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 .
Notice of Priority
This applications claims priority for U.S. Provisional Application 62/307,030, filed 11 March 2016.
DETAILED ACTION
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 10 July 2024 has been considered by the Examiner.
Claim Status
Acknowledged are applicant’s cancellation of Claim(s) 1-24.
Claim(s) 25-30 are examined on the merits herein.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 103
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 non-obviousness.
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.
Claim(s) 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sebti et al (Priority Filing: 30 March 2011; WO 2012/135641 A2; henceforth Sebti) in view of Furlan et al (Published: 25 November 2015; Furlan SN, et al. Transcriptome analysis of GVHD reveals aurora kinase A as a targetable pathway for disease prevention. Sci. Transl. Med. 7 (315); henceforth Furlan).
Claim 25, and its dependent claims 26-30, detail a method for treating graft versus host disease (GVHD) using various aryl 2,4-pyrimidinediamines. In regards to the mentioned claims, Sebti teaches compounds of the core structure below, with inhibitory concentrations in the 0.001-100 uM range for Aurora kinase A [pg. 38-45; Tables 1-4]:
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393
482
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Several of these compounds are the same compounds as structures reported in this disclosure, namely:
3a, the same compound as Instant 3a [pg. 108 of 170; Library 3]
6c, the same compound as Instant 6c [pg. 111 of 170; Library 6]
9b, the same compound as Instant 9a [pg. 113 of 170; Fig. 7a]
6h, the same compound as Instant 14 [pg. 111 of 170; Library 6]
Sebti does not teach a method of reducing the risk of, preventing or treating GVHD.
Furlan teaches a transcriptomic analysis of GVHD targets that reveal Aurora Kinase A (AURKA) to be a druggable target in GVHD, alongside in vivo studies of GVHD treatment by AURKA inhibition using MLN8237. In particular, Furlan teaches in Fig. 8 that inhibition of the AURKA pathway with in vivo MLN8237 administration was indeed able to mitigate clinical severity and lethality in the murine GVHD model, significantly extending MST from 22.5 (vehicle) to 40.5 days (MLN8237) (P < 0.0001) [pg. 9; Inhibition of AURKA mitigates GVHD and prolongs survival in a murine model of aGVHD; par. 1]. Additionally, Furlan addresses the treatment of GVHD as it is attributed to a hematopoietic stem cellular transplant [pg. 2; Figure 1], as required by Instant Claim 30.
A prima facie case of obviousness can be made for one of ordinary skill in the art to utilize the compounds disclosed by Sebti in the method of treatment of GVHD taught by Furlan. The Sebti compounds are reported therein to be inhibitors of Aurora kinase A, with Furlan further supporting the concept of Aurora kinase A being an effectively druggable target for GVHD treatment using MLN8237 as an Aurora kinase A inhibitor. The substitution of MLN8237 for the Sebti compounds would represent nothing more than the use of prior art elements according to their established functions, yielding predictable results. In regards to substitution, “[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. In re KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Therefore, one of ordinary skill in the art would have sufficient and practical evidence to be motivated to reproduce the Instant invention, a method of treating GVHD with the compounds of the Instant Claims, before the effective filing date of the Instant disclosure.
Therefore, Claim(s) 25-30 are rejected under 35 USC § 103.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STANLEY BRAM whose telephone number is (571)272-8779. The examiner can normally be reached 7:30 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee R Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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