Prosecution Insights
Last updated: April 19, 2026
Application No. 18/455,152

METHODS AND KITS FOR LABELING CELLULAR MOLECULES

Non-Final OA §103§DP
Filed
Aug 24, 2023
Examiner
HAVLIN, ROBERT H
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSITY OF WASHINGTON
OA Round
1 (Non-Final)
53%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
80%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allow Rate
534 granted / 1016 resolved
-7.4% vs TC avg
Strong +27% interview lift
Without
With
+27.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
99 currently pending
Career history
1115
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
30.8%
-9.2% vs TC avg
§102
24.8%
-15.2% vs TC avg
§112
28.2%
-11.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1016 resolved cases

Office Action

§103 §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. Priority This application is a CON of 18/188,504 (03/23/2023), 18/188,504 is a CON of 17/122,321 (12/15/2020, US11634751), 17/122,321 is a CON of 14/941,433 (11/13/2015, US10900065), 14/941,433 has PRO 62/080,055 (11/14/2014). Nucleotide and/or Amino Acid Sequence Disclosures Summary of Requirements for Patent Applications Filed O n Or After July 1, 2022, T hat Have Sequence Disclosures 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted: 1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying: a. the name of the XML file b. the date of creation; and c. the size of the XML file in bytes; or 2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying: a. the name of the XML file; b. the date of creation; and c. the size of the XML file in bytes. SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS: Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. The statement regarding the size of the XML file is in kilo bytes, not bytes. Required response - Applicant must: • Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of: • A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); • A copy of the amended specification without markings (clean version); and • A statement that the substitute specification contains no new matter. Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. The Figures, for example Fig. 1 includes 10 nt sequences without an identifier. Required response – Applicant must provide: Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers; AND/OR A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of: • A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); • A copy of the amended specification without markings (clean version); and • A statement that the substitute specification contains no new matter. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The 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 . Claims 1-6 , 10-12, 14, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ke et al. ( Nat Methods 10, 2013 -07-14, p. 857–860 and Supplemental, 35 pages) in view of Saliba et al. ( Nucleic Acids Research, 2014 -07-22 , Vol. 42, No. 14 , p. 8845–8860 ) . Ke teaches in situ sequencing in cells as depicted in Fig. 1a: through providing fixed and permeabilized cells (p. 5: “Fixation was performed in 3% (w/v) paraformaldehyde”, “ The tissue was permeabilized in 2 mg/ml pepsin ”), generating cDNA via RT using primers (p. 5: “ In situ reverse transcription ”, “cDNA primer or 5 μM of unmodified random decamers (all oligonucleotides sequences are listed in Supplementary Tables 4–6)”), tagging with barcode sequence (p. 5: “ Barcode padlock probing ”) . Regarding claim 1, Ke does not teach lysing the cells and isolation. Saliba reviews single-cell RNA-seq (Title, Abstract) including utilizing the cell as a compartment to perform RNA-seq (p. 8851: “ Sub-single-cell sequencing: localizing transcripts within a cell ”, “ A first strategy consists of isolating a compartment of a cell and applying the previously described RNA-seq techniques ”). Saliba also describes details of the RNA-seq technique in Fig. 3 (p. 8851-52: “ massively parallel RNA-seq of single cells (Figure 3) ”) which when not performed within a cell includes lysis and isolation (Fig. 3: “Cell lysis” “bead immobilization”). One of ordinary skill in the art following the teaching of Ke would have considered the teaching of Saliba which cites to Ke which are in the same field of endeavor of single cell sequence analysis. One of ordinary skill in the art would have considered combining the known technique of RNA-seq adapted for an in situ manner as taught by Ke and modify the steps to perform lysis and isolation after RT and tagging to maintain the integrity of the cell for use as a compartment as specifically suggested by Saliba. The level of skill in the art is very high as evidenced by the cited references and one of ordinary skill in the art routinely modifies and adapts known techniques to improve the information that can be derived from samples. Regarding claims 2 and 3 further amplifying the isolated cDNA and sequencing, Ke teaches amplification and sequencing (p. 1, Fig. 1) as does Saliba (p. 8851, Fig. 3: “library preparation” and “library sequencing”) and one of ordinary skill in the art would consider applying the same steps as to obtain sequence information from the cell in the same manner as in the prior art. Regarding claim 4 specifying RT primers comprise poly-T or a random sequence, Ke teaches random sequence (p. 3: “ We generated cDNA from total RNA in situ by random- decamer priming ”) and Saliba teaches oligo(dT) (Fig. 3) which corresponds to the claimed invention. Regarding claim 5 specifying RT primers comprise a gene-specific sequence, Ke teaches gene-specific sequences (p. 27: Supp Table 4) as does Saliba (p. 8851: “ Transcripts are converted into cDNA using gene-specific (126) or random primers ”) which corresponds to the claimed invention. Regarding claim 6 to cell-specific tagging, Saliba teaches “ Cellular and molecular barcoding strategies ” (p. 8851) which localizes transcripts within a cell to facilitate cell-specific barcoding (p. 8851-52, Fig. 3) which corresponds to the claimed invention. Regarding claims 10-11 specifying a biotin capture agent attached, Saliba