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
This application claims priority to US Provisional Application 63/423,968 filed on 9 November 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6 December 2023; 31 January 2024; 11 September 2024; 30 October 2024 are acknowledged and have been considered.
Specification
The specification is objected to for containing an illustration; specifically, the graph on page 13 (MPEP § 608.01(VI)). Drawings, including graphical illustrations, should be submitted in accordance with 37 CFR 1.81.
Additionally, the data points in the graph on page 13 of the specification are not discernible from one another because the same symbols are used in a black and white illustration. Examiner suggests using different symbols to distinctly point out the data points for the corresponding examples. Appropriate correction is required.
Claim Objections
Claims 16-18 are objected to for minor informalities.
Claim 16 recites: “The topical composition of claim 1 wherein the topical composition comprises . . .”
Claim 17 recites: “The topical composition of claim 1 the topical composition comprises . . .”
Claim 18 recites: “The topical composition of claim 1 wherein the topical composition components comprise one . . .”
The second instance of “topical composition” in each claim is redundant. Examiner suggests amending claims 16-18 to a form similar to that recited in claim 19,“[t]he topical composition of claim 1 further comprising . . .”.
Claim 22 recites: "A composition of claim 1." Dependent claims should refer to a preceding claim with the definite article “the” and use consistent preamble language (e.g., “The topical composition of claim 1”). Further, the claim recites "meadowfoam seed oil" and “squalane” without defining which component is being further limited. Examiner suggests amending “A composition of claim 1”, to “The topical composition of claim 1”.
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, 3-22 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 and distinctly claim the subject matter which the inventor or a joint invent (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites: “A topical composition comprising… one or more extracted vegetable oils, one or more extracted plant oils, and one or more cannabinoids.” Cannabinoids may be extracted from cannabis plants, such as Cannabis sativa, and often exist in oil form. The genus of extracted plant oils encompasses extracted vegetable oils. Given the overlap of genre recited, it is unclear how many distinct components are required to meet claim 1. Thus, the “extracted plant oils” and “cannabinoids” components overlap and render the claim indefinite because it is not clear if three distinct components are required. Clarification is requested. Claims 3-16 and 18-22 depend from claim 1 and fail to cure the indefiniteness.
Claim 15 recites “the CBD.” There is insufficient antecedent basis for this limitation because claim 1 makes no mention of “a CBD”. While there is mention of cannabinoids, claim 15 as currently constructed is indefinite as there is no explicit mention of CBD belonging to the “cannabinoids” component in claim 1. By contrast, claim 14 properly introduces the limitation “CBD” belonging to the cannabinoid genus, so it is unclear if claim 15 was intended to depend from claim 14. Appropriate correction is required.
Claim 17 recites: “The topical composition of claim 1 the topical composition comprises . . . and (ii) about 1-45 wt% of at least one extracted vegetable oil and one extracted plant oil.” It is unclear whether the range of 1-45 wt% refers to the cumulative concentration of at least one extracted vegetable oil and one extracted plant oil, or if the extracted vegetable and plant oil are separately present in the range of 1-45 wt%. Appropriate correction is required. For purposes of examination, claim 17 is interpreted as the extracted vegetable and plant oil are separately present in the range of about 1-45 wt%.
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, 6-10, 14, 17-18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cameron (US Publication No. US20190247299A1).
Regarding claims 1 and 14, Cameron teaches topical compositions comprising a combination of a pharmacologically effective amount of one or more extracted vegetable oils, one or more extracted plant oils, and one or more cannabinoids (Abstract; ¶ [0009], ¶[0322]). For example, Cameron describes a topical composition containing coconut oil (a vegetable oil), sunflower oil (a plant oil), and cannabidiol (the cannabinoid CBD).
Regarding claims 6-9, Cameron teaches an embodiment containing 5 wt% squalene (¶ 0318) that falls within the claimed ranges of 1-25 wt%, 5-20 wt%, 3-7 wt%, and 0.5-5 wt% squalene in claims 6, 7, 8, and 9, respectively.
