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 .
Claim Status
Claims 1-20 are pending and under examination.
Priority
This application is a national stage entry of PCT/EP2022/062717 filed on 5/11/2022, which claims priority from PCTCN2021101152 filed on 6/21/2021 and EP21187344.3 filed on 7/23/2021.
Information Disclosure Statements
The information disclosure statement filed on 11/29/2023 has been considered by the examiner.
Claim Objections
Claim 1 is objected for use of “decanol, and nonanol;” when the recitation needs to be “decanol, or nonanol;” in this group of options that uses “selected from..” rather than “selected from the group consisting of…”. Appropriate correction is required.
Claim 3 is objected for use of “ethoxylated glyceryl ester, and ester of ethoxylated sorbitol.” when the recitation needs to be “ethoxylated glyceryl ester, or ester of ethoxylated sorbitol.” in this group that uses “selected from..” rather than “selected from the group consisting of…”. Appropriate correction is required.
Claim 4 is objected for use of “vaccenic acid, and erucic acid.” when the recitation needs to be “vaccenic acid, or erucic acid.” in this group of options that uses “selected from..” rather than “selected from the group consisting of…”. Appropriate correction is required.
Claim 10 is objected to as it needs “further” in between “comprises” and “a propellant” as this is a new item in the composition from claim 1. Appropriate correction is required.
Claim 19 is objected for use of “polyglyceryl-10 octoate, and polyglyceryl-10 decanoate.” when the recitation needs to be “polyglyceryl-10 octoate, or polyglyceryl-10 decanoate.” in this group of options that uses “selected from..” rather than “selected from the group consisting of…”. Appropriate correction is required.
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.
Claim 13 is rejected under USC 101 as the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is a Use claim without reciting any steps, and therefore, blurs the line between a method of use claim and a composition with an intended use. See Use claims in MPEP 2173.05(q). It is noted that the claim only refers to the composition that is in claim 11 rather than to the method that is in claim 11.
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 1-20 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.
Claim 1 is indefinite for the recitation of “at least one organic compound selected from fatty acid having 10-22 carbons,
and fatty alcohol which is selected from oleyl alcohol, isostearyl alcohol….” as it is unclear if the group of “at least one organic compound” is supposed to include the options of fatty acid and fatty alcohol or if “at least one organic compound” is chosen from fatty acid having 10-22 carbons while fatty alcohol is a separate item that needs to be present to meet the limitation of claim 1, part (iii). For the purpose of compact prosecution, the examiner will address both fatty acid and fatty alcohol as if applicant intended the at least one organic compound to be fatty acid and then to add fatty alcohol as another component. However, the alternate reading of them being options to one another will also apply in interpreting the prior art for a complete search. Applicant can provide clarity by removing the comma between “10-22 carbons” and “and fatty alcohol” or if applicant intends fatty alcohol to be a separate and needed component for the composition, then they may consider dividing (iii) into (iii-a) and (iii-b) parts.
Claims 2-20 are rejected as being dependent, directly or indirectly, on an indefinite claim.
Claims 8 and 18 recite the limitation "the organic acid" in the claim when it is preceded by “at least one organic compound” in claim 1. There is insufficient antecedent basis for this limitation in the claim. Applicant should amend the recitation to “the at least one organic compound”.
Claim 11 recites the limitation "the desired skin surface" in the claim when there is no earlier introduction of “a desired skin surface”. There is insufficient antecedent basis for this limitation in the claim. Applicant should amend the recitation to “a desired skin surface”.
Claims 12 and 13 are rejected as being dependent on an indefinite claim.
Claim 12 recites the limitation "the underarms" in the claim when there is no earlier introduction of “underarms”. There is insufficient antecedent basis for this limitation in the claim. Applicant should amend the recitation to “applied on underarms”.
Claim 13 is indefinite for being a Use claim where there are no steps in the claim, and thus, it is unclear if this is a method of use or a composition with intended use recitation. It is noted that the claim only refers to the composition that is in claim 11 rather than to the method that is in claim 11. See Use claims in MPEP 2173.05(q).
