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 .
FINAL ACTION
Priority
Instant application 17/789,047 filed on 06/24/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1, 34, 42, 46, 49, 50, 51, 52, 54 are pending.
Response to Arguments/Amendments
The amendment filled on 02/17/2026 has been entered.
Applicant cancelled claims 2, 3, 37-39, 41, 43-45, 48 and 53.
Applicant amended claims 1, 34, 42, 50, 51, 52 and 54.
Regarding 102 rejection, Applicant’s arguments and Applicant’s amendment has overcome the rejection. Kwiatkowski teaches anti-PD1 antibody can be combined with CDK7 inhibitors, however, Kwiatkowski does not teach anti-PD1 antibody combined with the instant CDK7 inhibitors in one single embodiment. Therefore, the 102 rejection is withdrawn.
However, based on the teachings of Kwiatkowski it would have been obvious to combine an anti-PD1 antibody with the CDK7 inhibitors disclosed by Kwiatkowski.
Regarding 103 rejection, Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Applicant submitted that the combined teaching of Kwiatkowski and Garris “would in no way motivate the skilled person to arrive at the presently claimed invention”. Further, Applicant submitted that “The present invention is directed to combinations of CDK7 inhibitors and anti-PD-1 antibodies. Garris reports studies directed to understanding the mechanism by which anti-PD-1 antibodies function in vivo. These studies demonstrated that CD40 agonism or cIAP inhibition enhance anti-PD-1-mediated tumor control (Garris, page 1158, second column, last full paragraph, last sentence) but is silent with respect to combinations including CDK7 inhibitors. Considering Garris as a whole, the skilled person would be motivated to combine anti-PD-1 antibodies with CD40 agonists or cIAP inhibitors in the treatment of certain cancers but would in no way be motivated to combine an anti-PD-1 antibody with a CDK7 inhibitor. As Garris in combination with Kwiatkowski provides no motivation to combine an anti-PD-1 antibody with a CDK7 inhibitor, the rejection is improper.”
Applicant's arguments have been fully considered but they are not persuasive because Kwiatkowski teaches combination therapies including the compounds of Formula (I), and immunotherapies therapies. The Garris reference is only used for the specific immunotherapy, clone 29F.1.A12.
Regarding CDK7 inhibitors, it should be noted that Kwiatkowski teaches the same compounds as recited in instant claims. Kwiatkowski teaches the instant elected species (page 152, Table 3, compound 214):
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Further, it should be noted that instant claim 1 allows for a combination with any anti-PD-1 antibody and instant claim 42 limits the anti-PD-1 antibody to: nivolumab, pembrolizumab, atezolizumab, tislelizumab, durvalumab, avelumab, or cemiplimab.
Kwiatkowski teaches e.g. pembrolizumab (see page 127, second line):
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It is examiner position that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by Kwiatkowski for treatment of SLCL. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab) with a different anti-PD1 antibody.
In addition, it should be noted that “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” In the instant case, as pointed by Applicants, the pending claims recite a combination of a subset of CDK7 inhibitors disclosed by Kwiatkowski in combination with anti-PD-1 antibodies, optionally in combination with cisplatin and/or etoposide. Pembrolizumab, an anti-PD-1 antibody, cisplatin, and etoposide are among the over 280 possible agents listed by Kwiatkowski. As such, it would be obvious to select the claimed anti-PD-1 antibody from the list disclosed by Kwiatkowski, arriving at the presently claimed method with a reasonable expectation of success.
Therefore, the 103 rejection is maintained.
However, if applicable, Applicant is encouraged to discuss unexpected results for the combination of instant CDK7 inhibitors with the specific anti-PD1 antibody disclosed by Garris.
Regarding Nonstatutory Double Patenting over U.S. Application 17/628794 in view of Kwiatkowski and Garris, Applicant's arguments that the claims of the present invention have been amended to encompass only CDK7 inhibitors of Formula IV-b, which excludes compound (I-1) have been fully considered but they are not persuasive because Kwiatkowski teaches compounds of Formula (I):
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wherein
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Further, the compounds recited in claims of Application 17/628794 and the instant compounds differ only in one position. The compound recited in claim of 17/628794 bear methyl substituent attached to a nitrogen atom of the pyrazole moiety whereas the instant compounds of formula IV-b require hydrogen atom at the corresponding position. It would have been prima facie obvious to one of ordinary skill in the art to select compound I-1 recited in claims of 17/628794 and substituting the methyl on the nitrogen atom of the pyrazole ring with a hydrogen atom. The motivation to make such substitution is because not only Kwiatkowski teaches hydrogen and methyl are interchangeable at that position, but also because Kwiatkowski teaches compound 214 that contains a hydrogen atom at that position. One would reasonably expect the modified compound to exhibit CDK7 inhibitory activity with success.
