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 .
Claim Status
Claims 1, 3, 6, 10, 12, 16, 18, 22, 24, and 26-28 are amended (5/29/2026). Claim 2 is cancelled (5/29/2026). Claims 34-40 are new (5/29/2026). Thus, claims 1, 3, 6, 8-10, 12, 15-20, 22, 24, 26-28 and 33-40 are under examination (5/29/2026).
Priority
Claims 1, 3, 6, 8-10, 12, 15-20, 22, 24, 26-28 and 33-40 are given a priority date of 6/12/2020, the filing date of SG10202005599R.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Information Disclosure Statements from 4/24/2026 are considered.
Objections Withdrawn
Specification:
The objections to the specification due to the use of a trademark are withdrawn in view of Applicant’s amendments.
The objection to the specification due to the lack of Sequence Listing has been withdrawn in view of Applicant’s incorporation of a new Sequence Listing, to comply with 37 CFR 1.831(b).
Claims:
The objection to claims 27 and 28 to correct minor informalities, is withdrawn due to Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112(b)
The rejections of claims 1-3, 6, 8-10, 12, 15-20, 22, 24, 26-28 and 33 under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 2nd paragraph, are withdrawn in view of Applicant’s amendments of claims 1, 3, 12 and 18.
Claim Rejections - 35 USC § 101
The rejection of claims 2-3 and 17-18 under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, is withdrawn in view of Applicant’s cancellation of claim 2, significant amendments of claim 1, and Applicant’s arguments (5/29/2026). Specifically, the 101 rejection is withdrawn because amended claim 1, from which claims 3, 17, and 18 ultimately depend, now requires an integrated physical single-cell sequencing workflow in which the same sequencing results, obtained within a single library preparation, are used both to detect vector presence and classify each partitioned cell. These limitations meaningfully constrain the claimed analysis to a specific technological process rather than merely collecting biological information and performing abstract mental or mathematical analysis.
Claim Rejections - 35 USC § 102 (a)(1), 102 (a)(2)
The rejections of claims 1-3, 6, 8-10, 12, 15-20, 22, 24, 26-28 and 33 under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated Brock et al. (WO 2018/031864 A1, published 2/15/2018), are withdrawn in view of Applicant’s arguments (5/29/2026) and significant amendments of independent claim 1 (5/29/2026). Specifically, the Applicant’s arguments are persuasive because Brock does not teach the amended limitations requiring detection of one or more of a plurality of different vectors in each partitioned cell and classification of that same cell using sequencing results obtained within a single library preparation. Thus, Brock does not teach every limitation as arranged in amended independent claim 1, as required for anticipation under MPEP 2131.
New 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 3, 6, 8-10, 12, 15-20, 22, 24, 26-28 and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Brock et al. (WO 2018/031864 A1, published 2/15/2018) and Michelfelder et al. (“Successful Expansion but Not Complete Restriction of Tropism of Adeno-Associated Virus by In Vivo Biopanning of Random Virus Display Peptide Libraries”, PLOS One, published 2009), and further in view of Omichi et al. (“Hair Cell Transduction Efficiency of Single- and Dual-AAV Serotypes in Adult Murine Cochleae”, Methods and Clinical Development, published originally 5/13/2020). The rejection has been modified as a result of submitted amendments (5/29/2026).
