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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 March 2026 has been entered.
Status
Applicant’s response dated 10 March 2026 to the previous Office action dated 11 December 2025 is acknowledged. Pursuant to amendments therein, claims 12, 19-23, 25, 27-30, and 32-35 are pending in the application.
Although claims 12 and 25 are identified as Currently Amended, the claim text lacks markings indicating the changes made as required per 37 CFR 1.121(c)(2). Nevertheless, in the interest of compact prosecution, the claims are examined herein as presented. Applicant is reminded that claim listings must include claim text markings indicating any changes made as required per 37 CFR 1.121(c)(2).
A new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but new rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.
Claim Rejections - 35 USC § 112
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 25, 27-30, and 32-35 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 25 recites that the first antimicrobial agent comprises a carbonate and/or bicarbonate salt of quaternary ammonium cation or a tertiary amine, and subsequently recites that the first antimicrobial agent comprises an alkyl dimethyl benzyl ammonium chloride, a dialkyl dimethyl ammonium chloride, an alkyl dimethyl ethyl benzyl ammonium chloride, or mixture thereof, such that it is unclear which recitation applies or whether both recitations apply, rendering the claim indefinite. Claims 27-30 and 32-35 are rejected as depending upon claim 25 without remedying such deficiency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 12, 19-23, 25, 27-30, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirst et al. (WO 2013/098547 A1; published 04 July 2013) in view of Colurciello et al. (US 2015/0125502 A1; published 07 May 2015; of record).
Hirst et al. discloses an anti-microbial composition comprising a quaternary ammonium compound, a polar solvent, a non-ionic surfactant, and a chelate (abstract; claim 1) wherein the composition comprises an additional antimicrobial component (claim 19) such as polyhexamethylene biguanide or N,N-bis(3-aminopropyl)-dodecylamine (claim 21) wherein polyhexamethylene biguanide is PHMB (page 8 line 31) wherein the composition can comprise N,N-bis(3-aminopropyl)-dodecylamine and PHMB (page 9 lines 16-18) wherein preferred polar solvents include water, ethanol, and mixtures thereof (page 14 lines 25-31) wherein the polar solvent is present in the composition more preferably from about 95 to about 99.8% by weight (page 19 lines 26-30) wherein suitable non-ionic surfactants include alkyl polyglucosides or glucosides (page 15 lines 10-11; page 16 lines 12-15) wherein the composition comprises 400-3000 ppm (i.e., 0.04-0.3 wt%) chelate (claim 16) wherein the quaternary ammonium compound can be a benzalkonium compound of formula (B) with anion such as chloride, carbonate, or bicarbonate (claim 8) such as benzyl-C12-C16-alkyl-dimethyl-ammonium chloride (i.e., an alkyl dimethyl benzyl ammonium chloride) (claim 10) wherein the ratio by weight of component (a) to the additional anti-microbial agent (b) is typically from about 1:2 to about 50:1 (i.e., about 50:1 to about 1:2) (page 19 lines 20-24) wherein component (a) is quaternary ammonium compounds and component (b) is additional anti-microbial agents (page 5 lines 1-3) wherein the composition may be applied to a surface by wiping the composition onto the surface (page 22 lines 7-8).
Hirst et al. does not explicitly disclose that the composition is contained within a liquid absorbent substrate to form a premoistened wiping product as claimed.
