Prosecution Insights
Last updated: April 19, 2026
Application No. 16/551,620

SAMPLE MULTIPLEXING USING CARBOHYDRATE-BINDING AND MEMBRANE-PERMEABLE REAGENTS

Final Rejection §103§112§DP
Filed
Aug 26, 2019
Examiner
BUNKER, AMY M
Art Unit
1684
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cellular Research Inc.
OA Round
10 (Final)
29%
Grant Probability
At Risk
11-12
OA Rounds
4y 4m
To Grant
76%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allow Rate
142 granted / 484 resolved
-30.7% vs TC avg
Strong +46% interview lift
Without
With
+46.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 4m
Avg Prosecution
63 currently pending
Career history
547
Total Applications
across all art units

Statute-Specific Performance

§101
8.4%
-31.6% vs TC avg
§103
28.4%
-11.6% vs TC avg
§102
20.7%
-19.3% vs TC avg
§112
28.9%
-11.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 484 resolved cases

Office Action

§103 §112 §DP
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 . DETAILED ACTION The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action. Status of Claims Claims 15, 16, 18, 19, 21-25 and 27-36 are currently pending. Claims 15 and 18 have been amended by Applicants’ amendment filed 02-18-2026. Claims 1-14 have been canceled by Applicants’ amendment filed 02-18-2026. Claims 27-36 have been added by Applicants’ amendment filed 02-18-2026. Applicant's election without traverse of Group II, claims 15-20, directed to a method for sample identification; and the election of Species without traverse as follows: Species (A): wherein identifying the same origin comprises identifying the presence or absence of the sample indexing sequence (claim 17); and Species (D): wherein the cell membrane-permeable reagent is internalized into the one or more cells (claim 20), in the reply filed on August 26, 2021 was previously acknowledged. Claims 1-14 and 21-25 (claims 1-14, now canceled) were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim. Claims 16 and 19 were previously withdrawn, and claims 27-35 are newly withdrawn, from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim. The restriction requirement was deemed proper and was made FINAL. Please Note: in the Response to the Election/Restriction filed August 26, 2021, Applicant elected for Species (D): wherein the cell membrane-permeable reagent is internalized into the one or more cells (claim 20). Thus, instant claims 27, 28, 30-33 and 35 are withdrawn as being directed to a non-elected Species (e.g., cell membrane-permeable reagent covalently attached to a first sample indexing oligonucleotide, cell membrane-permeable reagent conjugated to a first sample indexing oligonucleotide, etc.). Instant claim 29 depends from withdrawn claim 28; and claim 34 depends from withdrawn claim 33. The claims will be examined insofar as they read on the elected species. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01. Therefore, claims 15, 18 and 36 are under consideration to which the following grounds of rejection are applicable. Priority The present application filed August 26, 2019 claims the benefit of US Provisional Patent Application 62/723,958, filed August 28, 2018. Information Disclosure Statement The information disclosure statement (IDS) submitted on February 18, 2026 has been considered. An initialed copy of the IDS accompanies this Office Action. Withdrawn Objections/Rejections Applicants’ amendment and arguments filed February 18, 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn. Claim Rejections - 35 USC § 112(d) The rejection of claim 18 is withdrawn under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends due to Applicant’s amendment of claim 18, in the reply filed 02-18-2026. In view of the withdrawn rejection, Applicant’s arguments are rendered moot. Claim Rejections - 35 USC § 103 The rejection of claims 15 and 18 is withdrawn under 35 U.S.C. 103 as being unpatentable over Ji et al. (hereinafter “Ji”) (BioProtocol, Feb 2019) in view of Diebold et al. (hereinafter “Diebold”) (US Patent Application Publication No. 20170268981, published September 21, 2017) as evidenced by Bectin-Dickinson (Bectin-Dickinson Company, Aug. 2019, 1-230); and BD Biosciences (BD Biosciences, 2016, 1-4). Due to Applicant’s amendment of claim 15, Ji is not prior art to US Provisional Patent 62/723,953, filed August 28, 2018. In view of the withdrawn rejection, Applicant’s arguments are