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 .
Request for Continued Examination (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/16/26 has been entered.
Priority
This application is a CON of PCT/US2021/012361 (01/06/2021);
PCT/US2021/012361 has PRO 63/105,148 (10/23/2020);
PCT/US2021/012361 has PRO 63/041,090 (06/18/2020);
PCT/US2021/012361 has PRO 62/959,783 (01/10/2020);
PCT/US2021/012361 has PRO 62/958,260 (01/07/2020);
Status
Claims 1, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, and 190 are pending.
Rejections not reiterated in this action are withdrawn.
Claim Interpretation
Claim 1 is to “A method of treating a disease or disorder, comprising administering to a subject” a “SHP2 inhibitor therapy, the therapy comprising a 7-day intermittent dosing schedule consisting of a first dose of the SHP2 inhibitor and a second dose of the SHP2 inhibitor”. Regarding the use of comprising and consists of in the claim, MPEP 2111.03 states:
The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”).”)
…
When the phrase “consisting of” appears in a clause of the body of a claim, rather than immediately following the preamble, there is an “exceptionally strong presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements.” Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1359, 119 USPQ2d 1773, 1781 (Fed. Cir. 2016) (a layer “selected from the group consisting of” specific resins is closed to resins other than those listed). However, the “consisting of” phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole. Mannesmann Demag Corp.v. Engineered Metal Products Co., 793 F.2d 1279, 230 USPQ 45 (Fed. Cir. 1986). See also In re Crish, 393 F.3d 1253, 73 USPQ2d 1364 (Fed. Cir. 2004) (The claims at issue “related to purified DNA molecules having promoter activity for the human involucrin gene (hINV).” Id., 73 USPQ2d at 1365. In determining the scope of applicant’s claims directed to “a purified oligonucleotide comprising at least a portion of the nucleotide sequence of SEQ ID NO:1 wherein said portion consists of the nucleotide sequence from … to 2473 of SEQ ID NO:1, and wherein said portion of the nucleotide sequence of SEQ ID NO:1 has promoter activity,” the court stated that the use of “consists” in the body of the claims did not limit the open-ended “comprising” language in the claims (emphases added). Id. at 1257, 73 USPQ2d at 1367. The court held that the claimed promoter sequence designated as SEQ ID NO:1 was obtained by sequencing the same prior art plasmid and was therefore anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. Id. at 1256 and 1259, 73 USPQ2d at 1366 and 1369. The court affirmed the Board’s interpretation that the transition phrase “consists” did not limit the claims to only the recited numbered nucleotide sequences of SEQ ID NO:1 and that “the transition language ‘comprising’ allowed the claims to cover the entire involucrin gene plus other portions of the plasmid, as long as the gene contained the specific portions of SEQ ID NO:1 recited by the claim[s].” Id. at 1256, 73 USPQ2d at 1366.).
In this case, while “the therapy comprising a 7-day intermittent dosing schedule consisting of” may be closed with respect to the “7-day intermittent dosing schedule”, the method has “comprising administering to the subject” a “therapy comprising” which is open-ended and allows for additional unrecited method steps. Thus, giving claim 1 its broadest reasonable interpretation (BRI) of in view of MPEP 2111.03, the method steps of “comprising administering … therapy comprising a … intermittent dosing schedule consisting of” is construed as closed-ended with respect to any intermittent dosing schedule and additional therapies or dosing schedules. Thus, the claim language allows for additional unrecited steps including dosing on every other day or every day.
Claim Rejections - 35 USC § 102
Claim 1, 23, 29, 33, 54, 56, 68, 74, 75, 91, 94, 108, 119, 189, and 190 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koltun et al. (WO2018013597).
Regarding claim 1, Koltun teaches administering “inhibitors of SHP2 and their use in the treatment of disease” (Abstract), including cancer (claims 50 and 55), by administering to the subject a compound of A-290 with the following structure (claim 47):
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where the subject is a human ([0075]). Koltun teaches daily dose arrangements ([0237]-[0238]) which administered at an interval of 48 hours corresponding to the instant claims first dose on D1 and second dose on D4 which anticipates at least claims 1, 23, 29, 108, 119. Also, as per the claim interpretation the claims are anticipated by Koltun’s teaching of daily dosing.
Regarding claim 33, Koltun teaches combinations with a second therapeutic agent ([0238]).
