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 .
Current Status of 18/722,364
This Office Action is responsive to the amended claims of 06/20/2024. Claims 1-16 are pending and have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/US2022/053331, filed 12/19/2022, which claims priority to U.S. Provisional Patent Application No. 63/292,117, filed 12/21/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/20/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The specification inconsistently characterizes the disclosed composition as both “antibacterial” and “antimicrobial.” Although [0030] defines “antimicrobial” as substances capable of killing or inhibiting the growth of microorganisms, including bacteria and fungi, the specification also identifies the invention as an antibacterial liquid composition (see [0001]). Because “antimicrobial” is a broader term than “antibacterial,” the inconsistent use of these terms renders the scope of the claimed invention unclear. It is unclear whether the invention is directed broadly to antimicrobial compositions or limited to only the antibacterial activity of the compositions.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: “salmonella” should be capitalized in the second line of page 22 to be consistent with the other entries of the claim. “Salmonella” should be capitalized if used as a genus. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 7, and 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The Examiner notes that claims 3 and 4 recite the that the composition “is used for killing or inhibiting the growth of” the listed microorganism. The recited uses do not further define or structurally limit the compositions of claim 1, and instead merely recite intended uses. Claims 3 and 4 carry no patentable weight and are intended use claims.
Claim 3 recites various microorganisms using genus-level terminology followed by the term “species,” for example Moraxella species. It is unclear which particular species are encompassed by the genus terms that are followed by the phrase “species.” These recitations therefore fail to particularly point out and claim the subject matter regarded as the invention.
Claims 3 and 4 recite the composition is “used for” killing or inhibiting growth of the recited microorganisms. As written, it is unclear whether the claims are directed to the composition, a method of use, or an intended use of the composition. Additionally, base claim 1 identifies the composition as an antibacterial composition. The microorganisms listed in claims 3 and 4 contain species that are not bacteria, such as Candida albicans, Candida tropicalis, and Aspergilus. It is unclear whether the claimed composition is limited to antibacterial activity or if it requires broader antimicrobial activity against bacteria and fungi.
Claim 7 recites the limitation “wherein the composition can provide synergistic effect” in lines 1 and 2 of the claim. The term “can provide” renders the claim indefinite because it is uncertain whether the recited synergistic effect is required by the claims or merely a preferred embodiment.
Claim 11 recites the limitation "preparing antibacterial liquid composition" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Adding the article “the” before the indicated phrase will render this rejection moot.
Claim 12 recites the limitation "the antimicrobial composition of claim 1" in the second to last and last lines of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 is directed to an antibacterial liquid composition.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The composition of claim 1 defines (b) as including diols having carbon chain lengths from 3-12 atoms. Claim 2 lists suitable diols of the claimed invention, but includes hexadecan-1-ol as part of the list. Hexadecane-1-ol is not a diol and expands the established scope of (b) of claim 1 to include alcohols that are not diols. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are not directed to a process, machine, manufacture, or composition of matter. The indicated claims do not recite positive method steps, a machine, an article of manufacture, or a composition of matter. As written, it is unclear whether the claims are directed to a method of using the compositions, a product comprising the composition, or an intended use of the compositions.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 2, and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Nanjing (CN 111407682 A, found in IDS filed 06/20/2024) .
Nanjing teaches a cosmetic preservative which contains raspberry ketone, sodium dehydroacetate, glycol, and solubilizer (pg 1, first para of Summary of the invention). In some embodiments the raspberry ketone accounts for 10-40% of the composition, the sodium dehydroacetate accounts for 5-30%, the glycol accounts for 15-75%, and the solubilizer accounts for 1-10% (pg 1, third para of Summary of the invention). The reference teaches that other preservatives can be included in the composition, including phenoxyethanol and phenyl propanol to achieve synergy to reduce the amount of preservatives added (pg 1, fourth para of Summary of the invention). Nanjing teaches that the compositions include diols, exemplified diols include propylene glycol, butylene glycol, pentanediol, hexanediol, octanediol, decanediol, and polyethylene glycol (pg 1, fifth para of Summary of the invention). The reference teaches the method of preparing the composition comprises mixing, stirring, and dissolving the raspberry ketone, sodium dehydroacetate and glycol, followed by adding the solubilizer and stirring to obtain the preservative (pg 2, second para of Summary of the invention). Some embodiments of the invention include the incorporation of solubilizers including sorbitols, polyoxyethylenes, alkanol polyethers, fatty alcohol polyoxyethylene ethers, POE castor oil or hydrogenated castor oil derivatives, fatty acids, one or more esters, sucrose fatty acid esters, or alkyl glycosides (pg 2, first para of Summary of the invention). Nanjing’s composition is taught as providing application of the disclosed cosmetic preservative in cosmetics, wherein the amount of cosmetic preservative is 0.5-3.0% and teaches that in some embodiments the cosmetic is a skin cream (pg 2, third and sixth para of Summary of the invention). The disclosed cosmetic preparation has an effective inhibitory and killing effect on gram-positive bacteria, gram-negative bacteria, molds, and yeasts (pg 2, second para of Beneficial effect).
