DETAILED ACTION
Status of the Claims
Claims 1-20 are pending in this application. Claims 1-20 are under examination.
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 .
Priority
The instant application, which is a national stage entry of PCT/EP2020/075435 filed on 09/11/2019, which claims priority from the foreign applications # EP19206801.3 and # PCT/CN2019/106212 filed on 11/04/2019 and 09/17/2019 respectively.
Information Disclosure Statement
The information disclosure statements from 07/25/2022, 09/23/2022, 08/28/2023, 04/03/2024, 10/25/2024 and 04/22/2025 have been considered by the examiner.
Claim Objections
Claim 1 is objected to for “selected from…. and….” since this is not “selected from the group consisting of… and….” where “and” is conventionally used. The more appropriate conjunction for this phrase would be “or” instead of “and” placed between “phenoxyethanol” and “mixtures thereof” in the claim.
Claim 15 is objected to as “and/or scalp” is more grammatically correct as “and/or a scalp”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 and 18 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 12 recites the limitation "the cationic guar" in dependence to claim 1 which has a “cationic polymer”, which is a large group of polymers that are cationic. As there is no introduction of the cationic polymer being a cationic guar, there is no antecedent basis for “the cationic guar”. There is insufficient antecedent basis for this limitation in the claim.
In claim 18, it is not clear what units the instantly claimed 20 to 80% refers to. For instance, all other claims include the “by weight of the premix” or “by weight of the composition” terms. The instantly claimed amounts can be by weight or by volume. For the purposes of compact prosecution, the instant claim will be interpreted as “wherein the water is present in an amount of from 20 to 80% by weight of the premix.” It is not clear if applicant intends to change units in claim 18 or continue with “by weight of the premix”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8-12, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chang US 20190328647A1 (filing date of provisional application of 10-25-2018).
In claim 8, the portion of the claim that starts “wherein said composition is produced by a process comprising…” is a product-by-process limitation. If the composition contains the ingredients and amounts provided by the claims for the hair care composition, then it reads on the claims. To make a hair care composition can involve using more water or aqueous components as ingredients, and thus, the ratio of co-solvent to water in claim 1 does not apply to claim 8.
Chang teaches compositions with 0.25% sodium benzoate (co-solvent), water, (0.5% to 1wt%) piroctone olamine, and guar hydroxypropyltrimonium chloride (table on bottom of page 20, also bottom of page 18 tables and first column on page 19 table). Chang teaches applying the compositions to hair and/or scalp (paragraphs 205 and 217). Chang teaches antidandruff compositions (abstract), and thus, notes the use for treating dandruff. The table at the top of page 20 provides for a composition with (0.5%) piroctone olamine, water, 0.25% sodium salicylate and guar hydroxypropyltrimonium chloride.
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.
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 1-11, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Waltraud Simsch et al (US8877234B2, publication date: 11/04/2014) (Hereinafter Simsch).
Regarding claim 1, Simsch teaches a composition comprising “1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2(1H)-pyridone” (piroctone olamine), “phenoxyethanol” “in an amount by weight of 35% to 99.9%” (claim 1) and “further comprising c) water in an amount by weight of 0.1% to 35%” (claim 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. MPEP 2144.05 I. Here, 35% of phenoxyethanol and 35% of water taught by Simsch overlaps with the instantly claimed 1:1 ratio. It is also noted that instantly claimed “premix” language in the preamble is intended use which does not constitute a functional limitation. That said, Simsch teaches embodiments examples 1-12 which comprise piroctone olamine, water and 2-Phenoxyethanol which are later added to formulations A-R which means that Simsch examples 1-12 are premixes. It is noted that formulation examples in Simsch provide for the ability to add more water to make other formulations (see example A, B and others).
Regarding claim 2, Simsch teaches phenoxyethanol as discussed above. Simsch also teaches “sodium salicylate”, “sodium benzoate” (claim 22), “hexanediol” (C5 lines 32-33).
Regarding claim 3, Simsch teaches phenoxyethanol and sodium salicylate as discussed above.
Regarding claim 4, Simsch teaches a ratio of 1:1 as discussed above.
Regarding claim 5, Simsch teaches “water in an amount by weight of 0.1% to 35%” as discussed above which overlaps with the instantly claimed 10-90% by weight.
Regarding claim 6, Simsch teaches co-solvent “in an amount by weight of 35% to 99.9%” as discussed above which overlaps with the instantly claimed 3-70% range.
Regarding claim 7, Simsch teaches piroctone olamine “in an amount of 1.1% to 10% by weight” (claim 26) which is within the instantly claimed 0.01-70% range.
Regarding claim 8, it is noted that the instant claim is directed to a product-by-process claim. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113 I. Simsch teaches hair care composition (example D) comprising “Preservative composition from example 1” at 0.5 % by weight wherein Preservative composition from example 1 comprises 2-Phenoxyethanol at 97% by weight (example 1), which equates to about 0.485% by weight of the composition, which is within the instantly claimed 0.01 to 4% range. Additionally, it is noted that Simsch teaches mixing piroctone olamine with 2-Phenoxyethanol, and water is added after (C8 lines 43-46). Other ingredients in Simsch are added after (example D). Thus, the only difference between the instantly claimed product-by-process steps and Simsch is addition of water to co-solvent before adding piroctone olamine. That said, since other structural elements of the claim are met and since the instant claim is a product-by-process claim, a prima facie case of obviousness has been established.
Regarding claim 9, Simsch teaches piroctone olamine (octopirox) in an amount by weight of 0.1% to 20% of a preservative composition (claim 1) and also at 0.1% to 2% by weight of the completed formulation (claim 22) which is within the instantly claimed 0.01-10% by weight of the composition range.