Regarding claim 10, Cameron teaches an embodiment of the topical containing 0.2 wt% of cannabidiol. (¶ [0100], ¶ [0322]). The weight percent in the embodiment falls within the claimed range of 0.05-5 wt%, and therefore anticipates the claim (MPEP §2131.03(I)).
Regarding claim 17, Cameron discloses a composition comprising about 6 wt% of squalene, 5% coconut oil, and 0.2% cannabidiol (¶ [0100], ¶ [0322]), and therefore anticipates the claim (MPEP §2131.03(I)).
Regarding claim 18, with respect to feature (b), Cameron teaches cannabidiol (CBD) is present in example 6 (¶[0322]). Since the claim recites: “The topical composition of claim 1 wherein the topical composition components comprise one or more of the following features…”, the claim is anticipated by Cameron.
Regarding claim 19, Cameron discloses examples 2-6 containing glyceryl stearate, an emulsifier (¶[0105], ¶[0318] - ¶[0322]).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 2-5, 11-13, 15-16, 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Cameron as evidenced by a Sharon Laboratories webpage, https://www.specialchem.com/cosmetics/product/sharon-laboratories-beautyderm-k10 (accessed 13 January 2026) (last updated 19 July 2022) (“Sharon”).
Cameron teaches compositions comprising sunflower oil (a type of plant oil), coconut oil (a type of vegetable oil), and cannabidiol (a type of cannabinoid) (¶ [0008]) to treat various skin related diseases including eczema, pruritic, dry skin, etc. (Abstract). Specific embodiments are taught where the topical compositions consist of squalene and cannabidiol (Example 6, ¶ [0322]). Furthermore, meadowfoam seed oil (¶ [0071], 2nd column, line 7) and tetrahydrocannabinol (THC) (¶ [0069], line 19) are non-limiting examples of a plant oil and cannabinoid that can be utilized in certain embodiments. The claimed weight percentages of meadowfoam seed oil and THC are taught by Cameron by way of the weight percentages of sunflower oil and cannabidiol, respectively. For example, ¶ [0071] mentions non-limiting examples of different plant oils that are covered, and ¶ [0072] discusses the various weight percentages of sunflower oil in certain embodiments. The teachings of this disclosure suggest meadowfoam seed oil can also be present in lieu of sunflower oil, and be present at the same weight percentages. The weight percentages of cannabidiol are also mentioned in ¶ [0069] and suggests THC may also be present at those weight percentages in certain embodiments.
Cameron does not disclose specific embodiments containing meadowfoam seed oil and THC nor does it specifically point out having components that promote a waterproof shield on skin.
The Sharon product page teaches components cetearyl alcohol, cetearyl glucoside, and sorbitan olivate make up the emulsifier Beautyderm K10. (p. 1, [Description]). Beautyderm K10 is explicitly stated to “Exhibit moisturizing and water-resistant properties. Beautyderm K10 is used to formulate creams and milks.”
The Sharon product page does not teach topical compositions containing meadowfoam seed oil, squalene, cannabinoids, and/or THC.
Cameron and Sharon are considered to be analogous art to the claimed invention because they are in the same field of formulating topical compositions to apply to the skin of a subject. Therefore, the substitution of meadowfoam seed oil for sunflower oil and THC for CBD would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) since both are presented by Cameron as equivalents within the plant oil and cannabinoid genera, respectively (MPEP 2144.06). Further, a PHOSITA would have found it prima facie obvious to apply the teachings of Cameron to formulate a topical composition containing meadowfoam seed oil, squalene, cannabidiol, and/or THC and further optimize it to provide a waterproof shield on skin based on the teachings of Sharon.
Regarding claim 2, Cameron teaches topical compositions containing, sunflower oil, squalene and cannabidiol (Example 6, ¶ [0322])). Meadowfoam seed oil may be present in certain embodiments and therefore would have been prima facie obvious to a PHOSITA to substitute the sunflower oil explicitly taught in Cameron for meadowfoam seed oil with a reasonable expectation of success (see above citations).