Regarding claims 54, 56, 68, 74 Koltun teaches combinations with a second therapeutic agent that are administered simultaneously and sequentially ([0238]: “For example, the different therapeutic compounds or compositions can be administered either in the same formulation or in a separate formulation, either simultaneously, sequentially, or by separate dosing of the individual components of the treatment.”).
Regarding claims 75 and 91, Koltun teaches combinations with a second therapeutic agent that are administered on different days, i.e., after one week ([0238]).
Regarding claim 94, Koltun teaches the SHP2 inhibitors are allosteric (Title).
Regarding claim 189, as with claim 1’s interpretation “comprising administering … on an intermittent schedule” allows for an interpretation that includes every day, in addition Koltun teaches diseases including Noonan Syndrome include a mutation in SHP2 ([0005]), and treating such disease (claim 50). Thus, the claim is anticipated.
Regarding claim 190 specifying decreasing activation of a component of a RAS signaling pathway, Koltun’s administering the compound A-290 in treating diseases including Noonan Syndrome in a subject (claim 50) would inherently result in the same decreasing activation as in the instant claim. In addition, as with claim 1’s interpretation “comprising administering … on an intermittent schedule” allows for an interpretation that includes every day. Thus, the claim is anticipated.
Response to Remarks - 35 USC § 102
Applicant argues the amended claims cannot be construed to allow for dosing on every other day or every day of said intermittent schedule.
This argument is not persuasive because the amended language of “the therapy comprising a 7-day intermittent dosing schedule consisting of” may be closed with respect to the “7-day intermittent dosing schedule”, the method has “comprising administering to the subject” a “therapy comprising” which is open-ended and allows for additional unrecited method steps. Thus, while there may be a closed 7-day intermittent schedule, the dosing schedule can be combined with other dosing schedules, including non-intermittent dosing. Thus, giving claim 1 its broadest reasonable interpretation (BRI) of in view of MPEP 2111.03, the method steps of “comprising administering … therapy comprising a … intermittent dosing schedule consisting of” is construed as closed-ended with respect to any intermittent dosing schedule and additional therapies or dosing schedules.
Claim Rejections - 35 USC § 103
Claims 1, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, and 190 are rejected under 35 U.S.C. 103 as being unpatentable over Koltun et al. (WO2018013597) in view of Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34).
Koltun teaches administering “inhibitors of SHP2 and their use in the treatment of disease” (Abstract), including cancer (claims 50 and 55), by administering to the subject a compound of A-290 with the following structure (claim 47):
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where the subject is a human ([0075]). Koltun teaches dose arrangements including D1 and D4 ([0237]-[0238]) which anticipates and renders obvious at least claims 1, 23, 29, 108, 119 and as per the claim interpretation.
Koltun teaches administration of the compounds in appropriate dosage regimens ([0235]-[0238]) where “[one] of ordinary skill in the art can readily determine and prescribe the effective amount of the drug required to prevent, counter or arrest the progress of the condition” ([0235]). Koltun teaches a variety of daily dose arrangements, including multiple doses of the same compound ([0237]) and suggests spacing intervals between different dosages (“[0238]: “therapeutic compounds or compositions can be administered within one hour, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, or a week of one another.”).
Nichols teaches successful targeting of KRAS and BRAF mutant cancers (Abstract: “we show that targeting the SHP2 phosphatase (encoded by PTPN11) with RMC-4550, a small-molecule allosteric inhibitor, is effective in human cancer models bearing RAS–GTP-dependent oncogenic BRAF (for example, class 3 BRAF mutants), NF1 loss or nucleotide-cycling oncogenic RAS (for example, KRASG12C). SHP2 inhibitor treatment decreases oncogenic RAS/RAF/MEK/ERK signalling and cancer growth”;) with the SHP2 allosteric inhibitor RMC-4550 (Fig. 1):
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.
Gumerlock teaches treating tumors in a patient by administering a EGFR kinase inhibitor intermittently in combination with dosing docetaxel (Abstract; claim 1). Gumerlock teaches that the intermittent dosing reduces side effects and provides a synergistic antitumor effect ([0049]).
Stuart teaches treating proliferative diseases through an intermittent dosing of a BRAF inhibitor (Abstract; claim 1). Stuart teaches that the intermittent dosing suppresses resistance to treatment with the inhibitor ([0016]-[0017]).
