DETAILED ACTION
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 .
Election/Restrictions
1. The Election filed 6/1/2026 in response to the Office Action of 3/31/2026 is acknowledged. Applicant elected with traverse Group I and the species of SEQ ID NO:71, SEQ ID NO:57 and SEQ ID NO:53.
2. Applicants argue that Groups I and II have unity of invention because the special technical feature includes the sequences listed in claim 2 of SEQ ID NOs:1-12 and 71-72 and the reference cited as prior art, Van Eenennaam, does not disclose or enable any amino acid sequences to a CD70-binding designed ankyrin repeat domains. Applicants argue that because claim 2 is generic for the species listed in claims 9 and 16, Applicant is entitled to examination of all species listed in claims 9 and 16 without restriction.
The arguments have been considered but are not persuasive. Groups I-II lack unity of invention because even though Applicant argues that the inventions of these groups require the technical feature of recombinant binding proteins comprising an ankyrin repeat domain which specifically binds to CD70 and wherein said ankyrin repeat domain comprises an amino acid sequence with at least 85% sequence identity with any one of SEQ ID NOs:1-12 and 71-71, this argued technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US Patent 11,834,504, Reschke (effectively filed 3/9/2021) for the reasons stated in the prior art rejection below.
Thus, “special technical feature” does not define a contribution over the prior art.
With regards to species restrictions, the arguments are not persuasive. The species listed in claims 9 and 16 are drawn to a structurally distinct sequences that do not share a technical feature, therefore the species restriction is proper. As stated in the species restriction of record for Group I: “Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim.” Given claim 2 is not allowed, Applicants are not entitled to consideration and rejoinder of species in claims 9 and 16.
For these reasons, the restriction requirement is deemed to be proper and is therefore made FINAL.
3. Claims 2-7, 9, 11, 14, 16, and 19-20 are pending. Claims 21 and 23-26 have been withdrawn from further consideration by the examiner under 35 CFR 1.142(b) as being drawn to non-elected inventions. Claims 2-7, 9, 11, 14, 16, and 19-20 are currently under prosecution as drawn to the elected species.
Priority
4. Application claims the benefit and priority of PCT/IB2022/053275 filed on 4/7/2022 which claims benefit of provisional applications 63/172,973 filed on 4/9/2021, 63/173,186 filed on 4/9/2021, and 63/265,181 filed on 12/9/2021. Following review priority has been granted to provisional application 63/173,186 and the effective filing date of 4/9/2021.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 1, paragraph 4 lines 6 and 8; and page 33 paragraph 3 line10. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 2-7, 9, 11, 14, 16, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection.
The claims are drawn to a recombinant binding protein comprising an ankyrin repeat domain that binds human CD70 and comprises at least 85% amino acid sequence identity with SEQ ID NO: 71.
Claim 5-7 and 9 are further drawn to a recombinant binding protein that binds CD70 and further comprises an ankyrin repeat domain binding moiety that binds CD3 expressed on a T cell and comprises at least 85% of the amino acid sequence of SEQ ID NO: 57.
Claims 14 and 16 are further drawn to a recombinant binding protein that binds human CD70 and further comprises a half-life extending moiety that binds human serum albumin (HSA) and comprises an amino acid sequence of at least 85% identity to SEQ ID NO: 53.
Thus, the claims encompass a vast genus of recombinant binding proteins that bind to human CD70, bind to human CD70 and CD3 on an immune cell, bind to human CD70 and ankyrin repeat domains on immune cells, bind human CD70 and human CD3 on an immune cell, and bind human CD70 and HSA with the partial amino acid sequence structures of at least 85% of SEQ ID NO: 71 binding CD70, SEQ ID NO: 57 binding CD3, and SEQ ID NO: 53 binding HSA, that encompass sequence variants having up to 15% sequence discrepancy from the claimed SEQ ID NOs.
