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 .
Status of the Claims
The Office Action is in response to the application filed June 27, 2024. Amended claims 1-16, 18-20, and 30-41 are being examined on the merits herein.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16, 18-20, and 30-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of US 11,865,102. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a botanical drug substance comprising greater than or equal to 90% (w/w) CBD based on total amount of cannabinoid in the botanical drug substance and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC), wherein the THC is present as a mixture of trans-THC and cis-THC. The patented claims are drawn to a cannabidiol (CBD) preparation comprising greater than or equal to 90% (w/w) CBD based on total amount of cannabinoid in the preparation and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC), wherein the THC is present as a mixture of trans-THC and cis-THC, and wherein the ratio of trans-THC to cis-THC is about 0.7:1.0 to about 5.0:1.0. The instant claims embrace the patented claims.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable.
Claims 1-16, 18-20, and 30-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of US 11,207,292. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a botanical drug substance comprising greater than or equal to 90% (w/w) CBD based on total amount of cannabinoid in the botanical drug substance and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC), wherein the THC is present as a mixture of trans-THC and cis-THC. The patented claims are drawn to a cannabidiol (CBD) preparation comprising greater than or equal to 95% (w/w) CBD based on total amount of cannabinoid in the preparation and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC) wherein the THC is present as a mixture of trans-THC and cis-THC, and wherein the ratio of trans-THC to cis-THC is about 0.7:1.0 to about 2.0:1.0. The instant claims embrace the patented claims.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Guy (GB 2531282) of record (IDS 5/6/24, page 10/47, reference #223) in view of Smith (Phytochemistry, 1977) of record (IDS 5/6/24, page 36/47, reference #493).
Guy teaches the CBD is present as a highly purified extract of cannabis which comprises at least 98% (w/w) CBD. Preferably the extract further comprises up to 1% CBDV (cannabidivarin) and less than 0.15% THC (tetrahydrocannabinol) (abstract; claims 1-7).
Guy teaches the purity of the CBD drug substance achieved is greater than 98%. The other cannabinoids which may occur in the extract are: CBDA, CBDV, CBD-C4 and THC [0054]; Table 1).
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Guy teaches distinct chemotypes of Cannabis sativa L. plant have been produced to maximize the output of the specific chemical constituents, the cannabinoids. One type of plant produces predominantly CBD [0055].
Guy teaches the phytocannabinoids can be isolated from plants to produce a highly purified extract or can be reproduced synthetically ([0003]; [0042]).
Guy teaches pharmaceutical formulations wherein the CBD is used in combination with one or more concomitant anti-epileptic drugs (AED) (abstract).
Guy does not specifically teach wherein the THC is present as a mixture of trans-THC and cis-THC as required by the limitations of claim 1 or the specific trans-THC to cis-THC ratios as recited in claims 5, 20, 30, 31, 37, 39, and 41.
Smith teaches Cannabis sativa plant samples having CBD-THC ratios of about 16:1 had trans-THC to cis-THC ratios of about 1:1 or 2:1, whereas samples having phenotype ratios less than 1 had trans-THC-cis-THC 10:1 (page 1088, column 2, 1st full ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have expected, with a reasonable degree, that the compositions as taught by Guy contain THC as a mixture of trans-THC and cis-THC. The motivation, provided by Smith, teaches that Cannabis sativa plant samples having CBD-THC ratios of about 16:1 (~94% CBD) have trans-THC to cis-THC ratios of about 1:1 or 2:1. Thus, the skilled artisan would have found it obvious that the at least 98% CBD compositions as taught by Guy would also contain a mixture of trans-THC and cis-THC as required by the limitations of the instant claims and in varying ratios, depending on the amount of CBD and THC present in the composition.
Additionally, employing a pharmaceutically acceptable carriers and excipients and the form of the pharmaceutical composition are generally considered prima facie obvious.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-16, 18-20, and 30-41 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR JAVANMARD whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/
Primary Examiner, Art Unit 1627