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 election of the invention of Group IV (claims 81-82, 85-86, 90, 106, 109 and 114-115) in the reply filed on 02/18/2026 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)).
Applicant further elected the Species (a) wherein the non-peptidyl linkage is: ii) a non-covalent linkage; and (b) wherein the molecule comprises: i) IL-15.
Claims 1, 3, 17, 29, 62, 89, 98 and 110-113 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 81-82, 85-86, 90, 106, 109 and 114-115 are presently under consideration.
3. Claim 109 is objected to because of an apparent typographical error in the repetitive phrase “wherein the wherein the.” Appropriate correction is required.
4. 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.
5. Claims 81-82, 85-86, 90, 106, 109 and 114-115 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 81 is indefinite, because the recitation (emphasis added):
“a) the first and second domains each independently comprise: i) a first polypeptide chain”
is in contradiction with other clauses of the claim, which recite embodiments wherein e.g. the first domain is comprised within, rather than comprises, the first polypeptide chain. For example:
b) (1) “a first dimerizing polypeptide [is] attached by a peptide bond or via a peptide linker to the first N-terminus of the first domain.”
(ii) Claim 81 is further indefinite in the recitation of a “collectrin-like domain,” because the degree of “likeness” to collectrin required for a domain to be within the scope of the claim is not defined.
(iii) Claim 81 is further indefinite in the recitation of a “collectrin domain,” because it is unknown which domain of collectrin is within the scope of the claim.
(iv) Claim 90 is indefinite, because the meaning of the abbreviation ACE2 “PD” is unknown. Applicant is reminded that while a claim should be interpreted in light of the specification disclosure, it is improper to import claim limitations from the specification. See MPEP 2111.01(II).
(v) Claims 82, 85-86, 90, 106, 109 and 114-115 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.
6. 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.
7. Claims 81-82, 85, 90 and 114-115 are 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
Instant claims encompass an embodiment taught by Reiter. Excerpts from claim 81 which define this embodiment are summarized below. Subclause b) recites an embodiment wherein the first and the second dimerizing polypeptides are each a collectrin-like domain (CLD); accordingly, “CLD” is used in place of each of the first and the second dimerizing polypeptides.
Claim 81 is directed to a tetrahedral molecule comprising a first, second, third, and fourth domain, wherein
the first CLD is attached by a peptide bond to the N-terminus of the first domain, and
the second CLD is attached by a peptide bond to the N-terminus of the first domain (subclause “b) (1)”), and
the third domain is attached at its C-terminus by a peptide bond the N-terminus of the first CLD (subclause “c) i)”), and
the fourth domain is attached at its C-terminus by a peptide bond the N-terminus of the second CLD (subclause “f) i)”).
The molecule defined by the above excerpts consists of two polypeptide chains comprising, from N- to C terminus:
Third domain – CLD – First domain, and
Fourth domain – CLD – Second domain.
The two polypeptide chains are joined to each other by a non-covalent linkage between the two CLD domains, which form a homodimer, as required by subclause “b) (1)” of claim 81, and recited in claim 85.
Claim 81 does not place any structural or functional limitations on the first through fourth domains, while claim 82 recites an embodiment wherein the first and second domains are Fc domains (subclause “d)”). Claim 90 recites an embodiment wherein the molecule does not comprise an ACE2 transmembrane domain at the C-terminal side of either dimerizing polypeptide (subclause “b)”).
Reiter teaches a fusion protein of ACE2 containing the extracellular domain of either enzymatically active or enzymatically inactive ACE2 linked to the Fc domain of human IgG1 (e.g. [0009]). Human ACE2 of SEQ ID NO: 1 has 805 amino acids, and comprises a signal peptide, an N-terminal extracellular peptidase domain followed by a collectrin-like domain, a transmembrane domain and a short intracellular segment (e.g. [0055]). The extracellular domain of human ACE2 is identified by the amino acids 18 to 740 of SEQ ID NO: 1 (Id).
Accordingly, the fusion protein taught by Reiter comprises, from N- to C terminus: Peptidase domain – CLD – Fc. The fusion protein forms a homodimer via its CLD domains, and as such is structurally within the scope of instant claims 81-82, 85 and 90.
Claims 114 and 115 are included in the rejection, because vectors, host cells and methods of producing a polypeptide are inherent in teachings of a recombinant polypeptide.
8. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
9. Claim 81 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 11 of copending application USSN 19/394102.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
10. 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.
11. Claims 81-82, 85, 90, 106 and 114-115 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 molecule comprising a first, second, third, and fourth domain, wherein:
a) the first domain and the second domain are each a Fc domain of an IgG antibody;
b) the third domain and the fourth domain are each a Fab domain of an anti-CD20 antibody;
k) wherein the molecule comprises an ACE2 collectrin-like domain dimerizing polypeptide (CLD), wherein the molecule comprises two H1 chains, each H1 chain comprising, from N- to C terminus, the heavy chain portion of the Fab domain, followed by CLD, followed by Fc.
This structure is within the scope of instant claims 81-82, 85, 90 and 106.
Claims 2-4 of US ‘363 are directed to vectors, host cells and methods of producing the tetrahedral antibody molecule, thereby anticipating instant claims 114 and 115.
12. Claims 81-82, 85-86, 90, 106 and 114-115 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, and fourth domain, wherein:
the first and second domains are IgG1 Fc domains,
the third and fourth 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 81-82, 85, 90 and 106.
US ‘611 claim 7 specifies that IgG1 Fc domains are heterodimers, thereby anticipating instant claim 86.
Claims 114 and 115 are included in the rejection for the same reasons as presented in section 7 above.
13. Claims 82, 85, 90, 106, 109 and 114-115 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/394102.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by claims 11-35 of USSN ‘102, which recite a tetrahedral molecule within the scope of instant claims.
As addressed in section 9 above, USSN ‘102 claim 11 recites the same tetrahedral molecule as instant claim 81.
USSN ‘102 claim 20 recites embodiments of the tetrahedral molecule comprising various combinations of domains one through four being an Fc domain, a Fab domain, IL-15, ACE2 peptidase domain, a secreted protein, or the extracellular domain of a transmembrane protein, i.e. the same embodiments as recited in instant claim 82, including the limitations of instant claims 90, 106 and 109.
USSN ‘102 claim 12 specifies that the dimerizing polypeptides form a homodimer, thereby anticipating instant claim 85.
Claims 114 and 115 are included in the rejection for the same reasons as presented in section 7 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 81-82, 85-86, 90, 106 and 114-115 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)
18/153840 20230220116 (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, and fourth domain, wherein the first and second domains are Fc domains, the third and fourth domains are Fab domains, and CLD is located between Fab and Fc domains within the heavy chains (see claim 1 or USSN ‘972, claim 1 or USSN ‘940, claim 1 or USSN ‘412, and claims 1-2 of USSN ‘840). The tetrahedral molecule recited in USSN ‘840 also comprises IL-15 (claim 2).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Claims 81-82, 85, 90 and 114-115 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/367947.
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 ‘947.
USSN ‘947 claim 1 recites a fusion protein dimer of the following structure:
Third domain – CLD – First domain, and
Fourth domain – CLD – Second domain.
USSN ‘947 claim 2 specifies that the first and second domains are Fc domains.
As explained in section 7 above, this structure is within the scope of instant claims 81-82, 85 and 90. Claims 114 and 115 are included for the same reasons as presented in section 7 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
16. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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