Regarding claim 1, Brock teaches methods and platforms related to modulating expression of a gene of interest within a select population of cells comprising: providing a population of cells; providing a vehicle, plasmid, vector or recombinant virus, or equivalent thereof, capable of stably expressing a guide nucleic acid comprising randomized barcodes, thereby producing a population of barcoded cells; allowing said barcoded cell to divide, thereby forming a barcoded progeny of cells; saving an aliquot of cells; identifying the barcode in a lineage of interest from the barcoded progeny of cells; reconstituting the aliquot of saved cells, and transforming the reconstituted aliquot of cells with a transcriptional element comprising a transcriptional effector, the barcode of the lineage of interest, and a gene of interest; utilizing the transcriptional effector to modify expression of the gene of interest within the lineage of interest (Abstract). Brock further teaches methods for delivering vectors or other nucleic acid (such as RNA) into mammalian cells in culture (termed transfection) are routine, and a number of transfection methods find use with the invention and these include but are not limited to calcium phosphate precipitation, electroporation, lipid-based methods (liposomes or lipoplexes) such as Transfectamine® (Life Technologies™) and TransFectin™ (Bio-Rad Laboratories), cationic polymer transfections, for example using DEAE-dextran, direct nucleic acid injection, biolistic particle injection, and viral transduction using engineered viral carriers (termed transduction, using e.g., engineered herpes simplex virus, adenovirus, adeno-associated virus, vaccinia virus, Sindbis virus), and sonoporation (p. 12, Paragraph 1). Specifically, Brock teaches that the demonstration that expressed gRNA barcodes can be used to efficiently perform lineage-specific manipulation of gene expression opens up the possibility for a broad range of studies investigating the potential of lineage-specific perturbations within the context of a heterogeneous, evolving cell population, where the ability to concurrently track clonal fitness dynamics and generate lineage-specific genomic and transcriptomic data over longitudinal studies will provide unprecedented insight into cancer adaptation and other diseases with an evolutionary basis (p. 34, Paragraph 1). Brock also teaches that cells in the lineage of interest can be selected in a variety of ways, known to those of skill in the art; where for example, cells can be selected on the basis of phenotype, wherein the phenotype can be created from the gene of interest and selecting the cells on the basis of phenotype can comprise selecting the cells on the basis of protein expression, RNA expression, or protein activity and in some cases selecting the cells on the basis of the phenotype comprises fluorescence activated cell sorting, affinity purification of cells, or selection based on cell motility (cell sorting can be done using single cell sorting, fluorescent activated cell sorting (FACS), physical cell manipulation, laser capture, or magnetic cell sorting (p. 28, Paragraphs 1-2).
Brock further teaches that specifically, disclosed herein is a method of generating a population of cells that display a desired characteristic when exposed to a candidate agent, the method comprising: providing a population of cells; providing a vehicle, plasmid, vector or recombinant virus, or equivalent thereof, capable of stably expressing a guide nucleic acid comprising randomized barcodes, thereby producing a population of barcoded cells; saving an aliquot of cells; exposing the barcoded cells to one or more candidate agents; identifying a desired characteristic in a barcoded cell exposed to a candidate agent; reconstituting the aliquot of cells and exposing the reconstituted aliquot of cells to a nucleic acid comprising a transcriptional activator, a barcode, and a gene of interest, wherein the barcode is the same as that of the barcoded cell with the desired characteristic; utilizing the transcriptional activator to drive expression of the gene of interest; identifying and selecting barcoded cells with the desired characteristic; and allowing the selected barcoded cell to divide, thereby forming generating a population of cells that display a desired characteristic when exposed to a candidate agent (p. 29, Paragraph 1).
Regarding claim 3, Brock teaches that the previously described method includes application to polypeptides of two or more sequences or subsequences that are the same ("identical") or have a specified percentage of amino acid residues or nucleotides that are
identical ("percent identity") when compared and aligned for maximum correspondence with a
second molecule, as measured using a sequence comparison algorithm (e.g., by a BLAST alignment, or any other algorithm known to persons of skill), or alternatively, by visual inspection (p. 20, Paragraph 2).
Regarding claims 6 and 8, Brock teaches methods and compositions wherein each cell in a population is uniquely tagged with a stably integrated barcode-gRNA under control of a constitutive promoter and following barcode instantiation, cells are permitted to proliferate and at intervals the genomically encoded barcode region is sequenced for quantitation of clonal barcodes; a parallel sample portion is archived for retroactive analysis, where RNA sequencing of barcode gRNA can be performed directly in one example and lineage dynamics may inform the identification of specific lineages of interest for subsequent gene activation in archival samples (p. 22, Paragraph 1).
