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 claims
Claims 1-20 are original, pending, and under examination.
Priority
This application claims priority to U.S. Provisional Application No. 63/471,890, filed June 8, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/04/2024 and 01/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-4, 6, 8, 10, and 19-20 are objected to because of the following informalities:
Claims 1-4, 6, 8, 10, and 19-20 recite “PDE5 inhibitor”. However, “PDE5”is an abbreviation for the term “Phosphodiesterase 5”, and such term should be explicitly stated in the claim set.
Appropriate correction is required.
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.
Claims 1 and 2 recites the term “quantity of… PDE5 inhibitor”. However, no units of measurement (e.g., mass, concentration, volume) is provided to define the quantity. The above claims are thus indefinite.
Claims 1-3, 19, and 20 recite the term “full prescription quantity or dose”. However, no units of measurement (e.g., mass, concentration, volume) is provided to define the quantity or dose. The above claims are thus indefinite.
Claims 1 and 3 recites the term “quantity of… cannabinoid component”. However, no units of measurement (e.g., mass, concentration, volume) is provided to define the quantity. The above claims are thus indefinite.
The term “full prescription quantity or dose” in claims 1-3, 19, and 20 is a relative term which renders the claim indefinite. The term “full prescription quantity or dose” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It will be assumed that any dose is a full prescription quantity or dose.
The phrase “quantity of a cannabinoid component sufficient to… amplify the PDE5 inhibiting effect of the PDE5 inhibitor” in claims 1 and 3 is relative which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It will be assumed that any quantity is sufficient.
Claims 4-18 are also rendered indefinite for being dependent to indefinite claim 1 without fixing all of the above issues.
The term “about” in claim 2 is a relative term which renders the claim indefinite. The term “about is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purpose of examination, “about” is deemed to be any value within 15% of the number it is referring to.
Claim 18 is indefinite for the recitation of “..vitamin C, and/or damiana, and compositions that increase…” as it is unclear if the Markush group should end with the “and/or damiana” or the group should end with “and compositions…”. For the purpose of compact prosecution, the examiner will read on the groups to include “and compositions….”. Applicant may remove the “and/or”. Additionally, note that as a Markush structure is “selected from the group consisting of …..and….”. If applicant wants to allow a combination, applicant could end the group with “and a combination thereof.”
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.
Claims 1-3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Docherty et al. (US20200323773A1).
Docherty et al. discloses improved compositions and methods for infusing food and beverage compositions with PDE5 inhibitors, alone or in combination with other lipophilic active agents such as cannabinoids, nicotine, non-steroidal anti-inflammatory drugs (NSAIDs), and vitamins. In independent claim 37, Docherty et al. claims a food product comprising a therapeutically effective amount of a phosphodiesterase type 5 (PDE5 inhibitor) in combination with one or more additional lipophilic active agents. In its subsequent independent claim 41, Docherty et al. teaches that the one or more additional lipophilic active agents is a cannabinoid.
Claims 1-3, 12-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Docherty et al. (US20180360896A1).
Docherty et al. discloses pharmaceutical preparations include at least one component that enhances sexual response and at least one other compound that enhances sexual sensitivity and pleasure. Docherty et al. claims the following:
A tablet or capsule for enhancing sexual response and sensitivity in a human, consisting essentially of:
a cannabinoid component consisting essentially of about 10 mg to about 500 mg of tetrahydrocannabinol (THC) and about 10 mg to about 500 mg of cannabidiol (CBD); and
a pharmaceutically effective amount of a sexual response enhancing component selected from the group consisting of sildenafil, tadalafil, and vardenafil.
The tablet or capsule of claim 1, wherein the cannabinoid component contains at least one of cannabinol (CBN), tetrahydrocannabivarin (THCV), cannabigerol (CBG), dronabinol, nabilone, a derivative of THC, or a derivative of CBD.
