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 .
Detailed Action
This application is a national stage application of PCT/US2022/050350, filed November 18, 2022, which claims benefit of provisional applications 63/414674, filed November 10, 2022, and 63/281175, filed November 19, 2021. Claims 1, 2, 4, 16, 17, 22, 29, 30, 35, 42, 43, 48-50, 56, 74, 75, 77, 83, 85, 86, 93, and 104 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted December 9, 2024, is acknowledged wherein claims 2, 4, 16, 17, 22, 29, 30, 42, 43, 49, 50, 75, 77, 83, 85, 86, and 93 are amended and claims 3, 5-15, 18-21, 23-28, 31-34, 36-41, 44-47, 51-55, 57-73, 76, 78-82, 84, 87-89, 94-103, and 105-111 are canceled.
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 16 and 29 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 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:
Claim 16 includes the additional limitation requiring that the topical formulation does not comprise at least one of a number of other ingredients recited in the claim. It is unclear from the wording of the phrase “does not comprise at least one of…” whether this limitation requires that the composition not comprise any of these ingredients at all, or whether it merely requires that at least one of these ingredients be absent from the composition. For the sake of the present action this claim will be interpreted in accordance with its broadest reasonable interpretation, which is that it is infringed by a composition lacking at least one of the recited ingredients.
Claim 29 recites a number of ingredients including Mariliance®, Sensityl®, Rymsitive® 1609, and Apritone®, all of which are trademarks referring to various cosmetic ingredients. (See trademark registrations included with PTO-892) The use of a trademark or trade name in a patent claim is indefinite as these names refer to a source of goods rather than to the goods themselves, thereby creating ambiguity as to the actual limitations on the product that can be referred to by said name.
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.
(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, 4, 16, 17, 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoag. (PCT international publication WO2018/085535, Reference included with PTO-892)
Independent claim 1 is directed to a composition comprising a TRPV1 (Transient Receptor potential Vanilloid 1) antagonist and one of a large number of recited plant extracts. Hoag describes a topical pharmaceutical composition comprising a TRPV1 antagonist and a TRPA1 antagonist, along with sodium hyaluronate, an NSAID, and/or a cannabinoid. (p. 26 paragraph 70) Omega-3 and omega-9 fatty acids are described as being TRPV1 antagonists usable in the invention. (p. 34 paragraph 101, p. 35 paragraph 103) A specific composition is described (pp. 55-56 examples 1-2) which is a topical cream comprising Omega-3 and Omega-9 fatty acids, along with other plant extracts including Linum usitatissimum oil and Prunus armeniaca extract, which are extracts recited in present claim 1. Therefore this composition anticipates present claim 1. Regarding present claim 4, figure 7 of Hoag describes a composition comprising sodium hyaluronate at a concentration of 0.20%. Regarding present claim 16, the disclosed compositions do not include any of the recited ingredients. Regarding claim 17, p. 45 paragraph 129 of Hoag describes the composition as having a pH of between 4.7-7.3. Regarding present claim 35, p. 33 paragraph 99 of Hoag describes the composition as having a topical form including a gel or spray.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hoag. (PCT international publication WO2018/085535, Reference included with PTO-892)
The disclosure of Hoag is discussed above. Hoag further discloses an embodiment (figure 1) wherein the TRPV1 antagonist (omega-3 and omega-9 fatty acids) are each present in 1-10% by weight of the composition. These ranges overlap with the claimed range of 0.00001-4.0%, rendering the present claims obvious.
Claims 42, 43, 48-50, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Hoag as applied to claims 1, 4, 16, 17, and 35 above, and further in view of Duarte. (Reference included with PTO-892)
The disclosure of Hoag is discussed above. Hoag does not disclose a method of treating a condition associated with menopause or reduced estrogen level as recited in the above claims. However, Hoag does describe using these compositions to treat dermatitis and pruritus. (pp. 33-34 paragraph 100)
Duarte et al. discloses a review of skin disorders associated with menopause. (p. e16 right column first paragraph) Duarte et al. further discloses that pruritus is the primary skin concern reported in women over 65, and can be caused by xerosis resulting from menopause-related transepidermal water loss.
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the pharmaceutical composition described by Hoag to a subject suffering from pruritus wherein the pruritus is related to menopause, or to dry skin arising from menopause. One of ordinary skill in the art would have seen the disclosure of Duarte et al. as suggesting administering any existing treatment known to treat pruritus to patients suffering from these conditions due to menopause.
Therefore the invention taken as a whole is prima facie obvious.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hoag as applied to claims 1, 4, 16, 17, and 35 above, and further in view of Vielhaber et al. (US pre-grant publication 2012/0121737, cited in PTO-1449)
The disclosure of Hoag is discussed above. Hoag does not describe a composition wherein the TRPV1 antagonist is t-butyl cyclohexanol. However, Vielhaber et al. discloses that 4-trans-tert-butyl-cyclohexanol is a TRPV1 antagonist, and is useful for reducing skin irritation. (p. 2 paragraphs 21-24) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use 4-t-butyl cyclohexanol as the TRPV1 antagonist in the method described by Hoag. One of ordinary skill in the art would have seen the omega fatty acids described by Hoag and 4-t-butyl cyclohexanol described by Vielhaber as equivalents usable for the same purpose.
Therefore the invention taken as a whole is prima facie obvious.
