DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
The claim set filed on 11/21/2023 is acknowledged. Claims 1-35 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed on 11/21/2023, 4/15/2025, 11/18/2025 and 1/05/2026 are acknowledged and have been considered except where lined through.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-11, and 29-31 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Taiho Pharmaceuticals (WO2020/145374A1, 2020-07-17, priority 2019-01-11, US11078207B2, 2021-08-11 as English translation). Note: All references will be made to the US Patent.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Taiho Pharmaceuticals teach pyrimidine compounds having the general formula
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that inhibits HER2 activity and exhibits brain penetration properties and a pharmaceutical composition comprising the same (abstract). With regards to the compound, the Patent teaches a compound which is identical to that claimed in the instant application having the formula (
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(see claim 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claim 16 of the Patent). With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39). Regarding the administration, the Patent teaches that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (column 40, lines 16-25). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/ke/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
Claim(s) 1-5 and 29-31 is/are rejected under 35 U.S.C. 102(a)( 2) as being anticipated by Nakamura et al. (US12492208B2, 2025-12-09, priority date: 2020-07-15).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Nakamura teach a compound which is identical to that claimed in the instant application having the formula
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, in particular various crystal structures (Abstract and column 9, lines 19-50). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
Claim(s) 1-13, 29-31, 33 and 35 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Oguchi et al. (US20230255972A1, 2023-08-17, priority to 2020-07-15).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Oguchi et al. teach a tumor treating method using pyrimidine compounds having the general formula
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(abstract). With regards to the compound, Oguchi et al. teach a compound which is identical to that claimed in the instant application having the formula (
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(see Table 1, cmpd 11). With regards to the tumor, Oguchi et al. teach that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, Oguchi et al. teach that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). Regarding the administration, Oguchi et al. teach that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (paragraph 0446). Oguchi et al. further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line or Luciferase Gene-Introduced Exon 20 Insertion Mutant EGFR Expressing Cell Line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days or 12.5mg/kg/day or 25 mg/kg/day for 38 days(Test Example 11 and Test Example 13). Note: 12.5mg/kg/day given orally to a mouse equates to approximately 250 mg/day considering a typical lab mouse weighs between 20g and 25g.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 32-35 is/are rejected under 35 U.S.C. 103 as being obvious over Taiho Pharmaceuticals (WO2020/145374A1, 2020-07-17, priority 2019-01-11, US11078207B2, 2021-08-11 as English translation), as applied above to claims 1-7, 9-11, and 29-31 above. Note: All references will be made to the US Patent..
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Taiho Pharmaceuticals teach pyrimidine compounds having the general formula
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that inhibits HER2 activity and exhibits brain penetration properties and a pharmaceutical composition comprising the same (abstract). With regards to the compound, the Patent teaches a compound which is identical to that claimed in the instant application having the formula (
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(see claim 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claim 16 of the Patent). With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39). Regarding the administration, the Patent teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (column 40, lines 16-25). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/ke/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
The US Patent does not explicitly teach that the pyrimidine compounds is administered twice per day or in an amount of 5mg to about 480 mg or 15 mg to about 240 mg or administered daily for at least 28 days.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the US Patent in order to optimize the dosing protocols of the pyrimidine compounds for treating cancer. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-regarding at least the daily dose, the US Patent teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg.
Moreover, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claims 8 and 12-13 is/are rejected under 35 U.S.C. 103 as being obvious over Taiho Pharmaceuticals (WO2020/145374A1, 2020-07-17, priority 2019-01-11, US11078207B2, 2021-08-11 as English translation), as applied above to claims 1-7, 9-11, and 29-31 above, in view of Oguchi et al. (US20230255972A1, 2023-08-17, priority to 2020-07-15).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Taiho Pharmaceuticals teach pyrimidine compounds having the general formula
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that inhibits HER2 activity and exhibits brain penetration properties and a pharmaceutical composition comprising the same (abstract). With regards to the compound, the Patent teaches a compound which is identical to that claimed in the instant application having the formula (
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(see claim 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claim 16 of the Patent). With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39). Regarding the administration, the Patent teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (column 40, lines 16-25). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/ke/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
The US Patent does not explicitly teach that the cancer has a EGFR exon 20 insertion mutation or has an EGFR mutation.
