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 1-20 are pending as amended 1/3/25 and are considered herein.
Formalities:
The drawings of 5/23/24 are accepted.
The specification of 1/3/25 is accepted.
Applicant’s priority is noted to be:
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Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 7 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 7 requires the codon optimization to be in the first region. However, codon optimization can only be present in the region coding for the polypeptide. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 112
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.
Claim 1 is 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.
Claim 1 contains elements (c) and (d). (c) a terminal region located 3’ to (b), while (d) is a 3’ tailing region. It is not clear if (c) and (d) are the actually the same, or if (c) or (d) is actually the terminal region.
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.
To establish nonstatutory double patenting under an obviousness analysis: (A) the conflicting design claims must have overall appearances with basically the same design characteristics; and (B) the differences between the two designs must be insufficient to patentably distinguish one design from the other. Differences may be considered patentably insufficient when they are de minimis or obvious to a designer of ordinary skill in the art. While the conflicting application or patent (if less than a year older than the application) used to establish nonstatutory double patenting is not considered "prior art," the principle involved is basically the same. See In re Zickendraht, 319 F.2d 225, 138 USPQ 22 (CCPA 1963)(see concurring opinion of Judge Rich).
U.S. Patent No. 9,597,380
Claims 1-8 and 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Patent Claim 1 teaches a region of linked nucleosides encoding a protein antigen (b), a 5’ UTR region comprising a translation enhancer which may be a Cap1 (e.g., Claim 8 and (a)), a 3’ UTR (c), and a tailing region (d).
Claims 2-5: Patent Claim 1 teaches 1-me-pseudouridine and 5’-me-cytidine.
Claims 6-7: Claim 2 teaches codon optimization, which necessarily is the same region, being to the coding region.
Claim 8: Claim 1 teaches the 5’UTR.
Claim 12: Claim 7 teaches the 5’ cap.
Claim 13: Claim 8 teaches Cap1.
Thus, in light of the patent, the compositions claimed are obvious. The Artisan would make them to practice the methods of the patent. The Artisan would expect success, as it is claimed.
+Native IRES
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380 in view of U.S. Patent No. 7,763,458.
As shown above, the patent claims the various aspects, save for the presence of a native IRES.
On the other hand,
+ TEE
Claims 1-8 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380, in view of U.S. Patent Application Publication No. 2009/0226470 to Mauro, et al.
As shown above, the base claims are obvious over the patent alone, but the aspect of a translation enhancer elements that are not cap1, being utilized is not claimed.
On the other hand, Mauro teaches for expression of proteins, including SEQ ID NOs 1-35.
Thus, in light of the patent and Mauro, the invention is obvious. The Artisan would utilize the TEEs of Mauro, in order to enhance transcription. The Artisan would expect success, as Mauro teaches it for such use.
+miR-122 binding site
Claims 1-8, 12-13, and 15-17 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380, in view of Wong, et al. (2010) “Cordycepin Inhibits Protein Synthesis and Cell Adhesion through Effects on Signal Transduction”, The Journal of Biological Chemistry, 285(4): 6210-21.
As shown above, the base claims are obvious over the patent alone, but the aspect of utilizing a miR-122 binding site is not claimed.
On the other hand, Broderick discloses that the miR-122 binding site represses expression in liver (e.g., Introduction).
Thus, at the time of invention, it would have been obvious to incorporate the miR-122 binding site into the mRNA. The Artisan would do so to inhibit liver cell expression. The Artisan would expect success, as the site is used in the construct for art-recognized purposes.
+Cordycepin
Claims 1-8, 12-13, and 18-19 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380, in view of Broderick, et al. (2011) “MicroRNA therapeutics”, Gene Therapy, 18: 1104-10.
As shown above, the base claims are obvious over the patent alone, but the aspect of terminating the mRNA with cordycepin is not claimed.
On the other hand, Wong teaches 3’-deoxyadenosine (cordycepin) has relatively minor effects on transcription of mRNA, but inhibits polyadenylation, when incorporated at the 3’ end as a chain terminator (p. 2610, paragraph bridging columns).
Thus, at the time of invention, it would have been obvious to modify the invention to utilize the cordycepin of Wong. The Artisan would do so to inhibit polyA tail formation. The Artisan would expect success, as it is utilized for art-recognized purposes.
+stem-loop in 3’ end
Claims 1-8, 12-13, and 20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380, in view of Williams, et al. (1994) “Changes in the stem-loop at the 3’ terminus of histone mRNA affects its nucleoplasmic transport and cytoplasmic regulation” Nucleic Acids Research, 4660-66.
As shown above, the base claims are obvious over the patent alone, but the aspect of of a 3’ end containing a stem-loop structure is not claimed.
On the other hand, it has long been known that the 3’ end of histone mRNA not only favors nuclear localization, but inhibits degradation (e.g., Williams, ABSTRACT).
Thus, at the time of invention, it would have been obvious to modify the invention to contain the stem loops of Williams in the 3’ end of the mRNA. The Artisan would do so to localize it to the nucleus and inhibit degradation. The Artisan would expect success, as the components are utilized for art-recognized purposes.
U.S. Patent No. 10,155,029
Claims 1-8, 12-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,155,029. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Patent Claim 1 teaches a region encoding a polypeptide of interest (b), which may comprise a translation initiation sequence in Claim 5, a first terminal region 5’UTR (a), a 3’UTR (c), and a 3’ tailing region (d). The TEE may be cap1 (e.g., Claim 15).
Claim 2: Claim 1 requires modified uridines.
Claim 3: Claim 2 teaches pseudouridine analogs.
Claim 4: Claim 3 teaches 1-me-pseudoU.
Claim 5: Claim 4 requires 5-me-C.
