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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 07/09/2022 has been entered.
DETAILED ACTION
Claims 1-22 are pending in the Claim Set filed 07/09/2025.
Claims 1, 13, 15 and 22 have been amended.
The species election remains extended to include: N-isobutyl pyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butyl pyrrolidone (branched C4). Further, the elected species include: Water is the diluent (claims 1,4,15,17); Formic acid and salts thereof as the second antimicrobial agent (claims 1,6,15); Additional antimicrobial selected other than those in (ii): citric acid and salts thereof (claims 7-19,19); Anionic surfactant, e.g., alkyl sulfonic acids (claims 10,20); and salts thereof; Phenoxyethanol as antimicrobial solvent (claims 11,12,21); and, Nonionic surfactant for an ingredient species (claims 13,14,22).
Herein, claims 1-22 are for examination.
Rejection has been reformulated in view of the 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
Claims 1-6, 10, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Coruzzi et al (WO2002/050225, cited in IDS filed 6/11/2021) [Coruzzi] in view of Vandeputte et al (WO2013/107822, cited in IDS filed 6/11/2021) [Vandeputte], Kabra (US 20080095863, of record) [Kabra], and Reid (The Disinfectant Action of Certain Organic Acids, American Journal of Epidemiology, p.540, Sept, 1932, of record) [Reid]. Reformulated in view of the claim amendments
Claim Interpretation
Claim 1 has been amended to recite: ‘wherein the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant’
As an initial matter, it is important to note a recitation of an intended use, i.e., the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant, 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. Here, the prior art composition is capable of performing the intended use given the intended use does not impart any structural difference. Applicants’ have not demonstrated that the intended use: the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant, of the claimed composition would provide a structural difference between the instantly claimed composition and the cited prior art.
Regarding claims 1-6, 10, 13 and 14,
Coruzzi teaches aqueous (i.e., water) antimicrobial cleaning compositions which is designed in particular for the hygienic cleaning of surfaces, such as hard surfaces in the household, or in institutional or hospital environments, or the surface of the skin, or fabric surfaces or personal care applications. The composition comprises an antimicrobially active mixture of anionic surfactant, a carboxylic acid and a solvent that is a N-alkylpyrrolidone derivative, wherein the antimicrobial composition shows improved hygienic cleaning performance (Abstract; p.1, lns.1-10; p.2, lns.26-31; p.3, lns.4-10; pp.11-13; claim1-4; See entire document).
Coruzzi teaches the disinfecting properties of the formulations of Examples 1 to 4 were measured by evaluating their bactericidal activity according to the methodology described in European standard EN 1276. This specifies a test method and 15 requirements for the minimum bactericidal activity of a disinfecting composition. The formulations of Examples 1 to 4 pass this test at high soil with 5 minutes contact time, giving at least log 5 kill against the test bacterial strains P.aeruginosa, E.coli, S.aureus and Ent.hirae (pages 17-18). Especially, the term ‘disinfecting’ inherently includes antimicrobial efficacy. Disinfectants are antimicrobial agents provided (designed) to destroy or inactivate bacteria, fungi, and viruses on surfaces: thus, disinfectants are intended to have antimicrobial properties. Moreover, a chemical composition and its properties are inseparable, thus, it would necessarily follow that the compositions as taught by Coruzzi are antimicrobial composition that comprise a surface sanitizer, disinfectant or a sterilant.
Coruzzi teaches N-(n-alkyl) pyrrolidones where the n-alkyl group has 6 to 20 carbons (C6-20) (p.9). Coruzzi teaches the antimicrobial compositions provide the requisite level of bacterial kill for this type of application (p.3, lns.4-10). Coruzzi teaches compositions of the invention are aqueous compositions which preferably contain relatively low levels of actives. Typically, the principal ingredient is water, which is normally present at a level of at least 50%, preferably at least 80%, more preferably at least 90%, by weight based on total weight (i.e., water is diluent) (p.11, lns.20-28). Further, Coruzzi teaches the compositions comprise a surfactant from 1-10%, acid 2-6%, N-alkylpyrrolidones derivative from 0.2 to 4%, water 70% w/w (p.12).
Coruzzi teaches that a pH adjusting agent (typically sodium hydroxide) can be present to adjust the pH of the composition (p.11).
Coruzzi teaches anionic surfactants (i.e., salts of alkyl sulfuric acids) includes alkyl sulphates, alkyl sulphonates, alkyl aryl sulphonates, alkyl alkoxylated sulphates, or mixtures thereof (i.e., salts of alkyl sulfuric acids: anionic surfactant) (pp.5-8)
With regards to the composition being substantially free of peroxygen compounds, antibiotics and chloroacetamide, it is noted that Corruzi’s composition does not contain peroxygen, antibiotics or chloracetamide (See entire document) so that the absence of these ingredients in the composition meets the claims.
In addition, Coruzzi teaches carboxylic acids that are malic acid and salicylic acid from about 4% (pp.8-12) (organic acids are recited in claim 1). Coruzzi teaches the composition further comprises ingredients which aids in cleaning performance and maintain the physical and chemical stability of the product, for example, perfumes (i.e., fragrances), dyes, hygiene agents, foam-control agents, viscosity modifying agents (rheology modifier) and mixtures thereof (i.e., at least one ingredient selected from claims 13 and 14)
Coruzzi differs from the claims in that the document does not teach N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) (extended elected species of Formula 1) and that the N-alkylpyrrolidone derivative is an antimicrobial agent (i.e., first antimicrobial agent recited in claim 1). Coruzzi does not teach that the carboxylic acid is formic acid (elected species) as the second antimicrobial agent); or a nonionic surfactant (elected species recited in claims 13 and 14).
