DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
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.
This is the second Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 27 August 2025, Applicant amended claims 12-14 and 16, and cancelled claims 1-11, 15, and 17-18. Claims 12-14 and 16 are pending.
Status of the Rejections
The rejection of claims 12-14 and 16 under 35 U.S.C. 112(a) or (pre-AIA ) first paragraph is maintained. Applicant’s recent amendment/argument is considered in paragraph 25 of this Office action.
The rejection of claims 12-14 and 16 under 35 U.S.C. 112(b) or (pre-AIA ) second paragraph is maintained. Applicant’s arguments are considered in paragraphs 31-36 of this Office action.
The rejection of claims 12-14 and 16 under 35 U.S.C. 103(a) as being unpatentable over Hinderson (US 2013/0216628 A1) in view of Northey (WO 2011/014809 A1) is maintained. Applicant’s argument is considered in paragraphs 51-52 of this Office action.
All non-statutory double patenting rejections set forth in the previous Office action (27 February 2025) are maintained. The examiner notes that Application No. 17/842,100 issued recently as Patent No. 12,419,910 (September 23, 2025). Accordingly, the corresponding provisional double patenting rejection has been converted to a non-provisional double patenting rejection.
Claims of Benefit and/or Priority
Applicant’s claim of benefit recites, inter alia, that the present application is a divisional of Application No. 15/852,622 (parent application), which is a continuation-in-part of Application No. 15/612,571 (grandparent application), which is a continuation-in-part of Application No. 15/267,220 (great-grandparent application). It is critical to recognize, however, that claims in a continuation-in-part application must be directed solely to subject matter adequately disclosed under 35 U.S.C. 112 in the parent nonprovisional application to receive the benefit of the filing date of the parent nonprovisional application. MPEP § 211.05(I)(B). If a claim in a continuation-in-part application recites a feature that was not disclosed or adequately supported by a proper disclosure under 35 U.S.C. 112 in the parent nonprovisional application, but instead was first introduced or adequately supported in the present continuation-in-part application, such a claim is entitled only to the filing date of the present application. Id. Additionally, “[i]f there is a continuous chain of copending nonprovisional applications, each copending application must disclose the claimed invention of the later-filed application in the manner provided by 35 U.S.C.112(a) in order for the later-filed application to be entitled to the benefit of the earliest filing date.” Id. (emphasis added). With these controlling principles in mind, the examiner now addresses the claims of the present application:
Regarding claim 12, neither the grandparent application (’571) nor the great-grandparent application (’220) discloses a hypochlorous acid concentration range that has no maximum. Consequently, neither of those applications supports the following limitation now recited in claim 12: “hypochlorous acid at a concentration of at least about 50 ppm.”
In further regard to claim 12, the great-grandparent (’220) application does not support the following limitation: “acetic acid at a concentration of at least about 0.1 wt%.”
In still further regard to claim 12, the great-grandparent application (’220), which is directed to a hand disinfectant, focuses exclusively on skin. Although skin is a species of tissue, the great-grandparent application does not disclose the tissue genus or even describe tissues other than skin. Consequently, the great-grandparent application (’220) does not adequately support any claim that broadly recites or incorporates the tissue genus.
Regarding claim 13, the following feature is not supported by the great-grandparent (’220) application: “wherein the concentration of acetic acid is sufficient to penetrate skin.”
Regarding claims 14 and 16, the great-grandparent (’220) application does not support any of the recited acetic acid concentration ranges.
In further regard to claim 14, the following hypochlorous acid concentration is not supported by the great-grandparent (’220) application: “50 ppm.” As a courtesy, Applicant is referred to Figure 4 of the great-grandparent (’220) application, which contains the only relevant disclosure concerning ppm of hypochlorous acid.
In further regard to claims 14 and 16, the great-grandparent (’220) application does not support the adverb <about> in relation to the hypochlorous acid concentrations of “500 ppm” (claim 14) and “200 ppm” (claim 16).
Because all the claims currently under consideration depend on claim 12, none of the claims under consideration is entitled to the benefit of the filing date of great-grandparent Application No. 15/267,220 (16 September 2016). The examiner notes that Hinderson (US 2013/0216628 A1), which is applied later in this Office action, therefore qualifies as prior art.
