DETAILED ACTION
This action is in response to papers filed on 10/10/2025. Claims 1-14, and 29-96 of Saha et al., 17078255 (10/23/2020) are pending: claims 1, 4 and 14 are amended, claims 15-28, and 97 have been canceled without prejudice, and non-elected claims 29-96 remains withdrawn. Claims 1-14 are rejected.
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 .
Priority
This application is a:
DIV of 15/797,593 (10/30/2017 US10881646),
15/797,593 is a CON of 15/161,137 (05/20/2016 ABN),
15/161,137 is a CIP of PCT/US14/71749 (11/29/2017 ABN),
PCT/US14/71749 has PRO 61/919,551 (12/20/2013).
Election/Restrictions
Applicant previously elected of Group I, claims 1-14, in the reply filed on 1/10/23, treated as without traverse.
Withdrawn Claim Rejections/Objections
The objection of claim 14 is withdrawn in view of Applicants amendment, removing the CAS # in parenthesis as well as company names. Applicant’s Remarks at page 23.
Modified Claim Rejections - 35 USC § 103
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez-Botella et al. (US7354939) (“Martinez-Botella”), in view of Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750) (“Morris”), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706) (“Jin”), and Emery et al., (2010), BioMed Valley Discoveries (“Emery”).
Regarding claim 1 drawn to:
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the claim essentially recites a method of treating the effects of a cancer that is refractory or resistant to non-ERK MAPK pathway inhibitor therapy in a subject, by administering an effective amount of an ERK inhibitor that does not inhibit ERK phosphorylation. This includes obtaining a biological sample from the subject, screening the sample to determine whether the subject carries a double mutation per claim 1, and administering and effective amount of BVD-523 or a pharmaceutically acceptable salt thereof.
Martinez-Botella teaches methods of treating cancer by administering inhibitors of ERK protein kinase, using compounds of general formula I, including the claimed and administered compound BVD-523 as I-9 (col 9 Table 1, and claim 7),
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for use in treating melanoma in a patient, col 31:
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Martinez-Botella also teaches in col. 3 that ERK is a therapeutic target for the treatment of melanoma, as ERK-activation plays a major role in the metastatic behavior of melanoma:
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Although Martinez-Botella teaches the claimed BVD 523 compound in treating cancer, the reference does not expressly teach claim 1’s language of “which cancer is refractory or resistant to non-ERK MAPK pathway inhibitor therapy”.
The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires (MPEP § 2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
Morris teaches ERK1/2 inhibitors against cancers that are BRAF or MEK inhibitor-resistant, and that there is a clear need for the clinical development of other ERK inhibitors for tumors refractory to MAPK inhibitors and provided an example (Morris’ abstract: "SCH772984, a novel and selective inhibitor of ERK1/2 ... SCH772984 effectively inhibited MAPK signaling and cell proliferation in BRAF or MEK inhibitor-resistant models as well as in tumor cells resistant to concurrent treatment with BRAF and MEK inhibitors. These data support the clinical development of ERK inhibitors for tumors refractory to MAPK inhibitors").
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
Martinez-Botella as discussed above, teaches the claimed BVD 523 as an ERK inhibitor used in the treatment of cancer, and discusses compounds of formula I (including BVD-523 as I-9) that are effective ERK inhibitors.
Morris teaches a finding that at the relevant time, there had been a recognized problem or need in the art for the clinical development of other ERK inhibitors for tumors refractory to MAPK inhibitors (targeting BRAF or MEK).