Colurciello et al. discloses a wipe comprising a substrate impregnated with a disinfectant composition (claim 22) comprising an antimicrobial biguanide (i.e., component (i)), a quaternary ammonium compound (i.e., component (ii)), and a basic compound (i.e., component (iii)) 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 about 10:1 to 1.5:1) (claim 1) wherein the biguanide comprises polyhexamethylene biguanide (i.e., PHMB, a polybiguanide) and the quaternary ammonium compound comprises a combination of alkyl dimethyl benzyl ammonium chloride and dialkyl dimethyl ammonium chloride (i.e., halide salts) (claim 8) wherein the substrate comprises meltblown, coform, spunbound, airlaid, hydroentangled nonwovens, spunlace, bonded carded webs, or laminates thereof (claim 23). An example discloses saturating a wipe with a disinfectant solution comprising 0.344 wt% of a combination of di-C8-10 alkyldimethyl ammonium chloride and benzyl C12-16 alkyl dimethyl ammonium chloride (i.e., an alkyl dimethyl benzyl ammonium chloride) (i.e., quaternary ammonium cations, halide salts thereof) (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%), 0.6 wt% monoethanolamine, tetrasodium ethylenediaminetetraacetate (i.e., a chelating agent), and ethanol (i.e., an organic solvent, an alcohol), 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 resulting in 97.3 wt% water (Example 1; Table 1; paragraphs [0047], [0057]). Suitable anions for the quaternary ammonium compound can be halides such as chloride or carbonates or bicarbonates or mixtures thereof (paragraph [0038]). The disinfecting composition is impregnated into the wipe such that the wipe is pre-moistened (paragraph [0051]). The composition may further optionally contain surfactants such as non-ionic surfactants such as a linear or secondary alcohol ethoxylate (paragraph [0047]) wherein disposable wipes provide advantages over other application vehicles in that they are used a single time and disposed of rather than used repeatedly (paragraph [0050]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hirst et al. and Colurciello et al. by impregnating the composition of Hirst et al. as discussed above into a disposable wipe substrate as in Colurciello et al. such that the wipe is pre-moistened and wherein the substrate comprises meltblown, coform, spunbound, airlaid, hydroentangled nonwovens, spunlace, bonded carded webs, or laminates thereof as in Colurciello et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to provide a convenient way of applying the composition to a surface by wiping the composition onto the surface and to achieve advantages over other application vehicles by using it a single time and disposing of it rather than using it repeatedly as suggested by Colurciello et al., given that Hirst et al. discloses applying the composition to a surface by wiping the composition onto the surface.
Further regarding claim 12, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Hirst et al. as discussed above and to make the composition of Hirst et al. with water as polar solvent, with polyhexamethylene biguanide (i.e., a polybiguanide) and N,N-bis(3-aminopropyl)-dodecylamine (i.e., a tertiary amine) as additional antimicrobial agents, and with glucoside (i.e., a species of glycoside) as non-ionic surfactant, with a reasonable expectation of success.
Further regarding claim 12, although Hirst et al. does not disclose the claimed weight ratio of tertiary amine to polybiguanide of about 50:1 to about 1:2, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize antimicrobial effectiveness of the antimicrobial composition in the wipe of Hirst et al. in view of Colurciello et al. as discussed above by varying the concentration of N,N-bis(3-aminopropyl)-dodecylamine (i.e., a tertiary amine) antimicrobial agent and the concentration of polyhexamethylene biguanide (i.e., a polybiguanide) therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because active agents such as antimicrobial agents are known result-effective variables. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Further regarding claims 19 and 27, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Hirst et al. and to make the composition of Hirst et al. in the wipe of Hirst et al. in view of Colurciello et al. as discussed above with about 95 to about 99.8% by weight water polar solvent, with a reasonable expectation of success.
Further regarding claims 20, 28, and 32, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Hirst et al. and to make the composition of Hirst et al. in the wipe of Hirst et al. in view of Colurciello et al. as discussed above with ethanol (i.e., an organic solvent, an alcohol) in the polar solvent therein, with a reasonable expectation of success.
Further regarding claim 25, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Hirst et al. as discussed above and to make the composition of Hirst et al. with water as polar solvent, with benzyl-C12-C16-alkyl-dimethyl-ammonium chloride (i.e., an alkyl dimethyl benzyl ammonium chloride) with anion of chloride, carbonate, and/or bicarbonate as quaternary ammonium compound, with polyhexamethylene biguanide (i.e., a polybiguanide) as additional antimicrobial agent, wherein the ratio by weight of quaternary ammonium compound to polyhexamethylene biguanide is from about 50:1 to about 1:2, and with glucoside (i.e., a species of glycoside) as non-ionic surfactant, with a reasonable expectation of success.
Further regarding claim 33, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Hirst et al. and to make the composition of Hirst et al. in the wipe of Hirst et al. in view of Colurciello et al. as discussed above with 0.04-0.3 wt% of chelate (i.e., chelating agent), with a reasonable expectation of success.
Claims 25, 27-30, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colurciello et al. (US 2015/0125502 A1; published 07 May 2015; of record) in view of Koenig et al. (US 2012/0171300 A1; published 05 July 2012; of record).
