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
Claims 16-48 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 16-41; directed to a compound of Formula 1) and a species of Compound 30 without traverse in the reply filed February 11, 2026 is acknowledged.
The Examiner was able to search the scope of the elected species and compounds encompassed without undue burden, the restriction(election) requirement previously set forth in the Office Action mailed December 16, 2025 has been withdrawn.
Claims 42-48 have been searched and examined on the merits in addition to claims 16-41. Applicant’s elected species and invention has been found free of the prior art; however, the present claims are not allowable under for non-statutory double patenting issues, which are discussed below.
In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 08/06/2024 and 02/11/2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Drawings
Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear. See (37 CFR 1.84(u)(1). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 16-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 11 of U.S. Patent No. 11,466,000 (henceforth the ‘000 Patent). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a similar genus of compounds of Formula 1.
Claim 1 of the ‘000 Patent discloses a compound of Formula 1. See instant claim 16. Claim 1 of the ‘000 Patent discloses where R5 in the compound of Formula 1 is an aryl of 3-12 atoms substituted by at least one substituent J, where J comprises halogen. See instant claims 27-40.
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Claim 10 of the ‘000 Patent discloses a pharmaceutical composition comprising a compound of claim 1, or a stereoisomer, hydrate, or pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carriers. See instant claim 41.
Claim 11 of the ‘000 Patent discloses a several compounds which are encompassed by instant Formula 1 where R1 is methoxy, R2 is hydrogen, R4 is
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, and R5 is phenyl. See, for example, the first compound of claim 11 of the ‘000 Patent in column 1862 (pictured below); also see instant claims 16-21, 23-26.
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Claim 11 of the ‘000 Patent also discloses compounds (see last compound of column 1865 and last compound of column 1872) encompassed by instant Formula 1 where R5 is
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and
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. See instant claims 27 and 30.
Claims 16-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 and 38-39 of U.S. Patent No. 12,157,730. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a similar genus of compounds of Formula 1.
Claim 1 of the ‘730 Patent discloses a method of treating cancer in a patient in need thereof, wherein the cancer in the patient comprises one or more mutations in EGFR or HER2, comprising administering to the patient an effective amount of a compound of Formula 1. See instant claim 16 and 42. Claim 1 of the ‘730 Patent discloses where R5 in the compound of Formula 1 is an aryl of 3-12 atoms substituted by at least one substituent J, where J comprises halogen. See instant claims 27-40.
Claim 10 of the ‘730 Patent discloses a method of treating cancer in a patient in need thereof, wherein the cancer in the patient comprises one or more mutations in EGFR or HER2, comprising administering to the patient several compounds which are encompassed by instant Formula 1 where R1 is methoxy, R2 is hydrogen, R4 is
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, and R5 is phenyl. See, for example, the first compound of claim 10 of the ‘730 Patent in column 1877 (pictured below); also see instant claims 16-21 and 23-26.
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Claim 10 of the ‘730 Patent also discloses compounds (see last compound of column 1879 and compounds of column 1886-1887) encompassed by instant Formula 1 where R5 is
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,
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,
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and
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. See instant claims 27-30.
Claim 38 of the ‘730 Patent discloses the method of claim 10 of the ‘730 Patent, wherein the one or more mutations in EGFR is selected from the group consisting of EGFR Del19/T790M, EGFR L858R/T790M, EGFR L858R, EGFR Exon20 ins NPH, EGFR Exon20 ins SYD, EGFR Exon20 ins FQEA, EGFR Exon20 ins H, and EGFR Exon20 ins ASV, and wherein the mutation in HER2 is Her2 Exon20 ins YVMA. See instant claim 43.
Claim 39 of the ‘730 Patent discloses the method of claim 10 of the ‘730 Patent, wherein the cancer in the patient is selected from the group consisting of pseudomyxoma, intrahepatic biliary tract cancer, hepatoblastoma, liver cancer, thyroid cancer, colon cancer, testicular cancer, myelodysplastic syndrome, glioblastoma, oral cancer, cleft lip cancer, mycelia, acute myelogenous leukemia, acute lymphocytic leukemia, basal cell carcinoma, ovarian cell carcinoma, Ovarian germ cell carcinoma, male breast cancer, brain cancer, pituitary adenoma, multiple myeloma, gallbladder cancer, biliary tract cancer, colon cancer, chronic myelogenous leukemia, chronic lymphocytic leukemia, retinoblastoma, choroidal melanoma, barter bulge cancer, bladder cancer, peritoneal cancer, parathyroid cancer, Adrenal cancer, non-sinus cancer, non-small cell lung cancer, tongue cancer, astrocytoma, small cell lung cancer, pediatric brain cancer, pediatric lymphoma, pediatric leukemia, small intestine cancer, meningioma, esophageal cancer, glioma, renal cancer, kidney cancer, heart cancer, duodenal cancer, Malignant soft tissue cancer, malignant bone cancer, malignant lymphoma, malignant mesothelioma, malignant melanoma, eye cancer, vulvar cancer, ureteral cancer, urethral cancer, primary site unknown cancer, gastric lymphoma, gastric cancer, gastric carcinoma, gastrointestinal interstitial cancer, Wilms cancer, breast cancer, sarcoma, penile cancer, pharyngeal cancer, pregnant villi Diseases, cervical cancer, endometrial cancer, uterine sarcoma, prostate cancer, metastatic bone cancer, metastatic brain cancer, mediastinal cancer, rectal cancer, rectal carcinoma, vaginal cancer, spinal carcinoma, auditory nerve sheath cancer, pancreatic cancer, salivary gland cancer, Kaposi's sarcoma, Paget's disease, tonsils Cancer, squamous cell carcinoma, lung adenocarcinoma, lung cancer, lung squamous cell carcinoma, skin cancer, anal cancer, rhabdomyosarcoma, laryngeal cancer, pleural cancer, blood cancer, and thymic cancer. See instant claims 44-48.
Conclusion
Claims 16-48 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626