Based on the teachings of Martinez-Botella and Morris, it would have been obvious to one of ordinary skill in the art to try selective ERK1/2 inhibitors, such as the claimed BVD-523 ERK inhibitor, against cancers that are BRAF or MEK inhibitor-resistant. The motivation to do so is the clinical development of ERK inhibitors for tumors refractory to MAPK inhibitors per Morris’ teachings. Moreover, by carrying out this method, it would have been obvious to obtain a biological sample from the subject, screening the sample to determine whether the subject carries the respective mutations as recited in claim 1, and administering and effective amount of BVD-523 or a pharmaceutically acceptable salt thereof; thus, arriving at the invention.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
Emery teaches BVD-523 as Ulixertinib: “… a highly potent and selective ERK1/2 inhibitor” (c.f., Background), and that “As emerging resistance mechanisms to KRASG12C inhibitors continue to be dominated by MAPK pathway re-activation, blockade with an ERK inhibitor at the terminal node of the MAPK pathway should provide durable intervention”. See, for example Emery: “4. Ulixertinib plus KRASG12C inhibitor resulted in superior tumor growth inhibition and suppression of KRAS signaling”:
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Emery teaches that based on their data that “By targeting the last node in the MAPK pathway with ulixertinib, we believe that more durable MAPK inhibition will be possible and that the pathway reactivation resistance mechanisms will be addressed…” (c.f., Conclusion). Moreover, “To date, over 500 patients have been treated with ulixertinib. Confirmed responses have been observed in patients harboring alterations within the RAS-MAPK pathway” (c.f., Background).
Jin (Jin p 5695, col 1, para 2: "ERK1/2 direct inhibitor BVD-523 was in clinical phase1/2 for advanced malignancies").
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Given the high level of skill in the art of cancer therapeutics, one of ordinary skill in the art would have readily consider the combined teaching of the art, and utilize Martinez-Botella’s compound in treating cancers including those resistant to BRAF inhibitor and MEK inhibitor therapy and arrive at the claimed invention in view of Morris and Emery. One of ordinary skill in the art would have a further expectation of success because the same compound was already in clinical studies for cancer treatment as taught by Jin (Jin p 5695, col 1, para 2: "ERK1/2 direct inhibitor BVD-523 was in clinical phase1/2 for advanced malignancies").
Per the teachings discussed above, it would have therefore been prima facie obvious to try BVD-523 in view of Martinez-Botella, Morris, Emery and Jin teachings and arrive at the claimed invention per claim 1. One of skill in the art would have been motivated to do so, with reasonable expectation of success because, ERK inhibitors, such as the claimed BVD-523, have been shown to treat cancer as disclosed by Martinez-Botella. Morris teaches that there is a clear need to clinically identify and/or develop ERK inhibitors for tumors refractory to MAPK inhibitors, and to one of ordinary skill in the art, identify their mechanism of action. Emery teaches confirmed responses have been observed in patients harboring alterations within the RAS-MAPK pathway treated with BVD-523 and suggested that blockade with an ERK inhibitor at the terminal node of the MAPK pathway should provide durable intervention. BVD-523 has been demonstrated to do so. Therefore, one would be motivated to pursue ERK inhibitors such as BVD-523 for tumors refractory to MAPK inhibitors per the teachings discussed above and arrive at the claimed invention with reasonable expectation of success. Additionally, obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02. Claim 1 is therefore obvious.
Regarding claims 2 and 3 specifying the resistant inhibitor therapy is a BRAF or MEK inhibitor, based on the specific teaching of Morris that ERK inhibitors would be useful in such resistant cancers one of ordinary skill in the art would have had a reasonable expectation of success in using BVD-523 in the same manner and arrive at the claimed invention.
Regarding claim 4 the newly amended limitation: wherein substantially all phosphorylation of RSK is inhibited after administration of BVD-523 or a pharmaceutically acceptable salt thereof is inherent to the administration of the compound and it simply expresses the intended result of a process step positively recited (see MPEP 2111.04), thus it is not given weight and is rendered obvious as with claim 1.
Regarding claims 5-7 wherein the subject is a human, Martinez-Botella and Jin describe use on humans such that one of ordinary skill in the art would have reasonably considered administering the compound to a human.
Regarding claim 8 wherein the cancer has MAPK activity, one of ordinary skill in the art would have considered such cancers based on the teaching of Martinez-Botella (col 3: “evidence that implicates constitutive activation of the ERK MAPK pathway in the oncogenic behavior of select cancers”) and Morris (Morris abstract: "a novel and selective inhibitor of ERK1/2 ... effectively inhibited MAPK signaling and cell proliferation in BRAF or MEK inhibitor-resistant models as well as in tumor cells resistant to concurrent treatment with BRAF and MEK inhibitors.”) and arrived at the claimed invention.
