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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims Status
Applicant's election with traverse of Group I (composition) and the species for composition of: betaine comprising cocamidopropyl betaine, an amphoacetate comprising disodium cocodiamphoacetate, a glycinate comprising sodium cocoyl glycinate and a polyglucoside comprising decyl glucoside in the reply filed on 11/03/2025 is acknowledged.
The traversal is on the ground(s) that more than one invention is permitted if all inventions are linked to form a single general inventive concept. Applicants argue that it is well settled that when a set of inventions is claimed the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled when there is a technical relationship among those inventions involving one or more of the same corresponding technical features. Applicants have claimed a superior cleansing composition and method that uses that same composition.
This is not found persuasive because Per PCT Rule 13.1, the international application shall relate to a group of inventions so linked as to form a single general inventive concept or a “unity of invention” (see MPEP 1850). Per PCT Rule 13.2, “unity of invention” is fulfilled by defining a special technical feature that is shared amidst the claimed inventions. The Rule further specifies that “[t]he expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.” A lack of unity of invention determination begins with a consideration of the claims in light of the description and drawings. Lack of unity of invention may be directly evident “a priori,” or before considering any prior art when no special technical feature is common to each of the independent claims. Alternatively, lack of unity of invention may only become evident “a posteriori,” or after considering the claims in relation to the prior art.
The common technical feature of Groups I-II is an aqueous sulphate-free cleansing composition for female intimate hygiene, the composition comprising: a) 1 to 20 wt% of a non-soap surfactant system comprising a combination of at least three sulphate-free surfactants selected from glycinates, betaines, alkyl polyglucosides and amphoacetates; b) 0.05 to 4 wt% of a prebiotic capable of being broken down by Lactobacilli to lactic acid; and, c) 0.001 to 3 wt% lactic acid or a salt thereof added as a postbiotic; wherein said composition is free of live bacteria including Lactobacilli.
Cruz et al. (US20210299020) discloses a surfactant combination of sulfate free anionic surfactants, see Table 3 wherein the sulfate free surfactants are present from 1-25% by weight, see Table 3. . The surfactants are sulfate free, see paragraph [0053]. The anionic surfactant can comprise a combination of two or more, see claim 46. The surfactants include glycinates and betaines, see claims 44-47. The composition may include prebiotic of polysaccharide, see claim 57 and a lactic acid, see paragraphs [0058]-[059]. The composition does not contain live bacterial cells. The composition include cleanser thus is capable of being a feminine hygiene product, see paragraph [0025]. While more than one invention is permitted, Examiner submits that a lack of unity of invention has been found a posteriori. Based on the prior art, the common technical feature of the instant claims lacks novelty over the prior art. Since the common technical feature is taught by the prior art, the common technical feature does not rise to the level of a special technical feature. Thus, the groups lack unity of invention a posteriori and restriction between them is proper. Accordingly, any subsequent patentably distinct invention lacks unity with the first group, see 37 CFR § 1.476 (d).
With regards to the specie elections Applicants traverse and submit that they have presented a reasonable number of species and criteria such that the claims can be searched without undue burden on the Examiner.
This is not found persuasive because search per PCT rule 13.1 and 13.2 search burden is not a criterion for lack of unity of invention. With regards to the species claimed, the species lack the same or corresponding special technical feature because the species represent distinct characteristics. As noted in the restriction requirement, the species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: the species represent distinct characteristics. Cruz et al. (US20210299020) discloses a surfactant combination of sulfate free anionic surfactants, see Table 3 wherein the sulfate free surfactants are present from 1-25% by weight, see Table 3. . The surfactants are sulfate free, see paragraph [0053]. The anionic surfactant can comprise a combination of two or more, see claim 46. The surfactants include glycinates and betaines, see claims 44-47. The composition may include prebiotic of polysaccharide, see claim 57 and a lactic acid, see paragraphs [0058]-[059]. The composition does not contain live bacterial cells. The composition include cleanser thus is capable of being a feminine hygiene product, see paragraph [0025].