The instant specification discloses 14 ankyrin repeat domains that specifically bind to CD70 (SEQ ID NOs:1-12, 71, and 72), 5 ankyrin repeat domains that specifically bind to CD3 (SEQ ID NOs:55-59), and 3 ankyrin repeat domains that specifically bind to HAS (SEQ ID NOs:52-54). (Examples, pgs., 48-51).
The instant specification discloses two sequences with amino acid substitutions, SEQ ID NOs:62 and 63. The specification identifies that the amino acid substitutions could be made to produce any of the sequences that bind to CD70, CD3, or HSA and does not make any distinctions between substitutions that are required to maintain binding for specifically CD70, CD3, or HSA.
The specification discloses at pages 21-22:
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317
636
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272
635
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Thus, the instant specification identifies 14 structurally distinct ankyrin repeat domains that bind CD70, 5 structurally distinct ankyrin repeat domains that bind CD3, and 3 structurally distinct ankyrin repeat domains that bind HSA. The specification fails to disclose any other ankyrin repeat domain amino acid sequence variants comprising at least 85% of the SEQ ID NO: 71 that can be altered and still maintain the function of binding CD70; or at least 85% of the SEQ ID NO: 57 that can be altered and still maintain the function of binding CD3; or at least 85% of the SEQ ID NO: 53 that can be altered and still maintain the function of binding HSA.
To provide adequate written description and evidence of possession of the claimed recombinant binding protein genus, the instant specification can structurally describe representative recombinant binding protein variants that function to bind CD70, CD3, or HSA, or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.).
In this case, the only factor present in the claims is a recitation of that function, “binding specificity for human CD70”, “binding specificity for human CD3”, and “binding specificity for HSA” and the partial amino acid structures as stated above. The instant specification fails to describe structural features common to the members of the ankyrin repeat domain genus specific for binding to CD70, CD3, or HSA, which features constitute a substantial portion of the genus because the instant specification fails to disclose representative ankyrin repeat domain variant sequences that function as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the ankyrin repeat domain does, rather than what it is. Other than for the amino acid sequences disclosed on pages 48-51, the specification fails to provide the amino acid sequence structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of ankyrin repeat domain sequence variants for the recombinant binding proteins that function as claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to make the claimed recombinant binding proteins.
The claims broadly encompass any sequence variant having at least 85% identity to SEQ ID NO: 71 and binding CD70, and any sequence variant having at least 85% identity to SEQ ID NO: 57 and binding CD3 or having at least 85% identity to SEQ ID NO: 53 and binding HSA. Applicants have not established any reasonable structure-function correlation with regards to the sequences in the ankyrin repeat domains that can be altered and still maintain CD70 binding function, or established any reasonable structure-function correlation with regards to the sequences in the ankyrin repeat domains that can be altered and still maintain CD3 binding function, or established any reasonable structure-function correlation with regards to the sequences in the ankyrin repeat domains that can be altered and still maintain HSA binding function. Given the well-known high level of polymorphism of amino acid binding sequences and structure, the skilled artisan would not have been in possession of the vast repertoire of recombinant binding proteins encompassed by the claimed invention.
One could not reasonably or predictably extrapolate the structure of a single recombinant binding protein comprising at least 85% of the amino acid structure of SEQ ID NO: 71 to the structure of any variants required to bind CD70 as broadly claimed, or the structure of a single recombinant binding protein comprising at least 85% of SEQ ID NO: 57 to the structure of any variants required to bind CD3 as broadly claimed, or the structure of a single recombinant binding protein comprising at least 85% of SEQ ID NO: 53 to the structure of any variants required to bind HSA as broadly claimed. Therefore, one could not readily envision members of the broadly claimed genus.
Although Applicants may argue that it is possible to screen for ankyrin repeat domains that bind CD70, CD3, or HSA and function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future antibodies yet to be discovered that may function as claimed. The CD70, CD3, or HSA antigen provides no information about the structure of an ankyrin repeat domain that binds to it.
