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 .
Application Status
The claim set filed on 7/24/2023 is acknowledged. Claims 1-40 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 4/30/2025 has been considered except where lined through.
Claim Objections
Claim 33 is objected to because of the following informalities: Claim 33 recites the limitation “wherein the compound is selected from Table 1.” 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) (citations omitted). Appropriate correction is required.
Claim Interpretation
Claim 1 recites “A compound … having the structure of Formula (I0):
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wherein,
A is a ring selected from an optionally substituted carbocycle, optionally substituted 4-to 8- membered heterocycle, optionally substituted tetrahydro-triazolopyrazine and optionally substituted isoindoline; …
each R1 is independently selected from halogen, -CN… and optionally substituted heterocycle;
m is selected from 0 to 5;….”. Thus, while the definition allows for optional substitution of ring A, the examiner is interpreting the substitution to be defined by R1 and m being 0 to 5 R1.
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 1-40 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.
Regarding claim 1, Claim 1 recites “A compound … having the structure of Formula (I0):
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wherein,
A is a ring selected from an optionally substituted carbocycle, optionally substituted 4-to 8- membered heterocycle, optionally substituted tetrahydro-triazolopyrazine and optionally substituted isoindoline; …
each R1 is independently selected from halogen, -CN… and optionally substituted heterocycle;
m is selected from 0 to 5;….”. Thus, it is unclear whether the definition allows for optional substitution of ring A in addition to R1 or if R1 is the optionally substituted variable. In other words, if m is 0, can ring A still be substituted with something encompassed by R1 or something different such as a sulfonamide.
Moreover, claim 1 recites the limitations “… if A is an optionally substituted piperidine sulfonamide…” and “…wherein if A-R1 is
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….”. There is insufficient antecedent basis for this limitation in the claim since R1 is not defined as encompassing a sulfonamide.
Regarding claims 25 and 26, claims 25 and 26 depend from claim 1 and recites “…wherein the N containing heterocyclic ring depicted as
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in Formula (IA). However, claim 1 does not recite the Formula (IA). To overcome this rejection, it is suggested that applicants amend the claim to recite… “wherein Z0 is nitrogen having a formula
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formula (IA)….”
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 3 and 13 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. Both claims 3 and 13 recite formula’s and variables that were not recited in claim 1 and/or appear to broaden the scope of the compound of claim 1. For example, formula’s IA of claim 3 and IAA of claim 13 recite (R8)n or R9, wherein n is 0 to 9. First, it is unclear if R8 or R9 are R1 of claim 1 and further whether n is m of claim 1, with the understanding that claim 1 m is limited to 0 to 5. As such, n of claims 3 and 13 have added at least 4 more variables that were not present in claim 1. Similarly, it is unclear of whether R10, R11, R12, R13, R14, R15, R16 or R17 are R1 or p, q, or r are m of claim 1. If the R variables are supposed to correspond to claim 1 R1, the definition of R14 do not appear to be supported by R1. For formula IB of claim 3 and IBB of claim 13, R10 can be a substituted alkyl or a substituted heterocycloalkyl. However, the if statement in claim 1 contains the limitation that if A1 is a phenyl, m is 1-5, at least 1 R1 is a hetercycloalkyl. Accordingly, a substituted alkyl broadens the claims. 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.
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 1-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 19/025,976 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating cancer claimed in the reference application uses the same compounds claimed in the instant application as well as their method of use for treating cancer. .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Therefore, No claim is allowed.
Claims 1-40 appear to be free of the prior art. WO2018097297A1 to Teijin Pharma Ltd (2018-05-31) (IDS), US20190270742 to Yang et al. (2019-09-05) and US 11207321B2 to Martin et al. (2021-12-28) are considered to be the closest prior art. The instant claims differ from the compounds taught in the prior art by the “if” statements in claim 1 specifically limiting what R1 or R4 can be and/or the definition of R4. Please note: a heterocycloalkyl, in view of the specification, is a saturated heterocycle. Accordingly, the claimed compounds are not taught or suggested by the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626