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
Applicant’s election without traverse of Group II, drawn to claims 6-39, in the reply filed on 02/17/2026 is acknowledged. Applicants also elected without traverse the following species:
A) Immune checkpoint inhibitor: SEQ ID NO: 5
B) Secretion signal peptide: SEQ ID NO: 66
C) Cleavable peptide: SEQ ID NO: 123
D) Amino acid encoded by polycistronic nucleic acid: SEQ ID NO: 337
E) Antigenic peptide: SEQ ID NO: 364
F) x in polycistronic nucleic acid: x = 4.
Regarding the amino acid encoded by polycistronic nucleic acid (“D” of election of species), the elected species of SEQ ID NO: 337 (claims 21, 27, and 33-34) was determined to be free of the prior art. Therefore, search was extended to other species enumerated in claims 19 and 21-23 (also encompassed by claims 24-26 and 31-32), which are SEQ ID NOs: 309-324 (claim 19), 325-336 and 338-340 (claims 21, 24-26), 341-344 (claim 22), and 345-348 (claim 23).
Claims 7-8, 12, 14-15, 17, 29, and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Claims 6, 9-11, 13, 16, 18-28, 30-34, and 37-39 are examined on the merits herein.
Priority
The instant application is a CON of PCT/US2022/014970 filed 02/02/2022, which claims benefit of US Provisional application 63/144,834 filed 02/02/2021.
Claim Objections
Claim 6 is objected to because of the following informalities: The limitation “((M)(Secretion Signal Peptide-Immune Checkpoint Inhibitor Peptide-Cleavable Peptide)x(Secretion Signal Peptide-Immune Checkpoint Inhibitor Peptide)), wherein x = 1-10” should be corrected to clarify that that x refers specifically to the number of repeats of (Secretion Signal Peptide-Immune Checkpoint Inhibitor Peptide-Cleavable Peptide). As currently written, there is ambiguity as to which portion of the polycistronic nucleic acid “x” refers to. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the phrase “SEQ ID NOS” should be
followed by a colon. Appropriate correction is required.
Duplicate Claim Warning
Applicant is advised that should claim 25 be found allowable, claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof; and should claim 27 be found allowable, claim 33 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 31-34 are directed to an rMVA viral vector comprising an amino acid sequence. The metes and bounds of the limitation “viral vector comprising an amino acid sequence” are unclear. A viral vector does not necessarily comprise an amino acid sequence. A viral vector comprises a nucleic acid sequence, which may or may not encode an amino acid sequence.
Claim Rejections - 35 USC § 112(a)
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.
Claims 6, 9-11, 13, 16, 18-28, 30-34, and 37-39 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 claim(s) contains 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.
From M.P.E.P. § 2163, the analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention from the standpoint of one of skill in the art at the time the application was filed. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
For claims drawn to a genus, possession may be shown (for example) through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus, and is an inverse function of the skill and knowledge in the art. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
Regarding the immune checkpoint inhibitor peptide in claims 6 and 9:
Claim 6 is drawn to an rMVA viral vector comprising a heterologous, polycistronic nucleic acid, wherein the polycistronic nucleic acid encodes ((M)(Secretion Signal Peptide-Immune Checkpoint Inhibitor Peptide-Cleavable Peptide)x(Secretion Signal Peptide-Immune Checkpoint Inhibitor Peptide)), wherein x = 1-10, wherein M is methionine, and wherein the Immune Checkpoint Inhibitor comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 1-15, or an amino acid sequence at least 90% identical thereto.
Claim 6 recites a structure: an rMVA viral vector comprising a heterologous, polycistronic nucleic acid, wherein the polycistronic nucleic acid encodes an Immune Checkpoint Inhibitor, wherein the Immune Checkpoint Inhibitor comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 1-15, or an amino acid sequence at least 90% identical thereto. Claim 6 also recites a function: wherein the amino acid sequence selected from the group consisting of SEQ ID NOS: 1-15, or an amino acid sequence at least 90% identical thereto, functions as an Immune Checkpoint Inhibitor in the rMVA viral vector. Thus, the claims are each drawn to a product comprising a very large genus of an rMVA viral vector comprising the claimed function.