17/628794
Instant elected species/Kwiatkowski compound 214
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Therefore, the double patenting rejections over Application 17/628794 is maintained.
Regarding Nonstatutory Double Patenting over U.S. Patent No. 10,870,651 in view of Kwiatkowski and Garris, Applicant's arguments that “Kwiatkowski generally discusses combination therapies employing CDK7 inhibitors, including the elected species. Combinations of CDK7 inhibitors with immunotherapies are among the constellation of possibilities that Kwiatkowski lists, but there is no teaching, motivation, or suggestion in Kwiatkowski to guide the skilled artisan to select the currently claimed CDK7 inhibitors in combination with anti-PD-1 antibodies, optionally in combination with cisplatin and/or etoposide” have been fully considered but they are not persuasive because Kwiatkowski teaches the instant CDK7 inhibitors. Kwiatkowski teaches the instant elected species (page 152, Table 3, compound 214):
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Further, it should be noted that instant claim 1 allows for a combination with any anti-PD-1 antibody and instant claim 42 limits the anti-PD-1 antibody to: nivolumab, pembrolizumab, atezolizumab, tislelizumab, durvalumab, avelumab, or cemiplimab.
Kwiatkowski teaches e.g. pembrolizumab (see page 127, second line):
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It is examiner position that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by Kwiatkowski for treatment of SLCL. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab) with a different anti-PD1 antibody.
In addition, it should be noted that “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” In the instant case, as pointed by Applicants, the pending claims recite a combination of a subset of CDK7 inhibitors disclosed by Kwiatkowski in combination with anti-PD-1 antibodies, optionally in combination with cisplatin and/or etoposide. Pembrolizumab, an anti-PD-1 antibody, cisplatin, and etoposide are among the over 280 possible agents listed by Kwiatkowski. As such, it would be obvious to select the claimed anti-PD-1 antibody from the list disclosed by Kwiatkowski, arriving at the presently claimed method with a reasonable expectation of success.
Further, Applicant's arguments that “Garris teaches combinations of anti-PD-1 antibodies with CD40 agonists or cIAP inhibitors but is silent with respect to combinations with CDK7 inhibitors. As such, Applicant respectfully submits that this rejection is improper. Reconsideration and withdrawal of this rejection in view of the amendments and foregoing discussion are respectfully requested” have been fully considered but they are not persuasive because the Garris reference is only used for the specific immunotherapy, clone 29F.1.A12.
Therefore, the double patenting rejection over U.S. Patent No. 10,870,651 is maintained.
Regarding Nonstatutory Double Patenting in view of U.S. Patent No. 12,168,663 in view of Kwiatkowski and Garris, Applicants arguments that Applicant's arguments that” Kwiatkowski generally discusses combination therapies employing CDK7 inhibitors, including the elected species. Combinations of CDK7 inhibitors with immunotherapies are among the constellation of possibilities that Kwiatkowski lists, but there is no teaching, motivation, or suggestion in Kwiatkowski to guide the skilled artisan to select the currently claimed CDK7 inhibitors in combination with anti-PD-1 antibodies, optionally in combination with cisplatin and/or etoposide” have been fully considered but they are not persuasive because Kwiatkowski teaches the instant CDK7 inhibitors. Kwiatkowski teaches the instant elected species (page 152, Table 3, compound 214):
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Further, it should be noted that instant claim 1 allows for a combination with any anti-PD-1 antibody and instant claim 42 limits the anti-PD-1 antibody to: nivolumab, pembrolizumab, atezolizumab, tislelizumab, durvalumab, avelumab, or cemiplimab.
Kwiatkowski teaches e.g. pembrolizumab (see page 127, second line):
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It is examiner position that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by Kwiatkowski for treatment of SLCL. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab) with a different anti-PD1 antibody.
In addition, it should be noted that “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” In the instant case, as pointed by Applicants, the pending claims recite a combination of a subset of CDK7 inhibitors disclosed by Kwiatkowski in combination with anti-PD-1 antibodies, optionally in combination with cisplatin and/or etoposide. Pembrolizumab, an anti-PD-1 antibody, cisplatin, and etoposide are among the over 280 possible agents listed by Kwiatkowski. As such, it would be obvious to select the claimed anti-PD-1 antibody from the list disclosed by Kwiatkowski, arriving at the presently claimed method with a reasonable expectation of success.
