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 .
Priority
Applicant’s claim to priority from Application PCT/US2019/065963 filed 12/12/2019 and from Provisional Applications 62/778,861 and 62/778,866 filed 12/12/2018 is hereby acknowledged.
Application Status
This Application is a National Entry stage under 35 U.S.C §371 of Application PCT/US2019/065963 filed 12/12/2019.
Amendments to claims filed 10/02/2025 are hereby acknowledged. Claims 1-54, 56 and 59 are cancelled. Claims 55, 57-58, 60, 63, 65 and 77 are currently amended. Claims 55, 57-58 and 60-77 are currently pending. Claims 66-75 are withdrawn from consideration. Therefore, claims 55, 57-58, 60-65 and 76-77 are under consideration in this Office Action.
Any objection or rejection not reiterated herein has been overcome by Applicant’s amendments and is therefore withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/02/2025 is hereby acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
Replacement sheets for Drawings, as well as high quality Supplemental files for Drawings, filed 10/02/2025 are hereby acknowledged and are acceptable.
Specification
Substitute and clean copies of Specification filed 19/02/2025 are hereby acknowledged and are acceptable.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
The following rejections are maintained from the office action dated 07/02/2025, however, they are modified to reflect Applicant’s amendments:
Claims 55, 57, 60-65 and 76-77 are rejected under 35 U.S.C. §103 as being unpatentable over Heller (Heller, K.N. et al. JCI Insight, Vol. 2, No. 9 (2017), p: e93309) and Leary (Leary, T.P. et al. US Patent No. 6,395,472 B1, published May 28, 2002). The rejection of claim 57 is evidenced by Liou (Liou, S-H. et al. BioRxiv preprint doi: https://doi.org/10.1101/2022.07.01.498313; posted July 2, 2022).
Regarding claim 55, Heller teaches a proteinaceous exterior comprising a polypeptide encoded by a virus nucleic acid (i.e. AAV) and a genetic element comprising a promoter element (i.e. MCK, muscle creatine kinase promoter) operably linked to a heterologous nucleic acid sequence encoding an exogenous effector (i.e. micro-dystrophin), wherein the exogenous effector comprises a polypeptide that is endogenous to muscle cells, wherein the genetic element is enclosed within the proteinaceous exterior (see abstract, lines 6-7; and page 10, “DNA constructs and AAV production” section of “[M]ethods”).
Heller does not teach a proteinaceous exterior comprising a polypeptide encoded by an Anellovirus ORF1 nucleic acid.
However, Leary teaches an Anellovirus, i.e. TTV (see column 5, lines 10-23 and column 47, lines 59-67, and column 48).
Leary teaches that the invention encompasses a TTV-based vector comprising: 1) a promoter; 2) a heterologous DNA sequence; and 3) a nucleotide sequence encoding TTV (i.e. encoding the proteinaceous exterior), or a fragment of the nucleotide sequence; wherein the heterologous sequence is operably linked to the promoter. Leary also teaches that the heterologous DNA sequence may encode a protein, and that the TTV vector may be capable of being packaged into TTV particles for stable maintenance or expression of the heterologous DNA sequence (see column 5, lines 10-23). Leary teaches that gene therapy can alternatively be performed using virions (i.e. proteinaceous exterior already encoded/synthesized) isolated from cell culture and used to infect the host (see column 48, lines 31-34).
Regarding claim 55, Leary also teaches that the nucleotide sequence encoding for TTV vector can be selected from Table 11 (column 39-40), wherein multiple ORFs from multiple subtypes of TTV, including ORF1 can be used. Leary teaches multiple full-length isolates, wherein the amino acid sequences of ORF1 exhibited 65.1% to 95.6% identity (Table 11; column 42, lines 3-5).
