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 the Claims
Claims 1, 12, 16, 18, 21, 23, 34-36, 38, 43, and 46 are pending in this application. Claims 2-11, 13-15, 17, 19-20, 22, 24-33, 37, 39-42 and 44-45 have been cancelled by Applicant.
Specification
The title of the invention is still not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “Benzodiazol‐2‐one and Imidazo[4,5‐b]pyrazin‐2‐one Compounds as Inhibitors of YAP/TAZ and TEAD Protein-Protein Interactions for the Treatment of Cancers”
Claim Objections
In claim 34, the structure
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is no longer referenced in the instant Formula II-1 and should be deleted.
Appropriate correction is required.
Examiner Notes
Applicant is advised that removal of embodiments wherein R2 is cyclopropyl (a C3 cycloalkyl) in instant claim 1 would suffice to overcome prior art rejections of record and move case to allowance.
See response to arguments section regarding provisional NSDP rejections of record.
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, 12, 16, 18, 21, 23, 34-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (US 2018/0222904 A1 – previously cited) (“Liao”).
Applicant is advised that a recitation of the intended use of the claimed invention, such as “wherein the compound inhibits protein protein interaction of YAP/TAZ and TEAD” in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. Furthermore, products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 1, 12, 16, 21, and 36, Liao discloses the Btk inhibitor compounds of Formula I (Liao’s claim 1) in methods of treating cancers – which is the same intended use of the instant compounds (see Liao’s claims 10-12) – wherein A and D are N or CR1, wherein R1 (corresponding to instant R1) can be H, etc.; C and B can be CH; R2 (corresponding to instant ring E-(R2)m) can be one of
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, wherein X can be a bond and E, can be H, a saturated carbocycle, etc.; and R3 (corresponding to instant ring D-R4) can be
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, or
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wherein Y can be -C(O)-; and R6-8 can be H, etc. (Liao’s claim 3).
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(278)
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(250)
Liao specifically discloses their preferred embodiments 250 and 278 (page 173) above, which reads on the instant claims when instant R2 is H and C3 cycloalkyl (while preferred embodiment 278 has a phenyl corresponding to instant ring D, compound 250 has a 5-membered heterocycle); ring E is phenyl; R3 is H; R4 is
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, wherein R5-7 are H and L3 corresponds to a bond (as in 250). While Liao’s preferred embodiments do not show their group corresponding to instant B2 as a CH, Liao discloses their group B (corresponding to instant B2) can be CH or N.
Therefore, regarding claim 1, 12, 16, 21, and 36, particularly regarding embodiments wherein the group corresponding to instant R2 are cyclopropyl (as described above), one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Liao’s disclosed formula and preferred embodiments; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds Btk inhibitors for the treatment of cancers (see abstract) disclosed by Liao. Accordingly, one having ordinary skill in the art would have been motivated to prepare the instantly claimed compounds, as outlined above.
Regarding claim 18, Liao discloses their group corresponding to instant ring D can be a heterocycle (see Liao’s claims 3-4).
Regarding claim 23, as mentioned above, Liao’s preferred embodiment reads on the instant claim when L3 is -CH2-NH-, given how compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Regarding claim 34, Liao’s compound reads on the instant claim when the instant core is
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.
Regarding claim 35, Liao discloses their group corresponding to instant ring D can be
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.
Regarding claim 38, Liao claims pharmaceutical compositions comprising their compounds and an excipient (Liao’s claim 11).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (US 2018/0222904 A1 – previously cited) (“Liao”); as applied to claims 1, 12, 16, 18, 21, 23, 34-36, and 38; in view of Chen et al. (US 2019/0144451 A1 – previously cited) (“Chen”).
The teachings of Liao are disclosed above and incorporated herein.
While Liao does not teach the specific cancers listed in the instant claim; the teachings of Chen are relied upon for these disclosures.