Further, Applicant's arguments that “Garris teaches combinations of anti-PD-1 antibodies with CD40 agonists or cIAP inhibitors but is silent with respect to combinations with CDK7 inhibitors” have been fully considered but they are not persuasive because the Garris reference is only used for the specific immunotherapy, clone 29F.1.A12.
Therefore, the double patenting rejection over U.S. Patent No. 12,168,663 is maintained.
Election/Restrictions
Claims 50-52 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/08/2025.
Regarding species election, Applicant’s elected without traverse:
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in the reply filed on 09/08/2025.
Claim Interpretation
The term "isotopically labeled derivative” has been defined in instant specification as:
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Therefore, the "isotopically labeled derivative” recited in instant claims is interpreted as a compound that necessarily falls under the structure of Formula (I) wherein one or more atoms has been replaced with an isotope of the same element.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 34, 42, 46 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Kwiatkowski (WO-2016105528-A2, publication date 30 June 2016; also published as US-20190055248-A1) in view of Garris (Garris et al., 2018, Immunity 49, 1148–1161).
Kwiatkowski teaches compounds of Formula (I) as cyclin-dependent kinase 7 (CDK7) for treatment of cancer (see abstract).
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Further, Kwiatkowski teaches compounds of Formula (I) in combination with immunotherapy:
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Regarding the elected compound, Kwiatkowski teaches (page 152, Table 3, compound 214):
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Regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating cancers, including small cell lung cancer (see paragraphs 0219 and 0283):
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In paragraph 00283, Kwiatkowski teaches SCLC:
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Further, regarding the elected cancer species, Kwiatkowski claims a method of treating a proliferative disease, including small cell lung cancer (see claims 59 and 84):
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Further, regarding instant claim 46, Kwiatkowski teaches additional chemotherapeutic agents, including PLATINOL (cisplatin), PLATINOL-AQ (cisplatin), and TOPOSAR (etoposide) (see paragraph 0265).
Regarding immunotherapy and instant claim 42, Kwiatkowski teaches for example, pembrolizumab that acts as an immune checkpoint inhibitor (see page 127, second line):
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Kwiatkowski teaches synergistic effect of the disclosed compounds in combination with additional pharmaceutical agents (see paragraph 0264):
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Kwiatkowski does not teach CDK7 inhibitors in combination with an anti-PD-1 antibody in one single embodiment. Also, Kwiatkowski is silent about the specific immunotherapy: the elected Clone 29F.1 A 12.
However, “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” In the instant case, as pointed by Applicants, the pending claims recite a combination of a subset of CDK7 inhibitors in combination with anti-PD-1 antibodies, optionally in combination with cisplatin and/or etoposide. Pembrolizumab, an anti-PD-1 antibody, cisplatin, and etoposide are among the over 280 possible agents listed by Kwiatkowski. As such, it would be obvious to select the claimed anti-PD-1 antibody from the list disclosed by Kwiatkowski, arriving at the presently claimed method with a reasonable expectation of success.
Regarding the elected Clone 29F.1 A 12, the deficiency is cured by Garris.
Garris teaches that anti-PD-1 mAbs can induce sustained clinical responses in cancer (see abstract and summary, page 1148).
Garris teaches the elected species: clone 29F.A A12 (see key resources table, page e1)
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Applying KSR prong (A) and/or (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method disclosed by Kwiatkowski for treatment of SLCL. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab) with a different anti-PD1 antibody. One of ordinary skill would have been motivated by teachings of Garris that anti-PD-1 mAbs can induce sustained clinical responses in cancer.
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, 34, 42, 46 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 43, 75, 80, 85, 103, 104, 106, 115, 124, and 125 of copending Application No. 17/628794 (reference application) in view of Kwiatkowski (WO 2016105528-A2).
This rejection applies to expended species.
Claims of Application No. 17/628794 (reference application) recite a compound of Formula (I) and a method of treating disease comprising administering a compound of Formula (I):
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Claims of Application No. 17/628794 recite proviso the compound is not the instant elected compound (see claim 1):
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However, the claims of Application No. 17/628794 recite, for example (see claim 75):
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The compounds recited in claims of Application No. 17/628794 bear methyl substituent attached to a nitrogen atom of the pyrazole moiety whereas the instant compounds of formula IV-b require hydrogen atom at the corresponding position. Further, claims of Application No. 17/628794 are silent about combination of compounds of Formula (I) with immunotherapy.
The deficiency is cured by Kwiatkowski.
Kwiatkowski teaches compounds of Formula (I) as cyclin-dependent kinase 7 (CDK7) for treatment of cancer (see abstract).
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wherein
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Further, Kwiatkowski teaches compounds of Formula (I) in combination with immunotherapy:
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Regarding the elected compound, Kwiatkowski teaches (page 152, Table 3, compound 214):
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Regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating cancers, including small cell lung cancer (see paragraphs 0219 and 0283):
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In paragraph 00283, Kwiatkowski teaches SCLC:
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Further, regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating a proliferative disease, including small cell lung cancer (see claims 59 and 84).
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Further, Kwiatkowski teaches additional chemotherapeutic agents, including PLATINOL (cisplatin), PLATINOL-AQ (cisplatin), and TOPOSAR (etoposide) (see paragraph 0265).
Regarding immunotherapy and instant claim 42, Kwiatkowski teaches for example, pembrolizumab that acts as an immune checkpoint inhibitor (see page 127, second line):
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Regarding instant claim 44, Kwiatkowski teaches synergistic effect (see paragraph 0264):
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Applying KSR prong (A) and (B) - It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to select compound I-1 recited in claims of 17/628794 and substituting the methyl on the nitrogen atom of the pyrazole ring with a hydrogen atom. The motivation to make such substitution is because not only Kwiatkowski teaches hydrogen and methyl are interchangeable at that position, but also because Kwiatkowski teaches compound 214 that contains a hydrogen atom at that position. One would reasonably expect the modified compound to exhibit CDK7 inhibitory activity with success.
Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compounds in combination with immunotherapy as taught by Kwiatkowski. The skilled artisan would have been motivated to use the compounds for the same purpose, treatments of cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 34, 42, 46 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 43, 75, 80, 85, 103, 104, 106, 115, 124, and 125 of copending Application No. 17/628794 (reference application) in view of Kwiatkowski (WO 2016105528-A2) and further in view of Garris (Garris et al., 2018, Immunity 49, 1148–1161).
This rejection applies to the elected species (anti-PD1 antibody).
The recitation of claims of copending Application No. 17/628794 (reference application) in view of Kwiatkowski (WO 2016105528-A2) has been discussed above and is herein incorporated by reference.
The combination of claims of copending Application No. 17/628794 (reference application) and teachings of Kwiatkowski is silent about the specific immunotherapy; the elected Clone 29F.1 A 12.
The deficiency is cured by Garris.
Garris teaches that anti-PD-1 mAbs can induce sustained clinical responses in cancer (abstract).
Garris teaches the elected species 29F.A A12 (see key resources table, page e1)
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Applying KSR prong (A) and/or (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compounds recited in claims of Application No. 17/628794 in combination with immunotherapy. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab that acts as an immune checkpoint inhibitor) with a different anti-PD1 antibody. One of ordinary skill would have been motivated by teachings of Garris that anti-PD-1 mAbs can induce sustained clinical responses in cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 34, 42, 46 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. US 10870651-B3 in view of Kwiatkowski (WO 2016105528-A2).
This rejection applies to expended species.
Claims of U.S. Patent No. US 10870651-B3 recite:
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The claims of U.S. Patent No. US 10870651 recite the instant, elected compound:
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Claims of U.S. Patent No. US 10870651 does not recite a method of treating cancer and are silent about combination of the recited compounds with immunotherapy.
The deficiency is cured by Kwiatkowski.
Kwiatkowski teaches compounds of Formula (I) as cyclin-dependent kinase 7 (CDK7) for treatment of cancer (see abstract).
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Further, Kwiatkowski teaches compounds of Formula (I) in combination with immunotherapy:
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Regarding the elected compound, Kwiatkowski teaches (page 152, Table 3, compound 214):
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Regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating cancers, including small cell lung cancer (see paragraphs 0219 and 0283):
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In paragraph 00283, Kwiatkowski teaches SCLC:
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Further, regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating a proliferative disease, including small cell lung cancer (see claims 59 and 84):
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Furthermore, Kwiatkowski teaches additional chemotherapeutic agents, including PLATINOL (cisplatin), PLATINOL-AQ (cisplatin), and TOPOSAR (etoposide) (see paragraph 0265).
