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 . Claims included in prosecution are claims 1-12 and 14-24.
Previous Rejections
Applicants' arguments in the Request for Continued Examination, filed Aug. 8, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112 (New)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1. Claims 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites “and the composition defines a nonporous surface disinfectant composition”.
The instant specification teaches a hydrogen peroxide disinfectant composition that may be used for disinfecting surfaces, which may include hydrogen peroxide, an organic solvent (e.g. benzyl alcohol), at least one fatty acid having 6 to 9 carbon atoms or an aromatic carboxylic acid, at least two surfactants with the first surfactant being an amphoteric surfactant and the second surfactant being a nonionic surfactant, and an acidic pH adjuster.
However, the instant specification does not offer sufficient description of the common structural elements or identifying characteristics that constitute the composition defining a nonporous surface disinfectant composition. There is no description of structural elements of a nonporous surface disinfectant composition that are sufficient to distinguish the claimed composition from other compositions comprising said components. Furthermore, the instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics. Furthermore, the instant specification is silent as to which structural elements the inventor has determined to be sufficient to characterize the claimed composition as a nonporous surface disinfectant composition. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed a “nonporous” surface disinfectant composition.
Since no basis has been found to support the new claim limitation in the specification, the claims are rejected as incorporating new matter.
Claim Rejections - 35 USC § 103 (Maintained)
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.
1. Claims 1-8, 10-12, 14-17 and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Omidbakhsh et al. (US 2013/0259823, Oct. 3, 2013) (hereinafter Omidbakhsh).
Omidbakhsh teaches of an aqueous skin disinfecting solution that has a pH of from about 2 to about 6, and consists of at least (a) hydrogen peroxide in a concentration of from about 0.01 to about 4% w/w; (b) at least one surfactant chosen from alkyl betaines, alkyl amidopropyl betaines, alkyl amidopropyl betaine amides, alkylsulfobetaines, alkyl amphocarboxylates and amine oxides in a concentration of from about 0.01 to about 15% w/w (satisfies first surfactant of claim 1, 11, and 22-24); (c) at least one hydrogen peroxide stabilizer in a concentration of from about 0.01 to about 4% w/w; (d) at least one member chosen from cyclic carboxylic acids and salts thereof in a concentration of from about 0.01 to about 4% w/w; (e) at least one skin conditioning agent in a concentration of from about 0.01 to about 10% w/w; and (f) an effective amount of at least one solvent (Abstract). Suitable peroxide stabilizers include, but are not limited to, phosphoric acid (satisfies claim 6 and 24) (¶ [0020]). Suitable cyclic carboxylic acids include benzoic acid and salicylic acid (satisfies aromatic carboxylic acid of claim 1, 10 and 24) (¶ [0021]). Suitable conditioning agents include glycols and essential fatty acids (¶ [0022]). The solution may further comprise about 0.01 to about 10% w/w of a hydrogen peroxide compatible surfactant. Suitable hydrogen peroxide compatible surfactants include, but are not limited to, alcohol ethoxylates (satisfies second surfactant of claim 1, 11 and 24) (¶ [0024]). The solution can comprise at least one C1 to C8 alcohol in a concentration of from about 0.01 to about 10% w/w of solution. Suitable C1 to C8 alcohols include, but are not limited to benzyl alcohol and glycols (satisfies organic solvent of claim 1, 17, and 24) (¶ [0025]). The balance of the solution consists of deionized water which is also a solvent (¶ [0029]). Amine oxides useful in the solution are R1R2R3NO wherein each of R1, R2, and R3 is independently a saturated, substituted or unsubstituted linear or branched alkyl group having from 1 to 28 carbon atoms (satisfies claim 12) (¶ [0040]).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A). Accordingly, it would have been obvious to have made a disinfectant composition comprising: hydrogen peroxide; an organic solvent; a fatty acid or an aromatic carboxylic acid; a first surfactant comprising an amine oxide; a second surfactant comprising an alcohol ethoxylate; and an acidic pH adjuster, as instantly claimed, because this combination is suggested by the Omidbakhsh and this combination yielded nothing more than predictable results to one of ordinary skill in the art.
