DETAILED ACTION
Status of Claims
Claims 1-17 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final
Claim Objections
The following claims are objected to because of the following informalities:
A. Claim 1 is objected to because the claim should read drawn to:
1. ([…]) A composition comprising
(a) at least one substituted azacycle according to formula (I), a salt or a solvate thereof
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wherein
n is 0 or 1 and R1 is selected from
(i) halogen,
(ii) C6-C10 aryl,
(iii) […],
(iv) C6-C10 aryl substituted with up to four substituents independently selected from the group consisting of halogen; OH; C═N; NO2; C1-C6 alkyl; C1-C6 alkyl comprising up to 5 halogen atoms; C1-C3 alkyl comprising up to 3 OH groups; C2-C6 alkenyl; C1-C6 alkoxy; C1—C6 alkoxy comprising up to 3 halogen atoms; C1-C3 alkoxy; C1-C3 alkyl; C3-C7 cycloalkyl; —C(O)R10 wherein R10 is selected from C1-C3 alkyl; —OC(O)R11 wherein R11 is selected from H, and C1-C3 alkyl; —C(O)O—R12 wherein R12 is selected from hydrogen and C1-C3 alkyl; —(CH2)mN(R13)R14 wherein m is 0 or 1, R13 is selected from hydrogen, C1-C3-alkyl, and —SOR15 wherein R15 is C1-C3-alkyl, and R14 is selected from hydrogen, C1-C3-alkyl, and —SO2R16 wherein R16 is C1-C3-alkyl, or wherein R13 and 14 form together with the N atom to which they are attached morpholine, thiomorpholine, or 1,1-dioxothiomorpholine; —SR17 wherein R17 is selected from hydrogen and C1-C3 alkyl; and —S(O)2R18 wherein R18 is selected from hydrogen and C1-C3 alkyl; with the proviso that when the aryl ring is substituted with two or more substituents, two substituents may form a cyclic ring together with the carbon atoms to which they are attached, and
(v) C5-C10 mono- or bicyclic heteroaryl wherein up to 2 C-atoms are replaced by [[a ]]hetero atoms independently selected from sulfur, nitrogen, and oxygen, substituted with up to four substituents selected from the group consisting of halogen; OH (hydroxyl); C═N (cyano); NO2 (nitro); C1-C6 alky; C1-C6 alky comprising up to 5 halogen atoms; C2-C6 alkenyl; C1-C6 alkoxy; C1-C6 alkoxy comprising up to 3 halogen atoms; C1-C3 alkoxy C1-C3 alkyl; C3-C7 cycloalkyl; —C(O)R20 wherein R20 is selected from C1-C3 alkyl; —OC(O)R21 wherein R21 is selected from H, and C1-C3 alkyl; —C(O)O—R22 wherein R22 is selected from hydrogen and C1-C3 alkyl; —(CH2)mN(R23)R24 wherein m is 0 or 1, R23 is selected from hydrogen, C—C alkyl, and —SOR25 wherein R25 24 1 3 2 is C1-C3 alkyl, and R is selected from hydrogen, C 26 26 1-C3 alkyl, and —SO2R wherein R is C1-C3 alkyl, or wherein R23 and R24 form together with the N atom to which they are attached morpholine, thiomorpholine, or 1,1-dioxothiomorpholine; —SR27 wherein R27 is selected from hydrogen and C1-C3 alkyl; and —S(O)2R28 wherein R28 is selected from hydrogen and C1-C3 alkyl;
Y is a monocyclic or bicyclic, unsaturated or aromatic heterocyclic ring comprising one, two, three or four heteroatoms independently selected from nitrogen, sulfur and oxygen, wherein the ring is optionally mono-, di-, or tri-substituted with a group selected from halogen, methyl, ethyl, —N(R40)R41, —CON(R40)R41, —[CR40R41]—C(O)OR40, —C 40 40 41 p (O)R, and —SO2N(R)R wherein R40 and R41 are independently selected from hydrogen and C1-C4 alkyl, and p is 0, 1, or 2;
A is a 5 to 7 membered heterocyclic ring optionally comprising one additional hetero atom selected from oxygen and sulfur, wherein the heterocyclic ring A is optionally substituted by one or two groups selected from —OH and ═O;
Z is either C, S or S(O);
and R4, R5 and R6 form together with the carbon atom to which they are attached a hydrocarbon group optionally comprising up to five hetero atoms selected from O, N, S, and F;
(b) at least one physiological cooling or warming agent, and/or
(c) at least one aroma or flavoring compound, and/or
(d) at least one fragrance,
wherein the compounds are present in a ratio by weight (a):(b+c+d) of from about 1:1,500,000:1 to about 1:1.
wherein the limitations for “Y,” “A” and “z” of “formula (I)” should be separate from “(v)” for “R1” of “formula (I).” Further, the “R” groups should be recited with superscripts consistent with “formula (I),” e.g., “R1” should be recited as “R1.”
