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 third 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.
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 29 April 2026 has been entered.
Information Disclosure Statement
Applicant is alerted that one of the non-patent literature (NPL) documents listed on the Information Disclosure Statement filed 01 May 2026 was not considered by the examiner because the citation failed to include a date of publication. Specifically, NPL Citation No. 1, which concerns a “GelSpray Liquid Bandage,” does not include a publication date. Applicant is referred to 37 CFR 1.98(b)(5), which provides as follows: “Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication.”
Status of the Claims
Applicant amended claims 10 and 15. Additionally, Applicant added four new claims, i.e., claims 18-21. Claims 1-9, 11, and 16-17 were cancelled previously by Applicant. Claims 10, 12-15, and 18-21 are pending. Claims 12-14 remain withdrawn because they are directed to various non-elected species of tissue. Claims 10, 15, and 18-21 are under consideration.
Status of the Rejections and Objections
The rejection of claims 10 and 15 under 35 U.S.C. 112(a) or (pre-AIA ) first paragraph is withdrawn in view of Applicant’s recent amendment to claim 10. The examiner appreciates Applicant’s effort to advance prosecution.
The rejection of claims 10 and 15 under 35 U.S.C. 112(b) or (pre-AIA ) second paragraph is withdrawn in view of Applicant’s recent amendment to claim 10. Again, the examiner appreciates Applicant’s effort to advance prosecution.
The rejection of claims 10 and 15 under 35 U.S.C. 103(a) as being unpatentable over Hinderson (US 2013/0216628 A1) in view of Goldan (US 2010/0285151 A1) and Northey (WO 2011/014809 A1) is withdrawn.
The objection to claim 21 is new.
The rejection of claim 20 under 35 U.S.C. 112(b) or (pre-AIA ) second paragraph is new.
The rejection of claims 10, 15, and 18-21 under 35 U.S.C. 103(a) as being unpatentable over Hinderson (US 2013/0216628 A1) in view of Goldan (US 2010/0285151 A1) and Shimomura (WO 2007/094413 A1) is new. The examiner notes that Shimomura is newly cited. Applicant’s arguments are considered in paragraphs 51-55 of this Office action.
All non-statutory double patenting rejections set forth in the previous Office action (29 December 2025) are maintained. Contrary to Applicant’s statement on page 6 of the Reply (29 April 2026), no Terminal Disclaimers have been submitted for this application.
Claims of Benefit and/or Priority (updated)
Applicant’s claim of benefit recites, inter alia, that the present application is a continuation of Application No. 15/612,571 (parent application), which is a continuation-in-part of Application No. 15/267,220 (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 10, the following feature is not supported by the grandparent (’220) application: “acetic acid at a concentration of at least about 0.1 wt%.”
Regarding claim 10, the grandparent application (’220) does not support the hypochlorous acid concentration range of “at least about 10 ppm.” As a courtesy, Applicant is again referred to Figure 4 of the grandparent (’220) application, which contains the only relevant disclosure concerning ppm of hypochlorous acid.
Regarding claim 10, the grandparent (’220) application, which is directed to a hand disinfectant, focuses exclusively on skin. Although skin is a species of tissue, the grandparent application does not disclose the tissue genus or even describe tissues other than skin. Consequently, the grandparent (’220) application does not adequately support any claim that broadly recites or incorporates the tissue genus.
Regarding claim 15, the grandparent (’220) application does not support the recited acetic acid concentration range of “about 0.5 wt % to about 5.0% wt %.”
Regarding claim 18 (new), the grandparent (’220) application does not support any of the species of wound recited in the corresponding Markush group.
Regarding claim 19 (new), the grandparent (’220) application does not support oral or local administration.
Regarding claim 20 (new), the grandparent (’220) application does not provide support for an emollient.
Regarding claim 21 (new), the grandparent (’220) application does not support the range of 0.01 to 1,000 mg.
In sum, none of the claims under consideration is entitled to the benefit of the filing date of 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.
Objections to the Claims
Claim 21, which depends on claim 10, is objected to because of the following informality: The phrase “the therapeutic amount” is inconsistent with the corresponding phrase recited in claim 10. Appropriate correction is required. The examiner recommends amending the phrase to read as follows: “the therapeutically effective amount.”
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.
Claim 20 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 that the inventor regards as the invention.
Regarding claim 20, it is unclear how the composition recited in claim 10 can be “in a” pharmaceutically-acceptable emollient, emulsifier, thickening agent, or solvent. Moreover, if that composition is “in” another substance, thereby seemingly yielding a second composition, how can a person having ordinary skill in the art reliably evaluate whether the concentration ranges recited in claim 10, which do not even pertain to the second composition, are satisfied? Perhaps the composition recited in clam 10 further comprises an emollient, emulsifier, thickening agent, or solvent?