Given the complexity and length of the claim of benefit for this application, Applicant is alerted that the examiner’s analysis set forth above is not exhaustive. The examiner will extend his analysis of the claim of benefit, as needed, to address any future claim amendments made by Applicant.
Claim Rejections - 35 U.S.C. 112(a) or pre-AIA first paragraph
The following is a quotation of 35 U.S.C. 112(a):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 12-14 and 16 are rejected under 35 U.S.C. 112(a) or (pre-AIA ) first paragraph because the specification — while being enabling for treating a bacterial infection in tissue by administering an effective amount of a composition comprising significant concentrations of hypochlorous acid and acetic acid — does not reasonably provide enablement for treating a bacterial infection by administering ineffective amounts of that composition.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronics, 8 USPQ2d 1217 (Fed. Cir. 1988)). MPEP § 2164.01. Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. MPEP § 2164.01(a). These factors were outlined in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988) and include the following: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of any working examples; and (8) the quantity of experimentation necessary needed to practice the claimed invention based on the content of the disclosure. MPEP § 2164.01(a).
There is no requirement in claim 12 that an effective amount of the composition comprising hypochlorous acid and acetic acid is administered to the tissue. Applicant’s specification does not reasonably provide enablement for treating a bacterial infection by administering a negligible or otherwise ineffective amount of that composition. Therefore, a person having ordinary skill in the art could not practice the full scope of Applicant’s invention, as recited in claim 12 and the claims depending thereon (claims 13-14 and 16), without first engaging in undue experimentation.
Response to Applicant’s Amendment/Argument
Applicant’s recent amendments to claim 12 do not overcome the foregoing enablement rejection because the claim still encompasses administering a negligible amount of the recited composition. Although the concentration ranges now recited in claim 12 assist in fleshing out the claims, a concentration is not an amount. For example, claim 12 continues to encompass administering a negligible volume of the recited composition, regardless of the concentration ranges corresponding to the acetic acid and hypochlorous acid, respectively. Accordingly, the enablement rejection is maintained.
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Claim Rejections - 35 U.S.C. 112(b) or pre-AIA second paragraph
The following is a quotation of 35 U.S.C. 112(b):
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 12-14 and 16 are rejected under 35 U.S.C. 112(b) or (pre-AIA ) second paragraph as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 12, the claim, as presently drafted, still appears directed to a laboratory procedure, rather than a medical procedure. For example, the infected tissue could be in a petri dish. There is no indication in the claim that the tissue, itself, is actually part of a living organism, such as a human (or other mammal) who is suffering from a bacterial infection. Thus, the claim fails to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 13, the following functional limitation is unclear: “wherein the acetic acid is in a concentration sufficient to penetrate skin.” A person having ordinary skill in the art — even after carefully reviewing the specification of the present application — would not be able to discern with reasonable certainty the compositional implications of the foregoing functional limitation. There is no consensus among persons having ordinary skill in the art as to the minimum concentration of acetic acid necessary to penetrate skin. Furthermore, there is no consensus among persons having ordinary skill in the art concerning a protocol for evaluating whether skin penetration by acetic acid has occurred. The examiner notes that the specification fails to even identify such a protocol. MPEP § 2173.05(g) (“the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite”).
Response to Applicant’s Amendment/Argument
The following remarks are provided in response to the arguments raised by Applicant on pages 3-4 of the Reply filed 27 August 2025:
Regarding claim 12, Applicant argues: “However, whether or not the claim is directed to a medical procedure or a laboratory procedure is inconsequential. The claim recites a method to treat a bacterial infection in tissue, which may be effective regardless of the source of the tissue.” Reply, pp. 3-4. As explained below, this argument is not persuasive.