rendered moot. Maintained Objections/Rejections Double Patenting The provisional rejection of claims 15 and 18 is maintained, and claim 36 is newly provisionally rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 22 of copending Application No. 16/540,971 in view of Fan et al. (US Patent Application No. 20160289669, published October 6, 2016) for the reasons of record. The rejection of claims 15 and 18 is maintained, and claim 36 is newly rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent Nos. 10676779 and claims 1-19 of US Patent Application No. 11834715 for the reasons of record. Response to Arguments Applicant’s arguments filed February 18, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) Applicant requests the Examiner to hold the rejections in abeyance until the present application is otherwise in condition for allowance (Applicant Remarks, pg. 16, second and third full paragraphs). Regrading (a), Applicant did not specifically indicate how the claims of the copending applications recited supra are patentably distinct from the instant claims as required by 37 CFR 1.111(b). Thus, the claims remain rejected for the reasons already of record. Claim Rejections - 35 USC § 112(b) The rejection of claims 15 and 18 is maintained, and claim 36 is newly rejected, under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The rejection of claim 15 is maintained as being indefinite for the recitation of “identifying a sample origin” such as recited in claim 15, lines 35, 40 and 43 because claim 15, line 1 recites that the claim is directed to a method for sample identification; while claim 15, lines 35-48 recite three (3) different method steps for “identifying a sample origin” such that it is unclear whether all three steps of “identifying” are required for finally identifying a sample origin; or whether any one of the three steps can identify a sample origin. For example, claim 15 recites that “identifying a sample origin” is: (i) based on sequences selected from the group consisting of the first sample indexing sequence…and a portion thereof”; (ii) comprises identifying whether the at least one single cell originates from the first sample or the second sample; and (iii) comprises identifying the presence or absence of a sequence selected from the group consisting of the first sample indexing sequence…and a portion thereof and, thus, the metes and bounds of the claim cannot be determined. The rejection of claim 15 is maintained as being indefinite for the recitation of the term “at least one single cell” in claim 15, lines 35, 40 and 43. There is insufficient antecedent basis for the term “at least one single cell” in the claim because claim 15, lines 2-3, 7, 9-11 and 19 recite the terms: a first plurality of single cells, a second plurality of single cells, single cells, mammalian cells, at least 1000 single cells, and a single cell. Moreover, it is unclear if the sample origin is identified for any single cell in the sorted sample, whether the at least one single cell is associated with the first plurality of single cells, or whether the at least one single cell is associated with the second plurality of single cells and, thus, the metes and bounds of the claim cannot be determined. Claim 18 is indefinite for the recitation of the term “the sequencing data” such as recited in claim 18, line 16. There is insufficient antecedent basis for the term “the sequencing data” in the claim. Claim 36 is indefinite insofar as it ultimately depends from instant claim 15. Response to Arguments Applicant’s arguments filed February 18, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) the terms “identifying a sample origin” and “at least one single cell” is clear to one of ordinary skill in the art based on the claim language and teachings in the Specification including Figure 8A, and paragraph [0353] (Applicant Remarks, pg. 9, entire page; and pg. 10, entire page). Regarding (a), the term “at least one single cell” has insufficient antecedent basis. Regarding the term “identifying a sample origin”, Applicant’s argument is unclear. Moreover, (1) it is unclear whether all three steps of “identifying” are required for finally identifying a sample origin; (2) whether any one of the three steps can identify a sample origin; (3) if a sample origin is actually identified for any single cell in the sorted sample; and/or (4) whether the at least one single