5 times, by weight with water to afford a liquid cleansing formulation with pH ranging from 5.0 to 6.0 and viscosity ranging from 2,000 to 10,000 cps at 25 °C.” If a composition is physically the same, it must have the same properties. See MPEP § 2112.01(II). Therefore, it would be reasonable for one of ordinary skill in the art to expect that a composition comprising all the claimed ingredients in the claimed amounts as stated above would afford a liquid cleansing formulation with pH ranging from 5.0 to 6.0 and viscosity ranging from 2,000 to 10,000 cps at 25 °C when diluted 3-5 times. This is evidenced by Dai, which teaches a pH of less than 8 (Dai, abstract) and Wankhade, which teaches the compositions are used to create transparent liquids that have a pH similar to the skin’s pH (Wankhade, abstract), and exemplifies a formulation comprising water wherein the pH is 6 and the viscosity is 4000 cps at 25 °C (Wankhade, column 16, example 7A), which both lie within the claimed ranges. Wankhade does not specify dilution with water by 3-5 times compared to the weight of the powder, but does teach the amount of water used is controlled to yield the desired solid content of the blend of O-acyl isethionates and N-acyl glutamate (Wankhade, column 7, lines 2-4), suggesting the amount of water can be optimized to directly affect the viscosity.
Formula I and II:
PNG
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214
339
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Greyscale
(Wankhade, claim 1).
Wankhade is also considered to be analogous to the claimed invention, because both are in the same field of skin cleansing compositions comprising surfactants. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition based on the teachings of Dai and Nacharaju to include the ratio of surfactants taught by Wankhade to lead to ideal foaming (Wankhade, column 17, formulation A), because Wankhade teaches zwitterionic surfactants such as cocamidopropyl betaine are very good lipid solubilizers which lead to good foaming (Wankhade, column 2, lines 60-65). Based on the teachings of Wankhade, it would also be reasonable to expect the powder would result in a liquid cleansing formulation with the claimed properties if diluted with water.
Dai teaches antimicrobial agents to include organic acids (Dai, page 9, paragraph 0096), but does not teach a specific preservative from the claimed list of instant claim 2.
Nacharaju teaches suitable preservatives to include benzoic acid, sorbic acid, and dehydroacetic acid (Nacharaju, column 28, lines 44-45). It would have been obvious to one of ordinary skill in the art to utilize a specific organic acid as taught by Nacharaju to be a suitable preservative, because Dai teaches organic acids to be suitable for benefiting the skin (Dai, page 9, paragraph 0096), while Nacharaju teaches specific embodiments of suitable preservatives as sorbic and benzoic acid for personal care compositions.
Nonstatutory double patenting rejection
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/311,361 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite concentrated reconstitutable liquid composition comprising of: a. blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate, in the molar ratio of 1:2 and with solids content of minimum 40 %; b. cocamidopropyl betaine with solids content of minimum 40% ; c. 1.0% to 2.5% by weight of total composition, an antimicrobial preservative; d. 0.5% to 5% by weight of total composition, a cosmetically and pharmaceutically acceptable auxiliaries; and wherein, the blend of sodium lauroyl methyl taurate and sodium lauroyl methyl isethionate is synthesized using lauroyl chloride; wherein the ratio of a : b 5.0 to 6.0 : 3.5 to 4.5 by weight; and the said composition is without any additionally added fatty alcohol or fatty acid as a structurant; wherein the said composition when diluted 3 - 5 times, by weight with water to afford a liquid cleansing formulation with pH ranging from 5.0 to 6.0 and viscosity ranging from 2,000 to 10,000 cps at 25 °C. The copending claims recite a reconstitutable concentrated powder composition, said composition comprising: a. 50 to 70% by weight of a total powder composition, of a blend of O-acyl methyl isethionate and N-acyl amino acid surfactants; b. 25 to 40% by weight of the total powder composition, of an alkylamidopropyl betaine; C. 2.0 to 6.0% by weight of the total powder composition, of an antimicrobial preservative; and d. optionally, 1.0 to 10.0% by weight of the total powder composition, of one or more cosmetically or pharmaceutically acceptable auxiliary, wherein said blend of O-acyl methyl isethionate and N-acyl amino acid surfactants is prepared sequentially from a fatty acid chloride, wherein the fatty acid chloride used to prepare O-acyl methyl isethionate and N-acyl amino acid surfactants is the same; said O-acyl methyl isethionate and N-acyl amino acid surfactants being present at a ratio ranging from 2:1 to 1:2; wherein said reconstitutable concentrated powder composition, when diluted with water by 4 to 12 times by weight of said powder, affords a transparent liquid formulation with a pH ranging from 5.0 to 6.0 and a viscosity ranging from 1,000 to 15,000 cps at 25° C; and wherein the composition is free from polymeric gelling or thickening agents. The dependent claims 2-3 recite sodium lauroyl methyl isethionate and sodium lauroyl methyl taurate. The copending claims reciting a reconstitutable concentrated powder which can be diluted to form a liquid formulation. Therefore, it would have been obvious to one of ordinary skill to have made a liquid composition and come to the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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