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 .
Current Status of 18 /549564
Claims 1-12 filed 2023 September 7 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2023 September 7 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by 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.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for the slowing down, lessening the symptoms of, or halting the progression of leukemia with NU6027 and non-enabling for the prophylaxis of leukemia with NU6027. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating leukemia with NU6027. The “treatment” concept encompassed Thus, the claims taken together with the specification imply that leukemia can be alleviated or prevented with NU6027.
The state of the prior art and (4) the predictability or unpredictability of the art:
SAIKIA (Current Oncology Reports, 2018, 20:12, 1-8) describes that the curing of chronic myeloid leukemia requires more research (page 5, “conclusions” section).
DEININGER (Blood, 2000, 96:10, 3343-3356) describes that more work is needed to understand the molecular biology of chronic myeloid leukemia (pages 2251-3352, “conclusion” section).
The relative skill of those in the 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 alleviation or prevention of leukemia).
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for the enabling for the slowing down, lessening the symptoms of, or halting the progression of leukemia with NU6027.
The specification does not provide guidance for the prophylaxis of leukemia with NU6027.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to alleviation or prevention of leukemia and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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
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).
BOFFO describes that CDK inhibitors are linked to treatment of acute myeloid leukemia or acute lymphocytic leukemia ) (ALL) (page 7, column 1, last paragraph).
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.
Allowable Subject Matter
Claims 1-12 are not allowed.
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.
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