DETAILED ACTION
Claims 1-4, 6, 8-21, 34, 38-39, 42-45, 49, 67-72, 74, 78-82, 85-86, 95-96, 107-108 and 110-116 are currently pending. Claims 110-116 are currently under examination.
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 .
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 10/14/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejections
The prior rejection of claims 110-117 under 112(b) is withdrawn in light of Applicant’s amendment to specify the radical source.
The prior rejection of claims 110-117 under 112(d) is withdrawn as a result of Applicant specifying the conditions of use and concentration of radical generating catalyst and radical source.
The prior rejection of claims 110-116 under 102(a)(1) as being anticipated by US 2015/0174091 is withdrawn as a result of Applicant specifying the radial to be selected from a group consisting of chlorous acid, ions of chlorous acid, salts of chlorous acid, bromous acid, ions of bromous acid, salts of bromous acid, iodous acid, ions of iodous acid and salts of iodous acid, which the ‘091 publication does not teach.
Examiner’s Note
Applicant's amendments and arguments filed 10/14/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 10/14/2025, it is noted that claims 110, 112-116 have been amended and no new matter or claims have been added.
Modified Rejection:
The following rejection is modified based on Applicant’s claim amendments.
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.
Claim(s) 110-116 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agricola et al. (US Patent 4902498, Published 02/20/1990, previously applied) as evidenced by EPA (EPA, Chlorous acid, sodium salt (1:1), pgs. 1-2 (9/25/2025)).
Agricola et al. teach an oral composition (abstract) such as a rinse (column 5, lines 34-35) comprising aspartic acid, NaClO2, and water (column 6, lines 18-33) which is a chlorous acid liberating compound (column 2, lines 25-40). EPA evidences sodium chloride is a synonym for chlorous acid, sodium salt (page 1). The amount of protic acid used should be sufficient to lower the pH of the compositions to less than about 5.5 (column 2, lines 45-65). The about language allows for amounts above and below the recited 5.5, thus reading on instant claims 110 and 111. MPEP 2144.05(I) teaches “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. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” With regard to the limitations of instant claims 113-116, these are intended use claims, a recitation of 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.
Claim(s) 110-116 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0064565 (previously applied) as evidenced by EPA (EPA, Chlorous acid, sodium salt (1:1), pgs. 1-2 (9/25/2025)).
Regarding claims 110-112, the limitation of a drug comprising a radical generating catalyst comprises at least one selected the from the group which includes amino acids, a radical source is at least one selected from the group consisting of including chlorous acid, ions of chlorous acid and salts of chlorous acid, does not include reduced glutathione, wherein the pH of the drug is 5.5 or more, 6 to 11.5 is met by the ‘565 publication teaching an anti-microbial liquid ophthalmic composition for direct application onto an eye of a living being comprising chlorite compound, at a pH between 7 and 7.8. Preferably the chlorite compounds metal chlorite wherein the metal is chosen from sodium (abstract) wherein chlorous acid is taught [0011] specifically sodium chlorite [0121] and water is taught ([0064]). A stable gel is taught to include liposomes including a phospholipid (0065], [0080]). EPA evidences sodium chlorite is a synonym for chlorous acid, sodium salt (page 1).
Regarding alims 113-116, with regard to the limitations of instant claims 113-116, these are intended use claims, a recitation of 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. Therefore, the instant claims are anticipated by the prior art.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, sodium chlorite and phospholipids) from within the prior art disclosure of the ‘565 publication, to arrive at the instantly claimed drug composition “yielding no more than one would have expected.
Response to Arguments:
Applicant’s arguments have been considered and are not deemed to be persuasive.
103: The ‘498 patent (Agricola)
Applicant argues Agricola teaches acidification is necessary to activate the chlorite or chlorous acid liberating compound. In contrast the instant claims recite a pH of 6 or more. The ‘498 patent repeatedly emphasizes that such higher pH conditions would inhibit chlorine dioxide formation and thereby dimmish the desired antimicrobial effect defining low pH is below 5.5. A person of skill in the art would therefore have been discouraged from modifying Agricola system to operate at pH of greater than or equal to 6.
In response, Agricola et al. teach an oral composition (abstract) such as a rinse (column 5, lines 34-35) comprising aspartic acid, NaClO2, and water (column 6, lines 18-33) which is a chlorous acid liberating compound (column 2, lines 25-40). The amount of protic acid used should be sufficient to lower the pH of the compositions to less than about 5.5 (column 2, lines 45-65). The about language allows for amounts above and below the recited 5.5, thus reading on instant claims 110 and 111. MPEP 2144.05(I) teaches “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. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).”
Applicant argues Agricola lists various amino acids, for example aspartic acid, only as examples of protic acid or pH adjusters to control solution acidity. Agricola neither teaches or suggests that amino acids catalyze radical formation or function as electron-transfer agents. In fact Agricola teaches malic acid and citric acid in place of amino acids in Example 1. In contrast claim 110 expressly recites that the radial generating is amino acids and peptides serve as Lewis acidic catalysts that promote radical formation. The claimed invention employs a different functional role for amino acids than Agricola and thus is non-obvious.