The requirement is still deemed proper and is therefore made FINAL.
Claims 6 and 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 6 and 9-13 recite species that are unelected for the composition and claim 14 recites a treatment method that was unelected. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/03/2025. Examiner notes however that at the time of allowance, all withdrawn claims can be considered for rejoinder should they require all of the limitations of an allowable claim.
Claims 1-5 and 7-8 are under current examination to the extent of the elected species of betaine comprising cocamidopropyl betaine, an amphoacetate comprising disodium cocodiamphoacetate, a glycinate comprising sodium cocoyl glycinate and a polyglucoside comprising decyl glucoside.
Abstract-Objection
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, the abstract is objected to for the use of the legal phraseology “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 01/31/2024, 12/09/2024 and 11/05/2025 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Rejections - 35 USC § 112(b)-indefinite
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “ wherein said composition is free of live bacteria including Lactobacilli. It is unclear if said composition must be free of all live bacteria, or if the composition must only be free of Lactobacilli bacteria in which case the composition can contain other live bacteria, because the claim recites the phrase including Lactobacilli. If it is Applicants intention is to claim a composition free of all live bacteria, it is suggested that “including Lactobacilli” can be deleted. For the purpose of examination, the claim will be interpreted of being free of all live bacteria.
Dependent claims 2-5 and 7-8 do not rectify the indefinite issue of claim 1 and are rejected by virtue of their dependency.
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.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cruz et al. (United States Patent Publication 2021/0299020- filing date of 3/29/2021) in view of Marie Drago (WO2020064977) and Kischnick et al. (WO2020/027797).
The instant claims are being examined to the extent of the elected composition to: cocamidopropyl betaine (CAPB), disodium cocodiamphoacetate (amphoacetate), sodium cocoyl glycinate (glycinate), decyl glucoside (polyglucoside) and glycogen prebiotic.
Regarding the recitation “for female intimate hygiene”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the prior art cited below is to sulfate (also spelled sulphate) free aqueous personal care cleaning compositions, the prior art composition is capable of performing the intended use claimed.
Cruz et al. teach aqueous (i.e. containing water) personal care compositions for cleaning skin or hair which comprise sulfate free surfactant systems, see claim 44 and paragraph [0001] and paragraph [0099]. The surfactant system comprises anionic and amphoteric surfactants. The amphoteric surfactant includes cocamidopropyl betaine and can be present from 2 to 10% by weight, see paragraph [0054] and claim 47. Decyl glucoside (a polyglucoside comprising ether) is taught to be present at 0-3% by weight or less, see paragraph [0082].The anionic surfactant can comprise a glycinate including sodium cocoyl glycinate, see paragraph [0009]. Anionic surfactant is present from 1-15% by weight, see paragraph [0052]. The composition can further contain lactic acid organic acid present from 0.2-2% by weight, see paragraph [0058] and a prebiotic polysaccharide, see paragraph [0023] and [0068]-[0078] and claims 57 and 59. The pH of the composition is from 3.5-10, see paragraph [0019]. The viscosity is 2,000-20,000 cp (equivalent to 2000-20,000cps), see paragraph [0064]. Cruz is silent to the inclusion of any live bacteria.
Cruz et al. do not expressly teach disodium cocodiamphoacetate or that the polysaccharide prebiotic is glycogen.
Drago teaches formulations useful for hygiene of the body which include at least one prebiotic and at least one postbiotic, see abstract and pages 3, 5 and 17. The post biotic is inclusive of lactic acid and the prebiotic includes polysaccharides such as glycogen, see pages 4, 6-7 and 26. The prebiotic feeds commensal bacteria and has a negative effect on opportunistic bacteria and is capable of perfecting the cleaning of skin, see pages 3 and 7.
Kischnick et al. that disodium cocoamphodiacetate (also known as disodium cocodiamphoacetate) as an antimicrobial boosting agent enhances the antimicrobial activity of antimicrobial including lactic acid, see Fig 4 and claims 8 and 13 and pages 9, 11 and 23. The antimicrobial boosting agent is present at 1% or less by weight with antimicrobial agent including lactic acid present from 0.001-5% by weight, see pages 9-10 and claims 8 and 13.
