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 .
Claims 1-17 are pending as originally filed and are considered herein.
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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Claims 1-12 and 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,324,839. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Patent Claim 1 treats a disorder, by administration of a circular DNA vector, comprising a gene encoding a polypeptide, and lacking a drug resistance and a site-specific recombination recognition site. Claim 14 teaches a promoter upstream of the gene, however, to obtain expression of the gene, it necessarily has an operably linked promoter.
Claim 2: Claim 13 requires a delivery vehicle of the same Markush members.
Claim 3: Claim 14 requires the promoter to be substantially devoid of CpG islands.
Claim 4: Claim 15 requires the downstream polyA site.
Claim 5: Claim 16 requires supercoiled DNA.
Claim 6: Claim 17 requires monomeric and the specification’s essential written description provides for the same range (e.g., section “IV. Pharmaceutical Compositions”). Also, 100% monomeric is also 99.9% monomeric.
Claim 7: Claim 3 provides for four methods of administration, which do not infringe, but as the claim indicates administrations covered by the broad claims must be drawn to more than these, and the specification provides essential written description to the embodiments of present Claim 7 (e.g., paragraph 60), providing for intravenous administration as essential written description for the claim. Lastly, the compositions, for delivery by the claimed methods is not different from the formulations for the claimed methods of delivery.
Claim 8: Claim 18 requires at least 5Kb length gene.
Claim 9: Claim 19 requires the vector to be substantially devoid of CpG islands.
Claim 10: Claim 45 requires no significant increases of cytokine levels.
Claim 11: Claim 1 requires a polypeptide.
Claim 12: Claim 9 requires a replacement polypeptide.
Claim 14: Claim 1 requires 10ug to 10mg.
Claim 15: Claims 23 and 25, indicates less immunogenic responses, and the specification as part of the essential written description, teaches that it is substantially devoid of immunogenic components (e.g., paragraph 37), as it has no CpG motifs and bacterial signatures).
Claim 16: Claim 12 teaches the same Markush of elements to be substantially devoid.
Claim 17: Claim 9 teaches a replacement polypeptide and Claim 4 teaches human disorders, and thus, in these instances it is clear that it must mean using the human polypeptide to replace the human gene that is defective in the disorder(s).
Thus, in light of the patent, the invention is obvious. The Artisan would do so and expect success as it is claimed for use in the methods and provided as essential written description of the claimed scope.
Claims 1-12 and 13-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,602,569. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 1: Patent Claim 1 teaches a circular DNA vector, lacking a drug resistance gene and lacking a site-specific recombination site, and also comprising a gene operably linked to a promoter capable of inducing expression in the subject. Claim 24 teaches the same, but the gene specifically being ABCA4.
Claim 2: Claim 2 teaches the same Markush of vehicles.
Claim 3: Claim 3 teaches the promoter is substantially devoid of CpG islands.
Claim 4: Claim 4 teaches the polyA downstream of the gene.
Claim 5: Claim 5 teaches supercoiled.
Claim 6: Claim 6 teaches 70-99.9% monomeric.
Claim 7: Claim 3 provides for four methods of administration, which do not infringe, but as the claim indicates administrations covered by the broad claims must be drawn to more than these, and the specification provides essential written description to the embodiments of present Claim 7 (e.g., paragraph 60), providing for intravenous administration as essential written description for the claim. Lastly, the compositions, for delivery by the claimed methods is not different from the formulations for the claimed methods of delivery.
Claim 8: Claim 8 teaches at least 5Kb in length.
Claim 9: Claim 9 teaches the vector is substantially devoid of CpG islands.
Claim 10: Claim 12 teaches it does not raise cytokine levels when administered to the subject.
Claim 11: Claim 1 requires the gene encoding a polypeptide.
Claim 12: Claim 15 requires a replacement polypeptide.
Claim 13:
Claim 14: Claim 17 requires 10 ug to 10 mg.
Claim 15: Claim 18 requires substantially devoid of immunogenic component.
Claim 16: Claim 19 requires the same immunogenic components to be absent.
Claim 17: Claim 20 teaches a human gene.
In light of the patent, the invention is obvious. The Artisan would make the invention and expect success, as it is claimed.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,684,680. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claim 1 teaches a circular DNA vector, comprising a promoter linked to a gene, and lacking a drug resistance gene, and a site-specific recombination site, the promoter capable of inducing expression in a subject.
