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 .
Applicant’s 4-21-26 election of the species of the species corresponding to subpart (ii) of claim 67, i.e., a light chain variable region wherein the amino acid in position corresponding to position F10 in SEQ ID NO: 10 is not F, and wherein one or more of the amino acid positions corresponding to the positions T41, K55, and L97 in SEQ ID NO: 10 are not T, K, and L is acknowledged.
Claims 67-80 are pending and under examination as they read on the species corresponding to subpart (ii) of claim 67, i.e., a light chain variable region wherein the amino acid in position corresponding to position F10 in SEQ ID NO: 10 is not F, and wherein one or more of the amino acid positions corresponding to the positions T41, K55, and L97 in SEQ ID NO: 10 are not T, K, and L.
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 67-76, 78 and 79 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 metes and bounds of claim 67 and dependent claims thereof would be unclear to the ordinarily skilled artisan because, on the one hand, the beginning of claim 67 (“A nucleic acid comprising a nucleotide sequence encoding (a) a heavy chain and/or (b) a light chain of a humanized or chimeric antibody which binds to human CD3…”) suggests that the claimed nucleic acid may comprise ONLY a heavy chain OR ONLY light chain (and not necessarily both), and, on the other hand, the claim goes on to recite that the “…humanized or chimeric antibody which binds to human CD3…comprises VH CDR1, CDR2, and CDR3 domains comprising the amino acid sequences set forth in SEQ ID NOs: 1, 2, and 3, respectively, and a VL region comprising the amino acid sequence of SEQ ID NO: 10, but wherein…,” which seems to suggest that the claimed nucleic acid must at least encode the VH CDR1, CDR2, and CDR3 domains of SEQ ID NOs: 1, 2, and 3, respectively, AND ALSO encode at least a VL region comprising the amino acid sequence of SEQ ID NO: 10 having one or more point mutations as recited in parts (i)-(vi) of claim 67.
Given the lack of certainty as to the metes and bounds of claim 67, for the purposes of examination under other statutes such as 35 USC § 102(a)(1)/(a)(2) and obviousness-type double patenting, claim 67 and dependent claims thereof will be considered as they read on a nucleic acid comprising ONLY a nucleic acid encoding the heavy chain VH CDR1, CDR2, and CDR3 domains of SEQ ID NOs: 1, 2, and 3, respectively, or as they read on a nucleic acid comprising ONLY a nucleic acid encoding a light chain comprising the amino acid sequence of SEQ ID NO: 10 having one or more point mutations as recited in parts (i)-(vi) of claim 67.
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 67-79 are rejected on the ground of nonstatutory double patenting as being unpatentable over certain claims of certain U.S. Patent Nos. set forth below in view of Neijssen et al (20140170149) and Feng et al. (mAbs 2:5, 466-477; September/October 2010)(all cited herewith).
patent #
ref claims
ref clm embodiments
10465006 (cited on an IDS)
1-19
drawn to anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
10544220 (cited on an IDS)
1-20
drawn to anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
10590206 (cited on an IDS)
11
drawn to anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11485796 (cited on an IDS)
9
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11008399 (cited herewith)
12-20
drawn to anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11130819 (cited herewith)
1-24
drawn to anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11970544 (cited herewith)
13, 14, 17-21, 24-31
drawn to methods of making a bispecific antibody comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, and drawn to nucleic acids encoding anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3 and expression vectors and host cells thereof, and further drawn to which may include the epcoritmab antibody
11535679 (cited herewith)
1-27
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11548952 (cited herewith)
1-27
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11608383 (cited herewith)
1-30
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11814437 (cited herewith)
1-13
drawn to nucleic acids encoding anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3 and expression vectors and host cells thereof; methods of making with said host cells., which may include the epcoritmab antibody
11845805 (cited herewith)
1-33
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
11858995 (cited herewith)
1-28
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
12435154 (cited herewith)
1-29
drawn to a method of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody
As set forth in the table above, the various sets of reference claims are drawn to:
anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody;
methods of treatment comprising administering anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody;
methods of making a bispecific antibody comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3, which may include the epcoritmab antibody; and
nucleic acids encoding anti-CD3 antibodies comprising a Vh of any one of SEQ ID NOs: 6-9 or comprising VH CDRs of SEQ ID NOs: 1-3 and expression vectors and host cells thereof, which may include the epcoritmab antibody.
