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 .
This is a second non-final office action. See Note at the end of the rejection.
Previously presented office action 10/07/2025 is withdrawn.
Claims 161-163, 165, 167-176 are under Examination.
Election/Restrictions
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Applicant’s election of Group V in the reply filed on 08/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Pending claims other than
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and 167-176 regardless claim identifiers are withdrawn.
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.
Claim(s) 161-163, 165 and 167-176 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez US 20150126754, and Murty US 20160184258.
Instant Base claim 161. A liquid or solid composition, comprising cannabidiol (CBD),cannabinol (CBN), and exo-tetrahydrocannabinol (exo-THC, herein after exo).
CBD, CBN and exo (and other compounds/limitations of dependent claim are well-established, previously known compounds found in naturally occurring cannabinoid isolates.
Fernandez teaches compositions containing CBD, CBN and exo at page 6 column A:
Claim 7 A Cannabis plant THC isolate comprising by weight of dry matter (w/w): a) 97.0-99.5% .DELTA.9-tetrahydrocannabinol (THC); b) 0-0.5 Cannabinol (CBN) c) 0-0.2% .DELTA.8-tetrahydrocannabinol (.DELTA.8-THC); d) 0-0.5% .DELTA.9(11)-tetrahydrocannabinol (exo-THC) e) 0-0.5% Cannabidiol (CBD) f) 0-0.2% Cannabigerol (CBG) g) 0-0.5% Cannabichromene (CBC) h) 0-0.5% Tetrahydrocannabinol-C3 (THC-C3) i) 0-0.5% Tetrahydrocannabinol-C4 (THC-C4) wherein components b) to i) together represent 0.4-2.0% by weight of dry matter, and wherein CBN and CBD together represent at least 0.3% by weight of dry matter.
Fernandez teaching includes composition containing the combination of CBD, CBN and exo, as well as other compounds in the dependent claims, as shown below (wherein the numbers in square bracket identifies the location of the relevant teachings)
At page 2 column A
[0020] c) 0-0.2% .DELTA.8-tetrahydrocannabinol (.DELTA.8-THC); d) 0-0.5% .DELTA.9(11)-tetrahydrocannabinol (exo-THC)
e) 0-0.5% Cannabidiol (CBD)
f) 0-0.2% Cannabigerol (CBG)
g) 0-0.5% Cannabichromene (CBC)
h) 0-0.5% Tetrahydrocannabinol-C3 (THC-C3)
i) 0-0.5% Tetrahydrocannabinol-C4 (THC-C4)
[0023] The term "cannabinoid" or "cannabinoids" as used herein encompasses at least the following substances: .DELTA.-8 tetrahydrocannabinol, .DELTA.-9-tetrahydrocannabinol (THC), cannabinol (CBN), olivetol, cannabidiol (CBD), cannabigerol (CBG), .DELTA.-9(11)-tetrahydrocannabinol (exo-THC), cannabichromene (CBC), tetrahydrocannabinol-C3 (THC-C3), tetrahydrocannabinol-C4 (THC-C4).
[0058] A second aspect of the present invention relates to a Cannabis plant THC isolate comprising by weight of dry matter (w/w):
[0059] a) 97.0-99.5% .DELTA.9-tetrahydrocannabinol (THC);
[0060] b) 0-0.5 Cannabinol (CBN)
[0061] c) 0-0.2% .DELTA.8-tetrahydrocannabinol (.DELTA.8-THC);
[0062] d) 0-0.5% .DELTA.9(11)-tetrahydrocannabinol (exo-THC)
[0063] e) 0-0.5% Cannabidiol (CBD)
[0064] f) 0-0.2% Cannabigerol (CBG)
[0065] g) 0-0.5% Cannabichromene (CBC)
[0066] h) 0-0.5% Tetrahydrocannabinol-C3 (THC-C3)
[0067] i) 0-0.5% Tetrahydrocannabinol-C4 (THC-C4)
[0085] Analysis of the cannabis plant THC isolate thus obtained has shown that the THC isolate comprises more than 98% THC, and about 0.13% CBN, 0.3% CBD, 0% delta-8-THC, 0% exo-THC, 0% CBG, 0.1% CBC, 0.1% THC-C3 en 0.1% THC-C4 by weight of dry matter.