Claim 2: Claim 2 teaches the same Markush of delivery vehicles.
Claim 3: Claim 3 teaches the promoter devoid of CpG islands.
Claim 4: Claim 4 teaches a polyA site downstream of the gene.
Claim 5: Claim 5 teaches a supercoiled vector.
Claim 6: Claim 6 teaches 70-99.9% monomeric.
Claim 7: Claim 7 teaches the same formulation Markush.
Claim 8: Claim 8 teaches a gene at least 5kB in length.
Claim 9: Claim 9 teaches the vector is substantially devoid of CpG islands.
Claim 10: Claim 10 teaches it does not cause significant elevation of cytokine levels, upon administration.
Claim 11: Claim 11 teaches a polypeptide.
Claim 12: Claim 12 teaches a replacement polypeptide.
Claim 13: Claim 13 teaches a therapeutic nucleic acid.
Claim 14: Claim 14 teaches 10 ug to 10 mg.
Claim 15: Claim 15 teaches substantially devoid of an immunogenic component.
Claim 16: Claim 16 teaches the same Markush of immunogenic components.
Claim 17: Claim 17 teaches a human gene.
Thus, in light of the patent, it would be obvious to make the invention. The Artisan would do so, and expect success, as it is claimed.
Claims 1-7, 10-12, and 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,766,490. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 1: The patent administered a circular DNA encoding a therapeutic polypeptide(s), and lacking an ORI, a drug resistance gene, and site-specific recombination site. The coding sequence may be linked to a promoter (Claim 14). Moreover, as seen by the whole of the specification, the gene is expressed, and necessarily requires a promoter (e.g., paragraph 41: “As used herein, a “vector” refers to a nucleic acid molecule capable of carrying a heterologous gene into a target cell in which the heterologous gene can then be replicated, processed, and/or expressed in the target cell. After a target cell or host cell processes the genome of the vector (e.g., by generating a DD element), the genome is not considered a vector.”).
Claim 2: Claim 13 teaches the same Markush of vehicles.
Claim 3: Claim 14 teaches the promoter substantially free of CpG islands.
Claim 4: Claim 15 teaches a polyA sequence downstream the gene.
Claim 5: Claim 16 teaches supercoiled.
Claim 6: Claim 17 teaches monomeric, which is equivalent to 99.9% monomeric.
Claim 7: Claim 18 teaches the same Markush of administrations, which necessarily means it is so formulated.
Claim 10: Claim 25 teaches it does not cause increase of cytokine levels.
Claim 11: the genes encode polypeptides (e.g., Claim 1).
Claim 12: the protein is a replacement (e.g., Claim 10).
Claim 14: AS part of the essential written description, the specification provides administration of 10ug to 10mg (e.g., paragraph 116).
Claim 15: Claim 12 teaches devoid of immunogenic component.
Claim 16: Claim 19 teaches the same Markush of immunogenic components.
Claim 17: the gene may be human (e.g., Claim 28 teaches human, and paragraph 88 as part of the essential written description).
Thus, in light of the patent, the invention is obvious. The Artisan would make the compositions in the process of treating cancers. The Artisan would expect success, as it is claimed, and part of the essential written description for the claimed subject matter.
Claims 1-2, 5-8, 10-12, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-44 of copending Application No. 18/626,384 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: the reference teaches a process of amplifying an AAV genome via rolling circle amplification to generate a concatemer, which AAV comprises a heterologous gene, digesting the genomes into monomers, and allowing them self-ligate, and providing a large list of transgenes which may be encoded. The process produces a circular DNA with no required resistance gene or recombination site. Claim 38 does similar with stages. Claim 41 again produces similar. Thus, as a result of the claimed process the composition is made. As far she required promoter, it is necessarily required, for production of the encoded proteins.
Claims 2 and 5: Claims 37 and 42 teach supercoiled, and thus, they are necessaril compolexed with polycationic material.
Claim 6: the claims produce monomeric embodiments, as they self-ligate, and thus, the same is presumed to be equivalent to 99.9% monomeric.
Claim 7: the produced composition is presumed to meet the formulations for such deliveries.
Claim 8: e.g., Claim 35 teaches CEP290 which is over 5kb in length.
Claim 10: the structure being present, it is presumed to not cause such increases of cytokine levels if administered.