Regarding claims 9-11 wherein the cancer is a solid tumor, breast cancer, or melanoma, based on the teaching of Martinez-Botella (col 31) one of ordinary skill in the art would have had a reasonable expectation of success in using the compound in the same manner and arrive at the claimed invention.
Applicant’s Remarks – 35 USC 103 Rejection above
Applicant argues that none of the cited prior arts teach the method of treatment claim as amended to comprise a process of screening a biological sample from the subject to determine whether the subject carries a double mutation of BRAFV⁶⁰⁰⁰:MEK1 Q⁵⁶, and when in the presence of the double mutation, the subject will receive an effective amount of BVD-523 or a pharmaceutically acceptable salt thereof. Applicant’s Remarks at page 25. Applicant argues that BVD-523 is not subjected to this mechanism of acquired resistance, and points to Example 7 in the Specification for support. Applicant argues that BVD-523 in treating cancer that is refractory or resistant to non-ERK MAPK pathway inhibitor therapy in a subject carrying the disclosed double mutation is not taught by the prior art references. Applicant’s Remarks at page 26.
Examiner’s Response
Applicant’s arguments are acknowledged, but are not found to be persuasive.
Martinez-Botella teaches methods of treating cancer by administering inhibitors of ERK protein kinase, using compounds of general formula I, including the claimed and administered compound BVD-523 as I-9 (col 9 Table 1, and claim 7),
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Martinez-Botella also teaches in col. 3 that ERK is a therapeutic target for the treatment of melanoma, as ERK-activation plays a major role in the metastatic behavior of melanoma:
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Although Martinez-Botella teaches the claimed BVD 523 compound in treating cancer, the reference does not expressly teach claim 1’s language of “which cancer is refractory or resistant to non-ERK MAPK pathway inhibitor therapy”.
However, the rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires (MPEP § 2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
Morris teaches ERK1/2 inhibitors against cancers that are BRAF or MEK inhibitor-resistant, and that there is a clear need for the clinical development of other ERK inhibitors for tumors refractory to MAPK inhibitors and provided an example (Morris’ abstract: "SCH772984, a novel and selective inhibitor of ERK1/2 ... SCH772984 effectively inhibited MAPK signaling and cell proliferation in BRAF or MEK inhibitor-resistant models as well as in tumor cells resistant to concurrent treatment with BRAF and MEK inhibitors. These data support the clinical development of ERK inhibitors for tumors refractory to MAPK inhibitors"). In Example 7 of Applicant’s Specification, SCH772984 was compared to BVD-523 when assessing IC50 across parental cells and the respective knock out cells (c.f., Specification, Table 17 at page 116).
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
Martinez-Botella as discussed above, teaches the claimed BVD 523 as an ERK inhibitor used in the treatment of cancer, and discusses compounds of formula I (including BVD-523 as I-9) that are effective ERK inhibitors.
Morris teaches a finding that at the relevant time, there had been a recognized problem or need in the art for the clinical development of other ERK inhibitors for tumors refractory to MAPK inhibitors (targeting BRAF or MEK). Morris teaches SCH772984, a novel and selective inhibitor of ERK1/2 ... SCH772984 effectively inhibited MAPK signaling and cell proliferation in BRAF or MEK inhibitor-resistant models as well as in tumor cells resistant to concurrent treatment with BRAF and MEK inhibitors as an example teaching.
Based on the teachings of Martinez-Botella and Morris, it would have been obvious to one of ordinary skill in the art to try other selective ERK1/2 inhibitors, such as the claimed BVD-523 ERK inhibitor per Martinez-Botella teachings, against cancers that are BRAF or MEK inhibitor-resistant, similar to Morris’ teachings.
