DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 5-10, 12-14, 16-21, 23-24, 27 and 32 are pending.
Information Disclosure Statement
The information disclosure statements submitted on 30 November 2023 and 17 March 2025 were filed before the mailing of an Office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 5 is 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 5 recites the limitation “the polymeric sulfonic resin functionalized resin” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Instant claim 1 recites a polymeric sulfonic acid resin based chelator, but does not recite a resin functionalized resin. The examiner recommends amending claim 5 to recite “the polymeric sulfonic acid resin”. Applicant should also amend claim 6 to replace “resin functionalized resin” with “acid resin based”.
Claim 5 also states that the resin includes a divinyl benzene/styrene copolymer. The copolymer recited does not contain a sulfonic acid moiety. Therefore, it is unclear whether Applicant intends for the polymeric sulfonic acid resin to include a copolymer that does not contain sulfonic acid.
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, 5-6, 10, 12-14, 16-21, 23-24, 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (US 2016/0074549 A1) in view of Larson et al. (US 2010/0120913 A1).
Lei et al., throughout the reference, teach a hydrogen peroxide disinfectant composition, a two-part formulation, and a method of disinfecting a surface of microorganisms (Abstract; [0002], [0014], [0025], [0026]; Claims 1-44).
Regarding instant claim 1, Lei et al. teach a concentrate or ready-to-use composition comprising hydrogen peroxide, a non-surfactant organic sulfonic acid or salt thereof, an additional acid other than the organic sulfonic acid, water, a water-miscible solvent, a buffer, a stabilizer, and a corrosion inhibitor ([0014]-[0015], [0018], [0020], [0024]-[0026], [0029]-[0030], [0034]-[0035], [0037], [0039], [0041], [0047]-[0048]; Examples 1-3; Claims 1, 7, 9, 17, 20, 34 and 40). The additional acid can be a carboxylic acid such as C1 to C8 monocarboxylic acid, including acetic acid, and mixtures thereof ([0018], [0035]).
Regarding instant claim 6, Lei et al. teach that the non-surfactant organic sulfonic acid is typically about 2 to about 15 wt.% of the total concentrate ([0017]); and the non-surfactant organic sulfonic acid is typically about 0.005 to about 3.0 wt.% of the total ready-to-use solution ([0022]).
Regarding instant claims 1 and 5, Lei et al. do not explicitly disclose the polymeric sulfonic acid resin based chelator of claim 1, or the divinyl benzene/styrene copolymer, perfluorosulfonic acid resin or polymer containing a 2-acrylamido-2-methylpropane sulfonic acid resin of claim 5.
However, Larson et al. throughout the reference teach a method of stabilizing a peracid or peracid concentration in a peracid-containing composition during storage comprising the steps of providing a peracid-containing composition and a cationic exchange resin, and then stabilizing the peracid-containing composition or peracid concentration by contacting the peracid-containing composition with the cationic exchange resin during storage ([0011]; Claim 1). Larson et al. teach the peracid being stabilized can be produced by adding or contacting an amount of cationic exchange resin to a solution of water, a carboxylic acid, and hydrogen peroxide. Any carboxylic acid can be used in the manufacturing methods, including acetic acid ([0018]; Claims 60-63). The cationic exchange resins used in the systems and methods of the present application can be of any type known in the art, including sulfonated polystyrene resins such as sulfonated polystyrene-divinylbenzene copolymers ([0019]; Claims 35-36).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Lei et al. wherein the non-surfactant organic sulfonic acid is replaced with a sulfonated polystyrene resin such as sulfonated polystyrene-divinylbenzene copolymers, as reasonably taught by Larson et al. A person of ordinary skill in the art would have been motivated to substitute the organic sulfonic acid of Lei et al. with the sulfonated polystyrene-divinylbenzene copolymers in order to stabilize the peracid-containing formulation during storage, as reasonably suggested by Larson et al.
A person of ordinary skill in the art would have a reasonable expectation of success because Lei et al. teach combining hydrogen peroxide and an optional carboxylic acid in water, and Larson et al. teach the formation of the stabilized peracid formulation by combining hydrogen peroxide, a carboxylic acid such as acetic acid, a sulfonated polystyrene resin and water.
Regarding instant claim 10, Lei et al. teach that the corrosion inhibitor is include benzotriazole ([0042]).
Regarding instant claims 12-13, Lei et al. do not explicitly disclose the solubilizer is propylene glycol present from about 9.5% to about 10.5% of claims 12-13.