Regarding claim 10, Simsch teaches 0.485% by weight of the composition as discussed above, which is within the instantly claimed 0.1-2 by weight of the composition range. Simsch also teaches a range of 0.1% to 2% by weight of the completed formulation (claim 22).
Regarding claim 11, Simsch teaches “cationic polymers” (C7 lines 25-27).
Regarding claim 16, Simsch teaches sodium salicylate and phenoxyethanol as discussed above.
Regarding claim 18, Simsch teaches “water in an amount by weight of 0.1% to 35%” as discussed above which overlaps with the instantly claimed 20-80%.
Regarding claim 19, Simsch teaches co-solvent “in an amount by weight of 35% to 99.9%” as discussed above which overlaps with the instantly claimed 7-50% range.
Regarding claim 20, Simsch teaches piroctone olamine “in an amount of 1.1% to 10% by weight” (claim 26) which overlaps the instantly claimed 0.1-50% range.
It would have been obvious to one of ordinary skill in the art at the time of instant application to modify the embodiments of Simsch and achieve the instant invention. While Simsch embodiments do not meet the instantly claimed ratio range for co-solvent to water, the claims of Simsch teaches ranges that are within or overlap with the instantly claimed ranges. Thus, a prima facie case of obviousness has been established.
Claims 13-14 in addition to claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Waltraud Simsch et al (US8877234B2, publication date: 11/04/2014) (Hereinafter Simsch) and Julia Puschmann et al (Correlation of antimicrobial effects of phenoxyethanol with its free concentration in the water phase of o/w-emulsion gels, European Journal of Pharmaceutics and Biopharmaceutics, Volume 131, October 2018, Pages 152-161) (Hereinafter Puschmann).
Regarding claims 1 and 8, Simsch teaches as discussed above.
Regarding claims 13-14, Simsch teaches as discussed above. The only difference between Simsch and the instant invention is that Simsch adds water after mixing piroctone olamine with co-solvent, whereas the instant claims add water to co-solvent prior to adding piroctone olamine.
Regarding claims 13-14, Puschmann teaches “Correlation of antimicrobial effects of phenoxyethanol with its free concentration in the water phase of o/w-emulsion gels” (title) and discloses the finding that “the lower the content of the aqueous phase with regard to dissolved ingredients the more preferably distributed is phenoxyethanol to the water phase and, consequently, the higher was the efficacy against the microbes” (abstract).
It would have been obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Simsch and Puschmann and achieve the instant invention. Puschmann provides the motivation that phenoxyethanol achieves superior distribution in water when other ingredients are not present. Thus, a person of ordinary skill in the art would modify the teachings of Simsch and mix phenoxyethanol with water prior to adding piroctone olamine to improve dissolving of phenoxyethanol.
Claims 12, 15 and 17 in addition to claims 1, 4, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Waltraud Simsch et al (US8877234B2, publication date: 11/04/2014) (Hereinafter Simsch) and James Anthony Staudigel (US20170252277A1, publication date: 09/07/2017) (Hereinafter Staudigel).
Regarding claims 1, 4, 8 and 11, Simsch teaches as discussed above.
Regarding claim 12, while Simsch teaches the genus cationic polymers (discussed above), Simsch does not teach the instantly claimed species of “guar hydroxytripropyltrimonium chloride.”
Regarding claim 15, while Simsch teaches “dermatological, cosmetic and pharmaceutical products” comprising “antidandruff agents” (C7 lines 25-36), Simsch does not teach a method of treating and/or preventing dandruff comprising the step of applying the hair care composition.
Regarding claim 17, Simsch at most teaches a 1:1 range of co-solvent to water (discussed above) and does not teach a ratio within the instantly claimed co-solvent to water ranging from 1:5 to 1:3.
Regarding claim 12, Staudigel teaches “a personal care composition” (claim 1) with formulations “a” “c” (page 14, para 132) comprising Piroctone Olamine, sodium benzoate (co-solvent) and Guar hydroxypropyltrimonium chloride.
Regarding claim 15, Staudigel teaches “a personal care composition” comprising “an anti-dandruff active” (claim 1) and “A method for achieving hair smoothing wherein the composition of claim 1 is applied to the hair” (claim 18). Staudigel also teaches “a need to minimize the anti-dandruff particulate impact on hair feel” (para 2) and “deposition of anti-dandruff active” onto scalp (para 107). Thus, Staudigel teaches a method of treating and/or preventing dandruff comprising the step of applying the hair care composition.
Regarding claim 17, Staudigel teaches water as carrier which is present a level of from about 20% to about 95%, or from about 60% to about 85% (para 108). Thus, Staudigel teaches a higher amount of water for its formulations and increasing the amount of water in Simsch would yield a co-solvent to water ratio lower than 1:1 taught by Simsch and would allow for producing the claimed co-solvent to water ratio range of 1:5 to 1:3.
It would have been obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Simsch and Staudigel and achieve the instant invention. As discussed above, Simsch already teaches cationic polymers and does not provide any species. Staudigel teaches Guar hydroxypropyltrimonium chloride as a cationic polymer, thus incorporating that into Simsch is interpreted as combining prior art elements according to known methods to yield predictable results. Additionally, Simsch also teaches including antidandruff agents, thus a person of ordinary skill in the art would rely on the teachings of Staudigel to achieve a method of treating dandruff. Thus, a person of ordinary skill in the art would incorporate the teachings of Staudigel into the teachings of Simsch with a reasonable expectation of success.
Conclusion
No claims are allowed.
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/A.A./ Examiner, Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613