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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/440,489, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional discloses menthyl ethylamido oxalate and menthol. While these compounds modulate TRPM8 receptors, the disclosure of these specific compounds does not provide adequate support for claiming the genus of cooling agents that modulate TRPM8 receptors. Additionally, the recitation of 1,1,1,3,3-pentafluoropropane, 1,1,1,2-tetrafluoroethane, and isobutane as vapocoolants does not provide adequate support for claiming the genus of compounds that may be used as vapocoolants as this embraces compounds not previous contemplated by Applicant. Finally, the provisional fails to disclose the claimed invention as having sun protective properties or comprising UV protective agents.
Accordingly, claims 1-8 are not entitled to the benefit of the prior application.
Specification
The disclosure is objected to because of the following informalities:
Throughout the specification, “oxalyate” should read “oxalate”.
[0004] line 3 “UC protection” should read “UV protection”.
[0004] line 3 “30 SPF of higher” should read “30 SPF or higher”.
[0010] and [0011] refer to drawings/figures that are not present. Amendment of the specification is required to cancel all references to the omitted drawings.
Appropriate correction is required.
The use of the terms Lidoderm, CERAPHYLTM 230, and FRESCOLAT® X-Cool, which are trade names or marks used in commerce, has been noted in this application. These terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware of in the specification.
Claim Objections
Claims 3 and 7 are objected to because of the following informalities:
Claims 3 and 7: “oxalyate” should read “oxalate”.
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 1-8 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 claims “an effective amount of vapocoolant.” The phrase "an effective amount" has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In re Fredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954). See MPEP 2173.05(c). In this case, the specification and prior art indicate that vapocoolants, such as propane and isobutane, may function as both cooling/numbing agents and as propellants.
Claims 2-6 depend from parent claim 1 and are rejected on the basis of inherited deficiencies of claim 1.
Claims 4 and 7 both claim “5-10% cooling oil.” This limitation is indefinite because the language could be interpreted to indicate, for example, “5-10% cooling oil, by volume”, “5-10% cooling oil, by weight,” or a “5-10% concentration of cooling oil.” Applicant should amend and/or add clarifying language.
Claim 8 depends from parent claim 1 and is rejected on the basis of inherited deficiencies of claim 1.
For purposes of compact prosecution, the limitation in both claims 4 and 7 is being understood as reciting the scope of “5-10% cooling oil, by volume”.
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)(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.
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipatedby Tamarkin et al. (US 2012/0237453, filed 1/8/2009, published 9/20/2012), as evidenced by Zhang (US 2014/0113971 A1, published 4/24/2014).
Regarding claim 1, the claim preamble recites, “for providing a cooling effect and for protecting from the sun.” This is a recitation of intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). A recitation of intended use must result in a structural difference in the claimed invention and the prior art in order for the recitation to limit the claim. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim. As the prior art anticipates the claimed composition, the limitations of the claim have been met.
Claim 1 recites a formulation comprising an effective amount of an active cooling agent that modulates TRPM8 receptors and an effective amount of vapocoolant.
Tamarkin teaches several foamable compositions which provide a cooling effect comprising a cooling agent such as menthol or peppermint oil (which reads on the active cooling agent that modulates TRPM8 receptors); and a propellant comprising a mixture of propane and butane [Examples 1, 2, 3, 4, 5, 6, 7, and 12].
As evidenced by Zhang, menthol and its derivatives are known modulators of TRPM8 receptors. See Zhang et al. (US 2014/0113971 A1, published 4/24/2014), paragraph [0038] and Technical Background below for support.
Tamarkin also teaches that the example compositions may be adapted such that an excess of propellent may be used to provide an initial physical cooling sensation (which reads on propellant being used as a vapocoolant) [0494], and further teaches that an effective amount of propellant may be from about 3% to about 25% or more by weight of the composition [0496 et seq.]. The compositions of Tamarkin were dispensed from aerosol canisters pressurized by propellant [0466, 0467], thus the compositions disclosed read on both an effective amount of vapocoolant used as propellant, and an effective amount of vapocoolant used as a cooling agent.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin (US 2012/0237453), as evidenced by Zhang (US 2014/0113971), as applied to claim 1 above, and further in view of Hamer (WO 2015/061829 A1, published 5/7/2015). Claim 2 recites the composition of claim 1, wherein the active cooling agent present in an amount of about 5% total final volume.
Tamarkin teaches compositions comprising a cooling agent and a propellant. Tamarkin further teaches cooling agents in varying amounts in different embodiments of the compositions, e.g. 15% menthol by weight [Example 6] and 10% peppermint oil by weight [Example 7] but fails to explicitly disclose a composition wherein the cooling agent is present in the amount of about 5.0% total final volume.
Hamer teaches a topical cooling fluid comprising menthol oil (which reads on active cooling agent) in the amount of 5% to 25% by volume [010]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Tamarkin with that of Hamer to include a cooling oil in the amount of 5-25% by volume to induce a cooling effect. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Furthermore, 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) See MPEP 2144.05.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin (US 2012/0237453) as applied to claim 1 above, and further in view of Johncock et al. (US 2022/0071872 A1, published 3/10/2022). Claim 3 recites the composition of claim 1, wherein the active cooling agent comprises menthyl ethylamido oxalate.
Tamarkin teaches compositions comprising a cooling agent and a propellant. Tamarkin discloses a number of cooling agents that modulate TRPM8, but fails to explicitly teach menthyl ethylamido oxalate.
Johncock teaches a sunscreen composition having a cooling action and discloses both menthol and menthyl ethylamido oxalate as examples of active cooling compounds that may be employed individually or in combination with one another to provide a cooling action [0238]. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Tamarkin with that of Johncock to substitute menthol with menthyl ethylamido oxalate as the active cooling agent in the composition to yield predictable results. Simple substitution of one known element for another to obtain predictable results supports a finding of obviousness. MPEP 2143.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin (US 2012/0237453), as evidenced by Zhang (US 2014/0113971), as applied to claim 1 above, and further in view of Hamer (WO 2015/061829 A1). Claim 4 recites the composition of claim 1, further comprising 5-10% cooling oil.
Tamarkin teaches compositions comprising a cooling agent and a propellant. Tamarkin further teaches that in some embodiments, the composition may further comprise cooling oils, such as peppermint oil and spearmint oil [0042]. Tamarkin does not explicitly teach the amount in which cooling oil may be present in the composition.
Hamer teaches a topical cooling fluid comprising menthol oil (which reads on cooling oil) in the amount of 5% to 25% by volume [010]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Tamarkin with that of Hamer to include a cooling oil in the amount of 5-25% by volume to induce a cooling effect. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Furthermore, 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) See MPEP 2144.05.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin (US 2012/0237453), as evidenced by Zhang (US 2014/0113971), as applied to claim 1 above, and further in view of Zhang et al. (previously cited). Claim 5 recites the composition of claim 1, further comprising a topical anesthetic.
As discussed, Tamarkin teaches compositions comprising a cooling agent and a propellant. Tamarkin further teaches that anesthetics may be added to the disclosed compositions [0044]. Tamarkin fails to explicitly disclose examples of specific topical anesthetics that would be suitable for such purpose.
Zhang teaches a topical pharmaceutical composition comprising a topical NSAID and a sensate (i.e. cooling agent). Zhang teaches that in some embodiments, the composition may further comprise anesthetics such as benzocaine, lidocaine, lidocaine hydrochloride, tetracaine, or tetracaine hydrochloride [Zhang 0016]. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would be obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Tamarkin with that of Zhang to select an anesthetic from the list of suitable examples taught by Zhang.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Johncock (US 2022/0071872 A1). Claim 6 recites the composition of claim 1, further comprising an effective amount of UV protective agents that provide an SPF of at least 30.