The artisan would have experience formulating and screening of antimicrobial compositions, including cosmetic and personal care preservative systems. The artisan would be familiar with conventional preservatives, antimicrobial alcohols, solubilizers, emulsifiers, stabilizers, and other related formulation additives. The artisan would have understood that varying the relative amounts of these components could effect the desired antimicrobial activity of the compositions. The artisan would have understood that adjusting the amounts of these components is routine in the art to obtain suitable compositions possessing the desired antimicrobial activity.
As discussed above, Nanjing teaches a cosmetic preservative composition comprising the same components of the instantly claimed invention, including raspberry ketone, dihydric alcohols, and preservatives such as phenyl propanol. Although Nanjing does not expressly disclose the exact amounts of each of the components of the pharmaceutical composition, the amounts of preservative components in antimicrobial compositions the artisan would be aware that these are result-effective variables. Variations in the relative amounts of these components affect properties such as solubility, stability, skin irritation, and antimicrobial efficacy. It would have been obvious to the artisan to optimize the relative amounts of these result-effective variables through routine formulation screening to obtain a stable liquid antimicrobial composition having the desired antimicrobial properties. The artisan would have reasonably expected that an antimicrobial composition comprising raspberry ketone, dihydric alcohols, and preservatives such as phenyl propanol would be useful in cosmetics based on the disclosure of Nanjing.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nanjing.
The teachings of Nanjing are discussed above and are incorporated by reference into this rejection. Nanjing teaches an antimicrobial composition comprising raspberry ketone in an amount of 10-40% and dihydric alcohols in an amount of 15-75%, which overlap with the claimed ranges of about 10-40% and about 20-60%, respectively. Nanjing also teaches that additional preservatives, including phenoxyethanol, phenyl propanol, and ethylhexylglycerol may be included in the compositions to achieve synergy and reduce the total amount of preservatives added. Nanjing does not expressly disclose the percentage of the additional preservatives. However, the artisan would have been motivated to select and optimize the relative amounts of each of the components of the composition through routine formulation screening. Such screening is routine in the art. The artisan would expect that optimization and routine screening of these components would result in an antimicrobial composition suitable for cosmetic applications based on Nanjing’s disclosure.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nanjing in view of Koehl (US 2019/0124921 A1).
The teachings of Nanjing are discussed above and are incorporated by reference into this rejection. Nanjing teaches an antimicrobial composition comprising raspberry ketone in an amount of 10-40% and dihydric alcohols in an amount of 15-75%, which overlap with the claimed ranges of about 10-40% and about 20-60%, respectively. Nanjing also teaches that additional preservatives, including phenoxyethanol, phenyl propanol, and ethylhexylglycerol may be included in the compositions to achieve synergy and reduce the total amount of preservatives added. Nanjing does not expressly disclose the percentage of the additional preservatives, nor does it expressly disclose benzyl alcohol.
Koehl teaches antimicrobial organic preservatives that are effective against bacteria and fungi (Abstract). The disclosed compositions are effective at protecting personal care products against degradation associated with bacterial and fungicidal growth (see [0002]). These compositions may include aromatic alcohols such as phenoxyethanol, phenyl propanol, phenyl ethanol, benzyl alcohol, and mixtures thereof (see [0017]). Therefore, Koehl teaches that benzyl alcohol and phenyl propanol belong to a recognized class of aromatic alcohol preservatives useful in antimicrobial compositions for personal care products.
It would have been obvious to the artisan to substitute benzyl alcohol into the antimicrobial composition disclosed by Nanjing because the reference teaches that the compositions may include additional preservatives, including other aromatic alcohols, to achieve synergy and reduce the total amount of preservative used in the composition. Koehl teaches that benzyl alcohol and phenyl propanol are alternative aromatic alcohols useful in antimicrobial compositions for personal care product. The substation of benzyl alcohol for phenyl propanol represents the selection of one known aromatic alcohol for another. The artisan would expect that substitution of one species of aromatic alcohol for another would produce a composition with similar antimicrobial activity. The artisan would have been motivated to select and optimize the relative amounts of each of the components of the composition through routine formulation screening. Such screening is routine in the art. The artisan would expect that optimization and routine screening of these components would result in an antimicrobial composition suitable for cosmetic applications based on Nanjing’s disclosure and Koehl’s disclosure that benzyl alcohol belongs to a recognized class of compounds frequently employed in cosmetic preservative compositions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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