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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/10/2026 has been entered.
Response to Arguments
Applicants’ claim amendments and Remarks of 2/10/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to 102 rejection, this rejection is withdrawn. Applicants have amended the ranges in the base claim so that the ranges of CBD and THC are outside the values as disclosed by BOTANACOR and VETCS.
In regard to the first 103 rejection, this rejection is withdrawn. Applicants remarks with Examiner’s reply is summarized below:
Applicants submit that the cited prior art does not teach the CBD and THC ranges.
VETCS teaches a CTS comprising 8.24% total cannabinoids (7.42% of CBD), 0.14% THC (page 1 of BOTANACOR), and two or more terpenes. There is no teaching in VETCS or the other cited prior art to lower these ranges. Additionally, Applicants have amended the ranges in the base claim so that the ranges of CBD and THC are outside the values as disclosed by BOTANACOR and VETCS.
In regard to the double patenting rejection over US patent 11,759,447, Applicants submit that the claim amendments render the claims distinct from the reference claims. This rejection is withdrawn.
In regard to the double patenting rejection over US patent 11,622,956, Applicants submit that the claim amendments render the claims distinct from the reference claims. This rejection is maintained as the reference claims (ref claim 1) are directed to a ratio of two or more terpenes and two or more cannabinoids to form a terpenoid to cannabinoid ratio from approximately 1.2:1 to 4:1. The reference claims teach a method of treating a disease, state, or disorder in a non-human animal comprising administering a CTS. The reference composition teaches between 10-20% of terpenes of the CTS (the instant range is between 13-17% of the CTS), the base references claims do not limit a ratio of CBD to THC.
Response to Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains to a method of treating a state in a non-human animal with a cannabinoid-terpenoid solution (CTS).
The breadth of the claims: The breadth of the claims is drawn to a method of treating a state in a non-human animal with a cannabinoid-terpenoid solution (CTS).
The predictability or unpredictability of the art: Some of the states of claim 3 have no or negative impact in treating the state. For example, treating Parkinson’s disease with cannabis has no conclusive evidence that it helps with Parkinson’s disease symptoms (“Medical Marijuana”). ABDEL teaches that cannabis worsens memory (i.e. cognitive issues; ABDEL abstract).
The amount of direction or guidance presented: Applicants do not show any data or evidence for all the states listed in claim 3 using the instant composition had been tested for all the states of instant claim 3.
The presence or absence of working examples: No working examples are shown in the Instant Specification for treating all of the states of claim 3 (for example cognitive issues). Applicants do not show any data or evidence that the composition of the claims had been tested for states that are known in the prior art to have made states actively worse. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally find the amounts of the instant combination needed to treat the states of claim 3.
The artisan would not be able to anticipate the amount of the instant combination in order treat the states of claim 3 without undue experimentation, absent working examples from Applicants or the art.
Moreover, the lack of a working example is noteworthy. There are no teachings or guidance in the specification which would lessen the amount of experimentation to a reasonable amount. Additionally, a person of ordinary skill in the art would have to engage in undue experimentation to create an effective “state” treatment, with no assurance of success.
Thus, Claim 3 is rejected as lacking enablement.
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 1-3 are 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.
Regarding claim 1, the limitation "state" renders the claim indefinite because it is unclear what the limitation includes. The specification’s paragraph [00060] has some description of “disease, state, or disorder”. It is not clear on what is a “state”, for example being awake, catatonic, or normal/altered is a state. However “cancer” or “palsies” are diseases and not states.
Claims 2-3 are similarly rejected for not resolving the rationale underpinning this rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 lists commonly known diseases. Without knowing what qualifies as a “state” as per claim 1, claim 3 fails to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over VetCBD (“VetCBD – Best CBD products”, VetCBD, December 22, 2014) as evidenced by REDDIT (“I'm Dr. Tim Shu, I make medical cannabis for animals. Pets can also benefit from cannabis, AMA!”, Reddit, 2018) and in view of Lowcountry Dog (“Benefits of CBD for your Dog”, Lowcountry Dog, April 20, 2019) and Donsky et al. (US2016/0279073A1).
VetCBD teaches a 10:1 CBD:THC cannabis tincture for veterinary use (page 5). This teaches a cannabinoid-terpenoid solution wherein the CBD is 10% and the THC is 1.0% (thus making a 10:1 ratio).