Given the lack of representative examples to support the full scope of the claimed variant recombinant binding proteins, and lack of reasonable structure-function correlation with regards to the unknown variable sequences in the ankyrin repeat domains that provide CD70, CD3, and HSA-binding function, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of recombinant binding protein variants that bind CD70, CD3, and/or HSA and comprise at least 85% of the amino acid sequence that is required to practice the claimed invention.
Examiner Suggestion: Examiner suggests amending claim 2 to recite:
“wherein said ankyrin repeat domain comprises the amino acid sequence set forth in SEQ ID NO: 71.”
Examiner suggest amending claim 5 to recite:
“The recombinant binding protein of claim 2, further comprising a binding moiety with binding specificity for a target expressed on an immune cell, wherein said binding moiety with binding specificity for a target expressed on an immune cell is an ankyrin repeat domain with binding specificity for human CD3, and wherein said ankyrin repeat domain with binding specificity for human CD3 comprises the amino acid sequence set forth in SEQ ID NO: 57.”
Examiner suggests amending claim 14:
“The recombinant binding protein of claim 2, wherein said binding protein further comprises a half-life extending moiety, wherein said half-life extending moiety is an ankyrin repeat domain with binding specificity for human serum albumin, wherein said ankyrin repeat domain with binding specificity for human serum albumin comprises the amino acid sequence set forth in SEQ ID NO: 53.”
Claim Rejections - 35 USC § 102
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)(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 2-7, 9, 11, 14, 16, and 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Reschke (US11834504 B2, effectively filed 3/9/2021).
The applied reference has a common Applicant and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Reschke discloses a recombinant binding protein comprising an ankyrin repeat domain that has specific binding for human CD70 and comprises the amino acid sequence identity of SEQ ID NO:71 (See Reschke, column 101, section D, also SEQ ID NOs: 95-99 and 101 alignments below).
Reschke discloses the CD70 recombinant protein has a dissociation constant (KD) of below 150 nM in PBS (Table 3c) and an EC50 of between 0.2-500 nM (Table 5c DARPin protein #56).
Reschke discloses a recombinant protein that comprises a binding moiety that is an ankyrin repeat domain with binding CD3 on a T cell and comprises the amino acid sequences of SEQ ID NO:57. (See Reschke, column 90, example 1, section A, also see alignment of SEQ ID NO:3 below).
Reschke discloses a recombinant binding protein comprising ankyrin repeat domains with binding specificities of human CD70 and targets expressed on an immune cell that can be covalently linked with a peptide linker. (See Reschke, column 52, lines 65-67).
Reschke discloses a half-life extending moiety that is an ankyrin repeat domain with binding specificity to human serum albumin comprising the amino acid sequence of SEQ ID NO:53. (See Reschke, column 7 lines 64-67, also see alignments below).
Reschke discloses a nucleic acid encoding the recombinant binding protein and pharmaceutical compositions including the protein or the nucleic acids. (See Reschke, abstract).
