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
Response to Amendment
The amendment filed 2/19/2026 has been entered. Newly amended Claims 1, 15, and 21-38 are pending in the application. Applicant’s amendments to the Claims have overcome every rejection previously set forth in the Non-Final Office Action mailed 12/10/2025.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32 recites “wherein the composition is a vegetable oil”. “composition” should instead read “oil”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33 and 36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant claims “sunflower oil”. However, sunflower oil is not disclosed before amendments to the application. No mention of sunflower oil is found in the specification of the instant application or applications to which the instant invention claims priority. For example, on Page 10 of Prov. App. No. 62840972 and in Para 54 of the instant specification, only corn, peanut, and coconut oil are disclosed. Therefore, the limitation of sunflower oil is new matter.
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.
Claim 33 is 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 regards as the invention.
Claim 33 depends on Claim 1 and states “the vegetable oil”. No vegetable oil is recited in Claim 1. It is unclear to what “the vegetable oil” refers. For the purpose of compact prosecution, Claim 33 is interpreted to depend on Claim 32, a preceding claim, which does recite “a vegetable oil”.
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.
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, 23, 25, 28, 32, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siurkus (WO2017178937).
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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comprising: 6:6% CBD:CBDA (or 1:1 by weight), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
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The weight ratio of 1:1 is equivalent to a molar ratio of 0.877 (MWCBD/MWCBDA = 314.47g/mol / 358.48g/mol) which is “approximately” that claimed. Applicant discusses interpretation of numbers of the invention as follows in Para 26: “the numerical parameters set forth in the specification and claims are approximations that may vary…each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.” 0.877 rounded to the nearest whole number is 1, which is equivalent to a ratio of 1:1. Therefore, 0.877 is encompassed by the claimed ratio of “approximately 1:1” as claimed.
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.
Claims 1, 15, 23, 25, 28, 32, 34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Siurkus (WO2017178937).
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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comprising: 6:6% CBD:CBDA (or 1:1), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
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The composition is useful for reducing inflammation (Abstract).
The weight ratio of 1:1 is equivalent to a molar ratio of 0.877 (MWCBD/MWCBDA = 314.47g/mol / 358.48g/mol) which is “approximately” that claimed. Applicant discusses interpretation of numbers of the invention as follows in Para 26: “the numerical parameters set forth in the specification and claims are approximations that may vary…each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.” 0.877 rounded to the nearest whole number is 1, which is equivalent to a ratio of 1:1. Therefore, 0.877 is encompassed by the claimed ratio of “approximately 1:1” as claimed.
Siurkus does not disclose additional agents in the composition but additionally teaches “the present invention can substitute or complement a therapy based on synthetic NSAIDs and corticosteroids for reduction of inflammation lesions in the deep tissues of skeletal system” (Page 1). Therefore, one of skill in the art seeking to treat inflammation with both agents, cannabinoids and NSAIDs/corticosteroids, would seek to formulate the combination together for ease of administration to a patient because Siurkus specifically suggests complementing the one therapy with the other before the effective filing date of the examined invention.
Claims 1, 21-26, 28-33, 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Stott (US20180228751, published 2018) in view of Chen (Current Opinion in Food Science 2019, 28:7–13).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Liquid compositions with saline (water) are also contemplated (Para 72). Transdermal compositions of the above forms are contemplated, which is applied topically to the skin (Page 3, Para 28).
Stott does not teach particular dosage forms comprising the compositions.
Chen teaches compositions comprising phytocannabinoids are administered with sesame or coconut oil and “contained in gelatin capsules” to improve bioavailability (Page 7, Right Col., Para 2; Page 8). Cannabinoids are often formulated into tablets and capsules, which are pills (Page 10, Solid formulations).
One of skill in the art formulating the Stott composition for administration to a subject for the treatment of epilepsy would find it obvious to use any of those forms taught as acceptable in Stott for the composition or those taught by Chen as used in cannabinoid compositions. One would expect success in formulating the compositions described before the effective filing date because Stott extends great flexibility to any artisan seeking to form a composition with the claimed ratio of cannabinoids and Chen teaches that cannabinoids are commonly formed in oil for delivery. Chen teaches several oil species and does not preclude the use of any combination thereof to achieve the formulation.
