DETAILED ACTION
This action is in reply to papers filed 4/22/2024. Claims 41, 43-53, and 55-58 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220378842A1, Published 12/1/2022.
Withdrawn Rejection(s)
The 103 (a) rejection of claims 41-57 as being unpatentable over Ma et al. (PgPub US20180162939A1, Published 6/14/2018) in view of Wagner et al. (PgPub US20160237407A1, Published 8/18/2016) is withdrawn in view of amendments made to independent claims 41 and 57.
The nonstatutory double patenting rejection of instant claims over claims 1-31 of U.S. Patent No. 10993967 is withdrawn in view of amendments made to independent claims 41 and 57.
Rejection(s) Necessitated by Amendments
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.
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Double Patenting Rejection 1
Claims 41, 43-53, 55-56 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10993967. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons:
Instant claim 41 is drawn to an engineered human cell comprising a) a promoter; and b) an exogenous polynucleotide sequence comprising an expression cassette described in a formula, oriented from 5' to 3', comprising S1-E1-L-S2-E2 wherein S1 comprises a polynucleotide sequence encoding a first signal peptide, E1 comprises a polynucleotide sequence encoding a first effector molecule, L comprises a linker polynucleotide sequence, S2 comprises a polynucleotide sequence encoding a second signal peptide, E2 comprises a polynucleotide sequence encoding a second effector molecule, and wherein the promoter is operably linked to the expression cassette, the first signal peptide is operably linked to the first effector molecule, and the second signal peptide is operably linked to the second effector molecule, wherein the engineered human cell is selected from the group consisting of: a mesenchymal stem cell (MSC), natural killer (NK) cell, NKT cell, and macrophage, wherein the engineered human cell is selected from the group consisting of: a mesenchymal stem cell (MSC), natural killer (NK) cell, NKT cell, and macrophage, wherein, inter alia, c) the first effector molecule comprises CCL21a, IL7, IL15, IL18, an IL12p70 fusion protein, Flt3L, an anti-PD1 antibody, CD40L, or a CXCL10-CXCL11 fusion protein and the second effector molecule comprises IL21.
Claim 1 of U.S. Patent ‘967 is drawn to an engineered mesenchymal stem cell
(MSC) comprising: a) a promoter; and b) an exogenous polynucleotide sequence comprising an expression cassette described in a formula, oriented from 5′ to 3′, comprising S1−E1−L−S2−E2
wherein S1 comprises a polynucleotide sequence encoding a first signal peptide,
E1 comprises a polynucleotide sequence encoding a first effector molecule, L comprises a linker polynucleotide sequence, S2 comprises a polynucleotide sequence encoding a second signal peptide, E2 comprises a polynucleotide sequence encoding a second effector molecule, wherein the promoter is operably linked to the expression cassette, the first signal peptide is operably linked to the first effector molecule, and the second signal peptide is operably linked to the second effector molecule, and wherein the first effector molecule comprises an IL12P70 fusion protein and the second effector molecule comprises CCL21a, IL7, IL11S, IL21, Flt3L, an anti-PD1 antibody, CD40L, or a CXCL10-CXCL11 fusion protein.
It is clear that all of the elements of instant claims can be found in the claims of the patent.
Double Patenting Rejection 2
Claims 41, 43-53, 55-56 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 of U.S. Patent No. 10993967. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons:
Instant claim 41 is drawn to an engineered human cell comprising a) a promoter; and b) an exogenous polynucleotide sequence comprising an expression cassette described in a formula, oriented from 5' to 3', comprising S1-E1-L-S2-E2 wherein S1 comprises a polynucleotide sequence encoding a first signal peptide, E1 comprises a polynucleotide sequence encoding a first effector molecule, L comprises a linker polynucleotide sequence, S2 comprises a polynucleotide sequence encoding a second signal peptide, E2 comprises a polynucleotide sequence encoding a second effector molecule, and wherein the promoter is operably linked to the expression cassette, the first signal peptide is operably linked to the first effector molecule, and the second signal peptide is operably linked to the second effector molecule, wherein the engineered human cell is selected from the group consisting of: a mesenchymal stem cell (MSC), natural killer (NK) cell, NKT cell, and macrophage, wherein the engineered human cell is selected from the group consisting of: a mesenchymal stem cell (MSC), natural killer (NK) cell, NKT cell, and macrophage, wherein, inter alia, c) the first effector molecule comprises CCL21a, IL7, IL15, IL18, an IL12p70 fusion protein, Flt3L, an anti-PD1 antibody, CD40L, or a CXCL10-CXCL11 fusion protein and the second effector molecule comprises IL21.