Claims 5, 14 and 15 is indefinite for recitations of “weight ratio of the amount of the amount of the lecithin to the amount of surfactant…” as it is unclear if “the amount of surfactant” is to the total amount of surfactant including the nonionic surfactant that would exist in the composition or if it is supposed to be toward “the nonionic surfactant” that is presented in claim 1. Applicant may amend the recitations to say “weight ratio of the amount of the amount of the lecithin to the amount of the surfactant…” if applicant intends the ratio to include the lecithin and the nonionic surfactant that was already introduced in claim 1.
Claim Rejections - 35 USC § 112(d)
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 4 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. Octanoic acid only has 8 carbons while claim 1 indicates that the fatty acid would have 10-22 carbons. Therefore, claim 4 does not further limit claim 1 as it includes a fatty acid that falls outside the range of 10-22. 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. Applicant may delete “octanoic acid” from claim 4 as one option.
Claim 19 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. Claim 19 includes polyglyceryl-2 tetraisostearate which has an HLB of 6-8 while claim 1 says the nonionic surfactant has to either have an HLB lower than 4.7 or higher than 8.6. Thus, this includes an item with an HLB outside of the range presented in claim 1. 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. Applicant may delete “polyglyceryl-2 tetraisostearate” from claim 19 as one option.
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 1-3, 5-9, 11-18 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Holovsky WO 2021127768A1 (effective filing date of 12-24-2019 and 12-22-2020).
In this reading, the fatty acid is an option in the group of at least one organic compound with the other being fatty alcohol. The nonionic surfactant is either one having an HLB lower than 4.7 or higher than 8.6. Thus, only one nonionic surfactant has to exist as long as it meets one of the HLB conditions.
Holovsky teaches antiperspirant compositions having glyceryl stearate, stearic acid (18 carbons) and lecithin in pharmaceutically acceptable carriers (abstract). Holovsky teaches other components that can be included are surfactants, fatty materials and others (abstract). Holovsky teaches a composition in example 3 that has 10% glyceryl stearate, 10% stearic acid and 5% sunflower lecithin with no water. Glyceryl stearate has an HLB of about 3.8 and is a known surfactant that is nonionic and the glycerol component is a polyol (polyol ester with stearic acid). The weight ratio of lecithin to stearic acid here would be 1:2. Paragraph 56 notes the compositions as being emulsions. Paragraph 54 teaches cosmetic use in the armpit region and skin application sites. Paragraph 30 provides for creams and lotions. Paragraphs 27 and 33 note that stearic acid can be between 5 and 20% by mass. 20% by mass stearic acid is allowed for the formulation.
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 1-9, 11-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maniga US 20110200545 and Banowski US 20080241089.
Maniga teaches a deodorant composition for skin, hair and fibers (abstract). Maniga teaches a composition for treating bromhidrosis that can be in the forms of sprays, solid sticks, soft solid, cream or gel (claim 1 of Maniga). Maniga teaches antiperspirant as a component (claim 1 of Maniga). Maniga teaches lecithin as a skin moisturizer and provides for amounts of 5%, 10%, 15%, 20%, 25%, 30%, 35% and 40% by weight (paragraph 77). Maniga teaches one tenth to forty percent by weight of lecithin (claim 8 of Maniga). Maniga teaches additional components including optional deodorant ingredients like glyceryl laurate, stearic acid (18 carbons) and/or ricinoleate such as glyceryl ricinoleate (paragraph 82 and claim 14 of Maniga). Maniga teaches carrier such as water (abstract), and thus, water is just an option for a type of carrier. Maniga teaches water is an optional carrier or diluent (paragraph 57). Maniga teaches application of a thin veneer or spray of the formulation on any skin or garment (paragraphs 91-92). Maniga teaches under the arm for application (paragraph 92). Maniga teaches reducing body odor (paragraph 95).
Maniga does not teach the combination of nonionic surfactants as in the claim.
