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 .
Claims 1, 35, 10-12, 14-18 and 20 are presented for examination.
Claims 4 and 19 are withdrawn from examination.
The remarks filed on 03/10/2026 have been received and entered.
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his response alleges criticality to the demonstrated synergism between the claimed quaternary ammonium compounds and the claimed biguanide. However, the presented data show partial synergism. From the presented data it is not clear if the claimed concentration range of about 2% to about 12% creates synergism or if there are concentration within such range, which do not create synergism. Additionally, claims 15-18 and 20 are not directed at any concentrations. Applicant in his remarks further argues that "McGeehan specifically touts that "[a]advantageously, the disinfectant formulations and the formulation concentrates of the present invention are free of sequestrants such as an acetic acid derivative selected from the group consisting of ethylenediaminetetraacetic acid, nitrilotriacetic acid, tetrasodium EDTA." Therefore, McGeehan teaches away from inclusion of a complexing agent chosen from trisodium methylglycine acetic acid, tetrasodium ethylenediaminetetraacetic acid, or combinations thereof and the independent claims are nonobvious over the cited references for at least this additional reason". It is the examiner's position that Colurcilleo teaches the presence of EDTA in combination quaternary ammonium compounds and a biguanide. Therefore, such reference reads on the presence of EDTA as claimed in the instant application. Applicant’s attention is drawn to In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981), which cites “the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art”. In the instance case Colurcilleo teaches the presence of EDTA in combination quaternary ammonium compounds and a biguanide. Therefore, such reference reads on the presence of EDTA as claimed in the instant application.
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.
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(ethylbenzy) 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 t.%+8.5 wt.%) X 1.6wt.%=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)). The use of a complexing agent, such as, EDTA is taught in Para [0047].
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 Claim 17. 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 Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980), it is 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 form a 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 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. Furthermore, since the combination of the claimed quaternary ammonium compounds and biguanide results in partial synergism, therefore from the presented data it is not clear which concentrations within the scope of about 2% to about 12% would produce synergism.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZOHREH A FAY/Primary Examiner, Art Unit 1617
Prosecution Insights