Leary also teaches that TTV is a small genome DNA virus, that does not appear to be associated with any disease, as evidenced by its presence in nearly 100% of humans and normal population (see column 2, lines 65-67). Leary teaches that re-infection is common, and occurs readily. Leary teaches that these traits are desirable in a gene therapy vector, which should be uncomplicated, non-pathogenic, easily delivered and have the potential for multiple treatments, or for being maintained over extended periods of time (see column 3, lines 1-7).
It would have been obvious to one with ordinary skills in the art before the effective filing date of the claimed invention to have substituted the proteinaceous exterior comprising AAV polypeptides taught by Heller, with a TTV ORF1 polypeptide, encoded by the TTV ORF1 nucleic acid, as taught by Leary. One with ordinary skills in the art could have used TTV nucleic acid fragments to use as a vector for carrying the micro-dystrophin gene instead of AAV nucleic acid fragments as taught by Heller. One motivated in using a versatile, uncomplicated, non-pathogenic, easily delivered viral vector, that can also be maintained over extended periods of time, could have made this substitution with a reasonable expectation of success and arrived at the claimed invention.
Regarding claim 57, the combination of Heller and Leary does not render obvious a synthetic particle “wherein the ORF1 molecule has been proteolytically processed”.
However, according to Liou, the processing of ORF1 is an inherent feature due to the presence at the N-terminus of several arginine residues and some lysines which are consistently observed in anelloviruses of all genera (see “[M]ain Text”, lines 40-42). Liou teaches that after cell lysis and purification, the expected mass of the purified ORF1 was 73.3 kDa (Fig. 1C), while the observed mass was actually below the 62 KDa marker. Liou discloses that the difference suggests proteolysis (see “[A]nellovirus LY1 ORF1 fragment structure” section, lines 63-66). Liou teaches that the discrepancy could be explained by the removal/processing of the ARM motif at the N-terminus region and part of the C-terminus (see lines 57-64 and Fig. 1). Liou further teaches that absence of the C-terminus as well improves particle formation, and given that anelloviruses have evolved to evade the immune system, and since the C-terminal region is the immunodominant region of ORF1 and is antagonistic to particle formation, Liou hypothesizes that the helical C-terminal region is required for wild-type particle assembly with somehow modified ORF1 during viral maturation to permit formation of particles and immune evasion (see lines 172-178).
MPEP § 2124 states: “ Exception to the Rule That the Reference Must be Prior Art. IN SOME CIRCUMSTANCES A FACTUAL REFERENCE NEED NOT ANTEDATE THE FILING DATE.”
“In certain circumstances, references cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism”.
In this case, Examiner’s interpretation of claim 57 such that, either the claim requires a processed ORF1 or that the processing of ORF1 from Anellovirus is obtained as an end-result of production of particles within a host cell, matches the facts and characteristics brought forth by Liou’s disclosure. Liou teaches that an anellovirus particle issued from cell lysis and purification, comprises an ORF1 that is proteolytically processed. Therefore, the processing of ORF1 is required to obtain adequate particle assembly. This is an inherent feature of a fully functional, matured virus particle as described by Liou.
Regarding claim 60 (b) (ii), Leary teaches the TTV genome such as origin of replication, transcriptional controls, genes, packaging signals etc. are used for the vector, and that the DNA fragment of interest can be inserted into the TTV vector (see column 48, lines 42-46). Leary is silent on ORF1 or ORF2 or ORF3 being absolute part of the genetic element inside the virions.
Regarding claim 61, Leary teaches that the TTV genome is a single stranded DNA genome (see column 1, lines 25-28), therefore, it is obvious that the vector derived from TTV can be a single stranded DNA vector for the genetic element.
Leary also teaches that the TTV genome is circular, negative stranded DNA genome (see column 30, lines, 32-41).
Leary also teaches that TTV likely replicates its genetic element by rolling circle replication in a host cell (see column 30, lines 1-28).
Leary also teaches that TTV has a N22 sequence with a region that is 89% GC (see column 29, lines 15-17).
Regarding claim 62, Leary teaches that the promoter element can be derived from TTV or other sources (see column 48, lines 11-15).
