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 .
Status of the Claims
Claims 1-2, 4, 7, 9-10, 13-14, and 17-19 are original. Claims 3, 5-6, 8, 11-12, 15-16, and 20 are currently amended. Claims 21-24 are cancelled. Claims 1-20 are pending and under examination.
Priority
This application is a 371 of PCT/IL2022/050625, filed on 06/12/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent provisional application of 63/210,024, filed on 06/13/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/12/2023 and 06/04/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 recites “A composition in the form of an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid or a lubricating gel, ointment, balm comprising a cannabinoid and a phytoestrogen”. The phrase “an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid or a lubricating gel, ointment, balm” is unclear because it is uncertain if the “or” is properly placed and the options would include the last item being “or a lubricating gel, ointment, balm” (i.e. a balm that acts as lubricating gel and ointment) or if the claim should read “form of an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid, a lubricating gel, an ointment, or a balm” where each of the items is a separate option to choose from. Because the scope of the claim is unclear, one with ordinary skill cannot determine with reasonable certainty the metes and bounds of the claimed inventions. Appropriate correction may include revising the claim to clarify that the composition in any of the recited forms comprises the cannabinoid and phytoestrogen, for example: “A composition in the form of an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid, a lubricating gel, an ointment, or a balm, comprising a cannabinoid and a phytoestrogen”.
Claims 2-20 are rejected because they are dependent claims of indefinite claim 1.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed subject matter is directed to products of nature and includes no additional elements that amount to more than that. Claim 1 is directed to a composition that may only include a liquid containing a cannabinoid and phytoestrogen. All three of these components are broad genera that may be found in nature (e.g., water as a liquid, cannabidiol as a cannabinoid, Isoflavones as phytoestrogens), while claims 3-5 merely state their possible concentrations. Claim 2 is directed towards broad genera of lubricants and prebiotics. Both of these elements are also found in nature (e.g., intestinal mucus is a form of lubricant; onions contain inulin as prebiotics). Claim 6 recites α-glucan oligosaccharides as a prebiotic agent, which are naturally found as intermediate components and breakdown products of starch metabolism within tubers such as potatoes. Claim 7 merely states the concentrations of α-glucan oligosaccharides, which can also occur naturally. Claim 8 recites hyaluronic acid, which is a naturally occurring product found in human skin, connective tissues, synovial (or joint) fluid, and eyes; claims 9 and 10 merely state hyaluronic acid concentrations. Claim 11 recites cannabidiol as a cannabinoid, which is a naturally occurring product found in plants such as Hemp (Cannabis sativa).
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.
Claims 1, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raz et al. (WO2019003163A2).
Raz et al. teaches a product for treating conditions and/or symptoms associated with women’s health, in which the product comprises at least one cannabinoid in a specific amount, and a primary terpene in a specific amount (abstract). Raz et al. teaches that the composition can be in the form of a nano-emulsion, creams, sublingual oils, and topicals. Raz et al. teaches that the administered product may comprise at least one phytoestrogen and one cannabinoid (paragraph 9). Raz et al. teaches that according to the embodiment, the product comprises (a) at least one cannabinoid from the group consisting of CBD and their non-decarboxylated form thereof (paragraph 14), with CBD being an abbreviation for cannabidiol (paragraph 13). Raz et al. teaches that the composition produces an enhanced therapeutic effect in treating conditions and/or symptoms associated with perimenopause and menopause (paragraph 9). Raz et al. teaches that such symptoms of menopause treated by the composition include vaginal atrophy presentations such as vaginal dryness and inflammation (paragraph 6). In a single embodiment (page 162, example 77), Raz et al. teaches the composition in oil form containing cannabinoids (including CBD) at concentrations ranging from 3-40% (w/w) and prenylnaringenin (a form of phytoestrogen) for treating vaginal dryness.
Claims 1, 2, 12-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Epstein (WO2018156960A1).
