Prosecution Insights
Last updated: July 17, 2026
Application No. 15/926,977

SYNTHETIC MULTIPLETS FOR MULTIPLETS DETERMINATION

Non-Final OA §101§112
Filed
Mar 20, 2018
Priority
Mar 24, 2017 — provisional 62/476,522
Examiner
MINCHELLA, KAITLYN L
Art Unit
1685
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Becton, Dickinson and Company
OA Round
8 (Non-Final)
27%
Grant Probability
At Risk
8-9
OA Rounds
0m
Est. Remaining
49%
With Interview

Examiner Intelligence

Grants only 27% of cases
27%
Career Allowance Rate
42 granted / 157 resolved
-33.2% vs TC avg
Strong +22% interview lift
Without
With
+22.1%
Interview Lift
resolved cases with interview
Typical timeline
4y 4m
Avg Prosecution
37 currently pending
Career history
207
Total Applications
across all art units

Statute-Specific Performance

§101
19.9%
-20.1% vs TC avg
§103
45.2%
+5.2% vs TC avg
§102
4.9%
-35.1% vs TC avg
§112
7.0%
-33.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 157 resolved cases

Office Action

§101 §112
DETAILED ACTION Applicant’s response, filed 02 March 2026 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. 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 . Status of Claims Claims 1, 3-10, 12, 15-24, 26-30, 34-36, 38, 40-45 are cancelled. Claims 47-48 are newly added. Claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 are pending. Claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 are rejected. Priority The effective filing date of the claimed invention is 24 March 2017. Information Disclosure Statement The information disclosure statement (IDS) submitted on 02 March 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner. Claim Objections The objection to claim 3 in the Office action mailed 29 Sept. 2025 has been withdrawn in view of the cancellation of this claim received 02 March 2026. Claim Interpretation Independent claim 25 recite “targets”. Applicant’s specification at para. [0103] defines the word “target” to refer to a composition which can be associated with a barcode, including oligonucleotides, DNA, mRNA, microRNA, tRNA, etc. Therefore, the term target is interpreted to mean the entity to which the barcode can be attached (e.g. an RNA molecule). Claim 25 recites “(a) obtaining, with the computer system, gene expression data comprising a plurality of mRNA expression profiles of a plurality of cells in a sample”, which is interpreted to mean a computer system receives (i.e. obtains) already generated gene expression data comprising mRNA expression profile. The claim does not require generating the gene expression data from the sample. Dependent claims 47-48 recite “wherein the occurrence…is obtained by sequencing…” and “wherein the plurality of mRNA expression profiles is obtained by sequencing and/or digital PCR”, which is interpreted to define the process in which the gene expression data received by the computer system of claim 25 was previously generated. However, the claims do not require a step of generating the mRNA expression profiles by performing sequencing and/or digital PCR. Claim 14 recites “…wherein the one or more expression profiles…used in training the machine learning model comprises a percentage of the plurality of expression profiles determined in (b)”, respectively. Claim 14 is interpreted to mean that the one or more expression profiles used in training comprise less than the total number of the plurality of expression profiles determined in (b). Response to Arguments Applicant's arguments filed 02 March 2026 regarding the claim interpretations have been fully considered but they are not persuasive. Applicant remarks that Applicant does not necessarily agree with the interpretations and that claims are to be given their broadest reasonable interpretation (Applicant’s remarks at pg. 6, para. 2). This argument is not persuasive because While Examiner agrees that generally claims are to be given their broadest reasonable interpretation consistent with the specification, where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. See MPEP 2111. It is noted that Applicant’s specification defines the term “target” as indicated above, and therefore this term does not receive the broadest reasonable interpretation of the term “target”. Claim Rejections - 35 USC § 112(b) The previous rejection of claims 3, 7-8, 35-36, 38, 40, and 43-44 in the previous Office action mailed 29 Sept. 2025 under 35 U.S.S. 112(b) has been withdrawn in view of the cancellation of these claims received 02 March 2026. The rejection of claims 11, 13-14 in the previous Office action mailed 29 Sept. 2025 under 35 U.S.S. 112(b) has been withdrawn in view of the claim amendments received 02 March 2026. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. Claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. This rejection is newly recited and necessitated by claim amendment. Claim 25, and claims dependent therefrom, are indefinite for recitation of “(c)….a projected mRNA expression profile associated with the cell label”. Claim 25 previously recites “wherein each mRNA expression profile of the plurality of mRNA expression profiles…is associated with a cell label that is unique among the plurality of mRNA expression profiles”, such that there is a different cell label for each mRNA expression profile. As a result, it is unclear which cell label, “the cell label” in step (c) is referring to. Clarification is requested. For purpose of examination the limitation will be interpreted to mean “associated with a cell label”. Response to Arguments Applicant's arguments filed 02 March 2026 regarding 35 U.S.C. 112(b) have been fully considered but they do not pertain to the new grounds of rejection set forth above. Claim Rejections - 35 USC § 101 The previous rejection of claims 3, 7-8, 35-36, 38, 40, and 43-44 in the previous Office action mailed 29 Sept. 2025 under 35 U.S.S. 112(b) has been withdrawn in view of the cancellation of these claims received 02 March 2026. 