Oguchi et al. teach a tumor treating method using pyrimidine compounds having the general formula
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(abstract). With regards to the compound, Oguchi et al. teach a compound which is identical to that claimed in the instant application having the formula (
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(see Table 1, cmpd 11). With regards to the tumor, Oguchi et al. teach that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, Oguchi et al. teach that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). Regarding the administration, Oguchi et al. teach that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (paragraph 0446). Oguchi et al. further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line or Luciferase Gene-Introduced Exon 20 Insertion Mutant EGFR Expressing Cell Line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days or 12.5mg/kg/day or 25 mg/kg/day for 38 days(Test Example 11 and Test Example 13). Note: 12.5mg/kg/day given orally to a mouse equates to approximately 250 mg/day considering a typical lab mouse weighs between 20g and 25g.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the US Patent to include cancers having EGFR mutations/amplification in view of the teachings of Oguchi et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Oguchi et al. teach that the pyrimidine compounds are useful in treating cancers harboring EGFR mutations/amplification.
Claims 14-17 is/are rejected under 35 U.S.C. 103 as being obvious over Taiho Pharmaceuticals (WO2020/145374A1, 2020-07-17, priority 2019-01-11, US11078207B2, 2021-08-11 as English translation), as applied above to claims 1-7, 9-11, and 29-31 above, in view of Pan et al. (Journal of Thoradic Oncology 2019; 14(11): 2003-2008).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Taiho Pharmaceuticals teach pyrimidine compounds having the general formula
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that inhibits HER2 activity and exhibits brain penetration properties and a pharmaceutical composition comprising the same (abstract). With regards to the compound, the Patent teaches a compound which is identical to that claimed in the instant application having the formula (
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(see claim 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claim 16 of the Patent). With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39). Regarding the administration, the Patent teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (column 40, lines 16-25). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/ke/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
The US Patent does not explicitly teach that the cancer is harboring an aberration in NRG1, wherein the aberration in NRG1 is an NRG1 fusion-driven cancer..
Pan et al. teach the detection of novel NRG1, EGFR and MET fusions in lung adenocarcinomas in the Chinese population (Title). In particular, Pan et al. teach that NGR1 fusions ranked the most prevelant fusions in common driver-negative lung adenocarcinoma from Chinese population (Conclusions)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the US Patent to include cancers having a NRG1 fusion in view of the teachings of Pan et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- The US patent teaches that the pyrimidine compounds are useful for treating various forms of lung cancer, and
-Pan et al. teach that NGR1 fusions ranked the most prevalent fusions in common driver-negative lung adenocarcinoma from Chinese population.
Claims 18-28 is/are rejected under 35 U.S.C. 103 as being obvious over Taiho Pharmaceuticals (WO2020/145374A1, 2020-07-17, priority 2019-01-11, US11078207B2, 2021-08-11 as English translation), as applied above to claims 1-7, 9-11, and 29-31 above, in view of Kunte et al. (Cancer 2020;126:4278-4288).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
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that inhibits HER2 activity and exhibits brain penetration properties and a pharmaceutical composition comprising the same (abstract). With regards to the compound, the Patent teaches a compound which is identical to that claimed in the instant application having the formula (
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(see claim 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claim 16 of the Patent). With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39). Regarding the administration, the Patent teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (column 40, lines 16-25). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/ke/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
The US Patent does not explicitly teach that the cancer is unresectable or recurrent/refractor HER2-positive cancer, wherein the cancer is refractory to tyrosine kinase inhibitors or HER2-antibodies..
Kunte et al. teach that human epidermal growth factor receptor 2 (HER2) is overexpressed in approximately 20% of all breast cancers, wherein prior to the development of HER2-antibodies was associated with a rather poor prognosis (Abstract). Kunte et al. teaches that as successful as HER2-poitive-target drugs have been in extending OS in MBC, drug resistance remains a major clinical problem, and most patients eventually progress (page 4278, 2nd full paragraph). Despite drug resistance being a major problem, Kunte et al. teaches that new HER-2 antibodies have been developed which overcome resistance. For example, Kunte et al. teach that Margetuximab is a chimeric monoclonal anti-HER2 antibody which has shown the ability to overcome trastuzumab resistance (page 4282, 2nd column (Margetuximab). More recently, Kunte et al. discuss the results of an international, placebo-controlled randomized phase 3 trial (A study of Tucatinib vs. Placebo in combination with Capecitabine and Trastuzumab), wherein the FDA granted approval of this combination in the treatment of patients with unresectable, HER2-positive, locally advanced breast cancer or MBC after at least 1 prior line of HER2-directed therapy in the metastatic setting (page 4282, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the US Patent to include cancers which are unresectable or whom have developed resistance to traditional HER2 directed therapies. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Kunte et al. provides numerous successes in HER2 directed therapies in patients suffering from cancers which are unresectable or whom have developed resistance to traditional HER2 directed therapies.
Claims 32 and 34 is/are rejected under 35 U.S.C. 103 as being obvious over Oguchi et al. (US20230255972A1, 2023-08-17, priority to 2020-07-15), as applied above to claims 1-13, 29-31, 33 and 35 above.
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Oguchi et al. teach a tumor treating method using pyrimidine compounds having the general formula
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(abstract). With regards to the compound, Oguchi et al. teach a compound which is identical to that claimed in the instant application having the formula (
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(see Table 1, cmpd 11). With regards to the tumor, Oguchi et al. teach that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, Oguchi et al. teach that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). Regarding the administration, Oguchi et al. teach that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (paragraph 0446). Oguchi et al. further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line or Luciferase Gene-Introduced Exon 20 Insertion Mutant EGFR Expressing Cell Line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days or 12.5mg/kg/day or 25 mg/kg/day for 38 days(Test Example 11 and Test Example 13). Note: 12.5mg/kg/day given orally to a mouse equates to approximately 250 mg/day considering a typical lab mouse weighs between 20g and 25g.
The publication does not explicitly teach that the pyrimidine compounds is administered twice per day or 15 mg to about 240 mg.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the publication in order to optimize the dosing protocols of the pyrimidine compounds for treating cancer. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-regarding at least the daily dose, the publication teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg.
Moreover, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 14-17 is/are rejected under 35 U.S.C. 103 as being obvious over Oguchi et al. (US20230255972A1, 2023-08-17, priority to 2020-07-15), as applied above to claims 1-13, 29-31, 33 and 35 above, in view of Pan et al. (Journal of Thoradic Oncology 2019; 14(11): 2003-2008).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Oguchi et al. teach a tumor treating method using pyrimidine compounds having the general formula
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(abstract). With regards to the compound, Oguchi et al. teach a compound which is identical to that claimed in the instant application having the formula (
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(see Table 1, cmpd 11). With regards to the tumor, Oguchi et al. teach that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, Oguchi et al. teach that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). Regarding the administration, Oguchi et al. teach that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (paragraph 0446). Oguchi et al. further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line or Luciferase Gene-Introduced Exon 20 Insertion Mutant EGFR Expressing Cell Line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days or 12.5mg/kg/day or 25 mg/kg/day for 38 days(Test Example 11 and Test Example 13). Note: 12.5mg/kg/day given orally to a mouse equates to approximately 250 mg/day considering a typical lab mouse weighs between 20g and 25g.
Oguchi et al. does not explicitly teach that the cancer is harboring an aberration in NRG1, wherein the aberration in NRG1 is an NRG1 fusion-driven cancer..
Pan et al. teach the detection of novel NRG1, EGFR and MET fusions in lung adenocarcinomas in the Chinese population (Title). In particular, Pan et al. teach that NGR1 fusions ranked the most prevelant fusions in common driver-negative lung adenocarcinoma from Chinese population (Conclusions)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Oguchi et al. to include cancers having a NRG1 fusion in view of the teachings of Pan et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Oguchi et al. teaches that the pyrimidine compounds are useful for treating various forms of lung cancer, and
-Pan et al. teach that NGR1 fusions ranked the most prevalent fusions in common driver-negative lung adenocarcinoma from Chinese population.
