DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 09/13/2024, are acknowledged.
Claims 1, 10, 31-44, 46, 50 are pending in this action. Claims 2-9, 11-30, 45, 47-49, 51-100 have been cancelled. Claims 31-34, 36, 38, 4042, 44, 46, 50 have been amended. Claims 1, 10, 31-44, 46, 50 are currently under consideration.
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
Inventorship
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.
Specification
The lengthy specification (113 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The publications recited in the instant application (e.g., Para. 0053, 00172) should be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). Appropriate correction is required.
The specification comprises multiple acronyms without proper definition (e.g., Para. 0055, 0056, 00115, 00147-00149, 00186, 00223, 00231). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The recitation of units of measurements as “ppm” and “PPM” (e.g., Para. 0056, 0057, 0089) should be corrected or clarified. Clarification is required.
The use of the trademarks/trade names has been noted in this application (e.g., Para. 0070, 00100, 00223). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The disclosure contains an embedded hyperlink and/or other form of browser-executable code (e.g., Para. 0074, 00172). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. MPEP 608.01.
The data provided in the specification are unclear, given that the data are shown without units of measurements (e.g., Para. 00103, 00104, 00118, 00120, 00172, 00174; Table 1; Para. 00235, 00315). Appropriate correction is required.
Drawings
The drawings, filed 09/13/2024, are objected to because: (i) in Figs. 1, 2 x-axis and/or y-axis is not clearly identified/shown; and (ii) in Figs. 9(A, B, D, E, F, G, H, I, J, K, L) the characteristics of the shown samples are unclear. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statements, filed 12/05/2025, 05/08/2024, 05/14/2024, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Applicant has submitted large information disclosure statements without specifically pointing out where relevant material can be found in each of the references. As a result, the examiner has considered said information disclosure statements to the extent permitted by the allotted time for such consideration and consistent with the MPEP. Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract or translated specific pages have been provided or available for foreign language documents then only the English abstracts and translated specific pages have been considered.
The information disclosure statement, filed 05/08/2024, fails to comply with 37 CFR 1.98(b)(5), which requires that 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. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
Claim Objections
Claims 1, 31-44, 50 are objected to because of the following informalities:
Claim 1 recites the limitation “glycerin having a concentration” that should be corrected to “glycerin present in a concentration”. Similar is applied to other constituents recited in claim 1.
Claim 31 comprises the typographic error “composition of Claim 1” that needs to be corrected to “composition of claim 1” (see claim 10). Similar is applied to claims 32, 33.
Claim 32 recites the limitation “in a subject comprising administering” that needs to be corrected to “in a subject by administering” for clarity. Similar is applied to claim 33.
Claim 34 comprises the typographic error “The method of claim 32, the microorganism being selected” that needs to be corrected to “The method of claim 32, wherein the microorganism is selected”. Similar is applied to claims 35-44.
Claim 35 recites 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. Similar is applied to claims 36, 37.
Claim 50 comprises the typographic error “where in” that needs to be corrected to “wherein”.
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 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.
Claim 1 discloses a composition comprising “(i) one or more quat or salts thereof; (ii) a high molecular iodine concentration composition comprising molecular iodine of a concentration of about 1,500 ppm by wt/v; (iii) glycerin having a concentration of about 99%wt of the total weight of the quat-I2 composition, and (iv) ethanol having a concentration of about 1% or less” that is not reasonably clear. First, the limitation “a high molecular iodine concentration composition comprising molecular iodine of a concentration of” is not clear. Is it a mixture comprising molecular iodine, OR iodine? Second, it is noted that the term "about” is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide 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. Third, it is noted that the recited concentration of glycerin and ethanol is about 100 wt%. Therefore, concentrations of quat and iodine in the claimed compositions are not clearly delineated. Fourth, 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, the scope of the claim is not clear. Clarification is required.
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 “adenoviruses (e.g., human adenovirus)”. To this point, it is noted that said claim is unclear and indefinite, because said claim recites a broad limitation (i.e., adenoviruses) together with a narrow limitation (i.e., human adenovirus) 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). Further, 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). Similar is applied to other constituents recited in claim 35, as well as to claims 36, 38, 43, 44. Clarification is required.
Claim 37 recites the limitation “the bacterium being selected from the group consisting of Bacillus oleronius, Streptococcus pyogenes, Erysipelothrix rhusiopathiae, Mycobacterium tuberculosis, Mycobacterium bovis, Escherichia coli, …, Pasteurella multocida, antibiotic resistant bacteria, and antibiotic-resistant flesh-eating bacteria" 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, whereas other members are defined by their properties (i.e., antibiotic resistant). Clarification is required.
Claim 46 (dependent on claims 32, 1) recites the limitation “wherein the treatment area”. Claims 1 and/or 32 do not include or identify the role/use of “a treatment area". Therefore, there is insufficient antecedent basis for this limitation in the claim. Therefore, the metes and bounds of the claim cannot be determined. Clarification is required.
Claims 10, 31, 34, 39-42 are rejected as being dependent on rejected independent claim 1 and/or rejected claims 32, 33 and failing to cure the defect.
Conclusion
Claims 1, 10, 31-44, 46, 50 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.
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. Applicant is advised to clarify the claim language and scope, 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615