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portion herein is necessitated by claim amendment. The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106. Step 1: The instantly claimed invention (claim 25 being representative) is directed a method for identifying a multiplet expression profile. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES] Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception. Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon. Independent claim 25 recites the following steps which fall under the mental processes groupings of abstract ideas: (b) generating…. a plurality of synthetic multiplet expression profiles from the plurality of mRNA expression profiles of the plurality of cells, comprising: for each synthetic multiplet expression profile of the plurality of synthetic multiplet expression profiles, (1) selecting at least two expression profiles of the plurality of expression profiles; and (2) for each of the at least 96 genes, combining occurrences of the target in the expression profiles selected in (1) into a combined occurrence of the target to generate the synthetic multiplet expression profile, wherein the synthetic multiplet expression profile is in the expression profile space; (c) identifying among the plurality of mRNA expression profiles at least one multiplet expression profile by: projecting…each synthetic multiplet expression profile of the plurality of synthetic multiplet expression profiles generated in (b) from the expression profile space into a lower dimensional projection space to generate projected synthetic multiplet expression profiles; projecting, with the computer system, one or more mRNA expression profiles of the plurality of mRNA expression profiles from the expression profile space into the lower dimensional projection space to generate one or more projected mRNA expression profiles, wherein the multiplet expression profile is identified based on the proximity of a projected mRNA expression profile associated with the cell label among the one or more projected mRNA expression profiles and one or more of the plurality of projected synthetic multiplet expression profiles in the lower dimensional projection space; (f) removing… the at least one multiplet expression profile identified in (c) from the gene expression data obtained in (a), thereby generating second gene expression data comprising singlet mRNA expression profiles corresponding to a tissue of the different tissues and/or to a cell type of the plurality of cell types in the sample. The identified claim limitations falls into the group of abstract ideas of mental processes for the following reasons. First, the steps of generating a plurality of synthetic multiplet expression profiles involves selecting at least two expression profiles and then combining the at least two of the expression profiles (e.g. by taking an average expression of each of 96 genes), which can be practically performed in the mind aided with pen and paper. The steps of identifying an expression profile as a multiplet based on determining a proximity of a projected expression profile with a projected synthetic profile in an expression profile space can be practically performed in the mind by comparing distances of the expression profile to the synthetic multiplet expression profile in a projected space (e.g. a two-dimensional space on an x-y axis) to determine if the expression profile is a singlet or multiplet. The step of removing the identified at least one multiplet from the gene expression data can be practically performed in the mind by analyzing the plurality of expression profiles to remove any profiles, or sequences associated with the profiles, identified to be a multiplet, thereby leaving a plurality of singlet expression profiles, which can be practically performed in the mind. Therefore, these limitations recite a mental process. See MPEP 2106.04(a)(2) III. In addition, the limitations of generating synthetic multiplet expression profiles by combining occurrences of a target in at least two expression profiles and identifying an expression profile as a multiplet based on a proximity of the expression profile to synthetic multiplet profiles in an expression profile space, projecting each multiplet expression profile into a lower dimensional projection space to generate projected multiplet expression profiles, projecting one or more RNA expression profiles from the expression profile space into the lower dimensional projection space to generated projected mRNA expression profiles, and identifying the at least one multiplet expression profile based on the proximity of a projected mRNA expression profile to a projected synthetic multiplet expression profile in the lower dimensional space further recite a mathematical concept. First, combining occurrences of two expression profiles amounts to a textual equivalent to summing two numbers, which is a mathematical calculation. First, combining occurrences of two expression profiles amounts to a textual equivalent to summing two numbers, which is a mathematical calculation. Similarly, the identifying step encompasses mathematical dimensionality reduction, as discussed in Applicant’s specification (see para. [0068]) and also recited in dependent claim 46, which discloses projecting the data into a lower-dimensional space using t-distributed stochastic neighbor embedding and calculating distances to determine the proximity between an expression profile and the synthetic profiles in an expression profile space, which is a statistical method that requires calculating distances between each datapoint. In other words, the above limitations