Regarding claims 9-10, Brock teaches that methods for delivering vectors or other nucleic acid (such as RNA) into mammalian cells in culture (termed transfection) are routine, and a number of transfection methods find use with the invention; including but are not limited to calcium phosphate precipitation, electroporation, lipid-based methods (liposomes or lipoplexes) such as Transfectamine® (Life Technologies™) and TransFectin™ (Bio-Rad Laboratories), cationic polymer transfections, for example using DEAE-dextran, direct nucleic acid injection, biolistic particle injection, and viral transduction using engineered viral carriers (termed transduction, using e.g., engineered herpes simplex virus, adenovirus, adeno-associated virus, vaccinia virus, Sindbis virus), and sonoporation (p.11, Paragraph 1).
Also, Brock teaches that Portions of polynucleotides can be any length, for example, at least 5, 10, 15, 20, 25, 30, 40, 50, 75, 100, 150, 200, 300 or 500 or more nucleotides in length (p. 21, Paragraph 3).
Regarding claim 12, Brock teaches that there are many uses for this versatile tool, including driving lineage specific expression of a reporter, allowing lineage isolation via cell sorting and other uses include driving lineage specific expression of a lethal protein, thereby allowing for targeted cell death of a specific lineage; use of an auxotrophic marker; use of a drug resistance gene/protein to allow for the targeted selection of a specific lineage of interest; or a differentiation marker to allow for lineage specific differentiation, where barcoded guide nucleotide can also be co-expressed with libraries of small non-coding RNA (microRNA) for functional assessment of microRNA (p. 22, Paragraph 1).
Regarding claims 15-18, Brock teaches that methods for delivering vectors or other nucleic acid (such as RNA) into mammalian cells in culture (termed transfection) are routine, and a number of transfection methods find use with the invention; including but are not limited to calcium phosphate precipitation, electroporation, lipid-based methods (liposomes or lipoplexes) such as Transfectamine® (Life Technologies™) and TransFectin™ (Bio-Rad Laboratories), cationic polymer transfections, for example using DEAE-dextran, direct nucleic acid injection, biolistic particle injection, and viral transduction using engineered viral carriers (termed transduction, using e.g., engineered herpes simplex virus, adenovirus, adeno-associated virus, vaccinia virus, Sindbis virus), and sonoporation (p.11, Paragraph 1). Brock also teaches that currently, cell populations carrying unique heritable barcode identifiers are bulk processed for quantitation of barcode frequency by sequencing (p. 2, Paragraph 1). Further Brock teaches methods and compositions wherein each cell in a population is uniquely tagged with a stably integrated barcode-gRNA under control of a constitutive promoter, and following barcode instantiation, cells are permitted to proliferate and at intervals the genomically encoded barcode region is sequenced for quantitation of clonal barcodes; a parallel sample portion is archived for retroactive analysis (p. 21, Paragraphs 4-5).
Specifically, Brock teaches that an existing workflow is established for the generation of high diversity barcode-tagged cell populations in patient-derived cultures, including reference standards, the efficiency of cellular lineage tracking and retrieval is tested using a) a reference set of low diversity barcodes and then b) a reference barcode in the background of a high diversity library of -106 barcodes (p. 38, Paragraph 1).
Regarding claim 19, Brock teaches that for developmental studies, screening in human and mouse pluripotent cells may pinpoint genes required for pluripotency or for differentiation into distinct cell types and to distinguish cell types, fluorescent or cell surface marker reporters of gene expression may be used and cells may be sorted into groups or compartments based on expression level; where any phenotype that is compatible with rapid sorting or separation may be harnessed for pooled screening (p. 29, Paragraph 3).
