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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 01/26/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1-6, 8, 11-20 and 22-25 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/05/2026 is being considered by the examiner.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6, 8, 11-20 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Almas (US20170000821) in view of Hinderson et al. (US20130216628) and Ishihara et al. (“Stability of Weakly Acidic Hypochlorous Acid Solution with Microbicidal Activity”, Biocontrol Science, 2017, Vol. 22, No.4, 223-227).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Almas teaches a composition comprising hypochlorous acid (HOCl); acetic acid (HAc); water, and an excipient such as polyethylene glycol (claims 1, 8-9) and the composition is produced in an air-free environment (claims 5-6). Almas teaches the composition is bottled in air-free environment (page 3, [0033]). Almas teaches sodium hypochlorite; pH about 3.7-5.8 with preferable pH about 4.76; stable HOCl based skin disinfectant with a long shelf-life; and pH adjuster NaOH (page 1, [0007-0008]; page 2, [0024]; claims 1-3).
Hinderson et al. teaches an aqueous composition comprising air-free hypochlorous acid (HOCl), acetic acid and water produced from an air-free environment (claims 1,10 and 25-26; page 1, [0007]; page 7, Table 2). Hinderson et al. teaches composition produced air-free, thus, substantially no dissolved oxygen or nitrogen. Hinderson et al. discloses the composition is bottled in air-free environment (page 5, [0054]). Hinderson et al. teaches sodium hypochlorite (claim 11); pH 3.6-5.6 and pH 4.07-4.62 (page 1, [0007]; page 7, table 2) and NaOH (page 1, [0009]); pH about 4.0-about 7.5, stable for long period of time form months to about 1 year (page 2, [0016]). Hinderson et al. teaches 1 part of acetic acid in 250 parts water (page 2-3, [0030]), about 1/(250+1) = about 0.4%. Hinderson et al. teaches HOCl at least 200ppm or 205ppm (claims 25 and 29; page 7, table 2).
Ishihara et al. teaches the storage of hypochlorous acid requires low temperature (below 10ºC) and in dark for stability (abstract; page 226, right column, 2nd paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Almas is that Almas do not expressly teach acetic acid concentration and chlorine concentration, a temperature of the composition less than about 10 degree C throughout production of the composition, as well as storage temperature between about 2 and about 10 degree C. This deficiency in Almas is cured by the teachings of Hinderson et al. and Ishihara et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Almas, as suggested by Hinderson et al. and Ishihara et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have a temperature of the composition less than about 10 degree C throughout production of the composition because this is optimization within prior art condition or through routing experimentation. MPEP 2144.05. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). Under guidance from Ishihara et al. teaching the storage of hypochlorous acid requires low temperature below 10ºC for stability, it is within skill of one artisan in the art to optimize the production temperature below 10ºC throughout the production of the hypochlorous acid composition to avoid generating impurity due to stability issue, thus, it is obvious for one of ordinary skill in the art to have a temperature of the composition less than about 10 degree C throughout production of the composition and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to have about 0.25% to 5.0% of acetic acid and about 100ppm to 1000ppm (200ppm-450ppm) of chlorine because this is optimization under prior art condition. MPEP 2144.05. Under guidance from Hinderson et al. teaching 0.4% of acetic acid and 205ppm of hypochlorous acid (chlorine), it is obvious for one of ordinary skill in the art to have about 0.25% to 5.0% of acetic acid and about 100ppm to 1000ppm )200ppm-450ppm) of chlorine and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to store the solution comprising hypochlorous acid at temperature between about 2 and about 10 degree C because the stability of hypochlorous acid requires storage at low temperature below about 10 degree C as suggested by Ishihara et al. Since it is important and advantage to have stable hypochlorous acid, it is obvious to store the solution comprising hypochlorous acid at temperature between about 2 and about 10 degree C and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1, 6, 11-13, 18-19, the limitation is met by Almas teaching a composition comprising hypochlorous acid (HOCl); acetic acid (HAc); water, and an excipient such as polyethylene glycol with pH 3.7-5.8 and the composition is produced in an air-free environment. As evidenced by applicant’s specification that hypochlorous acid is active chlorine (page 17, line 10); hypochlorous acid meets the limitation of claimed “chlorine in solvent (water)”.
Regarding the limitation of “chlorate is maintained below a threshold 5.4% of active species of the chlorine” in claim 1 and properties in claim 4 and 22 for 6 months, they are considered as inherent property of prior art composition. Since prior art discloses the same composition (produced by the substantially same procedure) stored at the same lower temperature as applicant’s claimed composition, this same composition is expected to have the same property. MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 2-3, 5, 8, and 20, the limitation is met by Almas teaching composition produced air-free, thus, substantially no dissolved oxygen or nitrogen. Almas discloses the composition is bottled in air-free environment (page 3, [0033]). One of ordinary skill in the art would also have been motivated to prepare the composition at the temperature lower than 25 C because Ishihara et al. teaches hypochlorous acid unstable at higher temperature, thus, there would be less side product or impurity generated when the preparation is performed at the temperature lower than 25 C. Since it is advantage to have less side product or impurity during preparation, it is obvious to do it at the temperature lower than 25 C.