However, Vandeputte, Kabra and Reid, as a whole, cure the deficiencies.
Vandeputte teaches solvents such as N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) are used as an alternative for N-methyl-pyrrolidone and N-ethyl-pyrrolidone solvents due to lower toxicity, i.e., non-reprotoxic (Abstract, pp.2-4, 7; claims 1-6) (instant claims 1-3). Vandeputte teaches N-methylpyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP) are undesirable for use as cleaning applications due to toxicity of the compounds for use as cleaning applications, wherein NMP is known to cause reproductive toxicity (pp. 4-8; claim 6). Moreover, Vandeputte teaches N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) compounds are particularly favoured because they are high-boiling non-corrosive and polar compounds, and further because they are able to dissolve a wide variety of other compounds, and thus are very suitable as solvents. Vandeputte teaches that they are also miscible with a wide variety of other solvents including water, ethanol, diethyl ether, chloroform, benzene, ethyl acetate and carbon disulfide (p.6; p.9: chemical properties). Also, Vandeputte teaches that due to their high solvency power for plastics, resins, oils and greases, the pyrrolidones according to the invention may be used for various cleaning purposes, in particular industrial cleaning purposes, in particular in the textile industry for the removal of polymeric materials, dyes and other contaminants. These cleaning purposes include the use as an efficient stripping agent for a varnish, a paint and another finish based on a cellulosic, vinyl, acrylic and/or other resin. Such a solvent contributes to the penetration of the film and exerts a lifting action at the substrate interface. Other examples are the removal of carbon deposits and/or other combustion products from internals of combustion engines. Furthermore, next to industrial uses, the pyrrolidones are used for various household applications such as hard surface cleaners. Vandeputte teaches that these pyrrolidones may be an efficient solvent, a dissolution agent, a dilution agent, an extraction agent, an absorption agent and/or a dispersion agent, for polymerization reactions, as well as for coating, spinning, laminating, moulding, extruding and stripping processes and for carrying out chemical or pharmaceutical reactions and used in microelectronics and ink systems (pp.10-13). Thus, the teachings of Vandeputte signify the functional advantages of N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4).
Kabra teaches antimicrobial preserving compositions with the antimicrobial agent of N-octyl-pyrrolidone which is enough to provide an antimicrobial reduction of at least 90%, wherein N-octyl-2-pyrrolidone, (alkyl group C8) without any other preservative or preservative aid in an isotonic pH 7.5 formulation, provided sufficient preservation to comply with the European Pharmacopoeia 5.0 standards in addition to the United States Pharmacopoeia 24 standards, whereas N-dodecyl-2-pyrrolidone required a second anti-microbial agent to achieve such preservation standards ([0022]; [0064-65]). Further, Kabra teaches that the composition can comprise pH adjusting agents, chelating agents and anionic surfactant (Abstract; [001-0019]; [0041-44]; [0049]; [0051-65]; claims 1); See entire document). Kabra teaches N-alkyl-2-pyrrolidones are nonionic surfactants (nonionic surfactant for an ingredient (elected species). Moreover, Kabra teaches that as the carbon number of the N-alkyl group increases, the solubility of the N-alkylpyrrolidones in water substantially decreases. For example, the N-octyl-2-pyrrolidone is soluble in water up to 0.124% and the N-dodecyl-2-pyrrolidone is soluble up to 0.002% [0032]. Kabra teaches the concentration of an N-alkyl-2-pyrrolidine where the alkyl is 8-11 carbons in compositions for preservation is from about 0.0005 w/v % to about 1.0 w/v % [0033]. In addition, Kabra teaches the solubility of alkyl-2-pyrrolidones are enhanced by a surfactant, wherein a surfactant may be nonionic, anionic, cationic, amphoteric, or amphiphilic. Exemplary nonionic surfactants or co-solvents include tyloxapol, polyoxyethylene sorbitan esters, polyethoxylated castor oils, polyethoxylated hydrogenated castor oils such as HCO-40, poloxamers, polyoxyethylene/polyoxy propylene surfactants, polyoxyethylene lauryl ether, polyoxyethylene stearate, polyoxyethylene propylene glycol stearate, hydroxyalkylphosphonate, and a combination thereof [0050] (claims 1-3).
Thus, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the antimicrobial cleaning compositions as taught by Coruzzi by substituting the N-(n-alkyl) pyrrolidones (carbons: C6) with N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) in view of Vandeputte and Kapra, as a whole. One skilled in the art would have been motivated to do so because N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) comprise lower toxicity in comparison to N-methylpyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP), i.e., N-alkyl pyrrolidines with lower number of N-alkyl carbons (C2-C3) and would be expected to provide enhanced solubility properties in contrast to N-alkyl pyrrolidines with higher number of N-carbons (C8). Moreover, N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) differ from the antimicrobial N-alkylpyrrolidones agents as taught by Kapra by the same chemical group, e.g., by -CH2- groups, where compounds (homologs) differing regularly by the successive addition of the same chemical group are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); See MPEP 2144.08. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). Therefore, in instant case, the N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) as taught by Vandeputte would be expected to be antimicrobial agents having a reasonable expectation of success. Accordingly, the necessary motivation to make the claimed compound(s), and thus the prima facie case of obviousness, arises from the reasonable expectation that compounds similar in structure will have similar properties. In re Gyurik, 596 F.2d 1012, 1018 (CCPA 1979).
Reid teaches organic acids that are disinfectants having bactericidal and inhibitory action against a variety of organisms, wherein formic acid is the most toxic and is useful as a disinfectant, wherein formic acid is more efficient than hydrochloric acid and sulphuric acid in inhibiting the growth of plant pathogens and is useful important as an (pgs. 540; 541; 543; 546, Table 2). Thus, due to formic acids strong antibacterial activity it would be a second antimicrobial agent of choice such that one of ordinary skill in the art would have recognized the additional advantage of providing formic acid in a cleaning composition because of its strong antimicrobial property it would require decreased (lower) amounts in an antimicrobial composition to provide an effective inhibitory activity against a broad range of varied bacteria having a reasonable expectation of success.
