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 Application
The Amendment filed on 10/27/23 is acknowledged.
Claims 1-3, 8-15, 19-20, 22-29, 33-41, 44, 46-48, and 50-57 were cancelled.
Claims 16, 30, 32, 42, 45, and 49 were amended.
New claims 58-61 were added.
Claims 4-7, 16-18, 21, 30-32, 42-43, 45, 49, and 58-61 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/27/23 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Claim Objections
Claims 4-7 are objected to because of the following informalities:
In claims 4-7, the phrase “about 10 mg to about 150 mg of Pueraria lobata” is repeated. One iteration of this phrase should be deleted.
Appropriate correction is required.
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 4-7, 16-18, 21, 30-32, 42-43, 45, 49, and 58-61 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 pre-AIA the applicant regards as the invention.
Claims 4-7, 21, and 32 recite several herbal components but the source and form of the herbal components is not recited. For example, it is unclear if the herbal components are extracts or ground up herbs. If the herbal components are extracts, the solvent used for extraction is not defined. If the herbal components are ground up herbs, are they dried, are the parts from roots, leaves, stems, flowers, seeds? For examination purposes, any disclosure of the recited herbs is deemed to read on the herbal components.
Dependent claims 16-18, 30-31, 42-43, 45, 49, and 58-61 are included in this rejection for not correcting the defects of the claims from which they depend.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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 § 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 4-7, 16-18, 21, 30-32, 42-43, 45, 58 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Finley et al. (US 2018/0344661 A1 – “Finley”) in view of Korthout et al. (EP 1 559 423 A1 – “Korthout”), Bech (WO 02/066041 A1), Jia (US 2001/0006983 A1), and Shorr (US 2017/0354640 A1).
Instant claim 4 is drawn to a composition comprising three categories of components (i), (ii), and (iii).
Finley teaches cannabis oil compositions (Abstract and claims 1-4, 8-10, 12-14, 16-20, 24-27). The composition comprises cannabidiol (CBD) ([0007], [0165], claims 1 and 2), cannabinol (CBN), and cannabigerol (CBG) ([0139], [0165], [0167], [0169], Example 4, TABLE 4, Example 6, TABLES 9-11, claims 1-2 and 14). Finley teaches the inclusion of Vitamin E or combinations of tocopherols ([0069], [0132]), herbal extracts such as Passiflora incarnata, Citrus reticulata, Withania somnifera, Lycopus virginicus, Poria cocos, Actaea rac, Pueraria Lobata, Asphodeloides, silymarin, Schisandra chinensis, Humulus lupulus, Grindelia, Panax ginseng, Rehmannia glutinosa, Scutellaria lateriflora, Piper methysticum, and Piper nigrum ([0180]). The cannabinoids and other compounds found in cannabis relieve pain, aid sleep, alleviate inflammation, and have therapeutic effects in patients with migraines, anxiety disorders, etc. ([0003]).
Finley does not expressly teach the dosage ranges of CBD, CBN, CBG, or the herbal extracts and their corresponding dosage ranges as recited in instant claim 4.
Korthout teaches a cannabis extract comprising the acidic cannabinoids CBD, CBN and CBG (Abstract). The cannabis extract (claim 6) comprises about 15-500 mg/g of the acidic cannabinoid based on the dry weight of the extract (claim 8) and the cannabinoids include CBD, CBN and CBG (claim 9). The compounds are used for relieving pain and/or for suppression of an inflammatory response ([0012]-[0013]).
Bech teaches a tablet composition comprising Passiflora incarnata at a dosage of 40 mg (Page 32, lines 10-15). The composition is used for the treatment of symptoms related to sleep disorder, anxiety, pain, etc. (Page 28, lines 18-22, claim 80).
Jia teaches a multicomponent biological vehicle comprising a combination of natural plant extracts (Abstract and claims 1-17), including an aqueous extract of Ziziphus jujuba fruits ([0007], [0018], [0030], [0032], claims 5 and 12) and an organic solvent extract of Piper nigrum ([0007], [0018], [0029], [0032]). Formulation 3 contains Ziziphus jujuba Mill var. spinosa seed extract at 200 mg daily dosage and an effective range of 50-600 mg, Withania somnifera root extract at an effective range of 50-600 mg, and Piper methylsticum rootstock extract at 50-500 mg effective range ([0053]). Hormones such as melatonin are also disclosed ([0008] and [0018]). Formulation 2 contains Schisandra extract at an effective range of 50-1500 mg ([0052]). Jia teaches the suppression of inflammatory responses by using their formulation (Example 4 - [0049]).