Chen discloses their related Btk inhibitor compounds in methods for the treatment of cancers like pancreatic cancer [0064], leukemia [0193], etc.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Liao’s Btk inhibitors for the treatment of pancreatic cancer, for example, in view of Chen. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Liao teaches their compounds as Btk inhibitors for the treatment of cancers, and discloses pharmaceutical compositions thereof; further because Chen discloses their related Btk inhibitors in methods for the treatment of pancreatic and other cancers.
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, 12, 16, 18, 21, 23, 34-36, 38, 43, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 and 30-36 of copending Application No. 18/839,000 (Copending ‘000).
Regarding claims 1, 12, 16, 18, 21, 23, 34-36, 38, 43, and 46, Copending ‘000 claims a pharmaceutical composition comprising the compounds of Formula I below, which anticipates the instant compounds:
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Claim 46 is rejected for claiming the compound above: 1-(1-(2-fluoroacryloyl)azetidin-3-yl)-3-(4-(trifluoromethyl)phenyl)-1,3-dihydro-2H-imidazo[4,5-b]pyrazin-2-one (compound 229).
Regarding claim 38, Copending ‘000 speaks to a pharmaceutical composition comprising their compounds and acceptable carriers (Copending ‘000 claims 1-8).
Regarding claim 43, Copending ‘000 speaks to a method of treating cancers like lung, prostate, rectal, and colon cancers etc. (Copending ‘000 claims 14-15).
Applicant is reminded that one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Copending ‘000. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the instant claims.
Furthermore, applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Specification
Amendments to the specification are acknowledged and have been entered. No new matter has been introduced.
Objections to the title of the disclosure are maintained, and a new title is suggested herein.
Drawings
Objections to the drawings are withdrawn. The drawings of 07/13/2026 are accepted.
Claim Rejections - 35 USC § 112(a)
In view of claim amendments, the 35 USC § 112(a) rejections of record have been withdrawn.
Claim Rejections - 35 USC § 102
In view of claim amendments, the 35 USC § 102 rejections of record have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 07/13/2026 have been fully considered but they are not persuasive. While rejections in view of Chen have been withdrawn, a new ground of rejections is presented herein over Liao in view of Chen, necessitated by claim amendments.
Applicant argues Liao fails to teach or suggest the specific core structure of the instant claims, wherein B1-4 are each C or CH; or B1, 4 are C or CH and B2, 3 are N or NH.
This is not persuasive. As outlined in the rejections presented herein, Liao specifically discloses their preferred embodiments 278 and 250 above, which read on the instant claims when instant R2 is H or C3 cycloalkyl; ring D is phenyl; ring E is phenyl; R3 is H; R4 is
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, wherein R5-7 are H and L3 corresponds to a bond. While Liao’s preferred embodiments do not show their group corresponding to instant B2 as a CH, Liao discloses their group B (corresponding to instant B2) can be CH or N.
Therefore, particularly regarding embodiments wherein the group corresponding to instant R2 are cyclopropyl (as described above), one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Liao’s disclosed formula and preferred embodiments. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds Btk inhibitors for the treatment of cancers (see abstract) disclosed by Liao. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is advised, that only embodiments wherein instant R2 is cyclopropyl are obvious. Removal of these embodiments from the scope of claim 1 should be enough to overcome the rejection of record.
It is noted, the courts have stated “[A] prior art reference must be considered in its entirety, i.e., as a whole” W.L. Gore& Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983) (see MPEP 2141.02 VI). Thus, while the rejections listed above present a modified interpretation of the teachings of the previously cited prior solely for the purpose of clarity, the claims remain rejected over the prior art of record.
Double Patenting
While applicant failed to acknowledge the provisional non-statutory double patenting rejections of record, claims stand rejected over Copending App. No. 18/839,000 (Copending ‘000). Applicant is advised, MPEP § 804(1)(B)(1)(b)(i) states, if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
Since the instant application has an earlier patent term date compared to Copending ‘000; once all other standing rejections are overcome, this provisional NSDP rejection will be withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
Examiner interviews are available via telephone 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 L. 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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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights