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 1-22 filed 07/24/2024 are pending in the application and are hereby examined on the merits.
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 20-22 are rejected under 35 U.S.C. 101 because they are 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 a claim directed to a “use” is considered to be an improper definition of a process per MPEP § 2173.05(q).
Claim Objections
Claim 1 is objected to because the following informality: line 10, “C(O)O-C1-C3-alkyl” should read “C(O)O-(C1-C3) alkyl”. Claims 5-6 are objected to for the same reason. Appropriate correction is required.
Claim 4 is objected to because a space is needed between “Claim 1” and “comprising”. Appropriate correction is required.
Claims 5 is objected to because of the unusual font size. Appropriate correction is required.
Claim 7 is objected to because of the following informality: “one or more of the following compounds” in the beginning and “mixture thereof” in the end do not really co-exist. Appropriate correction is required
Claims 8-11 are objected to because of the following informality: an “and” is needed to connect the last two substances in each of the claims. 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 1-6 and 8-22 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 rendered indefinite because R5 in formula (I) is not defined, and it is unclear whether the wavy line in line 19 is where substitute Y is connected to the ring A. Claims 2-6 and 9-22 are rendered indefinite because their ultimate dependency from claim 1. Note that R5 in formula (Ia) or formula (Ib) of claims 5-6 is not defined either. Appropriate correction is required.
Claim 8 recites “said physiological cooling compounds forming group (b1)”. There is insufficient antecedent basis for this limitation in the claim. Clarification is required.
Claim 9 recites “said physiological warming compounds forming group (b2)”. There is insufficient antecedent basis for this limitation in the claim. Clarification is required.
Claim 10 recites “said flavors forming group (c)”. There is insufficient antecedent basis for this limitation in the claim. Clarification is required.
Claim 11 recites “said fragrances forming group (d)”. There is insufficient antecedent basis for this limitation in the claim. Clarification is required.
Claim 13 recites “The preparation of Claim 9”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, claim 13 is interpreted to depend from claim 12. Appropriate correction is required.
Claim 14 recites “The preparation of Claim 9”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, claim 14 is interpreted to depend from claim 12. Appropriate correction is required.
Claim 18 recites “particularly”. The phase render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 21 is rejected for the same reason. Appropriate correction is required.
Claim 18 recites “said preparation”. There is insufficient antecedent basis for this limitation in the claim. It is further unclear what said preparation encompasses. Claim 19 is rejected for the same reason. Appropriate correction is required.
Claims 20-22 recites a use of a composition, without any steps as to how the use is to be practiced. Therefore, it is unclear what steps must be present in order to meet the claim.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cocito Armanino WO 2021/175971 A1 (cited in the IDS filed 10/24/2024, hereinafter referred to as Cocito Armanino).
Regarding claims 1-13 and 15, Cocito Armanino teaches a compound that meets present formula (I), formula (Ia), formula (Ib) and specific compounds as recited in claims 1 and 5-7 (page 2, line 16-page 3, line 24; page 8, line 1-page 9 line 11; page 10, line 18-page 11, line 24; page 13-16), and the compound is a TRPM8 modulator which could provide a cooling sensation on the human skin and/or mucosa (page 2, line 6-9). Further, Cocito Armanino teaches that the compound is combined with other cooling compounds or other actives such as flavoring, fragrance, and sweetening agents in a consumer product such as cosmetic (e.g., skincare, oral care, hair care, and personal care product) and foodstuff (page 22, line 8-13; page 23, line 13-15; page 19, line 11- page 20, line 5). The exemplar cooling compounds, flavoring, fragrance, and sweetening agents are menthol, WS-23, isopulegol, anethole, ethyl malto, vanillin, eugenol, cis-3-hexenol, linalool, ethyl butyrate, citral, ethyl acetate, cis-jasmone, decanal, citronellol, beta-ionone, geraniol, sucrose, xylitol, aspartame, etc. (page 22, line 15- page 23, line 11; page 24, line 22- page 25, line 13).
