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
PNG
media_image1.png
46
518
media_image1.png
Greyscale
Upon further considerations, 1-9, 28 and 10-18 and 54 are examined together.
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) 1-9, 28) for use (claims 10-18 and 53) rejected under 35 U.S.C. 103 as being unpatentable over Verzura US20160106705; Garabagi WO2020044119; Macnair, WO2019056128; Dely WO2018071581; E-Alfy, Pharmacology, Biochemistry, and Behavior, 2010, Vol. 95(4), pp. 434-442.
Instant claims drawn to: Formulation (claims 1-9, 28) for use (claims 10-18 and 53) in treating a neurological or mental health condition selected from the group consisting of depression, anxiety, post-traumatic stress disorder (PTSD), and combinations thereof, in a subject in need thereof, said formulation comprising cannabichromene (CBC), cannabidiol (CBD), and optionally tetrahydrocannabinol (THC), as primary cannabinoids, and an excipient; wherein the primary cannabinoids consist of, on a weight basis: THC:CBC:CBD, 0-1: 4-20: 10-25.
Verzura also teaches compositions comprising mixtures of the instant ingredients CBC, CBD and THC and method of using the compositions, at
Verzura in claims 1-5, different proportions in claims 9-15, different formulations in claims 16-20) and method of using the same for treating anxiety, post-traumatic stress disorder, in claims 40, 49. Also see Verzura at pages 9-11 Example 9 for different ratios.
Garabagi teaches cannabinoid formulations comprising one or more cannabinoids selected from THCA, THC, CBDA, CBD, CBC and CBG and
!their use for treating depression, anxiety disorders, post-traumatic stress disorder (PTSD), PTSD-associated insomnia, sleep disorder, anxiety-related restlessness and disturbed sleep due to anxiety (para 0029, 0041; claims 1-4, 11, 29 and 30). Specific examples include a 250 mg capsule comprising 1 mg THC and 25 mg CBD for anxiety and aiding sleep (page 18, Table IA, Form #4), and a unit dose form oral capsule comprising 6 mg CBD and 3 mg CBC (calculated ratio is 2:1) and other ingredients (page 41, Example 4, Example 4-7).
Macnair teaches, medical cannabis oils comprising tetrahydrocannabinol (THC), cannabichromene (CBC) and cannabidiol (CBD) as primary cannabinoids and their use in the treatment of insomnia, which can be resulted from psychological stress or due to nightmares (para 0005, 0080). The concentration of THC present in the study oil is <O.7-1 mg/mL and CBD is 10-20 mg/mL. The volume of oil being used is O.25-
0.5 mL or 1.0 mL. Specific examples include Oil 1 comprising 0.38 mg THC, 9.02 mg CBD and 0.47 mg CBC (calculated ratio 1.0:23:1.2) per each ml of the oil; and Oil 2 comprising 0.76 mg THC, 19 mg CBD, and 0.84 mg CBC (calculated ratio 1.0:25:1.1) per each ml of the oil (pages 33-35, Tables 4 and 5).
Dely teaches that a 1:20 THC:CBD capsule comprising 0.25 mg THC and 5.0 mg CBD and its use for treating conditions including PTSD, depression and sleep apnea (page 4, line 22 to page 5, line 11; page 7, Table l; claims).
Further E-Alfy specifically teaches the antidepressant-like actions of each of THC, CBC and CBD (see the whole document).
Thus the above cited references teach that compositions containing the instant active ingredients THC, CBC, CBD (claim 1) in different combinations (together and in pairs, claims 5-9) and also that these compositions are useful in treating the instant disease states (claims 2-5, 11-13). Therefore, the position taken is that the instant dependent claim limitations, such as the specific amounts (7-9), 16-18), and disease states, for example highlighted and pointed out Verzura and Garabagi disclosure are known in the art.
The above cited references do not teach the specific weight basis: THC:CBC:CBD, 0-1: 4-20: 10-25 as instantly limited (claim 1, 5, 10, 14, 28, 54).
The instant disclosure working examples 1 and 2 correspond to two specific weight ratios (as per claims). These exemplified combinations, without any comparative date, have not demonstrated any significant additive anti-anxiety effect on stress animals nor any significant additive anti-depressant effect. It is unclear if there is any synergistic effect resulted from the claimed combination of THC, CBD and CBC in the !treating depression, anxiety and post-traumatic stress disorder. As such there is no data for secondary consideration.
Therefore, the issue here is selective combination (the weight basis/ratio) of previously known ingredients. As per Examination guidelines,(see MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions [R-01.2024]) 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).
The critical limitations of the claims as to the ingredients and excipients are found throughout the cited references as well known in the art used for the intended purpose. Routine optimization of these with respect to amount and ratios are within the purview of one of skill in the art. If 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 will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such specific concentration 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).
The global cannabidiol market size was estimated at USD 9.14 billion in 2024 and is projected to reach USD 22.05 billion by 2030, growing at a CAGR of 15.8% from 2025 to 2030. The CBD market size is expected to grow with the increasing legalization of hemp-based products. 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.
Further 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).
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).
For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Therefore there is nothing unobvious is seen in the claims.
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 5, 7-9, 13, 15-18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term "about" in claims 5, 7-9, 13, 15-18 render the limits of the ratios recited vague and clear. There is no clear definition for the term. Some examples (see 0039) do not clarify the ratios/weight of the ingredients. Further examples are not explicit limitations.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Prosecution Insights