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 .
Status of the Claims
The listing of claims filed 26 April 2024 has been examined.
Claims 1-12 are pending.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 26 April 2024 is acknowledged and has been considered. Any lined-through references have not been considered and must be submitted or resubmitted in proper format for consideration. Specifically, the NPL document (“International Search Report and Written Opinion filed in PCT/ES2022/070713 filed on 2023/01/2023; 11 pgs.”) is entirely in Spanish, lacking any English translation or concise explanation of its relevance (see CFR 1.56(c)).
Priority
The instant application was received 26 April 2024; it is a national stage application of PCT/ES2022/070713, filed 04 November 2022, and claims foreign priority to ESP202131039, filed 05 November 2021. Acknowledgment is made of Applicant’s claim for foreign priority and certified copies of the priority documents have been received.
Claim Objections
Claims 1-6 are objected to because of the following informalities:
Claim 1 should begin with “A composition…” and claims 2-6 should begin with “The composition…” to improve clarity.
Appropriate correction is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 7-10 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because claims 7-10 and 12 recite “use” of a product. Specifically, a “use” as recited does not define a proper process because it lacks active steps. See MPEP 2173.05(q).
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 5, 7-10, and 12 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 5 recites the limitation "the concentration." There is insufficient antecedent basis for this limitation in the claim, which renders it unclear whether “the concentration” refers to the claimed compound’s concentration or some other newly introduced concentration. Examiner suggests amending to, “…the claimed compounds are in a concentration from 0.1% to 0.3% w/w,” or similar. Examiner interprets “the concentration” as referring to the claimed compound’s concentration.
Claims 7-10 and 12 recite “use” of a product and are indefinite because they recite use of a product without setting forth any active steps defining how the application is practiced, leaving the metes and bounds of the claim unclear. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kardash (RU2750598C1).
Regarding claims 1-2, Kardash teaches a 100 g disinfectant composition comprising 0.6 g undecylenamidopropyltrimonium methosulfate (Tetranil U), 0.375g polyethylene glycol E-200, and 4.0 g isopropyl alcohol in 92.755 g deionized water (Example 11, ¶ [0113]). Instantly claimed compound i) 3-(undec-10-enamido)-N,N,N-trimethyl-propan-1-aminium methyl sulfate is also called undecylenamidopropyltrimonium methosulfate:
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Figure 1. Structure of undecylenamidopropyltrimonium methosulfate, as drawn by JChem.
Thus, the disinfectant composition disclosed by Kardash contains 0.6% w/w undecylenamidopropyltrimonium methosulfate in deionized water which lies within the amounts of claim 2.
Regarding claims 4 and 9-10, Kardash teaches the disclosed disinfectants and antiseptic agents have virucidal activity against various viruses, including Coxsackie, ECHO, poliomyelitis, enteral and parenteral hepatitis, rotaviruses, noroviruses, HIV, influenza, including H5N1, HINI, and other pathogens of acute respiratory viral infections, adenoviruses, coronaviruses, herpes, cytomegalovirus, and others (¶ [0022]; ¶ [0083]).A skilled artisan would recognize lipid enveloped viruses includes viruses like HIV and herpes, whereas non-lipid enveloped viruses includes viruses like adenovirus and norovirus.
Regarding claim 11, Kardash discloses a disinfection time of 1-3 minutes (¶ [0145]; ¶ [0149]) and 5 minutes ((¶ [0146]) on test objects using the composition disclosed in Example No. 11 (¶ [0113]).
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.
Claims 1-5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kardash (RU2750598C1) in view of Lisowsky (WO2010078883A2).
Regarding Claims 3 and 5, Kardash teaches all of the claimed elements as stated above. Furthermore, Kardash discloses a 100 g antiseptic composition containing 62.0 g isopropyl alcohol (Example 10, ¶ [0111]; Example 13, ¶ [0117]) and a 100 g antiseptic agent composition containing 64.0 g ethyl alcohol (Example 14, ¶ [0119]).
Kardash does not explicitly teach a composition containing ethanol.
Lisowsky teaches disinfectants and decontamination agents which can kill microorganisms, which includes viruses (¶ [0001-0003]). The antimicrobial agent included in the disinfectant composition may be a quaternary ammonium compound, such as undecylenamidopropyltrimonium methosulfate, and used in a concentration of 0.01-25 wt.% (¶ [0020]). Additionally, Lisowsky indicates alcoholic agents used as antimicrobial agents may be included, with monohydric alcohols like ethanol being preferred in a concentration of 1-90% by weight (¶ [0016]). Lisowsky discloses dihydric and polyhydric alcohols, like propylene glycol and polyethylene glycol, may be included at a concentration of 0.01-20 wt.% (¶ [0017]).