Regarding the limitations about the ratio of a/(b +c +d) (e.g., the compound of formula (I) to the sum of the cooling/warming agent, aroma/flavoring and the fragrance) as recited in claims 1-4: it is noted that Cocito Armanino does not teaches the ratios as recited in those claims, however, Cocito Armanino teaches that the compound is very potent at relative low concentrations (page 21, line 18-19), and further teaches that the level of use for the compound depends upon the target TRPM8 area of the body but also on the cooling potency of compound or mixture of compounds. For examples in an oral application (e.g., dentifrice, floss, chewing gum, or white strip), the levels of use may be from about 0.00001% to about 0.1% and narrowly 0.00005- 0.1%, 0.0001% - 0.05% or 0.001% - 0.01%. When a compound of the present invention is used in a mouthwash, the level of use may be from about 0.000001 %-0.01 % and narrowly 0.0001% -0.001%. When a compound of the present invention is delivered topically, for example in shampoos and lotions the levels may be 0.001% -0.5% and narrowly 0.01% - 0.4% (page 20, line 19-33). Therefore, one of the ordinary skill in the art would have been motivated to manipulate the amount of the compound of formula (I), and the amounts of the other cooling agents, flavorings and/or fragrances depending on the cooling potency, intensity of flavor, and/or intensity of sensory feeling desired for the cosmetic or foodstuff. As such, the ratios as recited in claims 1-4 are merely obvious variant of the prior art. Note those claims recite a very broad range for the ratios.
Additionally, since claim 9 further limits the warming agent of claim 1 but the warming agent is in alternative form with other ingredients, claim 9 is construed to be met by Cocito Armanino.
Regarding claims 14 and 16, Cocito Armanino as recited above teaches that the level of use for the compound depends, inter alia, upon the target TRPM8 area of the body but also on the cooling potency of compound or mixture of compounds, for example, the level is from 0.00001-0.1%, 0.001-0.5% or 0.01-0.4% in a cosmetic (e.g., white strip, shampoo and lotion). Further, as recited above, one of the ordinary skill in the art would have been motivated to manipulate the amounts of the other cooling agents, flavorings and/or fragrances depending on the cooling potency, intensity of flavor, and/or intensity of sensory feeling desired for the cosmetic. As such, the proportions of the composition as recited in claims 14 and 16 are merely obvious variant of the prior art.
Regarding claims 17-19, Cocito Armanino as recited above teaches adding a composition comprising the compound of claim 1 and another cooling compound or flavoring or fragrance to a cosmetic or a foodstuff, wherein the amount of the compound of claim 1 is included in the cosmetic or the foodstuff at an amount of 0.00001-0.1%, 0.001-0.5% or 0.01-0.4%. Note that the amount of the compound alone overlaps with the working amount (e.g., 0.01-2%) as recited in the instant specification (see para. 0173). Further, the preamble limitation about “improving antimicrobial stability”, “masking unpleasant flavor” and “enhancing and/or boosting the performance of a flavor, a sweetener or a soothing agent” in claims 17-19 recites the purpose of the claims, and the recited purposes do not result in a manipulative difference between the claims and prior art because the actual steps recited in Cocito Armanino and the instant claim are the same and will necessarily provide the purposes in the preamble of claims 17-19. Note that claims 17-19 do not recite the degree of improving, masking, enhancing or boosting.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cocito Armanino as applied to claim 1 above, and further in view of Ishii US Patent Application Publication No. 2006/0079640 A1 (hereinafter referred to as Ishii).
Regarding claim 9, Cocito Armanino teaches what has been recited above but is silent regarding combining the compound of claim 1 with a warming agent such as capsaicin. What Cocito Armanino teaches is that the compound can be combined with a flavoring that imparts a capsicum flavor (page 23, line 32; page 24, line 8).
Ishii teaches that capsaicin is responsible for the hot flavor of capsicum (0081).
Both Cocito Armanino and Ishii are directed to capsicum flavor, and where Cocito Armanino teaches combining the compound with a flavoring that imparts a capsicum flavor, Ishii teaches that capsaicin is responsible for the hot flavor of capsicum. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Cocito Armanino by combining capsaicin with the compound with reasonable expectation of success, for the reason that prior art has established that capsaicin is the source of capsicum flavor.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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