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 .
DETAILED ACTION
This office action is response to communication filed on 11/26/2025.
Election/Restrictions
Applicant’s election of Group II, claims 17-21 and 23-25, drawn to a method of promoting neurite elongation and/or restoring neurite formation in a patient in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical formulation comprising at least one cannabinoid compound; and cannabigerolic acid (CBGA), having following structure, as the single disclosed species of the cannabinoid compound, in the reply filed 11/26/2025 is acknowledged.
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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)).
Claims 1-7, 9-13, 15-16 and 25-26 are withdrawn from being directed to non-elected inventions.
It’s noted the elected cannabigerolic acid (CBGA) read on compound of Formula I recited in claim 18, wherein
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Although compound of Formula I is subgenus of compound of Formula VII as recited in instant claims 18 and 21, compound of Formula VII comprise other subgenus that are directed non-elected compound of Formula VII which is much broader scope than compound of Formula I. The other non-elected species of compound of Formula I, Formula II to Formula VII, including compounds (B) through compound (V) as recited in claim 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Status of Claims
Claims 1-7, 9-13, 15-21 and 23-27 are pending in instant application.
Claims 1-7, 9-13, 15-16 and 26-27 are withdrawn from being directed to non-elected inventions/species.
Claims 17-21 and 23-25 are currently under examination in this office action.
Priority
This application 18/033,187 filed on 04/21/2023 is a 371 of PCT/CA21/51487 filed 10/21/2021, which claims US provisional application No. 63/094,822 filed 10/21/2020.
Claim Objections
Claims 17-21 and 23 are objected to because of following informalities:
Claims 17-18 and 21 recite “wherein the at least one cannabinoid compounds are independently selected from the group …” The phrase “at least one” is treated as singular and the noun following it should be singular. Thus, “the at least one cannabinoid compounds are” should read the at least one cannabinoid compound is.
Claim 19 reciting “ the at least one cannabinoid compounds are independently according to Formula I or a salt thereof” , should be the at least one cannabinoid compound is a compound of Formula I or a salt thereof.
Claim 20 reciting “ the at least one cannabinoid compounds are independently according to Formula VII or a salt thereof” , should be the at least one cannabinoid compound is a compound of Formula VII or a salt thereof.
Claim 23 recites “wherein when the salt is present”, should be wherein the salt is present.
Please note the amendment to the claims should not be in bold text,
Specification
The disclosure is objected to because of the following informalities: there are multiple “R4a is akylamine” should be alkylamine in definition for Formula III, IV, V, VI. See [0081] on page 16 and
page 17.
[0088] There is typo for incorporated reference WO2020/090923, it should be WO2020/090823.
Claim Interpretation
Instant claims are directed to a method of promoting neurite elongation and/or restoring neurite formation in a patient in need thereof, the method comprising administering a therapeutically effective amount of a pharmaceutical formulation comprising at least one cannabinoid compound selected from CBGA and vast variety of derivative thereof, prodrug thereof and combination thereof. The limitation “ promoting neurite elongation and/or restoring neurite formation” is construed as intended result of administering a therapeutically effective amount of a pharmaceutical formulation comprising at least one cannabinoid compound in a patient in need thereof. Instant claims only recite the subject in need thereof, but do not specifically recite what subject would be in need of “promoting neurite elongation and/or restoring neurite formation”. Instant specification (See [0010], USPGPub US20230381205A1) disclosed: “Patients in need of neurite elongation and/or restoration of neurite formation may include, e.g., those patients suffering from axonal injury, ischemic stroke, schizophrenia, Down syndrome, autism spectrum disorder (ASD), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis, spinal muscular atrophy, motor neuron diseases, chronic hearing loss, tinnitus, hyperacusis, presbycusis, and balance disorders associated with cochlear synaptopathy and vestibular synaptopathy”. As such, instant claims are construed as method of promoting neurite elongation and/or restoring neurite formation in a patient suffering from neurological disease, e.g. axonal injury, ischemic stroke, schizophrenia, Down syndrome, autism spectrum disorder (ASD), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis, spinal muscular atrophy, motor neuron diseases, chronic hearing loss, tinnitus, hyperacusis, presbycusis, and balance disorders associated with cochlear synaptopathy and vestibular synaptopathy, etc.