Coruzzi teaches (supra) compositions comprising N-alkyl pyrrolidones derivatives from 0.2 to 4 wt%, of which encompasses the claimed amount of 0.25% of an antimicrobial agent and carboxylic acids from about 4% (pp.8-12) that also overlaps with the claimed amounts recited in claim 1. Thus, it would have been well within the purview of one of ordinary skill in art to optimize the amount of the N-alkyl pyrrolidones derivatives and carboxylic acid or a mixture thereof to provide an effective amount of N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) (i.e., first antimicrobial agent) and formic acid (i.e., second antimicrobial agent) in view of the guidance by the teachings of the cited prior art. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955) & MPEP 2144.05.
Thus, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the antimicrobial compositions as taught by Coruzz, Vandeputte, Kabra and Reid, as a whole, comprising a combination of compounds, wherein the combination of compounds comprise an effective amount of from about 0.25% wt. of an antimicrobial agent selected from N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) and an effective amount of from about 0.02 to about 60 % wt. of a second antimicrobial agent that is formic acid, and a diluent: water, wherein the antimicrobial composition is substantially free of peroxygen compounds, antibiotics, N-methyl pyrrolidone (NMP), N-ethyl pyrrolidone (NEP), and chloroacetamide, and wherein the antimicrobial composition is a surface sanitizer disinfectant or sterilant; and further comprising an effective amount of a pH adjusting agent: sodium hydroxide, anionic surfactants and salts thereof: alkyl sulphates, viscosity modifying agents (rheology modifier) and perfumes (i.e., fragrances), in view of the teachings of Coruzz, Vandeputte, Kabra and Reid, as a whole,
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill as evidenced by Coruzzi, Vandeputte, Kabra and Reid, as a whole.
Claims 7-9 under 35 U.S.C. 103 as being unpatentable over Coruzzi et al (WO2002/050225, cited in IDS filed 6/11/2021) [Coruzzi] in view of Vandeputte et al (WO2013/107822, cited in IDS filed 6/11/2021) [Vandeputte], Kabra (US 20080095863) [Kabra] and Reid (The Disinfectant Action of Certain Organic Acids, American Journal of Epidemiology, p.540, Sept, 1932) [Reid] as applied to claims 1-6, 10, 13 and 14 above and further in view of Brown-Skrobot et al (USP 4975217) [Brown-Skrobot].
The teachings of Coruzzi, Vandeputte, Kabra and Reid, as a whole, are described above (Reformulated in view of the claim amendments), herein called modified Coruzzi).
Modified Coruzzi differs from the claims in that the document does not teach an additional antimicrobial agent selected other than those in (ii): citric acid (elected species).
However, Brown-Skrobot cures the deficiency.
Brown-Skrobot teaches virucidal compositions wherein citric acid was found to be highly efficacious against common respiratory viruses such as rhinoviruses and when used in the presence of an anionic surfactant then citric acid was found to be effective also against rhinoviruses, parainfluenza virus, Herpes simplex, respiratory syncytial virus; and adenovirus in an exposure time of one minute (col.5, lns.42-67; col.7, lns.4-22; cols 23-24, Table I-II, claim 1,2 4-20). Brown-Skrobot teaches products utilizing such compositions, e.g., citric acid, are used as ingredients in kitchen and bathroom cleansers, furniture and floor polishes, and similar household preparations (col.1, lns.15-35; See entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the antimicrobial composition as taught by modified Coruzzi to further comprise an additional antimicrobial agent that is citric acid. One skilled in the art would have been motivated to do so because Brown-Skrobot teaches that citric acid is highly efficacious against common respiratory viruses that includes rhinoviruses, parainfluenza virus, Herpes simplex, respiratory syncytial virus and adenovirus. Thus, the additional antimicrobial agent: citric acid, would further enhance the disinfecting efficacy of the modified Coruzzi composition having a reasonable expectation of success. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by Coruzzi, Vandeputte, Kabra, Reid and Brown-Skrobot, as a whole.
Claims 11 and 12 under 35 U.S.C. 103 as being unpatentable over Coruzzi et al (WO2002/050225, cited in IDS filed 6/11/2021) [Coruzzi] in view of Vandeputte et al (WO2013/107822, cited in IDS filed 6/11/2021) [Vandeputte], Kabra (US 20080095863) [Kabra], and Reid (The Disinfectant Action of Certain Organic Acids, American Journal of Epidemiology, p.540, Sept, 1932) [Reid] as applied to claims 1-6, 10, 13 and 14 above and further in view of Omidbakhsh et al (USP 8865196) [Omidbakhsh] and Lowe et al (The antimicrobial activity of phenoxyethanol in vaccines; p.115 September 1994) [Lowe].
The teachings of Coruzzi, Vandeputte, Kabra and Reid, as a whole, are described above (Reformulated in view of the claim amendments), herein called modified Coruzzi).
Modified Coruzzi, differs from the claims in that the document does not teach an antimicrobial solvent that is phenoxyethanol (elected species).
However, Omidbakhsh and Lowe, as a whole, cure the deficiency.
Omidbakhsh teaches an antimicrobial solution comprising an antimicrobially active solvent, wherein the solvent is phenoxyethanol (Abstract; col.1, lns.60-67; col.2, lns.18). Omidbakhsh teaches that phenoxyethanol is available in liquid form in ready-to-use solutions (col.3, lns.11-30; See entire document). Omidbakhsh teaches intended applications comprise sanitizer, disinfectant, sterilant, sporicide and applicable public health requirements (col. 1).
