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 .
Election/Restrictions
Applicant's election without traverse of Group II, claims 132, 170-172 and the species of cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9-tetrahydrocannabinol, cannabichromene, α-pinene, β- myrcene, β-pinene, 6-limonene, glucosamine HCl, chondroitin sulfate, brewer’s yeast, Arabic gum, guar gum, a flavoring agent, glycerin, sunflower lecithin, and water in the reply filed on 8/25/2023 is acknowledged. The traversal is on the ground(s) that the Notice states that the reply filed on July 28, 2023 is not fully responsive to the Restriction Requirement dated April 28, 2023 because of the omission(s) or matter(s): applicant elected claims that are dependent on non-elected claims. Applicant disagrees. Applicant elected Group II, claims 132, 170-172, and 174. While these claims depend from Group I claims to specify the pharmaceutical composition or dosage form, Applicant submits that such dependence is standard in restriction practice and should not prevent substantive examination. As described in the Examiner Interview section above, both Supervisory Patent Examiner McKelvey and Examiner Meller agree that the matter listed in the Notice does not make the reply filed on July 28, 2023 not fully responsive to the Restriction Requirement dated April 28, 2023. As further described in the Examiner Interview section above, Examiner Meller requested a correction of the claims that encompass the species elected in the reply filed on July 28, 2023. With this response, Applicant identifies claims 132 and 170-172 as encompassing the elected species. This is not found persuasive because of the extensive search which is not only US Patent data bases but also multiple databases outside of the PTO and which is quite extensive while not be co-extensive.
Therefore, claims 174 and 177 are withdrawn from further consideration by the Examiner as being drawn to non-elected inventions and the claims are ONLY DRAWN to a composition containing the combination of cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9-tetrahydrocannabinol, cannabichromene, α-pinene, β- myrcene, β-pinene, 6-limonene, glucosamine HCl, chondroitin sulfate, brewer’s yeast, Arabic gum, guar gum, a flavoring agent, glycerin, sunflower lecithin, and water used to treat pain.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 132, 170-172, 175, 176, 178 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kleidon et al. (US Patent 2017/0172977- “Ojai”-of record) in view of WO 2017/025712 (“GW”-of record), Verzura et al. (US 2016/0106705) and Koren et al. (US 2015/0057342).
Kleidon discloses a dosage form (see abstract) comprising: cannabidiol (Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD)...); cannabidiolic acid (Para. [0047], ...cannabidiolic acid (CBDA)...); cannabigerolic acid (Para. [(0047}; Para. [0043], Cannabinoids utilized in the compositions disclosed herein include but are not limited to...cannabigerolic acid (CBGA)...); A9-tetrahydrocannabinol (Para. [0047]; Para. [0050], The compositions of the present disclosure can comprise tetrahydrocannabinol (THC) as a type of cannabinoids. THC can comprise delta-9-THC, delta-8-THC, and combinations thereof); cannabichromene (Para. [0047]; Para. {0043}, ...cannabichromene-type (CBC)...); and one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants (Para. [0108], The compositions of the present disclosure can be administered in any oral dosage form, including liquid dosage forms (e.g., a suspension or slurry), and oral solid dosage forms (e.g., a tablet or bulk powder). Tablets can include tablets, caplets, capsules, including soft gelatin capsules, and lozenges. Tablets can further comprise suitable binders, lubricants, diluents, disintegrating agents, colorants, flavoring agents, flow-inducing agents, and melting agents). Note administration for pain in paragraphs 97 and 116.
Kleidon discloses a pharmaceutical composition (Abstract; Para. (0015]) comprising hemp extract and a carrier (Para. [0058], The compositions of the present disclosure can be enriched in cannabidiol compounds compared to hemp oil. For example, a composition can comprise hemp oil and cannabidio! compounds from plant sources such as extracts (e.g., hemp extract) and essential oils; Para. (0111], The compositions of the present disclosure can be provided as a food composition in combination with a food carrier...), wherein the hemp extract comprises: cannabidio!, and cannabidiolic acid (Para. [0058]; Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD), cannabidiolic acid (CBDA)...); but fails to explicitly disclose wherein the ratio of cannabidiol to cannabidiolic acid is about 0.1:1 to about 1:0.1.
