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
Claims 1-13 and 15-20 are currently pending in the instant application. Applicants have amended claims 1-13 and 15-20 and canceled claim 14 in an amendment filed on May 29, 2024. Claims 4-13 and 15-17 are rejected and claims 1-3 and 18-20 are considered allowable in this Office Action.
I. Priority
The instant application is a 371 of PCT/EP2022/083822, filed on November 30, 2022 and claims benefit of Foreign Application EPO 21211470.6, filed on November 30, 2021.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 4-13 and 17 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation tetrahydrocannabinolic acid alkanoate, and the claim also recites tetrahydrocannabinolic acid acetate which is the narrower statement of the range/limitation. . The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In the present instance, claim 4 recites the broad recitation cannabidiolic acid di-alkanoate, and the claim also recites cannabidiolic acid di-alkanoate di-acetate which is the narrower statement of the range/limitation. . The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Applicants are suggested to amend claim 4 to delete either the broader limitations or narrower limitations as stated above to overcome the rejection.
Claims 7-11 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. In claim 7, the limitation “a first CBDA di-acetate derivative” has not been clearly defined in the claim and/or specification so that one of ordinary skill in the art would know what structures are include and/or excluded by the limitation. Therefore the claims are considered indefinite. Applicants are suggested to amend claim 7 to include the structures that are included in the limitation “a first CBDA di-acetate derivative”.
In claim 8, the limitation “a CBDA mono-acetate derivative” has not been clearly defined in the claim and/or specification so that one of ordinary skill in the art would know what structure(s) are include and/or excluded by the limitation. Therefore the claims are considered indefinite. Applicants are suggested to amend claim 8 to include the structure(s) that are included in the limitation “a CBDA mono-acetate derivative”.
In claims 9-10, the limitation “a THCA mono-acetate derivative” has not been clearly defined in the claim and/or specification so that one of ordinary skill in the art would know what structure(s) are include and/or excluded by the limitation. Therefore the claims are considered indefinite. Applicants are suggested to amend claims 9-10 to include the structure(s) that are included in the limitation “a THCA mono-acetate derivative”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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.
Claims 15-16 are rejected under 35 U.S.C. 112(a) or 112, first paragraph, while being enabling for a method of treating a disease associated with a cannabinoid receptor does not reasonably provide enablement for a method of preventing a disease associated with a cannabinoid receptor. 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.
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 been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
Applicants are claiming a method of treating a disease associated with a cannabinoid receptor.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic or prophylactic effects of any condition mediated by inhibiting or activating cannabinoid receptors , whether or not the condition is affected by the instant compounds' activity would make a difference.
For example, Applicants' claim is drawn to a method of preventing Alzheimer’s disease. It is the state of the art that Alzheimer’s disease is a progressive neurologic disorder that causes the brain to atrophy and brain cells to die. Alzheimer’s disease is the most common cause of dementia. Medications may temporarily improve or slow progression of symptoms. These treatments can sometimes help people with Alzheimer’s disease maximize function and maintain independence for a time. There is no treatment that cures Alzheimer’s disease or alters the disease process in the brain. The exact cause of Alzheimer’s aren’t fully understood. Researchers trying to understand the cause of Alzheimer’s are focused on the role of two proteins: Beta-amyloid and Tau proteins. Alzheimer’s disease is not a preventable condition. Evidence suggests that changes in diet, exercise and habits may lower the risk of developing Alzheimer’s disease (see URL https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/symptoms-causes/syc)
Only a total of five drugs developed to improve the symptoms of Alzheimer’s disease have been approved by the FDA. The five drugs function by two different mechanisms> One is cholinesterase inhibition, which delays Alzheimer’s disease by blocking hydrolysis of the critical neurotransmitter acetylcholine. This category of drugs include donepezil (Aricept), rivastigmine (Exelon) and galantamine (Razadyne). The other one is memantine, a non-competitive N-methyl-D-aspartate (NMDA) channel blocker that reduces the activity of the neurotransmitter glutamate, which plays an important role in learning and memory by binding to the NMDA receptor. Namzaric is a combination of donepezil and memantine which reduces the levels of both acetylcholine and glutamate (see Chen, et al. Acta Pharmacologica Sinica 2017:1205-1235).
There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is minimal. There are no working examples present for preventing any disease encompassed the claimed invention.
Receptor activity is generally unpredictable and the data provided is insufficient for one of ordinary skill in the art in order to extrapolate to the other compounds of the claims. It is inconceivable as to how the claimed compounds can treat the extremely difficult diseases embraced by the instant claims.
Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The breadth of the claims
The breadth of the claims is a method of treating or preventing a disease associated with a cannabinoid receptor.
The quantity of experimentation needed and the level of the skill in the art
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases would be benefited by the effects of inhibiting or activating cannabinoid receptors and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment or prevention of the diseases.
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compound encompassed in the instant claims, with no assurance of success.
This rejection can be overcome, for example, by amending the claim to read on the subject matter that Applicants' specification are enabled for as indicated above.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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