DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election without traverse of Group I, encompassing claims (1,8, 39-41,44-49) in the reply filed on 07/29 /2026 is acknowledged. Applicants added claims 53-54. The newly added claims are considered.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Accordingly, claims 1,8, 39-41,44-49, and 53-54 are under examination.
Claims Status
Claims 1,8,19 and 39-48 are amended.
Claims 53-54 are new.
Claims 19, and 42-43 are withdrawn.
Claims 1,8, 39-41,44-49, and 53-54 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) was filed before the mailing date of the non-final first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,8, 39-41, 44-49, and 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Kahvejian et al ( US 2019/0211361 A1), in view of Biagini et al ( Journal of General Virology, 2007).
Regarding claims 1, Kahvejian et al teach a synthetic Anellovirus-based vector, referred to curon, that can be used as a delivery vehicle (e.g., for delivering a therapeutic agent to a eukaryotic cell) wherein curon comprises a particle comprising a genetic element encapsulated in a proteinaceous exterior, which is capable of introducing the genetic element into a cell. ([0004], and claim 1) ]. Kahvejian et al further describe Anellovirus ORF1/capsid sequences as components of the proteinaceous exterior. ( See claim 1). In other words, Kahvejian et al teach an Anellovirus-derived particle comprising the proteinaceous exterior, wherein the proteinaceous exterior comprising ORF1/capsid of an Anellovirus. Kahvejian et al also teach that the genetic element can comprise a promoter element, a sequence encoding an exogenous effector,(e.g., a payload), and a protein binding sequence (e.g., an exterior protein binding sequence, e.g., a packaging signal). [0006]. This reads on element (ii) of instant claim 1.
Kahvejian et al do not teach an Anellovirus ORF1 comprising SEQ ID NO:2466 or a polypeptide comprising at least about 70% sequence identity thereto.
Biagini et al supplement Kahvejian et al by teaching a TTV-like mini virus isolates, including LIL-y4, and reports analysis of the major ORF1 of the disclosed Anellovirus/TTMV sequences. The publication identifies LIL-y4 as a TT-like mini virus (TTMV) and reports that the LIL-y4 genome contained the complete coding sequences. The corresponding sequence data were deposited under GenBank/EMBL/DDBJ accession numbers EF538875-EF538883, including EF538883 for LiL-y4. It should be noted that the corresponding protein record A8DMR6 ( A8DMR6_9V1RU; with protein accession ABU55900.1) identifies a 648 amino acid capsid protein from TTV-like mini virus LIL-y4. The record further identifies the protein belonging to the Anelloviridae capsid protein group and describes the protein as self-assembling into icosahedral capsid. It should also be noted that sequences comparison of the LIL-y4 capsid protein with SEQ ID NO2466 provides approximately 84% amino acid sequence identity, as reflected in the sequence alignment below. Accordingly, the LIL-y4 capsid protein falls within the scope of claim 1’s limitation requiring a polypeptide comprising at least about 70% sequence identity to SEQ ID NO.2466.
Therefore, it would have prima facie obvious for one with ordinary skill in the art at the time the invention was filed to use the known LIL-y4 Anellovirus ORF1/capsid disclosed by Biagini as a proteinaceous exterior component of the Anellovirus particle of Kahvejian. Because Kahvejian et al teach that the ORF1/capsid of an Anellovirus can form a proteinaceous exterior of a viral particle. Biagini et al provides a known Anellovirus ORF1/capsid. Therefore, an ordinary skill in the art would have had a reason to select a known Anellovirus capsid/ORF1 protein for use in the known Anellovirus particle of Kahvejian. In other words, claim 1 is Combining prior art elements according to known methods to yield predictable results. See MPEP 2143 (I)(A).
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Regarding claim 8, Kahvejian et al expressly teach synthetic viral particle (i.e. curon) having structural differences from wild type Anelloviruses, including deletions, and specifically teach deletion of one or more ORF involved in replication, including ORPF1,ORF1/1,ORF1/2, ORF2, ORF2/2, and ORF2/3. [0691-692]. Thus, Kahvejian a genetic element comprises a deletion of an ORF as recited in instant claim.
Regarding claims 39-41, Kahvejian et al expressly teach that the genetic element maybe single-stranded DNA and maybe circular.[0005].
Regarding claims 44-45, Kahvejian et al expressly teach an exogenous effector for delivery to a cell and expressly describes therapeutic agents, therapeutic polypeptide, and therapeutic nucleic acids.[0005].
Regarding claims 46-47, Kahvejian et al teach that the genetic element is enclosed within a proteinaceous exterior and thereby retained protected within the curon/viral particle.[0116]. Kahvejian et al further describes treatment of material with endonucleases after formation of the viral particles consistent with the genetic element being protected by the proteinaceous exterior from nucleases degradation. ( See example 19-[0705]).