cell is associated with the first plurality of single cells, or whether the at least one single cell is associated with the second plurality of single cells. Thus, the rejection is maintained. New Objections/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 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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 15, 18 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (hereinafter “Fan”) (US Patent Application Publication 20160289669, published October 6, 2016) in view of Mao et. al. (hereinafter “Mao”) (US Patent No. 9670363, issued June 6, 2017) as evidenced by AAT Bioquest (AAT Bioquest, 2025, 1-10; of record); and Abcam (Abcam, 2014, 1-20; of record). This is a new rejection necessitated by amendment of the claims in the response filed 02-18-2026. Regarding claims 15 (in part) and 18, Fan teaches that a digital gene expression profile for each cell can be reconstructed when the barcoded transcripts are sequenced and assigned to the cell of origin (based on the cellular label identified) and counted (based on the number of unique molecular labels identified) (interpreted as determining cell/sample origin, claim 15) (paragraph [0159], lines 6-11). Fan teaches that the cells can be sorted prior to associating a cell with a bead including sorted by fluorescence-activated cell sorting (FACS), magnetic activated cell sorting, or more generally by flow cytometry (interpreted a sorting single cells including by flow cytometry, claim 15) (paragraph [0173]). Fan teaches loading cells, the concentration of the cell suspension (i.e. the number of cells per mL) is usually adjusted so that the probability of having more than one cell settle into a given microwell is very small; and typically, the concentration of the cell suspension will be adjusted so that the volume of cell suspension used to load, e.g. a microwell array, contains approximately one-tenth the number of cells as the number of wells in the microwell array (interpreted as single cells in a first sample; and single cells in a second sample, claim 15) (paragraph [0174]). Fan teaches that stochastic labels (also referred to as barcodes, tags, or indexes) used for single cell molecular barcoding studies comprise oligo-nucleotides, for example, oligo-deoxyribonucleotides (DNA), oligoribonucleotides (RNA), peptide nucleic acid (PNA) polymers, 2'-O-methyl-substituted RNA, locked nucleic acid (LNA) polymers, bridged nucleic acid (BNA) polymers, and the like (interpreted as sample/cell indexing or barcoding, claim 15) (paragraph [0176]). Fan teaches that stochastic labels can comprise a cellular label, such as a nucleic acid sequence that provides information for determining which target nucleic acid originated from which cell, wherein the cellular label is identical for all oligonucleotides attached to a given bead or solid support, but different for different beads or solid supports (interpreted as single cell indexing; for determining sample origin; and including a first index sequence and a second indexing sequence, claim 15) (paragraph [0182], lines 1-7). Fan teaches that Figure 3A depicts single cells that are trapped in microwells along with beads comprising libraries of tethered stochastic labels (one cell and one bead per well); and that Figure 3B depicts principal component analysis of stochastic barcoding data for human peripheral blood mononuclear cells; and Figure 3C depicts principle component analysis of stochastic barcoding data for a rare cell population (interpreted as a first sample indexing composition and a second sample indexing composition, claim 15) (paragraph [0037]; and Figure 3A-C). Figures 3A and 3C are shown below: PNG media_image1.png 762 644 media_image1.png Greyscale PNG media_image2.png 604 1060 media_image2.png Greyscale Fan teaches a subsection of the full array was cut and used, ranging from ~25,000 to 100,000 wells (Table 1), wherein Table 1 illustrates ~6250 K562 + Ramos cells loaded on an array; ~8000 Primary B + Ramos cells loaded; and an array comprising ~7680 anti-CD3/anti-CD28 negative control cells from Donor 1; ~4800 anti-CD3/anti-CD28 cells from Donor 2, etc. (interpreted as each plurality of single cells is at least 1000 single cells, claim 15) (paragraph [0481]; and Table 1). Fan teaches that the system software can provide integrated real-time image analysis and instrument control, so that cells may