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 .
Formal Matters
Applicant’s claim set filed on 22 October 2024 are acknowledged and have been fully considered. Claims 1-15 are pending. Claims 1-14 are under consideration in the instant office action. Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claims.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 22 October 2024 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. A signed copy is attached herein.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to cosmetic use of a topically applicable rinse-off composition, classified in A61K9/4825.
II. Claim 15, drawn to a non-therapeutic method for improving hair structure and hair loss reduction, classified in A61K31/4402.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the method steps as claimed can be used to apply other rinse-off or shampoo compositions containing other ingredients such as antidandruff agent.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The above described distinct inventions present a unduly search burden e.g., (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Enrique Perez on June 16, 2026 a provisional election was made without traverse to prosecute Invention I (claims 1-14). Affirmation of this election must be made by applicant in replying to this Office action. Claim 15 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “Cosmetical use of a topically applicable rinse-of composition (RC)”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not reflect the main inventive concept of Applicant’s invention and the major components of the “Cosmetical use of a topically applicable rinse-of composition (RC)”. The title is generic and can be applicable to any “Cosmetical use of a topically applicable rinse-of composition (RC)”. The examiner advises Applicant to consider including major components of the composition in the title to precisely reflect the inventive concept. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Claim Objections
Claims 1-14 are objected to because of the following informalities: Independent claim 1 recites “Cosmetic use of a topically applicable rinse-off composition (RC) comprising as components
sandal pentanol ((3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol) and/or one or more sandal pentanol analog(s),
(B) caffeine,
(C) at least one C10-C18 fatty acid and/or salts thereof,
(D) at least one surfactant, and
(E) at least one cosmetically acceptable solvent
for
(i) improving hair structure, and
(ii) hair loss reduction.”
Dependent claims 2-14 start recitations with “Cosmetic use according to claim …”.
The examiner notes that Applicant’s claims are drawn to a product or composition of matter. For purposes of clarity, the examiner recommends independent claim 1 to be amended to recite “A topically applicable rinse-off composition for improving hair structure and reducing hair loss comprising as components:
(A) sandal pentanol ((3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol) and/or one or more sandal pentanol analog(s),
(B) caffeine,
(C) at least one C10-C18 fatty acid and/or salts thereof,
(D) at least one surfactant, and
(E) at least one cosmetically acceptable solvent.”
Dependent claims 2-14 should recite: “The topically applicable rinse-off composition according to claim…, wherein…”. Appropriate correction is required.
Claims 1-14 are objected to because of the following informalities: Independent claims start recitations with the article “A” or “An” while dependent claims start with the proposition “The”. Instant claims 1-14 do not conform to such claim recitations. Appropriate correction is required.
Claims 1-2, 11-12, and 14 are objected to because of the following informalities: Independent claim 1 recites “rinse-off composition (RC)”. Instant claims 2 , 11-12, and 14 recite “rinse-off composition (RC)”. The examiner recommends Applicant to simply recite “rinse-off composition” in all the claims and remove “(RC)” for consistency and clarity reasons. 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.
Claim 7 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “wherein the weight ratio of component (A) to component (B) is in the range of from 1:2 to 2:1,”, and the claim also recites “more specifically in the range of from 1:1.5 to 1.5:1, and in particular in the range of from 1:1.2 to 1.2:1., which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The phrases “more specifically” and “in particular” in claim 7 render the claim indefinite. It is unclear to one of ordinary skill in the art whether these phrases introduce required narrowing limitations that further limit the scope of the claim (e.g., whether the claim requires the ratio to satisfy the narrowest “in particular” range 1:1.2 to 1.2:1), or merely indicate preferred or exemplary sub-ranges within the broader range (i.e., optional embodiments that do not further limit the claim scope. This creates ambiguity as to the metes and bounds of the claimed subject matter. For example, does a composition with 1 1:1.7 ratio of A:B satisfy claim 7 or must it fall within one of the narrower ranges? The use of hierarchical qualifying languages such as “more specifically” and “in particular” in the body of a dependent claim fails to clearly define the additional limitation being imposed on the parent claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-6, and 8-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Springob et al. (WO2022/112419, IDS reference 10/22/2024, Applicant’s own work).