Claims 1, 21-28, 31-33, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Stott (US20180228751) in view of Kubby (US20180104213).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Transdermal compositions of the above forms is contemplated, which is applied topically to the skin (Page 3, Para 28).
Stott does not teach an oil solvent for forming such compositions.
Kubby teaches forming solid compositions of cannabinoids in coconut oil, water, sodium chloride (salt), sugar (sweetener) yielded as dosages molded in “forms” upon cooling (Claim 13). The cooled solid forms are interpreted to be pills. Suitable dosage forms include capsules and tablets which are pills (Para 14). Kubby further teaches liquid compositions may comprise cannabinoids and diluents like water and oil and saline (Para 14).
One of skill in the art seeking to form a purified cannabinoid composition of equal parts CBD and CBDA taught by Stott for delivery to a patient would look to Kubby which provides specific guidance for formulating specific dosage forms of cannabinoids, either as liquid or solid dosages. Using the Kubby excipients and dosage forms to formulate compositions of the Stott combination which are also cannabinoids would be expected to yield pharmaceutically acceptable dosages before the effective filing date.
Regarding Claims 24 and 35, the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. See MPEP 2111.03. Kubby teaches liquid compositions consisting of the cannabinoid component and solvent as well as solids forms with excipients, which do not include additional cannabinoids or agents which would materially affect the “novel characteristics” of the invention.
Claims 1, 21-25, 28, 32-33, and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Stott (US20180228751) in view of Kumar (US20160271252).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Transdermal compositions of the above forms is contemplated, which is applied topically to the skin (Page 3, Para 28).
Stott does not teach an oil solvent for forming such compositions.
Kumar teaches a composition for pharmaceutical administration comprising a cannabinoid and a lipid, the lipid being a vegetable oil like sunflower oil, corn oil, or others, and combinations thereof (Claims 1-2). The cannabinoid is pure, at least 98% pure (Claim 5). The composition may contain 0-15% water (Para 45). “Preferably, the formulations are liquids” (Para 56).
One of skill in the art seeking to formulate the Stott combination for delivery to a patient would look to Kumar for specific guidance in doing so because both are directed to cannabinoids for pharmaceutical use and both teach formulating liquid compositions. Therefore, one of skill in the art would find it obvious to use the Stott cannabinoid (CBD and CBDA) in the compositions taught by Kumar before the effective filing date to administer said cannabinoid to a patient using the Kumar excipients as effective vehicles for administration.
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.
PROVISIONAL:
1. Claims 1, 15, 21-38 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 5-6 of copending Application No. 17931249 (hereinafter referred to as Altman) in view of Siurkus, Stott, Kubby, Kumar, and Chen.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a 1:1 CBD:CBDA combination of cannabinoids and oil (DHA and EPA) in a pill.
Altman does not teach particular solid or liquid formulations comprising the generic excipients and forms as claimed.
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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comprising: 6:6% CBD:CBDA (or 1:1), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
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The composition is useful for reducing inflammation (Abstract). Siurkus additionally teaches “the present invention can substitute or complement a therapy based on synthetic NSAIDs and corticosteroids for reduction of inflammation lesions in the deep tissues of skeletal system” (Page 1).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Liquid compositions with saline (water) are also contemplated (Para 72). Transdermal compositions of the above forms are contemplated, which is applied topically to the skin (Page 3, Para 28).
Chen teaches compositions comprising phytocannabinoids are administered with sesame or coconut oil and “contained in gelatin capsules” to improve bioavailability (Page 7, Right Col., Para 2; Page 8). Cannabinoids are often formulated into tablets and capsules, which are pills (Page 10, Solid formulations). Chen teaches several oil species and does not preclude the use of any combination thereof to achieve the formulation.
Kubby teaches forming solid compositions of cannabinoids in coconut oil, water, sodium chloride (salt), sugar (sweetener) yielded as dosages molded in “forms” upon cooling (Claim 13). The cooled solid forms are interpreted to be pills. Suitable dosage forms include capsules and tablets which are pills (Para 14). Kubby further teaches liquid compositions may comprise cannabinoids and diluents like water and oil and saline (Para 14).