Neither the specification nor the prior art establishes a structure-function relationship wherein an amino acid sequence, which is as little as 90% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-15, would be capable of functioning as claimed with any degree of predictability.
The instant specification discloses peptide sequences for immune checkpoint inhibitor peptides in Table 1, including the sequences set forth in SEQ ID NOs: 1-15 (p 42, ln 13-15; Table 1 on p 43-45). However, neither Table 1 nor the text of the specification identifies what changes, mutations, etc. could be made to the sequences set forth in SEQ ID NOs: 1-15 and that would be encompassed by the structural limitations of claim 6, and would predictably result in the claimed function of the peptide being an Immune Checkpoint Inhibitor. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 1-15 that are capable of providing for said function as claimed.
The prior art is unpredictable. For example, the sequence set forth in SEQ ID NO: 5 of the instant application, which is 100% identical to the sequence set forth in SEQ ID NO: 12 of Gutierrez (US 2018/339044 A1; Reference No. 68 in IDS filed 11/20/2023), is the sequence of a PD-1/CTLA4 dual inhibitor peptide (LD10). Gutierrez does not teach what modifications may be made to the PD-1/CTLA4 dual inhibitor peptide, such that the peptide retains its function as an inhibitor peptide. Thus, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species that are as little as 90% identical to the sequences set forth in SEQ ID NOs: 1-15 that provide for said function as claimed.
Claims 9-11, 13, 16, 18-28, 30, and 37-39 are included in the rejection because they depend from claim 6.
Regarding the secretion signal peptide in claims 11 and 13:
Claim 11 is drawn to the rMVA of claim 6, wherein the secretion signal peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 57-90, or an amino acid sequence at least 85% identical thereto. Claim 13 is drawn to the rMVA of claim 11, wherein the secretion signal peptide comprises an amino acid sequence selected from SEQ ID NO: 66, or an amino acid sequence at least 95% identical thereto.
Claims 11 and 13 recite a structure: an rMVA viral vector comprising a heterologous, polycistronic nucleic acid, wherein the polycistronic nucleic acid encodes a secretion signal peptide, wherein the secretion signal peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 57-90, or an amino acid sequence at least 85% identical thereto (claim 11), or an amino acid sequence selected from SEQ ID NO: 66, or an amino acid sequence at least 95% identical thereto (claim 13). Claims 11 and 13 also recite a function: wherein an amino acid sequence selected from the group consisting of SEQ ID NOS: 57-90, or an amino acid sequence at least 85% identical thereto (claim 11), or an amino acid sequence selected from SEQ ID NO: 66, or an amino acid sequence at least 95% identical thereto (claim 13), functions as a secretion signal peptide in the rMVA viral vector. Thus, the claims are each drawn to a product comprising a very large genus of an rMVA viral vector comprising the claimed function.
Neither the specification nor the prior art establishes a structure-function relationship wherein an amino acid sequence, which is as little as 85% identical to the sequences set forth in SEQ ID NOs: 57-90 (claim 11) or as little as 95% identical to SEQ ID NO: 66 (claim 13), would be capable of functioning as claimed with any degree of predictability.
The instant specification discloses peptide sequences for secretion signal peptides in Table 2, corresponding to the sequences set forth in SEQ ID NOs: 57-90 (Table 2 on p 47-48). However, neither Table 2 nor the text of the specification identifies what changes, mutations, etc. could be made to the sequences set forth in SEQ ID NOs: 57-90 and that would be encompassed by the structural limitations of claims 11 or 13, and would predictably result in the claimed function of the peptide being a secretion signal peptide. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 85% identical to the sequences set forth in SEQ ID NOs: 57-90 (claim 11) or as little as 95% identical to SEQ ID NO: 66 (claim 13) that are capable of providing for said function as claimed.