Banowski teaches “A deodorant or antiperspirant stick composition in the form of an oil-in-water dispersion/emulsion, containing a) at least one lipid or wax component with a melting point >50° C., which is not to be apportioned to the components b) or c), b) at least one nonionic oil-in-water emulsifier with an HLB value of more than 7 within an oil-in-water emulsifier mixture with an average HLB value in the range of 10-19, c) at least one nonionic water-in-oil emulsifier with an HLB value of more than 1.0 and less than/equal to 7.0, chosen from the mono- and di-esters of ethylene glycol and the mono-, di-, tri- and tetra esters of pentaerythritol with linear saturated and unsaturated fatty acids with 12-30 carbon atoms, which can be hydroxylated, as well as mixtures thereof, as consistency providers and/or water binders, d) at least one oil, liquid at 20° C., which represents neither a scent component nor an essential oil, whereby the (average) solubility parameter of the totality of the contained oils differs in the presence of linear saturated fatty alcohols with a chain length of at least 8 carbon atoms by a maximum of −0.7 (cal/cm3)0.5 or a maximum of +0.7 (cal/cm3)0.5 and in the presence of water-in-oil emulsifiers, which are different from linear saturated fatty alcohols with a chain length of at least 8 carbon atoms, linear saturated fatty alcohols with a chain length of at least 8 carbon atoms being absent, by a maximum of −0.4 (cal/cm3)0.5 or a maximum of +0.7 (cal/cm3)0.5 from the (average) solubility parameter of the water-in-oil emulsifier(s), e) at least one water-soluble polyhydric C2-C9-alkanol with 2-6 hydroxyl groups and/or at least one water-soluble polyethylene glycol with 3-20 ethylene oxide units, f) 5% up to less than 50% by weight of water of the total composition, and g) at least one deodorant or antiperspirant active substance.” (abstract and claim 1 of Banowski). Banowski teaches fatty alcohols with chain length of at least 8 carbon atoms (paragraph 293). Table 1 ingredients include oleyl alcohol, isostearyl alcohol, decyl alcohol, erucic acid, arachidic acid, isostearic acid, stearic acid, linoleic acid, oleic acid, ricinoleic acid and others. Banowski teaches fatty alcohols like arachidyl alcohol and lanolin alcohol (paragraphs 69-71). Banowski teaches alkanols and carboxylic acids with 8-24 or 16-22 carbon atoms and linear saturated C12-C30 alkanols (paragraphs 79-89). Banowski teaches less than 30% water (claim 22 of Banowski). Banowski teaches nonionic emulsifier from 0.1 to 15 wt% by weight (paragraph 90) and nonionic emulsifier with HLB above 8 being Banowski teaches a an HLB value table starting from paragraph 92. Banowski also teaches nonionic emulsifiers with an HLB above 8 of maximum of 20% by weight (paragraph 291). Banowski teaches emulsifiers including sorbitan trioleate and others including polyglyceryls (e.g. decaglyceryls) (starting from paragraph 92 and also paragraph 64). Cutina FS45 is 3.5 wt% of the compositions in tables 2-4 and it is noted that FS45 is a combination of palmitic acid (16 carbons) and stearic acid (18 carbons) (under table 4). Banowski recognize that its formulations allow for rapid release of active ingredient on skin and is an effective carrier as well as having excellent cosmetic care properties (paragraphs 17 and 18). The ranges for nonionic emulsifiers taught by Banowski when combined with lecithin of Maniga would be capable of producing composition with weight ratios of lecithin to surfactant of 1:1, 3:1 and others based on overlapping ranges for use provided in these references (MPEP 2144.05).
One of ordinary skill in the art before the time of filing would have produced compositions with items and amounts of the applicant’s claims as the references recognize the utility of these ingredients (lecithin, nonionic surfactants of claimed HLB values, low amounts of water, and fatty acids and/or fatty alcohols) and provide for the use as an antiperspirant with Banowski providing its compositions have excellent cosmetic properties and ability as a carrier for actives. The combination of Maniga and Banowski also allow for overlapping concentration ranges of the lecithin, surfactants, organic compounds and water that would allow one of ordinary skill in the art to work within such ranges to produce compositions with such ranges and weight ratios of components (MPEP 2144.05). The references also provide for use as an antiperspirant and use under the arms on the skin. Thus, there was a reasonable expectation of success in combining the teachings of the references to provide compositions and methods of applicant’s claims with a reasonable expectation of success in having the compositions provide excellent cosmetic properties and effective use as an antiperspirant.
Claims 10 and 18 in addition to Claims 1-9, 11-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maniga US 20110200545, Banowski US 20080241089 and Alvarez US 20180311119.
Maniga and Banowski teach the claims as discussed above.
Maniga and Banowski do not teach an aerosol with propellant, although Maniga allows for sprays.