Regarding claim 63, Leary teaches that the synthetic particle is capable of infecting human cells (see column 21, lines 19-21; column 48, line 33). Leary also teaches that the exogenous effector can be a DNA of interest, or any protein of interest such as an enzyme, antigen or recombinant vaccine protein, or a corrective gene (see column 48, lines 22-29, 36-41).
Regarding claim 64, Heller teaches that the vectors was delivered intramuscularly once diluted in a saline solution, i.e. a pharmaceutically acceptable excipient (see page 10, “[A]nimal studies” section, “[G]ene delivery” paragraph).
Regarding claim 65, Heller teaches 5 x 1011 vg of scAAVrh.74.MCK.micro-dystrophin (see page 10, “[A]nimal studies” section, “[G]ene delivery” paragraph).
Regarding claim 76, Heller teaches an exogenous effector that comprises micro-dystrophin (see title, abstract, and page 10, “[A]nimal studies” section, “[G]ene delivery” paragraph).
Regarding claim 77, Examiner interprets the claim as drawn to genetic elements that are a combination of viral vector elements, fragments of the viral genome necessary for the function of a vector, and an insert that is foreign to the viral genome, wherein the foreign insert can be a coding sequence for a polypeptide. Leary teaches that other sequences required for vector function can derived from TTV (e.g. promoter, enhancer sequences, Kozak sequences ; see column 48, lines 11-15); Examiner interprets that Leary teaches the limitation, according to the BRI of “a sequence having at least 75% sequence identity to the 5’ UTR conserved domain of a wild-type TTV”, since Leary further states that several full length genomes from TTV isolates presented with a range of 73.8% to 96.5% sequence identity to one another (see Table 11, and column 40, lines 22-25).
Claim 58 is rejected under 35 U.S.C. §103 as being unpatentable over Heller (Heller, K.N. et al. JCI Insight, Vol. 2, No. 9 (2017), p: e93309) and Leary (Leary, T.P. et al. US Patent No. 6,395,472 B1, published May 28, 2002), as applied to claim 55 above, and in further view of Galmès (Galmès, J. et al. European Respiratory Journal. Vol. 42, No. 2 (2012), pp: 470-479; listed as NPL #20 on IDS filed 06/29/2022) and NCBI-GenBank submission JX134045 (March 16, 2013), listed as NPL #13 on IDSs filed 06/29/2022).
The rejection of claim 55 is described above. The combination of Heller and Leary renders the elements of claim 55 obvious.
However, regarding claim 58, the combination of Heller and Leary does not render obvious a synthetic particle wherein the polypeptide encoded by the Anellovirus ORF1 nucleic acid comprises the amino acid sequence of SEQ ID NO: 217.
However, Galmès teaches sequences isolated from children with parapneumonia empyema corresponding to Torque Teno mini viruses sequences. See title and “[E]xperimental procedures” section, “TTMV isolation by pathogen discovery and genetic characterization” paragraph. One of the sequence isolated has been submitted to GenBank under accession no. JX134045. The alignment of JX134045 (Database Db) and SEQ ID NO: 217 (Query Qy) sequences is shown below:
Query Match 100.0%; Score 1159; Length 666;
Best Local Similarity 100.0%;
Matches 208; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PTYTTIPLKQWQPPYKRTCYIKGQDCLIYYSNLRLGMNSTMYEKSIVPVHWPGGGSFSVS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 39 PTYTTIPLKQWQPPYKRTCYIKGQDCLIYYSNLRLGMNSTMYEKSIVPVHWPGGGSFSVS 98
Qy 61 MLTLDALYDIHKLCRNWWTSTNQDLPLVRYKGCKITFYQSTFTDYIVRIHTELPANSNKL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 99 MLTLDALYDIHKLCRNWWTSTNQDLPLVRYKGCKITFYQSTFTDYIVRIHTELPANSNKL 158
Qy 121 TYPNTHPLMMMMSKYKHIIPSRQTRRKKKPYTKIFVKPPPQFENKWYFATDLYKIPLLQI 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 159 TYPNTHPLMMMMSKYKHIIPSRQTRRKKKPYTKIFVKPPPQFENKWYFATDLYKIPLLQI 218
Qy 181 HCTACNLQNPFVKPDKLSNNVTLWSLNT 208
||||||||||||||||||||||||||||
Db 219 HCTACNLQNPFVKPDKLSNNVTLWSLNT 246
The alignment shows 100% sequence identity between the two sequences. And the description of the sequence is as follow in GenBank:
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In the description copied above, the sequence is also described as “ORF1”.
