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 02/27/2026 are acknowledged.
Claims 1, 26, 109-110 and 124-131 are pending.
3. Applicant’s election of the invention of Group II (drawn to a tetrahedral antibody comprising six domains) in the reply filed on 02/27/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Claims 1, 26, 109-110 and 124-131 read on the elected invention.
Applicant further elected the species of non-covalent linkage as the non-peptidyl linkage. Claims 1 and 109-110 read on the elected species.
Claims 26 and 124-131 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected species.
Claims 1 and 109-110 are presently under consideration.
4. Claim 1 is objected to because of an apparent typographical error in the phrase “one of the other of” in each of subclauses “d) ii),” “e) ii),” “f) ii),” and “g) ii).” Appropriate correction is required.
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 and 109-110 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 as being in improper Markush format. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
For example:
d) if the first domain is joined to the second domain via a first dimerizing polypeptide attached to the first N-terminus of the first domain, then the third domain is attached at its C-terminus by a peptide bond or via a peptide linker to one of
i) the N-terminus of the first dimerizing polypeptide, “or”
ii) the second N-terminus of the first domain,
and the fifth domain is attached at its C-terminus by a peptide bond or via a peptide linker to one of [sic] the other of
i) the N-terminus of the first dimerizing polypeptide, “or”
ii) the second N-terminus of the first domain,
(ii) Claim 1 is further indefinite because, in the absence of a conjunction (such as “and,” “or,” or “and/or”) between subclause “f)” and subclause “g),” the relationship among subclauses “a)” through “g)” is unknown, i.e. it is unknown whether the claim requires the limitations of all subclauses to be met, or the limitations of any one subclause to be met.
(iii) Claim 109 is indefinite because, in the absence of a conjunction (such as “and,” “or,” or “and/or”) between the limitations recited under “a)” and the limitations recited under “i)” following “a),” the relationship between limitations under “a)” and limitations under “i)” through “iii)” is unknown:
a) the third and fourth domains comprise a first type of Fab and the second domain comprise a second type of Fab, [?]
i) the first type of Fab is formed by a VH-CH on a H1 or H2 chain [...]
(iv) Claims 109 and 110 are indefinite in the recitation of “chains” designated as H1, H2, L1 and L2, because their nature or relationship to other structural elements are not defined. For example, in claim 109 chains H1 and H2 are listed only in the alternative, but it is unknown how, or if, H1 differs from H2. It is also unclear how, if at all, these chains relate to the “first polypeptide chain” and the “second polypeptide chain” recited in claim 1.
(v) Claims 109 and 110 are further 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 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.
8. Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Reiter et al. (US 20210363512).
Claim interpretation
Giving claim 1 its broadest reasonable interpretation in the absence of a conjunction to define the relationship among subclauses “a)” through “g)” (see subsection 6(ii) above), claim 1 comprises and embodiment of a tetrahedral antibody comprising a first, second, third, fourth, fifth, and sixth domain, wherein each of the first and second domains are selected from the group consisting of a Fab domain and an Fc domain. Since the claim does not limit the structure of function of domains three through six, any stretch of a polypeptide chain is within the scope of a “domain.”
Reiter teaches a homodimeric fusion protein of ACE2 extracellular domain to Fc domain of human IgG1 (e.g. [0009]). The ACE2 extracellular domain comprises a peptidase domain and a collectrin-like domain (e.g. [0055]).
Accordingly, Reiter’s fusion protein comprises two copies of an Fc domain (first and second domains), two copies of a collectrin-like domain (third and fourth domains), and two copies of a peptidase domain (fifth and sixth domains), which is within the scope instant claim 1.
9. 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.
10. Claims 1 and 110 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,473,363 (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.
Claim 1 of US ‘363 recites a tetrahedral antibody comprising a first, second, third, fourth, fifth and sixth domain, wherein:
a) the first and second domains are Fc domains,
b) and c) the third, fourth, fifth and sixth domains are Fab domains,
i) the N-terminal portion of the first H2 polypeptide chain pairs with the first L2 polypeptide chain to form the fifth domain,
j) the N-terminal portion of the second H2 polypeptide chain pairs with the second L2 polypeptide chain to form the sixth domain, and
k) the tetrahedral antibody comprises collectrin-like domain (CLD) dimerizing polypeptides located, in one of the embodiments, between Fab and Fc domains.
This structure is within the scope of instant claims 1 and 110, and as such anticipates these claims.
11. Claims 1 and 110 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,612,611.
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 ‘611.
US ‘611 claim 1 recites a tetrahedral antibody molecule comprising a first, second, third, fourth, fifth and sixth domain, wherein:
the first and second domains are Fc domains,
the third, fourth, fifth and sixth domains are Fab domains, and
CLD is located between Fab and Fc domains within the heavy chains,
which is a structure within the scope of instant claims 1 and 110.
US ‘611 claim 8 recites the amino acid substitutions recited in instant claim 110.
12. Claims 1 and 110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications:
USSN PD Pub. No.
18/949972 20250092160
18/949940 20250084169 (IDS)
18/188412 20240158526 (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 each of the above copending applications, which recite tetrahedral molecules within the scope of instant claims.
Specifically, each of the copending applications recites a tetrahedral antibody molecule comprising a first, second, third, fourth, fifth and sixth domain, wherein the first and second domains are Fc domains, the third, fourth, fifth and sixth domains are Fab domains, and CLD is located between Fab and Fc domains within the heavy chains (see claims 1, 3, 6, 8 and 10 of USSN ‘972; claims 1, 3 and 4 of USSN ‘940; and claims 1, 10, 15, 18-20, 36 and 75 of USSN ‘412).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 1 and 109-110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18/153769, published as US 20230220115 (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 ‘769.
The latter recite a tetrahedral antibody molecule comprising a first, second, third, fourth, fifth and sixth domain, wherein the first and second domains are either Fab or Fc domains, the third, fourth, fifth and sixth domains are Fab domains, and CLD is located between Fab and Fc domains within the heavy chains (claims 1, 17, 19, and 27-32), which is within the scope of instant claims 1 and 109-110.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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