With respect to the reference claims drawn to anti-CD3 antibodies that meet the structural limitations of the instant claims / to the methods of treatment comprising administering anti-CD3 antibodies that meet the structural limitations of the instant claims, it would have been obvious to one of ordinary skill in the art to make nucleic acid sequences encoding said antibodies, expression vectors comprising said nucleic acid sequences, and host cells comprising said nucleic acid sequences given the teachings of Neijssen. In particular, Neijssen teaches a bispecific antibody comprising Her2 and CD3 binding regions, and further teaches nucleic acid sequences encoding said antibodies, expression vectors comprising said nucleic acid sequences, and host cells comprising said nucleic acid sequences at paras 83, 624-632 and exemplifies such in working Example 1. Given the reference claims and the teachings of Neijssen it would have been obvious to one of ordinary skill in the art, and one of ordinary skill in the art would have been motivated to make nucleic acid sequences encoding the antibodies of the reference patents, expression vectors comprising said nucleic acid sequences encoding the antibodies of the reference patents, and host cells comprising said nucleic acid sequences for the purpose of facilitate convenient, adequate production of said antibodies from a recombinant host cell modified with said nucleic acids / said expression vectors consistent with the well-known practice the antibody biopharmaceutical art as illustrated for example by Feng at pages 466-67. Likewise, in practicing a method of making an antibody as recited in the reference claims, one of ordinary skill in the art will be making use of the nucleic acids and host cell thereof of the instant claims.
Given the above, insofar as the reference claims set forth above fail to outright anticipate the claimed nucleic acid, expression vector and host cell comprising the claimed nucleic acid (which is true for some of the reference claims as set forth in the chart above), when the non-anticipatory reference claims are considered in the context of the reference teachings it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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.
Claim(s) 67-75 and 77-79 are rejected under 35 U.S.C. 102(a)(1) / 102(a)(2) as being anticipated by Huang et al. (WO2012162067A2) (cited on an IDS).
Huang teaches nucleic acids encoding a CD3-binding antibody having the Vh CDRs recited in claim 67, see e.g., “h-mab2 VH-8”; SEQ ID NO: 50, which comprises the VH CDRs 1-3 of SEQ ID NOs: 1-3 of the instant claims as exemplified by the attached alignment of Huang SEQ ID NO: 50 (see Huang at paragraphs 240-241 and claim 1), as well as vectors comprising said nucleic acids and host cells comprising said vectors (see paragraphs at page 68-72).
Thus, the teachings of Huang anticipate the instant claims.
Note that claims 68-75 while specifying certain types of VL domains do not require that such a VL domain be present for a sequence to anticipate said claims, i.e., claims 68-75 still encompass in their breadth the embodiment which encompasses a “nucleic acid comprising a nucleotide sequence encoding (a) a heavy chain…of a humanized or chimeric antibody which binds to human CD3, wherein the antibody comprises VH CDR1, CDR2, and CDR3 domains comprising the amino acid sequences set forth in SEQ ID NOs: 1, 2 and 3, respectively,…”
Claim(s) 67-75 and 77-79 are rejected under 35 U.S.C. 102(a)(1) / 102(a)(2) as being anticipated by Kischel et al. (8236308) (cited on an IDS).
Kischel teaches nucleic acids encoding a CD3-binding antibody having the Vh CDRs recited in claim 67, see e.g., SEQ ID NO: 110, which comprises the VH CDRs 1-3 of SEQ ID NOs: 1-3 of the instant claims as exemplified by the attached alignment of Kischel SEQ ID NO: 110 (see Examples 18 and 19) with SEQ ID NO: 6 of the instant claims (see below):
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240
703
media_image1.png
Greyscale
as well as vectors comprising said nucleic acids and host cells comprising said vectors (see col. 24, 2nd and 3rd full paragraphs).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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