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
2. Claims 1-8, 12, 15, 17, 20, 23, 26, 29, 33-38, 46-50 and 64-67 are pending and currently under prosecution.
Priority
3. Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 120 for benefit of the earlier filing date of applications, is acknowledged.
Claim Objections
4. Claim 1 is objected to because of the following informalities:
Claim 1 recites: “a first binding arm comprising which binds to human CD3ε (epsilon)” should be “a first binding arm
Double Patenting
5. 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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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6. Claims 1-8, 12, 15, 17, 20, 23, 26, 29, 33-38, 46-50 and 64-67 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-33 of U.S. Patent No. US 11,845,805. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1-8, 12, 15, 17, 20, 23, 26, 29, 33-38, 46-50 and 64-67 are herein drawn to a method of treating diffuse large B-cell lymphoma (DLBCL) in a human subject, the method comprising administering to the subject (a) a bispecific antibody, (b) rituximab, (c) cyclophosphamide, (d) doxorubicin, (e) vincristine and (f) prednisone in 21-day cycles, wherein (a) the bispecific antibody comprises:
(i) a first binding arm which binds to human CD3ε (epsilon) and comprises a heavy chain and a light chain comprising the amino acid sequences set forth in SEO ID NOs: 24 and 25, respectively, and
(ii) a second binding arm which binds to human CD20 and comprises a heavy chain and a light chain comprising the amino acid sequences set forth in SEO ID NOs: 26 and 27, respectively;
wherein a priming dose of the bi specific antibody is administered subcutaneously on
day 1 of the first 21-day cycle, an intermediate dose of the bispecific antibody is
administered subcutaneously on day 8 of the first 21-day cycle, and a full dose of 24
or 48 mg of the bi specific antibody is administered subcutaneously on day 15 of the first 21-day cycle, wherein the priming dose and intermediate dose are at a lower dose as compared with the full dose;
(b) rituximab is administered intravenously at a dose of 375 mg/m2 once every three weeks;
(c) cyclophosphamide is administered intravenously at a dose of 750 mg/m2 once every three weeks;
(d) doxorubicin is administered intravenously at a dose of 50 mg/m2 once every three
weeks;
(e) vincristine is administered intravenously weeks at a dose of 1.4 mg/m2 once every three; and
(f) prednisone is administered orally or intravenously at a dose of 100 mg once a day from
day 1 to day 5 of each 21-day cycle;
wherein administration of the combination continues at least until the subject exhibits a complete metabolic response (CMR), a partial metabolic response or stable disease, or until progressive disease develops or unacceptable toxicity occurs.
Claims 1-33 of U.S. Patent No. US 11,845,805 are drawn to a method of treating diffuse large B-cell lymphoma (DLBCL) in a human subject, the method comprising administering to the subject a bispecific antibody, and an effective amount of (a) rituximab, (b) cyclophosphamide, (c) doxorubicin, (d) vincristine and (e) prednisone, wherein the bispecific antibody comprises a first heavy chain and a first light chain comprising the amino acid sequences set forth in SEQ ID NOs: 24 and 25, respectively, and a second heavy chain and a second light chain comprising the amino acid sequences set forth in SEQ ID NOs: 26 and 27, respectively, and wherein rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and the bispecific antibody are administered in 21-day cycles, wherein: (a) the bispecific antibody is administered as follows: (i) in cycle 1, a priming dose of 0.16 mg is administered on day 1, an intermediate dose of 0.8 mg is administered on day 8, and a dose of 24 mg or 48 mg is administered on day 15; (ii) in cycles 2-4, a dose of 24 mg or 48 mg is administered on days 1, 8, and 15; (iii) in cycles 5 and 6, a dose of 24 mg or 48 mg is administered on day 1; (b) rituximab, cyclophosphamide, doxorubicin, and vincristine are administered on day 1 in cycles 1-6; and (c) prednisone is administered on days 1-5 in cycles 1-6.
It is noted that 35 USC § 121 does not provide protection for continuation or continuation in-part applications, and this application is a continuation of U.S. Patent No. US 11,845,805. See 92 USPQ2d 1289 Amgen Inc. v. F. Hoffmann-La Roche Ltd. (Fed. Cir. 2009) and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. 518 F.3d 1353 (Fed. Cir. 2008).
Conclusion
7. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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