DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification, drawings and claims as well as applicant arguments/remarks, filed 06/29/2026, is acknowledged. Amendments to the specification and drawings have been entered. To this point, it is noted that submitted amendments to the specification include original claims and abstract that have been entered previously and/or amended.
Claims 1, 10, 31-44, 46, 50, 101-105 are pending in this action. Claims 2-9, 11-30, 45, 47-49, 51-100 have been cancelled previously. Claims 1, 31-44, 46, 50 have been amended. New claims 101-105 have been added. No new matter was added. Claims 1, 10, 31-44, 46, 50, 101-105 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments and/or new claims necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of 371 of PCT/US2022/070687, filed February 16, 2022, which is a continuation-in-part of PCT/US2021/046035, filed August 13, 2021, which claims benefit of provisional U.S. Application No. 63/211,543, filed June 16, 2021, U.S. Application No. 63/147,743, filed February 9, 2021, U.S. Application No. 63/080,769, filed September 20, 2020, U.S. Application No. 63/077,520, filed September 11, 2020, U.S. Application No. 63/068,969, filed August 21, 2020, and U.S. Application No. 63/065,479, filed August 13, 2020
Information Disclosure Statement
The information disclosure statements, filed 02/26/2026 and 06/29/2026, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Claim Objections
Claims 1, 33, 35-37, 101, 103-105 are objected to because of the following informalities:
Claim 1 recites the limitation “1% or less” that should be corrected to “1 wt% of less” or clarified.
As stated previously, claim 33 recites the limitation “in a subject comprising administering” that needs to be corrected to “in a subject by administering” for clarity.
In claim 35, the limitation “flaviviruses (group b)” should be corrected to “group B of flaviviruses” or clarified.
Claims 35-37, 101 recite multiple acronyms. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed. The acronyms that are not used in subsequent claims should be removed.
Numeration of new claims 103-105 needs to be corrected, because “claim 103” is recited twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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 1, 10, 31-44, 46, 50, 101-105 are 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 which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Newly amended claim 1 is unclear and indefinite, because the concentrations/amounts of active compounds (i.e., quat, iodine) to be used for treatment of a wide spectrum of microorganisms (see claim 31) are not clearly delineated. To this point, it is noted that independent claim 1 discloses quat-I2 compositions comprising about 99 wt% of glycerin, about 1 % or less of ethanol; and also include a quaternary amine (quat) composition and a high molecular iodine composition. First, it is noted that the amounts of additional compounds/components to be included in said compositions can be less than 10 wt%, given that the term “about” is defined in the instant specification as ±10% (Specification, Para. 0091). Second, it is noted that a quaternary amine (quat) composition and a high molecular iodine composition may include additional/unrecited compounds even in large amounts (i.e., comprising). Third, as stated previously, the numerical limitation “1,500 ppm by wt/v” is not clear, because to convert “ppm” to “wt/v” (weight/volume), one need to know the density of the solution. Therefore, as stated previously, the concentrations of the active compounds, i.e., quat and iodine, to be used in the claimed compositions are not clearly delineated. Clarification is required.
Claim 10 recites the limitation “biostatic persistent” that is not reasonably clear, because neither the claims nor the instant specification provides a definition for said term/property, and/or provide/define a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
As stated previously, claim 32 provides for the “administering of the quat-I2 composition” but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use/administering without any active, positive steps delimiting how this use/administering is actually practiced. Similar is applied to claim 33. Clarification is required.
Claim 35 recites the limitation “virus and semliki forest virus” that is unclear, because it is not clearly stated which “virus” is disclosed. Clarification is required.
Claim 35 (dependent on claims 34, 32, 1) recites the limitation “the flaviviruses (group b)” that is unclear. To this point, it is noted that claims 1, 32, 34 do not disclose the use/treatment of flaviviruses. Therefore, it is unclear how said limitation in claim 35 limits the scope of the claims upon which claim 35 depends. Clarification is required.
Claim 35 is unclear and indefinite, because said claim recites a broad limitation together (e.g., herpesviruses) with a narrow limitation (i.e., Herpes Simplex virus 1 or 2) that falls within the broad limitation in the same claim. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Similar is applied to claim 39 regarding the limitation “yeast, Candida and candida albicans”. Clarification is required.
Claim 36 recites the limitation “wherein the condition is selected from the group consisting of COVID-19, SARS,…” that is not reasonably clear, because the conditions of a patient is defined as a virus. This limitation was interpreted as best understood as “wherein the condition of a patient is associated with a virus selected from the group consisting of COVID-19, SARS,…”. Similar is applied to claim 38, 40, 42, 44, 102, 103, 105. Clarification is required.
Claim 37 recites the limitation “the bacterium being selected from the group consisting of Bacillus oleronius, …, Staphylococcus aureus, …, MRSA, …" that is unclear and indefinite. In the present case, it is noted that the members of the Markush group must belong to a recognized physical or chemical class or to an art-recognized class. MPEP §803.02. In the present case, some members of said group are defined by their genus (e.g., Staphylococcus aureus), whereas other members are defined by their properties (i.e., MRSA as Methicillin-resistant Staphylococcus aureus). Clarification is required.
Claim 44 (dependent on claims 33) recites the limitation “caused by mites listed above” that is unclear, because it is not clearly state to which recitation “listed above” said limitation refers. Clarification is required.
New claim 101 recites the limitation “wherein the virus is selected from the group of …, “bunyawere (encephalitis)”, …, “vartola (Smallpox)”, …, “common cold (rhinovirus)”, …, “Severe acute respiratory syndrome” that is unclear. First, as stated previously, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). Second, it is noted that said claim is unclear, because it is not clearly stated what is claimed – a virus, or conditions of a patient. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Clarification is required.
Claims 31, 34, 41, 43, 46, 50, 104 are rejected as being dependent on rejected independent claims 1 and/or rejected claims 32, 33 and failing to cure the defect.
Response to Arguments
Applicant's arguments, filed 06/29/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the claim language and scope, the structure of the claimed quat-I2 compositions, as well as method steps for providing an effective treatment against a large variety of parasites and/or microorganisms recited, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance. As best understood, the applicant discloses compositions comprising a quaternary amine, iodine, glycerin and ethanol that are present in specific concentrations. Applicant teaches that said compositions can be used for skin treatment against a large variety of pathogens, have a high stability, low cytotoxicity, and provide little or no stain or irritancy on a subject's skin.
Conclusion
Claims 1, 10, 31-44, 46, 50, 101-105 are rejected, but would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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