Claim 11 of U.S. Patent ‘967 is drawn to an engineered mesenchymal stem cell (MSC) comprising: a) an SFFV promoter; and b) an exogenous polynucleotide sequence comprising an expression cassette described in a formula, oriented from 5′ to 3′, comprising S1−E1−L−S2−E2
Wherein S1 comprises a polynucleotide sequence encoding a first signal peptide, wherein the first signal peptide is a human IL12 signal peptide; E1 comprises a polynucleotide sequence encoding a first effector molecule, wherein the first effector molecule is a human IL12p70 fusion protein; L comprises a linker polynucleotide sequence, wherein the linker polynucleotide sequence encodes a Furin recognition polypeptide sequence, a Gly-Ser-Gly polypeptide sequence, and a T2A ribosome skipping tag in a Furin:Gly-Ser-Gly:T2A orientation from N-terminus to C-terminus; S2 comprises a polynucleotide sequence encoding a second signal peptide, wherein the second signal peptide is a human IL21 signal peptide; E2 comprises a polynucleotide sequence encoding a second effector molecule, wherein the second effector molecule is human IL21; and wherein the SFFV promoter is operably linked to the expression cassette, the first signal peptide is operably linked to the first effector molecule, and the second signal peptide is operably linked to the second effector molecule.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. For example, patent claims require the IL12p70 and IL21 to be human, the promoter to SFFV promoter, the first signal peptide to be a human IL12 signal peptide, the linker to encode a Furin recognition polypeptide sequence, a Gly-Ser-Gly polypeptide sequence, and a T2A ribosome skipping tag in a Furin:Gly-Ser-Gly:T2A orientation from N-terminus to C-terminus and the second signal peptide to be human IL21 signal peptide. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Double Patenting Rejection 3
Claim 57 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 17 of U.S. Patent No. 11419898. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Claim 57 is drawn to a method of inducing an immune response in a human subject,
the method comprising administering a therapeutically effective dose of an engineered human cell comprising a) a promoter; and b) an exogenous polynucleotide sequence comprising an expression cassette described in a formula, oriented from 5' to 3', comprising Si-E1-L-S2-E2
wherein SI comprises a polynucleotide sequence encoding a first signal peptide, E1 comprises a polynucleotide sequence encoding a first effector molecule, L comprises a linker polynucleotide sequence, S2 comprises a polynucleotide sequence encoding a second signal peptide, E2 comprises a polynucleotide sequence encoding a second effector molecule, and wherein the promoter is operably linked to the expression cassette, the first signal peptide operably linked to the first effector molecule, and the second signal peptide is operably linked to the second effector molecule, and wherein the engineered human cell is selected from the group consisting of: a mesenchymal stem cell (MSC), natural killer (NK) cell, NKT cell, and macrophage, wherein the first effector molecule comprises CCL21a, IL7, IL15, IL18, an IL12p70 fusion protein, Flt3L, an anti-PD1 antibody, CD40L or a CXCL10-CXCL11 fusion protein and the second effector molecule comprises IL21 wherein at least one of the first effector molecule and the second effector molecule does not comprise, nor is operably linked to, a transmembrane domain.
Claim 13 of U.S. Patent ‘898 is drawn to a method of inducing an immune response
in a human subject, the method comprising administering a therapeutically effective dose of an engineered human cell comprising: a) a promoter; and b) an exogenous polynucleotide sequence comprising an expression cassette described in a formula, oriented from 5′ to 3′, comprising S1-E1-L-S2-E2 wherein S1 comprises a polynucleotide sequence encoding a first signal peptide, E1 comprises a polynucleotide sequence encoding a first effector molecule, L comprises a linker polynucleotide sequence, S2 comprises a polynucleotide sequence encoding a second signal peptide, E2 comprises a polynucleotide sequence encoding a second effector molecule, and wherein the promoter is operably linked to the expression cassette, the first signal peptide is operably linked to the first effector molecule, and the second signal peptide is operably linked to the second effector molecule, and wherein the engineered human cell is selected from the group consisting of: a mesenchymal stem cell (MSC), natural killer (NK) cell, NKT cell, and macrophage, wherein, inter alia, (a) the first effector molecule comprises an IL12p70 fusion protein and the second effector molecule comprises CCL21a, IL7, IL15, IL21, Flt3L, an anti-PD1 antibody, CD40L, or a CXCL10-CXCL11 fusion protein, or (d) the first effector molecule comprises CCL21a, IL7, IL15, IL18, an IL12p70 fusion protein, Flt3L, an anti-PD1 antibody, CD40L, or a CXCL10-CXCL11 fusion protein and the second effector molecule comprises IL21, and wherein at least one of the first effector molecule and the second effector molecule does not comprise, nor is operably linked to, a transmembrane domain, and wherein the engineered human cell further comprises a chimeric antigen receptor (CAR) or exogenous polynucleotide sequence encoding the same.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. For example, patent claims require a the cell to further comprise a CAR. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632