Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendment and Arguments
The Amendment filed on 12/23/2025 in response to the previous Non-Final Office Action (7/2/2025) is acknowledged and has been entered.
Claims 1-39 are cancelled.
Claims 40-64 are pending and examined for a method of treating a patient with GD2 positive cancer comprising administering a preparation comprising anti-GD2 antibody ch14.18/CHO or ch14.18/SP2.0 on merits.
Rejections/Objection Withdrawn
The rejections of Claims 40-64 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over
Claim 1-18 of U.S. Patent No. 9,777,068 (original application 14/409,161),
claims 1-22 of U.S. Patent No.11,447,565 (original application 15/700,538),
claims 1-121 of U.S. Patent No. 10,294,305 (original application 13/182776) are withdrawn in view of Terminal Disclaimers filed and approved.
Rejection Maintained and response to applicant’s argument:
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 obviousness-type 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); 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
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.
Over Patents:
Claims 40-64 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over
Claim 1 of U.S. Patent No. 10,995,147 (original application 16/920,880), and
Claims 1-26 of U.S. Patent No. 11,492,412 (original application 17/190792).
Both patents are from the same family.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same method of treating same disease conditions with the same material ch14.18/CHO and ch1414.18/SP2/0 antibody. The claims of patents would anticipate or be obvious over presently claimed invention.
The instant claims are directed to
a method of treating a GD2 positive cancer comprising infusion a preparation comprising anti-GD2 antibody to a patient for 24 hours/day at daily dose at 1-25 mg/m2 of anti-GD2 antibody, and at dose 50-150 mg/m2/cycle,
wherein the antibody to GD2 includes ch14.18/CHO and ch1414.18/SP2/0,
wherein the method further includes administering IL-2, GM-CSF, analgesics and wherein the cancer includes neuroblastoma, melanoma….small cell lung cancer….
wherein the method further comprising administering morphine and/or an analgesic to the patient.
The instant claims are further directed the claimed method comprising administering the ch14.18/CHO and ch1414.18/SP2/0 followed by isotretinoin or another retinoid.
The claims of U.S. Patent ‘147 are drawn to
A method of treating a high-risk neuroblastoma in a pediatric patient, the method comprising: administering to the patient a ch14.18/SP2/0 chimeric anti-GD2 antibody at a dose of 17.5 mg/m2/day as an intravenous infusion over 10 or more hours per day up to 20 hours per day over 4 consecutive days in a cycle having from 24 to 32 days, for at least 1 and up to 5 cycles.
The claims of U.S. Patent ‘412 are drawn to
A method of treating a high-risk neuroblastoma in a patient, the method comprising: administering to the patient a ch14.18/CHO chimeric anti-GD2 antibody or a ch14.18/SP2/0 chimeric anti-GD2 antibody at a dose of 17.5 mg/m2/day over at least 10 hours per day over 4 consecutive days in a cycle having from 24 to 32 days (claim 1),
A method of treating a high-risk neuroblastoma in a patient, the method comprising: administering to the patient a ch14.18/CHO chimeric anti-GD2 antibody or a ch14.18/SP2/0 chimeric anti-GD2 antibody at a dose of 17.5 mg/m.sup.2/day as an intravenous infusion over 4 consecutive days; wherein the anti-GD2 antibody comprises a heavy chain and a light chain, the heavy chain encoded by the nucleic acid sequence of SEQ ID NO:2 and the light chain encoded by the nucleic acid sequence of SEQ ID NO:1; wherein the 4 consecutive days are comprised in a cycle having from 24 to 32 days; wherein the administering is for one treatment period of 4 consecutive days per cycle, for a total of 5 cycles; and wherein in each of cycles 1, 3, and 5 of the 5 cycles, the administering of the anti-GD2 antibody is on the fourth day to the seventh day of each of the cycles 1, 3, and 5, and in each of cycles 2 and 4 of the 5 cycles, the administering of the anti-GD2 antibody is on the eighth day to the eleventh day of each of the cycles 2 and 4. (claim 19);
wherein the administering of the anti-GD2 antibody is for a total of 5 cycles; in each of cycles 1, 3, and 5 of the 5 cycles, the administering of the anti-GD2 antibody is on the fourth day to the seventh day of each of the cycles 1, 3, and 5; in each of cycles 2 and 4 of the 5 cycles, the administering of the anti-GD2 antibody is on the eighth day to the eleventh day of each of the cycles 2 and 4; and administering retinoic acid in each of cycles 1, 3, and 5 of the 5 cycles on the eleventh day to the twenty-fourth day of the cycles 1, 3, and 5; and administering retinoic acid in each of cycles 2 and 4 of the 5 cycles on the fifteenth day to the twenty-eighth day of the cycles 2 and 4,
wherein the method further comprising in each of cycles 1, 3, and 5 of the 5 cycles, administering GM-CSF on the first day to the fourteenth day of the cycles 1, 3, and 5, wherein the GM-CSF is administered at a dose of 250 μg/m.sup.2/day by subcutaneous injection or by IV infusion over 2 hours.
wherein the patient has previously been treated with one or more therapies selected from the group consisting of surgery, chemotherapy, radiation therapy, myeloablative therapy (MAT), metaiodobenzylguanidine scintigraphy (mIBG), vaccine therapy, stem cell transplantation, and retinoid treatment.
The claims recited in both patent ‘147and patent ‘412 and present claims are drawn to the same methods for treating GD2 positive cancers including neuroblastoma etc. comprising administering the same antibody ch14.18/CHO or ch14.18/SP2/0 with the same doses and schedules or within the ranges. The claims ‘412 patent and present application also administrate Morphine or an analgesic. The claims of two patents would anticipate and be obvious over the presently claims.