According to Galmès, the sequences isolated are derived from the same larger genus of species isolated from human respiratory specimens (see “[I]ntroduction” section of Galmès, second paragraph). Galmès also states that “[W]e described for the first time that TTMV, like TTV, was able to replicate in cell lines after transfection of its genome and thus lead to the production of infectious virions (see page 477, third paragraph, lines 5-7)”. Galmès also describes the newly isolated TTMV as having a smaller genome, i.e. 2.9Kb (Galmès, “[R]esults” section, line 10), versus nearly 4Kb for TTV genome (Leary, column 29, lines 39-40).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the claimed invention to have substituted the ORF1 sequence taught by Leary with the sequence JX134045 taught by Galmès, since the ORF1 proteins are equivalent in their function and are derived from the same larger genus of species isolated from human respiratory specimens. One with ordinary skills in the art motivated in using the most recently isolated TT like virus from humans ensuring infectivity in human cells, with a smaller genome, could have performed this substitution with a reasonable expectation of success and arrived at the claimed invention.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant’s arguments on page 18 state “Contrary to the
Office's assertion, the cited publications, alone or in combination, fail to teach or suggest the synthetic particle of amended claim 55. In addition, even if Heller and Leary
could be combined to reach the presently claimed synthetic particle, which Applicant does not concede, a person of ordinary skill would not have had a reasonable expectation of success in doing so. Rather, the skilled artisan would have recognized at the time of filing, based on the art published as of the instant priority date, that developing a synthetic particle based on Anellovirus or delivering therapeutic agents into human cells is a complex undertaking, which would be expected to require extensive invention and experimentation.”
In response, Examiner would like to remind that Heller teaches a viral vector (AAV) , capable of self-assembling and packaging heterologous nucleic acid (see Heller, page 2, “results” section, second paragraph, and references 21 and 22).
Heller teaches delivering vectors in muscle tissue, i.e. muscle cells, for a combined AAV.miR-29c/micro-dystrophin therapy (see Figure 4).
Leary teaches that TTV infection does not appear to be associated with any disease, is prevalent in human population and occurs readily, re-infection is common and those traits are desirable in a gene therapy vector (see column 3, lines 1-7). Leary also teaches that gene therapy of host can be performed using virions isolated from cell culture and used to infect host (see column 48, lines 31-41). Therefore, Leary teaches “virions” which are made of proteinaceous exterior. Leary teaches the ORF1 encoding sequence and the use of vector to make said virions in vitro (see Table 11, and column 48).
“When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).”
Therefore, the combination of Heller and Leary suggests that, substituting the self-assembling AAV particles with virions obtained by expressing in cell culture after transfecting with recombinant nucleic acid comprising ORF1 encoding sequence, packaging signals, regulatory elements and gene of interest, is an experimentation that one of ordinary skills in the art can perform. Leary gives the rationale for using TTV in gene therapy, and Heller teaches the level of skills in the art.
MPEP § 2121, section I states “ Prior art is presumed to be operable/enabling”.
Applicant also argues “The skilled artisan, reading Heller, would be led towards using AAV as a delivery vector, and would certainly not seek out an entirely different, alternative viral system for delivering exogenous effectors, much less specifically select Anelloviruses from among possible viral systems.”