Regarding claims 48, Kahvejian et al expressly teach a synthetic curon capable of introducing a genetic element into eukaryotic cells, including mammalian cells, and provide examples involving infection of mammalian cells. ( [0004] and Example 17.).
Regarding claim 49, following the discussion of claim 1 above, Kahvejian et al teach an isolated cell comprising the recited first nucleic acid molecule and genetic element, this reads on element (i) of instant claim.[0303] . Biagini et al, on the other hand, teach an isolated Anellovirus genome comprising a nucleic acid encoding Anellovirus ORF1 and ORF2. In particular Biagini discloses the LIL-y4 Anellovirus sequence deposited under GenBank accession EF538883 and describes the corresponding ORF1 coding sequence. As discussed in claim 1, sequences comparison of the LIL-y4 capsid protein with SEQ ID NO2466 provides approximately 84% amino acid sequence identity. Accordingly, the LIL-y4 capsid protein falls within the scope of claim 1’s limitation requiring an ORF1 with amino acid sequence comprising at least about 70% sequence identity. Thus, Biagini provides a closely related known Anellovirus ORF1 protein corresponding to the type of genetic element recited in claim 49 element (ii). Thus, it would have been prima facie obvious to one with ordinary skill in the art at the time the invention was filed to use the known Biagini Anellovirus ORF1/capsid in the isolated cell/genetic system of Kahvejian, as applied to claim 1 because both sequences concern Anellovirus-derived particle. An ordinary skill in the art would have had a reasonable expectation of success that the constructed vector would retain the genetic and protein functions. In other words claim 49 is combining prior art elements according to known methods to yield predictable results. See MPEP 2143 (I)(A).
Regarding claim 53, following the discussion of claim 1 above, Kahvejian et al teach an Allenovirus-derived viral particle comprising a proteinaceous exterior comprising an Anellovirus ORF1 protein and enclosing a genetic element comprising a promoter operably link to nucleic acid encoding an exogenous effector. Baigini discloses an Anellovirus capsid polypeptide, specifically the capsid protein of LIL-y4/TTMV disclosed therein. The corresponding protein sequence, identified as ABU55900.1, is a 648 amino acid Anellovirus, and as established by the sequence comparison above, the Biagini capsid polypeptide has a approximately 84% amino acid sequence identity with the ORF1 polypeptide of instant application. Thus, Biagini polypeptide fall within the sequence identity range recited in claim 53. As such, it would have been prima facie obvious to one with ordinary skill in the art at the time the invention was filed to employ the Biagini Anellovirus capsid/ORF1 polypeptide as the proteinaceous exterior of the Anellovirus-based particle of Kahvejian. A person of ordinary skill in the art would have had a reasonable expectation that such modification would successfully produce the predictable results of providing the particle of Kahvejian with the proteaceous exterior.
Regarding claim 54, as discussed above, Kahvejian discloses a synthetic viral particle, referred to as a curon, comprising a genetic element and a proteinaceous exterior, wherein the genetic element is disclosed within the proteinaceous exterior. Kahvejian further teaches that the genetic element can comprise a promoter element, a nucleic acid sequence encoding an exogenous effector, including therapeutic payloads, and expressly describe the use of an Anellovirus-derived 5’UTR conserved domain as a protein binding sequence within such a genetic element.[0049]. Specifically, Kahvejian et al state that the protein binding sequence maybe a sequence having at least 85% sequence identity to the Anellovirus 5' UTR conserved domain nucleotide sequence of nucleotides 323-393 of the nucleic acid sequence of Table 11. ([0056]). It should be noted that sequence alignment between the 323-393 of the nucleic acid sequence( listed in Table 11) and the 1-64 sequence of SEQ ID NO: 2465 produce an 85.9% sequence identity. This reads on the claim limitation requiring at least 70% sequence identity with the 1-64 nucleotides of SEQ ID. NO 2465. Kahvejian et al also expressly state that the “ Curon generally includes a protein binding sequence that binds to the proteinaceous exterior, or a polypeptide attached thereto, to facilitate enclosure of the genetic element within the proteinaceous exterior and/or enrichment of the genetic element, relative to other nucleic acids, within the proteinaceous exterior”. As such, providing an ordinary skill in the art with the motivation to include a protein binding sequence in the genetic element encoding the effector protein to facilitate the enclosure of the genetic element within the proteinaceous exterior.
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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 1,8, 39-41, 44-49, and 53-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,13,17,24,26,28 of U.S. Patent No.11,446,344 B1, in view of Biagini et al ( Journal of General Virology, 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed Anellovrius-based particle of ‘344 patent represent indistinct variation of the same claimed Anellovirus delivery form of instant application , and the sequence-specific limitations of the pending claims would have been obvious in view of the known Anellovirus sequences described by Biagini et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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