SEQ ID NO: 95 (Reschke) 100% matches SEQ ID NO:71:
US-17-654-209-95
Sequence 95, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 95
LENGTH: 865
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 56
Query Match 100.0%; Score 627; Length 865;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 594 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 653
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 654 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 713
Qy 121 QKAA 124
||||
Db 714 QKAA 717
SEQ ID NO: 96 (Reschke) 100% matches SEQ ID NO:71:
US-17-654-209-96
Sequence 96, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 96
LENGTH: 847
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 57
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 97 (Reschke) 100% matches SEQ ID NO:71:
US-17-654-209-97
Sequence 97, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 97
LENGTH: 847
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 58
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 98 (Reschke) 100% matches SEQ ID NO:71:
US-17-654-209-98
Sequence 98, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 98
LENGTH: 847
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 59
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 99 (Reschke) 100% matches SEQ ID NO:71:
US-17-654-209-99
Sequence 99, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 99
LENGTH: 880
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 60
Query Match 100.0%; Score 627; Length 880;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 101 (Reschke) 100% matches SEQ ID NO:71:
US-17-654-209-101
Sequence 101, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 101
LENGTH: 865
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 62
Query Match 100.0%; Score 627; Length 865;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO:3 (Reschke) 100% matches SEQ ID NO:57:
US-17-654-209-3
Sequence 3, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 3
LENGTH: 124
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 3
Query Match 100.0%; Score 633; Length 124;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGQKLLEAAWAGQDDEVRELLKAGADVNAKNSRGWTPLHTAAQTGHLEIFEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGQKLLEAAWAGQDDEVRELLKAGADVNAKNSRGWTPLHTAAQTGHLEIFEVLLKAGAD 60
Qy 61 VNAKNDKRVTPLHLAAALGHLEIVEVLLKAGADVNARDSWGTTPADLAAKYGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKNDKRVTPLHLAAALGHLEIVEVLLKAGADVNARDSWGTTPADLAAKYGHQDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:11 (Reschke) 100% matches SEQ ID NO:53:
US-17-654-209-11
Sequence 11, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 11
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 11
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:12 (Reschke) 100% matches SEQ ID NO:53:
US-17-654-209-12
Sequence 12, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 12
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 12
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:13 (Reschke) 100% matches SEQ ID NO:53:
US-17-654-209-13
Sequence 13, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 13
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 13
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:14 (Reschke) 100% matches SEQ ID NO:53:
US-17-654-209-14
Sequence 14, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 14
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 14
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
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 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.
8. Claims 2-7, 9, 11, 14, 16, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 9-20 of U.S. Patent No.11834504 B2 (‘504) in view of Coccia (WO2008/074004 A2, pub. 6/19/2008).
Regarding instant claim 2, ‘504 claims a recombinant binding protein comprising an ankyrin repeat domain that has specific binding for human CD70 and comprises the amino acid sequence identity of SEQ ID NO:71 (See claims 9-12, 14-18, also alignments below).
Regarding instant claims 5-7 and 9, ‘504 claims a recombinant protein that comprises an ankyrin repeat domain binding moiety with binding for CD3 on an immune cell, and comprises the amino acid sequences of SEQ ID NO:57. (See claims 1 and 5-6, also alignments below).
Regarding instant claims 14 and 16, ‘504 claims a half-life extending moiety that is an ankyrin repeat domain with binding specificity to human serum albumin comprising the amino acid sequence of SEQ ID NO:53. (See claims 9 and 14, also see alignments below).
Regarding instant claims 19-20, ‘504 claims a nucleic acid encoding the recombinant binding protein and pharmaceutical compositions including the protein or the nucleic acids. (See claims 19-20).
Patent ‘504 does not claim the ankyrin repeat domain that specifically binds to human CD70 has a dissociation constant of below about 150 nM or an EC50 ranging from about 0.2-500 nM or that the CD70 binding domain could be linked to the target expressed cell on an immune cell through a peptide linker.
Coccia teaches that DARPins are antibody mimetics, capable of mimicking an antibody’s ability to bind an antigen but not limited to native antibody structure (See Coccia, pg. 27 lines 4-9), and specifically DARPins are known for high specificity and high affinity, with binding affinities in the single-digit nanomolar to picomolar range being obtainable. (See Coccia, pg. 65 lines 12-16). Coccia specifically discloses anti-CD70 antibodies with measured KD of 2.1, 5.1, 1.6, and 1.5 nM and an EC50 value of 0.9 nM. (See Coccia, Examples 6 and 7). Coccia also teaches peptide linkers as being used to connect polypeptide molecules. (See Coccia, pg. 106 lines 23-27).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the recombinant protein of Patent ‘504 with the teachings of Coccia to produce the instant claimed invention. It would have been obvious because Coccia teaches that DARPins are antibody mimics capable of binding affinity similar to antibodies, Coccia discloses anti-CD70 antibodies with measured KD and EC50 within the range claimed by the present invention, and peptide linkers are well known in the art as a useful way to connect two functional untis in a protein. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective date to use the recombinant protein of patent ‘504 with the teachings of Coccia with a reasonable expectation of success at producing the present claimed invention.