Lu teaches treating tumors in vitro and in vivo with SHP2 inhibitor (SHP099) in combination with MAPK pathway inhibitors where intermittent dosing regimens were suggested to overcome tolerability concerns (p. 1332: “combination benefit was still achieved with the tolerated dosing regimens and intermittent dosing could also be explored in preclinical models and eventually clinical studies.”).
Regarding claim 33, Koltun teaches combinations with a second therapeutic agent ([0238]) as does Lu which teaches a combination of SHP009 with trametinib (Lu p. 1330, Fig. 5A). Regarding claims 54, 56, 68, 74 Koltun teaches combinations with a second therapeutic agent that are administered simultaneously and sequentially ([0238]: “For example, the different therapeutic compounds or compositions can be administered either in the same formulation or in a separate formulation, either simultaneously, sequentially, or by separate dosing of the individual components of the treatment.”). Regarding claims 75 and 91, Koltun teaches combinations with a second therapeutic agent that are administered on different days, i.e., after one week ([0238]). Regarding claim 94, Koltun teaches the SHP2 inhibitors are allosteric (Title). Regarding claim 189, as with claim 1’s interpretation “comprising administering … on an intermittent schedule” allows for an interpretation that includes every day, in addition Koltun teaches diseases including Noonan Syndrome include a mutation in SHP2 ([0005]), and treating such disease (claim 50). Regarding claim 190 specifying decreasing activation of a component of a RAS signaling pathway, Koltun’s administering the compound A-290 in treating diseases including Noonan Syndrome in a subject (claim 50) would inherently result in the same decreasing activation as in the instant claim. In addition, as with claim 1’s interpretation “comprising administering … on an intermittent schedule” allows for an interpretation that includes every day.
Regardarding claim 37 specifying a RAS inhibitor, although Koltun teaches combinations with second therapeutic agents ([0238]), Koltun does not specifically teach this element. One of ordinary skill in the art would have also considered the teaching of Nichols which demonstrated success using the related RMC-4550 in suppressing RAS-driven cancers and in view of the cited art consider using a RAS inhibitor to achieve the same result.
Regarding claim 123-125, and 130, although Koltun teaches the cancers have mutations and that when SHP2, which is part of the RAS signaling pathway ([0003]: “SHP2 is involved in signaling through the Ras-mitogen-activated protein kinase”), has mutations several diseases are known ([0005] “Mutations in the PTPN1 1 gene and subsequently in SHP2 have been identified in several human diseases, such as Noonan Syndrome, Leopard Syndrome, juvenile myelomonocytic leukemias, neuroblastoma, melanoma, acute myeloid leukemia and cancers of the breast, lung and colon. SHP2, therefore, represents a highly attractive target for the development of novel therapies for the treatment of various diseases. The compounds of the present disclosure fulfill the need for small molecules to that inhibit the activity of SHP2.”), Koltun does not specifically teach the recited mutations in the claims. One of ordinary skill in the art following the teaching of Koltun would have also considered the teaching of Nichols which demonstrated success using the related RMC-4550 in suppressing RAS-driven cancers, including KRAS^G12C (Abstract: “we show that targeting the SHP2 phosphatase (encoded by PTPN11) with RMC-4550, a small-molecule allosteric inhibitor, is effective in human cancer models bearing RAS–GTP-dependent oncogenic BRAF (for example, class 3 BRAF mutants), NF1 loss or nucleotide-cycling oncogenic RAS (for example, KRASG12C). SHP2 inhibitor treatment decreases oncogenic RAS/RAF/MEK/ERK signalling and cancer growth”;) and in view of the cited art consider using a RAS inhibitor to achieve the same result.
Regarding claim 137 specifying the particular cancer type, although Koltun teaches cancers including neuroblastoma and lung cancer ([0005], [0216]), Koltun does not teach the cancers as claimed. Nichols teaches (p. 1064: “Among the tumour types with widespread hyperactivation of RAS/MAPK signalling is non-small cell lung cancer (NSCLC), in which oncogenic RAS/MAPK pathway activation is caused by mutations in KRAS”). One of ordinary skill in the art following the teaching of Koltun would have also considered the teaching of Nichols which demonstrated success using the related RMC-4550 in suppressing RAS-driven cancers and in view of the cited art which reasonably suggests NSCLC and arrive at the claimed invention with a reasonable expectation of success.