Alvarez teaches an antiperspirant aerosol product with anhydrous antiperspirant aerosol having propellant (abstract). Alvarez teaches various natural oils including oleic acid, linoleic acid and ricinoleic acid (paragraph 71). Alvarez teaches aliphatic alcohols including isostearyl alcohol and decanol (paragraph 75). Alvarez teaches 0 to 25% of a carrier oil (paragraph 67) of which natural oils and water miscible aliphatic alcohols are two. Amounts of such organic compounds up to 25% are allowable in antiperspirant formulations in teachings of Alvarez.
One of ordinary skill in the art before the time of filing would have added amounts of natural oils and/or aliphatic alcohols in such amounts up to 25wt% (MPEP 2144.05- overlapping ranges) and produced spray aerosols with propellant of such a product by the combined teachings of Alvarez with Maniga and Banowski which allows for aerosol antiperspirants having oily carriers. There would be a reasonable expectation of success in combining the teachings of the references to make a suitable aerosol formulation of the claimed ingredients and having it as an effectively delivery antiperspirant formulation.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maniga US 20110200545 and Li US 20240189212 (has different inventor and earlier effective filing dates of April 27, 2021 and June 2, 2021).
Maniga teaches a deodorant composition for skin, hair and fibers (abstract). Maniga teaches a composition for treating bromhidrosis that can be in the forms of sprays, solid sticks, soft solid, cream or gel (claim 1 of Maniga). Maniga teaches antiperspirant as a component (claim 1 of Maniga). Maniga teaches lecithin as a skin moisturizer and provides for amounts of 5%, 10%, 15%, 20%, 25%, 30%, 35% and 40% by weight (paragraph 77). Maniga teaches one tenth to forty percent by weight of lecithin (claim 8 of Maniga). Maniga teaches additional components including optional deodorant ingredients like glyceryl laurate, stearic acid (18 carbons) and/or ricinoleate such as glyceryl ricinoleate (paragraph 82 and claim 14 of Maniga). Maniga teaches carrier such as water (abstract), and thus, water is just an option for a type of carrier. Maniga teaches water is an optional carrier or diluent (paragraph 57). Maniga teaches application of a thin veneer or spray of the formulation on any skin or garment (paragraphs 91-92). Maniga teaches under the arm for application (paragraph 92). Maniga teaches reducing body odor (paragraph 95).
Maniga does not teach the nonionic surfactant limitation, although it allows for compounds that are nonionic surfactants and additional agents. Maniga does not teach aerosol with propellant or the 20% to 80% by weight of the organic compound(s).
Li teaches antiperspirant compositions with (i) at least one hydrophobic sorbitan ester having HLB value between 1 and 7.0; (ii) at least one hydrophilic sorbitan ester having HLB value between 7.0 and 20; (iii) at least one organic compound selected from C7-C24 fatty acid, or C7-C24 fatty alcohol; and (iv) a cosmetically acceptable carrier (abstract and claim 1). Li teaches 2 to 80 wt% of hydrophobic and of hydrophilic sorbitan ester surfactant (claims 8 and 9 of Li). Li teaches 5 to 90 wt% of organic compound (claim 10 of Li). Li teaches propellant and the composition being in the form of an aerosol (claim 12 of Li). Li teaches 20 to 80 wt% of the organic compound (claim 20 of Li). Li teaches fatty acids like oleic acid, etc. and fatty alcohols like oleyl alcohol, decanol and others (claims 4 and 5 of Li). Li teaches more particular hydrophobic and hydrophilic sorbitan esters (claims 2 and 3 of Li). Li provides for less than 30% of water (paragraph 46). Li provides for forms like roll on, lotion, firm solid, soft solid and others (paragraph 48). Li teaches methods of use (paragraphs 72-74). Li provides that its formulations provide stability to the formulation (paragraph 6).
One of ordinary skill in the art before the time of filing would have included surfactants and organic compounds as in Li into formulations of Maniga to make its lecithin containing antiperspirant products as the references provide for making antiperspirant compositions and Maniga even provides for lecithin in claimed amounts and additives that are surfactants and a fatty acid (stearic acid). Li provides the teachings to utilize types and amounts of nonionic surfactants with such HLB values and other organic compounds in antiperspirants that may be of various forms as taught in Maniga or Li. Thus, there was a reasonable expectation of success in including lecithin in levels greater than 3% by weight into antiperspirants formulations of the prior art like those of Li in order to provide new antiperspirant formulations for formulation stability and application to the user.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613