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 .
Election/Restrictions/Status of Claims
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 11/17/2025 is acknowledged. Applicant’s election of lactic acid for the species of organic acid; sodium benzoate for the species of preservative; and phenylpropanol for the species of microbial synergist is also acknowledged. Accordingly, Claims 4 and 16-20 are withdrawn as being directed to a non-elected invention/species. In addition, the nonelected species are withdrawn from each corresponding claim.
Claims 1-3 and 5-15 are examined on the merits herein.
Priority
The instant application filed 10/18/2023, claims benefit to U.S. Provisional Application No. 63/380,007, filed 10/18/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/02/2023 and 03/05/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 15 is 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 15 recites various percentages without reciting the basis for such percentages. Are they based on the weight of the total composition or of a specific component. As such, the claim is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 1-3, 5-9, and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vermeulen, Y., et al. (US 20160081897 A1, 03/24/2016, IDS dated 03/05/2024), hereinafter Vermeulen.
Vermeulen discloses an antibacterial cleansing composition which is free of triclosan and comprises lactic acid (abstract).
Regarding claim 1: Example 1 discloses composition A which comprises lactic acid (i.e., organic acid), sodium benzoate (i.e., preservative), and phenoxyethanol (i.e., microbial synergist) (p. 4, Ex. 1). Composition A exhibits potent antibacterial properties and satisfies the EN 1499 requirements for a hygienic hand wash.
Regarding claims 2 and 3: Lactic acid is taught above, which also reads on a carboxylic acid.
Regarding claims 5-7: Sodium benzoate is taught above, which also reads on a carboxylic acid salt and a salt of benzoic acid.
Regarding claims 8 and 9: Phenoxyethanol is taught above, which also reads on a alkyl aryl alcohol comprising a primary aryl alcohol.
Regarding claim 11: Composition A comprises sodium cumenesulfonate, sodium laureth sulfate, and cocamidopropyl betaine, all of which are examples of anionic or amphoteric surfactants as evidenced by Vermeulen ([0017]) and the instant specification ([0086]; [0092]; [0114]).
Regarding claim 12: The sodium cumenesulfonate and sodium laureth sulfate read on the sulfate and sulfonate of (i) while the cocamidopropyl betaine reads on the CAPB of (iii). Together, these surfactants read on (iv) a combination thereof.
Regarding claim 13: Composition A further comprises water and propylene glycol (i.e., a glycol ether).
Regarding claim 14: Composition A comprises sodium hydroxide, which reads on a pH modifier. The alcohol denatured and glutamate diacetate read on additional microbial synergists ([0012]-[0013]).
Regarding claim 15: Composition A comprises 11.10 wt.% of lactic acid (90%), thus the total amount of lactic acid in the composition is 9.99 wt.% (i.e., 11.10 x 0.90), which falls within the instantly claimed range of the organic acid (i.e., 0.01 to 15 wt.%). Sodium benzoate is present at 0.5 wt.% which falls within the instantly claimed range of the preservative (i.e., 0.1 to 10 wt.%). Phenoxyethanol is present at 0.9925 wt.% which falls within the instantly claimed range of the preservative (i.e., 0.1 to 15 wt.%).
Claims 1-3, 5-9, 11, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bobbert, I. (WO 2015091925 A1, 06/25/2015, IDS dated 03/05/2024), hereinafter Bobbert, as evidenced by SpecialChem, Lipo Polyglycerol® 400 (2025) (PTO-892), hereinafter SpecialChem.
Bobbert discloses an antimicrobial disinfecting composition (abstract). The composition has the advantage that it can be registered as a disinfectant, but at the same time has sufficient foaming and cleaning ability to be used as a hand soap, body wash or hard surface cleaner (p. 7, lines 16-20).
Regarding claim 1: Bobbert teaches formulation 7 which comprises lactic acid (i.e., elected organic acid); sodium benzoate (i.e., elected preservative); and phenoxyethanol (i.e., microbial synergist) (table 1).
