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 .
DETAILED ACTION
Status of Claims
Claims 1, 20, 22-35, and 43 are currently pending.
Priority
Instant application 17/416,876, filed 6/21/2021, claims priority as follows:
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The effective filing date of a claimed invention is determined on a claim-by-claim basis. See MPEP § 2152.01. The priority document US Provisional Application number 62/782,852 fails to provide support under 35 U.S.C. 112 for Formula IB, where X1 is a variable position. Therefore, claims 1, 20, 22, and 43 which contain limitations drawn to this feature, are not entitled to an effective filing date of 12/20/2018.
The priority document PCT/US2019/067879 contains support for the limitations of claim 1. Therefore, claims 1, 20, 22, and 43 are entitled to an effective filing date of 12/20/2019.
Response to Arguments/Amendments
The amendment filed 11/10/2025 has been entered. Claim 6 has been cancelled. Claims 1 and 20 have been amended.
Claim 20 was objected to for a minor informality in the Non-Final dated 7/9/2025. Upon amendment to claim 20, the objection has been overcome and withdrawn.
In the Non-Final dated 7/9/2025, claims 6 and 20 were rejected under 35 U.S.C. 112(b). In response, Applicant cancelled claim 6 to overcome and withdraw the rejection of claim 6. However, Applicant did not address the lack of antecedent basis rejection of claim 20. Thus, that rejection is maintained. The Examiner notes the lack of antecedent basis rejection has been expanded because claim 20 also recites compounds where X6 is CR1, where R1 is halogen, which is no longer allowed by independent claim 1.
In the Non-Final dated 7/9/2025, claim 6 was rejected under 35 U.S.C. 112(a). In response, Applicant cancelled claim 6 to overcome the rejection. Thus, the rejection is withdrawn.
Claims 1, 6, 22, and 43 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) in the Non-Final dated 7/9/2025. In response, Applicant has cancelled claim 6 and amended claim 1 to overcome and withdraw the rejection.
In the Non-Final dated 7/9/2025, claims 1, 6, 20, 22, and 43 were rejected on the grounds of nonstatutory double patenting. In response, Applicant has cancelled claim 6 and amended claim 1 to overcome and withdraw the rejection.
However, Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 5, 6, 20, 22, and 43), in the reply filed on 7/12/2024 is acknowledged.
Applicant’s elected compound J82:
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(See page 25 of the Specification) is also acknowledged.
Examination will begin on the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no applicable prior art was identified. In the Non-Final dated 11/15/2024, the Examiner expanded her search to compounds of Formula XIV:
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Where R1 is H. After the amendment to claim 1 to recite the limitation of “wherein within Formula IA, if Y2 is N, Y5 is N, Y3 is CH, Y6 is CH, A is NH, and B is C=O, then X2, X2, X3, X4, X5, X6, and X7 cannot all be CH”, which in turn does not allow R1 to be H in Formula XIV, but solely allows R1 to be Me or halogen, the search was expanded to additional compounds of Formula XIV and additional art has been identified. In response, Applicant has amended the claims to cancel claim 6, which recited Formula XIV, and amend claim 1 to recite, “wherein within Formula IA, if X6 is CR1, then R1 at the X6 position cannot be halogen”. Thus, the search was expanded to compounds of Formula IA where X2, X3, X4, X5, and X7 are CR1, where R1 is H, X6 is CR1, where R1 is C1 alkoxy, A is NH, B is C=O, Y2 is N, Y3 is CH, Y4 is CR2, where R2 is C1 alkyl, Y5 is N, and Y6 is CH, and prior art was identified. See the 102 rejection and double patenting rejection below. Examination has been limited to the expanded species, with claims drawn to species patentably distinct from the expanded species held withdrawn from further consideration. The search has not been extended unnecessarily to cover all nonelected species. Claims 1, 22, and 43 read on the expanded species. Claim 20 remains under examination because of 112(b) rejection that was not addressed in the latest reply, and the additional 112(b) identified after amendment. Claims 23-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 112(b)
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 20 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. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the compounds
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and
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, and claim 20 is dependent from claim 1. Claim 1 recites Formula IA, which requires a heteroatom in the fused bicycle moiety linked to a 6-membered ring, and Formula IB, which allows for an all-carbon or heteroatom in the fused bicycle moiety connected to a 5-membered ring. There is no formula in claim 1 which allows for a naphthalene connected to 6-membered ring, which creates a lack of antecedent basis for the above compounds. Appropriate correction is required.
NEW REJECTIONS NECESSITATED BY AMENDMENT
Claim Rejections - 35 USC § 112(b)
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 20 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 20 recites multiple compounds of Formula IA where X6 is CR1 and R1 is halogen, which is no longer allowed by independent claim 1. Thus, a lack of antecedent basis exists. This includes the elected species above. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 22, and 43 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by The Regents of the University of Michigan (WO 2016/187544, herein after “Michigan”). Though the prior art reference contains overlapping inventors and applicant with the instant disclosure, the document was published more than a year before the effective filing date of the instant application and therefore qualifies as prior art. This rejection applies to the expanded species.
The reference Michigan discloses small molecules with a quinoline-8-yl-nicotinamide structure for treating, ameliorating, or preventing various forms of cancer (abstract). Specifically, Michigan discloses the compound QN663 (page 57, Table 1):
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Which anticipates a compound of Formula IA:
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when X2, X3, X4, X5, and X7 are CR1, where R1 is H, X6 is CR1, where R1 is C1 alkoxy, A is NH, B is C=O, Y2 is N, Y3 is CH, Y4 is CR2, where R2 is C1 alkyl, Y5 is N, and Y6 is CH.
With respect to claim 22, Michigan discloses compounds dissolved in DMSO at 10 mM, indicating a pharmaceutical composition (page 77, lines 1-2).
With respect to claim 43, Michigan discloses a kit comprising a compound and instructions for administering the compound to patient an animal (page 12, lines 22-24) and further delineates instructions for administering a compound to a patient having a hyperproliferative disease (claim 20). Thus, Michigan anticipates claims 1, 22, and 43.
The Examiner notes that when the search is expanded to additional compounds of instant Formula (I), the argument can furthermore be expanded additional compounds disclosed by Michigan, and to a genus-wide obviousness argument per MPEP § 2144.08.
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, 22, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,457,662 (herein after the ‘662 Patent). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘662 Patent recites the following compound:
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,
Whereas claims 2 and 3 recite the pharmaceutical composition thereof and kits comprising said compound, respectively.
Similar to above, the Examiner notes that when the search is expanded to additional compounds of instant Formula (I), the argument can furthermore be expanded to additional compounds disclosed in claim 1 of the ‘662 Patent.
Conclusion
Claims 1, 20, 22, and 43 are rejected. Claims 23-42 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621