An ingestible dosage form for enhancing sexual response and sensitivity in a human, consisting essentially of:
an ingestible cannabinoid component containing about 10 mg to about 500 mg of tetrahydrocannabinol (THC) and about 10 mg to about 500 mg of cannabidiol (CBD); and
a tablet or capsule that contains a pharmaceutically effective amount of a sexual response enhancing component selected from the group consisting of sildenafil, tadalafil, vardenafil, and at least 2 g of L-arginine.
The ingestible dosage form of claim 13, wherein the ingestible cannabinoid component is a tablet or capsule.
The ingestible dosage form of claim 13, wherein the ingestible cannabinoid component is selected from the group consisting of lozenges, lollipops, brownies, cookies, chocolates, chews, gum drops, soft candies, and hard candies.
A composition for enhancing sexual response and sensitivity in a human, consisting essentially of:
a topical cannabinoid dosage form containing about 10 mg to about 500 mg of tetrahydrocannabinol (THC) and about 10 mg to about 500 mg of cannabidiol (CBD); and
a tablet or capsule that contains a pharmaceutically effective amount of a sexual response enhancing component selected from the group consisting of sildenafil, tadalafil, vardenafil, and at least 2 g of L-arginine.
The composition of claim 16, wherein the topical cannabinoid dosage form is selected from the group consisting of massage oil, lotion, gel, cream, lubricant, and vaginal patch.
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 1-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bunka et al. (US20210145036A1).
Bunka et al. discloses improved methods for infusing compositions with lipophilic active agents [¶abstract]. Bunka et al. teaches that the active ingredients can be selected from cannabinoids, PDE5 inhibitors, and combinations thereof [¶33]. Bunka et al. teaches that such PDE5 inhibitors including sildenafil, tadalafil, vardenafil, and avanafil may be included in the composition to treat erectile dysfunction [¶¶33, 173, 175]. Bunka et al. teaches that at least one cannabinoid including tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), and cannabinol (CBN) may be included in such compositions [¶¶97, 104, 105]. Bunka et al. teaches that such cannabinoids can be used as the lipophilic active agent to treat conditions such as sexual dysfunction and erectile dysfunction [¶34]. Bunka et al. teaches that for treating humans (which includes male and female), dosages of the above active ingredients for the composition can range from 0.5 mg to 500 mg [¶231]. Bunka et al. teaches that the composition can be formulated as a tablet, pill, capsule, liquid, gel, syrup, or slurry [¶241]. In an embodiment [¶261-298, example 1], Bunka et al. teaches such compositions in the form of chocolate and cookies. Bunka et al. further teaches that the composition can be infused in beverages [¶2].
It would have been obvious to a person of ordinary sill in the art, before the effective filing date of the claimed invention, to combine the various cannabidiols and PDE5 inhibitors taught by Bunka et al. into a single composition. This is because Bunka et al. teaches that all of the above cannabidiols and PDE5 inhibitors can be utilized at various concentrations overlapping with those in the present claims in a single dosage form for treating erectile and sexual dysfunction. Therefore, a person of ordinary sill in the art would have been motivated to combine all the above active ingredients for the purpose of obtaining an additive effect of treating erectile and sexual dysfunction, which would also render the process of optimizing the dose of each ingredient a matter of routine optimization of result-effective variables. All of the stated functional effects of (e.g., synergistic effects of the cannabidiols and PDE5 inhibitors, increasing sexual pleasure) would have also been inherent to such compositions taught by Bunka et al. as they encompass all required ingredients, dosages, and overlapping dosage forms stated in the above present claims. Furthermore, because Bunka et al. teaches these above ingredients as compatible for the same forms of delivery, a person of ordinary sill in the art would have had a reasonable expectation of success in combining them to reach the claimed invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bunka et al. (US20210145036A1) in view of Millet (US20200061004A1).
Bunka et al. teaches all required limitations of claims 1-17 and 19-20.
However, Bunka et al. fails to teach the limitation of claim 18.