Regarding immunotherapy and instant claim 42, Kwiatkowski teaches for example, pembrolizumab that acts as an immune checkpoint inhibitor (see page 127, second line):
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66
570
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Kwiatkowski teaches synergistic effect (see paragraph 0264):
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126
586
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Applying KSR prong (A) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compounds recited in claims of U.S. Patent No. US 10870651-B2 in combination with immunotherapy as disclosed by Kwiatkowski. The skilled artisan would have been motivated to use the compounds for the same purpose, treatment of cancer.
Claims 1, 34, 42, 46 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-36 of U.S. Patent No. US 10870651-B2 in view of Kwiatkowski (WO 2016105528-A2) and further in view of Garris (Garris et al., 2018, Immunity 49, 1148–1161).
This rejection applies to the elected species (anti-PD1 antibody).
The combination of recitation of claims of U.S. Patent No. US 10870651 and teachings of Kwiatkowski is silent about the specific immunotherapy; the elected Clone 29F.1A12.
The deficiency is cured by Garris.
Garris teaches that anti-PD-1 mAbs can induce sustained clinical responses in cancer (abstract).
Garris teaches the elected species 29F.A A12 (see key resources table, page e1):
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945
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Applying KSR prong (A) and (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compounds recited in claims of U.S. Patent No. US 10870651 in combination with immunotherapy. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab that acts as an immune checkpoint inhibitor) with a different anti-PD1 antibody. One of ordinary skill would have been motivated by the teachings of Garris that anti-PD-1 mAbs can induce sustained clinical responses in cancer.
Claims 1, 34, 42, 46 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 12168663-B2 in view of Kwiatkowski (WO 2016105528-A2)
This rejection applies to expended species.
Claims of U.S. Patent No. US 12168663-B2
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439
369
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Claims of U.S. Patent No. US 12168663-B2 recite:
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330
375
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Claims of U.S. Patent No. US 12168663 does not recite a combination of the recited compounds with immunotherapy.
Kwiatkowski teaches compounds of Formula (I) as cyclin-dependent kinase 7 (CDK7) for treatment of cancer (see abstract).
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307
221
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Further, Kwiatkowski teaches compounds of Formula (I) in combination with immunotherapy:
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215
598
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Regarding the elected compound, Kwiatkowski teaches (page 152, Table 3, compound 214):
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293
376
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Regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating cancers, including small cell lung cancer (see paragraphs 0219 and 0283):
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233
581
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In paragraph 00283, Kwiatkowski teaches SCLC:
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75
587
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Further, regarding the elected cancer species, Kwiatkowski teaches and claims a method of treating a proliferative disease, including small cell lung cancer (see claims 59 and 84):
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108
596
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120
555
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Further, Kwiatkowski teaches additional chemotherapeutic agents, including PLATINOL (cisplatin), PLATINOL-AQ (cisplatin), and TOPOSAR (etoposide) (see paragraph 0265).
Regarding immunotherapy and instant claim 42, Kwiatkowski teaches e.g., pembrolizumab that acts as an immune checkpoint inhibitor (see page 127, second line):
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66
570
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Kwiatkowski teaches synergistic effect (see paragraph 0264):
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126
586
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Applying KSR prong (A) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compounds recited in claims of U.S. Patent No. US 12168663-B2 in combination with immunotherapy as disclosed by Kwiatkowski. The skilled artisan would have been motivated to use the compounds for the same purpose, treatment of cancer.
Claims 1, 34, 42, 46 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 12168663-B2 in view of Kwiatkowski (WO 2016105528-A2) and further in view of Garris (Garris et al., 2018, Immunity 49, 1148–1161).
This rejection applies to the elected species (anti-PD1 antibody).
The combination of recitations of claims of U.S. Patent No. US 12168663-B2 and teachings of Kwiatkowski is silent about the specific immunotherapy; the elected Clone 29F.1 A 12.
The deficiency is cured by Garris.
Garris teaches that anti-PD-1 mAbs can induce sustained clinical responses in cancer.
Garris teaches the elected species 29F.A A12 (see key resources table, page e1)
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98
945
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Applying KSR prong (A) and (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compounds recited in claims of U.S. Patent No. US 12168663-B2 in combination with immunotherapy. In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute immunotherapy disclosed by Kwiatkowski (for example, pembrolizumab that acts as an immune checkpoint inhibitor) with a different anti-PD1 antibody. One of ordinary skill would have been motivated by the teachings of Garris that anti-PD-1 mAbs can induce sustained clinical responses in cancer.
Conclusion
No claim is allowed.
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.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621