Regarding claims 3-5, Cameron teaches that sunflower oil can be substituted for its equivalent meadowfoam seed oil, and may be present in certain embodiments in the weight percentage range of 2-20 wt. % (¶ [0072]). Therefore, substitution of sunflower oil for meadowfoam seed oil and choosing a concentration that overlaps with the range of the instant claims, would have been obvious to a PHOSITA to have a reasonable expectation of success (MPEP §2144.05(I) and § 2144.06).
Regarding claims 11-12 and 15-16, Cameron teaches that cannabidiol, and therefore cannabinoids including THC, may be present at the range of 0.1 – 4 wt. % in certain embodiments, from (¶ [0069]). Choosing these specific cannabinoids based on Cameron’s teachings at a concentration that overlaps within the range of the instant claims, would have been prima facie obvious to a PHOSITA to have a reasonable expectation of success (MPEP §2144.05(I)).
Regarding claim 13, Cameron teaches that a composition of a certain embodiment may contain THC (see above citations).
Regarding claim 20, Cameron teaches the topical composition may be formulated as an emulsion, spray, lotion, gel, etc. (¶ [0182]).
Claim 21 recites: “The topical composition of claim 1 comprising a waterproof shield on skin.” It would have been obvious to a PHOSITA to modify the topical composition taught by Cameron to include: at least one vegetable and plant oil, as well as at least one cannabinoid for the treatment of skin conditions, like eczema, that affect a large patient population. Also, it would have been within the level of skill of a PHOSITA to further modify said topical to include the teachings of Sharon to include the components that make up the emulsifier Beautyderm K10 to prevent the washing away of the active ingredients on a subject’s skin by way of a waterproof shield. Routine optimization of this type of topical would have been prima facie obvious to a PHOSITA to ensure that the active ingredients remain for extended periods of time at the necessitated site of treatment for a presumed subject (MPEP §2144.05(II)(A)).
Regarding claim 22, the intended result is not given much patentable weight as that language in the claims does not provide further structural limitations (MPEP §2111.02(II)). Claim 22 states, “wherein the cannabinoids topically penetrate the skin.” The intended result is not given much patentable weight. Accordingly, the topical compositions instantly claimed are taught by Cameron as mentioned previously and would have been obvious to a PHOSITA to formulate.
Regarding claim 23, Cameron teaches a method to apply embodiments of the invention to treat eczema in a subject in need (¶ [0178]). The intended result of topically penetrating the skin is not given much patentable weight because the similar composition in Cameron would be expected to be capable of that result (MPEP §2111.04(I)). Nevertheless, Cameron teaches that certain methods of the disclosure can be delivered via transdermal administration (¶ [0296]) and would be obvious to a PHOSITA to apply the teachings of Cameron to achieve this route of delivery.
The evidence in the specification was considered, but was not enough to overcome the above prima facie case of obviousness.
Accordingly, claims 2-5, 9, 11-13, 15-16, 18, 21-23 would have been obvious to a PHOSITA in view of Cameron and Sharon.
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 1-4, 6-7, 10-18, 20, and 22-23 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5-20 of co-pending Application No. 18/228,811 (reference application) (“the ‘811 application”). Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass the same composition due to overlapping components.
Instant claim 1 of the co-pending application recites a composition comprising a vegetable oil, a plant oil, and a cannabinoid. Although claim 1 of the ‘811 application requires lanolin, instant claim 1 uses the open-ended transition phrase “comprising,” which means other ingredients like lanolin can be included. Therefore, instant claim 1 encompasses claim 1 of the ‘811 application.
Instant claims 2 and 22 and claims 2 and 19 of the ‘811 application only differ in the component lanolin, but by virtue of the transition phrase “comprising” in instant claim 2, other ingredients like lanolin can be included. The intended result of topically penetrating the skin in claim 22 is not given much patentable weight because the similar composition encompassed in claim 19, by way of the additional component lanolin of the ‘811 application, would be expected to be capable of that result (MPEP §2111.04(I)).
Instant claims 13-14, claims 12-13 of the ‘811 application are encompassed by the same limitation of species of cannabinoids from the instant claims, namely THC or CBD.