Please note biological/pharmaceutical activities are the properties of compounds, and the products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. If prior art teaches a method of administering CBGA or derivative thereof to a patient suffering neurological disorder (e.g. schizophrenia) associated with cannabinoid receptor, the prior art is considered as read on instantly claimed method of promoting neurite elongation and/or restoring neurite formation even though the prior art is silent about promoting neurite elongation and/or restoring neurite formation.
Claim Rejections - 35 USC § 112
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.
Claims 17-21, 23 and 25 are rejected under 35 U.S.C. 112(a), because the specification, while might be enabling for a method of promoting neurite elongation and/or restoring neurite formation with cannabigerolic acid CBGA, the specification does not enable a person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The determination that "undue experimentation" would have been needed to practice the claimed invention in full scope is not a single, simple factual determination.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant application for the following reasons:
The Breadth of The Claims/ Nature of The Invention
Claims 17-21, 23 and 25 are directed to a method for promoting neurite elongation and/or restoring neurite formation with vast variety of compound genus, compound of Formula I to Formula VII , derivative thereof and prodrug thereof, which are extremely broad. The derivative and prodrug of instant claimed compounds might refer to compounds that have different core structures, different chemical and physical properties.
The State of the Prior Art and the Predictability or Lack Thereof in the Art
There are many types of injury that can cause damages to neurons such as traumatic brain injury (TBI), spinal cord injury (SCI), neurological diseases, optic nerve injury, stroke, and ischemia, etc. Neurogenesis is dynamically regulated by numerous intrinsic and extrinsic factors, and complex interactions between different stages of neuronal development, which is highly unpredictable and challenging. As elaborated in preceding Claim Interpretation, instant claims are construed as related to patients in need of restoring neurite formation/neurogenesis associated with treating neuronal disease. It is well known in the prior art that treatment of neuronal disorder and/or neurodegenerative disease/disorder is challenging and highly unpredictable. Different neurodegenerative disorder have different etiology, different symptoms and different treatment wherein restoring neurite formation might be associated with different pathological pathways.
More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity (e.g., cancer prevention) is generally considered an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The Amount of Direction Present and Presence or Absence of Working Examples
Instant specification disclosed in-vitro assay with cannabigerolic acid CBGA and other cannabinoid ( THC, CBD)(See Examples 1-6) . Instant Example 7 is a study design for administration CBGA to AD rodent model without activity data. Instant specification does not disclose assay with any other species from compound of Formula I to compound of Formula VII, or derivative, or prodrug thereof as recited in instant claims. Instant specification does not disclose any assay that support the administration route recited in claim 25, e.g. topically, intradermally, etc. Due to the blood-brain barrier, an ordinary skilled in the art would not know if instantly claimed compounds could be administered through the instantly claimed route (e.g. topically, intradermally, etc. ) for the intended treatment outcome.
The level of one of ordinary skill in the art
The level of skill required to make and/or use the instant invention would likely require many years of professional experience conducting research in the art (e.g., medicine, pharmaceutical science, biology, biochemistry, medicinal chemistry, etc.) as well as an advanced educational degree (e.g., M.D. and/or Ph.D.) commensurate in level with the advanced techniques involved in the preparation and/or use of the instant invention.
The quantity of experimentation needed
An unduly extensive amount of experimentation would be required for one of ordinary skill in the art to use the claimed invention in full scope. Working examples of various species of compound of Formula I to Formula VII and prodrug or derivative thereof would need to be explored for the therapeutically effective dose and administration variables for the intended treatment outcome. The therapeutically effective amount may vary depending on many factors, such the subjects being treated, the disease condition, administration route, and intended treatment outcome, etc. Therefore, it would be a great burden for one of ordinary skill in the art to carry out undue experimentation to use the claimed invention in full scope.