Claim 11: the compositions encode polypeptides (e.g., Claim 35).
Claim 12: the protein would be able to replace the endogenous polypeptide, absent reason to believe otherwise.
Claim 15: absent reason to believe otherwise, it is so-devoid of at least one immunogenic component.
Claim 16: absent reason to believe otherwise, it would be free of endotoxin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-7, 10-12, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 9,931,392 to Wren, et al.
Claim 1: Wren teaches a nucleic acid comprising an expression cassette comprising a sequence encoding the oligosaccharyltransferase enzyme (e.g., Claim 1). Claim 2 teaches it comprises a regulatable promoter, but being an expression cassette, it also necessarily requires a promoter. Claim 13 indicates the nucleic acid may comprise a bacterial resistance marker, which means that Claim 1 and separately depending claims necessarily specifically embrace the absence of the bacterial resistance marker. Claim 15 indicates that the it may include site-specific recombination sites, which also means the broad claims necessarily specifically embrace the absence of such recombination sites. Claim 18 teaches that the nucleic acid may be a plasmid. Thus, Claim 1 of Wren anticipates present Claim 1.
Claim 2: Claim 19 teaches the plasmid may be in a bacterial cell, and thus, is also supercoiled and complexed to histones (i.e., polycationic material), absent reason to believe otherwise.
Claim 5: Claim 19 teaches the plasmid may be in a bacterial cell, and thus, is also supercoiled and complexed to histones (i.e., polycationic material), absent reason to believe otherwise.
Claim 6: absent reason to believe otherwise, the plasmids in the cell are monomeric.
Claim 7: The composition is suitable in a buffer and may be administered by any of these methods (e.g., Example 5 teaches pH 7 buffer with 25 mM NaCl).
Claim 10: the office does not have the facilities to determine if the composition would induce significant increases in cytokine levels if it were administered to one subject or another. The structure being present, it is assumed that it would not so-cause increased cytokine levels.
Claim 11: the gene encodes oligosaccharyltransferase.
Claim 12: the polypeptide, in the right circumstance would be a replacement enzyme.
Claim 15: absent reason to believe otherwise, the composition is substantially devoid of an immunogenic component for at least one species.
Claim 16: it is presumed that the composition has no endotoxin, absent reason to believe otherwise.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-8, 10-12, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 9,796,986, to Schroeder, et al.
Claim 1: Schroeder teaches a vector comprising an ORI, a nucleic acid encoding a Markush of proteins, a promoter, and a polyA site (Claim 1). Claim 2 indicates that the vector may comprise a selection marker, which may be a Markush of resistance genes in Claim 16. Such indicates the broad claims specifically embrace the absence of a drug resistance gene. Claim 2 also indicates regulatory elements may be present, which may be recombination sites in Claim 16, indicating the broad claims specifically embrace the absence of recombination sites. The promoter may be a CMV promoter (e.g., Claim 16), which is widely expressed in many subjects. Finally, Claim 2 indicates it may be a plasmid, which is circular.
Claim 2: Claims 7-11 teaches it may be transfected into cells, and hence is presumed to be complexed with histones (a polycation), as well as supercoiled, absent reason to believe otherwise. Also, Calim 10 teaches FuGene or Lipofectamine.
Claim 4: Claim 3 teaches the polyA signal may be linked to the 3’ of the coding sequence.
Claim 5: Claims 7-11 teaches it may be transfected into cells, and hence is presumed to be complexed with histones (a polycation), as well as supercoiled, absent reason to believe otherwise.
Claim 6: absent reason to believe otherwise, because the structure is present, it is presumed to be 70-99.9% monomeric.
Claim 7: the composition may be with Lipofectamine reagent, which is certainly suitable for these forms of administration.
Claim 8: Claim 4 indicates SEQ ID NO: 18 may be used for vWF, which is over 5kBp in size.
Claim 10: the structure being present, it is presumed to not cause significant level of cytokine levels increases, if administered to at least one subject.
Claim 11: the gene encodes a polypeptide (e.g., Claim 1).
Claim 12: the polypeptide can replace a defective one, as it is functional.
Claim 15: it is presumed that the composition does not comprise all immunogenic components, and thus meets the claim.
Claim 16: it is presumed that the composition does not comprise endotoxin.
Claim 17: the vWF is the human gene sequence.
Conclusion
No claim is allowed.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638