SEQ ID NO: 95 (‘504) 100% matches SEQ ID NO:71:
US-17-654-209-95
Sequence 95, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 95
LENGTH: 865
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 56
Query Match 100.0%; Score 627; Length 865;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 594 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 653
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 654 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 713
Qy 121 QKAA 124
||||
Db 714 QKAA 717
SEQ ID NO: 96 (‘504) 100% matches SEQ ID NO:71:
US-17-654-209-96
Sequence 96, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 96
LENGTH: 847
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 57
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 97 (‘504) 100% matches SEQ ID NO:71:
US-17-654-209-97
Sequence 97, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 97
LENGTH: 847
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 58
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 98 (‘504) 100% matches SEQ ID NO:71:
US-17-654-209-98
Sequence 98, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 98
LENGTH: 847
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 59
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 99 (‘504) 100% matches SEQ ID NO:71:
US-17-654-209-99
Sequence 99, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 99
LENGTH: 880
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 60
Query Match 100.0%; Score 627; Length 880;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 101 (‘504) 100% matches SEQ ID NO:71:
US-17-654-209-101
Sequence 101, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 101
LENGTH: 865
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 62
Query Match 100.0%; Score 627; Length 865;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO:3 (‘504) 100% matches SEQ ID NO:57:
US-17-654-209-3
Sequence 3, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 3
LENGTH: 124
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 3
Query Match 100.0%; Score 633; Length 124;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGQKLLEAAWAGQDDEVRELLKAGADVNAKNSRGWTPLHTAAQTGHLEIFEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGQKLLEAAWAGQDDEVRELLKAGADVNAKNSRGWTPLHTAAQTGHLEIFEVLLKAGAD 60
Qy 61 VNAKNDKRVTPLHLAAALGHLEIVEVLLKAGADVNARDSWGTTPADLAAKYGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKNDKRVTPLHLAAALGHLEIVEVLLKAGADVNARDSWGTTPADLAAKYGHQDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:11 (‘504) 100% matches SEQ ID NO:53:
US-17-654-209-11
Sequence 11, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 11
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 11
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:12 (‘504) 100% matches SEQ ID NO:53:
US-17-654-209-12
Sequence 12, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 12
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 12
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:13 (‘504) 100% matches SEQ ID NO:53:
US-17-654-209-13
Sequence 13, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 13
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 13
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:14 (‘504) 100% matches SEQ ID NO:53:
US-17-654-209-14
Sequence 14, US/17654209
Patent No. 11834504
GENERAL INFORMATION
APPLICANT: MOLECULAR PARTNERS AG
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS
FILE REFERENCE: P031
CURRENT APPLICATION NUMBER: US/17/654,209
CURRENT FILING DATE: 2022-03-09
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 14
LENGTH: 569
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: DARPin protein 14
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
9. Claims 2-7, 9, 11, 14, 16, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, and 11-18 of copending Application No.18492484 (‘484) in view of Coccia (WO2008/074004 A2, pub. 6/19/2008).
Regarding instant claim 2, ‘484 claims a recombinant binding protein comprising an ankyrin repeat domain that specifically binds to CD70 with an amino acid sequence of SEQ ID NO:71. (See claims 11-14 and 16, also alignment below).
Regarding instant claims 5-7 and 9, ‘484 claims a binding moiety for a target expressed on an immune cell that comprises an ankyrin repeat domain that specifically binds CD3 and comprises the amino acid sequence of SEQ ID NO:57. (See claims 1 and 5-8, also see alignments below).