B. Claim 9 is objected to because:
“citral or its mixtures”
should instead read:
“citral,
citral mixtures,”
as two separate line listings.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claims 1-17 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 pre-AIA , that applicant regards as the invention.
A. Claim 1 is drawn to:
1. ([…]) A composition comprising
(a) at least one substituted azacycle according to formula (I), a salt or a solvate thereof
[…];
[…];
(b) at least one physiological cooling or warming agent, and/or
(c) at least one aroma or flavoring compound, and/or
(d) at least one fragrance,
wherein the compounds are present in a ratio by weight (a):(b+c+d) of from about 1:1,500,000:1 to about 1:1.
wherein the use of “and/or” is indefinite. The use of “and/or” renders the metes and bounds of the claim unclear, for instance as to whether the claim requires:
component (a), and any one of components (b), (c) or (d); OR
any one of components (a), (b), (c) or (d).
In this regard, it is noted that the Board has held: “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (expanded panel). Subsequent claims 2-17 depend on claim 1 and are thus, indefinite as well.
B. Claim 1 is indefinite because the recitations:
“—SOR25 wherein R25 24 1 3 2 is C1-C3 alkyl,” and “C 26 26 1-C3 alkyl” for “(v)” for “R1” of “formula (I)”; and
“—C 40 40 41 p (O)R” for “Y” of “formula (I)”;
render the metes and bounds of the claim unclear because the sequence of numbers are unclear, for instance, as to whether, for instance, “R25 24 1 3 2 is C1-C3 alkyl” refers to a listing of possible radicals for “R,” i.e., “R25, R24, R1, R3, R2” being a “C1-C3 alkyl,” or some other structure.
C. Claim 1 is indefinite in the recitation, “wherein the compounds are present in a ratio by weight (a):(b+c+d) of from about 1:1,500,000:1 to about 1:1,” wherein the ratio “1:1,500,000:1” appears to be drawn to 3 components, not two components as recited in “(a):(b+c+d)” and the lower bound, “1:1.”
D. Claim 6 is indefinite in the recitation, “(b1).” There is insufficient antecedent basis for this limitation in the claim as no “(b1)” is recited in claim 1 from which claim 6 depends. See MPEP § 2173.05(e).
E. Claim 7 is indefinite in the recitation, “(b2).” There is insufficient antecedent basis for this limitation in the claim as no “(b2)” is recited in claim 1 from which claim 7 depends. See MPEP § 2173.05(e).
F. Claim 11 is indefinite in the recitation, “The preparation.” There is insufficient antecedent basis for this limitation in the claim as no “preparation” is recited in claim 9 from which claim 11 depends. See MPEP § 2173.05(e).
G. Claim 12 is indefinite in the recitation, “The preparation.” There is insufficient antecedent basis for this limitation in the claim as no “preparation” is recited in claim 9 from which claim 12 depends. See MPEP § 2173.05(e).
H. Claim 16 is indefinite in the recitation, “said preparation.” There is insufficient antecedent basis for this limitation in the claim as no “preparation” is recited in claim 1 from which claim 16 depends. See MPEP § 2173.05(e).
I. Claim 17 is indefinite in the recitation, “said preparation.” There is insufficient antecedent basis for this limitation in the claim as no “preparation” is recited in claim 1 from which claim 17 depends. See MPEP § 2173.05(e).
Further clarification is required.