Shorr teaches a composition comprising a combination of synthetic chemical agents and herbal extracts as nutritional and dietary supplements ([0002]). The composition includes purified or synthetic whole-plant cannabis extract ([0010], [0012], [0070], [0082], claims 1, 11, and 15), 50 mg 5-HTP (5-hydroxytryptophan) and 3 mg melatonin ([0012], Formulation B – [0110], TABLES 4-7, claims 17 and 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising CBD, CBN, CBG, as well as Vitamin E, and herbal extracts such as Passiflora incarnata, Citrus reticulata, Withania somnifera, Lycopus virginicus, Poria cocos, Actaea rac, Pueraria Lobata, Asphodeloides, silymarin, Schisandra chinensis, Humulus lupulus, Grindelia, Panax ginseng, Rehmannia glutinosa, Scutellaria lateriflora, Piper methysticum, and Piper nigrum, as taught by Finley, in view of the cannabis extract comprising about 15-500 mg/g of the acidic cannabinoid based on the dry weight of the extract wherein the cannabinoids include CBD, CBN and CBG, as taught by Korthout, the tablet composition comprising Passiflora incarnata at a dosage of 40 mg, as taught by Bech, the multicomponent biological vehicle comprising a combination of plant extracts such as Ziziphus jujuba Mill var. spinosa seed extract at 200 mg daily dosage and an effective range of 50-600 mg, Withania somnifera root extract at an effective range of 50-600 mg, Piper methylsticum rootstock extract at 50-500 mg effective range, and Schisandra extract at an effective range of 50-1500 mg, as well as hormones such as melatonin, as taught by Jia, and the composition including purified or synthetic whole-plant cannabis extract, 50 mg 5-HTP and 3 mg melatonin, as taught by Shorr, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references teach that the compositions are used for treating pain or inflammation. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Finley teaches that cannabinoids and other compounds found in cannabis relieve pain, aid sleep, alleviate inflammation, and have therapeutic effects in patients with migraines, anxiety disorders, etc. ([0003]). Korthout teaches that the compounds are used for relieving pain and/or for suppression of an inflammatory response ([0012]-[0013]). Bech teaches that their composition is used for the treatment of symptoms related to sleep disorder, anxiety, pain, etc. (Page 28, lines 18-22, claim 80). Jia teaches the suppression of inflammatory responses by using their formulation (Example 4 - [0049]). One of ordinary skill in the art would have had a reasonable expectation of success in producing a composition having the combination of components recited in the cited prior art and effectively treat pain and or inflammation.
Furthermore, Finley and Shorr teach the combination of cannabinoids with other herbal extracts and with 50 mg 5-HTP and 3 mg melatonin. MPEP 2144.06 states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said cannabinoids, herbal components, and other nutritional components with a reasonable expectation of success because each component is taught to be useful for the same purpose and it is prima facie obvious to combine said actives to form a third composition to be used for the very same purpose.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 4-7 and 32, the limitations of a composition comprising (i) about 5 mg to about 80 mg of CBD, about 1 mg to about 15 mg of CBN, about 1 mg to about 30 mg of CBG, or any combinations thereof would have been obvious over the cannabis oil compositions (Abstract and claims 1-4, 8-10, 12-14, 16-20, 24-27) comprising CBD ([0007], [0165], claims 1 and 2), CBN, and CBG ([0139], [0165], [0167], [0169], Example 4, TABLE 4, Example 6, TABLES 9-11, claims 1-2 and 14), as taught by Finley, in view of the cannabis extract (claim 6) comprising about 15-500 mg/g of the acidic cannabinoid based on the dry weight of the extract (claim 8) wherein the cannabinoids include CBD, CBN and CBG (claim 9), as taught by Korthout.
Regarding instant claims 4 and 7, the limitations of (ii) one or more of the following: about 40 mg to 260 mg of Ziziphus spinosa, about 0.1 mg to 4 mg of melatonin, and about 30 mg to about 200 mg of Passiflora incarnata would have been obvious over the herbal extracts such as Passiflora incarnata ([0180]), as taught by Finley, in view of the tablet comprising Passiflora incarnata at a dosage of 40 mg (Page 32, lines 10-15), as taught by Bech, Formulation 3 which contains Ziziphus jujuba Mill var. spinosa seed extract at 200 mg daily dosage and an effective range of 50-600 mg ([0053]), as taught by Jia, and the composition comprising cannabis extract ([0010], [0012], [0070], [0082], claims 1, 11, and 15), and 3 mg melatonin ([0012], Formulation B – [0110], TABLES 4-7, claims 17 and 37), as taught by Shorr.