Claims 18-28 is/are rejected under 35 U.S.C. 103 as being obvious over Oguchi et al. (US20230255972A1, 2023-08-17, priority to 2020-07-15), as applied above to claims 1-13, 29-31, 33 and 35 above, in view of Kunte et al. (Cancer 2020;126:4278-4288).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Oguchi et al. teach a tumor treating method using pyrimidine compounds having the general formula
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(abstract). With regards to the compound, Oguchi et al. teach a compound which is identical to that claimed in the instant application having the formula (
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(see Table 1, cmpd 11). With regards to the tumor, Oguchi et al. teach that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, Oguchi et al. teach that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). Regarding the administration, Oguchi et al. teach that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (paragraph 0446). Oguchi et al. further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line or Luciferase Gene-Introduced Exon 20 Insertion Mutant EGFR Expressing Cell Line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days or 12.5mg/kg/day or 25 mg/kg/day for 38 days(Test Example 11 and Test Example 13). Note: 12.5mg/kg/day given orally to a mouse equates to approximately 250 mg/day considering a typical lab mouse weighs between 20g and 25g.
The publication does not explicitly teach that the cancer is unresectable or recurrent/refractor HER2-positive cancer, wherein the cancer is refractory to tyrosine kinase inhibitors or HER2-antibodies..
Kunte et al. teach that human epidermal growth factor receptor 2 (HER2) is overexpressed in approximately 20% of all breast cancers, wherein prior to the development of HER2-antibodies was associated with a rather poor prognosis (Abstract). Kunte et al. teaches that as successful as HER2-poitive-target drugs have been in extending OS in MBC, drug resistance remains a major clinical problem, and most patients eventually progress (page 4278, 2nd full paragraph). Despite drug resistance being a major problem, Kunte et al. teaches that new HER-2 antibodies have been developed which overcome resistance. For example, Kunte et al. teach that Margetuximab is a chimeric monoclonal anti-HER2 antibody which has shown the ability to overcome trastuzumab resistance (page 4282, 2nd column (Margetuximab). More recently, Kunte et al. discuss the results of an international, placebo-controlled randomized phase 3 trial (A study of Tucatinib vs. Placebo in combination with Capecitabine and Trastuzumab), wherein the FDA granted approval of this combination in the treatment of patients with unresectable, HER2-positive, locally advanced breast cancer or MBC after at least 1 prior line of HER2-directed therapy in the metastatic setting (page 4282, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the publication to include cancers which are unresectable or whom have developed resistance to traditional HER2 directed therapies. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Kunte et al. provides numerous successes in HER2 directed therapies in patients suffering from cancers which are unresectable or whom have developed resistance to traditional HER2 directed therapies.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9-11, and 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 19 of U.S. Patent No. US11078207B2 (2021-08-11) alone or alternatively, Claims 1-13, 29-31, 33 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 19 of U.S. Patent No. US11078207B2 (2021-08-11) in view of Oguchi et al. (US20230255972A1, 2023-08-17, priority to 2020-07-15).
The US Patent claims a compound represented by formula I:
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which encompasses the instantly claimed compound, as well as, a compound which is identical to that claimed in the instant application having the formula
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, and pharmaceutical composition comprising said compound (see claims 1-13 and 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claims 14-16 of the Patent).
The US Patent does not specifically claim that the tumor is a HER2 tumor. The portion of the specification of US11078207B2 that describes subject matter that falls within the scope of claim 1 may be relied upon to properly construe the scope of that claim, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)).
With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39).
Assuming arguendo that the examiner errored in employing MPEP (MPEP 804(II)(B)(1)), Oguchi et al. teach a tumor treating method using pyrimidine compounds having the general formula
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(abstract). With regards to the compound, Oguchi et al. teach a compound which is identical to that claimed in the instant application having the formula (
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(see Table 1, cmpd 11). With regards to the tumor, Oguchi et al. teach that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, Oguchi et al. teach that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). Regarding the administration, Oguchi et al. teach that they daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (paragraph 0446). Oguchi et al. further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line or Luciferase Gene-Introduced Exon 20 Insertion Mutant EGFR Expressing Cell Line, wherein 25mg/kg/day or 50 mg/kg/day of the test compound was orally administered to the mice once a day, every day, for 21 days or 12.5mg/kg/day or 25 mg/kg/day for 38 days(Test Example 11 and Test Example 13). Note: 12.5mg/kg/day given orally to a mouse equates to approximately 250 mg/day considering a typical lab mouse weighs between 20g and 25g.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by the US Patent to include cancers having EGFR mutations/amplification in view of the teachings of Oguchi et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Oguchi et al. teach that the pyrimidine compounds are useful in treating cancers harboring HER2/EGFR mutations/amplification.
