DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 3-17-26.
Claims 208, 211-215, 217, 220-227 are pending in this application.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 62/851548, 62/857,121, 62/681,617, 16/432,177, PCT/US2020/063494, PCT/US2020/034418, 63/022,248 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The lipid recited in claim 208 appears to have a priority date of 11-25-2021 (WO 2021/736855).
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 208, 211-215, 217, 220-227 is/are rejected under 35 U.S.C. 103 as being obvious over Hoge et al (US 2016/0194368) and Horhota et al (US 2021/0378980), the combination in view of Sadelain et al (Cancer Discov., Vol. 3, No. 4, pages 388-398 (2013)) for the reasons of record set forth in the Office action 9-17-25 and for the reasons set forth below.
The applied reference has a common inventor 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. 103 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); 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 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. See generally MPEP § 717.02.
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
Applicant’s Arguments
Applicant argues that Horhota does not teach the limitations of the claims in the manner described by the Office. According to applicant, Horhota does not teach circular RNA of any kind. While the Office points to several paragraphs of Horhota for the alleged teachings, none of these paragraphs describe circular RNA. Instead, Horhota teaches linear RNA throughout, not circular RNA.
Applicant submits that the combination/modification is more complicated (and thus the rationale more demanding) than the Office suggests regarding combining the teachings of Hoge, Horhota, and Sadelain.
Applicant argues that the Office must explain further why such a modified circular RNA of claim 208 based on the combined teachings of Hoge, Horhota, and Sadelain would have been used in combination with the particular lipid of instant claim 208, particularly as Horhota describes many other lipids and in no way singles out that of instant claim 208.
Applicant argues that the Office must also account for these additional claimed features, a polyethylene glycol (PEG)-lipid, a structural lipid, and a helper lipid, and that the claimed composition has a duration of therapeutic effect in vivo in a human greater than that of a composition comprising a reference linear RNA polynucleotide having the same expression sequence as the circular RNA polynucleotide.
Response to Applicant’s Arguments
Contrary to Applicant’s assertions and arguments, Hoge, Horhota and Sadelain properly render the instant invention obvious.
As stated previously, Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See below for structure search results of the lipid instantly claimed in claim 208.
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845
712
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840
705
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Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Contrary to Applicant’s assertions, Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
And, contrary to Applicant’s assertions, Horhota teaches pharmaceutical compositions further comprising cholesterol, DSPC, helper lipids, structural lipids in general, and PEG (see esp. paragraphs 110, 120, 171, 216-218, 260, 268, 387, 388, 399, 400, 725, 801, 803, 805, 811, 812, 814, 820, 822, Tables 1-3, claims 93-99, 107-114).
And, contrary to Applicant’s arguments, Sadelain et al (Cancer Discov., Vol. 3, No. 4, pages 388-398 (2013)) is properly relied upon for teaching chimeric antigen receptors (CARs), their design and optimization in providing antigen binding and T cell activation functions (see entire document).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to provide the instantly claimed compositions for providing targeting and therapeutic effects because all of the components have been previously disclosed in the combined teachings of Horhota and Hoge. One would have been motivated to include a chimeric antigen receptor (CAR) for delivery and treatment because Sadelain taught the clinical use and optimization of CARs for various treatments. One would also have been motivated to encapsulate circular RNA because of its increased stability in vivo, as disclosed by Hoge. All of the components were well known in the art and their combination was routinely used for enhanced delivery of therapeutic agents.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
For these and the aforementioned reasons, the instant invention would have been obvious to one of ordinary skill in the art prior to the filing date of the instant application.
New Rejections
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.
Claims 208, 211-215, 217, 220-227 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6-10, 15-20, 22-25 of copending Application No.18/069,621 in view of Horhota et al (US 2021/0378980) and Hoge et al (US 2016/0194368).
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
The claims of Application No.18/069,621 do not recite the lipid recited in claim 82.
Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See below for structure search results of the lipid instantly claimed in claim 208.
It would have been obvious to utilize a pharmaceutical composition comprising the lipid recited in claim 82 because the prior art taught this lipid in combination with the additional components of the nucleic acid constructs instantly claimed and those claimed.
This is a provisional nonstatutory double patenting rejection.
Claims 208, 211-215, 217, 220-227 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/327,476 in view of Horhota et al (US 2021/0378980) and Hoge et al (US 2016/0194368).
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
The claims of Application No. 19/327,476 do not claim the lipid recited in instant claim 82.
Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See the above 103 rejection for structure search results of the lipid instantly claimed in claim 208.
It would have been obvious to utilize a pharmaceutical composition comprising the lipid recited in claim 82 because the prior art taught this lipid in combination with the additional components of the nucleic acid constructs instantly claimed and those claimed.