Claim Rejections - 35 U.S.C. § 112(d)- Not Further Limiting
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 35 U.S.C. § 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 14 is rejected under 35 U.S.C. § 112(d) or 35 U.S.C. § 112 (pre-AIA ), 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 12 is drawn to
12. ([…]) The preparation of claim 9, comprising the composition in amounts of from about 0.01 to 1 wt.-percent—calculated on the preparation.
while claim 14 is drawn to:
14. ([…]) The preparation of claim 12, comprising the composition in amounts of from about 0.01 to 1 wt.-percent—calculated on the preparation.
wherein claim 14 appears to contain the same range requirement (i.e., “comprising the composition in amounts of from about 0.01 to 1 wt.-percent—calculated on the preparation”) as claim 12, and therefore, is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections – 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-17 are rejected under 35 U.S.C. § 103 as being unpatentable over COCITO (WO 2021/074281 A1, Apr. 22, 2021; filed Oct. 17, 2019; on 02/15/2024 IDS; hereinafter, “Cocito”).
Cocito is directed to:
Title: SUBSTITUTED AZACYLES AS TRMP8 MODULATORS
Abstract: Disclosed are TRPM8 modulators as defined by formula (I) for achieving a cooling effect on skin and mucousa.
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Cocito, title & abstract. In this regard, Cocito discloses “[a] composition comprising a cool sensation wherein the composition comprises a compound of formula (I)”:
9. A composition comprising a cool sensation wherein the composition comprises a compound of formula (I)
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10. A composition according to claim 9 comprising at least one compound of formula (I), a salt or solvate thereof, and a further cooling compound.
11. A composition according to claim 10 wherein the further cooling compound is selected from menthol, menthone, p-menthanecarboxamides, N-2,3-trimethyl-2- isopropyl-butanamide, menthyl lactate, menthone glycerol acetal, 3-(1- menthoxy)-propane-1,2-diol, p-menthane-3,8-diol, isopulegol, monomenthyl succinate, monomenthyl glutarate, o-menthylglycerol, menthyl N,N- dimethylsuccinamate, 2-(sec-butyl)cyclohexan-1-one, N-(pyrazol-3-yl)-N- (thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide, 2-(4-ethylphenoxy)-N-(pyrazol-3- yl)-N-(thiophen-2-ylmethyl)acetamide, 3-(benzo[d][1,3]dioxol-5-yl)-N,N- diphenylacrylamide, 4-(2-(4-allyl-2,6-dimethoxyphenoxy)-1-ethoxypropyl)-2- methoxyphenol, 4-(2-(4-allyl-2,6-dimethoxyphenoxy)-1-((2-isopropyl-5- methylcyclohexyl)oxy)propyl)-2-methoxyphenol, N-(2-Hydroxy-2-phenylethyl)-2-isopropyl-5,5-dimethylcyclohexane-1-carboxamide, N-(4-(Cyanomethyl)phenyl)- 2-isopropyl-5,5-dimethylcyclohexanecarboxamide and N-(3-Hydroxy-4- methoxyphenyl )-2-isopropyl-5,5-dimethylcyclohexanecarboxamide.
Cocito, claims 9-11.
Regarding independent claim 1 and the requirements:
1. ([…]) A composition comprising
(a) at least one substituted azacycle according to formula (I), a salt or a solvate thereof
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wherein
n is 0 or 1 and R1 is selected from
(i) halogen,
(ii) C6-C10 aryl,
(iii) C5-C10 mono- or bicyclic heteroaryl wherein up to 2 C-atoms are replaced by at least one hetero atom independently selected from sulfur, nitrogen, and oxygen,
(iv) C6-C10 aryl substituted with up to four substituents independently selected from the group consisting of halogen; OH; C═N; NO2; C1-C6 alky; C1-C6 alkyl comprising up to 5 halogen atoms; C1-C3 alkyl comprising up to 3 OH groups; C2-C6 alkenyl; C1-C6 alkoxy; C1—C6 alkoxy comprising up to 3 halogen atoms; C1-C3 alkoxy C1-C3 alkyl; C3-C7 cycloalkyl; —C(O)R10 wherein R10 is selected from C1-C3 alkyl; —OC(O)R11 wherein R11 is selected from H, and C1-C3 alkyl; —C(O)O—R12 wherein R12 is selected from hydrogen and C1-C3 alkyl; —(CH2)mN(R13)R14 wherein m is 0 or 1, R13 is selected from hydrogen, C1-C3-alkyl, and —SOR15 wherein R15 is C1-C3-alkyl, and R14 is selected from hydrogen, C1-C3-alkyl, and —SO2R16 wherein R16 is C1-C3-alkyl, or wherein R13 and 14 form together with the N atom to which they are attached morpholine, thiomorpholine, or 1,1-dioxothiomorpholine; —SR17 wherein R17 is selected from hydrogen and C1-C3 alkyl; and —S(O)2R18 wherein R18 is selected from hydrogen and C1-C3 alkyl; with the proviso that when the aryl ring is substituted with two or more substituents, two substituents may form a cyclic ring together with the carbon atoms to which they are attached, and