Kumar teaches a composition for pharmaceutical administration comprising a cannabinoid and a lipid, the lipid being a vegetable oil like sunflower oil, corn oil, or others, and combinations thereof (Claims 1-2). The cannabinoid is pure, at least 98% pure (Claim 5). The composition may contain 0-15% water (Para 45). “Preferably, the formulations are liquids” (Para 56).
One of skill in the art seeking to formulate the claimed ratio of CBD to CBDA would look to the particular formulations taught in the art to achieve effective delivery of the cannabinoids to a subject. Siurkus, Stott, Kubby, Kumar, and Chen all teach specific formulations comprising oils, water, salt, sweeteners, in various combinations in liquid and solid forms as pills, tablets, and gelatin capsules. Therefore, one of skill in the art seeking to use the Altman combination would look to the above references which all teach the formulation of cannabinoids for effective delivery. One would expect success in doing so because of the broad teachings regarding generic solid or liquid forms and solvents and excipients.
Since both applications teach the same combination, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Altman.
This is a provisional nonstatutory double patenting rejection.
2. Claims 1, 15, 21-38 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1, 3, 5-10, 12-16, and 18 of copending Application No. 19327282 (hereinafter referred to as Altman) in view of Siurkus, Stott, Kubby, Kumar, and Chen.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a 1:1 CBD:CBDA combination of cannabinoids with minimal or no other cannabinoids present.
Although the Altman claims are direct to methods of using the combination, said methods require the existence of the compositions.
Altman does not teach particular solid or liquid formulations comprising the generic excipients and forms as claimed.
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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comprising: 6:6% CBD:CBDA (or 1:1), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
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The composition is useful for reducing inflammation (Abstract). Siurkus additionally teaches “the present invention can substitute or complement a therapy based on synthetic NSAIDs and corticosteroids for reduction of inflammation lesions in the deep tissues of skeletal system” (Page 1).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Liquid compositions with saline (water) are also contemplated (Para 72). Transdermal compositions of the above forms are contemplated, which is applied topically to the skin (Page 3, Para 28).
Chen teaches compositions comprising phytocannabinoids are administered with sesame or coconut oil and “contained in gelatin capsules” to improve bioavailability (Page 7, Right Col., Para 2; Page 8). Cannabinoids are often formulated into tablets and capsules, which are pills (Page 10, Solid formulations). Chen teaches several oil species and does not preclude the use of any combination thereof to achieve the formulation.
Kubby teaches forming solid compositions of cannabinoids in coconut oil, water, sodium chloride (salt), sugar (sweetener) yielded as dosages molded in “forms” upon cooling (Claim 13). The cooled solid forms are interpreted to be pills. Suitable dosage forms include capsules and tablets which are pills (Para 14). Kubby further teaches liquid compositions may comprise cannabinoids and diluents like water and oil and saline (Para 14).
Kumar teaches a composition for pharmaceutical administration comprising a cannabinoid and a lipid, the lipid being a vegetable oil like sunflower oil, corn oil, or others, and combinations thereof (Claims 1-2). The cannabinoid is pure, at least 98% pure (Claim 5). The composition may contain 0-15% water (Para 45). “Preferably, the formulations are liquids” (Para 56).
One of skill in the art seeking to formulate the claimed ratio of CBD to CBDA would look to the particular formulations taught in the art to achieve effective delivery of the cannabinoids to a subject. Siurkus, Stott, Kubby, Kumar, and Chen all teach specific formulations comprising oils, water, salt, sweeteners, in various combinations in liquid and solid forms as pills, tablets, and gelatin capsules. Therefore, one of skill in the art seeking to use the Altman combination would look to the above references which all teach the formulation of cannabinoids for effective delivery. One would expect success in doing so because of the broad teachings regarding generic solid or liquid forms and solvents and excipients.
Since both applications teach the same combination, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Altman.
This is a provisional nonstatutory double patenting rejection.
3. Claims 1, 15, 21-38 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-20 of copending Application No. 19739723 (hereinafter referred to as Altman) in view of Siurkus, Stott, Kubby, Kumar, and Chen.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a 1:1 CBD:CBDA combination of cannabinoids and oil (DHA and EPA) in a pill.
Altman does not teach particular solid or liquid formulations comprising the generic excipients and forms as claimed.
