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 preliminary amendment filed on 4/11/2025 is acknowledged. Claims 1-32 are currently pending and under consideration.
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 1-32 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 claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 4 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 4 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 4 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 4 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 4, 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 1-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of copending Application No. 18357320 (reference application) in view of Luo et al. (Cancer Letters 2019, 454, 191-203).
The reference application claims compounds encompassed by the instantly claimed compound of Formula (10), as well as, method of treating cancer comprising administering said compounds.
The reference application does not specifically claim a method of treating cancer comprising administering a compound of formula (10) in combination with another therapeutic agent.
Luo et al. teaches reviews the emerging strategies in cancer therapy combining chemotherapy with immunotherapy (title). Specifically, Luo et al. teach a number of clinical trials using antibodies such as Nivolumab, Pembrolizumab and Atezolizumab in combination with numerous known chemotherapeutic agents such as, Doxorubicin, Docetaxel, Carboplatin and Etoposide for treating a variety of cancer (see page 193, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed in the reference application to include any known chemotherapy or immunotherapy in view of the teachings of Luo et al. . One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
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 1-32 appear to be free of the prior art. WO2018097297A1 to Teijin Pharma Ltd (2018-05-31), 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