specifically teaches such a configuration (Fig. 3A: “Streptavidin beads – Biot -…”) and one of ordinary skill in the art would have considered using the same configuration. Regarding claim 12 specifying next generation sequencing, Saliba specifically teaches the use of NGS as applied to RNA-seq (p. 8845). Regarding claim 14 specifying mammalian cells, Ke (p.1: “ human breast cancer tissue ”) and Saliba (p. 8846, 8856) both teach application of the technique on mammalian cells. Regarding claims 18-20 specifying details regarding the cells, isolated, tissue, adherent, Saliba teaches isolated cells and Ke teaches adherent tissue cells (p. 1,18). With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success. Claims 7 , 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ke et al. ( Nat Methods 10, 2013 -07-14, p. 857–860 and Supplemental, 35 pages) in view of Saliba et al. ( Nucleic Acids Research, 2014 -07-22 , Vol. 42, No. 14 , p. 8845–8860 ) as applied to claims 1-6, 10-12, 14, 18-20 above and further in view of Nolan et al. ( WO2012106385 ) . Regarding claim 7 specifying details regarding tagging comprising steps of dividing, coupling, and combining, Ke and Saliba do not teach the specific split-pool barcoding steps. Nolan is in the same field of endeavor of single cell analysis with details regarding unique barcoding. Nolan teaches kits for tagging target molecules of nucleic acids from transcripts ([0069]: “kits for individually tagging cells ”; [00250] -[ 00256]; claims 69-112; [00152]; [0063]; [00192]: “target nucleic acids may be obtained from a single cell.”; [00195]: “detect a novel transcript in order to diagnose or condition”). Nolan teaches fixing the cells ([0006]: “In some embodiments, the invention relates to methods for identifying whether a plurality of targets are in a plurality of cells comprising: binding to the targets a plurality of tags, wherein a tag comprises a code that represents a) the target identity and b) the identity of the cell in which tag is binding. ... In some embodiments, the cell is lysed or fixed.”). Nolan teaches permeabilizing the cells ([00116]: “Cells may be fixed prior to the addition of UBAs, ESBs or prior to COB assembly. Suitable cell permeabilization methods are known in the art and can be used to deliver components of the assay into cells and cellular components.”). Nolan teaches single-stranded tags / UBAs ([0010]: “In some embodiments, the tag comprises a UBA.”; [0082]: “In some embodiments, the UBA is an aptamer. Aptamers include nucleic acid aptamers (i.e., single-stranded DNA molecules …”) which are configured to hybridize to the transcriptome of the cell ([00229]: “the UBAs, e.g., oligonucleotide probe, have substantially the same length so that they hybridize to target nucleotide sequences at substantially similar hybridization conditions. As a result, the process of the present invention is able to detect infectious diseases, genetic diseases, and cancer”; [0064]; [00192]: “target nucleic acids may be obtained from a single cell.”; [00195]: “detect a novel transcript in order to diagnose or condition”) and has a second sequence that is the same in each of the nucleic acid molecules ([00110]: “The COB can be attached to the UBA via a common linker (CL). The CL can also be part of an oligonucleotide”). Nolan teaches a set of tags comprising multiple distinct barcode sequences comprising a sequence complementary to a common sequence ([00110]: “Substantially complementary or exact complementary annealing regions may be utilized for hybridization. An annealing region may be provided on both ends of an oligonucleotide ESB or APS. In some embodiments, the APSs are added in various steps of a split pool synthesis or any other suitable stepwise synthesis known in the art. An annealing region specific to each step of a stepwise synthesis maybe incorporated into the oligonucleotides”; [00111] -[ 00113]: “ APSs can be designed to hybridize to the CL ”). Nolan teaches ligation ([0021]: “the method further comprises ligation”; [0084]; [00121]; [00170]). Nolan teaches lysing the cell ([0006]: “ In some embodiments, the cell is lysed ”). Nolan teaches PCR amplification of DNA using polymerase ([0063]: “ PCR amplification ”; [00115]; [00125]: “the assembled products are amplified”, “products are amplified by polymerase chain reaction (PCR).”; [00191]; [00273]: “The COBs are optionally PCR amplified for sequencing using primers targeting the amplification primer complementary regions on the CL and the last APS subunit.”; [00170]: “ extended via polymerases ”; [0059]). Nolan teaches the tags are combined in a manner to uniquely identify the target molecules with a “split pool” approach where the number of unique tags are generated by dividing, coupling an aliquot-specific barcode, and pooling (Fig. 4; [00163] -[ 00170]). One of ordinary skill in the art would have had a reasonable expectation of success in utilizing Nolan’s barcoding technique because Nolan teaches it in the same context (cellular barcoding) and it was well-known in the art. Regarding claim 13 specifying ligation of tags, Saliba teaches the use ligation as applied to RNA-seq (p. 8845) as does Nolan ([0021]: “the method further comprises ligation”; [0084]; [00121]; [00170]) which one of ordinary skill in the art would consider routine in the art. Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ke et al. ( Nat Methods 10, 2013 -07-14, p. 857–860 and Supplemental, 35 pages) in view of Saliba et al. ( Nucleic Acids Research, 2014 -07-22 , Vol. 42, No. 14 , p. 8845–8860 ) as applied to claims 1-6, 10-12, 14, 18-20 above and further in view of Koh (Chapter 13 - Isolation of Genomic DNA from Mammalian Cells, in Methods in Enzymology, Academic Press, Editor(s): Jon Lorsch, Volume 529, 2013, Pages 161-169) . Regarding claims 8-9 specifying the lysing agent comprises proteinase K, Ke and Saliba do not teach the lysis agent. Koh is a text on techniques in the art and states “ isolation of genomic DNA from mammalian cells is a routine molecular biology laboratory technique ” and provides the lysis agent comprises proteinase K (p. 162). One of ordinary skill in the art would have considered using well-known and routine lysing agents as taught by Koh and arrived at the claimed invention with a reasonable expectation of success. Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ke et al. ( Nat Methods 10, 2013 -07-14, p. 857–860 and Supplemental, 35 pages) in view of Saliba et al. ( Nucleic Acids Research, 2014 -07-22 , Vol. 42, No. 14 , p. 8845–8860 ) as applied to claims 1-6, 10-12, 14, 18-20 above and further in view of Islam (“From Single-Cell Transcriptomics to Single-Molecule Counting”, Thesis - Karolinska Institutet (Sweden). 2013. 59 pages) . Regarding claims 15-17, Ke and Saliba do not teach the particular primers, however, Islam teaches that the use of these elements are part of standard sequencing library preparation in in reverse transcription (p. 15: “In standard library preparation for RNA-seq experiments, the RT reaction is primed by different types of primer and different RNA priming strategy can effect the efficiency of cDNA synthesis. Three priming strategies are available: sequence-specific primer, oligo (dT) primer and random hexamer.” ; p. 7: “ primer designed with an anchored poly T ” ) such that one of ordinary skill in the art would have reasonably considered their use , optimized them for priming in the combined technique, and arrive at the claimed invention. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-14 of U.S. Patent No. 12467076 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of U.S. Patent No. 12428671 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 12371735 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-21 of U.S. Patent No. 1237173 4 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 1237173 3 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 12305221 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-16 of U.S. Patent No. 12305220 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 12305219 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of U.S. Patent No. 12252735 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of U.S. Patent No. 12252736 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 12247247 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-15 of U.S. Patent No. 12252737 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of U.S. Patent No. 12252736 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 12252734 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 1225273 3 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 12252731 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 12252730 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 12247248 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of U.S. Patent No. 12234501 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 12252734 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 12252733 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 12247248 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-26 of U.S. Patent No. 12227793 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-22 of U.S. Patent No. 12195786 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of U.S. Patent No. 12180536 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of U.S. Patent No. 12043864 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of U.S. Patent No. 11987838 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 11634751 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-26 of U.S. Patent No. 11555216 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 11427856 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of U.S. Patent No. 11168355 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-26 of U.S. Patent No. 10900065 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of copending Application No. 19216139 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a kit used in a method that has components that anticipate the instant claims including fixation, permeabilization, ligation, and lysis agents, primers, polymerase, and nucleic acid molecules hybridizing to the same elements, including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of copending Application No. 18536654 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method that has components that anticipate the instant claims including fixation, permeabilization, ligation, and lysis agents, primers, polymerase, and nucleic acid molecules hybridizing to the same elements, including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 1-2 0 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-30 of copending Application No. 18406472 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a kit used in a method that has components that anticipate the instant claims including fixation, permeabilization, ligation, and lysis agents, primers, polymerase, and nucleic acid molecules hybridizing to the same elements , including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-22 of copending Application No. 18188504 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method that has components that anticipate the instant claims including fixation, permeabilization, ligation, and lysis agents, primers, polymerase, and nucleic acid molecules hybridizing to the same elements, including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ROBERT H HAVLIN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9066 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9am - 6pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Joseph McKane can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0699 . 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. /ROBERT H HAVLIN/ Primary Patent Examiner, Art Unit 1626
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Prosecution Timeline

Aug 24, 2023
Application Filed
Dec 02, 2025
Non-Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
53%
Grant Probability
80%
With Interview (+27.2%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 1016 resolved cases by this examiner. Grant probability derived from career allow rate.

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