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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
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.
Claim(s) 1, 3, 5, 10-12, 14-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGeehan et al. (US 20120157540) in view of Colurciello et al. (US 20150125502) and further in view of Whiteley et al. (20130203845).
McGeehan et al. teach a sanitizer formulation comprising: (a) an antimicrobial active agent selected from the group consisting of biguanides, monoguanides, and combinations thereof; (b) a dialkyldimethyl ammonium salt, and(c) a compound selected from the group consisting of an alkyldimethylbenzyl ammonium salt, an alkyldimethyl(ethylbenzyl) ammonium salt, an alkoxylated alcohol, and combinations thereof. The preferred component (a) is polyhexamethylene biguanide or the salts thereof. See Para [0007]. McGeehan et al. teach The concentration comprises from about 1% to about 11% of component (a), from about 5% to about 21% of component (b). In the concentrate, the component (a) and the component (b) are present in a weight ratio of from about 1:1 to 1:10, advantageously from about 1:1 to about 1:5, more advantageously from about 1:2 to about 1:5 and wherein the concentrate is free of sequestrants. See Para [0010]. The use of didecyldimethy| ammonium carbonate or bicarbonate is taught in Para [0052]. McGeehan et al. teach in addition
components (i) and (ii), the disinfectant formulations of the invention may additionally contain a non- ionic surfactant. Suitable non-ionic surfactant includes but are not limited to alkoxylated alcohols. See para [0054]. McGeehan et al. teach the alkoxylated alcohol is suitably present in the disinfectant composition concentrate in an amount of from about 2.5% to about 13%, preferably from about 3.5% to about 6.5% based on the total weight of the disinfectant composition concentrate. See Para [0066]. McGeehan et al. differs from the claimed invention in the presence of alkalinity builder and aromatic aldehyde. Colurciello et al. discloses impregnated a wipe with a disinfectant composition (claim 22 of Colurciello et al. ) comprising an antimicrobial biguanide, a quaternary ammonium compound, and a basic compound wherein the weight ratio of the biguanide to the quaternary ammonium compound is about 1:1.5 to 1:10 (i.e., weight ratio of quaternary ammonium compound to biguanide of 10:1 to 1.5:1) (claim 1) wherein the biguanide comprises polyhexamethylene biguanide (i.e., PHMB, a polybiguanide) the quaternary ammonium compound comprises a combination of alkyl dimethyl benzyl ammonium chloride and dialkyl dimethyl ammonium chloride (i.e., halide salts) and the basic compound comprises a monoethanolamine (i.e., a pH builder) (claim 8 of Colurciello et al.) wherein the pH of the composition is above 8 (claim 11 Colurciello et al.). Specifically, with regards to the claimed a quaternary ammonium carbonate/quaternary ammonium bicarbonate, Colurciello et al. teach that component (ii) of the disinfecting composition is a quaternary ammonium compound or a mixture of quaternary ammonium compounds. Quaternary ammonium compounds, also known as "quats", typically comprise at least one quaternary ammonium cation with an appropriate anion. Quats will generally have the general formula of a nitrogen being attached to R1, R2, R3 and R4. The groups R1, R2, R3 and R4 can vary within wide limits and examples of quaternary ammonium compounds that have anti-microbial properties will be well known to the person of ordinary skill in the art. Suitable substituents for the groups R1, R2, R3 and R4 may be selected from the group consisting of alkyl, substituted alkyl, alkenyl, substituted alkenyl, heterocyclic, substituted heterocyclic, cycloalkyl, substituted cycloalkyl, aryl, substituted aryl, alkylaryl, substituted alkylaryl, arylalkyl, substituted arylalkyl A is a monovalent anion or one equivalent of a polyvalent anion of an inorganic or organic acid. Suitable anions A: are in principle all inorganic or organic anions, in particular halides, for example chloride or bromide, carbonates, bicarbonates, carboxylates, sulfonates, phosphates or a mixture thereof ({0038-0040]. Typically, Colurciello et al. teach that the quaternary ammonium compounds used in the invention are those having at least two of R1, R2, R3 and R4 being methyl groups and two of R1, R2, R3 and R4 have 8 to about 18 carbon atoms ({0041]). Colurciello et al. teach that component (III) is a basic compound with is added to components (i) and (ii) to raise the pH of the composition to above 8. Any suitable basic compound may be used; however, it has been discovered that alkanolamines are effective in raising the pH of the composition with adversely affecting the function of the quaternary ammonium compounds. Essentially any alkanolamine may be used, including mono, di and tri alkanolamines ({0043]). Example 1 of Colurciello et al. discloses saturating a wipe with a disinfectant solution comprising 0.344 wt.% of a combination of di-Cs-10 alkyldimethyl ammonium chloride and benzyl C12-16 alkyl dimethyl ammonium chloride (i.e., a quaternary ammonium cation) (i.e., (13 wt.%+8.5 wt.%) X 1.6 wt.% =0.344 wt.%), 0.1 wt.% PHMB (i.e., a polybiguanide) (i.e., 0.50 wt.% x 20% = 0.1 wt.%), monoethanolamine (i.e., a pH builder), and ethanol (i.e., an organic solvent) and having a pH of about 11.6, wherein about 1 part by weight is combined with about 5 parts by weight of the disinfectant solution, and wherein the disinfectant solution is prepared by diluting a concentrate with water (Example 1; paragraph [0057)). Whiteley et al. teach the disinfecting composition comprises an aldehyde, which is aromatic dialdehyde, preferably o- phathalaldehyde. See Paras [0029]-[0031] and claims 1-4. The addition of other biocidal agents, such as quaternary ammonium compounds and biguanide is taught in Para [0037]. The use of a chelating agent is taught in Claim17. The teachings of McGeehan et al. Colurciello et al. and Whiteley et al. are directed to anti- microbial compositions comprising a quaternary ammonium compound , a biguanide and an aromatic aldehyde. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine the teachings of McGeehan et al. Colurciello et al. and Whitely to arrive at a cosmetic or hygiene product comprising a carbonate/bicarbonate salt of a quaternary ammonium cation, a biguanide and an alkalinity builder. Applicant’s attention is drawn to In re Kerkhof, 205 USPQ 1069 (C.C.P.A. 1980), itis prima facie obvious to combine two or more compositions each of which is taught by prior art to be useful for the same purpose in order to forma third composition that is to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in prior art, thus claims that requires no more than combining together two or three conventional anti- microbial compositions set forth prima facie obvious subject matter.
The data in the specification does not show the concentrations of each component used in order to obtain the FIC and the FIC of less than 1.00 for the claimed combination of quaternary ammonium and biguanides. The examiner from presented data is not able to determine if the concentrations used are within the scope 2%-12% and if the concentration of quaternary ammonium compound is less than the biguanides. Clarification is requested.
Response to Arguments
Applicant’s arguments are noted. Applicant his remarks argues that “in order to properly support a rejection on the basis that an invention is the result of “routine optimization’, the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail”. It is the examiner’s position that applicant is using dodecyl dimethyl ammonium bicarbonate in combination with a biguanide. McGeehan teaches such combination. To have different proportions of each ingredients than McGeehan does not create a patentably distinct composition in the absence of evidence to the contrary. There is no evidence of record to the advantages of such proportions. Furthermore, that the presented data in the specification do not show the concentrations of each biocide used in order to obtain the FIC described in the specification. The examiner needs to see such concentrations in order to see if they are within the scope of the claimed concentrations and if the first biocide is used at the lower concentrations. Additionally, claims 15-18 and 20 are not drawn to any specific concentrations or proportions. Applicant in his remarks further argues that “quaternary ammonium compounds and a biguanide, there would be no motivation for a skilled artisan to combine Colurciello and McGeehan. As Page 8 of 11mentioned previously, McGeehan teaches that the formulation concentrates of the present invention are free of sequestrants such as an acetic acid derivative selected from the group consisting of ethylenediaminetetraactic acid, nitrilotriacetic acid, and tetrasodium EDTA. This is not merely a passing remark in McGeehan. Moreover, McGeehan teaches that the formulation free of sequestrants exhibit enhanced antimicrobial efficacy (See McGeehan, paragraph [0013]). Applicant submits that a reference may be said to teach away”. It is the examiner’s position that Colurcillo teaches the use of EDTA in combination with quaternary ammonium compounds and biguanides. There is no evidence of record that addition of EDTA to McGeehan’s composition as selected by the applicant would create better biocidal property. Applicant is using the composition of McGeehan and adds a complexing agent taught by Colurciello . it would have been obvious o a person skilled in the art to add a complexing agent, which is known by Colurciello to be added to quaternary ammonium compounds and biguanide. The addition of an aromatic aldehyde would have also been obvious to a person skilled in the art considering that Wiley teaches the use of such compounds as biocides. The combination of ingredients being used for the same purpose flows logically from their individual use for the very same purpose. Applicant alleges criticality to the synergistic results shown in tables 2-5 of the instant specification. However, the data in the specification does not show the concentrations of each component used in order to obtain the FIC and the FIC of less than 1.00 for the claimed combination of quaternary ammonium and biguanides. The examiner from presented data is not able to determine if the concentrations used are within the scope 2%-12% and if the concentration of quaternary ammonium compound is less than the biguanides. Furthermore, claims 15-18 and 20 are not drawn to any concentrations or proportions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617