Applicant claims in independent claim 1 “Cosmetic use of a topically applicable rinse-off composition (RC) comprising as components
(A) sandal pentanol ((3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol) and/or one or more sandal pentanol analog(s),
(B) caffeine,
(C) at least one C10-C18 fatty acid and/or salts thereof,
(D) at least one surfactant, and
(E) at least one cosmetically acceptable solvent
for
(i) improving hair structure, and
(ii) hair loss reduction.”
Dependent claims thereof recite additional features.
Springob et al. disclose a composition for promoting hair growth, and/or reducing or preventing hair loss, respectively, comprises sandal pentanol, caffeine, one or more saturated and unsaturated C10-C18 fatty acids, and a solvent (see abstract and claim 1).The examiner notes that as sandal pentanol is part of the composition it is 100% by weight based on the total amount of component (A) meeting the limitation of claim 12. The solvent further may comprise one or more solubilisation enhancers. The solubilisation enhancers obviously are intended to solubilize compounds which are not or only partially soluble in the solvent at the concentration used in the compositions. Solubilisation enhancers generally include surfactants. Surfactants include anionic, cationic, amphoteric and non-ionic surfactants (paragraph 0070 and claim 22). Preferred surfactants encompass non-ionic surfactants, in particular polyoxyethylated fatty alcohols or oils. Particularly preferred non-ionic surfactants include polyoxyethylated Castor Oil and hydrogenated polyoxylated Castor Oil. Specific examples of non-ionic surfactants that may be used in the compositions of the present disclosure are PEG-35 Castor Oil, PEG-40 Hydrogenated Castor Oil, and combinations thereof (paragraph 0077). The compositions may further comprise care materials, such as hair-care providing or skin-care- providing plant or vegetable extracts, cationic polymers or cationic surfactants. Typical amounts of care materials in the compositions according to the present disclosure will be in the range of from 0.010 to 5.0, in particular 0.050-2.0 percent-by-weight, based on the weight of the composition (paragraph 0096). Additional cosmetically acceptable additives, which may be present in the compositions according to the present disclosure include:
• physiologically compatible silicone derivative compounds, such as volatile or non-volatile silicone or high molecular weight siloxane polymers, such as for example Quaternium-80, typically in an amount of from 0.05 to 20 percent-by-weight, in particular from 0.10 to 5.0 percent-by-weight, based on the weight of the composition (the examiner notice that Quaternium-80 is a cationic surfactant). Additives include combability improving agents, such as for example cationic surfactants such as Behentrimonium Chloride, or cationic polymers such as Polyquaternium-10, etc. The cosmetically acceptable additives may be used in the compositions according to the present disclosure in any combinations, as desired or required (see paragraphs 0097-0098). The composition of claim 1, wherein the C10-C18 fatty acid(s) is/are selected from capric acid (C10:0), lauric acid (C12:0), myristic acid (C14:0), isomyristic acid (C14:0), palmitic acid (C16:0), palmitoleic acid (C16:l), stearic acid (C18:0), oleic acid (C18:l), linoleic acid (C18:2), linolenic acid (C18:3), parinaric acid (C18:4), petroselinic acid (C18:l), or combinations thereof (see claim 2). The composition of claim 1 or 2, wherein the C10-C18 fatty acid(s) comprise lauric acid (C12:0), myristic acid (C14:0), or a combination thereof (claim 3). The examiner notes that since lauric acid is one of the three alternatives to be picked it will meet 100% based on the total weight of component (C) meeting the limitation of instant claim 11. The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 7). The composition of any of the preceding claims, wherein the caffeine is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 8). The composition of any of the preceding claims, wherein