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 .
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 9-10 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.
Regarding claim 9, the phrase "A formic salt" renders the claim indefinite because it is unclear if applicant is intending the formic acid salt to be a pharmaceutically acceptable salt or as a preparation step or embodiment of the structure. Ultimately, the metes and bounds of the claim is unclear.
Regarding claim 10, the phrase "Table 1" renders the claim indefinite because it is unclear what is the scope of Table 1. The compounds of Table 1 are not recited in the claims, therefore is rendered indefinite as to MPEP 2173.05(s): Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claim Rejections - 35 USC § 103
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 1-8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Judd et al. (WO 2020191151 A1).
Regarding claims 1-8 and 11-12, Judd teaches a pharmaceutical composition comprising Formula III
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or the pharmaceutically acceptable salt (para. 027) in combination with one or more additional pharmaceutically active agents (relevant to claim 12) (para. 073) and a pharmaceutically acceptable excipient (relevant to claim 11) (para. 069). Of the above compound Judd teaches the embodiments of E as
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or
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R1-R4, R6-R7 and R13-R19 on para. 027. Of the embodiments R1-R4, R6-R7, R13 and R15-R19 as H and R14 as OR14a wherein 14a is a substituted or unsubstituted aryl is embodied in compound
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and
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(relevant to claims 1-6) (Table 1). Of other embodiments Judd teaches compound
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(Table 1). Of aryl substituents Judd teaches substituents of a halogen, CN and fluoro(C1 -C4)alkyl (relevant to claims 7-8).
Therefore, it would have been obvious to produce a compound of
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from the teachings of Judd. One would have been motivated to do so from the above compound of
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wherein the substituent is on R15 and R14 as H. Judd teaches R15 as OR15a wherein 15a is a substituted or unsubstituted aryl. There is a reasonable expectation of developing structure
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from the teachings of Judd.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-12, 21, 24-25 and 27-33 of copending Application No. 19/278,896 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 6-12, 21, 24-25 and 27-33 of copending ‘896 teaches compound
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with overlapping limitations as claimed invention in combination with another therapeutic agent to treat a disease or condition mediated by YAP/TEAD.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-10, 18, 21-22 and 24-30 of copending Application No. 19/278,895 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 7-10, 18, 21-22 and 24-30 of copending ‘895 teaches compound
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with overlapping limitations as claimed invention in combination with another therapeutic agent to treat a disease or condition mediated by YAP/TEAD.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-12, 20-21, 24-25 and 27-33 of copending Application No. 19/278,892 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 9-12, 20-21, 24-25 and 27-33 of copending ‘892 teaches compound
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with overlapping limitations as claimed invention in combination with another therapeutic agent to treat a disease or condition mediated by YAP/TEAD.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-10, 23 and 27-33 of copending Application No. 18/785,056 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 7-10, 23 and 27-33 of copending ‘056 teaches compound
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with overlapping limitations as claimed invention in combination with another therapeutic agent to treat a disease or condition mediated by YAP/TEAD.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627