This is a provisional nonstatutory double patenting rejection.
Claims 208, 211-215, 217, 220-227 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/327,522 in view of Horhota et al (US 2021/0378980) and Hoge et al (US 2016/0194368).
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
The claims of Application No.19/327,522 do not claim the lipid recited in instant claim 82.
Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See the above 103 rejection for structure search results of the lipid instantly claimed in claim 208.
It would have been obvious to utilize a pharmaceutical composition comprising the lipid recited in claim 82 because the prior art taught this lipid in combination with the additional components of the nucleic acid constructs instantly claimed and those claimed.
This is a provisional nonstatutory double patenting rejection.
Claims 208, 211-215, 217, 220-227 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US. Patent No. 11,981,909 in view of Horhota et al (US 2021/0378980) and Hoge et al (US 2016/0194368).
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
The claims of U.S. Patent No. 11,981,909 do not claim the lipid recited in instant claim 82.
Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See the above 103 rejection for structure search results of the lipid instantly claimed in claim 208.
It would have been obvious to utilize a pharmaceutical composition comprising the lipid recited in claim 82 because the prior art taught this lipid in combination with the additional components of the nucleic acid constructs instantly claimed and those claimed.
Claims 208, 211-215, 217, 220-227 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.11,203,767
in view of Horhota et al (US 2021/0378980) and Hoge et al (US 2016/0194368).
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
The claims of U.S. Patent No. U.S. Patent No.11,203,767 do not claim the lipid recited in instant claim 82.
Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See the above 103 rejection for structure search results of the lipid instantly claimed in claim 208.
It would have been obvious to utilize a pharmaceutical composition comprising the lipid recited in claim 82 because the prior art taught this lipid in combination with the additional components of the nucleic acid constructs instantly claimed and those claimed.
Claims 208, 211-215, 217, 220-227 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,845,950
in view of Horhota et al (US 2021/0378980) and Hoge et al (US 2016/0194368).
The claims are drawn to pharmaceutical compositions and methods of delivery, treatment and prevention comprising administration of compositions comprising a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; or comprising an expression sequence encoding a chimeric antigen receptor (CAR), and a transfer vehicle comprising an ionizable lipid represented by the structure set forth in claim 208, or a pharmaceutically acceptable salt thereof, which circular RNA polynucleotide optionally comprises a poly A sequence, which circular RNA polynucleotide is made via circularization of a precursor RNA polynucleotide comprising in the following order a S’ external duplex forming region,3’ group I intron fragment, a 5’ internal spacer optionally comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer optionally comprising a 3’ internal duplex forming region, a S’ group I intron fragment, and a3’ external duplex forming region, a. a first polyA sequence, a S’ external duplex forming region, a 5’ external spacer,.a3’ group I intron fragment, 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, a 3’ external duplex forming region, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment, a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES an expression sequence, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence; or a first polyA sequence, a S’ external spacer, a 3’ group I intron fragment. a 5’ internal spacer comprising a 5’ internal duplex forming region, an IRES, an expression sequence, a stop codon cassette, a 3’ internal spacer comprising a 3’ internal duplex forming region, a 5’ group I intron fragment, a 3’ external spacer, and a second polyA sequence, which expression sequence optionally encodes a CAR, and optionally further comprises a targeting moiety operably connected to the transfer vehicle optionally comprising a polyethylene glycol (PEG)-lipid, a structural lipid optionally comprising cholesterol, or a helper lipid optionally comprising DSPC or DOPE.
The claims of U.S. Patent No. U.S. Patent No. 11,845,950 do not claim the lipid recited in instant claim 82.
Horhota et al (US 2021/0378980) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and an RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 487, 520, 547-559, 603-625). Horhota specifically claims the lipid recited in claim 208 (see claim 132 of Horhata).
Hoge et al (US 2016/0194368) teach compositions and methods of delivery and treatment comprising the administration of compositions comprising the lipid formula of claim 208, and a circular RNA polynucleotide comprising a 3’ post-splicing intron sequence of a 3’ group I intron fragment, an internal ribosome entry site (IRES), an expression sequence, and a 5’ post-splicing intron sequence of a 5’ group I intron fragment; which circular RNA polynucleotide optionally comprises a poly A sequence (see esp. ¶¶ 148, 166-172, 36-48, 239-240, 334-336, 20, 190, 200, 1406, example, Table 7). See the above 103 rejection for structure search results of the lipid instantly claimed in claim 208.
It would have been obvious to utilize a pharmaceutical composition comprising the lipid recited in claim 82 because the prior art taught this lipid in combination with the additional components of the nucleic acid constructs instantly claimed and those claimed.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
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Jane Zara
4-14-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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