Millet discloses pharmaceutical preparations including at least one component that enhances sexual response and at least one other compound that enhances sexual sensitivity and pleasure [¶abstract]. Millet teaches that the component that enhances sexual sensitivity and pleasure includes one or more cannabinoid compounds from the plant genus Cannabis, including extracted compounds, synthetic forms, and derivatives thereof. Examples include tetrahydrocannabinol (THC), the main psychoactive constituent of Cannabis, and cannabidiol (CBD) [¶abstract]. Millet teaches that the composition may include sexual response-enhancing component such as sildenafil (Viagra®), tadalafil (Cialis®), and vardenafil (Levitra®) [¶¶42. 43]. Millet further teaches that the composition may also include L-arginine, L-citrulline, yahimbe root, ginseng (e.g., Korean red ginsing), ginkgo biloba, horny goat weed, goosefoot, Chenopodium ambrosioides, Chlorophytum borivilianum, Desmodium gangeticum, garlic combined with vitamin C, and/or damiana to improve sexual response and performance [¶44]. Millet teaches that the composition may be orally or topically delivered [¶12].
It would have been obvious to a person of ordinary sill in the art, before the effective filing date of the claimed invention, to combine the above components of Millet into the formulations taught by Bunka et al. This is because Bunka et al. teaches that compositions containing cannabinoids and PDE5 inhibitors may be used to treat sexual disorders. Concurrently, Millet teaches that additional components (e.g., L-arginine, L-citrulline, yahimbe root, etc.) may be used in such compositions to further improve sexual response and performance. Thus, a person of ordinary sill in the art would have been motivated to incorporate such components taught by Millet into the composition of Bunka et al. in order to further enhance the sexual performance and response-enhancing effects of the formulation. Furthermore, because Millet teaches these components to be compatible with the composition of Bunka et al. using similar delivery routes, a person of ordinary sill in the art would have had a reasonable expectation of success in integrating them to reach the claimed invention.
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 1-9, 12, 14-16 18-20 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent No. US 10,220 ,063 B2 (patent ‘063): 1, 13, 16, 18 (for present claim 1-3); 1, 12 (for present claim 4-9); 1, 4-6, 13, 16, 18 (for present claim 12); 1, 7-9, 1, 16, 18 (for present claim 13); 2, 20 (for present claim 14); 1, 13, 16, 18 (for present claim 15); 11 (for present claim 16); 10, 15, 17 (for present claim 17); 14, 16, 19 (for present claim 18); 1, 13, 16, 18 (for present claim 19-20))––In view of Bunka et al. (US20210145036A1).
Each of the above claims (or claim groups) of patent ‘063 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: patent ‘063 does not teach the explicit doses of sildenafil, tadalafil, and vardenafil. Bunka et al. remedies this deficiency by teaching that the above drugs can be present in oral compositions in concentrations ranging from 0.5 to 500 mg for enhancing sexual activity [¶¶2, 33, 173, 175, 231, 241, 261-298]. The dosing of such conventional active ingredients is thus a matter of routine optimization of result effective variables, obvious to a person of ordinary skill in the art with a reasonable expectation of success. Additionally, all of the functional effects stated in the present claims (e.g., synergistic effects of the cannabidiols and PDE5 inhibitors, increasing sexual pleasure, amplify the PDE5 inhibiting effect) would have also been inherent to such compositions taught by patent ‘063 in view of Bunka et al. in further view of the aforementioned 35 USC § 112 (b) rejections made for the present claims. Accordingly, the present claims differ from the claims of patent ‘063 only by an obvious variation that does not impart a patentable distinction.
Claims 1-9, 12-15, 17-20 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent No. US 10,15,018 B1 (patent ‘018): 1, 15, 17 (for present claim 1-3); 1, 9 (for present claim 4-5); 1, 11 (for present claim 6-7); 1, 13(for present claim 8-9); 2, 3, 17 (for present claim 12); 4, 5, 17 (for present claim 13); 6, 20 (for present claim 14); 10, 12 (for present claim 15); 7, 8, 10, 12 (for present claim 17); 14, 16, 19 (for present claim 18); 1, 2-14, 17-20 (for present claim 19, 20)––In view of Bunka et al. (US20210145036A1).
