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 .
Status of claims
Pending claims 1-12 and 17-21 have been examined on the merits.
Claim Objections
Claims 1-10 recite a list of chemical structures without appropriate commas between the items. For clarity and proper interpretation, commas should be inserted to separate each element in the list (e.g., “A, B, and C”). Applicant is required to correct the claims by inserting commas between each item in the list.
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 17-19 and 21 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 17-19 and 21 recite administering “an effective amount” of the claimed compound or pharmaceutical composition. However, the claims and specification do not identify the amount or dosage constituting an “an effective amount,” nor do they specify the objective therapeutic result that must be achieved for an administered amount to qualify as “effective.” Therefore, a person of ordinary skill in the art (POSITA) would not be able to envisage which amount falls within the scope of “an effective amount” or what level of therapeutic effect is required for the amount to be considered effective. This further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
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.
Claims 1-8 are 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.
Claims 1-8 recite the phrase “may be” such as “V may be a 7-membered or 8 membered. Therefore, the phrase “may be” creates confusion and ambiguity whether the recited feature is a required or optional limitation of the claim. Therefore, a person of ordinary skill in the art (POSITA) would not be able to determine with reasonable certainty the scope of the claim, which renders the claim indefinite.
Subject Matter Free of the Art of Record
The subject matter of claims 1-12 and 17-21 is free of the art of record. The closest prior art reference is Bond et al., ACS Cent Sci. 2020 Aug 26;6(8):1367-1375 and Ling et al. WO 2021/207172 A1. While Bond and Ling teach the comparable concept vis-a-vis the instant claims, including developing compounds that act as KRAS G12 inhibitors/degraders to treat cancers including pancreatic cancer, the claimed compounds require substantially different substitution patterns at location “X-R4” than what is disclosed or fairly suggested by Bond and Ling. There is no motivation for a person of ordinary skill in the art (POSITA) to modify the teachings of Ling and Bond to arrive at the claimed compounds. These claims are not allowable until the objection and § 112 rejection are overcome.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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