Instant claim 20, claim 18 of the ‘811 application is encompassed by the same limitations of possible formulations of the instant claim.
Instant claims 3-4, 6-7, 10-12, and 15-18 are obvious in view of claims 5-11 and 14-17 of the ‘811 application due to the identical overlapping ranges of the components of the composition (MPEP §2144.05(I)).
Instant claim 23 is obvious in view of co-pending claim 20 of the ‘811 application, as it encompasses all the limitations of the co-pending claim. Both claims are directed towards topical compositions containing the same components, except that the instant claims do not require lanolin. However, by virtue of broader instant claim 1, the instantly claimed composition may comprise lanolin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (MPEP §804(I)(B)(1)).
The claims are mapped below for clarity:
Instant Claims
the ‘811 application ‘811
1. A topical composition comprising a combination of a pharmacologically effective amount of one or more extracted vegetable oils, one or more extracted plant oils, and one or more cannabinoids.
1. A therapeutic wound treatment topical composition comprising a combination of a pharmacologically effective amount of lanolin or derivatives thereof, one or more extracted vegetable oils, one or more extracted plant oils, and one or more cannabinoids.
2. A topical composition comprising pharmacologically effective amounts of meadowfoam seed oil, squalane and cannabinoids.
2. A therapeutic wound treatment topical composition comprising pharmacologically effective amounts of lanolin, meadowfoam seed oil, squalane and cannabinoids.
3. The topical composition of claim 1 comprising about 1-20 wt% meadowfoam seed oil.
5. The wound treatment topical composition of claim 1 comprising about 1-20 wt% meadowfoam seed oil.
4. The topical composition of claim 1 comprising about 4-15 wt% meadowfoam seed oil.
6. The wound treatment topical composition of claim 1 comprising about 4-15 wt% meadowfoam seed oil.
6. The topical composition of claim 1 comprising about 1-25 wt% squalane.
7. The wound treatment topical composition of claim 1 comprising about 1-25 wt % squalane.
7. The topical composition of claim 1 comprising about 5-20 wt% squalane.
8. The wound treatment topical composition of claim 1 comprising about 5-20 wt % squalane.
10. The topical composition of claim 1 comprising about 0.05-15 wt% cannabinoids.
9. The wound treatment topical composition of claim 1 comprising about 0.05-15 wt% cannabinoids.
11. The topical composition of claim 1 comprising about 0.25-10 wt% cannabinoids.
10. The wound treatment topical composition of claim 1 comprising about 0.25-10 wt% cannabinoids.
12. The topical composition of claim 1 comprising about 1-3 wt% cannabinoids.
11. The wound treatment topical composition of claim 1 comprising about 1-3 wt% cannabinoids.
13. The topical composition of claim 1 wherein the cannabinoids comprise THC.
12. The wound treatment topical composition of claim 1 wherein the cannabinoids comprise THC.
14. The topical composition of claim 1 wherein the cannabinoids comprise CBD.
13. The wound treatment topical composition of claim 1 wherein the cannabinoids comprise CBD.
15. The topical composition of claim 1 wherein the CBD comprises about 0.25-5 wt% of the total composition.
14. The wound treatment topical composition of claim 13 wherein the CBD comprises about 0.25- 5 wt% of the total composition.
16. The topical composition of claim 1 wherein the topical composition comprises about 0.25-5 wt% CBD and about 0.25-5 wt% THC.
15. The wound treatment topical composition of claim 1 wherein the topical composition comprises about 0.25-5 wt% CBD and about 0.25-5 wt% THC.
17. The topical composition of claim 1 the topical composition comprises (i) about 0.05-15 wt % of at least one cannabinoid; and (ii) about 1-45 wt% of at least one extracted vegetable oil and one extracted plant oil.
16. The wound treatment topical composition of claim 1 herein the topical composition comprises (i) about 0.05-15 wt% of at least one cannabinoid; and (ii) about 1-45 wt% of at least one extracted vegetable oil and one extracted plant oil.