Claims 40-64 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over
Claims 1-16 of U.S. Patent No. 9,840,566 (original application 15/036,519),
Claims 1-13 of U.S. Patent No. 11,597,775 (original application 15/824055).
Both patents are from the same family.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same method of treating same disease conditions with the same material ch14.18/CHO and ch1414.18/SP2/0 antibody. The claims of patents would anticipate or be obvious over presently claimed invention.
The instant claims are directed to as set forth above,
The claims of U.S. Patent ‘566 are drawn to
A method of treating a GD2 positive cancer in a patient comprising administering a preparation comprising a chimeric or humanized anti-GD2 antibody to the patient without concomitantly administering IL-2 within the same treatment cycle and/or within the same overall treatment period, wherein the anti-GD2 antibody is administered to the patient in a dose of 1 to 25 mg/m2/day and 50 to 150 mg/m2/cycle as a continuous infusion for 24 hours per day, and
wherein a GD2 positive cancer is treated in the patient,
wherein the anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0,
wherein the anti-GD2 antibody has the light chain amino acid sequence of SEQ ID NO:3 and/or the heavy chain amino acid sequence of SEQ ID NO:4, or fragments or homologs thereof with the same or similar native qualitative activity,
wherein the preparation is administered to the patient in a dose of 50, 60, 65, 68, 70, 75, 80, 100, 120, or 150 mg/m2/cycle,
wherein the patient suffers from primary refractory or relapsed high-risk neuroblastoma, or from minimal residual disease in high-risk neuroblastoma,
wherein the administering ch14.18/CHO or ch14.18/SP2/0 concomitantly with IL-2, GM-C SF and/or another cytokine.
The claims of U.S. Patent ‘775 are drawn to
A method of treating a GD2 positive cancer in a patient comprising administering a preparation comprising an anti-GD2 antibody to the patient without concomitantly administering IL-2 within the same treatment cycle and/or within the same overall treatment period, wherein a GD2 positive cancer is treated in the patient, wherein the anti-GD2 antibody is a 14.18 antibody, and wherein the preparation is administered to the patient in a dose of 10 mg/m2/day for 10 consecutive days or in a dose of 15, 20, or 25 mg/m2/day for 4 consecutive days,
wherein the anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0,
wherein the anti-GD2 antibody has the light chain amino acid sequence of SEQ ID NO:3 and/or the heavy chain amino acid sequence of SEQ ID NO:4, or fragments or homologs thereof with the same or similar native qualitative activity,
wherein the preparation is administered to the patient in a dose of 50-150 mg/m2/cycle,
wherein the administering ch14.18/CHO or ch14.18/SP2/0 concomitantly with IL-2, GM-C SF and/or another cytokine.
The claims in both patent ‘566 and patent ‘775 and present claims are drawn to the same methods for treating GD2 positive cancers including neuroblastoma etc. comprising administering the same antibody ch14.18/CHO or ch14.18/SP2/0 with the same doses and schedule or within the ranges. The claimed SEQ ID NOs: 3 and 4 are the light chain and heavy chain of ch14.18 antibody, therefore, the claims of two patents would anticipate and be obvious over the presently claims.
Response to applicant’s arguments:
At page 7, applicant argues:
The present application claims priority to PCT/EP2012/064970, filed July 31, 2012, which is a continuation-in-part of PCT/EP2012/061618, …….. By contrast, each of the asserted references-U.S. Patent Nos. 10,995,147 ("'147"), 11,492,412 ("'412"), 9,840,566 ("'566"), and 11,597,775 ("'775")-claims the benefit of PCT/EP2014/073515, filed November 21, 2014, which itself is a continuation-in-part of U.S. Appl. No. 14/086,696, …….
Hence, each of the references has a later effective filing date than the present application.
The PTAB's recent decision in Ex Parte Baurin, Appeal 2024-002920 (PTAB Nov. 6, 2024), confirms that a later-filed, later-expiring unrelated patent is not a proper obviousness-type double patenting (ODP) reference against an earlier-filed, earlier-expiring application, because it does not extend the life of an earlier patent and applies the doctrine in the wrong direction. The Board also recognized that the Office's handling indicates the earlier claims were separately patentable, and that what was claimed later could not have been presented in the earlier case. This orientation accords with Federal Circuit guidance that ODP polices control extension of a first patent's term through a later filed patent, not the converse. See Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014); Allergan USA, Inc. v. MSN Labs. Private Ltd., 111 F.4th 1358 (Fed. Cir. 2024).
Because the cited patents ('147, '412, '566, and '775) are later-filed and in different, unrelated families, they are not proper ODP reference patents against this earlier-filed application.
In response, first, the cited patents ('147, '412, '566, and '775) claim subject matters that are directedly related to the presently claimed invention even though they are from different families (see rejections including claims). without Terminal disclaimers, once the present application issued as a patent, it would extend life of the patents. For the reason, the ODP rejections over the reference patents are proper.
Regarding with the later-filed applications that have been patented, there is no rule against using a later-filed patent to reject earlier filed applications. See, for instance, Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212–1217 (Fed. Cir. 2014) (holding that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent). MPEP 804.
The examiner has consulted with a TC Quality Assurance Specialist, who ensured maintaining the double patenting rejection at this point.
Conclusion
No claim is allowed.
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/ Primary Examiner, Art Unit 1642