Colurciello et al. discloses a wipe comprising a substrate impregnated with a disinfectant composition (claim 22) comprising an antimicrobial biguanide (i.e., component (i)), a quaternary ammonium compound (i.e., component (ii)), and a basic compound (i.e., component (iii)) 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 about 10:1 to 1.5:1) (claim 1) wherein the biguanide comprises polyhexamethylene biguanide (i.e., PHMB, a polybiguanide) and the quaternary ammonium compound comprises a combination of alkyl dimethyl benzyl ammonium chloride and dialkyl dimethyl ammonium chloride (i.e., halide salts) (claim 8) wherein the substrate comprises meltblown, coform, spunbound, airlaid, hydroentangled nonwovens, spunlace, bonded carded webs, or laminates thereof (claim 23). An example discloses saturating a wipe with a disinfectant solution comprising 0.344 wt% of a combination of di-C8-10 alkyldimethyl ammonium chloride and benzyl C12-16 alkyl dimethyl ammonium chloride (i.e., an alkyl dimethyl benzyl ammonium chloride) (i.e., quaternary ammonium cations, halide salts thereof) (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%), 0.6 wt% monoethanolamine, tetrasodium ethylenediaminetetraacetate (i.e., a chelating agent), and ethanol (i.e., an organic solvent, an alcohol), 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 resulting in 97.3 wt% water (Example 1; Table 1; paragraphs [0047], [0057]). Suitable anions for the quaternary ammonium compound can be halides such as chloride or carbonates or bicarbonates or mixtures thereof (paragraph [0038]). The disinfecting composition is impregnated into the wipe such that the wipe is pre-moistened (paragraph [0051]). The composition may further optionally contain surfactants such as non-ionic surfactants such as a linear or secondary alcohol ethoxylate (paragraph [0047]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Colurciello et al. as discussed above and to use a carbonate and bicarbonate and chloride salt as anion in the quaternary ammonium compound such as combination of alkyl dimethyl benzyl ammonium chloride/carbonate/bicarbonate and dialkyl dimethyl ammonium chloride/carbonate/bicarbonate, and to use nonionic surfactant, in the wipe and disinfectant solution of Colurciello et al. as discussed above, wherein the weight ratio of quaternary ammonium compound to biguanide is about 10:1 to 1.5:1, with a reasonable expectation of success, given that Colurciello et al. discloses that suitable anions for the quaternary ammonium compound can be halides such as chloride or carbonates or bicarbonates or mixtures thereof.
Colurciello et al. does not disclose that the non-ionic surfactant in the disinfectant solution and wipe of Colurciello et al. as discussed above is specifically a glycoside as claimed.
Koenig et al. discloses antimicrobial compositions including surfactant (title) and quaternary ammonium cations wherein the surfactant may be non-ionic (abstract) and wherein suitable nonionic surfactants include C11-15 secondary alkanols condensed with 9 or 12 moles of ethylene oxide such as TERGITOL 15-S-9 or 15-S-12 (paragraph [0033]) or wherein suitable nonionic surfactants include alkyl polyglycosides (paragraph [0035]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Colurciello et al. and Koenig et al. by using the alkyl polyglycosides (i.e., a glycoside) of Koenig et al. as the nonionic surfactant in the disinfectant solution and wipe of Colurciello et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use therein a nonionic surfactant known in the art as suitable for use in quaternary ammonium antimicrobial compositions per Koenig et al. because Colurciello et al. suggests using a nonionic surfactant therein, and the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination per MPEP 2144.07.
Response to Arguments
Applicant's arguments filed 10 March 2026 have been fully considered but they are not persuasive.
Applicant’s remarks regarding the tertiary amine of Colurciello et al. (remarks pages 5-6) are moot given the claim amendments and thus the withdrawal of the rejection of claims 12 and 19-23 using Colurciello et al. as the primary reference, and given that claims 25, 27-30, and 32-35 do not require a tertiary amine.
Applicant argues that samples 1-6 demonstrate unexpected superior results (remarks pages 6-7). In response, applicant asserts that samples 2-4 and 6 exhibit unexpected results compared to samples 1 and 5, but the claims are not limited to the formulations of samples 2-4 and 6, including all ingredients and concentrations thereof, and thus the asserted unexpected results are not commensurate in scope with the claims. Moreover, sample 4 does not contain a first antimicrobial agent, and thus the importance of the claimed weight ratio appears unclear. The burden is on applicant to establish that results are in fact unexpected and unobvious and of both statistical and practical significance, per MPEP 716.02(b). Such evidence of unexpected results must be commensurate in scope with the claimed invention per MPEP 716.02(d), and must compare the claimed subject matter with the closest prior art (or closer) per MPEP 716.02(e).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617