Regarding the amounts of organic solvent or benzyl alcohol recited in instant claims 1, 17, and 24 (i.e., 0.9 wt.% to 4 wt.% and 2 wt.% to 4 wt.%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Omidbakhsh’s solution can comprise at least one C1 to C8 alcohol, such as benzyl alcohol, in a concentration of from about 0.01 to about 10% w/w of solution. Accordingly, because of the overlap, the range disclosed by Omidbakhsh meets the instantly recited limitations of 0.9 wt.% to 4 wt.% and 2 wt.% to 4 wt.%.
Regarding the amounts of hydrogen peroxide recited in instant claims 2 and 22-24 (i.e., 0.1 wt.% to 8 wt.%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Omidbakhsh’s solution comprises hydrogen peroxide in a concentration of from about 0.01 to about 4% w/w. Accordingly, because of the overlap, the range disclosed by Omidbakhsh meets the instantly recited limitations of 0.1 wt.% to 8 wt.%.
Regarding the amounts of aromatic carboxylic acid recited in instant claims 3, 5, and 22-24 (i.e., 0.1 wt.% to 1 wt.% and 0.1 wt.% to 0.4 wt.%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Omidbakhsh’s solution comprises cyclic carboxylic acids and salts thereof, such as benzoic acid and salicylic acid, in a concentration of from about 0.01 to about 4% w/w. Accordingly, because of the overlap, the range disclosed by Omidbakhsh meets the instantly recited limitations of 0.1 wt.% to 1 wt.% and 0.1 wt.% to 0.4 wt.%.
Regarding the amounts of first surfactant recited in instant claims 4-5 and 22-24 (i.e., 0.1 wt.% to 1 wt.%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Omidbakhsh’s solution comprises a surfactant, such as an amine oxide, in a concentration of from about 0.01 to about 15% w/w. Accordingly, because of the overlap, the range disclosed by Omidbakhsh meets the instantly recited limitations of 0.1 wt.% to 1 wt.%.
Regarding the amounts of pH adjuster recited in instant claims 7 and 22-24 (i.e., 0.1 wt.% to 2 wt.%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Omidbakhsh’s solution comprises a hydrogen peroxide stabilizer, such as phosphoric acid, in a concentration of from about 0.01 to about 4% w/w. Accordingly, because of the overlap, the range disclosed by Omidbakhsh meets the instantly recited limitations of 0.1 wt.% to 2 wt.%.
Regarding the pH recited in instant claim 8 and 24 (i.e., 1 to 3), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Omidbakhsh’s solution has a pH of about 2 to about 6. Accordingly, because of the overlap, the range disclosed by Omidbakhsh meets the instantly recited limitations of 1 to 3.
Regarding the weight ratios of the organic solvent and the fatty acid or aromatic carboxylic acid recited in instant claims 1, 17, and 24 (i.e., about 10:1 to about 30:1 and 3:1 to about 30:1), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (A). As discussed above, Omidbakhsh’s solution can comprise at least one C1 to C8 alcohol, such as benzyl alcohol, in a concentration of from about 0.01 to about 10% w/w of solution and comprises cyclic carboxylic acids and salts thereof, such as benzoic acid and salicylic acid, in a concentration of from about 0.01 to about 4% w/w. Accordingly, the claimed weight ratio would have been obvious for one of ordinary skill in the art selecting an amount of benzyl alcohol and an amount of benzoic acid/salicylic acid from the above ranges and the ratio thereof overlapping with the claimed ratio.
Regarding the weight ratios of the fatty acid or aromatic carboxylic acid and first surfactant recited in instant claims 1, 17, and 24 (i.e., about 0.1:1 to about 3:1), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (A). As discussed above, Omidbakhsh’s solution comprises cyclic carboxylic acids and salts thereof, such as benzoic acid and salicylic acid, in a concentration of from about 0.01 to about 4% w/w and surfactants, such as an amine oxide, in a concentration of from about 0.01 to about 15% w/w. Accordingly, the claimed weight ratio would have been obvious for one of ordinary skill in the art selecting an amount of benzoic acid/salicylic acid and an amount of an amine oxide from the above ranges and the ratio thereof overlapping with the claimed ratio.