One of ordinary skill in the art following the teaching of Koltun regarding dosing would also have reasonably considered applying the known technique of intermittent dosing in the same field of endeavor as taught by Gumerlock, Stuart, and Lu. One of ordinary skill in the art would have had a reasonable expectation of success in view of the success demonstrated by Gumerlock, Stuart, and Lu, and in particular because Lu used a SHP2 inhibitor. Futhermore, one of ordinary skill in the art would have been motivated to reduce side effects while providing a synergistic antitumor effect (Gumerlock), to suppress resistance to treatment (Stuart), and to overcome tolerability concerns (Lu). Thus claim 1 is prima facie obvious.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of teachings of the primary reference in with the secondary references all of which are in the same field of endeavor. Through the combined teachings, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Response to Remarks - 35 USC § 103
Applicant argues that Nichols does not overcome the deficiencies of Koltun, Gumerlock, Suart, and Lu because Nichol discloses that incubation of KRAS- and BRAF-mutant cancer cell lines with SHP2 inhibitor RMC-4550 decreases RAS signaling and cancer growth and not a 7-day intermittent dosing schedule or human clinical dosing.
This argument is not persuasive because Koltun teaches varying the dosing schedule including to 48 h intervals (D1 and D4) while Gumerlock, Suart, and Lu each teach success with intermittent dosing for therapeutic effect. In addition, Koltun also teaching use of the inhibitors on human subjects ([0053], [0544]) for treating human cancers ([0060]) such that one of ordinary skill in the art would have considered Koltun’s dosing guidance ([0058]) in view of the secondary references and arrive at the claimed invention with a reasonable expectation of success.
Applicant argues that in vivo dosing is not disclosed by the cited art because drug therapy is highly unpredictable.
This argument is not persuasive because the level of skill in the art is very high and one of ordinary skill in the art would consider routine the optimization of dosing to improve therapeutic effect as is commonly done in the art.
Double Patenting
Claims 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22, 27, 32, 40, 49 of U.S. Patent No. 10590090 in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 22, 27, 32 disclose the species A-290 as in Koltun and further claims 40 and 49 claims methods of treating disease. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
Claims 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11220501 in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-32 are to the same species as A-290 as in Koltun. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
Claims 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11596633 in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-21 are to the same species as A-290 as in Koltun. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
Claim 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 26 of copending Application No. 18124352 (reference application) in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 26 are to a genus that encompasses the same species as A-290 as in Koltun, and the reference application specification also discloses the compound which one of ordinary skill in the art would use to construe the claims. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 18655511 (reference application) in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because claims are to a genus that encompasses the same species as A-290 as in Koltun, and the reference application specification also discloses the compound on page 106 which one of ordinary skill in the art would use to construe the claims. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18819406 (reference application) in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim recites the same species as A-290 as in Koltun, for the treatment of lung cancer. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18880867 (reference application) in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim recites the same species as A-290 as in Koltun, for the treatment of cancer. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25 of copending Application No. 19120279 (reference application) in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim recites RMC-4630 which is the same species as A-290 as in Koltun, for the treatment of cancer. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 6, 16, 23, 29, 33, 37, 54, 56, 68, 74, 75, 91, 94, 108, 119, 123-125, 130, 137, 189, 190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 19090050 (reference application) in view of secondary references Koltun et al. (WO2018013597), Nichols et al. (Nature Cell Biology, volume 20, pages 1064–1073 (2018)), Gumerlock (US20070099856), Stuart et al. (US20140275136), and Lu et al. (Mol Cancer Ther 2019;18:1323–34). Although the claims at issue are not identical, they are not patentably distinct from each other because claims are to a genus that encompasses the same species as A-290 as in Koltun, and the reference application specification also discloses the compound on page 105 which one of ordinary skill in the art would use to construe the claims. As in the 35 USC 103 rejection above over the secondary references and incorporated herein, one of ordinary skill in the art would have arrived at the instant invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks – Double Patenting
Applicant argues that the claims as amended do not read on the 7-day dosing schedule. This is not persuasive as detailed in the above rejections and Claim Interpretation section supra.
Applicant also points to filing dates of copending applications as requiring reconsideration. This is not persuasive as detailed in MPEP 804 I.B.1, for example MPEP 804 I.B.1(b)(i) “Application under examination has the earlier patent term filing date”. Thus, when the double patenting rejection is the only remaining issue withdrawal be considered accordingly.
Conclusion
No claims allowed.
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