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 fourth 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 16 March 2026, Applicant amended claim 1 and cancelled claims 23-28. Claims 3-5, 7, and 9-18 were cancelled previously by Applicant. Claims 1-2, 6, 8, and 19-22 are pending and under consideration.
Claims of Benefit and/or Priority (Updated)
The following analysis has been updated in view of Applicant’s recent amendment to claim 1.
Applicant’s claim of benefit recites, inter alia, that the present application is a continuation of Application No. 15/852,615 (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), which is a continuation of Application No. 15/167,076 (great-great-grandparent application), which is a continuation-in-part of Application No. 14/618,799 (great-great-great-grandparent application), which is a continuation of Application No. 13/770,738 (great-great-great-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 prior-filed nonprovisional application to receive the benefit of the filing date of the prior-filed nonprovisional application. MPEP § 211.05(I)(B) (“Only the claims of the continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) in the prior-filed application are entitled to the benefit of the filing date of the prior-filed application.”). 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:
In regard to claim 1 (as recently amended), the following feature is not supported by the great-great-great-great-grandparent application (Application No. 13/770,738): “pharmaceutical.”
In further regard to claim 1, the following feature is not supported by Application No. 13/770,738 (the ’738 Application): “wherein the composition is formulated for pulmonary administration by inhalation via a nebulizer or inhaler.”
Because all the claims currently under consideration depend on claim 1, none of the claims under consideration is entitled to the benefit of the filing date of Application No. 13/770,738 (February 19, 2013). The foregoing application published on August 22, 2013, as US 2013/0216628 A1 (hereinafter, Hinderson 2013), which is more than one year before the next applications in Applicant’s chain of benefit were filed in parallel. Specifically, Application Nos. 14/618,799 and 14/618,820 were not filed until February 10, 2015. Therefore, Hinderson 2013, which is applied later in this Office action, continues to qualify as prior art under 35 U.S.C. 102(b) (pre-AIA ) and/or 35 U.S.C. 102(a)(1) (AIA ).
Regarding claim 6, the following feature is not supported by the ’738 application: “wherein the carrier is saline.”
Regarding claim 22, the following feature is not supported by the ’738 application: “wherein the carrier is isotonic.”
Accordingly, claims 6 and 22 are not entitled to the benefit of the filing date (February 19, 2013) of Application No. 13/770,738. Thus, Hinderson 2013 (US 2013/0216628 A1) also qualifies as prior art under 35 U.S.C. 102(b) (pre-AIA ) and/or 35 U.S.C. 102(a)(1) (AIA ) against claims 6 and 22 on the foregoing independent basis.
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.
Status of the Rejections
The rejection of claims 1-2, 6, 8, and 19-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, set forth in the previous Office action (16 December 2025) is withdrawn in view of Applicant’s clarifying amendments to claim 1. The examiner appreciates Applicant’s effort to advance prosecution.
The rejection of claims 1-2, 6, 8, and 19-22 under 35 U.S.C. 103(a) (pre-AIA ) as unpatentable over Hinderson (US 2013/0216628 A1) in view of Goldan (US 2010/0285151 A1) and Northey (WO 2008/112940 A1) is maintained. Applicant’s arguments are considered in paragraphs 36-40 of this Office action.
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 1-2, 6, 8, and 19-22 are rejected under 35 U.S.C. 103(a) (pre-AIA ) as unpatentable over Hinderson (US 2013/0216628 A1) in view of Goldan (US 2010/0285151 A1) and Northey (WO 2008/112940 A1).
Hinderson is directed to compositions of hypochlorous acid (HOCl). Abstract; see also page 8 at claim 25.
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. Due to the combination of its biocide properties and its safety profile, hypochlorous acid has been found to have many beneficial uses across many different industries, such as the medical, foodservice, food retail, agricultural, wound care, laboratory, hospitality, dental, or floral industries.” Para. [0003].
Hinderson discloses that the composition comprises hypochlorous acid and acetic acid (para. [0077] at Table 2). The carrier for the compositions disclosed in Table 2 is water (paras. [0073]-[0077]). Water qualifies as a “carrier,” according to claim 2 of the present application.