the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 9). The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.50 to 2.0 percent-by-weight, the caffeine is present in an amount of from 0.50 to 2.0 percent-by- weight, and the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.10 to 2.0 percent-by-weight, each based on the weight of the composition (see claim 10). The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.80 to 1.50 percent-by-weight, the caffeine is present in an amount of from 0.80 to 1.50 percent- by-weight, and the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.10 to 1.0 percent-by-weight, each based on the weight of the composition (see claim 11). The solvent system used in the compositions of the present disclosure is water-based, alcohol- based or water-alcohol-based. Typically, the solvent comprises water and one or more monovalent and/or polyvalent C1-C4 alcohols. According to embodiments, the solvent comprises water and an alcohol selected from ethanol, n-propanol, isopropanol, glycerol, ethylene glycol, propylene glycol or a combination thereof (paragraph 0069). According to embodiments, the compositions according to the present disclosure may be formulated as liquid formulations. The liquid formulation may have a conventional base for a cosmetic composition, for example an aqueous base, an alcoholic base or an aqueous-alcoholic base. The composition in the form of a liquid formulation may comprise (in addition to the active ingredient combination), for example, 70.0 to 99.5 percent-by-weight water-alcohol-based solvent. In particular, the composition in the form of a liquid formulation may comprise, for example, 90.0 to 99.0 percent-by-weight, for example 92.0 to 98.0 percent-by-weight, based on the weight of the composition, water-alcohol-based solvent (paragraph 0108). Analogs or derivatives, respectively, of sandal pentanol are believed to have a similar effect on mammalian hair growth, and may be used in the present disclosure alternatively or additionally to sandal pentanol. Sandal pentanol analogs suitable as active ingredients include:
• (4Z)-3-methyl-5-(2,2,3-trimethylcyclopent-3-en-l-yl)pent-4-en-2-ol (sandal pentenol) l-methyl-2-((l,2.2-trimethylbicyclo(3.1.0)hex-3-yl)methyl)-cyclopropane-methanol (sandal cyclopropane)
• (E)-3,3-dimethyl-5-(2,2,3-trimethylcyclopent-3-en-l-yl)pent-4-en-2-ol (santol pentenol)
• 2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-l-yl)butanol (sandal cyclopentane)
• (E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-l-yl)but-2-en-l-ol (sandalrome)
• (E)-2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-l-yl)-2-buten-l-ol (sandal butenol)
According to embodiments, the compositions according to the present disclosure comprise one or more of the above sandal pentanol analogs in addition to the active ingredient sandal pentanol. If present, sandal pentanol plus the one or more sandal pentanol analogs are present in total amounts as indicated below for sandal pentanol alone (paragraphs 0041-0042). The composition of any of claims 1-29, wherein the composition is a ready-to-use scalp-and-hair treatment product selected from hair tonic, hair lotion, hair conditioner, hair cream, hair shampoo, dry shampoo, hair rinse, hair liquid, hair oil, hair pomade, hair foam, hair spray (see claim 40).
With regard to the limitations of instant claims 3-6 and 10, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
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.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Springob et al. (WO2022/112419, IDS reference 10/22/2024, Applicant’s own work).
Applicants’ claims
Applicants claim “Cosmetic use of a topically applicable rinse-off composition (RC) comprising as components
(A) sandal pentanol ((3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol) and/or one or more sandal pentanol analog(s),
(B) caffeine,
(C) at least one C10-C18 fatty acid and/or salts thereof,
(D) at least one surfactant, and
(E) at least one cosmetically acceptable solvent
for
(i) improving hair structure, and
(ii) hair loss reduction.”
