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
1. Claims 1,2,5, 6,7, 10,21-25,57-66,71-76,78-80, 82,88,90,91 are pending.
2. Applicant’s election without traverse of Group I, claims 1,2,5,21-25,57-66,71-76,78-80,82,89,90 and 91 in the reply filed on 12/05/25 is acknowledged.
3. Claims 6,7,10, withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,2,5,21-25,57-66,71-76,78-80,82,89,90 and 91 read on a method of treating cervical cancer in a subject are under consideration in the instant application.
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 1,2,5,21-25,57-66, 71-76,78-80,82,89,90 and 91 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US Patent Application 20210177987.
US Patent ‘987 teaches a method of treating cervical cancer, in a subject comprising administering to the subject tisotumab vedotin. US Patent ‘987 teaches that tisotumab vedotin is administered at the dose of 1.2 mg/kg to 2.2 mg/kg. US Patent ‘987 teaches that each cycle of administering is once in 3 weeks. US Patent ‘987 teaches that subject might be previously treated with bevacizumab and or paclitaxel. US Patent ‘987 teaches that the subject might have ECOG score of 0 or 1. US Patent ‘987 teaches that objective response rate is between 10 to about 40 % and that the duration of response is at least 1 to 10 months . US Patent ‘987 teaches that cervical cancer can be adenocarcinoma or squamous cell carcinoma or metastatic cervical cancer.
US Patent ‘987 teaches that the subject has been previously treated with an agent that is not antibody-drug conjugate, such as paclitaxel. US Patent ‘987 teaches that a subject has receive at least one prior line of systemic therapy. US Patent ‘987 teaches that the subject has a TF H-score of at least 1. US Patent’987 teaches that the subject has one or more adverse events including conjunctivitis and/or keratitis
( see entire document, abstract and paragraphs 0006, 009, 0015, 0019, 0026, 0032, 0082,0083 0173, 0176, 0284 in particular)
The reference teaching anticipates the claimed invention.
6. 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.
7. Claims 1,2,5,21-25,57-66, 71-76,78-80,82,89,90 and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,324,841, claims 1-36 of US Patent 12453,781, claims 1-25 of US Patent 12,246025
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-26 of U.S. Patent No. 12,324,841, claims 1-36 of US Patent 12,453,378, claims 1-25 of US Patent 12,246025 each recite a method of treating a cervical cancer in a subject comprising administering to the subject tisotumab vedotin and wherein the subject has been previously treated with bevacizumab.
8. The claims 1,2,5,21-25,57-66, 71-76,78-80,82,89,90 and 91 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos 17/775279; 17/771784; 16/760373; 18/451780; 17/053346; 18/798557; 18/863144
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application Nos 17/775279; 17/771784; 16/760373; 18/451780; 17/053346; 18/798557; 18/863144 each recited a method of treating a cervical cancer in a subject comprising administering to the subject tisotumab vedotin and wherein the subject has been previously treated with bevacizumab.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644