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 .
Election/Restrictions
In view of claim amendments, the election of species set forth in the Restriction/Election filed 07/30/2025 is withdrawn. Therefore, the full scope of claims 1-2, 4-6, and 17-19 is under examination herein. Claims 7, 13-16, and 21 stand withdrawn from consideration as being drawn to a nonelected invention, there being no allowable linking claim.
Status of the Claims
Claims 1-2, 4-7, 13-19, and 21 are pending in this application. Claims 3, 8-12, and 20 have been cancelled by applicant. Claims 7, 13-16, and 21 are withdrawn from consideration. Claims 1-2, 4-6, and 17-19 are under examination herein.
Claim Objections
Claims 1-2 and 5 are objected to because of the following informalities resulting from claim amendments:
In claims 1-2, “cycloexyl” should read “cyclohexyl” in definition of R5.
In claim 5, “alcoky” should be “alkoxy”.
Appropriate correction is required.
Examiner Notes
The compounds of claim 6 are free of the prior art, however, claim 6 stands rejected over formal matters.
While claims 13 and 16 are not under consideration herein, for the purposes of compact prosecution, Examiner would like to point out that language like “preferably” and “such as”, renders the claims indefinite. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 is rejected for failing to further limit claim 1 from which it depends. Claim 1 limits R5 to “straight or branched (C1-C6) alkyl optionally substituted by phenyl…”; however, claim 4 expands this limitation to encompass “optionally substituted straight or branched (C1-C6) alkyl”, which may be substituted with anything, not just phenyl.
Also, in claim 4, amended claim 1 says “…or taken together with R6 may form an optionally substituted cyclohexyl”; however, claim 4 broadens this limitation by stating: “…or taken together with R6 may form an optionally substituted 4- to 7-membered cycloalkyl”.
Claim 5 is rejected for depending upon the limitations of claim 4, and also because it is broader that claim 1, which defines R1 as phenyl, tetrahydropyran, pyrazole, and pyridyl; however, claim 5 states R1 may be phenyl or indolyl.
Claim 6 is rejected for failing to further limit claim 1 from which it depends. Claim 1 has been amended to limit R1 to phenyl, tetrahydropyran, pyrazole, and pyridyl; however, claim 6 claims compounds 59 and 93, wherein the group corresponding to R1 is indole.
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Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 4-5, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Venkatesan et al. (US 10,471,051 B2 – Pub. Date: Nov. 12, 2019) (“Venkatesan”).
Regarding claim 1-2 and 4-5, Venkatesan discloses their compounds of Formula I below as ERK1/2 inhibitors for the treatment of cancers (abstract and col. 3-4) – which is the same intended use as the compounds of the instant invention. Venkatesan’s compounds render the instant compounds obvious when: M is a bond; Z is N; X and Y are N or C; R5 is H; R4 (corresponding to instant R1) is phenyl or tetrahydropyran (see preferred embodiments in col. 4); R6 (corresponding to instant R2) is H; R3 (corresponding to instant R3) is H; and…
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Venkatesan discloses the preferred embodiments 225, 248, 279, 328, and 254 below (col. 245, 255, 289, and 257). Embodiments 225, 248, and 254 render the instant compounds obvious when instant X is N, R7-8 are H, R1 is tetrahydropyranyl or phenyl, and R5 is phenyl. The preferred embodiments 279 and 328 below read on the instant compounds when R1 is tetrahydropyranyl; R3 is H; and R4 is alkyl substituted with a heteroaryl.
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(225)
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(248)
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(254)
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(279)
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(328)
While these embodiments show a methyl group in the position corresponding to Venkatesan’s R5, Venkatesan teaches this group can be H, as in the instant compounds. Applicant is also advised that H vs. Me is considered an obvious modification in the absence of superior, unexpected results. Note In re Wood 199 USPQ 137; In re Lohr 187 USPQ 548 and In re Bowers 149 USPQ 573. Note also In re Fauque 121 USPQ 425 in which differences were 2H’s vs 2 methyl groups. Also see MPEP 2144.09.
Furthermore, while the preferred embodiments above do not show pyrazole as the 5-membered heteroaryl group in the core of the compounds, Venkatesan teaches their X can be N and Y can be C, resulting in a pyrazole. While the connectivity of these pyrazoles would be different, Applicant is advised that the courts have found 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. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). 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. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Thus, Venkatesan discloses a relatively broad genus, which encompasses the instant subgenus.
Therefore, regarding claims 1-2 and 4-5, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Venkatesan’s disclosed formula; 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 anticancer compounds disclosed by Venkatesan. 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.
Further regarding claim 5, Venkatesan teaches their compound 254 above, which corresponds to R1 being phenyl substituted with alkoxy.
Regarding claim 17, Venkatesan discloses pharmaceutical compositions comprising their compounds of Formula I with other pharmaceutically inactive ingredients (such as carriers – see col. 45-46).
Regarding claim 18, Venkatesan discloses their pharmaceutical compositions may contain other medications or therapeutic agents (col.48, lines 10-16).
Regarding claim 19, Venkatesan discloses kits comprising their compounds in single formulations or in combination formulations (reading on sequential or simultaneous administration when formulations contain single ingredient or combination therapies, respectively) (col. 48, lines 17-21).
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 1-2, 4-5, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 9,284,298 B2 (US ‘298). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-2, 4-5, and 17-19, US ‘298 claims the compounds of Formula I below, which render the instant compounds obvious when: X is N-H; R1 is aryl or heterocycle; R4 is H; R2 is H or alkyl; and R3 is -CONR’’R’’’, wherein R’’ and R’’’ (corresponding to instant R3 and R4) can be H, optionally substituted alkyl, etc. (US ‘298 claims 1-2). Thus, US ‘298 claims a broad genus, which encompasses the instant subgenus of compounds.
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘298’s disclosed formula I. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘298. 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 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.
Further regarding instant claims 17-19, US ‘298 claims a pharmaceutical composition comprising their compounds of Formula I and an acceptable carrier or an additional therapeutic agent (US ‘298’s claims 8-9).
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been introduced.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 21, filed 02/06/2026, with respect to 35 USC § 112(b) rejections have been fully considered and are persuasive. The 35 USC § 112(b) rejection of the claims has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see page 21-24, filed 02/06/2026, with respect to 35 USC § 103 rejections have been fully considered and are persuasive. The 35 USC § 103 rejection of the claims has been withdrawn. However, upon further consideration in light of claim amendments, a new ground(s) of rejection is made in view of Venkatesan.
Double Patenting
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive.
Applicant argues that claim amendments obviate the double patenting rejection over US ‘298. However, this is not the case. As outlined in this office action, compounds claimed are still obvious in view of US ‘298.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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