Lowe teaches the activity of the antimicrobial preservative phenoxyethanol, wherein phenoxyethanol was shown to be effective in inactivating challenge doses of Gram-negative and Gram-positive micro-organisms, as well as a yeast. Lowe teaches use of phenoxyethanol in conjunction with antibiotics for the preservation of poliomyelitis (Abstract; p.115, left col.; See Results and discussion, p.116). Lowe teaches low toxicity of phenoxyethanol in children when phenoxyethanol is used as a solvent for intravenous penicillin with no reported adverse effects (left col. to right col.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the antimicrobial compositions as taught by modified Coruzzi to further comprise at least one antimicrobial solvent, wherein the antimicrobial solvent is phenoxyethanol. One skilled in the art would have been motivated to do so because phenoxyethanol is an effective antimicrobially solvent against Gram-negative and Gram-positive micro-organisms and has low toxicity properties as taught by Omidbakhsh and Lowe, as a whole. Moreover, one skilled din the art would have also recognized that phenoxyethanol is available in liquid form making it advantageously ready to be formulated as an antimicrobial solvent in the antimicrobial composition as taught by modified Coruzzi.
It would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by Coruzzi, Vandeputte, Kabra, Reid, Omidbakhsh and Lowe, as a whole.
Rejection has been reformulated in view of the 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
Claims 15-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Coruzzi et al (WO2002/050225, cited in IDS filed 6/11/2021) [Coruzzi] in view of Vandeputte et al (WO2013/107822, cited in IDS filed 6/11/2021) [Vandeputte], Kabra (US 20080095863, of record) [Kabra], Brown-Skrobot et al (USP 4975217, of record) [Brown-Skrobot] and Reid (The Disinfectant Action of Certain Organic Acids, American Journal of Epidemiology, p.540, Sept, 1932, of record) [Reid]. Reformulated in view of the claim amendments.
Claim Interpretation
Claim 1 has been amended to recite: ‘wherein the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant’
As an initial matter, it is important to note a recitation of an intended use, i.e., the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant, 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. Here, the prior art composition is capable of performing the intended use given the intended use does not impart any structural difference. Applicants’ have not demonstrated that the intended use: the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant, of the claimed composition would provide a structural difference between the instantly claimed composition and the cited prior art.
Regarding claims 1-6, 10, 13 and 14,
Coruzzi teaches aqueous (i.e., water) antimicrobial cleaning compositions which is designed in particular for the hygienic cleaning of surfaces, such as hard surfaces in the household, or in institutional or hospital environments, or the surface of the skin, or fabric surfaces or personal care applications. The composition comprises an antimicrobially active mixture of anionic surfactant, a carboxylic acid and a solvent that is a N-alkylpyrrolidone derivative, wherein the antimicrobial composition shows improved hygienic cleaning performance (Abstract; p.1, lns.1-10; p.2, lns.26-31; p.3, lns.4-10; pp.11-13; claim1-4; See entire document).
Coruzzi teaches the disinfecting properties of the formulations of Examples 1 to 4 were measured by evaluating their bactericidal activity according to the methodology described in European standard EN 1276. This specifies a test method and 15 requirements for the minimum bactericidal activity of a disinfecting composition. The formulations of Examples 1 to 4 pass this test at high soil with 5 minutes contact time, giving at least log 5 kill against the test bacterial strains P.aeruginosa, E.coli, S.aureus and Ent.hirae (pages 17-18). Especially, the term ‘disinfecting’ inherently includes antimicrobial efficacy. Disinfectants are antimicrobial agents provided (designed) to destroy or inactivate bacteria, fungi, and viruses on surfaces: thus, disinfectants are intended to have antimicrobial properties. Moreover, a chemical composition and its properties are inseparable, thus, it would necessarily follow that the compositions as taught by Coruzzi are antimicrobial composition that comprise a surface sanitizer, disinfectant or a sterilant.
Coruzzi teaches N-(n-alkyl) pyrrolidones where the n-alkyl group has 6 to 20 carbons (C6-20) (p.9). Coruzzi teaches the antimicrobial compositions provide the requisite level of bacterial kill for this type of application (p.3, lns.4-10). Coruzzi teaches compositions of the invention are aqueous compositions which preferably contain relatively low levels of actives. Typically, the principal ingredient is water, which is normally present at a level of at least 50%, preferably at least 80%, more preferably at least 90%, by weight based on total weight (i.e., water is diluent) (p.11, lns.20-28). Further, Coruzzi teaches the compositions comprise a surfactant from 1-10%, acid 2-6%, N-alkylpyrrolidones derivative from 0.2 to 4%, water 70% w/w (p.12).
Coruzzi teaches that a pH adjusting agent (typically sodium hydroxide) can be present to adjust the pH of the composition (p.11).
Coruzzi teaches anionic surfactants (i.e., salts of alkyl sulfuric acids) includes alkyl sulphates, alkyl sulphonates, alkyl aryl sulphonates, alkyl alkoxylated sulphates, or mixtures thereof (i.e., salts of alkyl sulfuric acids: anionic surfactant) (pp.5-8)
With regards to the composition being substantially free of peroxygen compounds, antibiotics and chloroacetamide, it is noted that Corruzi’s composition does not contain peroxygen, antibiotics or chloracetamide (See entire document) so that the absence of these ingredients in the composition meets the claims.
In addition, Coruzzi teaches carboxylic acids that are malic acid and salicylic acid from about 4% (pp.8-12) (organic acids are recited in claim 1). Coruzzi teaches the composition further comprises ingredients which aids in cleaning performance and maintain the physical and chemical stability of the product, for example, perfumes (i.e., fragrances), dyes, hygiene agents, foam-control agents, viscosity modifying agents (rheology modifier) and mixtures thereof (i.e., at least one ingredient recited in claim 22).
Coruzzi differs from the claims in that the document does not teach N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) (extended elected species of Formula 1) and that the N-alkylpyrrolidone derivative is an antimicrobial agent. Coruzzi does not teach citric acid (elected species), formic acid (elected species; or a nonionic surfactant (elected species recited in claim 22).
However, Vandeputte, Kabra, Brown-Skrobot and Reid, as a whole, cure the deficiencies.
Vandeputte teaches solvents such as N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) are used as an alternative for N-methyl-pyrrolidone and N-ethyl-pyrrolidone solvents due to lower toxicity, i.e., non-reprotoxic (Abstract, pp.2-4, 7; claims 1-6) (instant claims 1-3). Vandeputte teaches N-methylpyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP) are undesirable for use as cleaning applications due to toxicity of the compounds for use as cleaning applications, wherein NMP is known to cause reproductive toxicity (pp. 4-8; claim 6). Moreover, Vandeputte teaches N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) compounds are particularly favoured because they are high-boiling non-corrosive and polar compounds, and further because they are able to dissolve a wide variety of other compounds, and thus are very suitable as solvents. Vandeputte teaches that they are also miscible with a wide variety of other solvents including water, ethanol, diethyl ether, chloroform, benzene, ethyl acetate and carbon disulfide (p.6; p.9: chemical properties). Also, Vandeputte teaches that due to their high solvency power for plastics, resins, oils and greases, the pyrrolidones according to the invention may be used for various cleaning purposes, in particular industrial cleaning purposes, in particular in the textile industry for the removal of polymeric materials, dyes and other contaminants. These cleaning purposes include the use as an efficient stripping agent for a varnish, a paint and another finish based on a cellulosic, vinyl, acrylic and/or other resin. Such a solvent contributes to the penetration of the film and exerts a lifting action at the substrate interface. Other examples are the removal of carbon deposits and/or other combustion products from internals of combustion engines. Furthermore, next to industrial uses, the pyrrolidones are used for various household applications such as hard surface cleaners. Vandeputte teaches that these pyrrolidones may be an efficient solvent, a dissolution agent, a dilution agent, an extraction agent, an absorption agent and/or a dispersion agent, for polymerization reactions, as well as for coating, spinning, laminating, moulding, extruding and stripping processes and for carrying out chemical or pharmaceutical reactions and used in microelectronics and ink systems (pp.10-13). Thus, the teachings of Vandeputte signify the functional advantages of N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4).
Kabra teaches antimicrobial preserving compositions with the antimicrobial agent of N-octyl-pyrrolidone which is enough to provide an antimicrobial reduction of at least 90%, wherein N-octyl-2-pyrrolidone, (alkyl group C8) without any other preservative or preservative aid in an isotonic pH 7.5 formulation, provided sufficient preservation to comply with the European Pharmacopoeia 5.0 standards in addition to the United States Pharmacopoeia 24 standards, whereas N-dodecyl-2-pyrrolidone required a second anti-microbial agent to achieve such preservation standards ([0022]; [0064-65]). Further, Kabra teaches that the composition can comprise pH adjusting agents, chelating agents and anionic surfactant (Abstract; [001-0019]; [0041-44]; [0049]; [0051-65]; claims 1); See entire document). Kabra teaches N-alkyl-2-pyrrolidones are nonionic surfactants (nonionic surfactant for an ingredient (elected species). Moreover, Kabra teaches that as the carbon number of the N-alkyl group increases, the solubility of the N-alkylpyrrolidones in water substantially decreases. For example, the N-octyl-2-pyrrolidone is soluble in water up to 0.124% and the N-dodecyl-2-pyrrolidone is soluble up to 0.002% [0032]. Kabra teaches the concentration of an N-alkyl-2-pyrrolidine where the alkyl is 8-11 carbons in compositions for preservation is from about 0.0005 w/v % to about 1.0 w/v % [0033]. In addition, Kabra teaches the solubility of alkyl-2-pyrrolidones are enhanced by a surfactant, wherein a surfactant may be nonionic, anionic, cationic, amphoteric, or amphiphilic. Exemplary nonionic surfactants or co-solvents include tyloxapol, polyoxyethylene sorbitan esters, polyethoxylated castor oils, polyethoxylated hydrogenated castor oils such as HCO-40, poloxamers, polyoxyethylene/polyoxy propylene surfactants, polyoxyethylene lauryl ether, polyoxyethylene stearate, polyoxyethylene propylene glycol stearate, hydroxyalkylphosphonate, and a combination thereof [0050] (claims 1-3).
Thus, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the antimicrobial compositions as taught by Coruzzi by substituting the N-(n-alkyl) pyrrolidones (carbons: C4) with N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) in view of Vandeputte and Kapra, as whole. One skilled in the art would have been motivated to do so because N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) comprise lower toxicity in comparison to N-methylpyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP), i.e., N-alkyl pyrrolidines with lower number of N-alkyl carbons (C2-C3) and would be expected to provide enhanced solubility properties in contrast to N-alkyl pyrrolidines with higher number of N-carbons (C8). Moreover, N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) differ from the antimicrobial N-alkylpyrrolidones agents as taught by Kapra by the same chemical group, e.g., by -CH2- groups, where compounds (homologs) differing regularly by the successive addition of the same chemical group are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); See MPEP 2144.08. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). Therefore, in instant case, the N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) as taught by Vandeputte would be expected to be antimicrobial agents having a reasonable expectation of success. Accordingly, the necessary motivation to make the claimed compound(s), and thus the prima facie case of obviousness, arises from the reasonable expectation that compounds similar in structure will have similar properties. In re Gyurik, 596 F.2d 1012, 1018 (CCPA 1979).
Brown-Skrobot teaches virucidal compositions wherein citric acid was found to be highly efficacious against common respiratory viruses such as rhinoviruses and when used in the presence of an anionic surfactant then citric acid was found to be effective also against rhinoviruses, parainfluenza virus, Herpes simplex, respiratory syncytial virus; and adenovirus in an exposure time of one minute (col.5, lns.42-67; col.7, lns.4-22; cols 23-24, Table I-II, claim 1,2 4-20). Brown-Skrobot teaches products utilizing such compositions, e.g., citric acid, are used as ingredients in kitchen and bathroom cleansers, furniture and floor polishes, and similar household preparations (col.1, lns.15-35; See entire document). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the antimicrobial composition as taught by modified Coruzzi to further comprise an additional antimicrobial agent that is citric acid. One skilled in the art would have been motivated to do so because Brown-Skrobot teaches that citric acid is highly efficacious against common respiratory viruses that includes rhinoviruses, parainfluenza virus, Herpes simplex, respiratory syncytial virus and adenovirus. Thus, the additional antimicrobial agent: citric acid, would further enhance the disinfecting efficacy of the modified Coruzzi composition having a reasonable expectation of success.
Reid teaches organic acids that are disinfectants having bactericidal and inhibitory action against a variety of organisms, wherein formic acid is the most toxic and is useful as a disinfectant, wherein formic acid is more efficient than hydrochloric acid and sulphuric acid in inhibiting the growth of plant pathogens and is useful important as an (pgs. 540; 541; 543; 546, Table 2). Thus, due to formic acids strong antibacterial activity it would be a second antimicrobial agent of choice such that one of ordinary skill in the art would have recognized the additional advantage of providing formic acid in a cleaning composition because of its strong antimicrobial property it would require decreased (lower) amounts in an antimicrobial composition to provide an effective inhibitory activity against a broad range of varied bacteria having a reasonable expectation of success.
Coruzzi teaches (supra) compositions comprising N-alkyl pyrrolidones derivatives from 0.2 to 4 wt%, of which encompasses the claimed amount of 0.25% of an antimicrobial agent and carboxylic acids from about 4% (pp.8-12) that also overlaps with the claimed amounts recited in claim 15. Thus, it would have been well within the purview of one of ordinary skill in art to optimize the amount of the N-alkyl pyrrolidones derivatives and carboxylic acid or a mixture thereof to provide an effective amount of N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4), an effective amount of citric acid, formic acid and salicyclic acid and optionally maleic acid in view of the guidance provided by the teachings of the cited prior art. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955) & MPEP 2144.05.
Thus, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the antimicrobial compositions as taught by Coruzzi, Vandeputte, Kabra, Brown-Skrobot and Reid, as a whole, (herein called modified Coruzzi) comprising a combination of compounds, wherein the combination of compounds comprise an effective amount of from about 0.25% wt. of an antimicrobial agent selected from N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) and an effective amount of from about 0.02 to about 60 % wt. of a citric formic acid, citric acid and salicylic acid, and a diluent: water, wherein the antimicrobial composition is substantially free of peroxygen compounds, antibiotics, N-methyl pyrrolidone (NMP), N-ethyl pyrrolidone (NEP), and chloroacetamide, and wherein the antimicrobial composition is a surface sanitizer disinfectant or sterilant; and further comprising an effective amount of a pH adjusting agent: sodium hydroxide, anionic surfactants and salts thereof: alkyl sulphates, viscosity modifying agents (rheology modifier) and perfumes (i.e., fragrances), in view of the teachings of Coruzzi, Vandeputte, Kabra, Brown-Skrobot and Reid, as a whole.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill as evidenced by Coruzzi, Vandeputte, Kabra, Brown-Skrobot and Reid, as a whole.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Coruzzi et al (WO2002/050225, cited in IDS filed 6/11/2021) [Coruzzi] in view of Vandeputte et al (WO2013/107822, cited in IDS filed 6/11/2021) [Vandeputte], Kabra (US 20080095863, of record) [Kabra], Brown-Skrobot et al (USP 4975217, of record) [Brown-Skrobot] and Reid (The Disinfectant Action of Certain Organic Acids, American Journal of Epidemiology, p.540, Sept, 1932, of record) [Reid] as applied to claims 15-20 and 22 above and further in view of Omidbakhsh et al (USP 8865196) [Omidbakhsh] and Lowe et al (The antimicrobial activity of phenoxyethanol in vaccines; p.115 September 1994) [Lowe]. Reformulated in view of the claim amendments.
The teachings of Coruzzi, Vandeputte, Kabra, Brown-Skrobot, and Reid, as a whole, are described above (reformulated in view of the claim amendments), herein called modified Coruzzi).
Modified Coruzzi, differs from the claims in that the document does not teach an antimicrobial solvent that is phenoxyethanol (elected species).
However, Omidbakhsh and Lowe, as a whole, cure the deficiency.
Omidbakhsh teaches an antimicrobial solution comprising an antimicrobially active solvent, wherein the solvent is phenoxyethanol (Abstract; col.1, lns.60-67; col.2, lns.18). Omidbakhsh teaches that phenoxyethanol is available in liquid form in ready-to-use solutions (col.3, lns.11-30; See entire document). Omidbakhsh teaches intended applications comprise sanitizer, disinfectant, sterilant, sporicide and applicable public health requirements (col. 1).