Lisowsky does not explicitly teach an exemplary composition containing an instantly claimed compound, instead suggesting undecylenamidopropyltrimonium methosulfate is an antimicrobial agent that may be included in disinfectant compositions (¶ [0020]).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Kardash would have found it prima facie obvious to prepare a virucidal composition containing 0.01-5% w/w of an aminium methyl sulfate in a 70% ethanol solution based on the teachings of Lisowsky. Kardash discloses an exemplary disinfectant composition containing 0.6% w/w 3-(undec-10-enamido)-N,N,N-trimethyl-propan-1-aminium methyl sulfate. Lisowsky suggests disinfectant compositions may contain 0.01-25 wt.% undecylenamidopropyltrimonium methosulfate, 1-90 wt.% ethanol, and 0.01-20 wt.% propylene glycol. Thus, a PHOSITA could have optimized the amounts suggested by Lisowsky in order to produce a composition having the desired antimicrobial effect (MPEP 2144.05(II)(A)).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kardash (RU2750598C1) in view of Evans (WO2018033718A1; IDS dated 26 April 2024, Cite No. 2).
Regarding claim 6, Kardash teaches all of the claimed elements as stated above.
Kardash does not explicitly suggest packaging aminium methyl sulfate-containing compositions in a pressurized aerosol-generating container.
Evans teaches anti-microbial compositions containing undecylenamidopropyltrimonium methosulfate (Claim 3). Evans indicates the disclosed anti-microbial compositions are suitable for multiple formulations, including liquids, sprays, and wipes to be used in body or skin sanitization, like hand sanitizers (p. 17, Lines 7-11). Additionally, Evans presents exemplary compositions containing undecylenamidopropyltrimonium methosulfate, referred to as Rewocid UTM 185 (REW) (p. 23, Lines 34-36; p. 28, Table 1).
Evans does not explicitly teach an exemplary spray formulation containing an instantly claimed compound.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Kardash would have found it prima facie obvious to place the claimed composition inside a pressurized aerosol-generating container based on the teachings of Evans because Evans suggests such compositions are appropriate for spray formulations.
Regarding claims 7-8, Kardash in view of Evans teaches all of the claimed elements as stated above. Furthermore, Kardash indicates the disclosed compositions can be applied to the skin (¶ [0044-0045]) and are efficient skin antiseptics (¶ [0148]). Kardash suggests the disinfectants suitable for use in hospitals, such as for application to the hands of surgeons, nurses, and/or midwives, for disinfecting gloves, and for disinfecting surgical or injection sites, like the elbow folds of blood donors (¶ [0155]).
Additionally, Evans discloses the compositions may be used as hygienic cleansers in pet products that can be applied either to the animal’s fur or directly to the skin in order to kill potentially detrimental microorganisms (p. 18, Lines 6-17). Evans indicates the invention can also be used in plant sprays to eliminate insect pests like aphides (p. 19, Lines 5-6). Furthermore, Evans indicates such compositions also have utility in sanitizing wounds, sterilizing catheters, preventing infection, and surface cleaners such as for bathrooms or kitchens (p. 18, Lines 19-37).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Kardash would have found it prima facie obvious to use the claimed compositions on viruses pathogenic to any animal, including non-human mammalian animals, as well as plants based on the teachings of Evans. Both Kardash and Evans indicate the composition may be applied topically to the skin or hands. Furthermore, Evans suggests such compounds also have utility in pet and/or plant care products for removing unwanted pests. Thus, a PHOSITA would have been motivated to use the claimed compounds to kill viruses pathogenic to humans or other animals as well as plants and a skilled artisan would understand some viruses, like adenovirus, can impact humans as well as other animals, like dogs.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kardash (RU2750598C1) in view of Evans (WO2018033718A1; IDS dated 26 April 2024, Cite No. 2) and Gode (WO2021078685A1).
Regarding claim 12, Kardash in view of Evans teaches all of the claimed elements as stated above.
The combination of Kardash and Evans does not explicitly disclose “other routes” of medical and veterinary use besides topical administration and the disinfection of surfaces.
Gode teaches oral care compositions which contain an antimicrobial quaternary ammonium compound, such as undecylenamidopropyltrimonium methosulphate (Claims 1 and 11). The oral care composition may be a toothpaste, toothpowder, liquid, gel, serum, orally dissolvable film, tablet, or gum (p. 4, Lines 25-29).
Gode does not explicitly teach using the disclosed compositions in veterinary medicine.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Kardash would have found it prima facie obvious to use the claimed compounds in medicine and veterinary medicine by topical or other routes based on the teachings of Evans and Gode. Under its broadest reasonable interpretation, the term “other routes of medical and veterinary use” used in claim 12 could include dental use. A skilled artisan would understand compositions suitable for use on humans could also maintain their antimicrobial activity on other animals. Thus, a PHOSITA would have been motivated to administer undecylenamidopropyltrimonium methosulphate topically, because Kardash and Evans both indicate doing so can confer therapeutic benefit, as well as by other routes, because Gode indicates such quaternary ammonium compounds are beneficial in oral care compositions for reducing teeth sensitivity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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