Dependent claims thereof recite additional features.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Springob et al. teach a composition for promoting hair growth, and/or reducing or preventing hair loss, respectively, comprises sandal pentanol, caffeine, one or more saturated and unsaturated C10-C18 fatty acids, and a solvent (see abstract and claim 1).The examiner notes that as sandal pentanol is part of the composition it is 100% by weight based on the total amount of component (A) meeting the limitation of claim 12. The solvent further may comprise one or more solubilisation enhancers. The solubilisation enhancers obviously are intended to solubilize compounds which are not or only partially soluble in the solvent at the concentration used in the compositions. Solubilisation enhancers generally include surfactants. Surfactants include anionic, cationic, amphoteric and non-ionic surfactants (paragraph 0070 and claim 22). Preferred surfactants encompass non-ionic surfactants, in particular polyoxyethylated fatty alcohols or oils. Particularly preferred non-ionic surfactants include polyoxyethylated Castor Oil and hydrogenated polyoxylated Castor Oil. Specific examples of non-ionic surfactants that may be used in the compositions of the present disclosure are PEG-35 Castor Oil, PEG-40 Hydrogenated Castor Oil, and combinations thereof (paragraph 0077). The compositions may further comprise care materials, such as hair-care providing or skin-care- providing plant or vegetable extracts, cationic polymers or cationic surfactants. Typical amounts of care materials in the compositions according to the present disclosure will be in the range of from 0.010 to 5.0, in particular 0.050-2.0 percent-by-weight, based on the weight of the composition (paragraph 0096). Additional cosmetically acceptable additives, which may be present in the compositions according to the present disclosure include:
• physiologically compatible silicone derivative compounds, such as volatile or non-volatile silicone or high molecular weight siloxane polymers, such as for example Quaternium-80, typically in an amount of from 0.05 to 20 percent-by-weight, in particular from 0.10 to 5.0 percent-by-weight, based on the weight of the composition (the examiner notice that Quaternium-80 is a cationic surfactant). Additives include combability improving agents, such as for example cationic surfactants such as Behentrimonium Chloride, or cationic polymers such as Polyquaternium-10, etc. The cosmetically acceptable additives may be used in the compositions according to the present disclosure in any combinations, as desired or required (see paragraphs 0097-0098). The composition of claim 1, wherein the C10-C18 fatty acid(s) is/are selected from capric acid (C10:0), lauric acid (C12:0), myristic acid (C14:0), isomyristic acid (C14:0), palmitic acid (C16:0), palmitoleic acid (C16:l), stearic acid (C18:0), oleic acid (C18:l), linoleic acid (C18:2), linolenic acid (C18:3), parinaric acid (C18:4), petroselinic acid (C18:l), or combinations thereof (see claim 2). The composition of claim 1 or 2, wherein the C10-C18 fatty acid(s) comprise lauric acid (C12:0), myristic acid (C14:0), or a combination thereof (claim 3). The examiner notes that since lauric acid is one of the three alternatives to be picked it will meet 100% based on the total weight of component (C) meeting the limitation of instant claim 11. The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 7). The composition of any of the preceding claims, wherein the caffeine is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 8). The composition of any of the preceding claims, wherein the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 9). The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.50 to 2.0 percent-by-weight, the caffeine is present in an amount of from 0.50 to 2.0 percent-by- weight, and the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.10 to 2.0 percent-by-weight, each based on the weight of the composition (see claim 10). The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.80 to 1.50 percent-by-weight, the caffeine is present in an amount of from 0.80 to 1.50 percent- by-weight, and the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.10 to 1.0 percent-by-weight, each based on the weight of the composition (see claim 11). The solvent system used in the compositions of the present disclosure is water-based, alcohol- based or water-alcohol-based. Typically, the solvent comprises water and one or more monovalent and/or polyvalent C1-C4 alcohols. According to embodiments, the solvent comprises water and an alcohol selected from ethanol, n-propanol, isopropanol, glycerol, ethylene glycol, propylene glycol or a combination thereof (paragraph 0069). According to embodiments, the compositions according to the present