DETAILED ACTION
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 .
Priority
This application was filed 110/25/2023 and is a 371 of PCT/US2022/071971 (04/28/2022) and has a PRO 63/180872 (04/8/2021). Claims 1-10, 13, 20-21, 25-27, 35-36 and 54 are before the Examiner.
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.
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 36 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.
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”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is the method of treating a disorder that is modulated by binding A3R.
The state of the prior art: The state of the prior art is that it 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). 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. Liston teaches that A3R modulation has potential for the treatment of many conditions but further research is needed.
The predictability in the art: 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 instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the therapeutic effects of all diseases, whether or not the modulation of A3R receptors would make a difference in the disease. Hence, in the absence of a showing of a nexus between known diseases and the modulation of A3R, one of ordinary skill in the art is unable to fully predict possible results from the administration of the compound of claim 20 due to the unpredictability of the role of modulation of A3R receptors. Those of skill in the art recognize that in vitro assays and or cell-cultured based assays are generally useful to observe basic physiological and cellular phenomenon such as screening the effects of potential drugs. However, clinical correlations are generally lacking. The greatly increased complexity of the in vivo environment as compared to the very narrowly defined and controlled conditions of an in- vitro assay does not permit a single extrapolation of in vitro assays to human diagnostic efficacy with any reasonable degree of predictability. In vitro assays cannot easily assess cell-cell interactions that may be important in a particular pathological state. Furthermore it is well known in the art that cultured cells, over a period time, lose phenotypic characteristics associated with their normal counterpart cell type. As stated above by Liston, further research is needed before A3R modulation can be accepted as a treatment of diseases listed in claim 36.
The presence or absence of working examples: The compounds of the instant claims have been shown to have binding activity (in vitro). However, there are no real-world examples of the instant compounds treating any specific disease listed in the claim ranging from concussion to Parkinson’s disease to glaucoma to vertigo to deafness.
The amount of direction or guidance present: The guidance present in the specification is that of the compounds have this A3R modulation activity and therefore can treat any condition that has been linked to A3R activity (see the diseases listed in claim). Very similar compounds have been shown to have one work well and the other have no effect (see compounds I-1, I-2 and I-g page 140 of Specification). The specification does not seem to enable a correlation between the mediation of A3R receptors and the treatment of any and all diseases.
The breadth of the claims: The claims are drawn to the treatment of many diverse diseases mediated by the A3R receptor with the compound of claim 20.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what disease of the many diseases listed in claim 36 would be benefited by the mediation of A3R receptors and then would further need to determine which of the claimed compounds would provide treatment of the disease.
The level of the skill in the art: 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 and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment of any disease. As a result necessitating one of ordinary skill to perform an exhaustive search for which diseases can be treated by which compound of claim 1 in order to practice the claimed invention.
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 “[p]atent 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, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 102
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 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.
Claim 54 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by USGPGub 20180021363 Korinek. Korinek teaches compounds 2 and 3 on page 26 col 1 that anticipate the instant claim 54.
Claims 1-10, 13, 20, 25-26, 35-36 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suresh. Claims 1-8 are anticipated by the process on pages 2-3. The process of claims 9-10 and 13 are anticipated by the process on pages 2-3 compounds 9 ->16a-f -> 19 ->20a-f. Claims 20 and 25 are anticipated by compound 8a where R2 is H, R1 is methyl and X is S. Claim 26 is anticipated by the abstract and first page which teaches the compounds can be used as treatments for cancer, infectious diseases and other conditions. Claims 35 and 36 are anticipated by the first paragraphs where Suresh teaches the adenine moieties taught in the article can be used to treat cancer and infectious diseases. Claim 54 is anticipated by compound 6.
Claims 35 ad 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suresh in view of Tosh and Bozdemir. Suresh teaches compounds such as compound 8a as A3R modulators. Tosh and Bozdemir both teach that A3R modulators might be used in compositions to treat many of the conditions listed in the claims such as cancer and TBI.
Claim 27 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tosh. Tosh teaches compounds on page 5 such as #62-70 that anticipate the instant claim.
Claim 54 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tchilibon. Tchilibon teaches compounds such as #14 on page 149 that anticipate claim 54.
Claim Objections
Claim 21 is objected to because of the following informalities: This claim is dependent from a rejected base claim but would be allowable if rewritten in independent form with all intervening limitations. Appropriate correction is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625