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 .
Claims 1-17, 21, 23 and 47-48 have been presented for examination on the merits.
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 2-13, 16-17 and 47-48 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.
Claims 2-6 recite the limitation "a free available chlorine concentration …." in the kit of claim 1. There is insufficient antecedent basis for this limitation in the claim. The kit of claim 1 does not recite or support a hypochlorous acid solution or a chlorine.
Claim 6 is further indefinite for reciting “a chlorine concentration between about 200 and 50 ppm according to the kit of claim 5. However, claim 5 recites a concentration range of between about 7000 and 4000 ppm. Thus, claim 6 which depends on claim 5 contains a range that is outside of the claimed range of its parent claim.
Claim 7 recites the limitation "the hypochlorous acid solution …..” in the kit of claim 1. There is insufficient antecedent basis for this limitation in the claim. The kit of claim 1 does not recite or support a hypochlorous acid solution.
Claim 8 recites the limitation "for a predetermined amount of water" in the kit of claim 3. There is insufficient antecedent basis for this limitation in the claim. Neither claim 3 or its parent claim 1 support or recite water.
Claims 8-13 are indefinite for reciting an amount of hypochlorite or acid in g/L for a predetermine amount of water. It is not clear what is meant by “for a predetermine amount of water”. Is it meant to be g/L of water. It is not clear what is the correlation of the unit g/L and a predetermined amount.
Claim 9 recites the limitation "wherein the premeasured mixture of the weak acid…." in the kit of claim 8. There is insufficient antecedent basis for this limitation in the claim. Neither claim 8, 3 or 1 disclose or support a premeasured mixture.
Claims 10 and 13 are indefinite for reciting an amount of acid in g/L based upon a predetermine amount of water. It is not clear what is meant by “based upon a predetermine amount of water”. Is it meant to be g/L of water. It is not clear what is the correlation of the unit g/L and a predetermined amount.
Claim 12 recites the limitation "wherein the premeasured mixture of the weak acid…." in the kit of claim 11. There is insufficient antecedent basis for this limitation in the claim. Neither claim 11 or its parent claim 6 or claim 1 disclose or support a premeasured mixture.
Claim 12 recites the limitation "for a predetermined amount of water" in the kit of claim 11. There is insufficient antecedent basis for this limitation in the claim. Neither claim 11, 6 or 1 support or recite water.
Claim 16 is indefinite for reciting “component a),a mixture of …”. It is not clear what -a),a- refers to.
Claims 16-17 recites the limitation "a premeasured amount of surfactant" in the kit of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not support or recite a surfactant.
Claims 47-48 recite the limitation " to produce a hypochlorite acid " in claims 1 and 23 respectively. There is insufficient antecedent basis for this limitation in the claims. Parent claims 1 and 23 disclose producing a hypochlorous acid.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The Specification does not provide any examples of weak and strong aid cation exchange resins and is not limited to any specific weak and strong aid cation exchange resins.
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.
Claims 1-4, 6-7, 14, 16-17 and 23 rejected under 35 U.S.C. 103 as being unpatentable over Okazaki (US 20040226894) in view of Terada (Wo 2021090916 or US 20220371887) (recitations are from the US document).
Okazaki teach a method of preparing a sterile water containing hypochlorous acid, package of sterile source materials, and sterile water preparation kit. Disclosed is a container comprising components for producing hypochlorous acid. The resulting sterile water has a pH level within the slightly acidic or neutral region and a predetermined effective chlorine concentration around 50 to 300 ppm (See the Title and Abstract).
Regarding claim 1, Okazaki teach an easy to carry package of sterile source materials, comprising: a first component containing a hypochlorite or chlorite; a second component containing an acid; a single container holding the first component and the second component separately with a partition; and a movable member which can move under application of an intentional force from outside the container, wherein movement of the movable member permits the first component and the second component to merge and produce a sterile water in the container; and wherein the first component and the second component are conditioned to assure that the sterile water produced by mixture thereof has a predetermined effective chlorine concentration and a pH level within the slightly acidic or neutral region (See [0019]-[0020] and Claims 8-10).
Further regarding claim 1, Okazaki teach “a first container containing hypochlorite (chlorite) (referred to as “first component” hereunder) and a second container containing an acid (referred to as “second component” hereunder) are provided in combination for use by a consumer. The first and second components are conditioned to ensure that the sterile water prepared by a consumer by mixing the first and second components (as shown in FIG. 2) will have a pH level in the weak-acid or neutral region and a predetermined effective concentration of chlorine”. Typical source materials are hypochlorites and chlorites including sodium hypochlorite and calcium hypochlorite. Calcium hypochlorite is available typically in form of powder from manufacturers (See [0024] and [0021]).