Conclusion
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562,27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here with respect to the claimed method of promoting neurite elongation and/or restoring neurite formation with vast variety of compound of Formula I to Formula VII, and prodrug or derivative thereof, in view of the analysis above pursuant to In re Wands. In other words, one skilled in the art could not practice the claimed invention in full scope without undue experimentation.
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.
Claims 17-18, 23 and 25 are rejected under 35 U.S.C. 112(b) 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.
Claim 17 recites a method of promoting neurite elongation and/or restoring neurite formation in a patient in need thereof, the method comprising administering a therapeutically effective amount of a pharmaceutical formulation comprising at least one cannabinoid compound, wherein the at least one cannabinoid compound selected from the group consisting of CBGA, a salt thereof, a derivative thereof, a prodrug thereof, and combinations thereof. The term “derivative ” and “prodrug” are vague and indefinite. The “derivative” and “prodrug” and combination thereof might refer to vast variety of molecules that have different structures, might be in different recognized chemical classes and might have different chemical/physical properties, different pharmaceutical /biological activity and different pharmacokinetic/toxicological profile, etc. Thus, the limitation “prodrug” and “derivative” is not a definite functional group/moiety and comprise indefinite structural limitation. The limitation “derivative” “prodrug” and combination thereof render the claim(s) indefinite because an ordinary skilled in the art would not know what compounds/agent are encompassed by "prodrug" and “derivative”, thus, the scope of the claim(s) are unascertainable for the patent protection desired.
Claims 23 and 25 are rejected due to dependency of claim 17.
Claim Rejections - 35 USC § 102/103
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-21 and 23-25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over BARR et al. (WO2020/092823 A1).
Barr et al. teaches cannabinoid analogs (e.g. CBGA ), halogenated, hydroxylated, deuterated, and tritiated thereof, Compound of Formula I for treating a disease or condition mediated by cannabinoid receptor activity, such as Alzheimer's disease, Huntington's disease, multiple sclerosis and Parkinson's disease, and schizophrenia (See abstract, [0003]-[0008], [0030], [0034], Table 1, Embodiments 1-38).
Barr et al. explicitly teaches cannabigerolic acid (CBGA) and compound species that are encompassed by or very similar to instantly claimed cannabinoid compounds(See Table1, Exemplary Embodiments 1-38).
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Barr explicitly teaches cannabigerolic acid (CBGA) can be converted to further bioactive cannabinoids both enzymatically (e.g., by decarboxylation via enzyme treatment in vivo or in vitro to form the neutral cannabinoid cannabigerol) and chemically (by heating) (See page 4, [0010] lines 1-5).
Regarding claim 25, Barr teaches “administering" refers to oral, topical, parenteral intravenous, intraperitoneal, intramuscular, intralesional, intranasal, subcutaneous, pulmonary, or intrathecal administration to a subject (See [0025]). Barr teaches cannabinoid derivatives can be administered through various route, e.g. oral, pulmonary administration by aerosol spray, topically as a solution, ointment, cream, gel, suspension, eye-drops, etc. ( See [0133]- [0137]).
