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 .
Priority
This application was filed 11/15/2023 and is a 371 of PCT/US2021/033024 (05/18/2021) which has a PRO 63/027209 (05/19/2020). Claims 1, 4-9, 11-13, 16, 19-20, 26-28, 32-33, 36 and 56 are before the Examiner.
Election/Restrictions
Applicant's election without traverse of INCB054329 in the reply filed on 05/20/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 12-13, 16 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/20/2026.
Claims 1, 49, 11, 19, 26-28, 32, 33, 36 and 56 will be examined to the extent that they read upon the elected species.
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, 4-9, 11, 19, 26-28 and 32-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, does not reasonably provide enablement for preventing pancreatitis or preventing pancreatic cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Applicants are not enabled for preventing pancreatitis or pancreatic cancer. The only established prophylactics are vaccines not the compounds such as presently claimed. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit the symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. “The factors to be considered [in making an enablement rejection] have been summarized as a) the quantity of experimentation necessary, b) the amount of direction or guidance presented, c) the presence or absence of working examples, d) the nature of the invention, e) the state of the prior art, f) the relative skill of those in that art, g) the predictability or unpredictability of the art, h) and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. a) As discussed above, preventing diseases required identifying those patients who will acquire the disease before the disease occurs. This would require extensive and potentially open-ended clinical research on healthy subjects. B) The claim 1 lists pancreatitis and pancreatic cancer as the diseases applicant intends to prevent. C) There are no working examples of such preventive procedure in a man or animal in the specification. D) The claims rejected are drawn to the medical prevention and are therefore physiological in nature. E) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted with disease before the fact. F) The artisan using Applicant’s invention would be a board-certified physician who specializes in treating diseases. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of diseases generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of the practitioners in that art, Genetech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent diseases generally. That is, the skill is so low that no compound effective generally against diseases has ever been found let alone one that can prevent such conditions. G) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved”, and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 214 (CCPA 1970). H) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by formula (I).
The Examiner suggests deletion of the word “prevention”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-9, 11, 19, 20, 26-28, 32-33, 36 and 56 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by USPGPub 20210220471 Alonso. Alonso teaches the compound INCB054329 (claim 1 and 11) in claim 4 as a BRD4 inhibitor (claims 7-9) as well as in paragraph 7. Paragraph 8 teaches acute pancreatitis (instant claim 6). Paragraph 0127 teaches several different administration pathways including orally (claim 33) in a human (claim 26). Paragraphs 134-136 as well as claim 13 teach of a second active ingredient (claim 27-28). The instant claim 36 and 56 are taught by the Alonso claim 32 as having a composition for treatment in a kit for treating pancreatic cancer. Fig 6B shows ADM, Kras and Brd4 activity. This anticipates the instant claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/ Primary Examiner, Art Unit 1625
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