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(d)
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.
Claims 20-27 are 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. Rejected claims are directed to polymorph of claim 19 comprising additional X-say powder diffraction peaks. Claim 19 is directed to a single crystal form of a specific compound. The dependent claims are directed to the same crystal form and therefore fail to further limit claim 19. Since it is the same identical crystal form in all of the claims there is no difference in scope between claim 19 and the rejected claims. 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 § 112(a)
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 20-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are directed to a crystal form having x-ray powder diffraction pattern characterized by the 6 peaks recited in claim 19 and further comprising one or more listed peaks. The claims include crystal forms where only one of the listed peaks is present, but not the others. Specification describes a single crystal form where all of the recited peaks are present. There is no evidence that applicants had possession of a crystal form where (for example for claim 20) the x-ray powder diffraction comprises a peak at 12.313, but not at the other listed positions.
Claims 29-34 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 the recited conditions, does not reasonably provide enablement for prevention. 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.
A conclusion of lack of enablement means that, based on the evidence regarding each of the factors below, 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.
These factors include:
(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.
The breadth of the claims
Claim 29 is directed to a method of treatment of an autoimmune disease of a viral infection comprising administering to a subject in need the compound according to claim 19. The term “treatment” is defined in the specification on page 12, lines 2-5, as including prophylactic administration, which is prevention of the disease.
The state of the prior art
The examiner notes that the art does not recognize preventive therapeutic efficacy of DHODH inhibitors.
The level of one of ordinary skill
The skilled artisan in this field is that of an MD and/or a PhD skilled in the development and treatment of viral infections and autoimmune diseases
The level of predictability in the art
The examiner acknowledges the probability and predictability that the instantly claimed salts have applicability in treating the claimed disorders. There is not seen sufficient data to substantiate the assertion that viral infection and autoimmune diseases may be prevented by the compounds of the instant invention. One skilled in this art would not predict from the disclosure provided that viral infections and autoimmune diseases can be prevented in view of the data and examples provided.
The amount of direction provided by the inventor.
The instant specification is not seen to provide adequate guidance, which would allow the skilled artisan to extrapolate from the same to establish enablement for the prevention of viral infection and autoimmune diseases. There is not seen guidance as to how the skilled artisan would formulate the requisite active agents and use it in methods for the prevention of either of the claimed diseases.
There is not seen sufficient guidance, which would teach the skilled artisan how to administer, said active agents in methods for preventing viral infection and autoimmune diseases. To treat said diseases appears to be the limit of the applicability of the claimed compounds.
The existence of working examples
There are no working examples provided in the specification that indicate prophylactic efficacy of compound of claim 19
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Indeed, in view of the information set forth supra, the instant disclosure is not seen to be sufficient to enable the prevention of any disease or conditions and the skilled artisan would not extrapolate preventive efficacy from the compounds instantly claimed. Nor is this data alone recognized in the art, as sufficient data to assert compounds with a specific activity would be expected to prevent viral infection and autoimmune diseases.
Allowed claims
Claim 19 is allowed. Closest art is EP 2121614 which teaches obtaining the claimed compound as a yellow precipitate (P23, Example 20). There is no suggestion that the compound can be crystalized into a form having the claimed powder diffraction peaks
Conclusion
Claims 19-34 are pending
Claim 19 is allowed
Claims 20-34 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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