Claims directed to the treatment of a disease or other disorder are typically drafted in the following format, where [D] is the disease/disorder to be treated, [S] is the subject (e.g., human or other mammal), and [M] is the medication: “A method of treating [D] in a [S] in need thereof comprising administering to the [S] an effective amount of [M].” Applicant’s recent remarks amplify the need to clarify claim 12, which remains unclear as to whether (or not) the tissue is comprised in a living organism, such as a mammal, or instead is a discrete entity, such as a piece of tissue in a petri dish. MPEP § 2173.04 (“But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim).”). Applicant is advised that if a particular locus of the living organism is targeted for delivery of the medication, this is accomplished by including claim language defining the route of administration.
Regarding claim 13, Applicant argues, in relevant part: “The acetic acid may be present in an amount from about 0.1% to about 2.0%...” Id., page 4, lines 25-26. If acetic acid is in an amount sufficient to remove biofilm beneath the surface of skin, then it has penetrated the skin.” Reply, p. 4. As explained below, this argument is not persuasive.
In view of Applicant’s remarks and recent amendment to claim 12 adding a minimum concentration of acetic acid (“at least about 0.1 wt%”), it is now also unclear whether (and, if so, how) claim 13 further limits claim 12.
Accordingly, the indefiniteness rejection is maintained.
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Claim Rejections - 35 U.S.C. 103(a)
The following is a quotation of 35 U.S.C. 103(a), which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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 12-14 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hinderson (US 2013/0216628 A1) in view of Northey (WO 2011/014809 A1).
Hinderson is directed to highly pure and stable compositions of hypochlorous acid (HOCl) and their method of manufacture. Title/Abstract; para. [0007].
Hinderson discloses: “Hypochlorous acid (HOCl) is a weak acid that is known to rapidly inactivate bacteria, algae, fungus, and other organics, making it an effective agent across a broad range of microorganisms. Additionally, since hypochlorous acid is a weak acid and since people naturally produce certain compounds that allow them to tolerate hypochlorous acid (e.g., the amino acid taurin), it is generally not harmful to people.” (Emphasis added) Para. [0003].
Hinderson discloses that the composition comprises hypochlorous acid (HOCl) and acetic acid (HAc). Para. [0077] at Table 2; para. [0078]. The three exemplary compositions set forth in Table 2 of Hinderson are identical to the exemplary compositions set forth on page 37 of the specification of the present application, as originally filed. Those compositions comprise either 205 ppm or 207 ppm of hypochlorous acid, which anticipates the corresponding range now recited in claim 12 (“at least about 50 ppm”). MPEP § 2131.03(I). Additionally, the compositions disclosed in Table 2 of Hinderson achieve a pH of 4.62, 5.33, and 4.07, respectively, using acetic acid in combination with the designated concentration of hypochlorous acid. Although Hinderson is silent regarding the concentration of acetic acid, the foregoing observations provide a sound basis for the examiner’s position that the acetic acid concentration in the exemplified Hinderson compositions is “at least about 0.1 wt%,” as now recited in claim 12. The burden of production is shifted to Applicant. MPEP § 2112(V) (“once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden of production shifts to the applicant”).
Although Hinderson discloses that the HOCl/HAc composition can be used for medical applications, such as wound care (para. [0069]) and that HOCl rapidly inactivates bacteria (para. [0003]), Hinderson is silent as to whether the HOCl/HAc composition can be administered to treat a bacterial infection in skin or other tissue. As explained below, Northey compensates for this deficiency.
Northey is directed to a hydrogel formulation comprising oxidative reductive potential (ORP) water. Title/Abstract.
Northey teaches that the ORP water comprises hypochlorous acid. Paras. [0014]-[0015].
Northey teaches that the ORP water can be administered to treat a patient in need of skin bacterial disinfection. Para. [0053]. “For example, when used to treat an infection, a therapeutically effective amount of the formulation reduces the extent of the infection and/or prevents further infection.” Para. [0058].
Northey teaches that the ORP water can be topically administered to the skin. Para. [0051]-[0052]. However, “the application of liquid products to treatment sites is difficult to control, as run-off, spillage, and poor containment are commonly encountered problems.” Para. [0004]. Northey overcomes that problem by formulating the ORP water as a gel, by adding a gelling agent. Paras. [0031]-[0033] and [0037].