be optically monitored and classified according to a pre-determined set of characteristics, and subsequently included or excluded from the downstream sequence data analysis, wherein examples of cellular characteristics that can be optically monitored and used for classification purposes include, but are not limited to, cell size, cell shape, live cell/dead cell determination (e.g. using selectively absorbed chromophores such as Trypan blue, or fluorescent dyes such as calcein AM, ethidium homodimer-1, DiOCi3), DiOC5 (3), DiOCi3), DiSC3 (5), DiIC1(5), DiOC18(3), propidium iodide, SYBR14, SYTOX Green, etc.); cells exhibiting a specified range of intracellular pH (e.g. using intracellular pH-sensitive fluorescent probes such as 2',7'-Bis-(2-carboxyethy-1)-5-( and-6-)carboxy-fluorescein (BCECF), 2', 7'-bis-(2 carboxy-propyl)-5-( and-6-)-carboxy-fluorescein (BCPCF), etc.); cells exhibiting a specified range of membrane potential (e.g. using membrane potential sensitive fluorophores such as FluoVolt, di-3-ANEPPDHQ, Bis-(1, 3-Dibutylbarbituric Acid) Trimethine Oxonol (DiBACi3)), DiBACi5), DiSBACi(3), Merocyanine 540, JC-1, JC-9, Oxonol V, Oxonol VI, Tetramethylrhodamine methyl and ethyl esters, Rhodamine 123, Di-4-ANEPPS, Di-8-ANEPPS, Di-2-ANEPEQ, Di-3-ANEPPDHQ, Di-4-ANEPPDHQ, etc.), cells exhibiting a specified level of intracellular calcium (e.g. using Ca2+-sensitive fluorescent dyes such as fura-2, indo-1, fluo-3, fluo-4, Calcium Green-I, Quin 2, etc.); cells exhibiting one or more specified cell surface markers (e.g. using fluorescently-labeled antibodies directed towards the cell surface markers), cells expressing fluorescent proteins (e.g. GFP, bilirubin-inducible fluorescent protein, UnaG, dsRed, eqFP611, Dronpa, TagRFPs, KFP, EosFP, Dendra, IrisFP, etc.), and the like (interpreted as dye molecules and/or stains including calcein AM, claim 15) (paragraph [0438], lines 1-35), where it is known that when calcein AM permeates the cell membrane, it is converted to calcein, which fluoresces; however, calcein AM does not permeate the cell membrane of dead cells as evidenced by AAT Bioquest (pg. 2, last full paragraph; and pg. 3, Figure 1). Fan teaches that two or more dyes, fluorophores, or other optical probes having (e.g. non-overlapping excitation peaks, non-overlapping absorption non-overlapping spectral properties or emission peaks, etc.) can be selected so that cells can be simultaneously characterized with respect to two or more properties including real-time image processing and analysis is used to identify wells containing cells exhibiting one or more specified characteristics, followed by selection or exclusion of a subset of cells on the array from further analysis and/or real-time image processing and analysis is used to identify wells containing two or more cells, followed by the exclusion of the cells in those wells from further analysis, wherein as described above in more detail, examples of mechanisms that can be used to select or exclude a subset of cells from further analysis (interpreted as using calcein AM, a membrane-permeable reagent that becomes calcein; and an additional reagent for staining, claim 15) (paragraph [0438], lines 36-51). Fan teaches that a molecular label can comprise a nucleic acid sequence that provides information for identifying the specific type of target nucleic acid species hybridized to the oligonucleotide, wherein a molecular label can comprise a nucleic acid sequence that provides a counter for the specific occurrence of the target species hybridized to the oligonucleotide (interpreted as identifying the presence or absence of a sequence including a sample indexing sequence, claim 15) (paragraph [0188], lines 1-7). Fan teaches determining the number of different labeled nucleic acids can comprise determining the sequence of the labeled nucleic acid or any product thereof (e.g., labeled-amplicons, labeled-cDNA molecules), including conducting a sequencing reaction to determine the sequence of at least a portion of a sample label, a cellular label, a molecular label, at least a portion of the labeled target nucleic acid, a complement thereof, a reverse complement thereof, or any combination thereof (interpreted as identifying the sample origin or at least one single cell by identifying an indexing sequence, complement thereof or fragment thereof, claims 15 and 18) (paragraph [0230]). Fan teaches determining