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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2026has been entered.
Applicants' arguments, filed 09/10/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112—New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 56 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly added claim 56 recites, “wherein the composition is free of aryl alcohol”. However, this limitation constitutes new matter insofar as it was not supported by the disclosure as originally filed.
MPEP 2173.05(i) states: Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff'd mem., 738 F.2d 453 (Fed. Cir. 1984). The mere absence of a positive recitation is not basis for an exclusion [emphasis added].
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.
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.
Previous
1) Claim(s) 1-4, 7-9, 11, 15, 17, 49 remain rejected under 35 U.S.C. 103 as being unpatentable over Gluck et al., (WO 1998/53036) in view of Vincent et al., (ES 2257842, pub. 2006). This rejection also applies to newly added claims 50-51, 55.
Gluck et al. teaches, “An antiseptic cleansing composition comprising an antimicrobial agent, an effective amount of an alkylpolysaccharide surfactant, at least one alcohol and at least one aryl alcohol” (Abstract). Note: “The alkylpolysaccharide surfactants are also known in the art as alkylpolyglucosides, however, for the purposes of the following discussion, the surfactant will be termed an alkylpolysaccaride” (p. 2, lines 22-24). Note also that no additional surfactant is required.
Preferably the alkylpolysaccharide is “does not exceed 6% w/v” (p. 2, lines 22-26). Accordingly, it would have been obvious for the amount of alkylpolysaccharide to fall within the claimed range of 0.1wt.% to 1.5wt.%.
Suitable antimicrobial agents include “chlorhexidine, chlorhexidine salt” (bisgiquanide antimicrobial active)(Abstract). “When the antimicrobial agent is chlorhexidine digluconate it is used in an amount preferably not exceeding 4.5% w/v” (p. 3, lines 22-23).
The compositions further comprise “a solubilizing agent for example propylene glycol [C2-C8 glycol], a hydrotrope or mixtures thereof” (p. 4, lines 17-18); “a foaming agent such as an alkylaminooxide” (amine oxide) (Id. lines 21-22). The prior art is silent concerning a range for the solubilizing agents; however, because the presence of solubilizing agents is taught, it would have been obvious to optimize a range for solubilizing agents. Accordingly, "where 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." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
It should also be noted here that Gluck et al. teaches an embodiment comprising 10% propylene glycol (p. 8, Example VIII), which falls within the claimed range of 5.0 wt% to about 13.0% for the at least one C2-C8 glycol, as per claim 1, establishing a prima facie case of obviousness.
“The pH of the composition is typically adjusted to pH 5 to 7 . . . “ (p. 5, lines 8-9).
The prior art teaches a specific embodiment below:
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(p. 7). Here the embodiment is devoid of quaternary ammonium compounds. The “Cocodiethanolamide” is used herein as a foaming agent, which can be replaced with alkylaminooxide, thus satisfying the limitation of 0.1 wt% to 1 wt.% of amine oxide and being devoid of additional surfactants.
Since the prior art teaches the same relative amount of biguanide antimicrobial active, it would have been capable of passing European Standard EN-1499 (2013). The amount of propylene glycol appears close enough to the claimed range to reasonably expect the same properties, especially since 2% falls within the suitable range for C2-C6 glycols shown in the instant specification, i.e. “at least 0.1%” (p. 7, para. [0038]).
It would have been obvious to add the amine oxide as foaming agent in this embodiment. Note: Plantaren 2000 is a C8-C16 alkyl polyglucoside.
The compositions of Gluck et al. may optionally comprise additional “nonionic surfactants” (p. 5, lines 1-2), but the reference does not teach where the additional nonionic surfactant is ethylene oxide-propylene oxide block copolymer.
The nonionic surfactant is taught to be present within a range of 0 to 10% by weight (see claim 1) and “preferably a alkyl polyglucoside” (Id.). Quaternary ammonium compounds are not required. Accordingly, it would have been obvious to exclude them.
“Another non-ionic surfactant suitable for the present invention is a polymeric surfactant comprising polyoxyethylene and polyoxypropylene. These block copolymers are sold under the Pluronics brand” (p. 9, 1st and 2nd full paragraphs). The reference further teaches, “When nonionic surfactants are used, these they are preferably incorporated in amounts ranging from 0 to 10% by weight of active in the total composition, being the most preferred in the range of 0-2% by weight of asset.” (Id.). Accordingly, it would have been obvious to provide the nonionic surfactant within the claimed range of about 0.1wt% to about 0.8 wt.%.
Vincent et al. additionally teaches “an antibacterial cleaning composition having between 0.05 and 1% by weight of a cationic polymer having a charge density of 0.0025 or more, between 0, and 5% and weight of a zwitterionic surfactant, between 0.2 and 5% by weight of at least one biguanide compound, and optionally a non-ionic surfactant and a polymeric biocidal compound” (Abstract).
The composition “is highly effective in destroying bacteria and other microorganisms, but also soft enough for frequent use in a single day” (p. 4, 5th paragraph).
The prior art acknowledges the known “use of an alkyl polyglucoside as an agent used to increase the microbiocidal activity of biguanide compounds” (p. 3, 7th paragraph).