REDDIT is relied upon for the beneficial teaching that VetCBD’s products are used in methods for treating pain, anxiety, inflammation, nausea, seizures, and cognitive dysfunction for pets (page 1).
VetCBD teaches a lipophilic carrier (olive oil page 3).
This helps teach claims 1-3.
VetCBD does not teach terpenes in the CTS.
Lowcountry Dog teaches that although Cannabidiol itself has many health benefits for pets, these therapeutic benefits can be enhanced even further with the addition of different terpenes. Terpenes can mimic other cannabinoids giving you the same therapeutic benefits of a full spectrum oil without the need for THC-the active compound known to cause a “high or buzz” (page 1).
Donsky teaches a solution comprising one or more cannabinoids or its analogs and one or more terpene for pharmaceutical administration wherein the cannabinoids and its analogs include various tetrahydrocannabinols (THC), cannabidivarin (CBDV), cannabidiol (CBD), and their combinations of two or more of these compounds and the terpenes include limonene, humulene, guaiene, myrcene, linalool, pinene, caryophyllene, etc. wherein terpene is present in up to 50 % and cannabinoids or its analogues in an amount of about 0.001 to about 10% (e.g., [0033]-0034], claims 3 and 6-9 of prior art).
Donsky teaches administering its CTS to a “subject” which includes dogs, cats, horses or other animals (paragraph [0040]).
The artisan would have been motivated to add terpenes to the VetCBD tincture in order to enhanced the therapeutic benefits even further with the addition of different terpenes. The artisan would have expected that to be able to have the same therapeutic benefits of a full spectrum oil without the need for THC-the active compound known to cause a “high or buzz” (Lowcountry Dog page 1). This teaches claims 1 and 3.
The artisan would have been motivated to optimize the dosage of terpenes in the CTS. Donsky teaches terpene percentage up to 50%. Generally, 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. See MPEP 2144.05(II)A. Examiner has reviewed the instant specification and claims and has not found evidence that the dosage is critical. Thus, the artisan would be motivated and expected to optimize the dosage of terpenes in the CTS. This teaches claim 2.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over VetCBD (“VetCBD – Best CBD products”, VetCBD, December 22, 2014) as evidenced by REDDIT (“I'm Dr. Tim Shu, I make medical cannabis for animals. Pets can also benefit from cannabis, AMA!”, Reddit, 2018) and in view of Lowcountry Dog (“Benefits of CBD for your Dog”, Lowcountry Dog, April 20, 2019) and Donsky et al. (US2016/0279073A1 and in view of Hadener (Hadener et al., “Quantitative determination of CBD and THC and their acid precursors in confiscated cannabis samples by HPLC-DAD”, Forensic Science International, June 2019).
Claims 1-3 are taught above.
Additionally, Hadener teaches that “plants with up to 25% total CBD and less than 1% total THC are bred” (introduction). True CBD-rich strains, which have recently been bred, usually express 0.3–0.7% total THC (page 143).
The artisan would be motivated and expected to optimize the dosage ratio of CBD to THC. Hadener teaches percentages that teach/overlap with the instant percentages. Neither the instant claims nor the instant specification identifies that the ratios/percentages are criterial. See MPEP 2144.05 (II)(A): “Generally, 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”. This teaches claims 1-3.
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 1-3 are rejected on the ground of nonstatutory anticipatory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11622956. Although the claims at issue are not identical, they are not patentably distinct from each other. The reference method treating a disease, state, or disorder in a non-human animal by administering a cannabinoid-terpenoid solution (CTS) to an animal suffering from a disease, state or disorder, the CTS comprising two or more cannabinoids and one or more terpenes; and wherein the one or more terpenes and two or more cannabinoids are mixed within the CTS to form a terpenoid to cannabinoid ratio with respect to one another that ranges from approximately 1.2:1 to approximately 4:1.
The reference claims (ref claim 1) are directed to a ratio of two or more terpenes and two or more cannabinoids to form a terpenoid to cannabinoid ratio from approximately 1.2:1 to 4:1. The reference composition teaches between 10-20% of terpenes of the CTS (the instant range is between 13-17% of the CTS), the base references claims do not limit a ratio of CBD to THC. The artisan would have been motivated to optimize through routine optimization this ratio/weight percentage.
Conclusion
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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