DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-9, drawn to an antimicrobial composition of matter, classified in A01N 37/36.
II. Claim 10-20, drawn to a process of using the composition, classified in A01P 3/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, Invention II can also be achieved through using alcohol-based disinfectants or chlorine-based disinfectants that are chemically and structurally distinct that can accomplish the same end result. Invention I can be used in materially different processes like clean in place processes or used as a rinsing step despite method specifying no rinse is required.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions of Group I and Group II are categorized in different CPC codes, and a serious search and examination burden exists because the inventions require divergent searches in different fields of art with search spanning search of the chemical arts for carboxylic group and thio analogues, antimicrobial compounds, and fungicides.
Additionally, if Group II is elected, this application contains claims directed to the following patentably distinct species of hard surface and mammalian tissues. The species are independent or distinct because claims 15 and 16 are directed to use the product on hard surfaces while claim 18 is directed to use on mammalian tissue. In addition, these species are not obvious variants of each other based on the current record.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Attorney Jill Link on 18-Feb-2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 .
Claim Status
Claims 1-9 are pending.
Claims 10-20 are not elected.
Claims 1-9 have been examined.
Claims 1-9 are rejected.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 13-May-2024, 13-May-2024, 25-Jul-2024, 01-Aug-2024, 03-Dec-2024, 04-Apr-2025, 19-May-2025, and 02-Dec-2025 has been considered by the examiner.
Abstract
The abstract of the disclosure is objected to because “requires revision or removal. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Specification
The use of the terms Stepan GCC-Mild, Stephan 108, Tween 20, Tween 40, Tween 60, Tween 80, Span 20, Span 40, Span 60, and Span 80 in paragraph 125 are objected to because these are a trade name or a mark used in commerce. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
Paragraph 6: “no-rinse efficacy” is a relative term, what are the limitations of no-rinse efficacy?
Paragraph 7: Relative terms listed: “short contact times”, “clean conditions”, “dirty conditions”, and “soiled conditions”. How is clean, dirty, soiled, and short define?
Paragraph 13: EN13697, EN1650, EN1276, EN13697, and EN1447 listed as testing procedure, but no year provided for the test. i.e. for EN13697 has 2001, 2015, 2019, and 2023 versions. Changes between 2019 from 2015 includes updated A. Brasiliensis spore prep, harmonized CEN TC216 standards, updated conditions, and bacteria preparation procedures. The change log explicitly states that data from EN13697:2015 are valid with the exception of Pseudomonas aeruginosa and Candida albicans under clean conditions. Applicant will need to reference the date for the testing procedure/protocol and describe what testing is conducted rather than EN testing reference only since measurement standards change over time.
Paragraph 32: References “DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 Feb. 1998, and Guidance on the Biocidal Products Regulation Volume II Efficacy-Assessment and Evaluation (Parts B+C) Version 3.0 April 2018-ECHA (European Chemicals Agency)” followed by paragraph 33 “see Guidance document Appendices 2 and 4.” If these guidance documents are critical to the understanding of subsequent interpretation of the disclosure like log reduction, then relevant text ought be included in specifications.
The lengthy specification 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.
Claim Rejections - 35 USC § 112
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.
Claim 1, 2, 3, and 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a use pH” and is indefinite since pH could be of the composition, the composition after dilution, or the composition after being used for antimicrobial purposes.
Claim 1 recites “and n is from 1-6 to provide ;” and is indefinite because the hanging conjunction, i.e. what does the n is from 1-6 provide, creates grammatical ambiguity.
Claim 1 recites “yeasticidal and virucidal efficacy” is unclear whether the claim requires activity against all yeasts and viruses or only specific microorganisms.
Claim 2 recites a list of acid using inconsistent connectors: “glycolic acid, citric acid, tartaric acid, malic acid, or gluconic acid and/or the alkyl carboxylic acid.” This mixture of punctuation and conjunctions makes claim scope unclear. It is ambiguous whether the claim refers to a mixture of a hydroxycarboxylic acid with an alkyl carboxylic acid, if it is limited to a hydroxycarboxylic acid used exclusively with formic or acetic acid.
Claim 3 recites strong acid and/or weak acid, but weak acid and strong acid are not clearly defined since methane sulfonic acid is listed as a strong acid when it is not one of the seven strong acids. Paragraph 70 in the specification states that exemplary strong acids include methane sulfonic acid … pKa less than 2.5 versus standard definition of strong acid with pKa less than 1.
Claims 1 and 7 recites the term “about” to describe wt% and pH, but specification does not provide a specified range.
Claims 4-6, 8, and 9 are rejected for being dependent on rejected indefinite claims 1, 2, 3, and/or 7.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mathonneau et al. (US20180250218A1, Patent Published: 06-Sep-2018).