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 10, 15, and 18-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hinderson (US 2013/0216628 A1) in view of Goldan (US 2010/0285151 A1) and Shimomura (WO 2007/094413 A1).
As an initial matter, the examiner notes again that examination remains focused on the following species, both of which were previously elected by Applicant without traverse: (i) gel, as the form of the composition; and (ii) wound site, as the tissue. Reply (11 December 2024) at p. 3. The phrase “wound site” is interpreted in a manner consistent with page 26 of the specification, which states, in relevant part: “Wounds include bedsores, chronic wounds, burns, pressure wounds, diabetes wounds, and other forms of skin trauma.” Lines 8-10. In other words, “wound site” means a site of trauma to skin tissue. See also Office action (11 October 2024) at para. 20.
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 33 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 10 (“at least about 10 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 10. 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]) and breaks down bacterial biofilm (para. [0055]), Hinderson is silent as to whether the HOCl/HAc composition can be administered as a gel to treat a biofilm in or on a wound site (a site of trauma to skin tissue). As explained below, Goldan and Shimomura compensate for this deficiency.
Goldan is directed to “compositions and methods for treating a condition characterized by infection and/or inflammation, such as conditions of the eyes, ears, nose, mouth, and/or throat, by administering a hypohalous acid, such as HOCl, to the affected area as described herein.” Para. [0025].
Goldan teaches: “Hypochlorous acid (HOCl) is an oxidant and biocide that is produced by the human body’s natural immune system. HOCl is generated as the final step of the Oxidative Burst Pathway, with large quantities of HOCl being released into phagocytic vesicles to destroy invading microorganisms. It is considered, without wishing to be bound by any theory, that hypochlorous acid exerts a biocidal effect by attacking the surface and plasma membrane proteins, impairing transport of solutes and the salt balance of bacterial cells.” Para. [0026].
Goldan teaches: “Where the condition involves biofilm, the hypohalous acid deactivates the polymatrix material of the biofilm to facilitate removal (cleansing), and disinfection. Hypohalous acid contact with biofilm formation dissolves the protective polysaccharaide matrix of the biofilm aiding in the effective removal of pathogens and debris.” (Emphasis added) Paras. [0046] and [0072]; see also claim 4 (“wherein the condition involves a bacterial infection and/or biofilm”).
Goldan teaches: “The hypohalous acid and compositions of the present invention may be administered in any appropriate dosage form such as a liquid, aerosol, gas, or semi-solid including a solution, suspension, viscous or semi-viscous gel, ointment, cream, or other types of compositions.” (Emphasis added) Paras. [0059] and [0074].
Shimomura, which published in Japanese, is directed to a hydrogel comprising hypochlorous acid that exerts an excellent therapeutic effect on skin ulcers. Abstract. The examiner obtained an English machine translation of Shimomura using Google Patents. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Shimomura teaches that a hydrogel comprising hypochlorous acid as an active agent can be applied to treat a skin ulcer. Page 1/12 at para. [0001] and at claims 1, 4, and 16.
Shimomura teaches: “Skin ulcers are skin diseases in which the skin is lost due to pressure ulcers, burns, trauma, poor circulation, diabetes, and the like. Among skin ulcers, pressure ulcers (so-called bed sores) are skin ulcers that are common in elderly people who have poor health and are bedridden for a long time, and are known to be refractory.” (Emphasis added) Page 2/12 at para. [0002]; see also page 4/12 at para. [0035].
Shimomura teaches that effective concentrations of hypochlorous acid are usually 1 to 500 ppm, preferably 5 to 100 ppm, more preferably 10 to 50 ppm. Page 3/12 at para. [0016].
Prior to the time Applicant’s invention was made, the foregoing teachings of Goldan and Shimomura 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 administer the gel to a wound site, such as a skin ulcer, to treat a patient suffering from an infection at that site caused by a bacterial biofilm. Therefore, claims 10 and 18-19 are prima facie obvious.
Regarding claim 15, as established above, 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 33 of the specification of the present application, there is a sound basis for the examiner’s position that the acetic acid concentration range recited in claim 15 (“between about 0.5 wt % and about 5.0 wt %”) is either 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).
Regarding claim 20, Applicant is referred to paragraphs [0035], [0038], and [0039] of Goldan. Additionally (or alternatively), Applicant is referred to paragraph [0026] of Shimomura (page 4/12), which teaches various gelling agents (a/k/a thickeners), and to paragraph [0029] of Shimomura (page 4/12), which teaches emollients.
