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 .
DETAILED ACTION
Applicant’s election without traverse in the reply filed on 07/13/2026 is acknowledged. Applicants have elected a PRMT5 inhibitor with the following structure:
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Applicants also elected Osimertinib as an EGFR inhibitor species and non-small cell lung cancer (NSCLC) as a species of cancer.
Claims 1-20 are pending.
Claims 1-7 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Claims 8, 9, and 11-20 are under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 8, 9, and 11-20 have an effective filing date of 01/26/2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/31/2026 and 07/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections
35 U.S.C. 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 8, 9, 11-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US PG PUB 2025/0382296, filing date: 06/26/2023) and Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
On p. 23, Deng et al. teach a PRMT5 inhibitor having the following structure:
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This structure is indistinguishable from the elected PRMT5 inhibitor. At [0121] and [0122], Deng et al. teach that the compounds of the invention may be used to treat lung cancer.
Deng et al. do not teach or suggest a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, not do Deng et al. teach methods of treating cancer by administering to a subject in need thereof a PRMT5 inhibitor in combination with an EGFR inhibitor. These deficiencies are remedied by Bhonde et al.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Deng et al. with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because Deng et al. teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of Deng et al. to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of Deng et al. and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of Deng et al. to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
Therefore the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention, as evidenced by the references.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US PG PUB 2025/0382296, filing date: 06/26/2023) and Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Deng et al. with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because Deng et al. teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of Deng et al. to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. Neither Deng et al. nor Bhonde et al. teach or suggest treating brain metastatic cancer. This deficiency is remedied by Hayes et al.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Deng et al. and Bhonde et al. with those of Hayes et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of brain metastatic NSCLC. One of ordinary skill in the art would have been motivated to do so, because Deng et al. teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of Deng et al. to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. Additionally Hayes et al. teach that NSCLC metastasizes to the brain. As such one of ordinary skill in the art would have been motivated to administer the composition of Deng et al. and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of Deng et al. and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of Deng et al., Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
Therefore the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention, as evidenced by the references.
Nonstatutory 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 8, 9, 11-15 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 19/527,673 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
The primary difference between the instant and conflicting claims is that the conflicting claims recite a combination of PRMT5 inhibitor and an EGFR inhibitor, such as Osimertinib.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
This is a provisional nonstatutory double patenting rejection.
Claims 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 19/527,673 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated to administer the composition of the conflicting claims and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of the conflicting claims and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of the conflicting claims, Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
This is a provisional nonstatutory double patenting rejection.
Claims 8, 9, 11-15 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 19/539,109 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
The primary difference between the instant and conflicting claims is that the conflicting claims recite a combination of PRMT5 inhibitor and an EGFR inhibitor, such as Osimertinib.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
This is a provisional nonstatutory double patenting rejection.
Claims 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 19/539,109 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated to administer the composition of the conflicting claims and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of the conflicting claims and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of the conflicting claims, Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
This is a provisional nonstatutory double patenting rejection.
Claims 8, 9, 11-15 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/606,942 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
The primary difference between the instant and conflicting claims is that the conflicting claims recite a combination of PRMT5 inhibitor and an EGFR inhibitor, such as Osimertinib.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
This is a provisional nonstatutory double patenting rejection.
Claims 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/606,942 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated to administer the composition of the conflicting claims and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of the conflicting claims and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of the conflicting claims, Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
This is a provisional nonstatutory double patenting rejection.
Claims 8, 9, 11-15 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/608,084 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
The primary difference between the instant and conflicting claims is that the conflicting claims recite a combination of PRMT5 inhibitor and an EGFR inhibitor, such as Osimertinib.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
This is a provisional nonstatutory double patenting rejection.
Claims 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/608,084 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated to administer the composition of the conflicting claims and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of the conflicting claims and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of the conflicting claims, Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
This is a provisional nonstatutory double patenting rejection.
Claims 8, 9, 11-15 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/608,406 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
The primary difference between the instant and conflicting claims is that the conflicting claims recite a combination of PRMT5 inhibitor and an EGFR inhibitor, such as Osimertinib.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
This is a provisional nonstatutory double patenting rejection.
Claims 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/608,406 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated to administer the composition of the conflicting claims and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of the conflicting claims and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of the conflicting claims, Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
This is a provisional nonstatutory double patenting rejection.
Claims 8, 9, 11-15 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/605,460 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021).
The primary difference between the instant and conflicting claims is that the conflicting claims recite a combination of PRMT5 inhibitor and an EGFR inhibitor, such as Osimertinib.
At p. 43 and 44, Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC. At p. 17, Bhonde et al. teach the EGFR inhibitor Osimertinib.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
This is a provisional nonstatutory double patenting rejection.
Claims 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 19/605,460 in view of Bhonde et al. (WO 2021/079302, international publication date: 04/29/2021), as applied to claims 8, 9, 11-15 and 18-20, and further in view of Hayes et al. (US 2013/0338040, publication date: 12/19/2013).
As indicated above one of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of the conflicting claims with those of Bhonde et al. to develop a composition comprising a PRMT5 inhibitor in combination with an EGFR inhibitor, such as Osimertinib, for the treatment of cancer. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims teach the elected PRMT5 inhibitor. Furthermore Bhonde et al. teach that PRMT5 inhibitors may be combined with a targeted agent/cellular activity modulator, such as an EGFR inhibitor, for the treatment of NSCLC, and Bhonde et al. teach the EGFR inhibitor Osimertinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Osimertinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC. The invention of the conflicting claims and Bhonde et al. meets the limitations of claims 8-14 and 18-20.
With respect to claim 15, Bhonde et al. teach that PRMT5 inhibitors may be administered with the EGFR inhibitors Afatinib, Erlotinib, or Gefitinib. One of ordinary skill in the art would have therefore been motivated to modify the teachings of the conflicting claims to comprise the administration of the EGFR inhibitor, Afatinib, Erlotinib, or Gefitinib, as there would have been a reasonable expectation that the resultant invention is effective in the treatment of various cancers, such as NSCLC, including NSCLC that is resistant to Osimertinib.
At [0003], Hayes et al. teach that “[n]on-small-cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the United States with brain metastasis as one of the most malicious complications, which leads to very high morbidity and mortality. Historically, the prognosis of NSCLC with brain metastasis has been poor, with a median overall survival of 4.5 months for patients treated with standard whole brain radiation therapy (WBRT) and 4-11 weeks in untreated patients. The prevalence of brain metastasis in NSCLC is reported to be increasing…”
One of ordinary skill in the art would have been motivated to administer the composition of the conflicting claims and Bhonde et al. to NSCLC patients with brain metastasis, because there would have been a reasonable expectation that the composition of the conflicting claims and Bhonde et al. would provide a therapeutic benefit to NSCLC patients with brain metastasis. The invention of the conflicting claims, Bhonde et al., and Hayes et al. meets the limitations of claims 16 and 17.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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