Claim 1-3, 5-6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 36-37 and 49 of copending Application No. 18016103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method of treating a disease associated with EGFR, comprising administering an effective amount of compound (2) which is identical to the compound claimed in the instant application, wherein the disease associated with EGFR is a malignant tumor having EGFR overexpression, amplification or an EGFR mutation such as lung cancer, breast cancer, colorectal cancer or brain tumor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 29-31, 33 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 16-17 of copending Application No. 18015616 (reference application) alone or alternatively, Claims 1-7, 9-11 and 29-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 16-17 of copending Application No. 18015616 (reference application) in view of Taiho Pharmaceuticals (WO2020/145374A1, 2020-07-17, priority 2019-01-11, US11078207B2, 2021-08-11 as English translation). Note: All references will be made to the US Patent.
The reference application claims an antitumor agent composition comprising a antitumor pyrimidine compound and at least one additional antitumor agent and a method of treating a tumor comprising administering an effective amount of a pyrimidine compound or salt thereof and at least one additional antitumor agent to a patient in need thereof, wherein the pyrimidine compound is a compound represented by the following formula:
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. The reference application further claims that the pyrimidine compound is compound (2) which is identical to the compound claimed in the instant application (claim 5).
The reference application does not specifically claim that the tumor is a HER2 or EGFR tumor. The portion of the specification of reference application that describes subject matter that falls within the scope of claim 1 may be relied upon to properly construe the scope of that claim, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)).
With regards to the tumor, the reference application teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2/EGFR overexpression, HER2/EGFR gene amplification and HER2/EGFR mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (paragraphs 0387, 0450-0454). With regards to the HER2/EGFR mutations, The reference application teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (paragraph 0417). (Note: all references are made to the PGPUB US20230255972A1 as the specification)
Assuming arguendo that the examiner errored in employing MPEP (MPEP 804(II)(B)(1)), Taiho Pharmaceuticals teach pyrimidine compounds having the general formula
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that inhibits HER2 activity and exhibits brain penetration properties and a pharmaceutical composition comprising the same (abstract). With regards to the compound, the Patent teaches a compound which is identical to that claimed in the instant application having the formula (
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(see claim 19 of the patent). Moreover, the Patent teaches a method of treating a tumor in a subject, comprising orally administering to a subject in need thereof a therapeutically effective amount of a pyrimidine compound of formula I (claim 16 of the Patent). With regards to the tumor, the Patent teaches that the compounds have excellent inhibitory activity in malignant tumors having HER2 overexpression, HER2 gene amplification and HER2 mutations, wherein the tumors include, but are not limited to, lung cancer, brain cancer, as well as, cancer such as lung cancer that have metastasized to the brain (Column 27, lines 44-50 and Column 40, lines 34-67). With regards to the HER2 mutations, the Patent teaches that the compounds of the invention selectively inhibits insertion mutants such as exon 20 insertion mutation (column 28, lines 35-39). Regarding the administration, the Patent teaches that the daily dose of a drug is different depending on the symptoms, body weight, age, sex and the like of the subject, but will range from a daily dose of 0.05 mg to 5000 mg (column 40, lines 16-25). The Patent further provides a confirmation of the antitumor effects of the compound on direct brain transplantation of luciferase gene-introduced HER2 expressing human stomach cancer cell line, wherein 25mg/kg/day or 50 mg/ke/day of the test compound was orally administered to the mice once a day, every day, for 21 days (Test Example 8).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the reference application to include cancers having HER2 mutations/amplification in view of the teachings of Taiho Pharmaceuticals.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Taiho Pharmaceuticals teach that the pyrimidine compounds are useful in treating cancers harboring HER2 mutations/amplification.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626