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 .
Amended claims 161-163, 165, 167-173 and 176 are under Examination.
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, 167-173 and 176 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez US 20150126754, and Murty US 20160184258.
Response to Remarks filed 08/25/2026 is at the bottom of the rejection.
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(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.
Following is present in the previous action 02/27/2026:
(with added emphasis)
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, 173, 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, 167-173, 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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Response to Remarks filed 08/25/2026
Applicants response focus on the following:
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Applicant is encouraged to use word search *technique to locate disclosures in the cited references with respect to the presence (or absence/silence) for various active components in the claims.
*word search:
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The rejection is not under 35 USC § 102.
Using word search technique it would be apparent that the recited active components and the idea of combining them are in the cited references. For example, the word ‘combination’ occurs 30 times in Murty. Further it is well-known that combining different cannabinoids for beneficial effect known routine in the art (see below with regards to entourage effect).
Applicant also points out that Fernandez teaches away from the instantly claimed combination (as amended). Applicant also points to the affidavit filed 00/-6/2026
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(emphasis added by the Examiner).
The declaration and the citations presented therein are considered. This Examiner would not be persuaded by alleged ‘unexpected data’ based on ‘computed affinities’. Applicant is encouraged to contact this Examiner’s supervisors or other office personnel if Applicant deems the positon taken by the Examiner is improper.
Furthermore there is nothing in the declaration with respect to the % (amount) combination of the instant base claim components as limited.
The admitted to at [00221] the benefits of ‘entourage effect’ by combination made from isolated cannabinoids (custom cannabinoid blend or targeted multi-cannabinoid formulation) is *well-known in the art. For example, using the above noted word search technique, the *well-known US8628796 (not in the rejection statement).
Also see Vigil, Journal of Cannabis Research, J Cannabis Res. 2023 Feb 8;5(1):4 for leading references on this concept. Note that affidavit contains many post-filing references document for support.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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
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