Regarding claim 14, the limitation is met by Almas teaching sodium hypochlorite;
Regarding claim 23, this is considered as product by process. With respect to the USC 102/103 rejection above, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding claim 24, prior art teaches the composition stored below 10C, encompassing claimed about 6 degree C.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-6, 8, 11, 14-17, 20 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hinderson et al. (US20130216628) in view of Ishihara et al. (“Stability of Weakly Acidic Hypochlorous Acid Solution with Microbicidal Activity”, Biocontrol Science, 2017, Vol. 22, No.4, 223-227).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Hinderson et al. and Ishihara et al. teaching have already been discussed in the 103 rejection and are incorporated herein by reference.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Hinderson et al. s that Hinderson et al. do not expressly teach a temperature of the composition less than about 10 degree C throughout production of the composition, storage temperature between about 2 and about 10 degree C. This deficiency in Hinderson et al. is cured by the teachings of Ishihara et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hinderson et al., as suggested by Ishihara et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have a temperature of the composition less than about 10 degree C throughout production of the composition because this is optimization within prior art condition or through routing experimentation. MPEP 2144.05. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). Under guidance from Ishihara et al. teaching the storage of hypochlorous acid requires low temperature below 10ºC for stability, it is within skill of one artisan in the art to optimize the production temperature below 10ºC throughout the production of the hypochlorous acid composition to avoid generating impurity due to stability issue, thus, it is obvious for one of ordinary skill in the art to have a temperature of the composition less than about 10 degree C throughout production of the composition and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to store the solution comprising hypochlorous acid at temperature between about 2 and about 10 degree C because the stability of hypochlorous acid requires storage at low temperature between about 2 and about 10 degree C as suggested by Ishihara et al. Since it is important and advantage to have stable hypochlorous acid, it is obvious to store the solution comprising hypochlorous acid at temperature between about 2 and about 10 degree C and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1, 6, 11 and 22 the limitation is met by Hinderson et al. teaching an aqueous composition comprising air-free hypochlorous acid (HOCl), acetic acid with pH 3.6-5.6 (or pH 4.07-4.62) and water produced from an air-free environment (claims 1,10 and 25-26; page 1, [0007]; page 7, Table 2). As evidenced by Hinderson et al. that hypochlorous acid is formed when chlorine dissolves in water (page 1, [0004]), and applicant’s specification that hypochlorous acid is active chlorine (page 17, line 10); hypochlorous acid meets the limitation of claimed “chlorine in solvent (water)”.
Regarding the limitation of “chlorate is maintained below a threshold 5.4% of active species of the chlorine” in claim 1 and properties in claim 4 and 22, they are considered as inherent property of prior art composition. Since prior art discloses the same composition (produced by the substantially same procedure) stored at same lower temperature as applicant’s claimed composition, this same composition is expected to have the same property. MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 2-3, 5, 8 and 20, the limitation is met by Hinderson et al. teaching composition produced air-free, thus, substantially no dissolved oxygen or nitrogen. Hinderson et al. discloses the composition is bottled in air-free environment (page 5, [0054]). One of ordinary skill in the art would also have been motivated to prepare the composition at the temperature lower than 10 C because Ishihara et al. teaches hypochlorous acid unstable at higher temperature, thus, there would be less side product or impurity generated when the preparation is performed at the temperature lower than 10 C. Since it is advantage to have less side product or impurity during preparation, it is obvious to do it at the temperature lower than 10 C.
Regarding claim 8 and 14, the limitation is met by Hinderson et al. teaching sodium hypochlorite.
Regarding claims 15-16, the limitation is met by Hinderson et al. teaching 1 part of acetic acid in 250 parts water, about 1/(250+1) = about 0.4%.
Regarding claim 17 and 25, the limitation is met by Hinderson et al. teaching HOCl at least 200ppm or 205ppm (claims 25 and 29; page 7, table 2).
Regarding claim 23, this is considered as product by process. With respect to the USC 102/103 rejection above, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding claim 24, prior art teaches composition stored below 10 degree C, encompassing about 6 degree C.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argued that there is no teaching of a temperature of the composition less than about 10 degree C throughout production of the composition, and no teaching of “chlorate is maintained below a threshold 5.4% of active species of the chlorine”. All related arguments are incorporated herein by reference.
In response to this argument: this is not preservative. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the above 103 rejection, one of ordinary skill in the art would have been motivated to have a temperature of the composition less than about 10 degree C throughout production of the composition because this is optimization within prior art condition or through routing experimentation. MPEP 2144.05. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). Under guidance from Ishihara et al. teaching the storage of hypochlorous acid requires low temperature below 10ºC for stability, it is within skill of one artisan in the art to optimize the production temperature below 10ºC throughout the production of the hypochlorous acid composition to avoid generating impurity due to stability issue, thus, it is obvious for one of ordinary skill in the art to have a temperature of the composition less than about 10 degree C throughout production of the composition and produce instant claimed invention with reasonable expectation of success. Regarding the limitation of “chlorate is maintained below a threshold 5.4% of active species of the chlorine”, as discussed in the above 103 rejection, both Almas and Hinderson et al. teach stable composition, since prior art discloses the same composition (produced by the substantially same procedure) stored at same lower temperature as applicant’s claimed composition, this same composition is expected to have the same property. MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). ONCE A REFERENCE TEACHING PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS MADE THE BASIS OF A REJECTION, AND THE EXAMINER PRESENTS EVIDENCE OR REASONING TO SHOW INHERENCY, THE BURDEN OF PRODUCTION SHIFTS TO THE APPLICANT. "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
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 JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613