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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comprising: 6:6% CBD:CBDA (or 1:1), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
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The composition is useful for reducing inflammation (Abstract). Siurkus additionally teaches “the present invention can substitute or complement a therapy based on synthetic NSAIDs and corticosteroids for reduction of inflammation lesions in the deep tissues of skeletal system” (Page 1).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Liquid compositions with saline (water) are also contemplated (Para 72). Transdermal compositions of the above forms are contemplated, which is applied topically to the skin (Page 3, Para 28).
Chen teaches compositions comprising phytocannabinoids are administered with sesame or coconut oil and “contained in gelatin capsules” to improve bioavailability (Page 7, Right Col., Para 2; Page 8). Cannabinoids are often formulated into tablets and capsules, which are pills (Page 10, Solid formulations). Chen teaches several oil species and does not preclude the use of any combination thereof to achieve the formulation.
Kubby teaches forming solid compositions of cannabinoids in coconut oil, water, sodium chloride (salt), sugar (sweetener) yielded as dosages molded in “forms” upon cooling (Claim 13). The cooled solid forms are interpreted to be pills. Suitable dosage forms include capsules and tablets which are pills (Para 14). Kubby further teaches liquid compositions may comprise cannabinoids and diluents like water and oil and saline (Para 14).
Kumar teaches a composition for pharmaceutical administration comprising a cannabinoid and a lipid, the lipid being a vegetable oil like sunflower oil, corn oil, or others, and combinations thereof (Claims 1-2). The cannabinoid is pure, at least 98% pure (Claim 5). The composition may contain 0-15% water (Para 45). “Preferably, the formulations are liquids” (Para 56).
One of skill in the art seeking to formulate the claimed ratio of CBD to CBDA would look to the particular formulations taught in the art to achieve effective delivery of the cannabinoids to a subject. Siurkus, Stott, Kubby, Kumar, and Chen all teach specific formulations comprising oils, water, salt, sweeteners, in various combinations in liquid and solid forms as pills, tablets, and gelatin capsules. Therefore, one of skill in the art seeking to use the Altman combination would look to the above references which all teach the formulation of cannabinoids for effective delivery. One would expect success in doing so because of the broad teachings regarding generic solid or liquid forms and solvents and excipients.
Since both applications teach the same combination, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Altman.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claims 1, 15, 21-38 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-6 of U.S. Patent No. 12496307 (hereinafter referred to as Altman) in view of Siurkus, Stott, Kubby, Kumar, and Chen.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a 1:1 CBD:CBDA combination of cannabinoids.
Although the Altman claims are direct to methods of using the combination, said methods require the existence of the compositions.
Altman does not teach particular solid or liquid formulations comprising the generic excipients and forms as claimed.
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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439
800
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comprising: 6:6% CBD:CBDA (or 1:1), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
PNG
media_image2.png
131
810
media_image2.png
Greyscale
.
The composition is useful for reducing inflammation (Abstract). Siurkus additionally teaches “the present invention can substitute or complement a therapy based on synthetic NSAIDs and corticosteroids for reduction of inflammation lesions in the deep tissues of skeletal system” (Page 1).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Liquid compositions with saline (water) are also contemplated (Para 72). Transdermal compositions of the above forms are contemplated, which is applied topically to the skin (Page 3, Para 28).
Chen teaches compositions comprising phytocannabinoids are administered with sesame or coconut oil and “contained in gelatin capsules” to improve bioavailability (Page 7, Right Col., Para 2; Page 8). Cannabinoids are often formulated into tablets and capsules, which are pills (Page 10, Solid formulations). Chen teaches several oil species and does not preclude the use of any combination thereof to achieve the formulation.
Kubby teaches forming solid compositions of cannabinoids in coconut oil, water, sodium chloride (salt), sugar (sweetener) yielded as dosages molded in “forms” upon cooling (Claim 13). The cooled solid forms are interpreted to be pills. Suitable dosage forms include capsules and tablets which are pills (Para 14). Kubby further teaches liquid compositions may comprise cannabinoids and diluents like water and oil and saline (Para 14).
Kumar teaches a composition for pharmaceutical administration comprising a cannabinoid and a lipid, the lipid being a vegetable oil like sunflower oil, corn oil, or others, and combinations thereof (Claims 1-2). The cannabinoid is pure, at least 98% pure (Claim 5). The composition may contain 0-15% water (Para 45). “Preferably, the formulations are liquids” (Para 56).
