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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/29/2026 has been entered.
Status of 17/416,876
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 5/29/2026 has been entered. Claims 1 and 20 have been amended. No claims have been cancelled and no claims have been added.
In the Final dated 3/10/2026, claim 20 was rejected under 35 U.S.C. 112(b) for containing compounds with a lack of antecedent basis. In response, Applicant has struck through some compounds of the claim, but has not struck through all compounds with a lack of antecedent basis. For example, the compound at the top of page 15 does not map to instant Formula IA or IB. The rejection is maintained and is updated to reflect the changes to the claims.
In the Final dated 3/10/2026, claims 1, 22, and 43 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2). In response, Applicant has amended instant claim 1 to recite that R2 of Y4 cannot be methyl when Y2 is CH, Y3 is N, Y5 is CH, and Y6 is N of Formula IA, which overcomes the rejection. Thus, the rejection is withdrawn.
Claims 1, 22, and 43 were rejected on the ground(s) of nonstatutory double patenting in the Final dated 3/10/2026. In response, Applicant has amended instant claim 1 as stated above, which overcomes the rejection. Thus, the rejection is withdrawn.
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 the art was overcome in the response filed 5/29/2026. Subsequent examination is based on 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 H, Y5 is N, and Y6 is CH. 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 overcome in the latest reply. 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.
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figure 1 describes in vivo efficacy studies of compounds JR5-26B and JR4-187. However, compounds JR5-26B and JR4-187 are not defined nor described elsewhere in the disclosure, specifically the structure or the names of the compounds. Thus, Figure 1 is not able to be interpreted. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to for minor grammatical informalities. Claim 1 recites variables, “Y2”, “Y3”, “Y4”, “R2”, “Y5”, and “Y6” in the new amendment. These variables are not superscripted in the new amendment, but are superscripted in the formulae above. Appropriate correction is required.
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.
Claims 1, 20, 22, and 24 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. There is insufficient antecedent basis for the limitations in the claim.
Claim 1 recites multiple instances of “may be” in reference to variable definitions. The term is indefinite because the phrase is exemplary language and it is not clear if the contents after the term are required, or just examples of what is required. Dependent claims 22 and 43 do not resolve this issue by claiming specific variables, and are therefore also rejected. Appropriate correction is required.
Claim 20 recites the compounds such as
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, and claim 20 is dependent from claim 1. Claim 1 recites Formulas IA and IB, which require a ring consisting of Y2-Y6 or a 5-membered heteroaryl, respectively, connected to the A-B linkage, which in this case is NH-C=O. There is no formula in claim 1 which allows for this compound, which creates a lack of antecedent basis for the above compounds. Appropriate correction is required.
Claim Rejections – Improper Markush
Claims 1, 22, and 43 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
With respect to claim 1, the Markush groupings of Formula IA and IB are improper because the alternatives defined by the Markush groupings do not share both a single structural similarity and a common use for the following reasons: The Markush groups X1-X7, Y2-Y6, A, B, and Z of Formulas IA and IB contains variables that can be independently selected from various atoms and substituents, and in the case of Y6, can even be a bond. From this definition, the formulae may contain varying ring sizes with varying carbon and heteroatoms, and substituted atoms, and therefore share no common core. A skilled artisan would recognize the variation in ring size and atom selection can lead to variations in biological and chemical properties such as bond angles and binding pose of the substrate in the target. They do not belong to the same recognized physical or chemical class or to the same art-recognized class.
The instant specification discloses genes in MIA PaCa-2 cells that are upregulated or downregulated after contact with JR-1-235 and JR-1-272, and further discloses compounds JR-1-235, JR-1-157, JR-1-242, JR-3-6, and JR-2-298 against various cancer cell lines (pages 105-107). The above compounds all contain a quinoline substituted with an amide in the 8-position, and are connected to a pyrazine in the 2-position with a para-substituent. The scope of the compounds biologically evaluated compared to the instant claims is small; no other data supporting varying ring sizes or atom substitution of the common core is disclosed and therefore no structure-function relationship between the varying ring sizes or atom substitution is corroborated. In this case, the claims are so expansive that a common utility cannot be expected. Dependent claims 20 and 43 do not resolve the issue and are therefore also rejected.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 QN107 (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 H, 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.
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
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