Claim 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hoag as applied to claims 1, 4, 16, 17, and 35 above, and further in view of Wandrey et al. (Reference included with PTO-892)
The disclosure of Hoag is discussed above. Hoag does not describe a composition wherein the TRPV1 antagonist is pentapeptide-59. However, Wandrey et al. discloses that pentapeptide-59 is a TRPV1 antagonist, and is useful for reducing skin irritation. (p. 21 left column first and second paragraphs, p. 22 left column) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use pentapeptide-59 as the TRPV1 antagonist in the method described by Hoag. One of ordinary skill in the art would have seen the omega fatty acids described by Hoag and pentapeptide-59 described by Wandrey et al. as equivalents usable for the same purpose.
Therefore the invention taken as a whole is prima facie obvious.
Claim 104 is rejected under 35 U.S.C. 103 as being unpatentable over Hoag as applied to claims 1, 4, 16, 17, and 35 above, and further in view of Qadir. (Reference included with PTO-892)
The disclosure of Hoag is discussed above. Hoag does not describe a composition comprising Aloe vera, which is another name for Aloe barbadensis, can relieve itching. (p. 23 right column fourth paragraph) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to include aloe barabadensis in the compositions described by Hoag. One of ordinary skill in the art would have seen this combination to be obvious because both compositions are usable for the same purpose, and would be reasonably expected to be beneficial if used together.
Therefore the invention taken as a whole is prima facie obvious.
Claims 74, 75, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Hoag as applied to claims 1, 4, 16, 17, and 35 above, and further in view of Tamarkin et al. (US pre-grant publication 2008/0253973, cited in PTO-892)
The disclosure of Hoag is discussed above. Hoag does not describe a composition comprising Hammelis virginiana (witch hazel) leaf extract. However, Tamarkin et al. discloses a composition for providing a sensation to a body surface, comprising one or more sensory agents. (p. 2 paragraph 17) The sensation can be relaxing or soothing. (p. 2 paragraph 22) Relaxing or soothing agents include witch hazel or hamamelis extract. (p. 3 paragraph 45) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to include hamamelis extract in the compositions described by Hoag. One of ordinary skill in the art would have seen this combination to be obvious because both compositions are usable for the same purpose of soothing itching or irritated skin, and would be reasonably expected to be beneficial if used together. Furthermore regarding claim 93, Tamarkin additionally discloses coconut oil, which is reasonably considered to be an extract of coconut, as an ingredient in these compositions. (p. 3 paragraph 55)
Therefore the invention taken as a whole is prima facie obvious.
Claims 74, 75, 83, 85, 86, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Hoag in view of Duarte et al. (Reference included with PTO-892) as applied to claims 1, 4, 16, 17, and 35 above, and further in view of (US pre-grant publication 2008/0253973, cited in PTO-892)
The disclosures of Hoag and Duarte are discussed above. Hoag in view of Duarte does not describe a composition comprising Hammelis virginiana (witch hazel) leaf extract. However, Tamarkin et al. discloses a composition for providing a sensation to a body surface, comprising one or more sensory agents. (p. 2 paragraph 17) The sensation can be relaxing or soothing. (p. 2 paragraph 22) Relaxing or soothing agents include witch hazel or hamamelis extract. (p. 3 paragraph 45) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to include hamamelis extract in the compositions described by Hoag. One of ordinary skill in the art would have seen this combination to be obvious because both compositions are usable for the same purpose of soothing itching or irritated skin, and would be reasonably expected to be beneficial if used together. Furthermore regarding claim 93, Tamarkin additionally discloses coconut oil, which is reasonably considered to be an extract of coconut, as an ingredient in these compositions. (p. 3 paragraph 55)
Therefore the invention taken as a whole is prima facie obvious.
Claims 22 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Hoag in view of Tamarkin et al. (Reference included with PTO-892) as applied to claims 1, 4, 16, 17, 35, 74, 75, 83, 85, 86, and 93 above, and further in view of Sarkar et al. (US pre-grant publication 2023/0012087, cited in PTO-892)
The disclosures of Hoag and Tamarkin are discussed above. Hoag in view of Tamarkin does not describe the osmolality of the composition. However, Sarkar et al. discloses a composition for moisturizing dry skin, which avoids irritating sensitive areas. (p. 1 paragraphs 4, 6, and 7) The composition has a preferred osmolality of between 80-500 mOsm/kg. It would have been obvious to one of ordinary skill in the art at the time of the invention to prepare the compositions described by Hoag having a specific osmolality, as described by Sarkar. In particular, one of ordinary skill in the art would have expected the osmolality to be a result-effective variable for moisturizing dry skin and avoiding irritation. As the claimed range of 200-400 mOsm/kg falls within the broader range recited in the prior art, the prior art range renders the claimed range obvious.
Therefore the invention taken as a whole is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 16, 29, 30, 35, 42, 43, 48-50, 56, 74, 83, 65, 86, 93, and 104 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 112, 113, 115, 117-122, 124, and 126-131 of copending Application No. 19/728559 (reference application, unpublished, cited in PTO-892, herein referred to as ‘559). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘559 anticipate the present claims. Specifically, claim 112 of ‘559 claims an aqueous topical formulation comprising one of the same TRPV1 antagonists recited in present claims 1 and 29, water, a humectant, and one of the same plant extracts recited in present claims 1, 74, 93, and 104. Dependent claim 113 further defines the TRPV1 antagonist as pentapeptide-59. Dependent claims 115, 117, and 118 define the amounts of each ingredient similarly to present claims 2 and 4. Claim 119 recites the same exclusionary proviso ac present claim 16. Furthermore claims 126 and 127 claim a method of treating the same conditions recited in present claims 42, 43, and 48-50.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 7/9/2026
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