Regarding the weight ratios of the organic solvent and first surfactant recited in instant claims 1, 17, and 24 (i.e., 1:1 to about 30:1), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (A). As discussed above, Omidbakhsh’s solution can comprise at least one C1 to C8 alcohol, such as benzyl alcohol, in a concentration of from about 0.01 to about 10% w/w of solution and surfactants, such as an amine oxide, in a concentration of from about 0.01 to about 15% w/w. Accordingly, the claimed weight ratio would have been obvious for one of ordinary skill in the art selecting an amount of benzyl alcohol and an amount of an amine oxide from the above ranges and the ratio thereof overlapping with the claimed ratio.
Regarding claims 1, 17, and 24, reciting wherein the acidic pH adjuster is added to lower the pH of the disinfectant composition, Omidbakhsh’s solution comprises a hydrogen peroxide stabilizer, such as phosphoric acid. Therefore, the presence of phosphoric acid would meet the limitation of lowering the pH because this would be a property of phosphoric acid, whether the prior art discloses such use or not.
Regarding claims 14-15 & 17, Omidbakhsh does not teach the presence of peracids in the solution. As such, a solution free of peracids would have been obvious.
Regarding the disinfectant wipe recited in instant claim 16, this is merely a recitation of the intended use of the claimed disinfectant composition. Since the composition of Omidbakhsh is substantially the same as the claimed composition, where it comprises hydrogen peroxide; an organic solvent; a fatty acid or an aromatic carboxylic acid; a first surfactant comprising an amine oxide; a second surfactant comprising an alcohol ethoxylate; and an acidic pH adjuster, the composition of Omidbakhsh would be useable for in a disinfectant wipe, whether the prior art discloses such use or not.
Regarding claim 24 reciting a nonporous surface disinfectant composition, this is merely a recitation of the intended use of the claimed disinfectant composition. Since the composition of Omidbakhsh is substantially the same as the claimed composition, where it comprises hydrogen peroxide; an organic solvent; a fatty acid or an aromatic carboxylic acid; a first surfactant comprising an amine oxide; a second surfactant comprising an alcohol ethoxylate; and an acidic pH adjuster, the composition of Omidbakhsh would be useable to disinfect a nonporous surface, whether the prior art discloses such use or not.
Response to Arguments
Regarding Applicant’s argument that Omidbakhsh discloses “laundry lists” and broad ranges and does not provide motivation to utilize specific components in specific ratios, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). Furthermore, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (A). The Examiner points to the fact that Omidbakhsh requires most of the components recited in claim one. Specific components listed later in the Omidbakhsh disclosure are recited in short lists. Furthermore, Omidbakhsh requires very specific ranges and said ranges overlap those of the instant claims. Accordingly, one of ordinary skill in the art would find that Omidbakhsh provides sufficient motivation to select the specifically claimed components and it would have been obvious for one of ordinary skill in the art to have selected amounts from within the overlap of the aforementioned components disclosed by Omidbakhsh and the ratios that would result would therefore encompass the claimed ratios. Therefore, each instantly claimed component, range, and ratio is obvious over Omidbakhsh, absent of evidence to the contrary.
Regarding Applicant’s argument that routine optimization is not a credible position in the instant case, the Examiner points to the fact that routine optimization is not the basis of the rejections/arguments of record. The basis of the arguments of record is that the claimed amounts and weight ratios would have been obvious from the ranges disclosed by the prior art and arriving at amounts and weight ratios that overlap with the claimed ranges. Accordingly, the Examiner does not find Applicant’s argument to be persuasive.
Regarding Applicant’s arguments about the “consisting of” language used in claim 17, Omidbakhsh does not require components not encompassed by the claim. Omidbakhsh merely requires the presence of least (a) hydrogen peroxide in a concentration of from about 0.01 to about 4% w/w; (b) at least one surfactant chosen from alkyl betaines, alkyl amidopropyl betaines, alkyl amidopropyl betaine amides, alkylsulfobetaines, alkyl amphocarboxylates and amine oxides in a concentration of from about 0.01 to about 15% w/w; (c) at least one hydrogen peroxide stabilizer in a concentration of from about 0.01 to about 4% w/w; (d) at least one member chosen from cyclic carboxylic acids and salts thereof in a concentration of from about 0.01 to about 4% w/w; (e) at least one skin conditioning agent in a concentration of from about 0.01 to about 10% w/w; and (f) an effective amount of at least one solvent (Abstract), which are all encompassed by the components recited in instant claims 1 and 17. Accordingly, Omidbakhsh’s composition meets the transitional language of “consisting of”.
