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 06/28/2023 and is a 371 of PCT/KR2021/020165 (12/29/2021) which claims foreign priority to Korea 10-2020-0186082 (12/29/2020). Claims 1-20 have been canceled per paper dated 10/17/2023. Claims 21-39 are before the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. CLAIM 21 definition of R1 and R2 may each independently be….. or the R1and R2 may be linked… . All of the other definitions are defined as “are each” or “is”. This makes the meets and bounds of R1 and R2 ambiguous. It is suggested that the claim be amended to read ‘R1 and R2 are each independently…..or the R1 and R2 are linked to each other to form…’.
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 28-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification, does not reasonably provide enablement for preventing diseases. 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 any of these diseases. 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) There is no guidance as to the difference between prevention and treatment of EGFR related diseases/cancer. 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 § 103
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 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.
Claims 21-28, 31-34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 9428508 Xiao. Xiao teaches a generic formula (I) which fully encompasses the instant claims for the treatment of cancer. One specific compound is
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that fits within the instant chemical formula 1 of claim 1. X1 and X4 are N, X2 and X3 are C. Y1-Y4 are C, R1and R2 are methyl.
Z1-5 are C with Rf= O-R5 which is OMethyl. A second Rf being heterocycloalkl which is substituted. This compound 163 is also the last compound claimed in Xiao’s claim 1 with claim 2 being a pharmaceutical composition (salt, solvate or tautomer) and claim 3 being drawn to treatment of cancer. Isomers of the formula (I) are listed in paragraph 18 and column 12 of Xiao. Lung cancer is specified in the specification column 18. The difference between the prior art Xiao and the instant invention is that the prior art works on FAK/PYK2 inhibition while the instant invention works on EGFR inhibition and that while the Markush taught by Xiao partially encompasses the instant Markush, there are no commonly made compounds by both inventors. The closest prior art compound is #163. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to make another compound within the scope taught by Xiao in formula (I) and compound #163 with the reasonable expectation of getting a compound able to treat cancer. Xiao teaches a Markush of compounds that inhibit FAK/PYK2 and by that activity treat cancers. The specific compound 163 fits within the instantly claimed Markush. Both inventions treat cancer. The use of a prior art compound or another within its Markush to treat the same conditions as previously taught is within the skill of the ordinary artisan.
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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/D MARGARET M SEAMAN/ Primary Examiner, Art Unit 1625