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 .
Response to Amendment
Newly amended claims 1-12 filed 2026 May 11 overcome the 35 U.S.C. 112(a) rejection because the claims no longer recite prevention. The 35 U.S.C. 103 rejection over claim 1, 7, and 8 is maintained, as stated below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 nonobviousness.
Claims 1, 7, and 8 are rejected under 35 U.S.C. 103(a) as being unpatentable over EL-NAGGAR (Bioorganic Chemistry, 2021, 108, 1-15, published online 5 January 2021), ALZANI (Experimental Hematology, 2010, 38, 259-269), DEEP (New Journal of Chemistry, 2018, 42, 18500-18507) in view of BOFFO (Journal of Experimental & Clinical Cancer Research, 2018, 37:36, 1-10).
Determining the scope and contents of the prior art
BOFFO describes that CDK inhibitors are linked to treatment of acute myeloid leukemia or acute lymphocytic leukemia ) (ALL) (page 7, column 1, last paragraph).
EL-NAGGAR describes that NU6027 is a CDK inhibitor page 2, column 1, last paragraph to column 2, first paragraph; page 4, figure 4).
ALZANI describes that PHA-793887 is a pan-CDK inhibitor that can be used to treat chronic myeloid leukemia, acute lymphocytic leukemia, and acute myeloid leukemia (abstract; page 261, table 1; page 263, column 2, paragraph 2 to page 266, column 2, paragraph 2; page 267, column 2, paragraph 3 to page 268, column 2).
DEEP describes that flavopiridol, a CDK inhibitor, can treat acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) (page 18506, “Conclusion” section).
Ascertaining the differences between the prior art and the claims at issue
The prior art does not describe that NU6027 treats leukemia.
Resolving the level of ordinary skill in the pertinent art
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in treatment of leukemia with a CDK inhibitor).
Considering objective evidence present in the application indicating obviousness or nonobviousness
Based on the combined teachings of El-Naggar, Alzani, and Deep in view of Boffo, a reasonable expectation of success of substituting PHA-739887 or flavopiridol for NU6027 in the treatment of leukemia is present because both compounds are CDK inhibitors. Boffo describes that CDK inhibitors can treat AML or ALL. Deep describes that flavopiridol, a CDK inhibitor, can treat AML or CML. Due to the prior art showing that PHA-739887 and flavopiridol belonging to the same chemical class as NU6027, substitution of PHA-739887 or flavopiridol has a reasonable expectation of success in the treatment of leukemia.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Response to Arguments
This rejection is maintained because the non-final rejection did not state that claims 1, 7, and 8 are allowable due to a 35 U.S.C. 103 rejection. Due to NU6027, PHA-739887, and flavopiridol each being CDK inhibitors, a reasonable expectation of success is present to substitute PHA-739887 or flavopiridol for NU6027 in the alleviation of acute myeloid leukemia or acute lymphocytic leukemia.
Conclusion
Claims 1, 7, and 8 are not allowed.
Claims 2-6 and 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: EL-NAGGAR (Bioorganic Chemistry, 2021, 108, 1-15, published online 5 January 2021) does not describe that NU6027 treats leukemia. Additionally, El-Naggar does not describe the limitation that the leukemia is resistant to a tyrosine kinase inhibitor.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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