amount to a textual equivalent to performing mathematical calculations, and thus recite a mathematical concept as set forth in MPEP 2106.04(a)(2) I. C. Dependent claims 2, 11, 13-14, 31-33, 39, and 46 further recite an abstract idea and/or further limit the abstract idea of the independent claims above. Dependent claim 2 further limits the mental process of generating the synthetic multiplet expression profiles to comprise a doublet or triplet. Dependent claim 11 further recites the mental process of selecting a number of expression profiles as a number of 1-10 percent of the plurality of expression profiles determined in (b). Dependent claim 31 further recites the mental process of combining a number of labels with distinct sequences associated with a target in at least two expression profiles to generate a number of molecular labels for the synthetic multiplet expression profile. Dependent claim 32 further recites the mental process and mathematical concept of determining a sum of the occurrences of the target or molecular labels, respectively, in the expression profiles selected. Dependent claim 32 further recites the mental process and mathematical concept of determining a weighted sum of the occurrences of the target or the number of molecular labels, respectively, in the expression profiles selected. Dependent claim 32 further recites the mental process and mathematical concept of determining an average or weighted average of the number of molecular labels in the selected expression profiles. Dependent claims 13 and 33 further recites the mental process and mathematical concept of training a machine learning model for expression profile multiplet identification from the expression profiles of the plurality of synthetic multiplet expression profiles and one or more expression profiles of the plurality of expression profiles, given training a machine learning model encompasses performing an unsupervised clustering analysis (i.e. a k-nearest neighbor model, as discussed at para. [0031] of Applicant’s specification), which amounts to a textual equivalent to performing mathematical calculations (e.g. calculating distances between points); claims 13 and 33 further recite the mental process and mathematical concept of identifying the expression profile of the plurality of expression profiles associated with a cell of the plurality of cell as a singlet or a multiplet based on the expression profile using the machine learning model. Dependent claim 14 further limits the mental process and mathematical concept of training the machine learning model to use a percentage of the plurality of expression profiles. Dependent claim 36 further recites the mental process of selecting a number of expression profiles in a range of 2-20. Dependent claim 6 further limits the projecting to use the mathematical process of a t-distributed stochastic neighbor embedding (tSNPE) to perform the projection. Dependent claim 39 further limits the method to comprise not analyzing a sample tag to distinguish between mRNA molecules from different tissue types and/or cell types. Therefore, claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 recite an abstract idea. [Step 2A, Prong 1: YES] Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. Claims 2, 11, 13-14, 31-33, and 46 do not recite any elements in addition to the recited judicial exception and thus are part of the judicial exception. The additional elements of independent claim 25 include: (b) obtaining, with a computer system, gene expression data comprising a plurality of mRNA expression profiles of a plurality of cells in a sample wherein the sample comprises cells from different tissues or a plurality of cell types, wherein each mRNA expression profile of the plurality of mRNA expression profiles: comprises an occurrence of mRNA molecules of at least 96 genes, is in an expression profile space, and is associated with a cell label that is unique among the plurality of mRNA expression profiles (i.e. receiving data); and with the computer system (steps (b) and (d)). The additional elements of claim 37 and 47-48 include: wherein the sample comprises peripheral blood mononuclear cells (PBMC) and/or circulating tumor cells (claim 37); where in the occurrence of mRNA molecules of the at least 96 genes is obtained by sequencing amplicons generated using at least 96 target specific primers to amplify labeled cDNA molecules of the mRNA molecules of the at least 96 genes (claim 47); and wherein the plurality of mRNA expression profiles is obtained by sequencing and/or digital PCR (claim 48). The additional elements of claim 25 of receiving data by a computer, and a computer that carries out the abstract idea are generic computer components and functions. The additional elements of claims 37-47-48 only serve to further limit the data being received by the computer in claim 25, and therefore are part of the additional element of using a computer to receive data. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f). Furthermore, the additional elements of obtaining, by a computer, gene expression data generated by sequencing and/or digital PCR and target specific primers from a sample containing PBMC and/or circulating tumor cells only serve to collect sequencing and expression data for use by the abstract idea of generating synthetic multiplet expression profiles and ultimately identifying a multiplet expression profile, which amounts to necessary data gathering and does not integrate the recited judicial exception into a practical application. See MPEP 2106.05(g). Last, while Applicant’s specification at para. [0003] and [0208]] discloses detected expression profiles may be associated with two or more cells, which skews interpretation of the expression profile, and the disclosed methods are for identifying a multiplet expression profile using synthetic multiplet expression profiles, the specification does not provide a technical explanation regarding how the additional elements provide an improvement to technology. Instead, the disclosed improvement amounts to an improved analysis of sequencing data (i.e. an un-skewed interpretation), which is not an improvement to technology. Therefore, the additionally recited elements amount to mere instructions to apply the exception on a computer and/or amount to insignificant extra-solution activity and, as such, the claims as a whole do no integrate the abstract idea into practical application. See MPEP 2106.05(g). Thus, claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 are directed to an abstract idea. [Step 2A, Prong 2: NO] Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05. The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception. Claims 2, 7-8, 11, 13-14, 23-24, 28, 31-33, 36, and 41-46 do not recite any elements in addition to the recited judicial exception and thus are part of the judicial exception. Claims 25, 37, and 47-48 recite the additional elements identified above. The additional elements of claim 25 of receiving data by a computer, and a computer that carries out the abstract idea are conventional computer components and functions. The additional elements of claims 37-47-48 only serve to further limit the data being received by the computer in claim 25, and thus are part of the additional element of receiving data. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Therefore, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO] Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106. Response to Arguments Applicant's arguments filed 02 March 2026 regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant remarks that the Examiner impermissibly expands the mental process grouping to encompass claim limitations that cannot be performed in the human mind because claim 25 recites specific, step-wise detailed features, and the Examiner’s assertion that “calculating a distance between each pair of datapoints in the datasets and organizing the information on a two-dimensional plot via pen and paper” is based on an overly simplistic characterization of the claimed method and is indicative of impermissible expansion of the abstract idea grouping to encompass claim limitations that cannot be practically performed in the mind (Applicant’s remarks at pg. 7, para. 4 to pg. 8, para. 1). Applicant further remarks that projecting the synthetic multiplet expression profiles and one or more mRNA expression profiles into a lower dimensional space cannot be performed in the human mind (Applicant’s remarks at pg. 8, para. 2). This argument is not persuasive. An explanation detailing how each identified limitation reciting a mental process can be practically performed in the mind has been provided in the above rejection, and Applicant merely asserts the claim limitations cannot be performed in the human mind and is based on an overly simplistic characterization. MPEP 2106.04(a)(2) III states the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. Claim 25 requires “identifying…at least one multiplet expression profile…based on the proximity of a projected mRNA expression profile…and one or more of the plurality of projected synthetic multiplet expression profiles in the lower dimensional space”. As explained in the above rejection, this limitation can be practically performed in the mind by comparing distances of the expression profile to the synthetic multiplet expression profile in a projected space (e.g. a two-dimensional space on an x-y axis) to determine if the expression profile is a singlet or multiple, which is an evaluation of data. Last, the steps of “projection” each synthetic multiplet expression profile and one or more mRNA expression profiles into a lower dimensional space recite the abstract idea of a mathematical concept as discussed in the above rejection, and are not identified as reciting a mental process. Applicant remarks that there is no evidence to support projecting the synthetic multiplet expression profiles and one or more mRNA expression profiles from the expression profiles into a lower dimensional projection space falls within the mathematical concept grouping, and even if the recited projecting features were to involve a mathematical operation, reciting a limitation that can be performed by a mathematical operation may nevertheless not amount to reciting a mathematical concept where the limitation is merely based on or involves math but does not recite details for performing the limitation (Applicant’s remarks at pg. 8, para. 3 to pg. 9, para. 2). This argument is not persuasive. A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation. See MPEP 2106.04(a)(2) I. C. Therefore, as clearly set forth in MPEP 2106.04(a)(2) I. C., limitations that use mathematical methods may be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation. There is no requirement that explicit details for the mathematical calculations being performed must be in a claim for the claim to recite a mathematical calculation. In the instant case, the only supported embodiment for performing the claimed projections is performed using a t-distributed stochastic neighbor embedding (tSNE) method, as also recited in dependent 46, which simply uses words to describe a series of mathematical calculations (e.g. calculating high-dimensional similarities, calculating low-dimensional similarities, computing distances etc.). Therefore, projecting the expression profiles and synthetic expression profiles into a lower-dimensional space (e.g. dimensionality reduction) is not simply based on math, but uses words to describe a series of mathematical calculations. Applicant