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
Status of Application, Amendments, and/or Claims
1. Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 are pending and currently under consideration
Information Disclosure Statement
2. The information disclosure statement filed on 05/19/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 05/19/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
5. Basis for 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. See 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);and, 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/ guidance/eTD-info-I.jsp.
6. Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11-20 of US Patent No. 10,450,374 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 of the present application are drawn to a method for treating a solid tumor, the method comprising administering to a subject in need thereof an effective amount of an antibody that binds humanGalectin-9 (anti-Galectin-9 antibody), wherein the anti-Galectin-9 antibody comprises a light chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 1-3, respectively, and a heavy chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 4-6, respectively; wherein the subject has one or more of the following features: (i) has no resectable cancer; (ii) has no infection by SARS-CoV-2; (iii) has no active brain or leptomeningeal metastasis; and (iv) has unresectable metastatic cancer, which is adenocarcinoma, optionally squamous cell carcinoma.
Claims 11-20 of US Patent No. 10,450,374 B2 are drawn to a method for treating a solid tumor that expresses galectin-9 in a human subject, comprising administering to the human a subject in need thereof an effective amount of a pharmaceutical composition comprising an antibody, wherein the antibody comprises a heavy chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 361, 388, and 406, respectively, and a light chain complementary determining region comprising CDR1, CDR2, and CDR3 set forth in SEQ ID NOS: 328, 329, and 352, respectively. The antibody is identical to the antibody recited in claim 1 of the present application.
Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 of the instant application and claims 11-20 of US Patent No. 10,450,374 B2 vary in scope and are obvious over each other.
7. Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/250,165, 18/556,387, 18/556,394, 17/631378, 18/253, 754, 18/253,756, 17/607,879, and 17/851,930. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 of the present application are drawn to a method for treating a solid tumor, the method comprising administering to a subject in need thereof an effective amount of an antibody that binds humanGalectin-9 (anti-Galectin-9 antibody), wherein the anti-Galectin-9 antibody comprises a light chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 1-3, respectively, and a heavy chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 4-6, respectively; wherein the subject has one or more of the following features: (i) has no resectable cancer; (ii) has no infection by SARS-CoV-2; (iii) has no active brain or leptomeningeal metastasis; and (iv) has unresectable metastatic cancer, which is adenocarcinoma, optionally squamous cell carcinoma.
Claims 1, 4-7, 9-18, 21-27, 29-30, 32, 37, 39-43, 45, and 48 of copending Application No. 18/250, 165 are drawn to a method for treating an ocular melanoma in a human subject, comprising administering to the human subject in need thereof an effective amount of a pharmaceutical composition comprising an anti-galectin-9 antibody, which is identical to the antibody recited in claim 1 of the present application.
Thus, claims 1, 4-7, 9-18, 21-27, 29-30, 32, 37, 39-43, 45, and 48 of copending Application No. 18/250, 165 are related to the instant claims as species (an ocular melanoma) to genus (solid tumor). A species renders its genus obvious and thus anticipates the genus.
This is a provisional nonstatutory double patenting rejection.
Likewise, claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/556,387, 18/556,394, 17/631378, 18/253,254, 18/253,756, 17/607,879, and 17/851,930.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
8. The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “which is adenocarcinoma”, and the claim also recites “optionally squamous cell carcinoma”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections under 35 USC § 103(a)
10. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
11. Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2020/223702 A1 (International publication date: 05 November 2020; International filing date: 01 May 2020) or US 2022/0285896 A1 (Pub. Date: Jun 16, 2022; PCT filed: May 1, 2020). The following rejection is based upon WO 2020/223702 A1.
WO 2020/223702 A1 teaches a method for treating a solid tumor, the method comprising administering to a subject in need thereof an effective amount of an antibody that binds humanGalectin-9 (anti-Galectin-9 antibody), wherein the anti-Galectin-9 antibody comprises a light chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 1-3, respectively, and a heavy chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 4-6, respectively; wherein the anti-Galectin-9 antibody is administered to the subject at a dose of about 1 mg/kg to about 32 mg/kg.
WO 2020/223702 A1 teaches all the limitations of claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 of the present application (see claims 1-32) except a limitation recited in claim 1, “wherein the subject has one or more of the following features: (i) has no resectable cancer; (ii) has no infection by SARS-CoV-2; (iii) has no active brain or leptomeningeal metastasis; and (iv) has unresectable metastatic cancer, which is adenocarcinoma, optionally squamous cell carcinoma”. The antibody is identical to the antibody recited in claim 1 of the present application.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to treat a solid tumor in a subject, wherein the subject has one or more of the following features: (i) has no resectable cancer; (ii) has no infection by SARS-CoV-2; (iii) has no active brain or leptomeningeal metastasis; and (iv) has unresectable metastatic cancer, which is adenocarcinoma, optionally squamous cell carcinoma with a reasonable expectation of success. One would have been motivated to do so because WO 2020/223702 A1 teaches a method treating a solid tumor in a subject in need thereof in general.
12. Claims 1-6, 8-10, 11-13, 15-16, 19-20, 22, 24, 26, and 31-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 10,450,374 B2
US 10,450,374 B2 teaches a method for treating a solid tumor that expresses galectin-9 in a human subject, comprising administering to the human a subject in need thereof an effective amount of a pharmaceutical composition comprising an antibody, wherein the antibody comprises a heavy chain complementary determining region comprising CDR1, CDr2, and CDR3 set forth in SEQ ID NOS: 361, 388, and 406, respectively, and a light chain complementary determining region comprising CDR1, CDR2, and CDR3 set forth in SEQ ID NOS: 328, 329, and 352, respectively (claims 11-20). The antibody is identical to the antibody recited in claim 1 of the present application.
US 10,450,374 B2 does not teach a limitation recited in claim 1, “wherein the subject has one or more of the following features: (i) has no resectable cancer; (ii) has no infection by SARS-CoV-2; (iii) has no active brain or leptomeningeal metastasis; and (iv) has unresectable metastatic cancer, which is adenocarcinoma, optionally squamous cell carcinoma”.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to treat a solid tumor in a subject, wherein the subject has one or more of the following features: (i) has no resectable cancer; (ii) has no infection by SARS-CoV-2; (iii) has no active brain or leptomeningeal metastasis; and (iv) has unresectable metastatic cancer, which is adenocarcinoma, optionally squamous cell carcinoma with a reasonable expectation of success. One would have been motivated to do so because WO 2020/223702 A1 teaches a method treating a solid tumor in a subject in need thereof in general. It is also routine for one of skill in the art to determine the dosage and injection route for administering a drug, such as an antibody.
Conclusion
13. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
March 14, 2026