[0104] The THC isolate obtained was analyzed and has shown that comprises by weight of dry matter:
a) 77% .DELTA.9-tetrahydrocannabinol (THC);
b) 0.46% Cannabinol (CBN)
[0105] c) 0% .DELTA.8-tetrahydrocannabinol (.DELTA.8-THC); d) 0% .DELTA.9(11)-tetrahydrocannabinol (exo-THC)
e) 0% Cannabidiol (CBD)
f) 0.4% Cannabigerol (CBG)
g) 0.38% Cannabichromene (CBC)
h) 0% Tetrahydrocannabinol-C3 (THC-C3)
i) 0.22% Tetrahydrocannabinol-C4 (THC-C4)
162 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabinodiol CBN.
163 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicitran (lacks antecedent basis 161 see section under 112-2)
165 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabichromene (lacks antecedent basis 161 see section under 112-2)
167 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicyclol and cannabichromene and cannabicitran
168 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabigerol and cannabicitran and cannabichromene and cannabielsoin and cannabicyclol
169 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicitran and cannabicitran and cannabielsoin and cannabicyclol and cannabinodiol
170 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicitran and cannabielsoin and cannabicyclol and cannabinodiol
171 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicitran and cannabichromene and cannabicyclol
172 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicitran and cannabicyclol
173 Cannabidiol and cannabinol and exo-tetrahydrocannabinol and cannabicitran and cannabielsoin
Claims 162, 174-176 Cannabidiol and cannabinol and exo-tetrahydrocannabinol in different % amount in the composition (see more later for % amounts).
The additional compounds present in imitations of dependent claims 163, 165, 167-176 are found in Fernandez as pointed out above in the isolate from a crude solvent extract of Cannabis plant material.
Claim 162 limitation with respect to CBND is not explicitly found in the teachings of Fernandez.
Murty teaches, in addition to the cannabinoid compounds of Fernandez, cannabinodiol containing compositions. Cannabinodiol which is the same as the instant specification and claim 162 CBND. See claim 6 of Murty; Cannabinodiolappears 30 times in Murty.
The issue here is the limitations of specific combinations of the instant compounds as limited by the claims. Disclosure in the specification while acknowledging the existence and inherent (desirable) biological properties of the recited compounds does not provide any data for the specifically recited combinations (the limitations), for secondary consideration.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for their beneficial properties. Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
As to the limitations of claims wt% of claims 162, 174-176, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the
prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore there is nothing unobvious in the claims.
Following are few of the large number of prior art available but not relied upon:
Nye, High-affinity cannabinoid binding sites in brain membranes labeled with [3H]-5'-trimethylammonium Δ8-tetrahydrocannabinol, Journal of Pharmacology and Experimental Therapeutics (1985), 234(3), 784-91
Beardsley, Studies on the agonistic activity of Δ9-11-tetrahydrocannabinol in mice, dogs and rhesus monkeys and its interactions with Δ9-tetrahydrocannabinol, Journal of Pharmacology and Experimental Therapeutics (1987), 241(2), 521-6
Compton, Synthesis and pharmacological evaluation of ether and related analogs of Δ8-, Δ9-, and Δ9,11-tetrahydrocannabinol, Journal of Medicinal Chemistry (1991), 34(11), 3310-6.
Note:
An attempt to contact Attorney of record to explain major examination error in the previous action with regards to the structural aspect of the exo compound, identified with CAS Reg No. in the previous action.
This second Non-Final Action is due to the above acknowledged error.
No response is filed for the Remarks and Affidavit (in-silico information) in view of the withdrawal of the previous action. However the following is noted with respect to the modeling and in-silico data in the Affidavit: MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625