DETAILED ACTION
Claims 1 and 3-19 are pending.
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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 3-13, and 18) in the reply filed on 2/17/2026 is acknowledged. The traversal is on the ground(s) that there is not a serious search burden. This is not found persuasive because the instant claims are drawn to treating several unrelated conditions; post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS). The search of each condition, their standard of care, and their known interdictions requires a search of each one with a different search strategy. For example, the search of the art related to lung injury related to a coronavirus infection will not overlap with post-stroke brain ischemia-reperfusion injury. As such there is a serious search burden, and Applicant’s argument is not persuasive. Moreover, searching a “kit” as required in claims 14-15 requires searching pharmaceutical compositions of matter including the drug, pazopanib, and its equivalents. Furthermore, searching claims directed towards a biological assay for efficacy, claims 16-17 and 19 would require a completely different search strategy, looking for ROS production and the mechanism of action in certain models, regardless there is a serious search burden found as each invention would require a different search strategy in different classes and in different databases.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-17 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 3-13, and 18 are present for Examination and the subject of the Office Action below.
Priority
The instant application, filed 12/03/2025 is a Continuation of 19241602 , filed 06/18/2025, now abandoned. 19241602 is a Continuation of 18726486, filed 07/03/2024, now abandoned. 18726486 is a National Stage entry of PCT/US2023/060190, International Filing Date: 01/06/2023. PCT/US2023/060190 Claims Priority from Provisional Application 63357319, filed 06/30/2022.PCT/US2023/060190 Claims Priority from Provisional Application 63357499, filed 06/30/2022. PCT/US2023/060190 Claims Priority from Provisional Application 63296962, filed 01/06/2022. PCT/US2023/060190 Claims Priority from Provisional Application 63297061, filed 01/06/2022. PCT/US2023/060190 Claims Priority from Provisional Application 63296964, filed 01/06/2022. PCT/US2023/060190 Claims Priority from Provisional Application 63297057, filed 01/06/2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 8/19/2022, 11/8/2023, 3/4/2024, 3/8/2024, and 5/22/2025 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 USC § 102
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.
Claims 1, 3-13, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li, et al, WO 2013/148537.
Claim 1 is directed to a method of treating, ameliorating, and/or preventing at least one condition selected from the group consisting of post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof.
Li teaches substituted spirobicyclic compounds and methods of their use. It teaches treating lung fibrosis at paragraph [037], [0140], claim 14 and claim 17 by means of administration of the pharmaceutical composition containing pazopanib at paragraphs [034], [0130] and [0134] with at least one other pharmaceutically acceptable carrier at paragraph [0115]. The reference teaches that lung fibrosis can be treated with pazopanib alone or in combination with one or more other chemotherapeutic agents or other anti-proliferative agents, see paragraph [0128] to [0130]. The reference discloses oral administration or intravenously at paragraph [0110], [0112], [0244] and [0254]. The reference teaches administration times of one, two, or three times per day at the end of paragraph [0145]. The reference discloses that the pharmaceutical compositions are formulated in a dosage form adapted for administration to a patient by inhalation at paragraph [0110] and [0116]. The claimed invention deals with dosage in terms of a ratio based on the patient’s body weight as taught in the reference at paragraph [0126]. Paragraph of the reference teaches dosage of pazopanib of between 0.01 – 200 mg/kg body weight/day of the inhibitor can be administered to a patient at paragraph [0127]. The reference discloses use in mammals, especially humans in paragraphs [002], [0144] and the Abstract.
Claim Rejections - 35 USC § 102
Claims 1, 3-13, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xi, et al, United States Patent No. 9,718,841.
Claim 1 is directed to a method of treating, ameliorating, and/or preventing at least one condition selected from the group consisting of post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof.
Xi teaches bicyclic pyrazolone compounds and methods of their use. Xi teaches treating lung fibrosis and/or cancer at paragraphs (28), (32), and (143), and claim 12 and 16 by means of administration of the pharmaceutical composition containing pazopanib at paragraph (29) and claim 11 with at least one other pharmaceutically acceptable carrier at paragraphs (115) and (122). The reference teaches that lung fibrosis can be treated with pazopanib alone or in combination with one or more other chemotherapeutic agents or other anti-proliferative agents, see paragraph (155) and claim 10. The reference discloses oral administration at paragraph (106) to (107), (113) to (114), (193), and (452) or intravenously at paragraph (120), (193), (196), and (452). The reference teaches administration times of one, two, three, or four times per day at paragraph (194). The reference discloses that the pharmaceutical compositions are formulated in a dosage form adapted for administration to a patient by inhalation as a dry powder at paragraph (131). The claimed invention deals with dosage in terms of a ratio based on the patient’s body weight as taught in the reference at paragraph (196). The reference discloses overcoming side effects or other difficulties encountered with pazopanib administration at (e) of paragraph (198). Paragraph (98) of the reference teaches dosage ranges of from 0.5 mg to 1 g, or from 1 mg to 700 mg, or from 5 mg to 100 mg of pazopanib. The reference discloses use in mammals, especially humans in paragraph (1).
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.
US 11,166,953
Claims 1, 3-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,166,953. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims directed towards a method of treating, ameliorating, and/or preventing at least one condition selected from the group consisting of post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof.
‘953 is directed towards a method of treating or ameliorating acute lung injury (ALI) or lung fibrosis in a subject, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof, using an administration route selected from the group consisting of oral, parenteral, nasal, inhalational, intratracheal, intrapulmonary, and intrabronchial; wherein the pazopanib, or a salt or solvate thereof, is the only therapeutic agent administered to the subject to treat or ameliorate the ALI or lung fibrosis.
The ’953 claim anticipates the instant claim 1, therefore the instant invention is rejected for obvious double patenting.
US 11,890,283
Claims 1, 3-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,890,283. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating, ameliorating, and/or preventing at least one condition selected from the group consisting of post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof.
‘283 is directed towards a method of inducing reactive oxygen species (ROS) production by a neutrophil in a subject suffering from acute lung injury (ALI) or lung fibrosis, the method comprising administering to the subject an effective amount of pazopanib, or a salt or solvate thereof.
The ‘283 claim anticipates the instant claim 1, therefore the instant invention is rejected for obvious double patenting.
US 12,544,377
Claims 1, 3-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,544,377. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating, ameliorating, and/or preventing at least one condition selected from the group consisting of post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof.
‘377 is directed towards a method of treating or ameliorating acute lung injury (ALI) or lung fibrosis in a subject, the method comprising administering to the subject an effective amount of pazopanib, or a salt or solvate thereof, wherein the administered amount of the pazopanib, or salt or solvate thereof, is lower than an amount of pazopanib, or salt or solvate thereof, with which a subject suffering from cancer is dosed orally or systemically for cancer treatment.
The ‘377 claim anticipates the instant claim 1, therefore the instant invention is rejected for obvious double patenting.
US 11,497,747
Claims 1, 3-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,497,747. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating, ameliorating, and/or preventing at least one condition selected from the group consisting of post-stroke brain ischemia-reperfusion injury (IRI), ischemia-reperfusion injury (IRI) not caused by post-stroke brain ischemia, lung injury related to a coronavirus infection, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof.
‘747 is directed towards a method for treating, preventing, or reducing the severity of a lung injury associated with a coronavirus infection comprising administering to a human subject in need thereof a therapeutically effective amount of pazopanib, or a pharmaceutically acceptable salt or solvate thereof.
The ‘747 claim anticipates the instant claim 1, therefore the instant invention is rejected for obvious double patenting.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629