The biguanide compounds “is preferably a salt of chlorhexidine selected from the group consisting of gluconate, acetate, formate, lactate, isethionate and succinamate” (p 5, 3rd paragraph), as per claims 2-3.
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add the nonionic surfactant of Vincent et al., i.e. ethylene oxide-propylene oxide block copolymer (Pluronics brand) to the compositions of Gluck et al. based on its art recognized suitability for its intended use as a nonionic surfactant in an antibacterial cleaning composition comprising at least one biguanide compound. It would have been obvious to use about 0.1 wt% to about 0.8 wt.% of the surfactant of Vincent et al., as claimed, since Vincent teaches a preferred range of 0-2% by weight for nonionic surfactants.
2) Claim(s) 12 remains rejected under 35 U.S.C. 103 as being unpatentable over Gluck et al., (WO 1998/53036) in view of Vincent et al., (ES 2257842, pub. 2006), as applied to claim 1 above, and further in view of Lowe et al., (GB 2493041, pub. 2013). This rejection also applies to newly added claim 52.
The combination of Gluck et al. and Vincent et al., which is taught above, differs from claim 12 insofar as it does not teach coco glucoside.
Lowe et al. teaches compositions for treatment of skin disorders comprising “chlorhexidine or a pharmaceutical salt thereof” (Abstract).
Lowe et al. further teaches, “Surfactants may be included as cleansing agents, foamers, solubilizing agents and homogenisers. Examples include coco-glucoside and decyl glucoside” (p. 18, lines 18-19).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use coco-glucoside as glucoside in the compositions of Gluck et al. based on its art recognized suitability for its intended use as surfactant in topical compositions comprising chlorhexidine, as taught by Lowe et al.
3) Claim(s) 16 remains rejected under 35 U.S.C. 103 as being unpatentable over Gluck et al., (WO 1998/53036) in view of Vincent et al., (ES 2257842, pub. 2006) as applied to claim 1 above, and further in view of Cosmetic Ingredient Review (CIR) (www.cir-safety.org, Aug. 2013). This rejection also applies to newly added claims 54.
The combination of Gluck et al. and Vincent et al., which is taught above, differs from claim 16 insofar as it does not teach one or more of PEG-7/PPG-2 propylheptyl ether.
CIR provides a panel review of alky PEG/PPG ethers used in cosmetics (Ti.). “PEG-7/PPG-2 Propylheptyl Ether” is listed therein as an alkyl PEG/PPG ether that is “safe in the present practices of use and concentration in cosmetics described in this safety assessment” (p. 10, Conclusion).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add PEG-7/PPG-2 propylheptyl ether to the compositions of Gluck et al. since Gluck et al. teaches adding nonionic surfactants to its compositions. The artisan would have been reasonably expected to provide known polymers that are safe to use in cosmetics such as PEG-7/PPG-2 propylheptyl ether, as taught by CIR.
New by Amendment
4) Claim(s) 13 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gluck et al., (WO 1998/53036) in view of Vincent et al., (ES 2257842, pub. 2006) as applied to claims 1 and 49 above, and further in view of Taylor et al., (WO 2007/079022).
The combination of Gluck et al. in view of Vincent et al., which is taught above, differs from claim 13 and 53 insofar as it does not teach where the alkyl amine oxide is, e.g, lauramine oxide.
Taylor et al. teaches antimicrobial compositions comprising “an alkamine oxide” (Abstract).
Taylor et al. teaches, “In a preferred embodiment of the invention, the alkamine oxide is present in the amount of from about 0.1 to about 10% by weight. In one exemplary embodiment, the alkamine oxide is lauramine oxide” (p. 2, lines 29 through p. 3, line 3).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use lauramine oxide as the amine oxide in Gluck et al. based on its art recognized suitability for its intended use as amine oxide in an antimicrobial composition, as taught by Taylor et al.
Technological Background
The prior art made of record and considered pertinent to applicant's disclosure BASF (Technical Information). BASF is pertinent for teaching Plantaren® 2000 N UP is a “C8-C16 fatty alcohol glycoside” (see General characterization at p. 1).
Response to Arguments
i.) Applicant argues that the European Standard EN-1499 cannot be satisfied by the prior art insofar as the prior art product is not the same or substantially similar. Applicant postulates, “The bisbiguanide level is not what determines EN-1499 performance in these compositions; the synergistic surfactant system and the glycol are” (p. 8-9)
The Examiner disagrees.
The prior art teaches a specific embodiment that is substantially similar insofar as it comprises chlorhexidine digluconate, two surfactants and a glycol. No evidence has been presented showing that the prior art is not capable of passing the European standard. Furthermore, the combination of ingredients and amounts thereof are obvious in view of the prior art.
“Where . . . the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 USC 102, on “prima facie obviousness” under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Furthermore, “[a]rguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
ii) Applicant argues that it would have been obvious to select the block copolymer of Vincent for use as the nonionic surfactant in Gluck since Vincent, “preferred alkyl polyglucoside, which Gluck already includes, not the block copolymer disclosed as a non-preferred alternative in a list.
However, it is well-settled that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments” (see MPEP 2123).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)) (see MPEP 2123).
The fact that the block copolymer of Vincent is not preferred or optional does not make its selection less obvious.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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