The motivation to do so is the clinical development of ERK inhibitors for tumors refractory to MAPK inhibitors per Morris’ teachings. Moreover, by carrying out this method, it would have been obvious to obtain a biological sample from the subject, screening the sample to determine whether the subject carries the respective mutations as recited in claim 1, and administering and effective amount of BVD-523 or a pharmaceutically acceptable salt thereof; thus, arriving at the invention.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
Emery also teaches BVD-523 as Ulixertinib: “… a highly potent and selective ERK1/2 inhibitor” (c.f., Background), and that “As emerging resistance mechanisms to KRASG12C inhibitors continue to be dominated by MAPK pathway re-activation, blockade with an ERK inhibitor at the terminal node of the MAPK pathway should provide durable intervention”. See, for example Emery: “4. Ulixertinib plus KRASG12C inhibitor resulted in superior tumor growth inhibition and suppression of KRAS signaling”:
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Emery teaches that based on their data that “By targeting the last node in the MAPK pathway with ulixertinib, we believe that more durable MAPK inhibition will be possible and that the pathway reactivation resistance mechanisms will be addressed…” (c.f., Conclusion). Moreover, “To date, over 500 patients have been treated with ulixertinib. Confirmed responses have been observed in patients harboring alterations within the RAS-MAPK pathway” (c.f., Background).
Jin also teaches (Jin p 5695, col 1, para 2): "ERK1/2 direct inhibitor BVD-523 was in clinical phase1/2 for advanced malignancies".
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Given the high level of skill in the art of cancer therapeutics, one of ordinary skill in the art would have readily consider the combined teachings of the prior arts, and utilize Martinez-Botella’s compound in treating cancers including those resistant to BRAF inhibitor and MEK inhibitor therapy and arrive at the claimed invention in view of Morris and Emery. One of ordinary skill in the art would have a further expectation of success because the same compound was already in clinical studies for cancer treatment as taught by Jin (Jin p 5695, col 1, para 2: "ERK1/2 direct inhibitor BVD-523 was in clinical phase1/2 for advanced malignancies").
Per the teachings discussed above, it would have therefore been prima facie obvious to try BVD-523 in view of Martinez-Botella, Morris, Emery and Jin teachings and arrive at the claimed invention per claim 1. One of skill in the art would have been motivated to do so, with reasonable expectation of success because, ERK inhibitors, such as the claimed BVD-523, have been shown to treat cancer as disclosed by Martinez-Botella. Morris teaches that there is a clear need to clinically identify and/or develop ERK inhibitors for tumors refractory to MAPK inhibitors, and to one of ordinary skill in the art, identify their mechanism of action. Emery teaches confirmed responses have been observed in patients harboring alterations within the RAS-MAPK pathway treated with BVD-523 and suggested that blockade with an ERK inhibitor at the terminal node of the MAPK pathway should provide durable intervention. BVD-523 has been demonstrated to do so. Therefore, one would be motivated to pursue ERK inhibitors such as BVD-523 for tumors refractory to MAPK inhibitors per the teachings discussed above and arrive at the claimed invention with reasonable expectation of success. Additionally, obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez-Botella et al. (US7354939) (“Martinez-Botella”), in view of Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750) (“Morris”), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706) (“Jin”), and Emery et al., (2010), BioMed Valley Discoveries (“Emery”), as applied above to claims 1-11, and in further view of Scheuring et al. (US 20090306020) (“Scheuring”).
Martinez-Botella, Morris, Jin and Emery teachings as applied to claims 1-11 are discussed above
Regarding claims 12-14, further comprising an additional therapeutic agent that is an inhibitor of the PI3K/Akt pathway, Martinez-Botella teaches combination therapies (col 31-32: “chemotherapeutic agents or other anti-proliferative agents may be combined with the compounds of this invention to treat proliferative diseases and cancer.”) but does not teach the specific combinations recited.
However, one of ordinary skill in the art would have reasonably considered combinations such as those taught by Scheuring. Scheuring teaches triciribine, and that inhibitors of Pl3K/Akt pathway and inhibitors of MAPK pathway can be combined to inhibit melanoma growth (para [0007] "Blockade of Pl3K/AKT (AKT) and RAS/RAF/MEK/ERK (MAPK) signaling pathways inhibits invasive melanoma growth in human dermal reconstructs") and further teaches cytotoxic agents that inhibit the P13K/Akt pathway (para [0007] "Pl3K inhibitor wortmannin"; para [0021] "preference is given to an Aki-kinase inhibitor ... triciribine").
