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 .
Claims 1-27 have been canceled. Claims 28-36 have been added and are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 28-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “high risk” in claims 32 and 34 is a relative term which renders the claim indefinite. The term “high-risk” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. In the instant case it is unclear what applicant regards as the requirements for “high risk” neuroblastoma versus neuroblastoma which is of intermediate or lower risk. The specification provides no specific definition for “high risk” neuroblastoma.
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 28-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No.11,492,412. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims.
Claim 1 of the patent discloses the administration of the CH14.18 anti-GD2 antibody at a dose of 17.5mg/m2 per day over 4 consecutive days for at least 10 hours in a cycle of 24-32 days for a total of 5 cycles which meet the limitations of a dose of 15-20 mg/m2 per day over 4 consecutive days in 5 cycles in instant claims 28, 34 and 36 and also meets the limitations of claims 28 and 30 for 70mg/m2/cycle because 17.5 mg/m2 for 4 days is 70mg/m2 per cycle. Claims 1 of the patent discloses the administration of the anti-GD2 antibody 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, which meets the limitations of instant claim 32. Claim 1 of the patent discloses the administration of 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 which meets those limitations of instant claim 33. Claim 3 of the patent specifies that the retinoic acid is administered orally twice a days for a total dos of 160 mg/m2/day , which meets that limitation of instant claim 33. Claim 4 of the patent requires the administration of GM-CSF in each of cycles 1, 3 and 5 on the first day to the fourteenth day in a dose of 250ug/m2/day by sub-Q injection of I.V. infusion over 2 hours, which meets that limitation in claim 33. Claim 6 of the patent specifies that the anti-GD2 antibody is administered for at least 10 hours up to 20 hours per day, which mees the same limitation in instant claims 31 and 34. Claim 2 of the patent specifies that the patient is a pediatric patient, which meet that requirement in instant claims 29 and 35.
Claims 28-31 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No.10,995,147. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the patent anticipates the instant claims. The dose of 17.5mg/m2/day over 4 consecutive days in a cycle meets the limitation of 70mg/m2 per cycle and thus anticipates instant claim 28, 30 and 36. The administration of over 10 or more hours up to 20 hours mees the limitation of claim 31
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643