Epstein et al. discloses treatments for the improvement of male and female sexual function, cutaneous inflammation such as psoriasis, eczema, dermatitis and Female Sexual Disorders, such as Genitopelvic Pain/Penetration Disorders; vulvovaginal atrophy (which includes vaginal dryness), vestibulodynia, dyspareunia, Sexual Interest/Arousal Disorder, low female libido and Female Orgasmic Disorder (abstract). Epstein teaches that vulvar pain (a form of vulvovaginal atrophy) is a frequently occurring problem that affects both pre and postmenopausal women (page 2, lines 23-24). Epstein teaches that catechin compounds (a phytoestrogen) are effective at providing vaginal lubrication (page 11, lines 19-22). Thus, a lubricating agent. Epstein teaches that the composition may be an ointment, a lotion, an emulsion, an aqueous solution, or a non-aqueous solution (page 12, lines 21-23, examples provide ointment form). In independent claim 11, Epstein teaches a method for treating a female sexual disorder (FSD), comprising applying a pharmaceutical composition to an individual's genital or erogenous area, wherein said pharmaceutical composition comprises a catechin (a phytoestrogen). In its dependent claim 12, Epstein teaches that the pharmaceutical composition further includes a cannabinoid, while in its dependent claim 19, said catechin is applied to a vulva, a clitoris a vaginal introitus, a vagina, or a nipple. In claim 20, Epstein teaches a condom for use in sexual activity, wherein said condom (which can be the applicator) comprises a pharmaceutical composition applied thereon, wherein said pharmaceutical composition comprises catechin. In its dependent claim 22, Epstein teaches the condom of claim 20, wherein the pharmaceutical composition further includes a cannabinoid.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 3, 4, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. (WO2019003163A2).
In a single embodiment, Raz et al. teaches the limitations of claims 1, and 11-13.
However, Raz et al. fails to teach the limitations of claims 4, 14-16, and 18-19 in the same embodiment.
Raz et al. teaches a product for treating conditions and/or symptoms associated with women’s health, in which the product comprises at least one cannabinoid in a specific amount, and a primary terpene in a specific amount (abstract). Raz et al. teaches that the composition can be in the form of a nano-emulsion, creams, sublingual oils, and topicals, which covers the form element of present claim 1 (paragraph 10). Creams, emulsions and oils would be lubricating forms. Raz et al. teaches that the administered product may comprise at least one phytoestrogen and one cannabinoid (paragraph 9), fulfilling the residual limitations of present claim 1. Raz et al. teaches that according to the embodiment, the product comprises (a) at least one cannabinoid from the group consisting of THC, CBD, CBG, CBC, CBN, CBL THCV, CBDV and their non-decarboxylated form thereof (paragraph 14), with CBD being an abbreviation for cannabidiol (paragraph 13), which fulfills all required elements of present claim 11. Raz et al. teaches that the said CBD in the composition may be in a total concentration of at least 1% by weight, at least 2%, or at least 3%, or at least 80% by weight (paragraph 236), fulfilling all required elements of present claims 3 and 4. Raz et al. teaches that the composition produces an enhanced therapeutic effect in treating conditions and/or symptoms associated with perimenopause and menopause (paragraph 9), which satisfies the elements of present claim 14. Raz et al. teaches that such symptoms of menopause treated by the composition include vaginal atrophy presentations such as vaginal dryness and inflammation (paragraph 6), which satisfies the elements of present claims 12 and 13. Raz et al. Further teaches that the daily dose of the product/composition can vary between 0.5 milligram to 30 milligrams of cannabinoids per body kilogram of bodyweight (paragraph 304), and assuming the composition comprises 80% w/w of CBD (allowed per paragraph 236), the dose of the whole composition could be adjusted to squarely overlap with 1-5 grams depending on the weight of the patient (e.g., if the chosen dose of CBD was 28 mg/kg of body weight, and CBD made up 80% w/w of the whole composition, a 72 kg woman would thus administer a daily dose of approximately 2.52 grams of the whole composition which contains 2.016 grams of CBD), which would satisfy the required elements of present claim 15. Raz et al. teaches that the product can be administered topically with its therapeutic effects generated while administering it via tampons as the applicator (paragraph 257), which indicates that the product can be applied to the vagina, thus satisfying all required elements of present claims 16, 18, and 19. In a single embodiment (page 162, example 77), Raz et al. teaches the composition in oil form containing cannabinoids (including CBD) at concentrations ranging from 3-40% (w/w) and prenylnaringenin (a form of phytoestrogen) for treating vaginal dryness, which provides a point of reference for modifying such compositions.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the composition of Raz et al. for the treatment of vaginal dryness and for providing vaginal lubrication as recited in the present claims. This is because Raz et al. expressly teaches compositions comprising at least one cannabinoid and at least one phytoestrogen for treating conditions associated with woman’s health, including menopausal symptoms such as vaginal dryness and inflammation, and further teaches that such compositions may be administered topically to the vaginal area, including via tampon applicators. Raz et al. additionally teaches concentrations of cannabinoids that overlap or encompass the claimed ranges and identifies cannabidiol as a suitable cannabinoid species. Because Raz et al. teaches that the disclosed compositions improve symptoms associated with menopause and vaginal atrophy, a person of ordinary skill in the art would have been motivated to administer the composition in amounts effective to achieve the taught therapeutic benefit, including routine topical quantities such as those recited in the claims, as optimization of dosage and amounts of application constitutes routine experimentation for one with ordinary skill in the art. Moreover, the combination of cannabinoids and phytoestrogens for treating vaginal dryness would have been expected to produce predictable therapeutic results because both classes of compounds are taught to be compositions that alleviate symptoms associated with vaginal atrophy and menopause through complementary mechanism, thereby providing a reasonable expectation of success in achieving the claimed methods of treatment.