Each of the above claims (or claim groups) of patent ‘018 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: patent ‘018 does not teach the explicit doses of sildenafil, tadalafil, vardenafil, and avanafil. Bunka et al. remedies this deficiency by teaching that the above drugs can be present in oral compositions in concentrations ranging from 0.5 to 500 mg for enhancing sexual activity [¶¶2, 33, 173, 175, 231, 241, 261-298]. The dosing of such conventional active ingredients is thus a matter of routine optimization of result effective variable, obvious to a person of ordinary skill in the art with a reasonable expectation of success. Additionally, all of the functional effects stated in the present claims (e.g., synergistic effects of the cannabidiols and PDE5 inhibitors, increasing sexual pleasure, amplify the PDE5 inhibiting effect) would have also been inherent to such compositions taught by patent ‘018 in view of Bunka et al. in further view of the aforementioned 35 USC § 112 (b) rejections made for the present claims. Accordingly, the present claims differ from the claims of patent ‘018 only by an obvious variation that does not impart a patentable distinction.
Claims 1-9, 12-15, 17, 19-20 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent No. US 10,064,905 B1 (patent ‘905): 1, 11, 16 (for present claim 1-7); 1, 10 (for present claim 8-9); 1, 4-6, 11, 16 (for present claim 12, 13, 15, 17); 2, 12, 17 (for present claim 14); 1, 10-20 (for present claim 19, 20) ––In view of Bunka et al. (US20210145036A1).
Each of the above claims (or claim groups) of patent ‘905 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: patent ‘905 does not teach the explicit doses of sildenafil, tadalafil, vardenafil, and avanafil. Bunka et al. remedies this deficiency by teaching that the above drugs can be present in oral compositions in concentrations ranging from 0.5 to 500 mg for enhancing sexual activity [¶¶2, 33, 173, 175, 231, 241, 261-298]. The dosing of such conventional active ingredients is thus a matter of routine optimization of result effective variables, obvious to a person of ordinary skill in the art with a reasonable expectation of success. Additionally, All of the functional effects stated in the present claims (e.g., synergistic effects of the cannabidiols and PDE5 inhibitors, increasing sexual pleasure, amplify the PDE5 inhibiting effect) would have also been inherent to such compositions taught by patent ‘905 in view of Bunka et al. in further view of the aforementioned 35 USC § 112 (b) rejections made for the present claims. Accordingly, the present claims differ from the claims of patent ‘905 only by an obvious variation that does not impart a patentable distinction.
Claims 1-9, 12-20 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent No. US 10,555,927 B2 (patent ‘927): 1, 7-12, 17-19 (for present claim 1-9); 2-3, 14 (for present claim 12); 4-5, 14 (for present claim 13); 6 (for present claim 14); 7, 9, 15, 16, 18, 19 (for present claim 15); 8, 10, 15, 16, 18, 19 (for present claim 16); 7, 9, 15, 16, 18, 19 (for present claim 17); 13, 17, 20, 21, 22 (for present claim 18); 1, 2-11, 17-19 (for present claim 19); 12-16, 17-19 (for present claim 20); ––In view of Bunka et al. (US20210145036A1).
Each of the above claims (or claim groups) of patent ‘927 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: patent ‘927 does not teach the explicit doses of sildenafil, tadalafil, vardenafil, and avanafil. Bunka et al. remedies this deficiency by teaching that the above drugs can be present in oral compositions in concentrations ranging from 0.5 to 500 mg for enhancing sexual activity [¶¶2, 33, 173, 175, 231, 241, 261-298]. The dosing of such conventional active ingredients is thus a matter of routine optimization of result effective variable, obvious to a person of ordinary skill in the art with a reasonable expectation of success. Additionally, all of the functional effects stated in the present claims (e.g., synergistic effects of the cannabidiols and PDE5 inhibitors, increasing sexual pleasure, amplify the PDE5 inhibiting effect) would have also been inherent to such compositions taught by patent ‘927 in view of Bunka et al. in further view of the aforementioned 35 USC § 112 (b) rejections made for the present claims. Accordingly, the present claims differ from the claims of patent ‘927 only by an obvious variation that does not impart a patentable distinction.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
Prosecution Insights