Lowe teaches the activity of the antimicrobial preservative phenoxyethanol, wherein phenoxyethanol was shown to be effective in inactivating challenge doses of Gram-negative and Gram-positive micro-organisms, as well as a yeast. Lowe teaches use of phenoxyethanol in conjunction with antibiotics for the preservation of poliomyelitis (Abstract; p.115, left col.; See Results and discussion, p.116). Lowe teaches low toxicity of phenoxyethanol in children when phenoxyethanol is used as a solvent for intravenous penicillin with no reported adverse effects (left col. to right col.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the antimicrobial compositions as taught by modified Coruzzi to further comprise at least one antimicrobial solvent, wherein the antimicrobial solvent is phenoxyethanol. One skilled in the art would have been motivated to do so because phenoxyethanol is an effective antimicrobially solvent against Gram-negative and Gram-positive micro-organisms and has low toxicity properties as taught by Omidbakhsh and Lowe, as a whole. Moreover, one skilled din the art would have also recognized that phenoxyethanol is available in liquid form making it advantageously ready to be formulated as an antimicrobial solvent in the antimicrobial composition as taught by modified Coruzzi.
It would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by Coruzzi, Vandeputte, Kabra, Brown-Skrobot, Reid, Omidbakhsh and Lowe, as a whole.
Response to Arguments
Applicants argue that the prior art cited against either claim 1 or claim 15, as amended, does not teach or suggest an antimicrobial composition as instantly claimed. Applicants argue that the inventor has discovered that component (i) of claims 1 and 15 has antimicrobial properties on its own which is not taught by any of the prior art, whether taken alone or in any combination. As such, a prima facie case of obviousness is not established against claims 1 and 15, as amended. Applicants argue that patentability of the pending claims is further substantiated by the fact that the combination of components (i) and (ii) provide even more of an antimicrobial effect than the individual components themselves, as evidenced by test results presented in the specification. The prior art cited to support the rejections of claims 1 and 15 do not teach or suggest the effect produced by the combination of components (i) and (ii) of claims 1 and 15 and this failure weighs in favor of the patentability of these claims. In Addition, Applicants argue that Corruzzi excludes N-(n-alkyl) pyrrolidones where the alkyl group has fewer than 6 carbon atoms. Coruzzi does not teach, suggest or disclose pyrrolidone derivatives used in the invention or in the prior art as having any antimicrobial efficacy. Coruzzi merely teaches that its compositions, as a whole, are effective at both cleaning and disinfecting. Applicants argue that Vandeputte is primarily concerned with finding safer replacements for NMP but teaches that the same replacement solvents can also be used to replace NEP, DMF, and DMAc which may also give rise to negative health effects. Applicants argue that Kabra does not teach surface sanitizer, disinfectant, or sterilant compositions, where Kabra uses 2-pyrrolidone derivatives in topically acceptable ophthalmic, otic, and nasal formulations. Kabra discloses that pyrrolidone derivatives according to its invention includes N-hexyl 2-pyrrolidone in paragraph [0024]; however, this compound is not tested. Only N-octyl-2-pyrrolidone and N-dodecyl-2-pyrrolidone are tested which suggests that it would be undesirable to replace with tested compounds with any short variants, e.g., the compounds of Formula 1 of instant claim 1. Furthermore, Applicants argue that Reid, when read as a whole, teaches the skilled reader that the POSITA cannot expect that a compound which functions as a good preservative would function as a good bactericide. Furthermore, wide differences exist in relation to the antimicrobial efficacy of homologs. Also, the POSITA would expect that formic acid (elected species) would have weaker bactericidal action than the other monobasic acids (acetic, proprionic, butyric and valeric acids).
Applicants’ arguments directed Phaechamud are moot because the teachings of Phaechamu are not provided in the above rejections.
Applicant’s arguments have been fully considered but they are not persuasive, because it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the antimicrobial cleaning compositions as taught by Coruzzi by substituting the N-(n-alkyl) pyrrolidones (carbons: C6) with N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) in view of Vandeputte and Kapra, as a whole. One skilled in the art would have been motivated to do so because N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) comprise lower toxicity in comparison to N-methylpyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP), i.e., N-alkyl pyrrolidines with lower number of N-alkyl carbons, and would be expected to provide enhanced solubility properties in contrast to N-alkyl pyrrolidines with higher number of N-carbons (C8). Moreover, N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) differ from the antimicrobial N-alkylpyrrolidones agents as taught by Kapra by the same chemical group, e.g., by -CH2- groups, where compounds (homologs) differing regularly by the successive addition of the same chemical group are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); See MPEP 2144.08. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). Moreover, Reid teaches organic acids that are disinfectants having bactericidal and inhibitory action against a variety of organisms, wherein formic acid is the most toxic and is useful as a disinfectant, wherein formic acid is more efficient than hydrochloric acid and sulphuric acid in inhibiting the growth of plant pathogens and is useful important as an (pgs. 540; 541; 543; 546, Table 2). Thus, due to formic acids strong antibacterial activity it would most likely be a second antimicrobial agent of choice. Moreover, the prima facie obvious antimicrobial composition as taught by cited prior art would be structurally and chemically indistinguishable from the claimed antimicrobial composition, so that it would necessarily follow that the composition as taught by the cited prior art would be a composition having antimicrobial properties, wherein this property would be the natural result of the combination of the prior art elements, wherein when the limitation at issue is the 'natural result' of the combination of prior art elements." PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (quoting In re Oelrich, 666 F.2d 578,581 (CCPA 1981)).
