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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 17, 2025 has been entered.
In that response, claims 1-7 and 16-27 were amended and claims 8-13 were cancelled. Claims 1-7 and 16-27 are treated on the merits in this action. Claims 14 and 15 remain withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 25 and 26 are objected to because of the following informalities: dependence from a cancelled claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 16-27 are rejected under 35 U.S.C. 103 as being unpatentable over Goldan (WO 2008/089268 A2) in view of Panicheva (US 2012/0237616).
Goldan teaches an electrochemically activated solution (ECAS) comprising hypochlorous acid (HOCl) with available free chlorine at about 5 to 1000 ppm, e.g., 200 ppm (para.0029) or hypochlorous acid at 180 ppm or 180 mg/l (para.00104), which is generated by the electrolysis of NaCl, wherein the electrolyzed solution may “contain from about 0.2 to 2% w/v salt”, e.g., 2 g/l (para.0030). The electrolyzed solution has a redox potential greater than about +650mV, e.g., +950 mV (para. 0033), a “pH of from about 4 to about 7” (para.0021, 0027; see para. 0037) and with an acceptable osmolarity for an ophthalmic composition of between 250 and 350 mOsm (para. 0036).
A pH of “about 7” that Goldan teaches (para.0027; see para. 0037) includes the 7.1 in claim 1. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, i.e., similar acidity/alkalinity. MPEP § 2144.05(I) (citations omitted). Analogously, “about .. to 2% w/v salt” includes or at the least is close to the 3 g/l chloride in claim 16 and therefore the skilled person would have expected the same properties as Goldan’s ECAS.
Goldan describes using a buffer, such as boric acid or sodium phosphate to prevent pH drift (para. 0037). Regarding claims 2, 3, and 19-22, Goldan does not specifically teach an example ECAS formulation comprising phosphate salt or boric acid in the recited ranges. However it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to prepare such compositions because Goldan expressly teaches adding sodium phosphate, boric acid, or its salts “to prevent pH drift under storage conditions”. “The particular concentration will vary, depending on the agent employed”, in order to “maintain a target pH within the range of pH 4-7 or a range as described herein” (para.0037), i.e., “a pH of from about 4 to about 7” (para. 0027).
In view of Goldan’s express teachings on the suitable concentrations of total free chlorine, chloride, redox potential, osmolality, and pH values, the skilled artisan could experiment within Goldan’s guidelines to arrive at a concentration of the sodium phosphate or boric acid/salt to “maintain a target pH within the range of pH 4-7 or a range as described herein” including “about 7” (para.0027). Furthermore the present claims recite ECAS “comprising”, and thus could include any number and concentrations of other components. Consequently, without some showing of the cruciality of the expansive concentrations of the boric or phosphoric acids recited in claims 19-22, they are not considered to overcome prima facie obviousness over Goldan.
Claims have been amended to recite a “closed high-density polyethylene (HDPE) container comprising” the recited ECAS. Goldan does not specifically teach an HDPE container for its ECAS.
Panicheva is drawn to “stabilized hypohalous acid solution (or formulation thereof), which may be conveniently packaged for sale, or stored for later use on demand” as a disinfectant for skin, surfaces, food and others (abstract; see title; paras.0008-12, 0024, 0036). “The biocidal activity of the solution can be expressed in terms of available free chlorine”, preferably between about 140 to about 2000 ppm (para.0027). The solution may comprise disodium phosphate and sodium diphosphate (paras.0056, 0065), has a pH between about 4.0 to about 7.5 and storage stability for at least one year or more (para.0009; claim 1). “The stabilized solutions may be packaged for storage or sale, using any suitable container, such as any suitable plastic or glass bottles, or bags (e.g., plastic bags)” wherein “the packaging material has minimal gas permeability” to carbon dioxide, oxygen, etc. (para.0036). Panicheva specifically teaches storing hypochlorous acid disinfectant in a closed HDPE container for storage and stability testing (paras.0030, 0056, 0058).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Goldan and Panicheva and store Goldan’s composition in an HDPE container as recited in the instant claim(s). The skilled person would have been motivated to do so because both references are drawn to hypochlorous disinfecting compositions and Panicheva teaches that closed HDPE containers are suitable for storage and sale of such compositions with minimal gas permeability.
Regarding “wherein the ECAS is stable for more than one year…” in claim 1, and claim 27 which recites the redox potential of the ECAS over months of storage, the following is noted:
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
(B) "adapted to" or "adapted for" clauses,
(C) "wherein" or "whereby" clauses,
(D) contingent limitations,
(E) printed matter, or
(F) terms with associated functional language.
This list of examples is not intended to be exhaustive... For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05.
MPEP §2103(I)(C) (emphases added). In other words simply reciting a desirable property, without also reciting the structural limitations that obtain those properties, is not afforded patentable weight. Here the stability for more than one year in claim 1 and the “wherein the redox potential of said ECAS is reduced by 20% or less [ ] after 6 months of storage…” in claim 27 do not require the particular structure, e.g., the specific components and their concentrations needed to obtain the properties recited in the wherein clauses. Thus they do not limit the scope of the claim and are not afforded patentable weight. For instance a pH sufficiently above the “about 7” of Goldan, the concentration of the “at least one of boric acid,…salt of phosphoric acid”, and/or the range(s) of the other limitations which fall outside Goldan’s teaching and reflected in Applicant’s disclosure could, potentially, establish a surprising effect and overcome Goldan.
Further regarding this particular issue Applicant argues “a surprising stability effect that arises specifically from storage in HDPE containers” as shown in Example 2. (Remarks, 7 second para.-8 second para., September 17, 2025.)
However Table 2a shows all of ECAS, 0, 1, and 2 were stored in HDPE container at 20 °C (para.0055, pre-grant publication US 2021/0275579). ECAS 0 is the control, comprising no boric acid, phosphoric acid, or a salt thereof. Table 2a shows that at 12 months ECAS 0 comprises 961 mV redox potential which is an increase from 907 mV at 0 month. Table 2b shows, for ECAS 0, at least about 88% of antibacterial activity after 12 months. Notably Applicant defines “stable” as “the redox potential of the ECAS of the present invention is reduced by 25%, preferably 1-10%, at maximum after 12 months of storage under the respective storing conditions” (para.0021, pre-grant publication US 2021/0275579). Therefore ECAS 0, without any of boric acid, phosphoric acid, or a salt thereof, is “stable” at 12 months according to Applicant’s definition.
Regarding claims 5-7, Goldan teaches viscosity increasing agents and excipients (paras.0038-39). Goldan nowhere requires an additional active agent or a preservative.
Regarding claims 25 and 26, Goldan teaches that its ECAS was effective against bacteria such as Staphylococcus aureus strains at 180 ppm hypochlorous acid (para.00104) and antiviral against others (para.00107). Goldan teaches using its ECAS to treat eye infections (Abstract; paras. 0041-60, 0079) and therefore the excipients would be suitable for treating viral eye infections. However it is noted that the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP § 2111.02.
Response to Arguments
Applicant's arguments filed September 17, 2025 have been fully considered but they are not persuasive. Applicant argues that Goldan does not teach “that storage container material is relevant to stability (Remarks, 7 first para., September 17, 2025.)
However Panicheva contemplates the issue of suitable containers for hypohalous disinfectant solutions, and teaches using HDPE containers.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614