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 1-39 have been canceled. Claims 40-58 have been added and are examined on the merits.
Claim Objections
Claim 40 is objected to because of the following informalities: the typographical error of “marginal cell B-cell lymphoma” rather than “marginal zone B-cell lymphoma”. Appropriate correction is required.
Specification
The specification is objected to for the incorporation of “SEQ ID NO:5” (e.g. paragraphs [0161], [0438], [0455], [0458]) which is a skipped sequence, having no sequence information associated with it. Amendment of the specification to replace all instances of SEQ ID NO:5 with the actual sequence information will overcome this objection.
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 40-58 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.
Claim 40 is vague and indefinite in the recitation of “SEQ ID NO:5” which is a skipped sequence which has no sequence information associated with it. Thus, the metes and bounds of the claims cannot be determined.
Amendment of the claims to incorporate the actual sequence of the skipped sequence will overcome this rejection.
.
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 44-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No.10,688,181. 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 a method of treating an ROR-1 expressing cancer comprising the administration of a BTK antagonist and an anti-ROR1 antibody comprising the CDRs of SEQ ID NO: 1-3 in the heavy chain and the CDRs of SEQ ID NO: 4-6 in the light chain, which meet that limitation in instant claim 40. Claim 3 of ‘181 discloses that the BTK antagonist of claim 1 is ibrutinib, acalabrutinib, ONO/GS-4059, also known as tirabrutinib, BGB-3111, also known as Zanubrutinib or CC-292, also known as spebrutinib, which meets those limitation in instant claim 40. Claim 24 discloses, in part, that the ROR1 expressing cancer includes B cell ALL, which meets the limitation of a B cell malignancy in instant claim 40. Claim 25 discloses that the ROR-1 expressing cancer or cancer susceptible to a BTK antagonist is, in part, CLL, SLL, marginal zone B-cell lymphoma or B cell leukemia, which meets those limitation in instant claim 40. Claim5 of ‘181 discloses that the anti-ROR1 antibody is cirmtuzumab, anticipates instant claim 41. Claims 7-9 of the ‘181 patent discloses the limitations of instant claims 43-45, respectively. Claims 28 and 7 also anticipates instant claim 46 for separate administration because sequential administration in claim 7 requires separate administration. Claims 17-21 pf the ‘181 patent anticipate instant claims 47-51, respectively. Claim 23 of ‘181 discloses that the subject is human which meets the limitation of claim 42. Claims 10-16 of the ‘181 patent anticipate instant claims 52-58, respectively.
Claims 40-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No.11,654,193. 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 paten discloses a method of treating an ROR-1 expressing cancer or a cancer susceptible to a BTK antagonist comprising administering to said subject in need thereof a therapeutically effective amount of an ROR1 antagonist antibody comprising and an inhibitor of B-cell receptor signaling, wherein the ROR1 antagonist antibody comprising the heavy chain CDRs of SEQ ID NO: 1-3 and the light chain CDRs of SEQ ID NO: 4-6 which meet that limitation in instant claim 40. Claim 3 of the ‘193 patent disclose, in part, that the inhibitor of B-cell receptor signaling is ibrutinib, acalabrutinib, ONO/GS-4059, also known as tirabrutinib, BGB-3111, also known as Zanubrutinib or CC-292, also known as spebrutinib, which meets those limitation in instant claim 40. Claims 4 and 5 of the patent disclose, respectively, that the antibody is cirmtuzumab, and the subject is human which meets the limitations of instant claims 41 and 42. Claim 6 of ‘193 disclose that the ROR1 expressing cancer of claim 1 is, in part, B-ALL, which anticipates B cell leukemia in instant claim 40. Claim 7 of the ‘193 patent anticipates the CLL, SLL, MCL, marginal zone B-cell lymphoma and B cell leukemias required in instant claim 40.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
Prosecution Insights