The three compositions disclosed in Table 2 of Hinderson (para. [0077]) comprise either 205 ppm or 207 ppm of hypochlorous acid, which is close enough to the low end of the corresponding range (“about 250 ppm”) now recited in Applicant’s claim 1 to support a finding of prima facie obviousness. MPEP § 2144.05(I) (“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”). Alternatively, Figure 8 of Hinderson discloses a hypochlorous acid range of 100 – 500 ppm. That range is overlapped by the range recited in claim 1. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). It is worth noting that Hinderson also discloses that “the HOCl may have a concentration of at least about 200 ppm.” (Emphasis added) Para. [0016]; see also page 8 at claim 29.
The compositions disclosed in Table 2 of Hinderson (para. [0077]) achieve a pH of 4.62, 5.33, and 4.07, respectively, using acetic acid in combination with the designated concentration of hypochlorous acid. Hinderson discloses: “The data show that using acetic acid provides greater product stability, most likely due to greater stability in the pH.” (Emphasis added) Para. [0078]. Additionally, Hinderson discloses that “[t]he composition may have a pH from about 4 to about 7.5” (para. [0016] (underline added)), which allows for optimization of the acetic acid concentration. MPEP § 2144.05(II)(A) (“‘[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.’”), quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955). Therefore, the acetic acid concentration range recited in claim 1 (i.e., “about 0.25 wt% to about 2.0 wt%”) is prima facie obvious. The examiner’s position is supported by claim 21 of the present application, which depends on claim 1, and requires a similar pH of about 4.5 to about 7.5.
Although Hinderson discloses that the biocidal hypochlorous acid (HOCl)/acetic acid composition “can be used in numerous different applications, for example medical, foodservice, food retail, agricultural, wound care, laboratory, hospitality, dental, delignification, or floral industries” (para. [0069]) and for “the breaking down of bacterial biofilm” (para. [0055]), Hinderson is silent as to whether the HOCl/acetic acid composition can be “formulated for pulmonary administration by inhalation via a nebulizer or inhaler.” Consequently, Hinderson does not satisfy claim 1, as recently amended. As explained below, Goldan and Northey 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].
“For patients afflicted with a sinus infection and/or allergic condition,” Goldan continues, “the present invention provides for administration of the hypohalous acid as described herein to the nose and/or sinus cavity.” Para. [0076]; see also para. [0064] (“For example, the condition may be a sinus infection or ear infection of viral origin, which has developed a bacterial superinfection.”) and claim 4 (“wherein the condition involves a bacterial infection and/or biofilm”).
Goldan teaches that “the composition of the invention may be formulated so as to be delivered by aerosol, mist, or steam.” (Emphasis added) Para. [0032]; see also para. [0074] (“[t]he hypohalous acid and compositions of the present invention may be administered in any appropriate dosage form such as a liquid, aerosol, or semi-solid” (emphasis added)).
Northey is directed to “[m]ethods and products [that] are provided for treating a wound or infection in a mammal or disinfecting a surface with a hypochlorous acid solution that has been activated by a catalyst.” Abstract.
Northey discloses: “The invention additionally provides products for treating a wound or infection, the products comprising a first component comprising an effective amount of a hypochlorous acid solution, and a second component comprising a catalyst, which catalyzes the conversion of hypochlorous acid into dichlorine monoxide, wherein the first and second components produces when combined produce an activated solution comprising a therapeutically effective amount of dichlorine monoxide.” Para. [0014]; see also para. [0031] (showing equilibrium between hypochlorous acid and dichlorine monoxide). Acetic acid is identified as an exemplary catalyst. Para. [0035]. “[T]he hypochlorous acid solution has a pH of from about 5.0 to about 6.0.” Para. [0019]. “In other embodiments,” Northey continues, “the activated solution has a pH of from about 5.0 to about 6.0.” Id.
Northey discloses: “The antimicrobial solution also may be dispensed in aerosol form as part of an inhaler system for treatment of infections in the lungs and/or air passages or for the healing of wounds in such parts of the body.” (Emphasis added) Para. [0051]. “In accordance with the invention, the antimicrobial solution used can be administered topically, e.g., as a spray, mist, aerosol or steam, by any suitable method, e.g., by aerosolization, nebulization or atomization, e.g., in the form of droplets having a diameter in the range of from about 0.1 micron to about 100 microns, preferably from about 1 micron to about 10 microns.” (Emphasis added) Para. [0050].