In response, the ‘498 patent teaches an example specifically including aspartic acid wherein NaClO2 is taught to have been used (column 6, Example IV, lines 30-40). The ‘498 publication renders obvious a composition comprising aspartic acid, NaClO2 and the pH claimed and thus would be capable of generating radical absent factual evidence to the contrary. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant argues Agricola explicitly employs chlorous acid liberating compound such as sodium chloride, which relies on acid release of chlorous acid. The claimed invention differs in at least one selected form chlorous acid, ions of chloric acid, salts of chlorous acid is employed in a drug having a pH of 6 or higher. Radial generation occurs via catalyst by the defined radical generating catalyst rather than through acid decomposition of chloride salts. Agricola’s system requires external proton source and operates through acidic disproportionation of chloride to chlorine dioxide. In contrast the claimed invention maintains the halogen in defined +3 oxidation state and have controlled catalyst radial formation at pH of 6 or higher. The chemical identity and reaction mechanism and operating premise are different.
In response, the ‘498 patent teaches an example specifically including aspartic acid wherein NaClO2 is taught to have been used (column 6, Example IV, lines 30-40), wherein NaClO2 is a salt of chlorous acid as evidenced by EPA. The ‘498 publication renders obvious a composition comprising aspartic acid, NaClO2 and the pH claimed and thus would be capable of generating radical absent factual evidence to the contrary. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Applicant has presented no factual evidence to the contrary.
Applicant argues the claimed invention achieves efficient radical generation and antimicrobial efficacy without using strong acid conditions thereby enabling safe administration.
In response, Agricola et al. teach an oral composition (abstract) such as a rinse (column 5, lines 34-35) comprising aspartic acid, NaClO2, and water (column 6, lines 18-33) which is a chlorous acid liberating compound (column 2, lines 25-40). The amount of protic acid used should be sufficient to lower the pH of the compositions to less than about 5.5 (column 2, lines 45-65). The about language allows for amounts above and below the recited 5.5, thus reading on instant claims 110 and 111. MPEP 2144.05(I) teaches “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. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).”
103: US 2002/0064565 (Karagoezian)
Applicant argues the ‘565 publication discloses ophthalmic composition comprising a chlorite compound (sodium chloride) at pH of 7-7.8. The phospholipids are in the context of liposomal gels and are merely described as sustained release or stabilizing excipients, not as catalyst species. The antimicrobial activity in the ‘565 publication is attributed solely to direct oxidative action of the chilte ions or chlorine dioxide not any catalytic radical generation mechanism.
In response, the ‘565 publication teaching an anti-microbial liquid ophthalmic composition for direct application onto an eye of a living being comprising chlorite compound, at a pH between 7 and 7.8. Preferably the chlorite compounds metal chlorite wherein the metal is chosen from sodium (abstract) wherein chlorous acid is taught [0011] and water is taught ([0064]). A stable gel is taught to include liposomes including a phospholipid (0065], [0080]). “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Applicant has presented no factual evidence to the contrary.
Applicant argues the ‘565 publication does not disclose the radical source recited in claim 110. The ‘565 publication discloses only metal chlorites such as sodium chlorite (NaClO2) as the oxidant not HxO2 type acids or their salts.
In response, the ‘565 publication teaches an anti-microbial liquid ophthalmic composition for direct application onto an eye of a living being comprising chlorite compound, at a pH between 7 and 7.8. Preferably the chlorite compounds metal chlorite wherein the metal is chosen from sodium (abstract) wherein chlorous acid is taught [0011] specifically sodium chlorite [0121] and water is taught ([0064]). A stable gel is taught to include liposomes including a phospholipid (0065], [0080]). EPA evidences sodium chlorite is a synonym for chlorous acid, sodium salt (page 1).
Applicant argues the ‘565 publication describes phospholipids as an example of a sustained release component of liposomes and does not describe that phospholipid functional as radical generating catalyst. No examples of the ‘565 publication demonstrates the inclusion of liposomes or phospholipid. All working examples relate to compositions without liposomes.
In response, the ‘565 publication teaches the preparation maybe formulated for sustained release and contain a polymer matrix including phospholipids ([0065], [0080]-[0083]). “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Applicant has presented no factual evidence to the contrary.
Applicant argues the ‘565 publication teach pH of 7-7.8 and provides no teaching or suggestion that radical generation could occur under such mild conditions much less via catalyst by amino acids, peptides, or phospholipid. The claimed invention uniquely enables controlled radical generation through non-acid pH. The rejection would require both changing the function of the phospholipids form passive excipient to active catalyst and substituting the oxidant species with a chemically distinct halogenous acid or salt.
In response, Applicant’s arguments regarding the radical source are addressed above as first presented. The instant claims are directed to product claims, the ‘565 publication teaches the composition including the claimed ingredients and the claimed pH. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Applicant has presented no factual evidence to the contrary.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613