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
Claims 1-14 are currently pending and under prosecution.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “The antibody of claim 1, wherein the CDR2 of the VH has an amino acid sequence according to SEQ ID NO: 41.” Claim 3 recites “The antibody of claim 1, wherein the CDR1 of the VL has an amino acid sequence according to SEQ ID NO: 43.” Claim 1 recites that the VH CDR2 sequence is SEQ ID NO: 2 and the VL CDR1 sequence is SEQ ID NO: 4. Claims 2 and 3 do not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Examiner has interpreted claims 2-4 to replace the VH CDR2 of claim 1 and the VL CDR1 of claim 1 sequences with the respective sequences listed in the claims.
That is, the sequences of the antibody of claims 2-4 will be interpreted as:
Claim 2: VH CDR1-3: SEQ ID NO: 1-41-3; VL CDR 1-3: SEQ ID NO: 4-5-6
Claim 3: VH CDR1-3: SEQ ID NO: 1-2-3; VL CDR1-3: SEQ ID NO: 43-5-6
Claim 4: VH CDR1-3: 1-41-3; CDR1-3: SEQ ID NO: 43-5-6
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 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,545,727. Although the claims at issue are not identical, they are not patentably distinct from each other because the U.S. Patent recites an antibody that binds to Nectin-2 or antigen-binding fragment thereof, comprising the instantly claimed sequences of the antibody. [See sequence alignments below]
SEQ ID NOS: 1-41-3
RESULT 1
US-17-421-885A-17
Sequence 17, US/17421885A
Patent No. 12545727
GENERAL INFORMATION
APPLICANT: Yissum Research Development Company of the Hebrew
APPLICANT: University of Jerusalem Ltd.
APPLICANT: University of Rijeka Faculty of Medicine
TITLE OF INVENTION: ANTIBODIES SPECIFIC TO HUMAN NECTIN-2
FILE REFERENCE: 169.0142-US00
CURRENT APPLICATION NUMBER: US/17/421,885A
CURRENT FILING DATE: 2021-08-05
PRIOR APPLICATION NUMBER: PCT/IL2020/050047
PRIOR FILING DATE: 2020-01-13
PRIOR APPLICATION NUMBER: US 62/791808
PRIOR FILING DATE: 2019-01-13
NUMBER OF SEQ ID NOS: 32
SEQ ID NO 17
LENGTH: 116
TYPE: PRT
ORGANISM: Mus musculus
Query Match 85.0%; Score 139.4; Length 116;
Best Local Similarity 38.7%;
Matches 29; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 SYWIH--------------AVYPGNSDSNYNQKFKA------------------------ 22
||||| |||||||||||||||||
Db 31 SYWIHWVKQRPGQGLEWIGAVYPGNSDSNYNQKFKAKAKLTAVTSTSTAYMELSSLTSED 90
Qy 23 --------LVGTFDY 29
|||||||
Db 91 SAVYYCTKLVGTFDY 105
SEQ ID NOS: 43-5-6
RESULT 1
US-17-421-885A-18
Sequence 18, US/17421885A
Patent No. 12545727
GENERAL INFORMATION
APPLICANT: Yissum Research Development Company of the Hebrew
APPLICANT: University of Jerusalem Ltd.
APPLICANT: University of Rijeka Faculty of Medicine
TITLE OF INVENTION: ANTIBODIES SPECIFIC TO HUMAN NECTIN-2
FILE REFERENCE: 169.0142-US00
CURRENT APPLICATION NUMBER: US/17/421,885A
CURRENT FILING DATE: 2021-08-05
PRIOR APPLICATION NUMBER: PCT/IL2020/050047
PRIOR FILING DATE: 2020-01-13
PRIOR APPLICATION NUMBER: US 62/791808
PRIOR FILING DATE: 2019-01-13
NUMBER OF SEQ ID NOS: 32
SEQ ID NO 18
LENGTH: 107
TYPE: PRT
ORGANISM: Mus musculus
Query Match 82.2%; Score 114.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 KASQNVGINVV---------------SASYRYS--------------------------- 18
||||||||||| |||||||
Db 24 KASQNVGINVVWYQQRAGQSPKTLIYSASYRYSGVPDRFTGSGSGTDFTLTISNVQSEDL 83
Qy 19 -----QQYNTNPFT 27
|||||||||
Db 84 AEYFCQQYNTNPFT 97
Allowable Subject Matter/Closest Prior Art
Claims 1 and 5-14 are allowed.
The closest prior art made of record is Sato et al (US20100008928 A1; Published 1/14/2010). Sato teaches an antibody that binds to Nectin-2. However, the art does not teach anti-Nectin-2 antibodies comprising the instantly claimed sequences.
Conclusion
Conclusion: Claims 1 and 5-14 are allowed. Claims 2 and 3 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A ALSOMAIRY whose telephone number is (571)272-0027. The examiner can normally be reached Monday-Friday 7:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
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