the sequence of the labeled nucleic acid or any product thereof comprises paired-end sequencing, nanopore sequencing, high-throughput sequencing, shotgun sequencing, dye-terminator sequencing, multiple-primer DNA sequencing, primer walking, Sanger dideoxy sequencing, Maxim-Gilbert sequencing, pyrosequencing, true single molecule sequencing, or any combination thereof, wherein high-throughput sequencing methods include platforms such as Roche 454, Illumina Solexa, ABI-SOLiD, ION Torrent, Complete Genomics, Pacific Bioscience, Helicos, or the Polonator platform (interpreted as determining a sequence; and replicating via NGS, claims 15 and 18) (paragraph [0232], lines 1-8; and [0233], lines 1-5). Fan teaches that individual cells or sub-populations of cells that exhibit a predefined set of characteristics, e.g. that express a particular cell surface receptor (marker) or set of cell surface receptors, can be identified through any of a variety of suitable techniques, e.g. through immunohistochemical staining of individual cells in a microwell array format using fluorescently-labeled antibodies directed towards the cell surface markers and fluorescence imaging techniques, or through the use of flow-cytometry and fluorescence-activated cell-sorting methods (interpreted as sorting single cells that comprise calcein and those that do not comprise anther stain, claim 15) (paragraph [0206], lines 28-38). Fan teaches that the instrument systems of the present disclosure can further comprise interfaces with PCR thermocyclers, sequencers, cell sorters, fluorescence activated cell sorter (FACS) instruments, or other types of lab automation equipment (interpreted as sorting single cells that comprise calcein and those that do not comprise anther stain, claim 15) (paragraph [0423]). Fan teaches an interface is provided for cell sorters or FACS instruments such that sorted cells are deposited directly into a microwell array or cartridge, wherein the interface for FACS instruments ca,, for example, include both hardware and software components, where the software provides the capability for simultaneous control of the FACS instrument and the single cell, stochastic labeling or molecular barcoding system, wherein the software can provide analysis capability for identifying correlations between the FACS data (e.g. the presence or absence of specified cell surface markers) and the copy numbers for one or more genes in a specified sub-population of cells, such that FACS machines can be used to sort single cells directly into the microwell array of the disclosure (paragraph [0425]). Regarding claim 36, Fan teaches that the target molecules of interest are mRNA molecules expressed within a single cell, such that cDNA copies of all or a portion of the polyadenylated mRNA molecules in each cell are covalently archived on the surface of a corresponding bead (interpreted as the first sample indexing oligonucleotide comprises a polydA sequence, claim 36) (paragraph [0159], lines 1-5). Fan teaches that the bead of Figure 1 comprises a poly(dA) sequence (Figure 1), where Figure 1 (in part) is shown below: PNG media_image3.png 88 732 media_image3.png Greyscale Fan does not specifically exemplify Draq7 (claim 15, in part). Regarding claim 15 (in part), Mao teaches new substituted anthraquinone dyes that can be useful as cellular stains, wherein nuclear stains are useful for staining the nucleic of dead or fixed cells (Abstract, lines 1-4). Mao teaches that Draq5 and Draq7, two DNA-binding dyes developed by Biostatus (U.S. Pat. Nos. 7,605,280; 7,060, 427; and 6,468,753), are nuclear counterstains with far-red to near infrared fluorescence emission, which does not interfere with other detection channels in the visible spectral region useful for other probes; see also US Patent Application 2010/0062429; however, for fixed cells, the nuclear specificity of both Drq5 and Draq7 suffers, which poses problems for their application in immunofluorescence staining, where cell fixation and permeabilization is routine practice (col 2, lines 7-17). Mao teaches that counterstains for fixed and permeabilized cells are those anthraquinone dyes having the structures selected from Dye Nos. 6, 7, 9, 13, 15, 16 and 17. In various embodiments, the dyes are Dye Nos. 7, 13 and 15, where images of fixed and permeabilized cells stained with Dye Nos. 7, 13 and 15 and two commercial prior art nuclear counterstains