Regarding claims 2 and 3: Lactic acid is taught above, which also reads on a carboxylic acid.
Regarding claims 5-7: Sodium benzoate is taught above, which also reads on a carboxylic acid salt and a salt of benzoic acid.
Regarding claims 8 and 9: Phenoxyethanol is taught above, which also reads on a alkyl aryl alcohol comprising a primary aryl alcohol.
Regarding claim 11: Formulation 7 further comprises Mackamines as amphoteric surfactants (table 1; abstract).
Regarding claim 13: Formulation 7 comprises mono propylene glycol (i.e., glycol ether) and deionized water, both of which read on the instantly claimed solvents.
Regarding claim 14: Formulation 7 comprises Lipoxol 400 which reads on a humectant as evidenced by SpecialChem.
Regarding claim 15: Lactic acid is present at 0.95% w/w, which falls within the instantly claimed range for the organic acid (i.e., 0.01 to 15 wt.%); sodium benzoate is present at 0.6% w/w, which falls within the instantly claimed range for the preservative (i.e., 0.1 to 10 wt.%); and phenoxyethanol is present at 1.00% w/w, which falls within the instantly claimed range for the microbial synergist (i.e., 0.1 to 15 wt. %) (Table 1).
Claims 1-3, 5-9, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giuliani, G., et al. (WO 2022058952 A1, 03/24/2022, PTO-892), hereinafter Giuliani.
Giuliani discloses preservative compositions for cosmetics with antimicrobial action (p. 3, lines 23-25). The composition is a combination preservative composition to be added to products for topical application (p. 5, lines 22-25). For example, the preservative composition may be added to a cosmetic to treat or cleanse an individual’s sensitive skin or scalp (p. 10, lines 13-14), thereby reading on a composition which could function as a hand wash.
Regarding claim 1: Table 1 discloses formulation Ref. 1 which comprises lactic acid (i.e., organic acid), sodium benzoate (i.e., preservative), and phenoxyethanol (i.e., microbial synergist) (p. 13-14, Table 1).
Regarding claims 2 and 3: Lactic acid is taught above, which also reads on a carboxylic acid.
Regarding claims 5-7: Sodium benzoate is taught above, which also reads on a carboxylic acid salt and a salt of benzoic acid.
Regarding claims 8 and 9: Phenoxyethanol is taught above, which also reads on a alkyl aryl alcohol comprising a primary aryl alcohol.
Regarding claim 13: Formulation Ref. 1 further comprises water.
Regarding claim 14: Formulation Ref. 1 optionally comprises ammonium acryloyldimethyl taurate copolymer as a gelling agent, which reads on a thickener (Table 1).
Regarding claim 15: Formulation Ref. 1 comprises 0.1-1% of lactic acid, which falls within the instantly claimed range of the organic acid (i.e., 0.01 to 15 wt.%). Sodium benzoate is present at 0.3% which falls within the instantly claimed range of the preservative (i.e., 0.1 to 10 wt.%). Phenoxyethanol is present with ethylhexylglycerin at 1%, which falls within the instantly claimed range of the preservative (i.e., 0.1 to 15 wt.%).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-15 are rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen, Y., et al. (US 20160081897 A1, 03/24/2016, IDS dated 03/05/2024), hereinafter Vermeulen, in view of Foster, S., et al. (WO 2019090105 A1, 05/09/2019, PTO-892), hereinafter Foster.
Vermeulen discloses an antibacterial cleansing composition which is free of triclosan and comprises lactic acid (abstract).
Regarding claim 1: Example 1 discloses composition A which comprises lactic acid (i.e., elected organic acid), sodium benzoate (i.e., elected preservative), and phenoxyethanol (p. 4, Ex. 1). Composition A exhibits potent antibacterial properties and satisfies the EN 1499 requirements for a hygienic hand wash.
Regarding claims 2 and 3: Lactic acid is taught above, which also reads on a carboxylic acid.
Regarding claims 5-7: Sodium benzoate is taught above, which also reads on a carboxylic acid salt and a salt of benzoic acid.