Claim 1 recites An antimicrobial composition with yeasticidal and virucidal efficacy comprising: (the limitation of "antimicrobial composition with yeastial and virucidal efficacy," is an intended use of the composition, which is not given patentable weight.)
at least one acid comprising a hydroxycarboxylic acid and/or alkyl carboxylic acid providing (Example Formulation F on page 12 includes citric acid which is a hydroxycarboxylic acid, and further discloses the inclusion of salicylic acid in Formulation F.)
a use pH of the composition < about 5; (Example Formulation F has a final composition pH of about 5, further disclosing that compositions “The pH of the compositions according to the invention generally ranges from 3 to 10, preferably from 3.5 to 7 and better still from 4 to 5.5” page 11, paragraph 308.)
an alkyl ether carboxylic acid having the formula R-(CH2CH2O)n-CH2COOH,
wherein R is a C6-C11 alkyl group, and n is from 1-6 to provide ; and optionally an additional surfactant. (Mathonneau et al. discloses alkyl ether carboxylic acid such as Laureth-5 carboxylic acid in Formulation F)
Claim 2 depends on claim 1 and recites the limitation of the hydroxycarboxylic acid comprises glycolic acid, citric acid, tartaric acid, malic acid, or gluconic acid and/or the alkyl carboxylic acid comprises formic acid or acetic acid and is anticipated by Mathonneau et al. on page 12 Formulation F with citric acid.
Claim 3 depends on claim 1 and recites the limitation of the acid in claim 1 comprising methane sulfonic acid and/or an additional weak acid and is anticipated by Mathonneau et al. on page 12 Formulation F with 0.2 wt% of salicylic acid.
Claim 4 depends on claim 1 and recites that the R group for the alkyl carboxylic acid is a C6-C10 alkyl group and is anticipated by Mathonneau et al. on page 2, paragraph 54 disclosing the R can be represented by “a linear or branched C8-C22 alkyl or alkenyl group or mixture of group”.
Claim 5 depends on claim 1 and recites the additional surfactant comprising of an alpha olefin sulfonate, alkane sulfonate, alkyl sulfonate, sulfonated carboxylic acid ester, alkyl polyglucoside, phosphate ester or combination thereof and is anticipated by Mathonneau et al. on page 12, Formulation F with Sodium (C14-C16) olefin sulfonate.
Claim 6 depends on claim 4 recites the limitation as the additional surfactant comprises a C8-C22 alpha olefin sulfonate or a C8-C16 alpha olefin sulfonate and is anticipated by Mathonneau et al. on page 12, Formulation F with Sodium (C14-C16) olefin sulfonate.
Claim 8 depends on claim 1 and recites the limitation that the composition is a liquid concentrate and is anticipated by Mathonneau et al. on page 12, Formulation F is disclosed to be a composition comprising of water wherein the solution is made Q.S. to 100% with water, demonstrating that the composition is an aqueous liquid. Such compositions are interpreted as liquid formulations, a category that includes concentrates, as to be suitable for dilution prior to use.
Claim 9 depends on claim 1 and recites the limitation that the composition does not include fatty acid esters and/or hydrogen peroxide and is anticipated by Mathonneau et al. on page 12, Formulation F does not include fatty acid esters or hydrogen peroxide in the composition.
Claim 7 is rejected for being dependent on rejected claim 1.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mathonneau et al. in view of Hanson et al. (US20210176986A1, Patent Published 17-Jun-2021).
Mathonneau et al. teaches wherein the acid(s) comprise from about 10 wt-% to about 50 wt-% of the composition (salicylic acid at 0.2 wt%, page 12 Formulation F), the alkyl ether carboxylic acid comprises from about 5 wt-% to about 40 wt-% of the composition (Laureth-5 carboxylic acid at 6 wt%, page 12, Formulation F), and the optional surfactant comprises an anionic surfactant that comprises from about 0.1 wt-% to about 20 wt-% of the composition (Sodium (C14-C16) olefin sulfonate at 7 wt%, page 12 Formulation F).
However, Mathonneau et al. does not teach a composition having the acid(s) in the range of the 10 wt% to 50 wt% for the purpose of a concentrated liquid suitable for dilution. For this reason, Hanson et al. is added.
Hanson et al. teaches a liquid concentrate antimicrobial composition comprising of acid(s) at 10-80 wt% (page 6, Table 1A First Exemplary Range) such as citric acid (Page 8, paragraph 78) or methane sulfonic acid (page 8, paragraph 77) in addition to anionic surfactants, water, and additional functional ingredients including nonionic surfactant (page 6, Table 1A First Exemplary Range).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to modify Formulation F of Mathonneau et al. by increasing the concentration of the acid(s) component in order to fall within the range disclosed by Hanson et al. because adjusting the acid concentration to achieve a concentrated liquid suitable for dilution would have been a routine optimization and predictable modification, and one would have recognized that increasing acid levels is a well understood parameter to modify in order to achieve a concentrated solution suitable for dilution. Moreover, Hanson et al. teaches one would have been motivated to make such a modification based on a practical need to create a concentrated antimicrobial composition that can be conveniently diluted prior to use since commercial solutions only exist as ready-to-use solutions. For the foregoing reasons, claim 7 is rendered obvious by the teachings of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.L./ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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