(v) C5-C10 mono- or bicyclic heteroaryl wherein up to 2 C-atoms are replaced by a hetero atoms independently selected from sulfur, nitrogen, and oxygen, substituted with up to four substituents selected from the group consisting of halogen; OH (hydroxyl); C═N (cyano); NO2 (nitro); C1-C6 alky; C1-C6 alky comprising up to 5 halogen atoms; C2-C6 alkenyl; C1-C6 alkoxy; C1-C6 alkoxy comprising up to 3 halogen atoms; C1-C3 alkoxy C1-C3 alkyl; C3-C7 cycloalkyl; —C(O)R20 wherein R20 is selected from C1-C3 alkyl; —OC(O)R21 wherein R21 is selected from H, and C1-C3 alkyl; —C(O)O—R22 wherein R22 is selected from hydrogen and C1-C3 alkyl; —(CH2)mN(R23)R24 wherein m is 0 or 1, R23 is selected from hydrogen, C—C alkyl, and —SOR25 wherein R25 24 1 3 2 is C1-C3 alkyl, and R is selected from hydrogen, C 26 26 1-C3 alkyl, and —SO2R wherein R is C1-C3 alkyl, or wherein R23 and R24 form together with the N atom to which they are attached morpholine, thiomorpholine, or 1,1-dioxothiomorpholine; —SR27 wherein R27 is selected from hydrogen and C1-C3 alkyl; and —S(O)2R28 wherein R28 is selected from hydrogen and C1-C3 alkyl; Y is a monocyclic or bicyclic, unsaturated or aromatic heterocyclic ring comprising one, two, three or four heteroatoms independently selected from nitrogen, sulfur and oxygen, wherein the ring is optionally mono-, di-, or tri-substituted with a group selected from halogen, methyl, ethyl, —N(R40)R41, —CON(R40)R41, —[CR40R41]—C(O)OR40, —C 40 40 41 p (O)R, and —SO2N(R)R wherein R40 and R41 are independently selected from hydrogen and C1-C4 alkyl, and p is 0, 1, or 2; A is a 5 to 7 membered heterocyclic ring optionally comprising one additional hetero atom selected from oxygen and sulfur, wherein the heterocyclic ring A is optionally substituted by one or two groups selected from —OH and ═O; Z is either C, S or S(O);
and R4, R5 and R6 form together with the carbon atom to which they are attached a hydrocarbon group optionally comprising up to five hetero atoms selected from O, N, S, and F;
(b) at least one physiological cooling or warming agent, and/or
(c) at least one aroma or flavoring compound, and/or
(d) at least one fragrance,
wherein the compounds are present in a ratio by weight (a):(b+c+d) of from about 1:1,500,000:1 to about 1:1.
Cocito clearly teaches “[a] composition comprising a cool sensation wherein the composition comprises a compound of formula (I)” (Cocito, claims 9-11), WHEREBY it is noted:
Cocito’s “compound of formula (I)” (Cocito, claim 9) is “(a) at least one substituted azacycle according to formula (I)” of claim 1, and encompasses “(2-(4-phenyl-1 H-imidazol-2-yl)piperidin-1-yl)(1,2,3-thiadiazol-5-yl)methanone” (Cocito, claim 2), which is “(2-(4-phenyl-1H-imidazol-2-yl)piperidin-1-yl)(1,2,3-thiadiazol-5-yl)methanone” of claim 5:
5. ([…]) The composition of claim 1, wherein compound (a) is selected from the group consisting of
(2-(4-phenyl-1H-imidazol-2-yl)piperidin-1-yl)(1,2,3-thiadiazol-5-yl)methanone,
[…],
and mixtures thereof.
a “further cooling compound” (Cocito, claims 10-11) such as “menthol” (Cocito, claim 11) is encompassed by “(b) at least one physiological cooling or warming agent” of claim 1, as well as “physiological cooling agent forming group (b1)” and “Menthol” of claim 6:
6. ([…]) The composition of claim 1, wherein said physiological cooling agent forming group (b1) is are selected from the group consisting of:
Menthol,
[…],
and mixtures thereof.