18. The topical composition of claim 1 wherein the topical composition components comprise one
of more of the following features:
(a) the cannabinoid, the extracted vegetable oil, and extracted plant oil comprise a naturally derived product;
(b) the cannabinoid comprises CBD, THC, or CBD and THC;
(c) the CBD comprises about 0.25-10 wt% of the total composition;
(d) the composition comprises about 0.25-5 wt% of CBD and about 0.25-5 wt% of THC;
( e) the extracted vegetable oil and extracted plant oil comprise meadowfoam seed oil and squalane;
(f) the composition comprises about 1-20 wt% of meadowfoam seed oil and about 1-25 wt% squalane; or
(g) the composition comprises about 0.25-5 wt% of CBD, about 0.25-5 wt% of THC, about 4-15 wt% of meadowfoam seed oil, and about 5-20 wt% of squalane.
17. The wound treatment topical composition of claim 1 wherein the topical composition components comprise one of more of the following features:
(a) the cannabinoid, the extracted vegetable oil, and extracted plant oil comprise a naturally derived product;
(b) the cannabinoid comprises CBD, THC, or CBD and THC;
(c) the CBD comprises about 0.25-10 wt% of the total composition;
(d) the composition comprises about 0.25-5 wt% of CBD and about 0.25-5 wt% of THC;
(e) the extracted vegetable oil and extracted plant oil comprise meadowfoam seed oil and squalane;
(f) the composition comprises about 1-20 wt% of meadowfoam seed oil and about 1-25 wt% squalane; or
(g) the composition comprises about 0.25-5 wt% of CBD, about 0.25-5 wt% of THC, about 4-15 wt% of meadowfoam seed oil, and about 5-20 wt% of squalane.
20. The topical composition of claim 1 comprising a spray, an ointment, a cream, an emulsion, a lotion, a paste, an unguent, or a gel.
18. The wound treatment topical composition of claim 1 comprising a spray, an ointment, a cream, an emulsion, a lotion, a paste, an unguent, or a gel.
22. A composition of claim 1 comprising a pharmacologically effective antimicrobial composition comprising pharmacologically effective amounts of meadowfoam seed oil, squalane and cannabinoids; wherein the cannabinoids topically penetrate and treat skin.
19. A wound treatment topical composition of claim 1 comprising a pharmacologically effective antimicrobial composition comprising pharmacologically effective amounts of lanolin, meadowfoam seed oil, squalane and cannabinoids; wherein the cannabinoids release cholesterol contained in the lanolin releasing the cholesterol to topically penetrate and treat the wound.
23. A method to topically treat skin comprising applying the topical composition of claim 1 to a subject's skin, wherein the cannabinoids topically penetrate and treat skin ailments, conditions or diseases.
20. A method to topically treat a wound comprising applying the wound treatment topical composition of claim 1 to a subject's wound, wherein the cannabinoids release cholesterol contained in the lanolin releasing the cholesterol to topically penetrate and treat the wound.
Claims 1-16 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8, and 13 of copending Application No. 18/128,816 (most recent claims filed 21 January 2025) (“ the ‘816 application”). Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass the same composition due to overlapping components.
Instant claim 1 is directed to a composition comprising a vegetable oil, a plant oil, and a cannabinoid; while claim 1 of the ‘816 application is directed to a composition for use on skin comprising one or more cannabinoids, 5.00-20.00% by weight of meadowfoam seed oil, and 4.00-15.00% by weight of squalene. Although claim 1 of the ‘816 application specifically requires meadowfoam seed oil and squalene at specific concentrations, instant claim 1 encompasses any concentration of those components.
Instant claims 13-14 encompass claims 3, 5, and 7 of the ‘816 application by way of the same limitations of species of cannabinoids. For clarity, the base topical composition described in claim 1 of ‘ the ‘811 application 816 is narrower in scope to the topical composition in instant claim 1. Therefore, the instant claim limitations of 13-14, encompass those of claims 3, 5, and 7 of the ‘811 application ‘816.
Instant claim 19 encompasses claim 13 of the ‘816 application due it being narrower in scope by virtue of the base composition in claim 1 of the ‘811 application ‘816.