Larson et al. teach that it is believed that polyhydric alcohols can enhance stability of the peracid-containing compositions. Without being limited by theory, it is believed that the increased number of hydroxyl groups in the polyhydric alcohols enhance the potency of the disinfectant and sterilant solutions by interacting with the aqueous medium and the peracid thereby stabilizing the solution. The increase in the hydroxyl groups may also increase the number of hydroxyl radicals or groups in the disinfectant/sterilant solutions thereby further enhancing the potency or kill ability of the solutions/dispersions. Examples of polyhydric alcohols which can be used in the present application include but are not limited to ethylene glycol (ethane-1,2-diol) glycerin (or glycerol, propane-1,2,3-triol), and propane-1,2-diol ([0028]-[0029]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to include propylene glycol in the compositions according to Lei et al. in order to enhance stability of the peracid-containing compositions, as well as enhance the potency of the disinfectant and sterilant solutions, as reasonably suggested by Larson et al.
Regarding instant claim 14, Lei et al. teach that the water-miscible organic solvents include diethylene glycol monoethyl ether ([0024], [0029]; Claim 42).
Regarding instant claims 16-18 and 21, Lei et al. teach that the concentrate comprises about 2 to about 8 weight percent of hydrogen peroxide, about 0.2 to about 10 weight percent of optional acid (i.e., acetic acid), about 2 to about 15 weight percent of non-surfactant organic sulfonic acid, buffer in an amount to adjust the pH, and about 0.05 to about 0.5 weight percent of corrosion inhibitor, based on the total weight of the concentrate ([0016]-[0018], [0020]). Lei et al. teach that the concentrate can be diluted with water to form a ready-to-use formulation ([0021]). The ready-to-use formulation comprises about 0.05 to about 5.0 weight percent hydrogen peroxide, about 0.05 to about 6.0 weight percent optional acid (i.e., acetic acid), about 0.05 to about 5.0 weight percent non-surfactant organic sulfonic acid, buffer in an amount to adjust the pH, about 0.001 to about 0.5 weight percent of corrosion inhibitor, and about 0.5% to about 20% by weight of water-miscible organic solvent (i.e., solubilizer and cleaner), based on the total weight of the ready-to-use formulation ([0022]-[0023]). Lei et al. teach that the solution includes water and optionally a water-miscible organic solvent diluted in a range with water from about 0.5% to about 20% by weight of water present in the ready-to-use solution ([0029]).
Larson et al. teach that the cationic resin is present at a weight ratio of peracid to cationic exchange resin of about 1:100 w/w to 100,000:1 w/w. In another embodiment, the cationic exchange resin is present at a weight ratio of peracid to cationic exchange resin of about 1:10 w/w to 10,000:1 w/w. In one embodiment, the weight ratio of peracid to cationic exchange resin is 100:1 w/w to 100:5 w/w ([0020]).
Lei et al. teach the hydrogen peroxide source is typically about 2 to about 8 weight percent of the total concentrate, and the biocidal amount of hydrogen peroxide in the ready-to-use solution is typically from about 0.05 to about 5.0 weight percent of the total solution ([0016], [0022]). Lei et al. teach that the non-surfactant organic sulfonic acid is typically about 2 to about 15 wt.% of the total concentrate ([0017]); and the non-surfactant organic sulfonic acid is typically about 0.005 to about 3.0 wt.% of the total ready-to-use solution ([0022]). Lei et al. also teach the optional acid, such as acetic acid, is typically about 0.2 to about 10 weight percent of the total concentrate, and from about 0.05 to about 6.0 weight percent of the total solution ([0018], [0023]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the workable concentration ranges for the hydrogen peroxide, peracid, cationic exchange resin, buffer, anticorrosive agent, solubilizer and cleaner taught by Lei et al. and Larson et al.
The examiner respectfully points out the following from MPEP 2144.05: “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Regarding instant claims 19-20, Lei et al. teaches formulations optionally comprising a mineral acid such as sulfuric acid ([0036]), and formulations optionally comprising a stabilizer such as EDTA ([0039]). However, these components are optional, and Lei et al. teach that instead of the mineral acid the formulations may comprise a carboxylic acid such as acetic acid ([0035]), and instead of the EDTA the formulations may comprise other known organic and inorganic sequestering agents ([0039]).
Therefore, the formulations according to Lei et al. do not require the presence of either sulfuric acid or EDTA.
Regarding instant claim 23, Lei et al. do not explicitly disclose formulations comprising peracetic acid in a concentration of from about 2000 ppm to about 3000 ppm PAA of claim 23.
Larson et al. teach that the cationic resin is present at a weight ratio of peracid to cationic exchange resin of about 1:100 w/w to 100,000:1 w/w. In another embodiment, the cationic exchange resin is present at a weight ratio of peracid to cationic exchange resin of about 1:10 w/w to 10,000:1 w/w. In one embodiment, the weight ratio of peracid to cationic exchange resin is 100:1 w/w to 100:5 w/w ([0020]).