In response, Leary provides rationale for exploring new alternatives to AAV, stating “ DNA viruses with small genomes, such as TTV, typically encode relatively few proteins and rely on the host cell to provide most replication and expression functions, thereby reducing the complexity of their interaction with the host cell. Furthermore, TTV infection does not appear to be associated with any disease…” (see column 2, line 61-67).
Applicant further argues that “Rather, the published literature would have dissuaded the skilled artisan from attempting to develop Anelloviruses as a viral vector. It was well established in the published scientific literature at the time of filing that, compared to other viruses, Anellovirus particles were exceptionally difficult to produce in culture. In particular, at the time of the filing of the present application, the field lacked an established, robust, and reproducible culture system even for wild-type Anelloviruses, much less for engineered Anelloviruses in which the genome has been modified to carry an exogenous payload.”
In response, Applicant focuses on the review Kaczorowska et al (cited as NPL# 43 in IDS filed 06/29/2022) which states that there is no established cell culture system and no animal model to study the virus-host interactions. However, Examiner would like to point out that there are multiple viruses in the Anelloviridae family, including, but not limited to TTV. Galmès (cited as NPL #20 in IDS filed 06/29/2022) also teaches anelloviruses, and more specifically TTMV, a Betatorquevirus. Galmès teaches in “Results” section, page 474, that they monitored replication and release of viral particles of new TTMV isolates in the A549 and HEK293T cells after transfection (see also Figure 3). Therefore, Galmès shows success in producing viral particles after transfecting cells with a vector and genomes of TTMV-LY. Galmès tested different times post-infection and viral load numbers to optimize their production system (see page 475, “TTMV-LY infectious particles replicate in alveolar epithelial cells” section).
Leary further teaches in column 5 tat “a host cell may be eukaryotic” (line 25). Leary also teaches in column 48, “The capacity of TTV to carry these additional sequences and remain functional, is evaluated by transfection of experimental vector constructs into a permissive eucaryotic cell line” (see column 48, lines 15-18). Therefore, it is expected that a certain amount of manipulation and experimentation is needed for optimization based on techniques and principles already available in the art. However, the obviousness of a generic composition comprising a proteinaceous, i.e. virion, composed of ORF1 from an anellovirus, as carrier of nucleic acid of a gene of interest used to target a muscle cell, is shown by the combination of Heller and Leary. Galmès further demonstrates the skills in the art with anelloviruses and the permissiveness of eukaryotic cells dating from 2012.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
The following rejections are maintained from Office Action dated 07/02/2025, but have been modified to reflect Applicant’s amendments:
Claims 55, 57-58, 60-65 and 77 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 57, 59-60, 62-67 and 77 of co-pending Application No. 17/413,123 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 55, claim 57 of co-pending app. ‘123 recite the same elements, i.e. a synthetic particle comprising a genetic element comprising a promoter element and a nucleic acid sequence encoding an exogenous effector, and a proteinaceous exterior comprising a polypeptide encoded by an Anellovirus ORF1 nucleic acid, wherein the genetic element is enclosed within the proteinaceous exterior.
Regarding claim 57, claim 59 of co-pending app. ‘123 is drawn to the same element, i.e. an ORF1 molecule that is or has been proteolytically processed.
Regarding claim 58, claim 60 of co-pending app.’123 is drawn to the same elements and polypeptide comprising SEQ ID NO: 217.
Regarding claim 60, claim 62 of co-pending app. ‘123 is drawn to the same limitations, with corrections to “Table 16” presenting new sequence IDs.
Regarding claim 61, claim 63 of co-pending app. ‘123 is drawn to the same elements.
Regarding claim 62, claim 64 of co-pending app. ‘123 is drawn to the same elements.
Regarding claim 63, claim 65 of co-pending app. ‘123 is drawn to some identical limitations.
Regarding claim 64, claim 66 of co-pending app.’123 is also drawn to a pharmaceutical composition comprising the synthetic particle and a pharmaceutically acceptable carrier or excipient.