disclosure may be formulated as liquid formulations. The liquid formulation may have a conventional base for a cosmetic composition, for example an aqueous base, an alcoholic base or an aqueous-alcoholic base. The composition in the form of a liquid formulation may comprise (in addition to the active ingredient combination), for example, 70.0 to 99.5 percent-by-weight water-alcohol-based solvent. In particular, the composition in the form of a liquid formulation may comprise, for example, 90.0 to 99.0 percent-by-weight, for example 92.0 to 98.0 percent-by-weight, based on the weight of the composition, water-alcohol-based solvent (paragraph 0108). Analogs or derivatives, respectively, of sandal pentanol are believed to have a similar effect on mammalian hair growth, and may be used in the present disclosure alternatively or additionally to sandal pentanol. Sandal pentanol analogs suitable as active ingredients include:
• (4Z)-3-methyl-5-(2,2,3-trimethylcyclopent-3-en-l-yl)pent-4-en-2-ol (sandal pentenol) l-methyl-2-((l,2.2-trimethylbicyclo(3.1.0)hex-3-yl)methyl)-cyclopropane-methanol (sandal cyclopropane)
• (E)-3,3-dimethyl-5-(2,2,3-trimethylcyclopent-3-en-l-yl)pent-4-en-2-ol (santol pentenol)
• 2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-l-yl)butanol (sandal cyclopentane)
• (E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-l-yl)but-2-en-l-ol (sandalrome)
• (E)-2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-l-yl)-2-buten-l-ol (sandal butenol)
According to embodiments, the compositions according to the present disclosure comprise one or more of the above sandal pentanol analogs in addition to the active ingredient sandal pentanol. If present, sandal pentanol plus the one or more sandal pentanol analogs are present in total amounts as indicated below for sandal pentanol alone (paragraphs 0041-0042). The composition of any of claims 1-29, wherein the composition is a ready-to-use scalp-and-hair treatment product selected from hair tonic, hair lotion, hair conditioner, hair cream, hair shampoo, dry shampoo, hair rinse, hair liquid, hair oil, hair pomade, hair foam, hair spray (see claim 40).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Springob et al. teach the amount of the at least one cosmetically acceptable solvent, the amount of the at least one surfactant, and the weight ratio of component (A) to component (B) in obvious or overlapping manner. Springob et al. with regard to the amount of solvent teach that according to embodiments, the compositions according to the present disclosure may be formulated as liquid formulations. The liquid formulation may have a conventional base for a cosmetic composition, for example an aqueous base, an alcoholic base or an aqueous-alcoholic base. The composition in the form of a liquid formulation may comprise (in addition to the active ingredient combination), for example, 70.0 to 99.5 percent-by-weight water-alcohol-based solvent. In particular, the composition in the form of a liquid formulation may comprise, for example, 90.0 to 99.0 percent-by-weight, for example 92.0 to 98.0 percent-by-weight, based on the weight of the composition, water-alcohol-based solvent (paragraph 0108). With regard to the weight ratio of component (A) to component (B) Springob et al. teach the composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 7). The composition of any of the preceding claims, wherein the caffeine is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 8). For example, one can calculate a ratio of 2.0/0.1 to 0.1/2.0 which will be equivalent to 20:1 to 1:20 which encompasses all the claimed ratios in claim 7. This is further addressed by the prima facie argument. With regard to the amount of surfactants Springob et al. teach the compositions may further comprise care materials, such as hair-care providing or skin-care- providing plant or vegetable extracts, cationic polymers or cationic surfactants. Typical amounts of care materials in the compositions according to the present disclosure will be in the range of from 0.010 to 5.0, in particular 0.050-2.0 percent-by-weight, based on the weight of the composition (paragraph 0096). Additional cosmetically acceptable additives, which may be present in the compositions according to the present disclosure include:
• physiologically compatible silicone derivative compounds, such as volatile or non-volatile silicone or high molecular weight siloxane polymers, such as for example Quaternium-80, typically in an amount of from 0.05 to 20 percent-by-weight, in particular from 0.10 to 5.0 percent-by-weight, based on the weight of the composition (the examiner notice that Quaternium-80 is also a cationic surfactant). Additives include combability improving agents, such as for example cationic surfactants such as Behentrimonium Chloride, or cationic polymers such as Polyquaternium-10, etc. The cosmetically acceptable additives may be used in the compositions according to the present disclosure in any combinations, as desired or required (see paragraphs 0097-0098).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to produce the instant invention by following the teachings of Springob et al. because Springob et al. teach substantially identical or similar composition for the same purpose. Springob et al. teach a composition for promoting hair growth, and/or reducing or preventing hair loss, respectively, comprises sandal pentanol, caffeine, one or more saturated and unsaturated C10-C18 fatty acids, and a solvent (see abstract and claim 1).The examiner notes that as sandal pentanol is part of the composition it is 100% by weight based on the total amount of component (A) meeting the limitation of claim 12. The solvent further may comprise one or more solubilisation enhancers. The solubilisation enhancers obviously are intended to solubilize compounds which are not or only partially soluble in the solvent at the concentration used in the compositions. Solubilisation enhancers generally include surfactants. Surfactants include anionic, cationic, amphoteric and non-ionic surfactants (paragraph 0070 and claim 22). Preferred surfactants encompass non-ionic surfactants, in particular polyoxyethylated fatty alcohols or oils. Particularly preferred non-ionic surfactants include polyoxyethylated Castor Oil and hydrogenated polyoxylated Castor Oil. Specific examples of non-ionic surfactants that may be used in the compositions of the present disclosure are PEG-35 Castor Oil, PEG-40 Hydrogenated Castor Oil, and combinations thereof (paragraph 0077) With regard to the amount of surfactants Springob et al. teach the compositions may further comprise care materials, such as hair-care providing or skin-care- providing plant or vegetable extracts, cationic polymers or cationic surfactants. Typical amounts of care materials in the compositions according to the present disclosure will be in the range of from 0.010 to 5.0, in particular 0.050-2.0 percent-by-weight, based on the weight of the composition (paragraph 0096). Additional cosmetically acceptable additives, which may be present in the compositions according to the present disclosure include:
• physiologically compatible silicone derivative compounds, such as volatile or non-volatile silicone or high molecular weight siloxane polymers, such as for example Quaternium-80, typically in an amount of from 0.05 to 20 percent-by-weight, in particular from 0.10 to 5.0 percent-by-weight, based on the weight of the composition (the examiner notice that Quaternium-80 is also a cationic surfactant). Additives include combability improving agents, such as for example cationic surfactants such as Behentrimonium Chloride, or cationic polymers such as Polyquaternium-10, etc. The cosmetically acceptable additives may be used in the compositions according to the present disclosure in any combinations, as desired or required (see paragraphs 0097-0098). The composition of claim 1, wherein the C10-C18 fatty acid(s) is/are selected from capric acid (C10:0), lauric acid (C12:0), myristic acid (C14:0), isomyristic acid (C14:0), palmitic acid (C16:0), palmitoleic acid (C16:l), stearic acid (C18:0), oleic acid (C18:l), linoleic acid (C18:2), linolenic acid (C18:3), parinaric acid (C18:4), petroselinic acid (C18:l), or combinations thereof (see claim 2). The composition of claim 1 or 2, wherein the C10-C18 fatty acid(s) comprise lauric acid (C12:0), myristic acid (C14:0), or a combination thereof (claim 3). The examiner notes that since lauric acid is one of the three alternatives to be picked it will meet 100% based on the total weight of component (C) meeting the limitation of instant claim 11. The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 7). The composition of any of the preceding claims, wherein the caffeine is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 8). The composition of any of the preceding claims, wherein the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 9). The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.50 to 2.0 percent-by-weight, the caffeine is present in an amount of from 0.50 to 2.0 percent-by- weight, and the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.10 to 2.0 percent-by-weight, each based on the weight of the composition (see claim 10). The composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.80 to 1.50 percent-by-weight, the caffeine is present in an amount of from 0.80 to 1.50 percent- by-weight, and the one or more C10-C18 fatty acid(s) is/are present in an amount of from 0.10 to 1.0 percent-by-weight, each based on the weight of the composition (see claim 11). The solvent system used in the compositions of the present disclosure is