The prior art is unpredictable. For example, the sequence set forth in SEQ ID NO: 66 of the instant application is 100% identical to residues 2-35 of the sequence set forth in SEQ ID NO: 47 of Li (US 2021/0317168 A1). Li does not teach what modifications may be made to the sequence set forth in SEQ ID NO: 47 therein, such that the peptide retains its function as a secretion signal peptide. Thus, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species that are as little as 85% identical to the sequences set forth in SEQ ID NOs: 57-90 (claim 11) or as little as 95% identical to SEQ ID NO: 66 (claim 13) that are capable of providing for said function as claimed.
Regarding the cleavable peptide in claims 16 and 18:
Claim 16 is drawn to the rMVA of claim 6, wherein the cleavable peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 123-127, or an amino acid sequence at least 95% identical thereto. Claim 18 is drawn to the rMVA of claim 16, wherein the cleavable peptide comprises an amino acid sequence SEQ ID NO: 123, or an amino acid sequence at least 95% identical thereto.
Claims 16 and 18 recite a structure: an rMVA viral vector comprising a heterologous, polycistronic nucleic acid, wherein the polycistronic nucleic acid encodes a cleavable peptide, wherein the cleavable peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 123-127, or an amino acid sequence at least 95% identical thereto (claim 16), or an amino acid sequence SEQ ID NO: 123, or an amino acid sequence at least 95% identical thereto (claim 18). Claims 16 and 18 also recite a function: wherein an amino acid sequence selected from the group consisting of SEQ ID NOS: 123-127, or an amino acid sequence at least 95% identical thereto (claim 16), or an amino acid sequence SEQ ID NO: 123, or an amino acid sequence at least 95% identical thereto (claim 18), functions as a cleavable peptide in the rMVA viral vector. Thus, the claims are each drawn to a product comprising a very large genus of an rMVA viral vector comprising the claimed function.
Neither the specification nor the prior art establishes a structure-function relationship wherein an amino acid sequence, which is as little as 95% identical to the sequences set forth in SEQ ID NOs: 123-127 (claim 16) or as little as 95% identical to SEQ ID NO: 123 (claim 18), would be capable of functioning as claimed with any degree of predictability.
The instant specification discloses peptide sequences for hybrid cleavable peptides in Table 6, corresponding to the sequences set forth in SEQ ID NOs: 123-127 (Table 6 on p 55). However, neither Table 6 nor the text of the specification identifies what changes, mutations, etc. could be made to the sequences set forth in SEQ ID NOs: 123-127 and that would be encompassed by the structural limitations of claims 16 or 18, and would predictably result in the claimed function of the peptide being a cleavable peptide. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 95% identical to the sequences set forth in SEQ ID NOs: 123-127 (claim 16) or as little as 95% identical to SEQ ID NO: 123 (claim 18) that are capable of providing for said function as claimed.
The prior art is unpredictable. For example, the sequence set forth in SEQ ID NO: 123 of the instant application, which is 100% identical to the sequence set forth in SEQ ID NO: 36 of Bethune (US 2015/197771 A1), is the sequence of a 2A polypeptide (Furin-GSG-P2A). Bethune does not teach what modifications may be made to the sequence set forth in SEQ ID NO: 36 therein, such that the peptide retains its function as a cleavable peptide. Thus, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species that are as little as 95% identical to the sequences set forth in SEQ ID NOs: 123-127 (claim 16) or as little as 95% identical to SEQ ID NO: 123 (claim 18) that are capable of providing for said function as claimed.
Regarding the antigenic peptide in claims 28 and 30:
Claim 28 is drawn to the rMVA of claim 6, wherein the polycistronic nucleic acid further encodes an antigenic peptide. Claim 30 is drawn to the rMVA of claim 28, wherein the antigenic peptide is derived from an amino acid sequence selected from the group consisting of SEQ ID NOS: 358-394, or an amino acid sequence at least 95% identical thereto.