It is further disclosed that “The kit 80 preferably includes, in combination, an instruction manual 84 describing instructions concerning the mixing operation of the components by the user. The first to third bottles 81 to 83 preferably have scale marks 85. At least the first and second bottles 81, 82 are preferably made of a plastic material resistant to chemicals and capable of blocking light” (See [0152]).
It is disclosed that the first component containing a hypochlorite of a pre-adjusted concentration and contained in a first sealed space, and said second component containing an acid of a pre-adjusted concentration and contained in a second sealed space (See claims 25 and 28).
Regarding claims 2-4 and 6, Okazaki teach that the effective chlorine concentration is typically an arbitrary concentration in the range of 50 to 300 ppm approximately. However, the first and second components may be conditioned to adjust its effective chlorine concentration to 800 ppm approximately (See [0029] and [0116]).
Regarding claim 7, Okazaki teach that the first and second components are conditioned so that the sterile water produced by mixture thereof has a predetermined effective concentration of chlorine and a pH level within the slightly acidic or neutral region (See at least the abstract, claims, [0091] and [0098]). Okazaki also discloses making the hypochlorous acid of pH 5.5 and the effective chlorine concentration of 50 ppm (See [0162]).
Regarding claims 16-17 and 23, Okazaki teach a method of preparing a sterile water, comprising: preparing a first component containing hypochlorite or chlorite and held in a first sealed space, and a second component containing an acid and held in a second sealed space; and mixing the first and second components together to prepare a sterile water, wherein the first and second components are conditioned so that the sterile water resulting from mixture of the first and second components has a predetermined effective chlorine concentration and a pH level within the slightly acidic or neutral region.
Regarding claim 23, Okazaki teach a method of preparing a sterile water, comprising: preparing a first component containing hypochlorite or chlorite and held in a first sealed space, and a second component containing an acid and held in a second sealed space; and mixing the first and second components together to prepare a sterile water, wherein the first and second components are conditioned so that the sterile water resulting from mixture of the first and second components has a predetermined effective chlorine concentration and a pH level within the slightly acidic or neutral region (See claims 1).
Okazaki teaches contacting the hypochlorite with an acid, but lacks a disclosure on the acid being a weak acidic cation exchange resin and strong acid cation exchange resin. This is remedied by Terada.
Terada teach a method for preparing a hypochlorous acid aqueous solution by which a weakly acidic hypochlorous acid aqueous solution having a pH of about 3.5-7 can be obtained. The method for preparing the hypochlorous acid aqueous solution comprises an aqueous solution of hypochlorite is brought into contact with a weakly acidic cation exchanger to exchange a cation constituting the hypochlorite with hydrogen ions to increase the concentration of hypochlorous acid in the aqueous solution, a neutral salt solution of a strong acid and a strong base in an amount that may obtain the hypochlorous acid aqueous solution having a pH of at least 3.5 (See abstract).
Regarding claim 1, Terada teaches preparing a hypochlorous acid by contacting hypochlorite with a weak acid cation exchanger and a strong acid. The hypochlorite may be calcium hypochlorite (see [0032], [0035]). The weakly acidic ion exchanger can be weakly acidic cation exchange resins such as a methacrylic acid type weakly acidic cation exchange resin and an acrylic acid type weakly acidic cation exchange resin (See [0042]).
Terada also disclose “The inventors have now discovered that weakly acidic cation exchange resins may exhibit properties like strongly acidic cation exchange resins at the initial phase of ion exchange” (See [0018]). As an example, contact is made in a weakly acidic cation exchanger in sufficient quantity, time, and conditions to exchange the cation of neutral salt solutions with H of some exchange groups that have properties like strongly acidic cation exchange resins. The appropriate conditions depend on the weakly acidic ion exchanger used and can be easily selected by those skilled in the art (See [0056]).
Regarding claims 2-4 and 6, Terada teaches that the hypochlorite solution can be 500 ppm or higher. It is also possible to directly produce hypochlorous acid at concentrations of 50 to 1000 ppm, which is the concentration actually used for sterilization purposes (See 0037]).
Regarding claim 7, Terada teaches a method for preparing hypochlorous acid aqueous solution that can obtain a weakly acidic hypochlorous acid aqueous solution of pH 3.5 to 7 (See [0022] and [0027]).
Regarding claim 14, in part, Terada teaches that, weakly acidic cation exchange resins have a carboxylic acid group (—COOH) as an exchange group and are weakly acidic like acetic acid (See [0015]).