Claims 2 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. (WO2019003163A2) in view of Dominguez et al. (US20170014459A1).
Raz et al. teaches all limitations of claim 1, which include a composition in the form of an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid or a lubricating gel, ointment, balm comprising a cannabinoid and a phytoestrogen.
However, Raz et al. fails to teach the limitations of claims 2 and 6-10.
Dominguez et al. provides a topical composition comprising extract from Coriolus versicolor for use for preventing and/or treating by vaginal or cervical administration of a vaginal or cervical disorder (abstract). Dominguez et al. teaches that the composition may be applied topically to the skin and mucosa in the form of an oil, ointment, gel, dispersion, and delivered via a tampon or other forms of vaginal suppository (paragraph 68). Dominguez et al. teaches that the composition may include a prebiotic such as an alfa-glucan oligosaccharide (paragraph 52) and an emollient such as hyaluronic acid (paragraph 50), which satisfies all required elements of present claims 2, 6, and 8. Dominguez et al. teaches that the effective amount of prebiotic, such as alfa-glucan oligosaccharide, in the composition may be comprised from 0.01 to 10% w/w (paragraph 65), satisfying all required elements of present claim 7. Dominguez et al. teaches that the amount of moisturizing agent, such as hyaluronic acid, in the composition may be comprised from 0.01 to 10% w/w (paragraph 65), which satisfies all required elements of present claim 9 and 10.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the composition of Raz et al. to further include a prebiotic agent such as alfa-glucan oligosaccharide and/or a lubricating moisturizer such as hyaluronic acid as taught in Dominguez et al. This is because Dominguez et al. expressly teaches that such ingredients are beneficial in topical and vaginal compositions for treating vaginal or cervical disorders and for improving mucosal hydration and lubrication when applied to the vaginal mucosa. Since Raz et al. already teaches topical cannabinoid and phytoestrogen-containing compositions for treating women’s vaginal health conditions including dryness and atrophy, a person of ordinary skill in the art would have been motivated to incorporate the known moisturizing, lubricating and microbiome-supporting agents of Dominguez et al. into the composition of Raz et al. to obtain additive benefits and enhance vaginal comfort, hydration, and microbiome health, which represents predictable use of prior art elements according to their established functions. Furthermore, Dominguez et al. teaches concentration ranges for alfa-glucan oligosaccharide and hyaluronic acid that overlap or encompass the claimed ranges, and optimization of such ingredient concentrations would have constituted routine experimentation for one of ordinary skill in the art (see MPEP 2144.05). Furthermore, because both relate to the same field of topical vaginal therapeutic and utilize compatible formulation components ush as oils as a carrier, there would have been a reasonable expectation of success in producing the modified compositions of the claimed invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. (WO2019003163A2) in view of Heyda (EP1348439A1).
Raz et al. teaches all limitations of claim 1, which include a composition in the form of an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid or a lubricating gel, ointment, balm comprising a cannabinoid and a phytoestrogen.
However, Raz et al. fails to teach the limitations of claim 5.