However, it is noted that although Cocito teaches “[t]he level of use for compounds of the present invention (compounds as defined by formula (I), which encompass compounds of formula (Ia), (Ib) and (Ic)) depend, inter alia, upon the target TRPM8 area of the body but also on the cooling potency of compound or mixture of compounds,” e.g., in “oral application” and “delivered topically”:
The level of use for compounds of the present invention (compounds as defined by formula (I), which encompass compounds of formula (Ia), (Ib) and (Ic)) depend, inter alia, 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 of a compound of the present invention, such as dentifrice, floss, chewing gum, or white strip, the levels of use may be from about 0.00001 % (0.01 ppm) to about 0.1 % (1000 ppm); from about 0.00005% (0.5 ppm) to about 0.1 % (1000 ppm); from about 0.0001 % (1 ppm) to about 0.05% (500 ppm); or from about 0.001 % (10 ppm) to about 0.01 % (100 ppm) by weight of the composition. When a compound of the present invention is used in a mouthwash, the level of use may be from about 0.000001 % (10 ppb) to about 0.01 % (100 ppm) or from about 0.0001 % (1 ppm) to about 0.001 % (10 ppm) by weight of the composition. When a compound of the present invention is delivered topically, for example in shampoos and lotions the levels may be from about 0.001 % (10 ppm) to about 0.5% (5000 ppm) by weight of the composition or from about 0.01 % (100 ppm) to about 0.4% (4000 ppm) by weight of the composition.
(Cocito, p. 33, ln. 31 to p. 34, ln. 12), Cocito, however, DOES NOT EXPRESSLY TEACH a composition thereof in order to meet the requirements of claim 1 for “wherein the compounds are present in a ratio by weight (a):(b+c+d) of from about 1:1,500,000:1 to about 1:1,” or the requirements of claims 2-4 for:
2. ([…]) The composition of claim 1 comprising the ingredients in a ratio by weight (a):(b+c+d) of from about 1:1,500,000 to about 1:10.
3. ([…]) The composition of claim 1 comprising the ingredients in a ratio by weight (a):(b+c+d) of from about 1:100,000 to about 1:100.
4. ([…]) The composition of claim 1, comprising the compounds in a ratio by weight (a):(b+c+d) of from about 1:40,000 to about 1:500.
which is well within the purview of the ordinarily skilled artisan, in light of Cocito’s broader disclosure. In this regard, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange the disclosed above cited components of Cocito in order to arrive at a composition (Cocito, claims 9-11) containing
Cocito’s “compound of formula (I)” (Cocito, claim 9) in amount
“from about 0.00001 % (0.01 ppm) to about 0.1 % (1000 ppm)” for “oral application,” OR “from about 0.001 % (10 ppm) to about 0.5% (5000 ppm)” to be “delivered topically” (Cocito, p. 33, ln. 31 to p. 34, ln. 12); AND
a “further cooling compound” (Cocito, claims 10-11) such as “menthol” (Cocito, claim 11).
It is noted that the use of “and/or” in claim 1 is interpreted as minimally requiring at least one of instant omponents (b), (c) and (d). With regard to the range ratio requirements of claims 1-4, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘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).” Further in this respect, it is further noted, “[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); and also MPEP § 2144.05(II)(A). In the instant case, the amount of compounds of Cocito’s “formula (I)” is clearly a result-effective variable, which Cocito discloses as “depend[ing], inter alia, upon the target TRPM8 area of the body but also on the cooling potency of compound or mixture of compounds,” e.g., in “oral application” and “delivered topically.” Cocito, p. 33, ln. 31 to p. 34, ln. 12. Therefore, it would have been customary for an artisan of ordinary skill to select an appropriate amount of compounds of Cocito’s “formula (I)” in optimizing for the “target TRPM8 area of the body but also on the cooling potency of compound or mixture of compounds” (Cocito, p. 33, ln. 31 to p. 34, ln. 12), thereby rendering the range ratio requirements of claims1-4 obvious.
Thus, Cocito renders claims 1-6 obvious.
Regarding claim 7 and the requirements:
7. ([…]) The composition of claim 1, wherein said physiological warming agent forming group (b2) is are selected from the group consisting of:
vanillyl derivatives;
[…];
and mixtures thereof.