Regarding instant claims 4 and 21, the limitations of three or more of the listed components would have been obvious over the herbal extracts such as Passiflora incarnata, Citrus reticulata, Withania somnifera, Lycopus virginicus, Poria cocos, Actaea rac, Pueraria Lobata, Asphodeloides, silymarin, Schisandra chinensis, Humulus lupulus, Grindelia, Panax ginseng, Rehmannia glutinosa, Scutellaria lateriflora, Piper methysticum, and Piper nigrum ([0180]), as taught by Finley, in view of the Withania somnifera root extract at an effective overlapping range of 50-600 mg ([0053]), Piper methylsticum rootstock extract at 50-500 mg effective range ([0053]), and Schisandra extract at an effective range of 50-1500 mg ([0052]), as taught by Jia, as well as the composition comprising 50 mg 5-HTP and 3 mg melatonin ([0012], Formulation B – [0110], TABLES 4-7, claims 17 and 37), as taught by Shorr. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 5, the limitation of a composition comprising (i) about 40 mg to 260 mg of Ziziphus spinosa would have been obvious over the Ziziphus jujuba Mill var. spinosa seed extract at 200 mg daily dosage and an effective overlapping range of 50-600 mg ([0053]), as taught by Jia. Please see MPEP 2144.05.
Regarding instant claim 6, the limitation of component (i) comprising about 0.1 mg to 4 mg of melatonin would have been obvious over the 3 mg melatonin ([0012], Formulation B – [0110], TABLES 4-7, claims 17 and 37), as taught by Shorr.
Regarding instant claims 5-7, the limitations of (ii) four or more of the listed components would have been obvious over the herbal extracts such as Passiflora incarnata, Citrus reticulata, Withania somnifera, Lycopus virginicus, Poria cocos, Actaea rac, Pueraria Lobata, Asphodeloides, silymarin, Schisandra chinensis, Humulus lupulus, Grindelia, Panax ginseng, Rehmannia glutinosa, Scutellaria lateriflora, Piper methysticum, and Piper nigrum ([0180]), as taught by Finley, in view of the Passiflora incarnata at a dosage of 40 mg (Page 32, lines 10-15), as taught by Bech, the Withania somnifera root extract at an effective overlapping range of 50-600 mg ([0053]), Piper methylsticum rootstock extract at 50-500 mg effective range ([0053]), and Schisandra extract at an effective range of 50-1500 mg ([0052]), as taught by Jia, as well as the composition comprising 50 mg 5-HTP and 3 mg melatonin ([0012], Formulation B – [0110], TABLES 4-7, claims 17 and 37), as taught by Shorr. Please see MPEP 2144.05.
Regarding instant claims 16-18, the limitations of the method for improving sleep quality in a subject would have been obvious over the cannabinoids and other compounds found in cannabis that aid sleep ([0003]), as taught by Finley, and the treatment of symptoms related to sleep disorders (Page 28, lines 18-22), as taught by Bech. The limitations of improving sleep onset latency and sleep duration would have been obvious effects after treating a subject in need of sleep aid by administering the compositions taught by the prior art absent evidence of criticality or unexpected results.
Regarding instant claims 21 and 32, the limitations of a composition comprising (i) about 5 mg to about 80 mg of CBD and about 1 mg to about 30 mg of CBN would have been obvious over the cannabis oil compositions (Abstract and claims 1-4, 8-10, 12-14, 16-20, 24-27) comprising CBD ([0007], [0165], claims 1 and 2) and CBN ([0139], [0165], [0167], [0169], Example 4, TABLE 4, Example 6, TABLES 9-11, claims 1-2 and 14), as taught by Finley, in view of the cannabis extract (claim 6) comprising an overlapping range of about 15-500 mg/g of the acidic cannabinoid based on the dry weight of the extract (claim 8) wherein the cannabinoids include CBD and CBN (claim 9), as taught by Korthout. The limitation about 1 mg to about 10 mg of Piper nigrum would have been obvious over the Piper nigrum seeds at 17 mg (Page 32, line 20), as taught by Bech. The concentration of Piper nigrum is a parameter that can be modified and one of ordinary skill in the art would have found it obvious to modify the concentration of this component based on the desired dosage, therapeutic efficacy, and stability. The recited dosage range would have been an obvious variant over the teaching of the prior art absent evidence of criticality or unexpected results.