Based on the combined teachings, one of ordinary skill in the art would have had a reasonable expectation of success in combining BVD-523 with a second therapeutic such as triciribine, and arrive at the claimed invention. Combining BVD-523 with other therapeutics is also taught by Emery as discussed above.
Applicant’s Remarks/Examiner’s Response – 35 USC 103 Rejection above
Applicant argues similarly as with the rejection over Martinez-Botella, Morris, and Jin and is not persuasive for the same reason (Applicant’s Remarks at page 26). As discussed above, the combined teachings of the prior arts which newly includes Emery’s teachings is applied and discussed above. The same rationale applied above, is applied here. Therefore, the rejection is maintained.
Modified Double Patenting
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11007184 in view of Martinez-Botella et al. (US7354939), Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706), Emery et al., (2010), BioMed Valley Discoveries (“Emery”), and Scheuring et al. (US 20090306020) (“Scheuring”).
The patent claims a method of treating cancer using BVD-523 such that one of ordinary skill in the art would have considered using the same compound and arrive at the instantly claimed invention for the same reasoning as detailed in the 35 USC 103 rejections supra and incorporated herein.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11007183 in view of Martinez-Botella et al. (US7354939), Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706), Emery et al., (2010), BioMed Valley Discoveries (“Emery”), and Scheuring et al. (US 20090306020) (“Scheuring”).
The patent claims a method of treating cancer using BVD-523 such that one of ordinary skill in the art would have considered using the same compound and arrive at the instantly claimed invention for the same reasoning as detailed in the 35 USC 103 rejections supra and incorporated herein.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11013743 in view of Martinez-Botella et al. (US7354939), Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706), Emery et al., (2010), BioMed Valley Discoveries (“Emery”), and Scheuring et al. (US 20090306020) (“Scheuring”).
The patent claims a method of treating cancer using BVD-523 such that one of ordinary skill in the art would have considered using the same compound and arrive at the instantly claimed invention for the same reasoning as detailed in the 35 USC 103 rejections supra and incorporated herein.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11135225 in view of Martinez-Botella et al. (US7354939), Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706), Emery et al., (2010), BioMed Valley Discoveries (“Emery”), and Scheuring et al. (US 20090306020) (“Scheuring”).
The patent claims a composition useful in a method of treating cancer comprising BVD-523 such that one of ordinary skill in the art would have considered using the same compound and arrive at the instantly claimed invention for the same reasoning as detailed in the 35 USC 103 rejections supra and incorporated herein.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10668055 in view of Martinez-Botella et al. (US7354939), Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706), Emery et al., (2010), BioMed Valley Discoveries (“Emery”), and Scheuring et al. (US 20090306020) (“Scheuring”).
The patent claims a method of treating cancer using BVD-523 such that one of ordinary skill in the art would have considered using the same compound and arrive at the instantly claimed invention for the same reasoning as detailed in the 35 USC 103 rejections supra and incorporated herein.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10881646 in view of Martinez-Botella et al. (US7354939), Morris et al. (Cancer Discov., July 2013, Vol 3, No 7, pp 742-750), Jin et al. (Bioorg Med Chem., 15 September 2013, Vol 21, No 18, pp 5694-5706), Emery et al., (2010), BioMed Valley Discoveries (“Emery”), and Scheuring et al. (US 20090306020) (“Scheuring”).
The patent claims a method of treating cancer using BVD-523 such that one of ordinary skill in the art would have considered using the same compound and arrive at the instantly claimed invention for the same reasoning as detailed in the 35 USC 103 rejections supra and incorporated herein.
Response to Double Patenting Rejections above
Applicant states that terminal disclaimers will be considered upon indication of allowance. The rejections are maintained.
Conclusion
No claims are 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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/C A/Examiner, Art Unit 1622 February 2, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622