Lei et al. teach the hydrogen peroxide source is typically about 2 to about 8 weight percent of the total concentrate, and the biocidal amount of hydrogen peroxide in the ready-to-use solution is typically from about 0.05 to about 5.0 weight percent of the total solution ([0016], [0022]). Lei et al. teach that the non-surfactant organic sulfonic acid is typically about 2 to about 15 wt.% of the total concentrate ([0017]); and the non-surfactant organic sulfonic acid is typically about 0.005 to about 3.0 wt.% of the total ready-to-use solution ([0022]). Lei et al. also teach the optional acid, such as acetic acid, is typically about 0.2 to about 10 weight percent of the total concentrate, and from about 0.05 to about 6.0 weight percent of the total solution ([0018], [0023]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions comprising a peracid such as peracetic acid, about 0.05 to about 5.0 weight percent hydrogen peroxide, about 0.005 to about 3.0 wt.% of a polymeric sulfonic acid resin based chelator, and about 0.05 to about 6.0 weight percent acetic acid, wherein the ratio of peracid to polymeric sulfonic acid resin is 1:10 to 10,000:1 w/w.
The examiner respectfully points out the following from MPEP 2144.05: “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Regarding instant claim 24, Lei et al. teach that the pH of the concentrate is from about 0.5 to about 5 ([0037]).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding instant claim 27, Lei et al. teach a method of disinfecting a surface of microorganisms, said method comprising contacting the surface with the disinfecting composition ([0025], [0046], [0048]; Claims 34-37).
Regarding instant claim 32, Lei et al. teach a two-part disinfectant comprising two containers ([00265], [0047]; Claims 40-41).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a container (A) comprising hydrogen peroxide, acetic acid and peracetic acid, because Larson et al. teach the combination hydrogen peroxide, carboxylic acid, water and cationic exchange resin stabilizes the peracid containing formulation. A person of ordinary skill in the art would have been motivated to then prepare container (B) comprising the additional components, followed by mixing at the time of use.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (US 2016/0074549 A1) in view of Larson et al. (US 2010/0120913 A1) as applied to claims 1, 5-6, 10, 12-14, 16-21, 23-24, 27 and 32 above, further in view of Matta et al. (US 9,693,675).
The teachings of Lei et al. and Larson et al. are discussed above.
Matta et al. throughout the reference teach a cleaner composition comprising a chelator, buffer, cleaner, solubilizer, and diluent, wherein the cleaner is optionally applied with a disinfectant (Abstract; col. 1, ln. 28 to col. 2, ln. 8).
Regarding instant claim 7, Lei et al. teach that to alter the pH values, buffers such as sodium hydroxide and/or the alkali metal salts of phosphoric acid may be added to the formulations. The pH of the concentrate is from about 0.5 to about 5, and the pH of the ready-to-use solution is from about 1.0 to about 4.5 ([0037]).
Regarding instant claims 7-9, Lei et al. do not explicitly disclose the buffer comprising from about 3% to about 4.5% sodium hydroxide and from about 14% to about 18% potassium phosphate dibasic of claims 7-9.
Matta et al. teach that the buffer system comprises sodium hydroxide and potassium phosphate dibasic in a total amount of about 10 to about 20 wt.% of the composition, particularly 2.16 wt.% sodium hydroxide and 14.2 wt.% potassium phosphate dibasic (col. 1, ln. 35-38, 48-50, and 61-64; col. 5, ln. 59-61; Claims 1-2).
Matta et al. further teach that the composition comprises a cleaner that includes diethyl glycol monoethyl ether, present in about 5.0 wt.% of the composition, a solubilizer that includes propylene glycol, present in about 10.0 wt.% of the composition, and a diluent that includes water (col. 1, ln. 38-43, 51-55, and 64-67; col. 2, ln. 1; col. 5, ln. 61-65).
Matta et al. further teach a disinfectant comprising hydrogen peroxide, acetic acid, HEDP, polyoxypropylene-polyoxyethylene block copolymer, water, and peracetic acid (col. 5, ln. 40-46); wherein the substrates are cleaned with the cleaning composition and disinfected with the disinfectant (Abstract; Example 1).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare formulations according to Lei et al. wherein the buffer comprises sodium hydroxide and potassium phosphate dibasic, as reasonably suggested by Matta et al. A person of ordinary skill in the art would have been motivated to use the buffer system of Matta et al. comprising sodium hydroxide and potassium phosphate dibasic because Lei et al. teach that the buffer can include sodium hydroxide and alkali metal salts of phosphoric acid.
A person of ordinary skill in the art would have been able to determine through routine experimentation the optimum concentration of sodium hydroxide and potassium phosphate dibasic for maintaining the desired pH according to Lei et al. and Matta et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616