However, GW is in the field of cannabinoids (GW Abstract) and teaches a ratio of cannabidiol to cannabidiolic acid that is about 0.6:1 to about 1:0.6 (GW Para. [0041], Where CBDA is used in combination with CBD ratios of between 9:1 to 1:9 (CBDA:CBD) are preferred. Ranges of ratios include 8:2 to 2:8 (CBDA:CBD); 7:3 to 3:7 (CBDA:CBD); 6:4 to 4:6 (CBDA:CBD); and 1:1 (CBDA:CBD) and any ranges there between).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the composition of Kleidon with the teaching of GW for the purpose of including the cannabidiol and cannabidiolic acid in a proportion for treating epilepsy (GW Para. [0041]; Para. [0035)). Modified Kleidon discloses the pharmaceutical composition of the claims. Kleidon further discloses where in hemp extract further comprises: cannabigerolic acid (Para. [0058]; Para. (0043), Cannabinoids utilized in the compositions disclosed herein include but are not limited to...cannabigerolic acid (CBGA)...); A9-tetrahydrocannabinol (Para. [0058]; Para. (0050), The compositions of the present disclosure can comprise tetrahydrocannabinol (THC) as a type of cannabinoids. THC can comprise delta-9-THC, delta-8-THC, and combinations thereof); and cannabichromene (Para. [0058]; Para. [0043], ...cannabichromene-type (CBC)...). Kleidon further discloses the cannabidiol and cannabidiolic acid (Para. [0058); Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD), cannabidiolic acid (CBDA)...), but fails to explicitly disclose wherein the ratio of cannabidiol to cannabidiolic acid is selected from the group consisting of about 1:100, about 1:50, about 1:10, and about 1:1. However, GW is in the field of cannabinoids (GW Abstract) and teaches a ratio of cannabidiol to cannabidiolic acid that is about 1:1 (GW Para. [0041], Where CBDA is used in combination with CBD ratios of between 9:1 to 1:9 (CBDA:CBD) are preferred. Ranges of ratios include 8:2 to 2:8 (CBDA:CBD); 7:3 to 3:7 (CBDA:CBD); 6:4 to 4:6 (CBDA:CBD); and 1:1 (CBDA:CBD) and any ranges there between). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dosage form of Kleidon with the teaching of GW to include wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1 for the purpose of including the cannabidiol and cannabiciolic acid in a proportion for treating epilepsy (GW Para. [0041]; Para. [0035)).
Kleidon discloses the dosage form of the claims. Kleidon further discloses the cannabidiol and cannabidiolic acid (Para. [0058]; Para. [0047)), but fails to explicitly disclose wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1. However, GW teaches a ratio of cannabidiol to cannabidiolic acid that is about 1:1 (GW Para. [0041], Where CBDA is used in combination with CBD ratios of between 9:1 to 1:9 (CBDA:CBD) are preferred. Ranges of ratios include 8:2 to 2:8 (CBDA:CBD); 7:3 to 3:7 (CBDA:CBD); 6:4 to 4:6 (CBDA:CBD); and 1:1 (CBDA:CBD) and any ranges there between). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dosage form of Kleidon with the teaching of GW to include wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1 for the purpose of including the cannabidiol and cannabidiolic acid in a proportion for treating epilepsy (GW Para. [0041]; Para. [0035)).
Kleidon discloses the pharmaceutical composition of the claims. Kleidon further discloses the hemp extract (Para. [0058)), but fails to explicitly disclose wherein the hemp extract further comprises four or more of the following: a-pinene; B-myrcene; B-pinene; 5-limonene; linalool; B-caryophyllene; a-humulene; nerolidol 2; guaiol; caryophyllene oxide; and a-bisabolol.
However, Verzura is in the field of plant extracts (Abstract) and teaches a plant extract that comprises four or more of the following: a-pinene; B-myrcene; B-pinene; 5-limonene; linalool; B-caryophyllene; a-humutene; nerolidol 2; guaiol; caryophyllene oxide; and a-bisabolol (United Para. [0005] and (0006), The invention provides an extract comprising a mixture of at least 95% total cannabinoids, and at least one terpene/flavonoid...the terpene/flavonoid is for example, d-limonene linalool...a-pinene...8-myrcene). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Kleidon with the teaching of Verzura to include wherein the hemp extract further comprises four or more of the following: a-pinene; B-myrcene; B-pinene; 5-limonene; linalool; 8-caryophyllene; a-humulene; nerolidol 2; guaiol; caryophyllene oxide; and a-bisabolol. The motivation would have been to include compounds that synergistically enhance the therapeutic value of the cannabinoids (United Para. [0005] and [0006]; Para. [0045], The terpenes act synergistically with the cannabinoids to provide a therapeutic effect).