water-based, alcohol- based or water-alcohol-based. Typically, the solvent comprises water and one or more monovalent and/or polyvalent C1-C4 alcohols. According to embodiments, the solvent comprises water and an alcohol selected from ethanol, n-propanol, isopropanol, glycerol, ethylene glycol, propylene glycol or a combination thereof (paragraph 0069). According to embodiments, the compositions according to the present disclosure may be formulated as liquid formulations. The liquid formulation may have a conventional base for a cosmetic composition, for example an aqueous base, an alcoholic base or an aqueous-alcoholic base. The composition in the form of a liquid formulation may comprise (in addition to the active ingredient combination), for example, 70.0 to 99.5 percent-by-weight water-alcohol-based solvent. In particular, the composition in the form of a liquid formulation may comprise, for example, 90.0 to 99.0 percent-by-weight, for example 92.0 to 98.0 percent-by-weight, based on the weight of the composition, water-alcohol-based solvent (paragraph 0108). Analogs or derivatives, respectively, of sandal pentanol are believed to have a similar effect on mammalian hair growth, and may be used in the present disclosure alternatively or additionally to sandal pentanol. Sandal pentanol analogs suitable as active ingredients include:
• (4Z)-3-methyl-5-(2,2,3-trimethylcyclopent-3-en-l-yl)pent-4-en-2-ol (sandal pentenol) l-methyl-2-((l,2.2-trimethylbicyclo(3.1.0)hex-3-yl)methyl)-cyclopropane-methanol (sandal cyclopropane)
• (E)-3,3-dimethyl-5-(2,2,3-trimethylcyclopent-3-en-l-yl)pent-4-en-2-ol (santol pentenol)
• 2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-l-yl)butanol (sandal cyclopentane)
• (E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-l-yl)but-2-en-l-ol (sandalrome)
• (E)-2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-l-yl)-2-buten-l-ol (sandal butenol)
According to embodiments, the compositions according to the present disclosure comprise one or more of the above sandal pentanol analogs in addition to the active ingredient sandal pentanol. If present, sandal pentanol plus the one or more sandal pentanol analogs are present in total amounts as indicated below for sandal pentanol alone (paragraphs 0041-0042). The composition of any of claims 1-29, wherein the composition is a ready-to-use scalp-and-hair treatment product selected from hair tonic, hair lotion, hair conditioner, hair cream, hair shampoo, dry shampoo, hair rinse, hair liquid, hair oil, hair pomade, hair foam, hair spray (see claim 40). Springob et al. with regard to the amount of solvent teach that according to embodiments, the compositions according to the present disclosure may be formulated as liquid formulations. The liquid formulation may have a conventional base for a cosmetic composition, for example an aqueous base, an alcoholic base or an aqueous-alcoholic base. The composition in the form of a liquid formulation may comprise (in addition to the active ingredient combination), for example, 70.0 to 99.5 percent-by-weight water-alcohol-based solvent. In particular, the composition in the form of a liquid formulation may comprise, for example, 90.0 to 99.0 percent-by-weight, for example 92.0 to 98.0 percent-by-weight, based on the weight of the composition, water-alcohol-based solvent (paragraph 0108). With regard to the weight ratio of component (A) to component (B) Springob et al. teach the composition of any of the preceding claims, wherein the sandal pentanol is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 7). The composition of any of the preceding claims, wherein the caffeine is present in an amount of from 0.010 to 10.0 percent-by-weight, in particular in an amount of 0.10 to 2.0 percent-by-weight, based on the weight of the composition (see claim 8). For example, one can calculate a ratio of 2.0/0.1 to 0.1/2.0 which will be equivalent to 20:1 to 1:20 which encompasses all the claimed ratios in claim 7. This is further addressed by the prima facie argument. The examiner notes that the amounts of solvents and the weight ratios are classic result effective variables that a person of ordinary skill in the art in formulation science would routinely optimize and adjust. Furthermore, in the case where the claimed amounts of active and other ingredients and weight ratios "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration or any measurable parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). One of ordinary skill in the art would have had a reasonable chance of success in producing the instant invention by following the teachings of Springob et al. because Springob et al. teach substantially identical or similar composition for the same purpose.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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