Regarding claim 20, Brock teaches methods and compositions wherein each cell in a population is uniquely tagged with a stably integrated barcode-gRNA under control of a constitutive promoter and following barcode instantiation, cells are permitted to proliferate and at intervals the genomically encoded barcode region is sequenced for quantitation of clonal barcodes; a parallel sample portion is archived for retroactive analysis, where RNA sequencing of barcode gRNA can be performed directly in one example and lineage dynamics may inform the identification of specific lineages of interest for subsequent gene activation in archival samples (p. 22, Paragraph 1).
Regarding claim 22, Brock teaches that to confirm the specificity and efficiency of lineage-specific expression, recall was tested in the presence of a large diverse barcoded population; and the high-diversity barcode gRNA library was constructed with the template: GNSNWNSNWNSNWNSNWNSN (SEQ ID NO: 1), having a diversity potential greater than 500,000,000 unique sequences (Fig. 2) and this gRNA library was ligated into a gRNA expression lentiviral transfer vector and assembled into a pooled gRNA barcoded lentivirus (p. 33, Paragraph 3).
Regarding claims 24 and 26-28, Brock further teaches methods for delivering vectors or other nucleic acid (such as RNA) into mammalian cells in culture (termed transfection) are routine, and a number of transfection methods find use with the invention and these include but are not limited to calcium phosphate precipitation, electroporation, lipid-based methods (liposomes or lipoplexes) such as Transfectamine® (Life Technologies™) and TransFectin™ (Bio-Rad Laboratories), cationic polymer transfections, for example using DEAE-dextran, direct nucleic acid injection, biolistic particle injection, and viral transduction using engineered viral carriers (termed transduction, using e.g., engineered herpes simplex virus, adenovirus, adeno-associated virus, vaccinia virus, Sindbis virus), and sonoporation (p. 12, Paragraph 1).
Regarding claim 33, Brock teaches that the previously described method can be applied to, for example, an ex vivo patient-specific tool, tumor cells are labeled with a library (more than 106 unique tags) of novel expressed barcodes, cultured as patient-derived organoids (i.e., breast, lung, ovarian) and treated with the same first-line treatment as patients where in multiple parallel samples, one can monitor the growth dynamics of the post-treatment population and determine which clones survive the treatment or may even have a growth advantage and using BAAR, these resistant clones of interest can be purified from an untreated population and evaluated to identify appropriate second and third line treatments that target the resistant survivor cell population (p. 37, Paragraphs 3-4).
Regarding claims 34-40, Brock teaches that for developmental studies, screening in human and mouse pluripotent cells may pinpoint genes required for pluripotency or for differentiation into distinct cell types and to distinguish cell types, fluorescent or cell surface marker reporters of gene expression may be used and cells may be sorted into groups or compartments based on expression level; where any phenotype that is compatible with rapid sorting or separation may be harnessed for pooled screening (p. 29, Paragraph 3).
Brock teaches that methods for delivering vectors or other nucleic acid (such as RNA) into mammalian cells in culture (termed transfection) are routine, and a number of transfection methods find use with the invention; including but are not limited to calcium phosphate precipitation, electroporation, lipid-based methods (liposomes or lipoplexes) such as Transfectamine® (Life Technologies™) and TransFectin™ (Bio-Rad Laboratories), cationic polymer transfections, for example using DEAE-dextran, direct nucleic acid injection, biolistic particle injection, and viral transduction using engineered viral carriers (termed transduction, using e.g., engineered herpes simplex virus, adenovirus, adeno-associated virus, vaccinia virus, Sindbis virus), and sonoporation (p.11, Paragraph 1). Brock also teaches that currently, cell populations carrying unique heritable barcode identifiers are bulk processed for quantitation of barcode frequency by sequencing (p. 2, Paragraph 1). Further Brock teaches methods and compositions wherein each cell in a population is uniquely tagged with a stably integrated barcode-gRNA under control of a constitutive promoter, and following barcode instantiation, cells are permitted to proliferate and at intervals the genomically encoded barcode region is sequenced for quantitation of clonal barcodes; a parallel sample portion is archived for retroactive analysis (p. 21, Paragraphs 4-5).