Regarding Applicants’ arguments that the combination of components (i) and (ii) provide even more of an antimicrobial effect than the individual components themselves, as evidenced by test results presented in the specification. However, the results in Tables 5, 6, 7 and 8 show that there is no synergy between 0.1 wt.% N-butyl-gamma-butyrolactam with the carboxylic acids (compounds listed in i. through p., see page 167) See Specification para. [0168], whereas, the results in Tables 5, 6 and 7 show that N-butyl-gamma-butyrolactam at 0.5 wt.% (solution X3) acts synergistically with the tested carboxylic acids (See Specification pp.35-37). However, there is no test results and/or evidence that unequivocally demonstrates that about 0.25% wt, N-butyl-gamma-butyrolactam (about 0.25 wt% as claimed) provide a synergistic effect with the carboxylic acids (e.g., compounds with listed in i. through p., see page 167). Notably, Table 5 [00162] shows Test Results of 0.25% wt. N-butyl-gamma-butyrolactam provided log Base Ten Reduction of Staph aureus <0.19 (TNTC: means too numerous to count). Especially noted, the Test Results (Tables 5-8) are directed exclusively to the combination of N-butyl-gamma-butyrolactam with the corresponding carboxylic acids (e.g., compounds with listed in i. through p., see page 167), whereas the entire scope of instant claim 1 encompasses all the compounds of claim 1 consisting of at least one compound according to Formula 1, wherein R1 is a branched or unbranched, saturated or unsaturated, unsubstituted C3 to C5 alkyl chain or a C3 alkyl chain substituted with a methoxy group. Additionally, all of the Test Results described in Tables 5-8 are directed to log Base Ten Reduction of Staph aureus, at five 5 minutes and/or 10 minutes contact time, whereas instant claims are absence a limitation directed to an enhance antimicrobial property of the combination of the compounds based on the log Base Ten Reduction of Staph aureus at five 5 minutes and/or 10 minutes. Applicants must further show that the results over the entire claimed range were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The Nutrasweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) See MPEP 716.02(d). Thus, the results must be over the entire claimed range (i.e., not merely closely aligned). That is, the Test Results showing synergy between N-butyl-gamma-butyrolactam and with the corresponding carboxylic acids (e.g., compounds with listed in i. through p.: page 167) that generated said alleged unexpected results are not commensurate in scope with antimicrobial composition comprising an antimicrobial agent of claim 1 consisting of at least one compound according to Formula 1, wherein R1 is a branched or unbranched, saturated or unsaturated, unsubstituted C3 to C5 alkyl chain or a C3 alkyl chain substituted with a methoxy group, as claimed in Claim Set filed 7/9/2025). Therefore, it is the Office’s position that the scope of the showing that the combination of components (i) and (ii) provide even more of an antimicrobial effect than the individual components themselves, as evidenced by test results presented in the specification, is not commensurate with the scope of the subject matter of claims 1-22.
Particularly noteworthy, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Applicant is reminded that obviousness does not require absolute predictability. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Applicant's attention is directed to MPEP 2112.01 II, which discloses products of identical chemical composition cannot have mutually exclusive properties, so the skilled artisan would expect that its functionality would remain consistent. Notably, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).
The issue is whether one of ordinary skill in the art would been motivated to modify the teaching of Coruzzi in according with the teachings of additional cited prior art references to provide an antimicrobial composition wherein the antimicrobial composition is a surface sanitizer, disinfectant. or sterilant.
Kabra teaches antimicrobial preserving compositions with the antimicrobial agent of N-octyl-pyrrolidone which is enough to provide an antimicrobial reduction of at least 90%, wherein N-octyl-2-pyrrolidone, (alkyl group C8) provided sufficient preservation to comply with the European Pharmacopoeia 5.0 standards in addition to the United States Pharmacopoeia 24 standards, however, Kabra teaches that as the carbon number of the N-alkyl group increases, the solubility of the N-alkylpyrrolidones in water substantially decreases. Instantly Claimed composition requires the presence of water. On the other hand, Vandeputte teaches solvents such as N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) are used as an alternative for N-methyl-pyrrolidone and N-ethyl-pyrrolidone solvents due to lower toxicity and that Nmethylpyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP) (i.e., C2-N-alkylpyrrolidones) are undesirable for use as cleaning applications due to toxicity of the compounds for use as cleaning applications. Moreover, N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-tbutylpyrrolidone (branched C4) differ from the antimicrobial N-alkylpyrrolidones agents as taught by Kapra by the same chemical group, e.g., by -CH2- groups, where compounds (homologs) differing regularly by the successive addition of the same chemical group are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); See MPEP 2144.08. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). In addition, Moreover, Vandeputte teaches N-isobutylpyrrolidone (branched C4), N-(methoxy propyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) compounds are particularly favoured because they are high-boiling non-corrosive and polar compounds, and further because they are able to dissolve a wide variety of other compounds, and thus are very suitable as solvents and especially, they are also miscible with a wide variety of other solvents including water (claimed limitation). Also, Vandeputte teaches that due to their high solvency power for plastics, resins, oils and greases, make the pyrrolidones especially useful in particular in the textile industry for the removal of polymeric materials, dyes and other contaminants. Thus, it would have been obvious to modify Coruzzi in view of the teachings of the prior art references. Accordingly, the necessary motivation to make the claimed compound(s), and thus the prima facie case of obviousness, arises from the reasonable expectation that compounds similar in structure will have similar properties. In re Gyurik, 596 F.2d 1012, 1018 (CCPA 1979). Therefore, in instant case, the N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) as taught by Vandeputte would be highly anticipated antimicrobial agents in view of Kapra, wherein it would necessarily follow that that N-isobutylpyrrolidone (branched C4), N-(methoxypropyl) pyrrolidone (C3 alkyl chain substituted with a methoxy group) and N-t-butylpyrrolidone (branched C4) compounds would have antimicrobial properties for varied applications comprising a surface sanitizer, disinfectant. or sterilant.
Conclusions
No claim is allowed.
Contact Information
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619