Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 33-37, 39-46 and 48-50 are pending and being acted upon in this Office Action.
Priority
Applicant’ claim priority to provisional applications 61/776,724, filed March 11, 2013, 61/776,715 filed March 11, 2013 and 61/776,710 filed March 11, 2013 is acknowledged.
Rejection Withdrawn
The written description and enablement rejections of claims 35-36 and 51 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph are withdrawn in view of the claim amendment.
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 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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Claims 33-37, 39-46 and 48-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-14, 16 of US Patent 11,130,816 (reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the reference ‘816 patent.
The instant claim 33 recites an IgG antibody or antigen-binding fragment thereof comprising a CH1 domain, wherein the CH1 domain comprises an asparagine residue at amino acid position 114, according to Kabat numbering, and wherein a side chain of the asparagine residue is linked to a glycan, wherein the glycan is linked to a drug effector moiety to form an antibody drug conjugate (ADC), and wherein the drug effector moiety comprises Monomethyl Auristatin E (MMAE) or Dolastatin 10 (Dol10).
Issued claim 1 recites a binding polypeptide comprising at least one modified glycan comprising at least one moiety of Formula (IV):
-Gal-Sia-C(H)═N-Q-CON—X Formula (IV),
wherein: A) Q is NH or O;
B) CON is a connector moiety;
C) X is a diagnostic or therapeutic effector moiety;
D) Gal is a galactose moiety; and E) Sia is a sialic acid moiety.
The specification can be used as dictionary for claim terminology, see MPEP 804 II (b)(1).
The patent defines binding polypeptide to include IgG, see Detailed Description, col. 5, col. 6, line 58-60, in particular. Exemplary cytotoxic agents include MMAE (see Table 1, first structure, in particular), dolastin 10, see col. 29, line 56. Examples 1, 2, Table 4, 6. The issued patent also discloses the same antibodies of instant claim 49, see Table 5 SEQ ID NO: 3 for anti-CD-52 A114N, Table 6, anti-TEM1 A114N of SEQ ID NO: 11 in Table 7, anti-FAP in Table 7, anti-HER2 A114N of SEQ ID NO: 14 in Table 8, in particular.
Instant specification also discloses the modified glycan comprising at least one moiety of Formula (IV):
-Gal-Sia-C(H)═N-Q-CON—X Formula (IV),
wherein: A) Q is NH or O;
B) CON is a connector moiety;
C) X is a diagnostic or therapeutic effector moiety;
D) Gal is a galactose moiety; and E) Sia is a sialic acid moiety, see p. 43, in particular.
Thus, the subject matter claimed in the instant application is fully disclosed in the issued patent and would be covered by the patent since the claims represent an obvious variation.
Issued 2. The binding polypeptide of claim 1, wherein the modified glycan is a biantennary glycan, which corresponds to instant claim 39.
Issued claim 3. The binding polypeptide of claim 1, wherein the biantennary glycan is fucosylated.
4. The binding polypeptide of claim 1, wherein said modified glycan comprises at least two moieties of Formula (IV), and wherein Sia is present in either the connector moiety or the diagnostic or therapeutic effector moiety (genus) of Formula (IV). Instant claim 33 limits the therapeutic effector moiety to Monomethyl Auristatin E (MMAE) or Dolastin 10 (Dol10).
5. The binding polypeptide of claim 3, wherein said modified glycan comprises at least two moieties of Formula (IV), and wherein Sia is present in both the connector moiety and the diagnostic or therapeutic effector moiety of Formula (IV).
6. The binding polypeptide of claim 1, wherein the modified glycan is N-linked to the binding polypeptide, which corresponds to instant a side chain of asparagine residue is liked to a glycan of instant claim 33.
7. The binding polypeptide of claim 1, wherein the binding polypeptide comprises an Fc domain, which corresponds to IgG antibody, which comprises Fc of instant claim 33.
10. The binding polypeptide of claim 1, wherein the Fc domain is human, which corresponds to human IgG1 of instant claim 36.
11. The binding polypeptide of claim 1, wherein the binding polypeptide comprises a CH1 domain, which corresponds to instant claim 33, 35 and 36.
12. The binding polypeptide of claim 11, wherein the modified glycan is N-linked to the binding polypeptide, which corresponds to instant claim 33.
14. The binding polypeptide of claim 1, wherein the connector moiety comprises a pH-sensitive linker, disulfide linker, enzyme-sensitive linker or other cleavable linker moiety, which corresponds to instant 46.
16. The binding polypeptide of claim 1, wherein the binding polypeptide is an antibody (genus) or immunoadhesin, whereas instant claim limits the antibody to IgG antibody (species).
17. A composition comprising a binding polypeptide of claim 1 and a pharmaceutically acceptable carrier or excipient, which corresponds to instant claim 50.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