Claims 28 and 30 recite a structure: an rMVA viral vector comprising a heterologous, polycistronic nucleic acid, wherein the polycistronic nucleic acid encodes an antigenic peptide (claim 28), wherein the antigenic peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOS: 358-394, or an amino acid sequence at least 95% identical thereto (claim 30). Claims 28 and 30 also recite a function: wherein the polycistronic nucleic acid encodes a peptide functioning as an antigenic peptide in the rMVA viral vector (claim 28), or wherein an amino acid sequence selected from the group consisting of SEQ ID NOS: 358-394, or an amino acid sequence at least 95% identical thereto, functions as an antigenic peptide in the rMVA viral vector (claim 30). Thus, the claims are each drawn to a product comprising a very large genus of an rMVA viral vector comprising the claimed function.
Neither the specification nor the prior art establishes a structure-function relationship wherein an amino acid sequence, which is as little as 95% identical to the sequences set forth in SEQ ID NOs: 358-394, would be capable of functioning as claimed with any degree of predictability.
The instant specification discloses peptide sequences for antigenic peptides in Table 9, which include the sequences set forth in SEQ ID NOs: 358-394 (Table 9 on p 90-109). However, neither Table 9 nor the text of the specification identifies what changes, mutations, etc. could be made to the sequences set forth in SEQ ID NOs: 358-394 and that would be encompassed by the structural limitations of claim 30, and would predictably result in the claimed function of the peptide being an antigenic peptide. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 95% identical to the sequences set forth in SEQ ID NOs: 358-394 that are capable of providing for said function as claimed.
The prior art is unpredictable. For example, the sequence set forth in SEQ ID NO: 364 of the instant application is 99.6% identical to residues 2-535 of the sequence set forth in SEQ ID NO: 12 of Robinson (US 2019/0290745 A1; Reference No. 69 in IDS filed 11/20/2023). Robinson does not teach what modifications may be made to the sequence set forth in SEQ ID NO: 12 therein, such that the peptide retains its function as an antigenic peptide. Thus, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species that are as little as 95% identical to the sequences set forth in SEQ ID NOs: 358-394 that are capable of providing for said function as claimed.
Regarding the amino acid sequence encoded by the polycistronic nucleic acid (claims 19 and 21-27), the amino acid sequence encoded by the rMVA viral vector (claims 31-34), and the nucleic acid sequence of the polycistronic nucleic acid (claims 37-38).
Claims 19 and 21-27 are drawn to the rMVA of claim 6, wherein the polycistronic nucleic acid encodes an amino acid sequence selected from the group consisting of SEQ ID NOs: 309-324 (claim 19), 325-340 (claim 21), 341-344 (claim 22), 345-348 (claim 23), 325 (claim 24), 329 (claim 25), 333 (claim 26), 337 (claim 27), or an amino acid sequence at least 95% identical thereto. Claims 31 and 33 are drawn to an rMVA viral vector comprising an amino acid sequence of SEQ ID NO: 329 (claim 31) or 337 (claim 33), or an amino acid sequence at least 95% identical thereto. Claims 37-38 are drawn to the rMVA viral vector of claim 6, wherein the polycistronic nucleic acid comprises SEQ ID NO: 408 (claim 37) or 409 (claim 38), or a nucleic acid sequence at least 75% identical thereto.
Claims 19, 21-27, 31-34, and 37-38 recite a structure, as set forth above. Claims 19, 21-27, 31-34, and 37-38 also recite a function: wherein the polycistronic nucleic acid encodes a secretion signal peptide, an immune checkpoint inhibitor, and a cleavable peptide, as set forth in claim 6. Although claims 31-34 do not depend from claim 6, claims 31 and 33 are patentably indistinct from claims 25 and 27, respectively, both of which depend from claim 6. Thus, the claims are each drawn to a product comprising a very large genus of an rMVA viral vector comprising the claimed function.