Prior to the time Applicant’s invention was made, the foregoing teachings of Goldan and Northey would have motivated a person having ordinary skill in the art to formulate the HOCl/acetic acid composition disclosed in Hinderson for pulmonary delivery as an aerosol via actuation of a nebulizer/inhaler, in order to provide the end user with a biocidal formulation option that can be administered conveniently to treat lung infections. The foregoing modification would have been made with a reasonable expectation of success, especially considering the compositional similarity among the Hinderson formulations, the Goldan formulations, and the Northey formulations. Therefore, claims 1-2 and 19-21 are prima facie obvious. MPEP § 2143.02(I) (“Where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious provided there is also a reasonable expectation of success.”).
Regarding claims 6 and 22, Goldan teaches that suitable excipients include purified water, as a pharmaceutically-acceptable carrier, and tonicity agents, such as NaCl (paras. [0030], [0035]). “In some embodiments,” Goldan teaches, “the invention contains 0.4 to 1.5% w/v salt, or may be a normal saline solution (0.9% w/v NaCl).” (Emphasis added) Para. [0030]. “In some embodiments, the solution is isotonic with physiological fluids, such blood, saliva or tears.” (Emphasis added) Para. [0030].
Regarding claim 8, Hinderson discloses that “conducting the process with acetic acid instead of hydrochloric acid is optimal when the desired pH of the final solution is approximately the pKa of acetic acid.” Para. [0030]. Hinderson discloses buffering in paragraphs [0007], [0008], and [0030].
Response to Applicant’s Arguments
The remarks below are provided in response to the arguments raised by Applicant on pages 5-6 of the Reply filed 16 March 2016.
The examiner appreciates Applicant’s thoughtful arguments; however, they are not persuasive for the following reasons: Hinderson (the primary reference) discloses that hypochlorous acid “is a weak acid that known to rapidly inactivate bacteria” (para. [0003]), “is generally not harmful to people” (para. [0003]), and is useful for “breaking down of bacterial biofilm” (para. [0055]). Goldan (the secondary reference) teaches that hypochlorous acid, which is even produced by the human body’s natural immune system (para. [0026]), may be formulated for delivery by aerosol, mist, or steam (paras. [0032], [0074]) and administered to the nose and/or sinus cavity for the purpose of treating a bacterial infection and/or biofilm (para. [0076], para. [0064], claim 4). Those two prior art references, in combination, teach that hypochlorous acid, itself, (i) has anti-bacterial and anti-biofilm properties and (ii) can be safely administered in effective amounts to the upper respiratory system. The examiner acknowledges that Northey (the tertiary reference) focuses on dichlorine monoxide (Cl2O). See, e.g., Abstract and paras. [0031]-[0033]. Nevertheless, the “activated” antimicrobial solution of Northey, which employs a catalyst to favor the formation of dichlorine monoxide, also comprises hypochlorous acid (HOCl), as taught in the equilibrium reaction set forth in paragraph [0031], which is reproduced below:
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Northey confirms: “Through the addition of catalyst, it is possible to generate products ranging from HOCl to mixed HOCl/Cl2O.” Para. [0044] (emphasis added). Northey’s teaching that the activated antimicrobial solution can be dispensed, via a nebulizer, in aerosol form as part of an inhaler system for treatment of infections in the lungs and/or air passages (paras. [0050]-[0051]) provides support for the examiner’s position that Northey suggests that hypochlorous acid (HOCl) formulations, such as those of Hinderson and Goldan, are compatible with pulmonary administration. Hence, there would have been a reasonable expectation of success in pursuing the modification required by the foregoing §103 rejection, especially when considered in combination with Goldan’s encouraging teachings concerning the administration of hypochlorous acid (HOCl) formulations to the upper respiratory system.
In the interest of compact prosecution, the examiner makes the following observations: Even if Northey did somehow teach away from the claimed invention, Northey would remain available as an evidentiary reference tending to show that liquid hypochlorous acid formulations are generally safe for, and otherwise compatible with, pulmonary administration. Essentially, this is all that the following clause of claim 1 of the present application actually requires: “wherein the composition is formulated for pulmonary administration by inhalation via a nebulizer or inhaler.” See MPEP 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”). It is worth emphasizing that the claims of the present application are directed to a composition, not to a system (a device containing a composition) or to a method of treatment. Therefore, they do not (and cannot) require either a nebulizer/inhaler or the active step of pulmonary administration.
The foregoing §103 rejection is maintained.
* * *
Conclusion
Claims 1-2, 6, 8, and 19-22 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./
16 May 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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