Prior to the time Applicant’s invention was made, the foregoing teachings of Northey would have motivated a person having ordinary skill in the art (i) to add a gelling agent to the highly pure and stable HOCl/HAc composition of Hinderson to yield a gel, which is easier than a liquid to control/contain and, thereafter, (ii) topically administering the gel to treat a patient suffering from a bacterial skin infection. Therefore, claims 12 and 13 are prima facie obvious.
Regarding claims 14 and 16, as established above, the three compositions disclosed in Table 2 of Hinderson (para. [0077]) comprise either 205 ppm or 207 ppm of hypochlorous acid, which anticipates the corresponding ranges recited in Applicant’s claims. MPEP § 2131.03(I). The examiner notes that the range of “200 ppm” in claim 16 is modified by the adverb <about>, which is not defined in the specification and must be interpreted broadly. MPEP § 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”). Alternatively, the HOCl range recited in claim 16 is prima facie obvious. MPEP § 2144.05(I) (overlapping, approaching, or similar ranges are prima facie obvious). Again, the compositions disclosed in Table 2 of Hinderson achieve a pH of 4.62, 5.33, and 4.07, respectively, using acetic acid in combination with the designated concentration of hypochlorous acid. In view of the fact that the compositions set forth in Table 2 of Hinderson are identical to the exemplary compositions set forth on page 37 of the specification of the present application, there is a sound basis for the examiner’s position that the acetic acid concentration ranges recited respectively in claims 14 and 16 are anticipated or rendered prima facie obvious by Hinderson. The burden of production is shifted to Applicant. MPEP § 2112(V) (quoted above).
In the alternative, Northey identifies acetic acid as an exemplary buffering agent (para. [0034]) and teaches a buffering agent concentration range of “from about 0.01 weight-percent to about 5.0 weight-percent, based on the weight of the formulation” and “[p]referably, the buffering agent is present in an amount of from about 0.1 weight-percent to about 1.0 weight-percent” (para. [0035]). MPEP § 2144.05(I) (overlapping, approaching, or similar ranges are prima facie obvious).
Response to Applicant’s Arguments
The arguments set forth on pages 4-5 of the Reply filed 27 August 2025 are not persuasive because the burden of production is shifted to Applicant, as established in paragraphs 42 and 49 of this Office action and in paragraphs 38 and 45 of the previous Office action (27 February 2025). To rebut the foregoing §103 rejection, Applicant should submit evidence establishing that the none of the three exemplary compositions disclosed in Table 2 of Hinderson (para. [0077]) satisfies the compositional profile recited in the claims. With respect to Hinderson’s silence regarding the concentration of acetic acid in those three compositions, Applicant is reminded that “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” MPEP § 2112(II). Moreover, the Patent Office does not have a laboratory and, therefore, the examiner is unable to adjust the pH of the Hinderson compositions to 4.62, 5.33, and 4.07, respectively, using acetic acid (as disclosed therein) and, thereafter, determine the resulting acetic acid concentration. MPEP § 2113(III) (“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.”).
Accordingly, the obviousness rejection is maintained.
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Claim Rejections - Double Patenting (Non-Statutory)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 12-14 and 16 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 8-19 of Patent No. 10,675,299 (June 9, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 8-19 of the ’299 Patent are directed to a method for disinfecting skin by applying to the skin an HOCl/HAc composition. Conflicting claims 10-11 and 13 collectively disclose that the skin infection can be caused by a bacterial (Staphylococcus aureus) biofilm. In sum, the present claims are not patentably distinguishable over claims 8-19 of the ’299 Patent.
Claims 12-14 and 16 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-6 of Patent No. 11,452,741 (September 27, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 1 of the ’741 Patent is directed to “[a]n antimicrobial composition for treating and/or preventing pathogenic bacterial biofilms on a tissue surface without harming natural biofilm of the tissue, the composition comprising a mixture of acetic acid (HAc) and hypochlorous acid (HOCl) having concentrations optimized so as to achieve a synergistic effect.” Conflicting claim 2 discloses that “the tissue is skin tissue.” Conflicting claim 5 discloses “the composition is formulated in a spray, gel, cream, ointment, or oil.” A person having ordinary skill in the art would have readily envisaged that those are topical formulations and, therefore, would have been motivated to topically apply them to the skin or other tissue to treat the pathogenic bacteria. In sum, the present claims are not patentably distinguishable over claims 1-6 of the ’741 Patent.