Barr is silent about the cannabigerolic acid CBGA or its derivative promoting neurite elongation and/or restoring neurite formation in a patient in need thereof. However, neurite elongation and/or restoring neurite formation are crucial biological processes for the development and repair of the nervous system that are associated with neurological disease/neuronal disorder mediated by cannabinoid receptor. Instant specification (See [0010], USPGPub US20230381205A1) disclosed: “Patients in need of neurite elongation and/or restoration of neurite formation may include, e.g., those patients suffering from axonal injury, ischemic stroke, schizophrenia, Down syndrome, autism spectrum disorder (ASD), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis, spinal muscular atrophy, motor neuron diseases, chronic hearing loss, tinnitus, hyperacusis, presbycusis, and balance disorders associated with cochlear synaptopathy and vestibular synaptopathy”. As elaborated in preceding Claim Interpretation, instant claims are construed as method of promoting neurite elongation and/or restoring neurite formation in a patient suffering from neuronal disorder, e.g. schizophrenia, Down syndrome, autism spectrum disorder (ASD), amyotrophic lateral sclerosis (ALS), etc. Barr teaches cannabigerolic acid CBGA administered to a patient in need of treating a disease or condition mediated by cannabinoid receptor (e.g. schizophrenia) which is also a patient in need of promoting neurite elongation and/or restoring neurite formation. Products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. “promoting neurite elongation and/or restoring neurite formation” will inevitably flow by following Barr’s method of treating a disease or condition mediated by cannabinoid receptor (e.g. schizophrenia) since the same compound (e. g. CBGA and derivatives thereof ) is being administered to the same subjects in need thereof.
In other words, even though the prior art is silent about promoting neurite elongation and/or restoring neurite formation, by practicing Barr’s method of treating a disease or condition mediated by cannabinoid receptor (e.g. schizophrenia) by administrating CBGA or derivatives thereof to an individual in need thereof, one will also be promoting neurite elongation and/or restoring neurite formation even though the prior art was not aware of it. As such, Barr anticipates instant claimed invention.
In the alternative, even if the instantly claimed effect of “promoting neurite elongation and/or restoring neurite formation ” is not exactly the same as Barr, the differences between what is disclosed in prior art and what is claimed are considered to be so slight that the method taught by the cited reference is likely to possess the similar effects of instantly claimed method in view of the similar characteristics which they have been shown to share. It’s noted there are no dosage regimen or specific administration limitation recited in instant claims that are different from prior art. Thus, the claimed method of “promoting neurite elongation and/or restoring neurite formation would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the cited reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al. ( WO2019071302A1).
Arnold teaches a method of treating neurological disorder (e.g. seizure), comprising administering to the individual a therapeutically effective amount of cannabigerolic acid (See abstract, page 2, lines 18-30; Examples 1-4; claims 1- 20).
Arnold teaches cannabinoid family (e.g. CBD, CBGA, etc.) (See page 20 ) and explicitly teaches CBGA prevents or reduce the frequency of seizures, or reduce the severity of seizures in an individual in need thereof (See abstract, page 5, lines 10-15; Examples 1-4, Figure 1). Arnold teaches CBGA displays anticonvulsant properties by increasing tolerability to hyperthermia-induced seizures in two genetically distinct mouse models of Dravet syndrome(See Example 1, Figure 1, page 27, lines 17-25). Arnold also teaches CBGA is more effective in modulating seizures at a lower dose than CBD, a known anticonvulsant, indicating that CBGA may be a superior anticonvulsant, particularly in the context of Dravet syndrome (See page 27, lines 17-25).
Arnold teaches CBGA formulation can be adapted for administered through variety of routes, e.g. parenteral administration, such as intravenous, intraarterial, intramuscular, intrathecal, subcutaneous or intraperitoneal injection, intranasal, gastrointestinal, or other commonly used
routes for administration (See page 23,lines 16-20)(which reads on claim 25).
Arnold teaches epilepsy is a group of neurological disorders that are associated with neuronal activity in the brain (See page 8, lines 24-30). Arnold is silent about CBGA for promoting neurite elongation and/or restoring neurite formation. A skilled artisan would have known epilepsy associated with neuronal activity in the brain is also associated with neurite formation. The patient suffering epilepsy is also construed as patient in need of restoring neurite formation. Thus, the claimed method of “promoting neurite elongation and/or restoring neurite formation” with CBGA would have been obvious to those of ordinary skill in the art within the meaning of 35 USC 103.