remarks the improvement can be provided by the additional elements in combination with the recited judicial exception, and here the pending claim specifies how the features of gene expression data in (a) interact with the features recited in the rest of the claim to ultimately remove multiplet expression profiles from the data, and thus the features recited in (a) are not simply data gathering steps, but integrate any alleged judicial exception into a practical application (Applicant’s remarks at pg. 9, para. 4 to pg. 10, para. 1). This argument is not persuasive. It is agreed that an improvement can be provided by the additional elements in combination with the recited judicial exception. However, Applicant appears to argue that because the received expression data is required for ultimately analyzing the expression data to identify multiplet expression profile(s) and remove the identified mutliplet expression profile from the expression data(s), this additional element provides integration. MPEP 2106.05(g) states when determining whether an additional element is insignificant extra-solution activity, examiners may consider the following: whether the limitation is significant (i.e. it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and outputting (i.e. all uses of the recited judicial exception require such data gathering or data output). In the instant case, the step of receiving expression data amounts to necessary data gathering because all uses of the recited judicial exception require such data gathering, which does not integrate a recited judicial exception into a practical application, as a set forth in MPEP 2106.05(g). Therefore, a step of necessary data gathering in the claims does not provide integration simply because it is necessary for the subsequent abstract idea. The only additional elements of claim 25 involves using a computer to obtain expression data (i.e. receiving data) and using the computer to carry out the abstract idea. See MPEP 2106.05(f), stating the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) does not integrate a judicial exception into a practical application. Therefore, in considering the additional elements in combination with the recited judicial exception, the additional element of obtaining gene expression data only interacts with the judicial exception to provide the necessary data for the abstract idea. Applicant remarks the Application discloses an unconventional technical solution by differentiating between expression profiles based on mRNA targets from a single cell compared to mRNA targets from more than one cell which reduces the fraction of multiplet profiles that skew interpretation of the mRNA expression profiles, and thus as a whole, the claims represent an improvement in single-cell sequencing assays by reducing the number of multiplet expression profiles (Applicant’s remarks at pg. 10, para. 2). This argument is not persuasive. First, the argument is not commensurate with the scope of the claim because claim 25 does not require the mRNA expression profiles were generated by single-cell sequencing (e.g. as opposed to digital PCR). Furthermore, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. Furthermore, It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements or by the additional element(s) in combination with the recited judicial exception. See MPEP 2106.05(a). In the instant case, the alleged improvement of differentiating between singlet and multiplet expression profiles amounts to an improvement in the abstract idea itself (i.e. an improved analysis of expression data), which is not an improvement to technology. Furthermore, Applicant has not provided an explanation for how the additional element(s) relating to obtaining expression profiles from samples in the claim provide the alleged improvement in discriminating between singlet and multiplet profiles. Instead, the claims merely use a generic computer to receive mRNA expression profiles, but the claims do not actually require performing sequencing to generate the mRNA expression profiles in a particular way that improves sequencing itself. This argument is also not persuasive for the same reasons previously discussed in the Office action mailed 29 Sept. 2025 para. [058]-[062]. Therefore, the claims do not reflect an improvement to technology. Applicant remarks that claims 2, 11, 13, 14, 31-33, 37, 39, and 47-48 are patent eligible because of their dependence on claim 25 (Applicant’s remarks at pg. 10, para. 3-4). This argument is not persuasive for the reasons discussed above for claim 25. Conclusion No claims are allowed. Claims 2, 11, 13-14, 25, 31-33, 37, 39, and 46-48 for the reasons discussed in the Office action mailed 23 Nov. 2021. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN L MINCHELLA whose telephone number is (571)272-6485. The examiner can normally be reached 7:00 - 4:00 M-Th. 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, Olivia Wise can be reached at (571) 272-2249. 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. /KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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Prosecution Timeline

Show 18 earlier events
Dec 13, 2024
Non-Final Rejection mailed — §101, §112
May 12, 2025
Response after Non-Final Action
May 12, 2025
Response Filed
Aug 12, 2025
Response Filed
Sep 29, 2025
Final Rejection mailed — §101, §112
Mar 02, 2026
Request for Continued Examination
Mar 09, 2026
Response after Non-Final Action
Jun 02, 2026
Non-Final Rejection mailed — §101, §112 (current)

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Prosecution Projections

8-9
Expected OA Rounds
27%
Grant Probability
49%
With Interview (+22.1%)
4y 4m (~0m remaining)
Median Time to Grant
High
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