Claims 6-7: cap1 may be utilized (Claim 15).
Claim 8: Claim 1 teaches a 5’ UTR.
Claim 12: Claim 6 teaches a 5’ cap.
Claim 13: Claim 7 teaches several common caps.
Claim 15: Claim 1 requires the microRNA site.
Claim 16: Claim 8 teaches an immune specific microRNA site.
Claim 17: Claim 9 teaches the same miR sites.
Claim 18: Claim 10 teaches a chain terminating nucleoside.
Claim 19: Claim 11 teaches the same chain terminating nucleosides.
Claim 20: Claim 12 teaches a stem-loop in the 3’ tailing region.
Thus, in light of the patent the invention is obvious. The Artisan would make the invention and expect success, as it is claimed.
+ TEE
Claims 1-8, and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380, in view of U.S. Patent Application Publication No. 2009/0226470 to Mauro, et al.
As shown above, the base claims are obvious over the patent alone, but the aspect of a translation enhancer elements that are not cap1 are not claimed.
On the other hand, Mauro teaches for expression of proteins, including SEQ ID NOs 1-35.
Thus, in light of the patent and Mauro, the invention is obvious. The Artisan would utilize the TEEs of Mauro, in order to enhance transcription. The Artisan would expect success, as Mauro teaches it for such use.
+miR-122 binding site
Claims 1-8 and 12-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,597,380, in view of Wong, et al. (2010) “Cordycepin Inhibits Protein Synthesis and Cell Adhesion through Effects on Signal Transduction”, The Journal of Biological Chemistry, 285(4): 6210-21.
As shown above, the base claims are obvious over the patent alone, but the aspect of utilizing a miR-122 binding site is not claimed.
On the other hand, Broderick discloses that the miR-122 binding site represses expression in liver (e.g., Introduction).
Thus, at the time of invention, it would have been obvious to incorporate the miR-122 binding site into the mRNA. The Artisan would do so to inhibit liver cell expression. The Artisan would expect success, as the site is used in the construct for art-recognized purposes.
U.S. Patent No. 10,925,935
Claims 1-8, 12-13, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,925,935. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claim 1 teaches a region encoding the polypeptide of interest (b), a 5’UTR (a) which may comprise the TEE Cap1 (e.g., Claim 15), a 3’UTR (c) and a tailing region (d).
Claim 2: Claim 1 teaches modified uridines.
Claim 3: Claim 2 teaches pseudouridine analogs.
Claim 4: Claim 3 teaches 1-methylpseudouridine.
Claim 5: Claim 4 teaches 5-methyl pseudouridine.
Claims 6-7: Claim 13 teaches codon optimized coding region.
Claim 8: Claim 1 teaches a 5’ UTR.
Claims 12-13: Cap1 is taught (e.g., Claim 15).
Claim 15: Claim 1 teaches the miRNA binding site.
Claim 16: Claim 5 teaches immune-cell-specific miRNA site.
Claim 17: Claim 6 teaches the same miR sites.
Thus, in light of the patent, the invention is obvious. The Artisan would make it and expect success, as it is claimed.
+ TEE
Claims 1-8, and 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,925,935, in view of U.S. Patent Application Publication No. 2009/0226470 to Mauro, et al.
As shown above, the base claims are obvious over the patent alone, but the aspect of a translation enhancer elements that are not cap1 are not claimed.
On the other hand, Mauro teaches for expression of proteins, including SEQ ID NOs 1-35.
Thus, in light of the patent and Mauro, the invention is obvious. The Artisan would utilize the TEEs of Mauro, in order to enhance transcription. The Artisan would expect success, as Mauro teaches it for such use.
+Cordycepin
Claims 1-8, 12-13, and 15-19 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,925,935, in view of Broderick, et al. (2011) “MicroRNA therapeutics”, Gene Therapy, 18: 1104-10.
As shown above, the base claims are obvious over the patent alone, but the aspect of terminating the mRNA with cordycepin is not claimed.
On the other hand, Wong teaches 3’-deoxyadenosine (cordycepin) has relatively minor effects on transcription of mRNA, but inhibits polyadenylation, when incorporated at the 3’ end as a chain terminator (p. 2610, paragraph bridging columns).
Thus, at the time of invention, it would have been obvious to modify the invention to utilize the cordycepin of Wong. The Artisan would do so to inhibit polyA tail formation. The Artisan would expect success, as it is utilized for art-recognized purposes.
+stem-loop in 3’ end
Claims 1-8, 12-13, 15-17, and 20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,925,935, in view of Williams, et al. (1994) “Changes in the stem-loop at the 3’ terminus of histone mRNA affects its nucleoplasmic transport and cytoplasmic regulation” Nucleic Acids Research, 4660-66.
As shown above, the base claims are obvious over the patent alone, but the aspect of of a 3’ end containing a stem-loop structure is not claimed.
On the other hand, it has long been known that the 3’ end of histone mRNA not only favors nuclear localization, but inhibits degradation (e.g., Williams, ABSTRACT).
Thus, at the time of invention, it would have been obvious to modify the invention to contain the stem loops of Williams in the 3’ end of the mRNA. The Artisan would do so to localize it to the nucleus and inhibit degradation. The Artisan would expect success, as the components are utilized for art-recognized purposes.
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)(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, 8, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Welden, et al. (2011) “Vector Design for Optimal Protein Expression”, BioTechniques, 31: 572-82.
Claim 1, 8, 12-13: van der Welden teaches making mRNAs from T7TS-glob-GFP, which contains the appropriate Cap, 5’ and 3’ UTRs, coding sequence, and polyA tail (e.g., p. 574). The Cap may be considered a TEE.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