Kleidon discloses a pharmaceutical composition (Abstract; Para. [0015]) comprising hemp extract and a carrier (Para. [0058), The compositions of the present disclosure can be enriched in cannabidiol compounds compared to hemp oil. For example, a composition can comprise hemp oil and cannabidiol compounds from plant sources such as extracts (e.g., hemp extract) and essential oils; Para. [0111], The compositions of the present disclosure can be provided as a food composition in combination with a food carrier...), wherein the hemp extract comprises: cannabidiol (Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD)...); cannabidiolic acid (Para. [0047], ...cannabidiolic acid (CBDA)...); cannabigerolic acid (Para. [0047]; Para. [0043], Cannabinoids utilized in the compositions disclosed herein include but are not limited to...cannabigerolic acid (CBGA)...); A9-tetrahydrocannabinol (Para. [0047]; Para. [0050], The compositions of the present disclosure can comprise tetrahydrocannabinol (THC) as a type of cannabinoids. THC can comprise delta-9-THC, delta-8-THC, and combinations thereof); and cannabichromene (Para. [0047]; Para. [0043], ...cannabichromene-type (CBC)...); but fails to explicitly disclose wherein the carrier is grapeseed oil.
However, Koren is in the field of cannabinoids (abstract) and teaches grapeseed oil as a carrier (Para. [0016], In various embodiments, the edible oils in the immediate release fraction and in the sustained release fraction, when present, are independently selected...grape seed oil...). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Kleidon with the teaching of Koren to provide grapeseed oil as a carrier for the purpose of providing an edible carrier for the oral delivery of cannabinoids (Para. [0016]; Para. [0012)).
Kleidon further discloses the cannabidiol and cannabidiolic acid (Para. (0058); Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD), cannabidiolic acid (CBDA)...), but fails to explicitly disclose wherein the ratio of cannabidiol to cannabidiolic acid is selected from the group consisting of about 1:100, about 1:50, about 1:10, and about 1:1. However, GW is in the field of cannabinoids (GW Abstract) and teaches a ratio of cannabidio! to cannabidiolic acid that is about 1:1 (GW Para. (0041), Where CBDA is used in combination with CBD ratios of between 9:1 to 1:9 (CBDA:CBD) are preferred. Ranges of ratios include 8:2 to 2:8 (CBDA:CBD); 7:3 to 3:7 (CBDA:CBD); 6:4 to 4:6 (CBDA:CBD); and 1:1 (CBDA:CBD) and any ranges there between). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Kleidon with the teaching of GW to include wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1 for the purpose of including the cannabidiol and cannabidiolic acid in a proportion for treating epilepsy (GW Para. [0041]; Para. [0035)). Kleidon further discloses the cannabidiol and cannabidiolic acid (Para. [0058]; Para. [0047}), but fails to explicitly disclose wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1. However, GW teaches a ratio of cannabidiol to cannabidiolic acid that is about 1:1 (GW Para. [0041], Where CBDA is used in combination with CBD ratios of between 9:1 to 1:9 (CBDA:CBD) are preferred. Ranges of ratios include 8:2 to 2:8 (CBDA:CBD); 7:3 to 3:7 (CBDA:CBD); 6:4 to 4:6 (CBDA:CBD); and 1:1 (CBDA:CBD) and any ranges there between). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Kleidon with the teaching of GW to include wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1 for the purpose of including the cannabidiol and cannabidiolic acid in a proportion for treating epilepsy (GW Para. [0041]; Para. [0035)).
Applicant argues that allegedly Kleidon and GW do not teach or suggest that administering hemp extract with a ratio of CBD to CBDA in the range of about 0.1:1 to about 1:0.1 is effective in the treatment of pain.