Specifically, Brock teaches that an existing workflow is established for the generation of high diversity barcode-tagged cell populations in patient-derived cultures, including reference standards, the efficiency of cellular lineage tracking and retrieval is tested using a) a reference set of low diversity barcodes and then b) a reference barcode in the background of a high diversity library of -106 barcodes (p. 38, Paragraph 1).
Also, Brock teaches that Portions of polynucleotides can be any length, for example, at least 5, 10, 15, 20, 25, 30, 40, 50, 75, 100, 150, 200, 300 or 500 or more nucleotides in length (p. 21, Paragraph 3).
Brock further teaches methods for delivering vectors or other nucleic acid (such as RNA) into mammalian cells in culture (termed transfection) are routine, and a number of transfection methods find use with the invention and these include but are not limited to calcium phosphate precipitation, electroporation, lipid-based methods (liposomes or lipoplexes) such as Transfectamine® (Life Technologies™) and TransFectin™ (Bio-Rad Laboratories), cationic polymer transfections, for example using DEAE-dextran, direct nucleic acid injection, biolistic particle injection, and viral transduction using engineered viral carriers (termed transduction, using e.g., engineered herpes simplex virus, adenovirus, adeno-associated virus, vaccinia virus, Sindbis virus), and sonoporation (p. 12, Paragraph 1).
Further, Brock teaches that the previously described method can be applied to, for example, an ex vivo patient-specific tool, tumor cells are labeled with a library (more than 106 unique tags) of novel expressed barcodes, cultured as patient-derived organoids (i.e., breast, lung, ovarian) and treated with the same first-line treatment as patients where in multiple parallel samples, one can monitor the growth dynamics of the post-treatment population and determine which clones survive the treatment or may even have a growth advantage and using BAAR, these resistant clones of interest can be purified from an untreated population and evaluated to identify appropriate second and third line treatments that target the resistant survivor cell population (p. 37, Paragraphs 3-4).
Brock also teaches that to confirm the specificity and efficiency of lineage-specific expression, recall was tested in the presence of a large diverse barcoded population; and the high-diversity barcode gRNA library was constructed with the template: GNSNWNSNWNSNWNSNWNSN (SEQ ID NO: 1), having a diversity potential greater than 500,000,000 unique sequences (Fig. 2) and this gRNA library was ligated into a gRNA expression lentiviral transfer vector and assembled into a pooled gRNA barcoded lentivirus (p. 33, Paragraph 3).
Brock does not teach or suggest transducing a heterogeneous cell population with a plurality of different vectors and detecting which of those vectors are present in each partitioned cell.
Michelfelder teaches screening a diverse library of AAV vectors having different capsid peptide sequences to identify vectors having preferential transduction/tropism for particular target cells or tissues (Abstract). Further, Michelfelder teaches exposing target vector sequences from the transduced/internalized population, amplifies the recovered sequences by PCR, and performs repeated selection rounds to enrich vectors exhibiting desired transduction characteristics (Introduction); and further compares the resulting vectors’ transduction across different tissues to assess their relative tropism and specificity (Introduction; AAV titration and evaluation of vector homing and serum distribution). Additionally, Michelfelder teaches that AAV tropism differs among vectors and cell/tissue types and that screening can be used to select vectors efficiently transducing a cell type of interest, including demonstrating substantially enhanced transduction by selected AAV variants relative to wild-type or control vectors (Figure 1; Discussion).
Omichi teaches comparing the transduction efficiencies and cellular tropism of different AAV serotypes against particular cell types (Abstract). Further, Omichi teaches the administration of AAV1, AAV2, AAV8, AAV9, and Anc80L65 to adult murine cochleae and quantitatively determines the frequency/percentage of inner and outer hair cells transduced by each vector (Introduction), and further evaluates dual-vector co-transduction, demonstrating that multiple vectors can transduce the same cell and quantifying the resulting co-transduction frequencies (Co-transduction with Dual AAV2 Demonstrates Comparable IHC and OHC Transduction Rates to Single AAV2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Brock in view of Michelfelder and Omichi to expose a heterogeneous population of cells to a plurality of different viral vectors and determine the presence and relative transduction of the vectors in particular cell types. Michelfelder provides motivation for such a modification by teaching that AAV vectors exhibit different cellular/tissue tropisms and that libraries of different AAV variants can be screened to identify vectors having desirable or preferential transduction characteristics, thereby providing a reason to evaluate multiple vectors against target cells rather than merely track a single lineage-associated construct.
