Prosecution Insights
Last updated: April 19, 2026
Application No. 17/710,488

DETECTION METHOD FOR DETECTING OCCURRENCE OF NONSPECIFIC REACTION, ANALYSIS METHOD, ANALYZER, AND DETECTION PROGRAM FOR DETECTING OCCURRENCE OF NONSPECIFIC REACTION

Final Rejection §101§112
Filed
Mar 31, 2022
Examiner
PLAYER, ROBERT AUSTIN
Art Unit
1686
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Sysmex Corporation
OA Round
2 (Final)
25%
Grant Probability
At Risk
3-4
OA Rounds
1y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants only 25% of cases
25%
Career Allow Rate
2 granted / 8 resolved
-35.0% vs TC avg
Strong +86% interview lift
Without
With
+85.7%
Interview Lift
resolved cases with interview
Fast prosecutor
1y 0m
Avg Prosecution
50 currently pending
Career history
58
Total Applications
across all art units

Statute-Specific Performance

§101
32.8%
-7.2% vs TC avg
§103
32.6%
-7.4% vs TC avg
§102
1.4%
-38.6% vs TC avg
§112
22.0%
-18.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 8 resolved cases

Office Action

§101 §112
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 . Applicant's response filed 1/20/2026 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. Status of Claims Claims 16-18, 24-28, and 30-34 pending. Claims 1-15, 19-23, and 29 canceled. Claims 30-34 newly added. Claims 16-18, 24-28, and 30-34 examined on the merits. Priority The instant application filed on 3/31/2022 claims the benefit of foreign priority to Application No. JP2021-104323 filed on 6/23/2021. Thus, the effective filing date of the claims is 6/23/2021. The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing. Claim Objections The objection to claims 19-23 are rendered moot in view of Applicant canceling these claims in the amendments filed on 1/20/2026. The objection to claims 24-26 withdrawn in view of Applicant's claim amendments filed on 1/20/2026. However, a newly applied objection to claim 26 is been made below in view of Applicant's claim amendments filed on 1/20/2026. Claims 26 and 31 objected to because of the following informalities: Claim 26 line 2, "prepare a user interface designed to prompts for input" should read "prepare a user interface designed to prompt for input". Claim 31 line 2, "apply emissions of right at different wavelengths" should read "apply emissions of light at different wavelengths". Appropriate correction is required. Withdrawn Rejections 35 USC § 112(b) The rejection of claims 16, 26, and 28 under 35 USC 112(b) withdrawn in view of Applicant's claim amendments filed on 1/20/2026. 35 USC § 112(d) The rejection of claims 17 and 18 under 35 USC 112(d) withdrawn in view of Applicant's claim amendments filed on 1/20/2026. However, a newly applied rejection of claim 18 under 35 USC 112(d) has been made in view of Applicant's claim amendments filed on 1/20/2026 (see below section "Claim Rejections - 35 USC 112" for details). 35 USC § 103 The rejection of claims 16-19 and 21-29 under 35 USC 103 withdrawn in view of Applicant's claim amendments filed on 1/20/2026. Claim Rejections - 35 USC § 112 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 27 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 27 recites "the user interface is designed to prompt for selection of one of different types of re-analyses". The metes and bounds of the limitation are not clear, as it is not clear what "different types of re-analyses" are available to prompt a user to select from the user interface. Therefore, the claim does not particularly point out and distinctly claim the invention. The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 16-18, 24-28, and 30-34 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for methods of determining the concentration of a specific substance in the presence of a known nonspecific reactant, does not reasonably provide enablement for methods of determining the concentration of a specific substance in the presence of any unknown nonspecific reactant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims. In In re Wands (8 USPQ2d 1400 (CAFC 1988)) the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims. In considering the factors for the instant claims: a) In order to practice the claimed invention one of skill in the art must determine a calibration curve for each immunoassay which could be utilized for the method with every specific substance with every possible nonspecific reactant for populating the calibration curve database (instant specification para.0065-0066 and para.0074-0075). For the reasons discussed below, there would be an unpredictable amount of experimentation required to practice the claimed invention. While simply utilizing biological and technical control sample would overcome this issue, neither are mentioned in the instant specification. b), c) The specification cites the figures as