Regarding claim 23, Terada teaches a method for preparing an hypochlorous acid aqueous solution wherein an aqueous solution of hypochlorite is brought into contact with a weakly acidic cation exchanger to exchange a cation constituting the hypochlorite with hydrogen ions to increase the concentration of hypochlorous acid in the aqueous solution, wherein a neutral salt solution of a strong acid and a strong base in an amount that obtain the hypochlorous acid aqueous solution having a pH of at least 3.5. The hypochlorite is dissolved in water to prepare the hypochlorite solution (See [0003]-[0004] and claim 1).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Terada with that of Okazaki to arrive at the instant invention. It would have been obvious to do so because Okazaki teach a kit of parts comprising calcium hypochlorite, an acid and instructions for a user to combine the component with water to make a hypochlorous acid that is effective in killing pathogens (microorganisms). Okazaki does not elaborate on the acid. Terada teach a method of making hypochlorous acid by mixing calcium hypochlorite with water and adding a weak acid cation exchange resin and a strong acid. Terada teach that the said weak acid cation exchange resin has the same properties as a strong acid cation exchange resin. Thus, one of ordinary skill in the art having possession of the two references would have been motivated to have followed the guidance and incorporate Terada’s weak acid cation exchange resin and a strong acid cation exchange resin into the kit of Okazaki and the said acid with a reasonable expectation of success as both references teach that an acid is required to prepare a hypochlorous acid solution from a hypochlorite compound. It would have been obvious to substitute Terada’s mixed weak and strong acid components because of the disclosed benefits including aqueous solution of pH 3.5 to 7 without generating chlorine gas substantially and can suppress as much as possible the phenomenon of pH decrease in the initial phase of the reaction of weakly acidic cation exchanging the cation.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1-17, 23 and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Okazaki (US 20040226894) in view of Terada (Wo 2021090916 or US 20220371887) (recitations are from the US document) and Mallet et al (US 20140134224).
Teachings of Okazaki and Terada are delineated above and incorporated herein.
The combined references lack a disclosure on the amounts of each component, the packaging material and microorganism kill rate. These are disclosed by Mallet et al.
Mallet et al teach a stable antimicrobial aqueous hypochlorous acid solution that retains its activity for at least three months and can be provided with high levels of hypochlorous acid (more than 500 ppm), the aqueous hypochlorous acid composition having a pH between 3.5 and 7.0 to stabilize the composition without the need for additional stabilizers. A solid composition is also provided for producing the stable solution (See abstract).
Regarding claim 5, Mallet et al teach a hypochlorous acid solution containing about 5000 ppm chlorine at the time of making it (See [0141]).
Regarding claims 5-13, Mallet et al teach preparation of stable HOCl solution from anhydrous composition of 75% assay pure calcium hypochlorite and citric acid
Wherein “x” grams of a 75% assay pure calcium hypochlorite, such as that sold by Arch Chemicals, was mixed with “y” grams of citric acid and then placed in a water soluble, non-halogen demanding coating, such as gelatin or a gelatin substitute. Upon contact with water of a given volume “z” and a pH of “A”, HOCl is produced at a specific ppm and pH, as shown in Table 2 below. A pH of 5.5 was achieved using de-ionized water (See [0143] and Table 2).
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Regarding claims 15-17, Mallet et al teach that the said composition may comprise other additional components to make it more suitable for its intended use. Such additional components include moisturizing agents, surfactants, fragrances, etc (See [0032] and [0041]).
Regarding claims 47-48, Okazaki teach that, the hypochlorous acid of pH 5.5 and the effective chlorine concentration of 50 ppm, for example, can effectively kill yeast, staphylococcus aureus, CNS, bacillus, micrococcus, acinetobacter, MRSA, etc. Therefore, the embodiments of the invention, which enable sterilization with hypochlorous or chlorous acid whenever and wherever necessary, can immediately cope with social issues such as in-hospital infection without the need of special equipment (See [0162]).
Furthermore, Mallet et al teach that HOCl sporicidal activity has also been well documented (Rudolf and Levine 1941) where 25 ppm available chlorine solutions were applied at a range of pH levels and the time taken to produce a 99% kill of B. metiens spores was determined. The results show 2.5 mins for pH 6 (See [0017] and [0071]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Mallet et al and Terada with that of Okazaki to arrive at the instant invention. It would have been obvious to do so because Okazaki teach a kit of parts comprising calcium hypochlorite, an acid and instructions for a user to combine the component with water to make a hypochlorous acid that is effective in killing pathogens (microorganisms). Okazaki does not elaborate on the acid. Terada teach a method of making hypochlorous acid by mixing calcium hypochlorite with water and adding a weak acid cation exchange resin and a strong acid. Terada teach that the said weak acid cation exchange resin has the same properties as a strong acid cation exchange resin. Thus, one of ordinary skill in the art having possession of the two references would have been motivated to have followed the guidance and incorporate Terada’s weak acid cation exchange resin and a strong acid cation exchange resin into the kit of Okazaki and the said acid with a reasonable expectation of success as both references teach that an acid is required to prepare a hypochlorous acid solution from a hypochlorite compound. It would have been obvious to substitute Terada’s mixed weak and strong acid components because of the disclosed benefits including aqueous solution of pH 3.5 to 7 without generating chlorine gas substantially and can suppress as much as possible the phenomenon of pH decrease in the initial phase of the reaction of weakly acidic cation exchanging the cation.