Regarding the recitation of a “nonporous surface disinfectant composition”, this is merely a recitation of the intended use of the composition as discussed above. A disinfecting composition, such as Omidbakhsh’s, is formulated for the purpose of disinfection. As such, said composition would be expected to exhibit disinfecting activity when applied to a surface. In other words, it would have been reasonable for one of ordinary skill in the art to expect a disinfecting composition to disinfect a surface that it is applied to, as disinfection is the intended function of such a composition. This is especially true when taking into consideration that the composition of Omidbakhsh is substantially the same as the claimed composition. Accordingly, one of ordinary skill in the art would reasonably conclude that the composition of Omidbakhsh would be useable to disinfect a nonporous surface.
Regarding Applicant’s arguments that the instantly recited pH would make the instantly claimed composition not suitable for Omidbakhsh’s use since the pH might be too acidic, as discussed above, Omidbakhsh’s solution has a pH of about 2 to about 6 which overlaps with the instantly claimed pH of 1 to 3. Accordingly, one of ordinary skill in the art can reasonably conclude that the instantly recited pH does not render the instantly claimed composition too acidic for Omidbakhsh’s use.
Regarding Applicant’s continued argument that phosphoric acid would not adjust the pH down, the Examiner submits, that although, phosphoric acid is used as a stabilizer, it would affect the pH of the composition by lowering the pH because this would be a property of the phosphoric acid. A component, in this case phosphoric acid, when present, exhibits its characteristic chemical properties, irrespective of the nomenclature or designation applied to that component.
Further, regarding Applicant’s arguments about some of Omidbakhsh’s examples containing a basic pH adjuster and the different possible combinations that could be made from Omidbakhsh’s disclosure, a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). Omidbakhsh teaches an aqueous skin disinfecting solution that has a pH of from about 2 to about 6, and discloses wherein the composition may comprise a combination of: hydrogen peroxide, amine oxides, phosphoric acid, benzoic acid/salicylic acid, alcohol ethoxylates, benzyl alcohol/glycols, and water; and does not require the presence of a basic pH adjuster. Therefore, it would have been obvious for one of ordinary skill in the art to have made a composition comprising these aforementioned agents excluding a “basic” pH adjuster. As such, the Omidbakhsh disclosure meets the instantly recited limitations.
Regarding Applicant’s arguments that Omidbakhsh does not recite any ratios, as discussed above, Omidbakhsh discloses very specific ranges for the amounts of the disclosed components. Accordingly, where the prior art discloses ranges for each component, it would have been well within the abilities of one of ordinary skill in the art to calculate and select corresponding ratios falling within the ratios of the instant claims.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
2. Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Omidbakhsh et al. (US 2013/0259823, Oct. 3, 2013) (hereinafter Omidbakhsh) in view of Paul (US 2011/0098229, Apr. 28, 2011) (hereinafter Paul).
The teachings of Omidbakhsh are discussed above,
Omidbakhsh differs from the instant claims insofar as not disclosing wherein the composition comprises hexanoic acid.
However, Paul teaches of a topical composition for a patient comprising a branched chain amino acid, and an enzyme activator used in a method for improving one or more symptoms of a dermatological condition in a patient (Abstract). Optional ingredients include essential fatty acids (EFAs). Suitable EFA’s include, but are not limited to, hexanoic acid (¶ [0101]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Omidbakhsh discloses wherein the composition may include conditioning agents such as essential fatty acids. Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated Omidbakhsh’s composition to include hexanoic acid, since it is a known essential fatty acid as taught by Paul.
Response to Arguments
The Examiner's response above is repeated herein and the Examiner further submits that Paul cures any alleged deficiencies of Omidbakhsh, where Paul discloses that hexanoic acid is a known essential fatty acid for topical compositions.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 1-12 and 14-24 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612