Prosecution Insights
Last updated: August 17, 2026
Application No. 17/864,930

DECENTRALIZED WORKFLOWS FOR SINGLE CELL ANALYSIS

Non-Final OA §103§DP
Filed
Jul 14, 2022
Priority
Jul 15, 2021 — provisional 63/222,213
Examiner
CASH, KAILEY ELIZABETH
Art Unit
1683
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Illumina Inc.
OA Round
4 (Non-Final)
28%
Grant Probability
At Risk
4-5
OA Rounds
0m
Est. Remaining
86%
With Interview

Examiner Intelligence

Grants only 28% of cases
28%
Career Allowance Rate
5 granted / 18 resolved
-32.2% vs TC avg
Strong +58% interview lift
Without
With
+58.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
39 currently pending
Career history
71
Total Applications
across all art units

Statute-Specific Performance

§101
10.7%
-29.3% vs TC avg
§103
35.0%
-5.0% vs TC avg
§102
10.5%
-29.5% vs TC avg
§112
30.8%
-9.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 18 resolved cases

Office Action

§103 §DP
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 . Please note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Interview Summary Applicant’s summary of the interview of 4/2/2026 submitted on 4/20/2026 is acknowledged. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/15/2026 has been entered. Claim Status The claim amendments entered on 4/20/2026 After Final, and accepted for entry upon the Request for Continued Examination on 5/15/2026 are acknowledged. Claims 1, 6-7, 10, 12, and 15-22 are pending and being examined on the merits. Claim Interpretation Claims 21 and 22 are directed to the method of claim 1 wherein “the vessel containing the plurality of partitions is transported by courier or mail to a core facility” (claim 21) or “by mail to a core facility” (claim 22). The specification does not provide an explicit difference between shipment methods via courier or mail. The definition of a courier is a person or organization that delivers packages, messages, or letters. The USPS (postal service, or mail service) is also, by definition, a courier. Therefore, absent any alternative definitions provided by the specification, transportation via courier and mail are interpreted to be the same methods of shipment. Claim Rejections - 35 USC § 103 Withdrawn: The rejection of claims 1-7 and 10-22 under 35 U.S.C. 103 as being unpatentable over Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022) in view of Zhang et al. (WO2021/202970A1; published Oct 7, 2021; EFD of May 31, 2020) is withdrawn in light of Applicant’s amendments to the claims and cancellations of claims 2-5, 11, and 13-14. New: Claims 1, 6-7, 10, 12, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022) in view of Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025) and Hiddessen et al. (WO 2013/192351 A1). Regarding claim 1: Abate et al. teaches a method of particle-templated emulsification in which a mixture of cells is combined with template particles in an aqueous solution, which is mixed with a second immiscible fluid (e.g., oil) and then sheared in a vessel to create droplets (partitions) which contain a single cell and a single template particle (claim 1(a); paragraphs [00179]). Abate et al. teach that the oil is a fluorinated oil with a surfactant that stabilizes the partitions (paragraphs [0100-0101, 0236, 0263]). Abate et al. teach that a plurality of template particles are dispersed into a plurality of droplets in the shearing of a mixture of two fluids which are immiscible, which reads on the limitation that the plurality of partitions are generated simultaneously (paragraph [0005]). Additionally, Abate et al. refer to this method as “instant emulsion technology”, again indicating the simultaneous formation of multiple partitions (paragraphs [0042, 00281]). Abate et al. teach that the template particles contain functionalized RNA capture beads to capture mRNA, such as those available from Drop-Seq which contain barcoded oligos (paragraph [00179] and Figure 14A-B). Abate et al. teach lysing the cells in the droplets and capturing the mRNA with the barcoded oligos on the template particles (claim 1(b); paragraph [00179, 00242 and 00275] and Figure 14C). Abate et al. teach that the mRNA can be processed for downstream sequencing, which involves “standard in vitro transcription and library preparation for NGS” (paragraph [00178, 00242 and 00275]). The mRNA is copied into barcoded cDNA, which is then amplified, prepared for sequencing, and then sequenced to produce single cell gene expression data (claim 1(c-f); paragraphs [00179, 00242 and 00275] and Figure 14C). Regarding claim 6: Abate et al. teach generating the partitions via “shearing”, which can be accomplished with a “vortexer” (paragraph [0108]). This generates aqueous droplets containing cells surrounded by an immiscible second fluid (such as oil; paragraph [0016]). Regarding claim 7: Abate et al. teach that the droplets are formed around the template particles (paragraph [0005]). Regarding claim 10: Abate et al. teach that the cDNA is linked to the template particles via the barcoded oligos (paragraphs [00179, 00242, and 00279]; Figure 14B-C). Abate et al. does not teach transporting the partitions comprising the captured mRNA from a research lab to a core facility (claim 1). Abate et al. does not teach mailing samples between facilities (claims 21 and 22). Abate et al. does not teach that no PCR steps are performed by the research