Omichi further teaches that different AAV serotypes can be administered and their transduction efficiencies quantitatively compared in distinct cell types, and additionally demonstrates that multiple AAV vectors can successfully co-transduce the same cells. Omichi used equal vector concentrations to permit comparison of cellular tropism among the tested AAV serotypes and quantified transduction of different hair-cell populations. Thus, a skilled artisan would have been motivated to apply Michelfelder’s multi-vector screening and Omichi’s comparative transduction analysis to Brock’s cell-identification/sequencing framework to efficiently determine which vectors transduce particular cell types to assess the relative efficiency and specificity of those vectors.
A person of ordinary skill would have had a reasonable expectation of success because Michelfelder establishes that different AAV vectors can be screened against cells to determine preferential tropism, while Omichi experimentally demonstrates successful transduction with several different AAV serotypes and successful co-transduction of individual cells with multiple vectors. In particular, Omichi reports quantifiable and reproducible transduction efficiencies for both single and dual-vector administration, demonstrating that the proposed combination employs known viral-vector transduction and detection techniques according to their established functions. Accordingly, the combination would have represented the predictable use of known techniques to obtain the expected result of identifying which vectors are present in particular cell types and comparing their relative transduction efficiency and specificity.
Applicant’s Response: The Applicant argues that Brock does not anticipate amended claim 1 because Brock uses a single barcode as a clonal lineage identifier and does not disclose exposing a heterogeneous population of cells to a plurality of different vectors and detecting which of those vectors are present in each partitioned cell. The Applicant further argues that Brock does not teach an integrated single-cell sequencing assay in which the same sequencing results are used both to identify/classify each cell and determine vector identity within that cell, as now required by amended claim 1.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered and were found partially persuasive, as discussed below.
Specifically, Applicant’s arguments regarding the rejection under 35 USC 103 are persuasive to the extent that Brock alone does not disclose every limitation of amended claim 1, including exposing a heterogeneous population of cells to a plurality of different vectors and determining vector identity and cell type as presently claimed. Accordingly, the rejection under 35 102 is withdrawn.
However, the arguments do not overcome the new rejection under 35 USC 103 over Brock in view of Michelfelder and Omichi. While Brock provides the underlying cell/barcode identification and sequencing framework, Michelfelder teaches screening a plurality of different AAV vectors and determining their preferential transduction of target cells or tissues, and Omichi teaches quantitatively comparing the transduction of different AAV vectors in particular cell types, including co-transduction of individual cells by multiple vectors. It would have been obvious to incorporate these known vector-screening and comparative transduction-techniques into Brock to identify both the cell and the vectors associated with that cell and thereby evaluate vector transduction efficiency and specificity. The references demonstrate that the respective sequencing, AAV screening, and multi-vector transduction techniques were known and successfully practiced, providing a reasonable expectation of success in their combination.
Thus, although Brock does not independently anticipate amended claim 1, anticipation is not required for obviousness; the relevant inquiry is what the combined teachings would have suggested to one of ordinary skill in the art. See MPE 2141, explaining that multiple references may collectively establish obviousness where there is articulated reasoning for the combination and claimed differences would have been obvious to the skilled artisan.
Conclusions
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ROSE LAFAVE whose telephone number is (703)756-4747. The examiner can normally be reached Compressed Bi-Week: M-F 7:30-4:30.
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/ELIZABETH ROSE LAFAVE/ Examiner, Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
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