Neither the specification nor the prior art establishes a structure-function relationship wherein an amino acid sequence, which is as little as 95% identical to the sequences set forth in SEQ ID NOs: 309-348 (claims 19, 21-27, and 31-34), or a nucleic acid sequence, which is as little as 75% identical to the sequences set forth in SEQ ID NOs: 408-409 (claims 37-38) would be capable of functioning as claimed with any degree of predictability.
The instant specification discloses amino acid sequences for rMVA viral vectors in Table 8, which include the sequences set forth in SEQ ID NOs: 309-348 (Table 8 on p 82-88). However, neither Table 8 nor the text of the specification identifies what changes, mutations, etc. could be made to the sequences set forth in SEQ ID NOs: 309-348 and that would be encompassed by the structural limitations of claims 19, 21-27, and 31-34, and would predictably result in the claimed function of the peptide encoding a secretion signal peptide, an immune checkpoint inhibitor, and a cleavable peptide. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 95% identical to the sequences set forth in SEQ ID NOs: 309-348 that are capable of providing for said function as claimed.
The instant specification discloses nucleic acid sequences for rMVA viral vectors in Table 13, which include the sequences set forth in SEQ ID NOs: 408-409 (Table 13 on p 171-172). However, neither Table 13 nor the text of the specification identifies what changes, mutations, etc. could be made to the sequences set forth in SEQ ID NOs: 408-409 and that would be encompassed by the structural limitations of claims 37-38, and would predictably result in the claimed function of the nucleic acid sequence encoding a secretion signal peptide, an immune checkpoint inhibitor, and a cleavable peptide. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 75% identical to the sequences set forth in SEQ ID NOs: 408-409 that are capable of providing for said function as claimed.
The prior art is unpredictable. SEQ ID NOs: 309-324 (claim 19), 325-340 (claims 21, 24-27, 33-34), 341-344 (claim 22), 345-348 (claim 23), 408 (claim 37), and 409 (claim 38) appear to be free of the prior art. Thus, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species that are as little as 95% identical to the sequences set forth in SEQ ID NOs: 309-348, or that are as little as 75% identical to the sequence set forth in SEQ ID NOs: 408-409, that are capable of providing for said function as claimed. Claims 31 and 33 are included in the rejection because they depend from claims 30 and 32, respectively.
In conclusion, the skilled artisan would not have reasonable concluded at the time of the invention that application was in possession of the invention as claimed.
Closest Prior Art
SEQ ID NOs: 309-324 (claim 19), 325-340 (claims 21, 24-27, 33-34), 341-344 (claim 22), 345-348 (claim 23), 408 (claim 37), and 409 (claim 38) appear to be free of the prior art.
The sequences set forth in SEQ ID NOs: 5 (claims 6, 9-10), 66 (claims 11, 13), 123 (claims 16, 18), and 364 (claim 30) are taught in the prior art. Although said sequences are not relied upon for prior art rejections, the alignments thereof are set forth below for the clarity of record:
Regarding SEQ ID NO: 5: Gutierrez (US 2018/339044 A1; Reference No. 68 in IDS filed 11/20/2023) teaches a sequence of a PD-1/CTLA4 dual inhibitor peptide (LD10) identified as SEQ ID NO: 12 therein, which is 100% identical to the sequence set forth in SEQ ID NO: 5 of the instant application:
Query Match 100.0%; Score 85; Length 18;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 STGQISTLRVNITAPLSQ 18
||||||||||||||||||
Db 1 STGQISTLRVNITAPLSQ 18
Regarding SEQ ID NO: 66: Li (US 2021/0317168 A1) teaches a sequence identified as SEQ ID NO: 47 therein, which consists of 36 amino acid residues. Residues 2-35 of the sequence set forth in SEQ ID NO: 47 of Li is 100% identical to the sequence set forth in SEQ ID NO: 66 of the instant application:
Query Match 100.0%; Score 179; Length 36;
Best Local Similarity 100.0%;
Matches 34; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DAMKRGLCCVLLLCGAVFVSPSQEIHARFRRGAR 34
||||||||||||||||||||||||||||||||||
Db 2 DAMKRGLCCVLLLCGAVFVSPSQEIHARFRRGAR 35
Regarding SEQ ID NO: 123: Bethune (US 2015/197771 A1) teaches a sequence of a 2A polypeptide (Furin-GSG-P2A), identified as SEQ ID NO: 36 therein, which is 100% identical to the sequence set forth in SEQ ID NO: 123 of the instant application:
Query Match 100.0%; Score 134; Length 26;
Best Local Similarity 100.0%;
Matches 26; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RAKRGSGATNFSLLKQAGDVEENPGP 26
||||||||||||||||||||||||||
Db 1 RAKRGSGATNFSLLKQAGDVEENPGP 26
Regarding SEQ ID NO: 364: Robinson (US 2019/0290745 A1; Reference No. 69 in IDS filed 11/20/2023) teaches a sequence identified as SEQ ID NO: 12 therein, which consists of 535 amino acid residues. Residues 2-535 of the sequence set forth in SEQ ID NO: 12 of Robinson is 99.6% identical to the sequence set forth in SEQ ID NO: 364 of the instant application:
Query Match 99.2%; Score 2743; Length 535;
Best Local Similarity 99.6%;
Matches 532; Conservative 0; Mismatches 0; Indels 2; Gaps 2;
Qy 1 TPGTQSPFFLLLLLTVLTVVTGSGHASSTPGGEKETSATQRSSVPSSTEKNAVSMTSSVL 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 TPGTQSPFFLLLLLTVLTVVTGSGHASSTPGGEKETSATQRSSVPSSTEKNAVSMTSSVL 61
Qy 61 SSHSPGSGSSTTQGQDVTLAPATEPASGSAATWGQDVTSVPVTRPALGSTTPPAHDVTSA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 62 SSHSPGSGSSTTQGQDVTLAPATEPASGSAATWGQDVTSVPVTRPALGSTTPPAHDVTSA 121
Qy 121 PDNKPAPGSTAPPAHGVTSAPDTRPAPGST-PPAHGVTSAPDTRPAPGSTAPPAHGVTSA 179
|||||||||||||||||||||||||||||| |||||||||||||||||||||||||||||
Db 122 PDNKPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSA 181
Qy 180 PDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPP-HGVTSAPDNRPALGSTAPPVHNVTSA 238
||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||
Db 182 PDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDNRPALGSTAPPVHNVTSA 241
Qy 239 SGSASGSASTLVHNGTSARATTTPASKSTPFSIPSHHSDTPTTLASHSTKTDASSTHHST 298
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 242 SGSASGSASTLVHNGTSARATTTPASKSTPFSIPSHHSDTPTTLASHSTKTDASSTHHST 301
Qy 299 VPPLTSSNHSTSPQLSTGVSFFFLSFHISNLQFNSSLEDPSTDYYQELQRDISEMFLQIY 358
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 302 VPPLTSSNHSTSPQLSTGVSFFFLSFHISNLQFNSSLEDPSTDYYQELQRDISEMFLQIY 361
Qy 359 KQGGFLGLSNIKFRPGSVVVQLTLAFREGTINVHDVETQFNQYKTEAASRYNLTISDVSV 418
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 362 KQGGFLGLSNIKFRPGSVVVQLTLAFREGTINVHDVETQFNQYKTEAASRYNLTISDVSV 421
Qy 419 SDVPFPFSAQSGAGVPGWGIALLVLVCVLVALAIVYLIALAVCQCRRKNYGQLDIFPARD 478
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 422 SDVPFPFSAQSGAGVPGWGIALLVLVCVLVALAIVYLIALAVCQCRRKNYGQLDIFPARD 481
Qy 479 TYHPMSEYPTYHTHGRYVPPSSTDRSPYEKVSAGNGGSSLSYTNPAVAATSANL 532
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 482 TYHPMSEYPTYHTHGRYVPPSSTDRSPYEKVSAGNGGSSLSYTNPAVAATSANL 535
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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