Heyda discloses to vaginal or intimate hygiene compositions containing active ingredients of vegetable origin, more specifically compositions in the form of gel, creams, solutions, vaginal tablets/capsules or vaginal irrigations, containing isoflavones, in particular soy isoflavones, and a Mimosa tenuiflora extract (abstract). Heyda teaches that the composition may be used for topical treatment of post-menopausal symptoms including vaginal dryness and atrophic vaginitis (paragraph 3). Heyda teaches that phytoestrogens including genistein, daidzein, glycitein and their glycosides genistin, daidzin, and glycitin, will be present in such composition amounts preferably ranging from 0.01 to 3% by weight (paragraph 11), which squarely overlaps with the claimed phytoestrogen concentration in present claim 5. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the composition of Raz et al. to include the phytoestrogen concentration taught by Heyda. This is because Heyda expressly teaches topical vaginal compositions containing phytoestrogens such as genistein for treatment of post-menopausal symptoms including dryness and atrophic vaginitis, which are the same conditions addressed by Raz et al. Since Raz et al. already teaches compositions comprising cannabinoids and phytoestrogens for treating such vaginal conditions, a person of ordinary skill in the art would have been motivated to employ the phytoestrogen concentrations disclosed by Heyda into the compositions of Raz et al. in order to achieve effective therapeutic results, as selecting concentrations within known ranges for known active ingredients represents routine optimization of result-effective variables. Furthermore, because both references relate to topical vaginal compositions for treating menopausal symptoms and utilize the same class of active agents, there would have been a reasonable expectation of success in producing the composition of the claimed invention.
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. (WO2019003163A2) in view of Frid et al. (WO2021091908A1, published 5-14-2021, earliest filing date of 11-8-2019; citations from its national stage entry US20220401381A1)
Raz et al. teaches all limitations of claim 1, which include a composition in the form of an emulsion, a moisturizing gel, a cream, a lotion, an oil, a liquid or a lubricating gel, ointment, balm comprising a cannabinoid and a phytoestrogen. Raz et al. further teaches all limitations of claims 12, which includes method for treatment of vaginal dryness in a patient in need thereof, comprising administering to a patient in need thereof a composition according to claim 1. Raz et al. also teaches all limitations of claim 16, which includes a method for providing vaginal lubrication comprising administering to a sexual organ an effective amount of a composition according to claim 1.
However, Raz et al. fails to teach the limitations of claims 17 and 20.
Frid et al. discloses peripherally acting cannabidiol (CBD)-containing compositions and methods of using thereof for treating or enhancing female sexual function (abstract). Frid et al. teaches that in some embodiments, the compositions are provided in the form of a lotion, containing highly CBD-loaded liposomes, which is applied to female genitalia shortly prior to sexual activity (paragraph 10). Frid et al. further teaches that the compositions of the invention are applied either as lotion and/or as lubricant in the amount and for a period of time prior to a sexual activity such that sexual function of the subject is enhanced and/or the disorder is ameliorated during the sexual activity (paragraph 15), which covers all required elements of present claim 20. Frid et al. teaches that the composition is compatible with latex and polyisoprene condoms, and in some embodiments, may be provided by means of a condom pre-coated with such a composition (paragraph 17), which fulfills all required elements of present claim 17.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the compositions of Raz et al. in the manner taught by Frid et al., including applying the composition prior to sexual activity and/or providing the composition on a condom. This is because Frid et al. expressly teaches cannabidiol-containing compositions applied to the female genitalia shortly prior to sexual activity to enhance lubrication and sexual function, and further teaches that such compositions may be compatible with condoms and may be provided precoated with the composition. Since Raz et al. already teaches cannabinoid-containing compositions for treating vaginal dryness when applied to the vaginal area, a person of ordinary skill in the art would have been motivated to employ the administration approaches of Frid et al. in the compositions of Raz et al. to improve comfort during sexual activity, representing predictable use of known administration techniques for known topical compositions intended for the same anatomical region. Furthermore, because both references relate to topical cannabinoid formulations applied to the female genitals for vaginal comfort, there would have been a reasonable expectation of success in applying the compositions of Raz et al. according to the methods taught by Frid et al. to reach the claimed invention.
Conclusions
No claim is found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613