It would have been prima facie obvious and logical for an ordinary skilled artisan to further explore CBGA for neuroprotective properties in other neurological disease and reasonably expect CBGA exhibit some activity for other neurological disease associated with neurogenesis/restoring neurite formation. A skilled artisan would be motivated to do so since Arnold teaches CBGA demonstrates better anticonvulsant properties than CBD which is well-known for neuroprotective property. One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the collective teachings of prior art, together with further exploration/optimization based on general knowledge of cannabinoid and neurological disease treatment . Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 17-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al. ( WO2019071302A1) and Stone et al. (British Journal of Pharmacology, Volume 177, Issue 19 Oct 2020, Pages 4311-4560, first published July 2020, https://doi.org/10.1111/bph.15185A, “A systematic review of minor phytocannabinoids with promising neuroprotective potential”) and Nadal et al. (British Journal of Pharmacology (2017) 174 4263–4276 , DOI:10.1111/bph.14019, Tetrahydrocannabinolic acid is a potent PPARγ agonist with neuroprotective activity).
The collective teachings of Arnold is elaborated in preceding 103 rejection and applied as before. Arnold teaches CBGA is structurally related to CBG, CBD, THC and other cannabinoid compound.
Stone reviews neuroprotective potential for phytocannabinoids, e.g. cannabidiol (CBD),
Δ9-tetrahydrocannabinol, Δ9-tetrahydrocannabinolic acid, Δ9-tetrahydrocannabivarin, cannabidiolic acid, cannabidivarin, cannabichromene, cannabichromenic acid, cannabichromevarin, cannabigerol, cannabigerolic acid, cannabigerivarin, cannabigerovarinic acid, cannabichromevarinic acid, cannabidivarinic acid etc. (See abstract, whole article, Table 1). Stone teaches Δ9-THC and CBD are well studied and established for neuroprotective properties in variety of neurological diseases, e.g. Parkinson's, Alzheimer's and Epidiolex® (pure CBD) is licensed to treat Lennox–Gastaut syndrome and Dravet syndrome, which are severe forms of childhood epilepsy (See page 4331, left column; Table 1).
Stone and its incorporated reference teach CBDA, CBGV, and CBGA interact with various TRP channel isoforms including TRPV1, TRPV2,TRPA1, and TRPM8 channels wherein CBGV and CBGA were also potent desensitizers of TRPV3 and TRPV4 channels that are involved in a wide range of neurological disorders. For example,TRPA1-deficient mice were more likely to sustain damage post ischemia and TRPA1 channel activation in Alzheimer's disease may have a crucial role in regulating astrocyte-mediated inflammation (See page 4347, right column, 2nd para).
Nadal teaches phytocannabinoids ( Δ9 -THC, cannabidiol CBD and CBG) and their corresponding acidic precursors (Δ9 -THCA, cannabidiol acid (CBDA) and cannabigerol acid (CBGA), respectively) as agonists of PPARγ with neuroprotective activity for the treatment of Huntington's Disease (HD disease) and possibly other neurodegenerative, metabolic and inflammatory diseases (See abstract, page 4264, right column). Nadal teaches neuroprotective mechanism of PPARγ agonist in Huntington's Disease (See introduction, page 4264, left column) and teaches CBGA showed potency in binding and activating PPARγ (See page 4266, right column; Results).
CBGA is structurally related to CBG, CBD and THC and construed as the cannabinoid equivalent as taught by Arnold. Given the neuroprotective effects of Δ9-THC and CBD established as elaborated by Stone and Nadal, it would have been prima facie obvious for an ordinary skilled artisan to further explore CBGA or derivative cannabinoid for neuroprotective properties in neuronic disease with reasonable expectation that CBGA and its derivative may exhibit similar neuroprotective properties.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with further exploration/optimization based on general knowledge of cannabinoid and neurological disease treatment . Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed
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/LIYUAN MOU/
Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628