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 .
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.
Claims 10-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of disorders where modulation of c-kit kinase is implicated, does not reasonably provide enablement for treatment of disorders where modulation is of a kinase selected from CSF1R, PDGFRα or PDGFRβ. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
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, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims:
The claims are directed to a method of treating disease or disorder where modulation of a kinase selected from CSF1R, PDGFRα or PDGFRβ is implicated.
State of the prior art and level of predictability in the art:
Art recognizes pharmacological utility of inhibitors of kinases selected from CSF1R, PDGFRα or PDGFRβ.
Amount of direction provided by the inventor and existence of working examples:
Regarding treatment of treating disease or disorder where modulation of a kinase selected from CSF1R, PDGFRα or PDGFRβ is implicated inventors only provide statements of their intent to do so. The biological activity of the claimed compounds is exemplified in the c-kit kinase chemiluminescence assay and M-07e Cellular assay (pages 65-68). The c-kit kinase assay indicates that the claimed compounds are in fact inhibitors of c-kit kinase. The M-07e cellular assay is a model for acute megakaryoblastic leukemia and c-kit kinase activity. The experimental data provided supports possibility that the claimed compounds can be utilized in treatment of disorders where inhibition of c-kit kinase is implicated.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: Although the relative level of skill in the art is high, one of ordinary skill would not be able to treat disorders where modulation of a kinase selected from CSF1R, PDGFRα or PDGFRβ is implicated according to the claimed method without engaging in undue experimentation. In order to treat such disorders a skilled artisan would need to administer a pharmaceutical agent that has activity as an inhibitor of the above listed kinases. The currently claimed compounds have not demonstrated such activity and therefore their efficacy in inhibiting a kinase selected from CSF1R, PDGFRα or PDGFRβ is highly unpredictable.
Thus, given these considerations, one of ordinary skill in the art clearly would not be able to practice the claimed method such that it can be used as contemplated in the specification without first engaging in substantial and undue experimentation. Therefore, the claims are rejected under 35 U.S.C. §112, first paragraph, as lacking and enabling disclosure.
Allowed claims
Claims 1-6 are allowed. Closest art is US 20150011508. Art teaches compounds that are structurally similar to the claimed compound of formula (I). In the current claims ring “A” is limited to heteroaryl or naphthyl rings. In the art’s compounds Ring “A” is a benzene ring which is outside of the scope of pending claims
Conclusion
Claims 1-6 and 10-13 are pending
Claims 1-6 are allowed
Claims 10-13 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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