Furthermore, it would have been obvious to one of ordinary skill in the art to have looked at Mallet et al for what it teaches to prepare the desired hypochlorous acid. That is, Okazaki and Terada do not expressly disclose amount of each component mixed with water to make the said solution. Thus, it would have provided a reason for the skilled artisan to look in the art for guidance on the amounts, as taught by Mallet et al.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 14-17 and 21 is rejected under 35 U.S.C. 103 as being unpatentable over Okazaki (US 20040226894) in view of Terada (Wo 2021090916 or US 20220371887) (recitations are from the US document) and Nguyen et al (US 20050232848).
Teachings of Okazaki and Terada are delineated above and incorporated herein.
The combined references lack a disclosure on the packaging materials as claimed. This is taught by Nguyen et al.
Nguyen et al teach packaging for dilute hypochlorite and hypochlorous acid compositions to produce stable compositions. Container materials can be multilayer with additives such as opacifiers, colorants, and UV inhibitors in the intermediate or outer layers. Additionally, labels with opacifiers, colorants, and UV inhibitors can improve stability (See abstract).
Regarding claims 1, 16-17 and 21, Nguyen et al teach an article of commerce comprising: a. a container; and b. a composition, said composition comprising an oxidant selected from the group consisting of hypohalous acid, hypohalous acid salt, and combinations thereof, c. wherein said composition has an available chlorine concentration of between 1.0 ppm to about 1200 ppm; and d. wherein said container comprises a multilayer container comprising: ii. an inner layer; iii. an outer layer; iv. an optional intermediate layer; e. wherein at least one of said outer layer or said intermediate layer comprises an additive selected from the group consisting of opacifiers, colorants, UV inhibitors and combinations thereof; and wherein said inner layer comprises a thermoplastic material such as polyethylene terephthalate, polyethylene, and polypropylene (See [0008] and claim 1).
Nguyen et al teach that the composition may be stored or shipped in a variety of containers, including glass, high density polyethylene, low density polyethylene, linear low-density polyethylene, blends of polyethylene, low density polypropylene, polyethylene terephthalate, or polyvinylchloride (See [0043]).
Regarding claim 14, Terada teaches that, weakly acidic cation exchange resins have a carboxylic acid group (—COOH) as an exchange group and are weakly acidic like acetic acid (See [0015]). Additionally, Nguyen et al teach that the said composition may be adjusted for pH using a pH adjusting agent including hydrochloric acid, nitric acid, sulfuric acid, acetic acid, carboxylic acids, organic sulfonic acids, etc. The pH may be 5-8, or less than 7 and preferably 5.5 (See [0101], [0131] and claim 17).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Nguyen et al and Terada with that of Okazaki to arrive at the instant invention. It would have been obvious to do so because Okazaki teach a kit of parts comprising calcium hypochlorite, an acid and instructions for a user to combine the component with water to make a hypochlorous acid that is effective in killing pathogens (microorganisms). Okazaki does not elaborate on the acid. Terada teach a method of making hypochlorous acid by mixing calcium hypochlorite with water and adding a weak acid cation exchange resin and a strong acid. Terada teach that the said weak acid cation exchange resin has the same properties as a strong acid cation exchange resin. Thus, one of ordinary skill in the art having possession of the two references would have been motivated to have followed the guidance and incorporate Terada’s weak acid cation exchange resin and a strong acid cation exchange resin into the kit of Okazaki and the said acid with a reasonable expectation of success as both references teach that an acid is required to prepare a hypochlorous acid solution from a hypochlorite compound. It would have been obvious to substitute Terada’s mixed weak and strong acid components because of the disclosed benefits including aqueous solution of pH 3.5 to 7 without generating chlorine gas substantially and can suppress as much as possible the phenomenon of pH decrease in the initial phase of the reaction of weakly acidic cation exchanging the cation.
Furthermore, Okazaki teach the kit composing sealed packages but does not elaborate on the material suitable for the said packaging. Thus, it would have been obvious to one of ordinary skill in the art to have looked in the art for guidance on that. It would have been obvious to one of ordinary skill in the art to have looked at Nguyen et al for what it teaches on a proper method of storing and shipping hypochlorous acid solutions, including suitable material for the said packaging.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1-17, 21, 23 and 47-48 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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