Cocito teaches “In one particular embodiment the compounds of formula (I) (which encompass the compounds of formula (la), (lb) and (le)) may be combined with […], vanillin, […], ethyl-vanillin, […], or mixtures thereof” (Cocito, p. 38, ln. 16-34), which are encompassed by “vanillyl derivatives” of claim 7. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, Cocito renders claim 7 obvious.
Regarding claims 8-9 and the requirements:
8. ([…]) The composition of claim 1, wherein said flavoring compound is selected from the group consisting of:
[…]
citral;
[…];
and mixtures thereof.
9. ([…]) The composition of claim 1, wherein said fragrance forming group (d) is selected from the group consisting of:
[…],
citral or its mixtures,
[…],
and mixtures thereof.
Cocito teaches “In one particular embodiment the compounds of formula (I) (which encompass the compounds of formula (la), (lb) and (le)) may be combined with […], citral, or mixtures thereof” (Cocito, p. 38, ln. 16-34), which are encompassed by “citral” of claims 8-9. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, Cocito renders claims 8-9 obvious.
Regarding claims 10-14 and the requirements:
10. ([…]) A cosmetic preparation comprising the composition of claim 1.
11. ([…]) The preparation of claim 9, which is skin care, personal care, hair care, sun care or oral care preparation.
12. ([…]) The preparation of claim 9, comprising the composition in amounts of from about 0.01 to 1 wt.-percent—calculated on the preparation.
13. ([…]) A foodstuff preparation comprising the composition of claim 1.
14. ([…]) The preparation of claim 12, comprising the composition in amounts of from about 0.01 to 1 wt.-percent—calculated on the preparation.
Cocito teaches:
“In certain embodiments cosmetic products are skincare products, especially bath products, skin washing and cleansing products, skincare products, eye makeup, nail care products, foot care products, and the like” (Cocito, p. 33, ln. 5-7), which encompasses a “cosmetic preparation” of claim 10, and a “skin care, personal care, […] preparation” of claim 11; and
“In certain embodiments food products are iced consumable products such as ice cream, sorbet; confectioneries such as candies and chocolates; food products containing mint or mint flavour, sauces, dairy products such as milk-based drinks and yoghurts; and snacks” (Cocito, p. 32, ln. 27-30), which are encompassed by a “foodstuff preparation” of claim 13.
Since it would be obvious to rearrange the disclosed above cited components of Cocito in order to arrive at a composition (Cocito, claims 9-11) containing Cocito’s “compound of formula (I)” (Cocito, claim 9), “menthol” (Cocito, claim 11) and “citral” (Cocito, p. 38, ln. 16-34), it would have been customary for an artisan of ordinary skill to select an appropriate amount of compounds of Cocito’s “formula (I),” and a composition thereof, in optimizing for the “target TRPM8 area of the body but also on the cooling potency of compound or mixture of compounds” (Cocito, p. 33, ln. 31 to p. 34, ln. 12), e.g., in amounts “from about 0.00001 % (0.01 ppm) to about 0.1 % (1000 ppm)” for “oral application,” OR “from about 0.001 % (10 ppm) to about 0.5% (5000 ppm)” to be “delivered topically” (Cocito, p. 33, ln. 31 to p. 34, ln. 12).
Thus, Cocito renders claims 10-14 obvious.
Regarding claims 15-17 and the requirements:
15. ([…]) A method for improving antimicrobial stability of a cosmetic or foodstuff preparation, comprising the step of adding a working amount of the composition of claim 1 to said preparation.
16. ([…]) A method for masking unpleasant flavors, particularly unpleasant flavors of fluorine derivatives and bitter compounds, comprising the step of adding a working amount of the composition of claim 1 to said preparation.
17. ([…]) A method for enhancing and/or boosting the performance of a flavor, a sweetener or a soothing agent, comprising the step of adding a working amount of the composition of claim 1 to said preparation.
Cocito teaches the incorporation of a composition (Cocito, claims 9-11) containing Cocito’s “compound of formula (I)” (Cocito, claim 9), “menthol” (Cocito, claim 11) into “cosmetic products” (Cocito, p. 33, ln. 5-7) and “food products” (Cocito, p. 32, ln. 27-30), which encompasses the active step requirements of claims 15-17 for “adding a working amount of the composition of claim 1 to said preparation.”
Thus, Cocito renders claims 15-17 obvious.
Conclusion
Claims 1-17 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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