Further, there is no motivation to combine the teachings of Kleidon with GW, according to applicant. Kleidon teaches microcapsules containing at least one cannabinoid compound, according to applicant. Kleidon mentions that compounds can be used in the treatment of neuropathic pain along with nearly 40 other disease states, all which seem to have little to do with each other, according to applicant. Kleidon also teaches all of the components of claims 132, 170-172, 175, 176, 178 as well as every other known cannabinoid found in hemp combined in any combination and relative concentration without any teachings as to what particular combination would be preferred or effective in the treatment of pain or any other pathology, according to applicant. Kleidon provides no teaching that would motivate one of skill in the art to select the components of claims 132, 170-172, 175, 176, 178 for the treatment of pain with a reasonable expectation of success, according to applicant.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Kleidon provides no data showing the biological effectiveness of any compound let alone the one specified in the pending claims and provides no indication of what combination of the many cannabinoids provided in Kleidon might be effective in the treatment of pain or any other disease state, according to applicant. Kleidon is focused on the microencapsulation of cannabinoids and other chemical moieties, not on the methods of the pending claims, according to applicant. GW does not cure the deficiencies of Kleidon, according to applicant. GW teaches the use of mixtures of CBD and CBDA in the treatment of epilepsy, according to applicant. Pain is not mentioned in GW, according to applicant. One of ordinary skill in the art would not expect that a combination of cannabinoids that are effective for the treatment of epilepsy would be effective in treating pain, according to applicant. One of ordinary skill in the art would not be motivated to combine the teachings of Kleidon and GW to arrive at the subject matter of claims 132, 172, and 174- 179, according to applicant. The invention of claims 132, 170-172, 175, 176, 178 is based upon the unexpected finding that pharmaceutical compositions comprising CBD, CBDA, CBGA, D9-THC, and CBC, with a ratio of CBD:CBDA in the range of about 0.1:1 to about 1:0.1, have particularly advantageous pharmacokinetic and clinical properties, according to applicant.
For example, Example 11 demonstrates that such compositions “showed a significant decrease in pain and increase in activity” versus baseline and a placebo (pages 58 to 60), according to applicant. The advantage is further demonstrated in Example 13 which demonstrates that the composition is effective in the treatment of pain in canines with a reduction in pain severity score and pain interference score amongst other benefits (pages 76 to 87), according to applicant.
The data applicants cite in the specification shows the activity of their blend versus a placebo and baseline. However, how unexpected is it when one or more of the ingredients in the composition such as CBD are already well-known in the art for treating pain? Thus, there has been NO demonstration of any type of unexpected results based upon the specific, claimed composition. To show unexpected results, applicants need to show that the pain treatment activity of the whole composition is more than the additive pain treatment of the individual ingredients. The data simply doesn't support the alleged unexpected results.
Applicant argues that Kleidon provides no data showing the biological effectiveness of any compound let alone the one specified in the pending claims and provides no indication of what combination of the many cannabinoids provided in Kleidon might be effective in the treatment of pain or any other disease state, according to applicant.
While this is noted, it is also noted that applicant themselves have not provided unexpected results like they argue that Kleidon allegedly does not have.
Applicant notes that Kleidon treats pain and cannabidiol has been already mentioned on the record, see paragraph 47. Thus, applicant’s arguments are moot and unpersuasive.
Kleidon very clearly teaches to treat pain and for pain relief, see paragraphs 97, 116.
Very clearly it is taught in paragraphs 41 and 42 that the compositions of Kleidon contain cannabinoids and terpenes. Clearly an extract can be seen as isolated since a hemp extract was isolated from a hemp plant and a carrier reads on an extract by definition, see entire disclosure, especially paragraphs 44, 59.
Applicant’s arguments to the alleged unexpected results make little sense on their face. There is nothing compelling on the record which proves that the results are unexpected. There is nothing on the record that makes it unobvious to use the ratio of cannabidiol to cannabidiolic acid of about 01:1 to about 1:0.1. This is because such a ratio is completely obvious for the reasons of record.
Applicant’s attack on the WO 2017/025712 (“GW”) reference is completely in error. Applicant has indeed argued as was already pointed out on the record by the Examiner as a response against the references individually. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, the rejection is maintained for the reasons of record and for the above reasons.
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 132, 170-172, 175, 176, 178 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10, 12, 124-139 of copending Application No. 17/661,122 since 17/045,945 treats pain and clearly an animal with diseases/disorders such as claimed in 17/661,122 would experience pain. Note that both applications use a composition of cannabinoids and terpenes that are isolated from a hemp plant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655
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