One of skill in the art seeking to formulate the claimed ratio of CBD to CBDA would look to the particular formulations taught in the art to achieve effective delivery of the cannabinoids to a subject. Siurkus, Stott, Kubby, Kumar, and Chen all teach specific formulations comprising oils, water, salt, sweeteners, in various combinations in liquid and solid forms as pills, tablets, and gelatin capsules. Therefore, one of skill in the art seeking to use the Altman combination would look to the above references which all teach the formulation of cannabinoids for effective delivery. One would expect success in doing so because of the broad teachings regarding generic solid or liquid forms and solvents and excipients.
Since both claim sets teach the same combination, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Altman.
2. Claims 1, 15, 21-38 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-16 of U.S. Patent No. 12678451 (hereinafter referred to as Altman) in view of Siurkus, Stott, Kubby, Kumar, and Chen.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a 1:1 CBD:CBDA combination of cannabinoids and oil (DHA and EPA) in a pill.
Although the Altman claims are direct to methods of using the combination, said methods require the existence of the compositions.
Altman does not teach particular solid or liquid formulations comprising the generic excipients and forms as claimed.
Siurkus teaches the following topical oleo gel (liquid) composition (Pages 8-10):
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comprising: 6:6% CBD:CBDA (or 1:1), an olive fruit oil (vegetable oil solvent), and Mentha leaf oil. Water is also present in the extract:
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.
The composition is useful for reducing inflammation (Abstract). Siurkus additionally teaches “the present invention can substitute or complement a therapy based on synthetic NSAIDs and corticosteroids for reduction of inflammation lesions in the deep tissues of skeletal system” (Page 1).
Stott teaches treatment of epilepsy with up to 98% pure CBDA from plant extract wherein THC(A) is substantially removed (Abstract). The CBDA may be produced synthetically so as to remove other cannabinoids (Page 3, Para 36). One embodiment of the composition specifies that CBDA is preferably used with CBDA, wherein “the CBDA and CBD may be present in substantially equal amount[s] namely 55:45 to 45:55” and 1:1 (Page 3, Para 37-38 and 46). “It is envisaged that the composition be administered as one or more of: an oral liquid solution, solid, semi-solid, gel, injection” with excipients (Page 3, Para 50-51). Liquid compositions with saline (water) are also contemplated (Para 72). Transdermal compositions of the above forms are contemplated, which is applied topically to the skin (Page 3, Para 28).
Chen teaches compositions comprising phytocannabinoids are administered with sesame or coconut oil and “contained in gelatin capsules” to improve bioavailability (Page 7, Right Col., Para 2; Page 8). Cannabinoids are often formulated into tablets and capsules, which are pills (Page 10, Solid formulations). Chen teaches several oil species and does not preclude the use of any combination thereof to achieve the formulation.
Kubby teaches forming solid compositions of cannabinoids in coconut oil, water, sodium chloride (salt), sugar (sweetener) yielded as dosages molded in “forms” upon cooling (Claim 13). The cooled solid forms are interpreted to be pills. Suitable dosage forms include capsules and tablets which are pills (Para 14). Kubby further teaches liquid compositions may comprise cannabinoids and diluents like water and oil and saline (Para 14).
Kumar teaches a composition for pharmaceutical administration comprising a cannabinoid and a lipid, the lipid being a vegetable oil like sunflower oil, corn oil, or others, and combinations thereof (Claims 1-2). The cannabinoid is pure, at least 98% pure (Claim 5). The composition may contain 0-15% water (Para 45). “Preferably, the formulations are liquids” (Para 56).
One of skill in the art seeking to formulate the claimed ratio of CBD to CBDA would look to the particular formulations taught in the art to achieve effective delivery of the cannabinoids to a subject. Siurkus, Stott, Kubby, Kumar, and Chen all teach specific formulations comprising oils, water, salt, sweeteners, in various combinations in liquid and solid forms as pills, tablets, and gelatin capsules. Therefore, one of skill in the art seeking to use the Altman combination would look to the above references which all teach the formulation of cannabinoids for effective delivery. One would expect success in doing so because of the broad teachings regarding generic solid or liquid forms and solvents and excipients.
Since both claim sets teach the same combination, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Altman.
Conclusion
No claim is allowable.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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