Regarding instant claims 30-31, the limitations of the method for relieving pain in a subject would have been obvious over the cannabinoids and other compounds found in cannabis that relieve pain ([0003]), including chronic pain, fibromyalgia, and migraine ([0207]), as taught by Finley, the compounds used for relieving pain ([0012]-[0013]), as taught by Korthout, and the treatment of pain (Page 28, lines 18-22, claim 80), as taught by Bech.
Regarding instant claim 32, the limitations of two or more of the listed components would have been obvious over the herbal extracts such as Passiflora incarnata, Citrus reticulata, Withania somnifera, Lycopus virginicus, Poria cocos, Actaea rac, Pueraria Lobata, Asphodeloides, silymarin, Schisandra chinensis, Humulus lupulus, Grindelia, Panax ginseng, Rehmannia glutinosa, Scutellaria lateriflora, Piper methysticum, and Piper nigrum ([0180]), as taught by Finley, in view of the Withania somnifera root extract at an effective overlapping range of 50-600 mg ([0053]), Piper methylsticum rootstock extract at 50-500 mg effective range ([0053]), and Schisandra extract at an effective range of 50-1500 mg ([0052]), as taught by Jia, as well as the composition comprising 50 mg 5-HTP ([0012], Formulation B – [0110], TABLES 4-7, claims 17 and 37), as taught by Shorr. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 42 and 43, the limitations of the method for improving anxiety symptoms in a subject would have been obvious over the cannabinoids and other compounds found in cannabis that relieve anxiety disorders, including post-traumatic stress disorder ([0003], [0202]), as taught by Finley.
Regarding instant claims 45, 58, and 60, the limitations of oral delivery would have been obvious over the oral administration via a gelatin capsule ([0186]), as taught by Finley.
Claims 49, 59, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Finley et al. (US 2018/0344661 A1 – “Finley”) in view of Korthout et al. (EP 1 559 423 A1 – “Korthout”), Bech (WO 02/066041 A1), Jia (US 2001/0006983 A1), and Shorr (US 2017/0354640 A1), as applied to claims 4-7, 16-18, 21, 30-32, 42-43, 45, 58 and 60 above, in view of Haase (US 2019/0069585 A1).
Instant claim 49 is drawn to the composition of claim 4, wherein the composition further comprises about 5 mg to about 175 mg of medium chain triglyceride (MCT) oil.
The teachings of Finley, Korthout, Bech, Jia, and Shorr are discussed above.
Finley, Korthout, Bech, Jia, and Shorr do not expressly teach about 5 mg to about 175 mg of MCT oil.
Haase teaches compositions comprising micronutrients and phytochemicals (Title) comprising cannabinoids and MCT ([0011]). CBD is disclosed ([0145]) along with its use for treating anxiety, pain, and stress disorders ([0139]). MCT is present in a range of about 1 mg to about 30,000 mg ([0050] and claim 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising CBD, CBN, CBG, as well as Vitamin E, and herbal extracts such as Passiflora incarnata, Citrus reticulata, Withania somnifera, Lycopus virginicus, Poria cocos, Actaea rac, Pueraria Lobata, Asphodeloides, silymarin, Schisandra chinensis, Humulus lupulus, Grindelia, Panax ginseng, Rehmannia glutinosa, Scutellaria lateriflora, Piper methysticum, and Piper nigrum, as taught by Finley, in view of the cannabis extract comprising about 15-500 mg/g of the acidic cannabinoid based on the dry weight of the extract wherein the cannabinoids include CBD, CBN and CBG, as taught by Korthout, the tablet composition comprising Passiflora incarnata at a dosage of 40 mg, as taught by Bech, the multicomponent biological vehicle comprising a combination of plant extracts such as Ziziphus jujuba Mill var. spinosa seed extract at 200 mg daily dosage and an effective range of 50-600 mg, Withania somnifera root extract at an effective range of 50-600 mg, Piper methylsticum rootstock extract at 50-500 mg effective range, and Schisandra extract at an effective range of 50-1500 mg, as well as hormones such as melatonin, as taught by Jia, the composition including purified or synthetic whole-plant cannabis extract, 50 mg 5-HTP and 3 mg melatonin, as taught by Shorr, and the composition comprising CBD and MCT, wherein the MCT is present in a range of about 1 mg to about 30,000 mg, as taught by Haase, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references teach that the compositions containing CBD are used for treating pain, anxiety, or inflammation. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A) and MPEP 2144.06.
Regarding instant claims 49, 59, and 61, the limitations of about 5 mg to about 175 mg of MCT oil would have been obvious over the MCT present in an overlapping range of about 1 mg to about 30,000 mg ([0050] and claim 34), as taught by Haase. Please see MPEP 2144.05.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615