facility (claim 12). Abate et al. does not teach that at least one step is performed by the research lab at a remote location (claim 15). Abate et al. does not teach that the cells comprise an infectious agent (claims 16-18). And Abate et al. does not teach providing reagents necessary for the method in kits (claims 19-20). Zhang et al. teaches a methodology in which sample collection, preparation, and sequencing are performed at different locations for detection of infectious agents within cells (Figure 1A and paragraph [0058]). Regarding claims 1 and 21-22: Zhang et al. teaches that the samples are collected at a testing site for initial processing (hospital, reads on research facility) and are sequenced at a central facility (claim 1; reads on core facility; paragraph [0281] and Figure 1A-B). Zhang et al. teach that sample processing before shipment to the central facility for sequencing can involve all the preparation steps up to pooling the samples (lysing, amplification, barcoding and then pooling) or the samples can be directly shipped to the central facility for processing and sequencing (claim 1; paragraph [0281-0282]). This reads on the variations in which steps are performed at the research facility versus at the core facility defined by the limitations of “transporting the partitions comprising the captured mRNA”. The transport of the sample at a particular step of the preparation process is an obvious variant of the performing of steps either at the research facility/testing site or at the centralized sequencing facility. Zhang et al. teach shipping samples to the core facility (paragraphs [0168 and 0281-0282] and Figure 1A-B). Given that Zhang et al. also teach varying levels of preparation of the samples at the research facility before sending to the core facility (see above), shipping of the vessel with partitions comprising the capture mRNA (claims 1, 21, and 22) is an obvious variant of what is being shipped. Additionally, the method of shipment via courier or via mail are essentially the same given the lack of explicit differences provided in the instant specification (see Claim Interpretation above). Zhang et al. teaches using a courier to deliver samples, which reads on both by courier and by mail (claims 21 and 22; paragraph [0291]). Zhang et al. also teaches ensuring “safety of postal works during shipping of the inactivated samples”, implying shipping samples by “mail” (paragraph [0444]). With respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Therefore, the claimed order of steps is an obvious variant of the steps of the cited prior art. It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Abate et al. with the decentralized workflow of Zhang et al. One would be motivated to perform certain steps at a research facility and the final sequencing at a central sequencing facility given the assertion by Zhang et al. that this method of decentralization allows for “massively parallel population-scale screening with reduced cost and logistical overhead”. One would have a reasonable expectation of success given that Zhang et al. successfully demonstrate the collection of samples and initial stages of processing at research facilities, followed by final sequencing at a core facility (paragraph [0282]). Additionally, one would have a reasonable expectation of successfully shipping droplets (aqueous solutions surrounded by an immiscible fluid) given the teachings of Hiddessen et al. Hiddessen et al. teaches formation of stable droplets containing samples (paragraph [0099, 00102-00106]). Hiddessen et al. teaches that it is a known problem in the art that droplets tend to be unstable/coalesce and that steps need to be taken to make the droplets stable for storage and/or transportation (paragraph [00137]). Hiddessen et al. teaches making droplets that can be formed in a vessel (such as a tube) and shipped via any known method in the art such as mail, driving, flying, boating, etc. (paragraph [00205, 00211]). Hiddessen et al. teaches that preparing said droplets for transport involves the use of a fluorocarbon oil (reads on fluorinated oil) and at least one surfactant, which are additionally used in the method of Abate for formation of droplets (paragraph [0027]). Regarding claim 12: Zhang et al. teach shipping samples directly to the core facility, which inherently means that no PCR steps were performed by the research lab (paragraph [0282]). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Abate et al. with the decentralized workflow of Zhang et al. Given that samples are being processed at two different facilities, it is inherently necessary that the samples are shipped between the two geographical locations. Regarding claim 15: Zhang et al. teach that at least one step of the method is performed at a remote site (“at home”; paragraph [0282] and Figure 2A). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Abate et al. with the decentralized workflow of Zhang et al. One would be motivated to have at least one step performed at a remote site (such as at home) given the assertion by Zhang et al. that allowing for initial sample preparation at home would offer “higher public acceptance, lower potential for viral spread at diagnostic centers, and lower probability of sample cross-contamination”. One would have a reasonable expectation of success given that Zhang et al. demonstrate the use of reagent kits that contain sample collection vessels as well as packing materials for shipment to the central sequencing facility (paragraph [0168]). Regarding claims 16-18: Zhang et al. teaches that the cells comprise an infectious agent (claim 16; SARS-CoV2, paragraphs [0035-0038]). Zhang et al. teaches that samples are collected at testing sites (hospitals) where the staff is qualified to handle the infections reagent (paragraph [0281]). Zhang et al. teaches sterilization (reads on agent is neutralized) of the infectious agent before shipping to a central facility for sequencing (claim 18; Figure 1A-B). Zhang et al. does not explicitly state that the core facility is not qualified to handle the infection agent, however whether or not the core facility has the qualifications to handle the infectious agent is moot given that Zhang et al. teaches sterilization of the infectious agent before shipping. Additionally, whether or not the core facility possesses this qualification does not render the core facility patentably distinct from the central sequencing facility taught by Zhang et al. It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Abate et al. with the decentralized workflow of viral diagnostics of Zhang et al. One would be motivated to employ the decentralized workflow for the handling of infectious agents given the assertion by Zhang et al. that having samples taken at remote locations minimizes the risk of contaminating diagnostic facilities (paragraph [0168]) and enables the enablement of scalable logistics for tracking viral spread (paragraphs [0285-0286]). One would have a reasonable expectation of success given Zhang et al.’s in-depth deployment scenario of tracking viral spread of SARS-CoV2 in Germany (paragraphs [0281-0288]). Regarding claims 19-20: Zhang et al. teach kits for the initial processing and samples and for use with the pooling and sequencing methods describes. The kits contain reagents necessary for sample handling as well as vessels for holding samples and supplies for mailing the samples to facilities (claim 19; paragraphs [0093-0094 and 168]). Depending on the amount of processing expected to be done before shipment to the central facility, the kits may contain different reagents for use at the research facility (which reads on claim 20, wherein the kits are specific to the steps performed at the research lab and core facility; paragraph [0094]). Zhang et al. does not explicitly teach that the kits are provided by a third party, however this is not a patentably distinct limitation that would differentiate the instant application’s kits from those exemplified from Zhang et al. It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Abate et al. with the decentralized workflow with kits of reagents as taught by Zhang et al. One would be motivated to supply kits of reagent to the research facility for initial processing given the assertion by Zhang et al. that performing the initial barcoding at the research facility before shipment to a central sequencing facility allows for “massively parallel processing of multiple samples that are pooled together” (paragraph [0093]). Additionally, one skilled in the art would recognize the obvious advantage of including the reagents necessary for library preparation and sequencing in a kit due to the convenience of having all of the required assay materials provided together in one location. Response to Remarks Applicant's arguments filed 4/20/2026 have been fully considered but they are not deemed persuasive for the following reasons. Applicant argues on page 6 of Remarks that Abate and Zhang fail to teach “transporting partitions comprising the captured mRNA from a research lab to a core facility”, and thus the Examiner must establish a prima facie case of obviousness of the newly claimed invention. This argument pertains to a new amendment, and has been addressed in the new 103 rejections presented above. Double Patenting Withdrawn: The previous double patenting rejections detailed in the Office Action of 2/20/2026 are withdrawn in light of Applicant’s amendments to the claims and cancellations of claims 2-5, 11, and 13-14. New double patenting rejections, necessitated by said amendments, are made below. New (Necessitated by Amendments): Copending Application No. 17/717,851 Claims 1, 6-7, 10, 12, and 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-23, 28, 30, 34, and 35 of copending Application No. 17/717,851 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘851 claims are encompassed by the open claim language “comprising” found in the instant claims. Regarding claim 1: Claim 30 of ‘851 teaches that the second fluid is an oil but does not teach that the oil is a fluorinated oil that comprises a surfactant that stabilizes the partitions. Abate et al. teach that the oil is a fluorinated oil with a surfactant that stabilizes the partitions (paragraphs [0100-0101, 0236, 0263]). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of ‘571 with the method of Abate et al. One would be motivated to include a surfactant in the fluorinated oil given the assertion by Abate et al. that a surfactant stabilizes the emulsion (paragraph [0100]). This is a provisional nonstatutory double patenting rejection. Copending Application No. 17/518,135 Claims 1, 6-7, 10, 12, and 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-11, 15, and 19-21 of copending Application No. 17/518,135 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘135 claims are encompassed by the open claim language “comprising” found in the instant claims. This is a provisional nonstatutory double patenting rejection. Copending Application No. 17/864,655 Claims 1, 6-7, 10, 12, and 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 12, and 15 of copending Application No. 17/864,655 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘655 claims are encompassed by the open claim language “comprising” found in the instant claims. Regarding claim 6: Claim 1 of ‘655 teaches “shearing” the fluids to generate a plurality of partitions. Claim 1 does not explicitly teach that this shearing is accomplished via vortexing. Abate et al. teach generating the partitions via “shearing”, which can be accomplished with a “vortexer” (paragraph [0108]). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of ‘655 with the method of Abate et al. One would be motivated to use a vortexer given the assertion by Abate et al. that a vortexer is a machine which applies sufficient shear force to generate monodisperse droplets. This is a provisional nonstatutory double patenting rejection. Copending Application No. 19/570,381 Claims 1, 6-7, 10, 12, and 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 16-20, and 29-30 of copending Application No. 19/570,381 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘381 claims are encompassed by the open claim language “comprising” found in the instant claims. Regarding claim 1: The claims of ‘381 teach generating a library of amplicons which are generated from mRNA from a single cell. However, the claims of ‘381 do not teach sequencing the library of amplicons to generate single cell gene expression data. Abate et al. teaches a method of particle-templated emulsification in which a mixture of cells is combined with template particles in an aqueous solution, which is mixed with a second immiscible fluid (e.g., oil) and then sheared in a vessel to create droplets (partitions) which contain a single cell and a single template particle (claim 1; paragraphs [00179]). Abate et al. teach that the template particles contain functionalized RNA capture beads to capture mRNA, such as those available from Drop-Seq which contain barcoded oligos (paragraph [00179] and Figure 14A-B). Abate et al. teach lysing the cells in the droplets and capturing the mRNA with the barcoded oligos on the template particles (claim 1; paragraph [00179, 00242 and 00275] and Figure 14C). Abate et al. teach that the mRNA can be processed for downstream sequencing, which involves “standard in vitro transcription and library preparation for NGS” (paragraph [00178, 00242 and 00275]). The mRNA is copied into barcoded cDNA, which is then amplified, prepared for sequencing, and then sequenced to produce single cell gene expression data (claim 1; paragraphs [00179, 00242 and 00275] and Figure 14C). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of ‘381 with the method of Abate et al. One would be motivated to use the amplicon libraries for sequencing to generate single cell expression data, as taught by Abate et al. Abate et al. teaches that gathering a single cell gene expression analysis enables one to study gene expression changes, alternative splicing events, allele-specific gene expression and chimeric transcripts (paragraph [00178]). One would have a reasonable expectation of success given that Abate et al. teaches performing this single cell sequencing from amplicon libraries generated in monodisperse droplets (paragraph [00179]). This is a provisional nonstatutory double patenting rejection. Copending Application No. 19/658,803 Claims 1, 6-7, 10, 12, and 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10-12, and 14-17of copending Application No. 19/658,803 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘803 claims are encompassed by the open claim language “comprising” found in the instant claims. This is a provisional nonstatutory double patenting rejection. U.S. Patent No. 12,612,666 Claims 1, 6-7, 10, 12, and 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9-11 of U.S. Patent No. 12,612,666 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘666 claims are encompassed by the open claim language “comprising” found in the instant claims. Regarding claim 1: Claims 1-4 of ‘666 teach generating an emulsion of a first fluid in a second fluid. However, these claims do not teach the aspect of partitioning, wherein the first fluid is an aqueous solution and the second fluid is a fluorinated oil, wherein the fluorinated oil comprises a surfactant that stabilizes the plurality of partitions. Abate et al. teaches a method of particle-templated emulsification in which a mixture of cells is combined with template particles in an aqueous solution, which is mixed with a second immiscible fluid (e.g., oil) and then sheared in a vessel to create droplets (partitions) which contain a single cell and a single template particle (claim 1(a); paragraphs [00179]). Abate et al. teach that the oil is a fluorinated oil with a surfactant that stabilizes the partitions (paragraphs [0100-0101, 0236, 0263]). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of ‘666 with the method of Abate et al. One would be motivated to use an immiscible fluid such as a fluorinated oil in combination with an aqueous solution, as taught by Abate et al., given that Abate et al. demonstrate that this allows for droplet formation without the requirement of a microfluidic device (paragraph [0005]). One would be motivated to include a surfactant given that Abate et al. teaches that this stabilizes the emulsion (paragraph [0100]). One would have a reasonable expectation of success given that Abate et al. demonstrate the successful use of an aqueous phase solution and an oil to generate monodisperse droplets containing single cells and single template particles. Regarding claim 1(“amplifying the barcoded cDNA to create amplicons”): Claims 1-4 of ‘666 teaches the steps of lysing the cells inside the partitions, copying the mRNA into barcoded cDNA, preparing sequencing libraries and sequencing the RNA of the instant application. However, these claims do not teach wherein the cDNA is amplified to create amplicons. Abate et al. teaches a method wherein the mRNA is copied into barcoded cDNA, which is then amplified, prepared for sequencing, and then sequenced to produce single cell gene expression data (claim 1(c-f); paragraphs [00179, 00242 and 00275] and Figure 14C). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of ‘666 with the method of Abate et al. One would be motivated to generate amplicons from the barcoded cDNA given that this is a known method of preparation for sequencing, as taught by Abate et al. U.S. Patent No. 11,827,936 Claims 1, 6-7, 10, 12, and 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 11, and 13 of U.S. Patent No. 11,827,936 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘936 claims are encompassed by the open claim language “comprising” found in the instant claims. U.S. Patent No. 11,104,961 Claims 1, 6-7, 10, 12, and 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11, and 13-16 of U.S. Patent No. 11,104,961 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘936 claims are encompassed by the open claim language “comprising” found in the instant claims. Regarding claim 1: Claim 1 of ‘961 teaches releasing, barcoding, and sequencing nucleic acid molecules released from a single cell. However, ‘961 does not teach that the nucleic acid molecule is an mRNA. Abate et al. teach lysing the cells in the droplets and capturing the mRNA with the barcoded oligos on the template particles (claim 1(b); paragraph [00179, 00242 and 00275] and Figure 14C). It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of ‘961 with the method of Abate et al. One would be motivated to capture and sequence mRNA from a single cell given the assertion by Abate et al. that this would provide information on the expression profile of that cell (paragraphs [00179, 00242 and 00275]). U.S. Patent No. 11,866,782 Claims 1, 6-7, 10, 12, and 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10-13, 16, and 18-19 of U.S. Patent No. 11,866,782 in view of Abate et al. (WO2019/139650A2; cited on IDS submitted on 11/2/2022), Zhang et al. (WO2021/202970A1; EFD of May 31, 2020; cited on PTO-892 of 6/23/2025), and Hiddessen et al. (WO 2013/192351 A1) based on the citations and rationales provided above. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same limitations. Any additional limitations of ‘782 claims are encompassed by the open claim language “comprising” found in the instant claims. Response to Remarks In the Remarks of 4/20/2026, Applicant traverses the double patenting rejections made in the Office Action of 2/20/2026 in view of the amendments made to the claims (pg 7 of Remarks). The amendments made to the claims have been addressed in a new 103 rejection above, and the double patenting rejections have also been modified in light of this new 103 rejection and the amendments to the claims. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILEY E CASH whose telephone number is (571)272-0971. The examiner can normally be reached Monday-Friday 8:30am-6pm ET. 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, Anne Gussow can be reached at (571)272-6047. 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. /KAILEY ELIZABETH CASH/Examiner, Art Unit 1683 /STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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Prosecution Timeline

Show 5 earlier events
Feb 10, 2026
Request for Continued Examination
Feb 12, 2026
Response after Non-Final Action
Feb 20, 2026
Final Rejection mailed — §103, §DP
Apr 02, 2026
Examiner Interview Summary
Apr 20, 2026
Response after Non-Final Action
May 15, 2026
Request for Continued Examination
May 19, 2026
Response after Non-Final Action
Jun 16, 2026
Non-Final Rejection mailed — §103, §DP (current)

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4y 0m to grant Granted Feb 17, 2026
Patent 12509734
SYSTEMS AND METHODS TO ASSESS MICROBIOMES AND TREATMENTS THEREOF
4y 2m to grant Granted Dec 30, 2025
Patent 12385045
THERMOSTABLE POLYMERASE INHIBITOR COMPOSITIONS AND METHODS
3y 5m to grant Granted Aug 12, 2025
Study what changed to get past this examiner. Based on 4 most recent grants.

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Prosecution Projections

4-5
Expected OA Rounds
28%
Grant Probability
86%
With Interview (+58.3%)
3y 9m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 18 resolved cases by this examiner. Grant probability derived from career allowance rate.

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