Instant claims 3-12 and 15-16 are obvious in view of claims 1, 3, 6, and 8 of the ‘811 application ‘816. The ranges of the components that make up the topical composition with the narrowest scope in the instant claims (i.e., meadowfoam seed oil, squalene, CBD, and THC), overlap with the ranges of claims 1, 3, 6, and 8 of the ‘816 application (MPEP §2144.05(I)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (MPEP §804(I)(B)(1)).
The claims are mapped below for clarity:
Instant Claims
the ‘811 application ‘816
1. A topical composition comprising a combination of a pharmacologically effective amount of one or more extracted vegetable oils, one or more extracted plant oils, and one or more cannabinoids.
2. A topical composition comprising pharmacologically effective amounts of meadowfoam seed oil, squalane and cannabinoids.
1. (Currently Amended) An anti-microbial composition for use on skin comprising the combination of a pharmacologically effective amount of one or more cannabinoids and components comprising about 5.00-20.00% by weight of meadowfoam seed oil and about 4.00-15.00% by weight of hydrogenated squalene in a suitable base.
3. (Original) The composition of claim 1, where the cannabinoid comprises CBD, THC, or CBD and THC.
5. (Original) The composition of claim 3, where the cannabinoid comprises CBD.
7. (Original) The composition of claim 3, where the cannabinoid further comprises THC.
13. The topical composition of claim 1 wherein the cannabinoids comprise THC.
14. The topical composition of claim 1 wherein the cannabinoids comprise CBD.
19. The topical composition of claim 1 further comprising on or more of a solvent, a thickener, an anti-oxidant, a conditioner, a moisturizer, an emulsifier, a nutrient, an aroma or fragrance, a
preservative, a stabilizer, or a combination thereof.
13. (Previously Presented) The composition of claim [1] further comprising one or more of the following ingredients: a solvent, a thickener, an anti-oxidant, a conditioner, a moisturizer, an emulsifier, a nutrient, an aroma or fragrance, a preservative, a stabilizer, or a combination thereof.
Instant Claims
the ‘811 application ‘816
1. A topical composition comprising a combination of a pharmacologically effective amount of one or more extracted vegetable oils, one or more extracted plant oils, and one or more cannabinoids.
3. The topical composition of claim 1 comprising about 1-20 wt% meadowfoam seed oil.
4. The topical composition of claim 1 comprising about 4-15 wt% meadowfoam seed oil.
5. The topical composition of claim 1 comprising about 5-7 wt% meadowfoam seed oil.
7. The topical composition of claim 1 comprising about 5-20 wt% squalane.
8. The topical composition of claim 1 comprising about 3-7 wt% squalane.
9. The topical composition of claim 1 comprising about 0.5-5 wt% squalane.
10. The topical composition of claim 1 comprising about 0.05-15 wt% cannabinoids.
11. The topical composition of claim 1 comprising about 0.25-10 wt% cannabinoids.
12. The topical composition of claim 1 comprising about 1-3 wt% cannabinoids.
15. The topical composition of claim 1 wherein the CBD comprises about 0.25-5 wt% of the total
composition.
16. The topical composition of claim 1 wherein the topical composition comprises about 0.25-5
wt¾ CBD and about 0.25-5 wt% THC.
1. (Currently Amended) An anti-microbial composition for use on skin comprising the combination of a pharmacologically effective amount of one or more cannabinoids and components comprising about 5.00-20.00% by weight of meadowfoam seed oil and about 4.00-15.00% by weight of hydrogenated squalene in a suitable base.
3. (Original) The composition of claim 1, where the cannabinoid comprises CBD, THC, or CBD and THC.
6. (Original) The composition of claim 3, where the CBD comprises about 0.25- 1.10% by weight of the total composition.
8. (Original) The composition of claim 3, where the cannabinoid comprises about 0.25-1.10% by weight of CBD and about 0.25-1.50% by weight of THC the total composition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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, Adam C Milligan can be reached at (571) 270-7674. 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.
/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623