Regarding claim 65, claim 67 of co-pending app. ‘123 is also drawn to the same limitations.
Regarding claim 77, claim 77 of co-pending app. ‘123 is also drawn to a synthetic particle wherein the genetic element comprises a sequence having at least 75% sequence identity to the 5’ UTR conserved domain of a wild-type Anellovirus.
This is a provisional non-statutory double patenting rejection.
Claims 55, 57-58, 60-65 and 76-77 are rejected on the ground of non-statutory double patenting as being unpatentable over claims of U.S. Patent No. 11,166,996 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 55, 57-58, 60-65 and 76-77, claims 1-66 to US Pat. No. 11, 166, 996 B2 are drawn to elements recited in the Methods of use of the elements of the synthetic particle composition.
Claims 55, 57-58, 60-65 and 76-77 are rejected on the ground of non-statutory double patenting as being unpatentable over claims of U.S. Patent No. 11,446,344 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 55, 57-58, 60-65 and 76-77, claims 1-29 of US Pat. No. 11, 446, 344 B1 recites all the elements the instant claims are drawn to or are drawn to species in broader genus claimed in instant claims. See below:
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673
666
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490
660
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The following rejections are newly added:
Claims 55, 57-58, 60-65 and 77 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 4-9, 11, and 14-15 of co-pending Application No. 19/240,368 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 55, claim 1 of co-pending application 19/240,368 recites the same elements. Although the claim is drawn to exogenous effector comprising a secreted protein, instant claim 55 encompasses all types of exogenous effectors. Although claim 1 of co-pending app.’368 imparts the capability of the synthetic particle to deliver the genetic element into a human cell, there is no recited structure different from the structure recited in instant claim 55.
Regarding claim 57, claim 4 of co-pending app. ‘368 teaches “the ORF1 molecule is proteolytically processed”, which encompasses the terms “has been proteolytically processed”.
Regarding claim 58, claim 5 of co-pending app. ‘368 teaches the same elements in (i), (ii), (iii) and (iv).
Regarding claim 60, claim 6 of co-pending app. ‘368 recites the same elements (a), (b), (c), (d) and ( e). Instant claim 60 has been amended to recite “of any of SEQ ID NOs: 55-60” instead of “as listed in Table 16” in (a) and (b). However, the specification of co-pending app.’368 present identical SEQ ID NOs in Table 16 (see pages 245-246) from SEQ ID NOs: 55 to 60.
Regarding claim 61, claim 7 of co-pending app.’368 recites the same elements of instant claim 61.
Regarding claim 62, claim 9 of co-pending app.’368 recites “the promoter element is exogenous to wild-type Anellovirus, or wherein the promoter element is endogenous to wild-type Anellovirus”.
Regarding claim 63, claim 1 of co-pending app.’368 also recites “wherein the synthetic particle is capable of delivering the genetic element into a human cell”. Claim 11 of co-pending app.’368 teaches “the particle is substantially non-immunogenic, optionally wherein the substantially non-immunogenic particle has an efficacy in a subject that is at least about 10% of the efficacy in a reference subject lacking an immune response”. Claim 11 of co-pending app.’368 also recites elements in (iii) that are identical to claim 63(iii). Claim 11 (iv) recites exogenous effector that is a therapeutic secreted protein, that represents a species of elements claimed in instant claim 63(iv).
Regarding claim 64, claim 14 of co-pending app.’368 teaches a pharmaceutical composition comprising the synthetic particle of claim 1 and an acceptable carrier or excipient.
Regarding claim 65, claim 15 of co-pending app.’368 teaches “ the pharmaceutical composition comprises at least 103 synthetic particles”.
Regarding claim 77, claim 8 of co-pending app.’368 teaches “wherein the genetic element comprises a sequence having at least 75% sequence identity to the 5’ UTR conserved domain of a wild-type Anellovirus.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/A.D./Examiner, Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636