Regarding instant claims 14 and 16, ‘484 claims a half-life extending moiety comprising an ankyrin repeat domain specifically binding human serum albumin comprising the amino acid sequence of SEQ ID NO:53. (See claim 11 and alignments below).
Regarding instant claims 19-20, ‘484 claims a nucleic acid encoding the recombinant protein and a pharmaceutical composition comprising the recombinant protein and a pharmaceutically acceptable excipient. (See claims 17 and 18).
Application ‘484 does not claim the ankyrin repeat domain that specifically binds to human CD70 has a KD of below about 150 nM or an EC50 ranging from about 0.2-500 nM or that the CD70 binding domain could be linked to the target expressed cell on an immune cell through a peptide linker.
Coccia teaches that DARPins are antibody mimetics, capable of mimicking an antibody’s ability to bind an antigen but not limited to native antibody structure (See Coccia, pg. 27 lines 4-9), and specifically DARPins are known for high specificity and high affinity, with binding affinities in the single-digit nanomolar to picomolar range being obtainable. (See Coccia, pg. 65 lines 12-16). Coccia specifically discloses anti-CD70 antibodies with measured KD of 2.1, 5.1, 1.6, and 1.5 nM and an EC50 value of 0.9 nM. (See Coccia, Examples 6 and 7). Coccia also teaches peptide linkers as being used to connect polypeptide molecules. (See Coccia, pg. 106 lines 23-27).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the recombinant protein of Application ‘484 with the teachings of Coccia to produce the instant claimed invention. It would have been obvious because Coccia teaches that DARPins are antibody mimics capable of binding affinity similar to antibodies, Coccia discloses anti-CD70 antibodies with measured KD and EC50 within the range claimed by the present invention, and peptide linkers are well known in the art as a useful way to connect two functional units in a protein. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective date to use the recombinant protein of application ‘484 with the teachings of Coccia with a reasonable expectation of success at producing the present claimed invention.
This is a provisional nonstatutory double patenting rejection.
SEQ ID NO: 95 (‘484) 100% matches SEQ ID NO:71:
US-18-492-484-95
Filing date in PALM: 2023-10-23
Sequence 95, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 95
LENGTH: 865
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..865
QUALIFIERS: note = DARPin protein 56
FEATURE:
NAME/KEY: source
LOCATION: 1..865
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 627; Length 865;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 594 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 653
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 654 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 713
Qy 121 QKAA 124
||||
Db 714 QKAA 717
SEQ ID NO: 96 (‘484) 100% matches SEQ ID NO:71:
US-18-492-484-96
Filing date in PALM: 2023-10-23
Sequence 96, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 96
LENGTH: 847
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..847
QUALIFIERS: note = DARPin protein 57
FEATURE:
NAME/KEY: source
LOCATION: 1..847
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 97 (‘484) 100% matches SEQ ID NO:71:
US-18-492-484-97
Filing date in PALM: 2023-10-23
Sequence 97, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 97
LENGTH: 847
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..847
QUALIFIERS: note = DARPin protein 58
FEATURE:
NAME/KEY: source
LOCATION: 1..847
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 98 (‘484) 100% matches SEQ ID NO:71:
US-18-492-484-98
Filing date in PALM: 2023-10-23
Sequence 98, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 98
LENGTH: 847
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..847
QUALIFIERS: note = DARPin protein 59
FEATURE:
NAME/KEY: source
LOCATION: 1..847
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 627; Length 847;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 99 (‘484) 100% matches SEQ ID NO:71:
US-18-492-484-99
Filing date in PALM: 2023-10-23
Sequence 99, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 99
LENGTH: 880
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..880
QUALIFIERS: note = DARPin protein 60
FEATURE:
NAME/KEY: source
LOCATION: 1..880
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 627; Length 880;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO: 101 (‘484) 100% matches SEQ ID NO:71:
US-18-492-484-101
Filing date in PALM: 2023-10-23
Sequence 101, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 101
LENGTH: 865
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..865
QUALIFIERS: note = DARPin protein 62
FEATURE:
NAME/KEY: source
LOCATION: 1..865
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 627; Length 865;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 297 DLGIKLLTAAYDGQLDEVRILLKAGADVNAKDLRGQTPLHYAAGLGHLEIVEVLLKAGAD 356
Qy 61 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 VNAKDLHGWTPLHLAAWSGHLEIVEVLLKAGADVNAQDVEGVTPADLAAVQGHQDIAEVL 416
Qy 121 QKAA 124
||||
Db 417 QKAA 420
SEQ ID NO:3 (‘484) 100% matches SEQ ID NO:57:
US-18-492-484-3
Filing date in PALM: 2023-10-23
Sequence 3, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 3
LENGTH: 124
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..124
QUALIFIERS: note = DARPin protein 3
FEATURE:
NAME/KEY: source
LOCATION: 1..124
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 633; Length 124;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGQKLLEAAWAGQDDEVRELLKAGADVNAKNSRGWTPLHTAAQTGHLEIFEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGQKLLEAAWAGQDDEVRELLKAGADVNAKNSRGWTPLHTAAQTGHLEIFEVLLKAGAD 60
Qy 61 VNAKNDKRVTPLHLAAALGHLEIVEVLLKAGADVNARDSWGTTPADLAAKYGHQDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKNDKRVTPLHLAAALGHLEIVEVLLKAGADVNARDSWGTTPADLAAKYGHQDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:11 (‘484) 100% matches SEQ ID NO:53:
US-18-492-484-11
Filing date in PALM: 2023-10-23
Sequence 11, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 11
LENGTH: 569
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..569
QUALIFIERS: note = DARPin protein 11
FEATURE:
NAME/KEY: source
LOCATION: 1..569
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:12 (‘484) 100% matches SEQ ID NO:53:
US-18-492-484-12
Filing date in PALM: 2023-10-23
Sequence 12, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 12
LENGTH: 569
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..569
QUALIFIERS: note = DARPin protein 12
FEATURE:
NAME/KEY: source
LOCATION: 1..569
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:13 (‘484) 100% matches SEQ ID NO:53:
US-18-492-484-13
Filing date in PALM: 2023-10-23
Sequence 13, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 13
LENGTH: 569
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..569
QUALIFIERS: note = DARPin protein 13
FEATURE:
NAME/KEY: source
LOCATION: 1..569
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
SEQ ID NO:14 (‘484) 100% matches SEQ ID NO:53:
US-18-492-484-14
Filing date in PALM: 2023-10-23
Sequence 14, US/18492484
Publication No. US20240254229A1
GENERAL INFORMATION
APPLICANT: Molecular Partners AG (en)
TITLE OF INVENTION: NOVEL DARPin BASED MULTI-SPECIFIC T-CELL ENGAGERS (en)
FILE REFERENCE: 13081.0028-01000
CURRENT APPLICATION NUMBER: US/18/492,484
CURRENT FILING DATE: 2023-10-23
NUMBER OF SEQ ID NOS: 124
SEQ ID NO 14
LENGTH: 569
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..569
QUALIFIERS: note = DARPin protein 14
FEATURE:
NAME/KEY: source
LOCATION: 1..569
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 620; Length 569;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DLGKKLLEAARAGQDDEVRELLKAGADVNAKDYFSHTPLHLAARNGHLKIVEVLLKAGAD 60
Qy 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VNAKDFAGKTPLHLAAADGHLEIVEVLLKAGADVNAQDIFGKTPADIAADAGHEDIAEVL 120
Qy 121 QKAA 124
||||
Db 121 QKAA 124
Conclusion
10. Claims 2-7, 9, 11, 14, 16, and 19-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDSAY DUNN/Examiner, Art Unit 1644
/Laura B Goddard/Primary Examiner, Art Unit 1642
Prosecution Insights