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 .
Election/Restriction
Inventor’s election, without traverse (no arguments), of the subject matter of Group I (claims 41-60 when they are directed to a method of treating or preventing a hematopoietic malignancy or hematopoietic malignancy relapse comprising administering to a subject in need thereof a therapeutically effective amount of one or more BCR-ABL tyrosine kinase inhibitors, or a pharmaceutical formulation thereof, or its combinations) as the group elected to begin prosecution.
Inventor has also elected, without traverse (no arguments), the BCR-ABL tyrosine kinase inhibitor ponatinib as the species elected to begin prosecution.
The election/restriction is hereby made FINAL.
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 41 and 43-60 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 a method of treating or preventing a hematopoietic malignancy relapse, does not reasonably provide enablement for a method of preventing a hematopoietic malignancy per se. 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 use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (MPEP 2164.01(a)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a) The claims are extraordinarily broad: “A method of treating or preventing a hematopoietic malignancy or a hematopoietic malignancy relapse comprising…” (independent claim 41). The remaining claims further define the method.
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as hematopoietic malignancies, can be said to be prevented per se.
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation.
Hematopoietic malignancies are neither simple diseases, nor a single disease. While some hematopoietic malignancies can be treated in some hosts using specific compounds and methods for periods of time, the effective treatment – let alone prevention – of the universe of such malignancies remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor’s data do not demonstrate that the instant method prevents hematopoietic malignancies per se.
h) It would clearly require an extraordinary – and thus undue – amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant method is actually efficacious in the prevention of hematopoietic malignancies.
Markush Search
All claims have been examined with respect to formal matters.
The elected method and species have been searched and are not deemed free of the prior art.
All other elected, claimed but not yet examined subject matter is hereby withdrawn from consideration, for purposes of this Office Action, as being drawn to non-elected subject matter. This subject matter will be rejoined as appropriate as the Markush examination progresses.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 41, 43, 44 and 52-54, in so far as they read on the elected method and species, are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Cancer Cell (2009), 16, pp. 401-412.
The reference teaches the compound AP24534 (i.e. ponatinib) as a pan-BCR-ABL inhibitor useful in the treatment of chronic myeloid leukemia which inhibits the T315I mutant and overcomes mutation-based resistance (i.e. prevents relapse) (abstract).
With respect to instant claim 44, the T315I mutant of the cited prior art inhibits the effectiveness of first line ATP mimetic drug treatments (page 402, column 1, first full paragraph). That is, the subject having such a mutation has a high risk of hematopoietic malignancy relapse.
With respect to instant claim 52, the cited prior art appears to be silent with respect to the response phase, or the disease phase. That being the case, all phases are reasonably assumed to be intrinsically encompassed. Furthermore, as the cited prior art makes clear, most patients respond favorably to first line treatments (page 402, column 1, text line 3). That is, most patients can be successfully treated such that they enter a minimal disease phase of the hematopoietic malignancy. (Then a mutation such as T315I may arise which confers resistance.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 5/24/2026
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