DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 03/27/2026 are acknowledged.
Claims 1, 3-6, 10, 12-20, 22, 55, 59, 63, 67, 71 and 75 are pending.
3. Applicant’s election without traverse of the invention of Group I (drawn to a tetrahedral antibody comprising two Fc domains and four Fab domains, vectors encoding the polypeptide chains of the antibody, host cells and methods of producing the antibody) in the reply filed on 03/27/2026 is acknowledged.
Applicant further elected the species a tetrahedral antibody wherein:
the H1 chain comprises SEQ ID NO: 4775,
the H2 chain comprises SEQ ID NO: 4729,
the L1 chain comprises SEQ ID NO: 4819, and
the L2 chain comprises SEQ ID NO: 4809.
Applicant notes that the elected single variant tetrahedral antibody comprises the following features:
a) the first and second domains are each an Fc comprising S239D and I332E;
b) the third and fourth domains comprise the V region of a Fab domain of FMC59 (amino acids 1-120 of SEQ ID NO: 4777 in first chain and amino acids 1-107 of SEQ ID NO:4821 in second chain, as recited in claim 17); and
c) the fifth and sixth domains comprise the V region of a Fab domain of rituximab (SEQ ID NO: 7169 in first chain and SEQ ID NO: 7173 in second chain, as recited in claim 17).
The following claims read on the elected invention and species:
1,
3 (subclause “a)”),
4 (subclause “a)”),
5 (subclause “c)”),
10 (subclause “i)”),
12 (subclause “a)”),
13 (subclause “a)”),
14 (subclause “c)”),
15 (subclause “r)”),
16,
17 (subclauses “a)” and “d)”),
18 (subclauses “a)” and “d)”),
19 (subclauses “a)” and “d)”),
20 (subclause “tt)”),
55, 59, 63, 67 and
75 (subclause “a)”).
4. Claims 6, 22 and 71 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions and species.
Claims 1, 3-5, 10, 12-20, 55, 59, 63, 67 and 75 are presently under consideration, to the extent that they read on the elected species.
5. 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.
6. Claims 1, 3-5, 10, 12-20, 55, 59, 63, 67 and 75 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 1 is indefinite in the recitation of a specified antibody “or a variant thereof,” because it is unclear whether or not the claim is limited to antigen-binding variants of the respective antibodies.
(ii) Claims 1, 10, 15 and 20 are indefinite in the use of the term “preferably,” because it is unclear whether or not the preferred embodiments constitute claim limitations. Description of examples or preferences is properly set forth in the specification rather than the claims.
(iii) Claim 3, and claims 4-5 dependent thereon, are indefinite as being dependent on a canceled claim. Applicant may cancel the claims, rewrite the claims in independent form to include the relevant limitations of the base claims, or amend the claims to depend on other pending claims.
It appears that claim 3 was intended to depend on claim 1, which dependence is provisionally assumed for examination purposes.
(iv) Claim 12 is indefinite in the recitation of mutations in Fc domains that affect “receptor activity,” because the mutations are not in the respective receptors and as such do not affect their activity.
It appears that the claims were intended to recite “receptor-binding activity,” which interpretation is provisionally assumed for examination purposes.
(v) Claim 20 is indefinite in the listing of subclauses a) through d), followed by subclauses a) through xx), because the relationship between subclauses is unclear in view of the duplicative designations a) through d).
(vi) Claims 3-5, 10, 12-20, 55, 59, 63, 67 and 75 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
7. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 1, 3-5, 10, 12-20, 55, 59, 63, 67 and 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12473363 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘363.
Instant claims 1, 3-5, 10, 12-20 and 75 recite a tetrahedral antibody comprising four types of polypeptide chains forming six domains, wherein the polypeptide chains are:
H1 (SEQ ID NO: 4775),
H2 (SEQ ID NO: 4729),
L1 (SEQ ID NO: 4819), and
L2 (SEQ ID NO: 4809).
The first and second domains are 239D/332E Fc domains,
the third and fourth domains are anti-CD19 FMC59 Fab (amino acids 1-120 of SEQ ID NO: 4777 and 1-107 of SEQ ID NO:4821), and
the fifth and sixth domains are anti-DC20 rituximab Fab (SEQ ID NOS: 7169, 7173).
The antibody is exemplified in the specification as Protein ID: 21-97 (Table 54 at p. 368 and Table 55 at p. 371).
Claim 1 of US ‘363 is directed to a tetrahedral antibody of the same structure and specificity (exemplified as Protein ID: 21-98 in Table 54 at p. 368 and Table 55 at p. 371 of instant specification). Specifically, the antibody comprises four types of polypeptide chains forming six domains, wherein the polypeptide chains are:
H1 (SEQ ID NO: 4775, same as that of instantly claimed antibody),
H2 (SEQ ID NO: 4730),
L1 (SEQ ID NO: 4819, same as that of instantly claimed antibody), and
L2 (SEQ ID NO: 4810).
SEQ ID NO: 4730 differs from instant SEQ ID NO: 4729 by a single amino acid substitution, and SEQ ID NO: 4810 differs from instant SEQ ID NO: 4809 also by a single amino acid substitution (see SCORE). Neither substitution is in CDR regions, i.e. the tetrahedral antibody claimed in US ‘363 is within the scope of instant claims 1, 3-5, 10, 12-20 and 75. The limitations of instant claims 55, 59, 63 and 67 are recited in claims 2-6 of US ‘363.
9. Claims 1, 3-5, 10, 12-20, 55, 59, 63, 67 and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18949940, published as US 20250084169 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘940.
USSN ‘940 recites a tetrahedral antibody comprising four polypeptide chains of SEQ ID NOS: 4730, 4775, 4810, 4819 (claim 4e) (i.e. the same sequences as recited in US ‘363 Patent described in section 8 above), which include Fab domains of rituximab (anti-CD20) and FMC59 (anti-CD19) (claim 2a, 2b). In particular, rituximab Fab comprises SEQ ID NOS: 7169 and 7173 (claim 2a), and FMC59 Fab comprises amino acids 1-120 of SEQ ID NO:4777 and 1-107 of SEQ ID NO:4821 (claim 2b). Accordingly, the tetrahedral antibody claimed in USSN ‘940 is within the scope of instant claims 1, 3-5, 10, 12-20 and 75 for the same reasons as presented in section 8 above. The limitations of instant claims 55, 59, 63 and 67 are recited in claims 5-8 of USSN ‘940.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. The following US Patents and/or copending US applications share a coinventor and/or an assignee with the present application, and disclose and/or claim subject matter similar to that of the present claims, but do not contain patented or currently pending claims which would anticipate or make obvious the presently claimed invention:
US Patent No. 12612611
USSN 18/153840, published as US 20230220116
USSN 18/153769, published as US 20230220115
11. It is noted that the claims of copending application USSN 18/949972 (published as US 20250092160) read on a non-elected species of the invention recited instant claims.
12. Conclusion: no claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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