Johncock teaches several sunscreen compositions having a SPF of at least 30 [Examples 1, 2, 3, 4, 5, 6, 7, 8]. It would be obvious to include sunscreen agents in an effective amount necessary to provide an SPF level of at least 30. (See, e.g., Example 1 which comprises UV filters homosalate and bemotrizinol in effective amounts to achieve an in-vitro SPF level of 55.)
Johncock further teaches that the sunscreen compositions may comprise a cooling agent such as menthol or menthyl ethylamido oxalate [0237] (which reads on active cooling agent). Since Johncock discloses uses cooling agents for the purpose of providing a cooling action, it would be obvious to include a cooling agent in an effective amount known to provide such effect. Johncock also teaches that the sunscreen composition may be formulated as a spray with propellant (which reads on vapocoolant) [0243]. It would be obvious to include vapocoolant in an effective amount required to effectuate spraying a spray-formulation sunscreen composition.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Johncock (US 2022/0071872 A1), in view of Hamer (WO 2015/061829 A1). Claim 7 recites a cooling formulation comprising an effective amount of active cooling agent that modulates TRPM8 receptors, wherein the active cooling agent includes 5-10% by volume of menthyl ethylamido oxalate; an effective amount of UV protective agents providing an SPF of at least 30; and further comprising 5-10% cooling oil.
Johncock teaches several sunscreen compositions having a SPF of at least 30 [Examples 1, 2, 3, 4, 5, 6, 7, 8]. It would be obvious to include sunscreen agents in an effective amount necessary to provide an SPF level of at least 30. (See, e.g., Example 1 which comprises UV filters homosalate and bemotrizinol in effective amounts to achieve an in-vitro SPF level of 55.) Johncock teaches that the compositions may comprise menthyl ethylamido oxalate [0237]. Johncock also teaches that composition may comprise oils such as mint oil and clove oil [0219]. Johncock further teaches that the composition may comprise more than one cooling compound used in combination with one another [0238]. Johncock does not explicitly disclose a composition comprising menthyl ethylamido oxalate in the amount of 5%-10% by volume. Johncock also does not explicitly disclose a composition further comprising cooling oil in the amount of 5%-10% by volume.
As previously discussed, Hamer teaches a topical cooling fluid comprising menthol oil in the amount of 5% to 25% by volume [010]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Tamarkin with that of Hamer to include a cooling oil in the amount of 5-25% by volume to induce a cooling effect. Furthermore, differences in concentration or temperature generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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). Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Johncock with those of Hamer to include menthyl ethylamido oxalate in the amount of 5%-20% by volume.
Since 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) See MPEP 2144.05.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Johncock (US 2022/0071872 A1) and Hamer (WO 2015/061829 A1), as applied to claim 7 above, and further in view of Zhang (US 2014/0113971). Claim 8 recites the composition of claim 7, further comprising a topical anesthetic.
Johncock and Hamer do not explicitly teach a cooling composition comprising a topical anesthetic. Zhang teaches a topical composition comprising a cooling sensate, and further teaches that the composition may comprise anesthetics such as benzocaine, lidocaine, and tetracaine [0016]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Johncock and Hamer with that of Zhang, to modify the sunscreen composition as taught by Johncock, comprising menthyl ethylamido oxalate and cooling oil in the amounts taught by Hamer, with a topical anesthetic as taught by Zhang.
Zhang teaches combining a topical anesthetic with a cooling sensate to reduce pain on the skin, and it would have been obvious to a person having ordinary skill in the art to include a topical anesthetic in the sunscreen composition to improve the functionality of the sunscreen composition to both protect from the sun and soothe sunburned skin.
Technological Background
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Liu et al. (Pain, 2013) is pertinent for teaching that menthol, the cooling natural product derived from peppermint, induces a cooling sensation by activating TRPM8 receptor [Liu, Abstract].
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached M-F 730-5 ET.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613