Draq5 and Draq7 are shown in Figure 3, and Figure 4 shows that Dyn No. 7 can also be used to stain tissues with excellent nuclear specificity (interpreted as Draq7, claim 15) (col 29, lines 5-9 and 11-12). Mao teaches that the cell membrane impermeable anthraquinone dye is combined with another fluorescent probe selective for live cells, where such a staining method provides a way to detect the numbers of both live and dead cells in the same cell population, such that commercial fluorescent probes that are designed to detect live cells only are available, wherein calcein AM is a probe that enters live cells and becomes hydrolyzed intracellularly by endogenous esterases in live cells to produce a green fluorescent dye, while mitochondrial dyes that stain mitochondria in a membrane potential-dependent manner can be used to selectively stain live cells, which have healthy mitochondria, such that Dye No. 7 selectively staining dead cells in the presence of live cells is shown in Figure 5, where detection of emitted fluorescence signals can be made with a variety of instruments including, but not limited to, microscopes, flow cytometers, plate readers and any variations thereof (interpreted as combining calcein AM with Draq7, claim 15) (col 29, lines 21-38), wherein Draq7 is a cell impermeable fluorescent DNA dye that only stains the nuclei in dead and permeabilized cells, such that it does not enter intact, live cells as evidenced by Abcam (pg. 3, first and second full paragraphs). It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of detecting live cells; as well as, fixed, dead and/or permeabilized cells in a sample as exemplified by Mao, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of using barcoded beads to individually index thousands of single cells arrayed within microwells of the device, such that cells comprising one or more predetermined characteristics such as live cells/dead cells can be detected and/or sorted using two or more fluorophores, chromophores, dyes, and/or stains including calcein AM and propidium iodide as disclosed by Fan, to include different combinations of dyes and stains such as calcein AM with anthraquinone dyes such as Draq7 as taught by Mao with a reasonable expectation of success in using a combination of dyes/stains including calcein AM and Draq7 to determine at least one characteristic of the cell such as viability and/or the number of total, live cell counts; to selectively stain both live cells, dead cells, fixed cells and/or permeabilized cells within the arrays of single cells; and/or in detecting the emitted fluorescence signals using flow cytometers for the automated, high-throughput selection and/or sorting of live cells from dead or permeabilized cells for further downstream processing such as amplification and sequencing; and/or in isolating specific subpopulations of single cells from heterogenous populations of single cells. Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103(a) as obvious over the art. Conclusion Claims 15, 18 and 36 are rejected. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AMY M BUNKER/Primary Examiner, Art Unit 1684
Read full office action

Prosecution Timeline

Aug 26, 2019
Application Filed
Aug 13, 2021
Non-Final Rejection — §103, §112, §DP
Dec 17, 2021
Response Filed
Mar 22, 2022
Final Rejection — §103, §112, §DP
Jun 27, 2022
Request for Continued Examination
Jul 01, 2022
Response after Non-Final Action
Jul 13, 2022
Non-Final Rejection — §103, §112, §DP
Nov 18, 2022
Response Filed
Feb 15, 2023
Final Rejection — §103, §112, §DP
Jun 21, 2023
Request for Continued Examination
Jun 28, 2023
Response after Non-Final Action
Nov 29, 2023
Non-Final Rejection — §103, §112, §DP
Mar 04, 2024
Response Filed
Jun 13, 2024
Final Rejection — §103, §112, §DP
Sep 18, 2024
Request for Continued Examination
Sep 19, 2024
Response after Non-Final Action
Dec 31, 2024
Non-Final Rejection — §103, §112, §DP
May 06, 2025
Response Filed
Jul 08, 2025
Final Rejection — §103, §112, §DP
Nov 10, 2025
Request for Continued Examination
Nov 12, 2025
Response after Non-Final Action
Nov 14, 2025
Non-Final Rejection — §103, §112, §DP
Feb 18, 2026
Response Filed
Mar 12, 2026
Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

11-12
Expected OA Rounds
29%
Grant Probability
76%
With Interview (+46.5%)
4y 4m
Median Time to Grant
High
PTA Risk
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