Regarding claims 8 and 9: Phenoxyethanol is taught above, which also reads on a alkyl aryl alcohol comprising a primary aryl alcohol.
Regarding claim 11: Composition A comprises sodium cumenesulfonate, sodium laureth sulfate, and cocamidopropyl betaine, all of which are examples of anionic or amphoteric surfactants as evidenced by Vermeulen ([0017]) and the instant specification ([0086]; [0092]; [0114]).
Regarding claim 12: The sodium cumenesulfonate and sodium laureth sulfate read on the sulfate and sulfonate of (i) while the cocamidopropyl betaine reads on the CAPB of (iii). Together, these surfactants read on (iv) a combination thereof.
Regarding claim 13: Composition A further comprises water and propylene glycol (i.e., a glycol ether).
Regarding claim 14: Composition A comprises sodium hydroxide, which reads on a pH modifier. The alcohol denatured and glutamate diacetate read on additional microbial synergists ([0012]-[0013]).
Regarding claim 15: Composition A comprises 11.10 wt.% of lactic acid (90%), thus the total amount of lactic acid in the composition is 9.99 wt.% (i.e., 11.10 x 0.90), which falls within the instantly claimed range of the organic acid (i.e., 0.01 to 15 wt.%). Sodium benzoate is present at 0.5 wt.% which falls within the instantly claimed range of the preservative (i.e., 0.1 to 10 wt.%). Phenoxyethanol is present at 0.9925 wt.% which falls within the instantly claimed range of the preservative (i.e., 0.1 to 15 wt.%).
The teachings of Vermeulen differ from that of the instantly claimed invention in that Vermeulen does not disclose phenylpropanol (i.e., the elected microbial synergist) as defined in claim 10.
Foster discloses an antimicrobial composition comprising 3-phenylpropanol alone or in combination with an organic acid or salt thereof (abstract). Specifically, it has been found that 3-phenyl propanol is highly effective as an antimicrobial when combined with sodium benzoate ([0016]). Furthermore, a clear synergistic relationship between 3-phenyl propanol and sodium benzoate is shown in FIG. 20 for the log reduction of A. brasiliensis ([0061]). The 3-phenyl propanol of Foster reads on the instant microbial synergist of claims 1, 8-10, and 15.
Combinations of sodium benzoate with other components were found to be effective, however, combinations of sodium benzoate with parabens and phenoxy ethanol and phenoxy propanol are now disfavored due to irritation and sensitivity when applied topically and other toxic effect ([0014]).
The antimicrobial compositions of Foster have applications for use in personal care products, cosmetics, toiletries, household products, and laundry products, detergents and cleaners ([0024]).
Other organic acids may be useful in combination with 3-phenyl propanol such as lactic acid ([0076]; claim 3).
Amounts of 3-phenyl propanol useful to achieve antimicrobial effects range from 0.1 wt.% to 1.99 wt.% ([0077]), which falls within range of microbial synergist in claim 15 (i.e., 0.1 to 15 wt.%).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to substitute the phenoxyethanol of Vermeulen with 3-phenyl propanol of Foster since 3-phenyl propanol is known and routine in antimicrobial compositions also comprising organic acids and their salts. One of ordinary skill in the art would have been motivated to make the substitution for two reasons: 1) the 3-phenyl propanol of Foster is a highly effective antimicrobial when combined with sodium benzoate (which is present in the composition of Vermeulen) due to their synergistic relationship; 2) phenoxyethanol is now disfavored due to irritation and sensitivity when applied topically. Thus, one of ordinary skill in the art would have been motivated to substitute the phenoxyethanol of Vermeulen with 3-phenyl propanol in order to increase the antibacterial activity of the composition and decrease potential irritation and sensitivity. As such, the instantly elected microbial synergist and composition of claim 10 are obvious.