It would have been prima facie obvious to provide disodium cocoamphodiacetate in amounts of 1% by weight or less with the lactic acid composition of Cruz et al. and to substitute the polysaccharide of Cruz et al. for glycogen.
One of ordinary skill in the art would have been motivated to provide disodium cocodiamphoacetate at less than 1% by weight because Kischnick et al. teach that disodium disodium cocodiamphoacetate in this amount enhances the antimicrobial activity of antimicrobial agents including lactic acid. One or ordinary skill in the art would have been motivated to substitute the polysaccharide taught by Cruz et al. for glycogen because Draco teaches that glycogen and lactic acid are useful in cleaning compositions for the body, with glycogen prebiotic enabling the feeding of commensal bacteria while providing a negative effect on opportunistic bacteria.
There would have been a reasonable expectation of success because Cruz et al., Draco and Kischnick et al. all teach personal cleaning compositions (see page 9 and 23 of Kischnick, page 3,5,7 and 17 of Draco and paragraphs [0001], [0039][0042] and [0044] of Cruz et al).
Regarding instant claim 1, and the presence of 1-20% by weight a combination of surfactants which include cocamidopropyl betaine, cocoamphodiacetate, amphoteric surfactant, a glycinate anionic surfactant, and decyl glucoside, Cruz teaches a combination of surfactants and that the total amount of active surfactant can range from 5-20% by weight, see paragraph [0049]. The inclusion of the disodium cocodiamphoacetate is taught by Kischnick from 1% by weight or less. The inclusion of cocamidopropyl betaine amphoteric surfactant is from 2-10% by weight (paragraph [0054]) and the inclusion of decyl glucoside can be 0-3% by weight, see paragraph [0082]. The inclusion of anionic surfactants such as sodium cocoyl glycinate is 1-15% by weight see paragraphs [0009] and [0052]. Regarding the amount of lactic acid being from 0.05-4% by weight, as noted above, the lactic acid is present from 0.3-2% by weight which overlaps and renders obvious the claimed range. Regarding the amount of glycogen prebiotic, the substitution of polysaccharide component in Cruz et al. for the polysaccharide glycogen of Drago is from 0.1-5% by weight since Cruz teaches that polysaccharides can be present in this amount, see paragraph [0068] of Cruz et al. Thus, regarding the amount of the surfactant system, glycogen prebiotic and lactic acid, as Cruz in view of Draco and Kischnick render obvious overlapping amounts, 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).
Regarding instant claim 2, wherein the glycinate i.e. the elected sodium cocoyl glycinate is in the range of 0.5-5% by weight, Cruz teaches that the anionic surfactant which includes glycinate is present from 1-15% by weight, see paragraph [0009] and [0052]. Cruz exemplifies sodium cocoyl glycinate as a glycinate, see paragraphs [0115] and [0118].
Regarding instant claim 3, the elected cocamidopropyl betaine is present from 1-15% by weight, see paragraph [0013]. This amount overlaps and renders obvious the claimed amount of from 0.5-8% by weight of the betaines.
Regarding instant claim 4, Cruz teaches that the decyl glucoside can be incorporated from 0-3% by weight, see paragraph [0082].
Regarding instant claim 5, Cruz teaches a pH of from 3.5-10 which overlaps and renders obvious the instantly claimed range of from 3.0-7.5
Regarding instant claim 7, Cruz teaches that the viscosity is from 2,000-20,000cps, see paragraph [0064]. This viscosity overlaps and renders obvious the claimed viscosity from 2500-10000cps.
Regarding instant claim 8, Cruz in view of Draco render’s obvious the claimed complex polysaccharide of glycogen.
Accordingly, instant claims 1-5 and 7-8 are rendered prima facie obvious over the teachings of Cruz et al. in view of Drago and Kischnick et al.
Conclusion
Currently claims 1-5 and 7-8 are rejected and no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619