Claims 12-14 and 16 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-5 of Patent No. 11,484,549 (November 1, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 1 of the ’549 Patent is directed to “[a]n antimicrobial composition comprising a mixture of acetic acid (HAc) and hypochlorous acid (HOCl), wherein a minimum inhibitory concentration of HAc and HOCl is approximately 0.25% and 25 ppm, respectively, and a minimum bactericidal concentration of HAc and HOCl is 0.5% and 50 ppm, respectively, against at least one or more pathogenic strains of bacteria selected from the group consisting of Acinetobacter baumannii, Pseudomonas aeruginosa, Enterococcus faecium, and Staphyloccocus aureus.” Conflicting claim 2 discloses that “the acetic acid is present in a concentration sufficient to penetrate tissue.” Conflicting claim 4 discloses “the composition is formulated in a gel, cream, ointment, or oil.” A person having ordinary skill in the art would have readily envisaged that those are topical formulations and, therefore, would have been motivated to topically apply them to tissue to treat the pathogenic bacteria. In sum, the present claims are not patentably distinguishable over claims 1-5 of the ’549 Patent.
Claims 12-14 and 16 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 11-18 of Patent No. 12,419,910 (September 23, 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 11 of the ’910 Patent is directed to “[a] method for treating a biofilm in a wound, the method comprising providing to the wound a composition comprising hypochlorous acid and acetic acid.” A wound necessarily comprises tissue, and a person having ordinary skill in the art would have readily envisaged that biofilms are commonly caused by bacteria. MPEP § 2131.02(III) (a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure). Therefore, the present claims are not patentably distinguishable over claims 11-18 of the ’910 Patent.
Claims 12-14 and 16 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 11-12 and 14 of co-pending Application No. 17/953,209 (as amended on November 7, 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 11 of the ’209 Application is directed to “[a] method for treating bacterial infection in tissue, the method comprising providing to the tissue a composition comprising acetic acid and an amount of hypochlorous acid effective to modulate a toxic property of the acetic acid without harming natural flora of the tissue.” Conflicting claims 13-14 recite concentration ranges for hypochlorous acid and acetic acid, respectively, that are overlapped by the corresponding concentration ranges recited in present claims 14 and 16. MPEP § 2144.05(I). Therefore, the present claims are not patentably distinguishable over claims 11-12 and 14 of the ’209 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 12-14 and 16 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 5-8, and 10 of co-pending Application No. 17/975,454 (as amended on September 19, 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 10 of the ’454 Application is directed to a “method for treating a bacterial infection in tissue, the method comprising providing to the tissue the composition of any one of the preceding claims.” The preceding claims, i.e., conflicting claims 1-8, collectively disclose an HOCl/HAc composition that satisfies the compositional limitations recited in present claims 12-14 and 16. MPEP § 2144.05(I). Therefore, the present claims are not patentably distinguishable over claims 1, 5-8, and 10 of the ’454 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 12-14 and 16 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 10 and 12-15 of co-pending Application No. 18/197,292 (as amended on September 10, 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 10 of the ’292 Application is directed to “[a] method for treating a biofilm in or on tissue, the method comprising applying to the tissue a composition comprising acetic acid in a concentration sufficient to penetrate skin and hypochlorous acid in an amount sufficient to remove biofilm on and beneath a surface of the tissue.” A person having ordinary skill in the art would have readily envisaged that biofilms are commonly caused by bacteria. MPEP § 2131.02(III) (a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure). Conflicting claims 10-15 collectively disclose an HOCl/HAc composition that satisfies the compositional limitations recited in present claims 12-14 and 16. MPEP § 2144.05(I). Therefore, the present claims are not patentably distinguishable over claims 10 and 12-15 of the ’292 Application. This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 12-14 and 16 are rejected.
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 PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
11 December 2025
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611