Regarding the amount of 3-phenyl propanol to include, Foster teaches that 0.1 wt.% to 1.99 wt.% of 3-phenyl propanol is useful to achieve antimicrobial effects. As such, it would have been obvious to one of ordinary skill in the art to include the 3-phenyl propanol at this amount since it is a known and effective amount for use in an antimicrobial composition. Additionally, the composition of Vermeulen teaches 0.9925 wt.% of phenoxyethanol, so it is reasonable that one could substitute the phenoxyethanol with a similar amount of 3-phenyl propanol since this amount falls within the effective range taught by Foster.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Foster teaches 3-phenyl propanol as useful in antimicrobial compositions comprising sodium benzoate and lactic acid and Vermeulen teaches antibacterial compositions comprising sodium benzoate and lactic acid.
Claims 1-3, 5-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bobbert, I. (WO 2015091925 A1, 06/25/2015, IDS dated 03/05/2024), hereinafter Bobbert, as evidenced by SpecialChem, Lipo Polyglycerol® 400 (2025) (PTO-892), hereinafter SpecialChem.
Bobbert discloses an antimicrobial disinfecting composition (abstract). The composition has the advantage that it can be registered as a disinfectant, but at the same time has sufficient foaming and cleaning ability to be used as a hand soap, body wash or hard surface cleaner (p. 7, lines 16-20).
Regarding claim 1: Bobbert teaches formulation 7 which comprises lactic acid (i.e., elected organic acid); sodium benzoate (i.e., elected preservative); and phenoxyethanol (i.e., microbial synergist) (table 1).
Bobbert further teaches in addition to phenoxyethanol, that phenylpropanol (i.e., elected microbial synergist) is a suitable preservative (p. 14-15, lines 32-1).
Regarding claims 2 and 3: Lactic acid is taught above, which also reads on a carboxylic acid.
Regarding claims 5-7: Sodium benzoate is taught above, which also reads on a carboxylic acid salt and a salt of benzoic acid.
Regarding claims 8 and 9: Phenoxyethanol is taught above, which also reads on a alkyl aryl alcohol comprising a primary aryl alcohol.
Regarding claim 11: Formulation 7 further comprises Mackamines as amphoteric surfactants (table 1; abstract).
Regarding claim 13: Formulation 7 comprises mono propylene glycol (i.e., glycol ether) and deionized water, both of which read on the instantly claimed solvents.
Regarding claim 14: Formulation 7 comprises Lipoxol 400 which reads on a humectant as evidenced by SpecialChem.
Regarding claim 15: Lactic acid is present at 0.95% w/w, which falls within the instantly claimed range for the organic acid (i.e., 0.01 to 15 wt.%); sodium benzoate is present at 0.6% w/w, which falls within the instantly claimed range for the preservative (i.e., 0.1 to 10 wt.%); and phenoxyethanol is present at 1.00% w/w, which falls within the instantly claimed range for the microbial synergist (i.e., 0.1 to 15 wt. %) (Table 1).
The teachings of Bobbert differ from that of the instantly claimed invention in that Bobbert does not explicitly teach an embodiment comprising phenylpropanol (i.e., the elected microbial synergist) as defined in claim 10.
However, it would have been prima facie obvious to one of ordinary skill in the art to use the phenylpropanol of Bobbert in the formulation comprising lactic acid and sodium benzoate since phenylpropanol is known and routine in these compositions as taught by Bobbert. Specifically, one of ordinary skill in the art could have substituted the phenoxyethanol of formulation 7 with phenylpropanol to predictably generate the instantly claimed invention. Generally, the substitution of one known element for another to yield predictable results is considered prima facie obvious. It would have also been obvious to incorporate the phenylpropanol at the same amount as the phenoxyethanol (i.e., 1.00% w/w) since this is a known and effective amount of an alkyl aryl alcohol to include in the formulation. One of ordinary skill in the art would have had a reasonable expectation of success in making this substitution since Bobbert teaches phenoxyethanol and phenylpropanol as acceptable alternatives of one another. Phenylpropanol reads on the microbial synergist of claims 1, 8-10, and 15.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616