Regarding claim 21, Applicant is alerted that “‘[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.’” MPEP § 2144.05(II)(A), quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Response to Applicant’s Arguments
The following remarks are provided in response to the arguments raised by Applicant on page 5 of the Reply filed 29 April 2026, to the extent they remain applicable to the new §103 rejection set forth above:
Applicant argues: “Hinderson reports the use of acetic acid as a proton donor in the manufacture of hypochlorous acid. US 2013/0216628, [0007]. Table 2 in Hinderson shows ‘HOCl produced with acetic acid,’ not ‘acetic acid in combination with the designated concentration of hypochlorous acid’, as asserted in the Office Action at page 10. Nowhere does Hinderson disclose treating a biofilm with ‘a therapeutically effective amount of a composition comprising acetic acid and hypochlorous acid’. Thus, Hinderson cannot reasonably be said to teach or suggest the claimed invention.” Reply at p. 5. As explained below, this argument is not persuasive.
Acetic acid is present in the composition disclosed in Table 2 (para. [0077]) of Hinderson, where it assists in stabilizing the hypochlorous acid (HOCl) by providing buffering capacity. See Hinderson at paras. [0078], [0030], and [0007]. If the selected acids (i.e., hydrochloric acid or acetic acid) were exhausted during the production process, as Applicant asserts, then there would be no difference in Hinderson between the data set forth in Table 1 (hydrochloric acid) and the data set forth in Table 2 (acetic acid).
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.”).
Applicant’s remaining argument, which concerns Goldan, is not persuasive because one cannot show non-obviousness by attacking references individually where the rejection is based on a combination of references. MPEP § 2145(IV). It is worth emphasizing that an anticipatory prior art reference (35 U.S.C. 102) is not required to advance a proper rejection under 35 U.S.C. 103.
* * *
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 10, 15, and 18-21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 7-16 of Patent No. 10,577,244 (March 3, 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 7-11 of the ’244 Patent are directed to a method of providing wound care by applying a HOCl/HAc composition. Conflicting claims 12-16 of the ’244 Patent are directed to a method of breaking down a biofilm by applying a HOCl/HAc composition. Thus, claims 7-16 collectively disclose treating a biofilm in or on tissue by applying a HOCl/HAc composition. In sum, the present claims are not patentably distinguishable over claims 7-16 of the ’244 Patent.
Claims 10, 15, and 18-21 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 10, 15, and 18-21 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 a bacterial biofilm. In sum, the present claims are not patentably distinguishable over claims 1-6 of the ’741 Patent.
Claims 10, 15, and 18-21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3 of Patent No. 11,478,507 (October 25, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1 and 2 of the ’507 Patent are directed to a HOCl/HAc composition for treating bacterial biofilm on skin. Conflicting claim 3 discloses that the HOCl/HAc composition is in the form of a gel, cream, ointment or oil, which are topical dosage forms. Thus, the conflicting claims collectively teach or suggest topically applying a HOCl/HAc composition to skin or other tissue to treat a bacterial biofilm. In sum, the present claims are not patentably distinguishable over claims 1-3 of the ’507 Patent.
Claims 10, 15, and 18-21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-6 of Patent No. 11,672,825 (June 13, 2023).
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 ’825 Patent includes limitations directed to an HOCl/HAc composition for “deeper, subsurface treatment of biofilm infected tissue.” Conflicting claim 6 discloses that the HOCl/HAc composition is in the form of a gel, cream, ointment or oil, which are topical dosage forms. Thus, the conflicting claims collectively teach or suggest applying a HOCl/HAc composition to tissue to treat a biofilm. In sum, the present claims are not patentably distinguishable over claims 1-6 of the ’825 Patent.
Claims 10, 15, and 18-21 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. Therefore, the present claims are not patentably distinguishable over claims 11-18 of the ’910 Patent.
Claims 10, 15, and 18-21 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 12-14 and 16 of co-pending Application No. 17/970,906 (as amended on 27 August 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 12 of the ’906 Application is directed to “[a] method for treating a bacterial infection in tissue, the method comprising administering to the tissue a composition comprising acetic acid at a concentration of at least about 0.1 wt % and hypochlorous acid at a concentration of at least about 50 ppm.” A person having ordinary skill in the art would have readily envisaged that bacteria often aggregate to form a biofilm. Thus, the conflicting claims collectively teach or suggest applying a HOCl/HAc composition to tissue to treat a bacterial biofilm. Therefore, the present claims are not patentably distinguishable over claims 12-14 and 16 of the ’906 Application. This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 10, 15, and 18-21 are rejected.
Claim 21 is also objected to.
No claim is allowed.
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./ 16 May 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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