examples, however there is no specific working example that explains how the concentration of a known specific substance in the presence of unknown nonspecific reactants is calculated. Furthermore, there is no discussion of specifically how the calibration curves are generated. d) The invention is drawn to an analyzer and method of determining the concentration of a specific substance in the presence of any unknown nonspecific reactant (see claims 16 and 30). e) The determination of the concentration of a specific substance using immunoassays and calibration curves is well-known. As is the significant confounding effects that unknown nonspecific or multi-specific reactants can have on this determination. Broadly, this issue is addressed by treating the immunoassay with a blocking reagent in order to reduce the nonspecific adsorption (Lin et al. page 5 col 2 paragraph 2 " To eliminate the nonspecific adsorption of anti PSA–QD conjugates and achieve the highest sensitivity of the IEB, the amount of anti-PSA–QD conjugates applied on the contact zone was optimized. The blocking reagent BSA was used to treat the membrane of the strip for reducing the nonspecific adsorption" [Lin et al. Biosensors and Bioelectronics 23.11 (2008): 1659-1665] and Cox et al. page 3 section 2 [Cox et al. Assay guidance manual [Internet] (2019)]). The state of the art has not yet produced a calibration curve database sufficient for enabling the determining the concentration of a specific substance in the presence of any unknown nonspecific reactant. Significant skill, decision making and effort are required. f) The skill of those in the art of molecular biology is high. g) The prior art predicts that nonspecific binding will have confounding effects on the calculation of the concentration of a specific substance, as well as the light intensity over time of light passed through a measured sample. If the concentration of the specific substance in a biological sample is unknown, applying a calibration curve to the sequence of intensity data only allows the calculation of a specific concentration. Attempting to apply the same method to a deep learning model using 2-dimensional training data of "light intensity over time" and a calibration curve database (for not only the detection of nonspecific reaction, but for a determination of concentration of a specific substance in the presence of an unknown nonspecific reactant) leaves numerous variables unaccounted for - or at least not detailed in the instant specification (e.g. presence of a nonspecific substance in the reaction, the chemodynamics of the nonspecific substance to the immunoassay, the concentration of that nonspecific substance, etc.). h) The claims are broad because they are drawn to determining the concentration of a specific substance in the presence of any unknown nonspecific reactant. The bounds of "any unknown nonspecific reactant" is large. The skilled practitioner would first turn to the instant specification for guidance to determine this information for a specific substance in the presence of an unknown nonspecific reactant. However, the instant specification does not provide specific guidance to practice the invention as claimed. As such, the skilled practitioner would turn to the prior art for such guidance, however, the prior art shows that nonspecific binding of unknown reactants, while a known issue, is not addressed by generating a calibration curve database for all potential nonspecific reactants that could be present in a biological sample of a known specific substance. Instead, the state of the art is to reduce this nonspecific binding by treating immunoassays with a blocking reagent to optimize the detection and quantification of specific substances. Finally, said practitioner would turn to trial-and-error experimentation to determine these embodiments. Such represents undue experimentation. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 18 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 rejected as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claim 18 recites "the controller is programmed to analyze the sequence of intensity signals to determine the change of absorption of the emission of light caused by progress of the antigen-antibody reaction over the preset time duration with the specific substances in the measurement sample", which does not further limit claim 17 because "the sequence of intensity signals" of claim 18 is generated in claim 16 from "the set of detection signals" of claim 17, therefore analysis of the set of detection signals "to determine the change of absorption of the emission of light" is essentially the same as analyzing the sequence of intensity signals. In other words, "the sequence of intensity signals" is "the set of detection signals". Claim Rejections - 35 USC § 101 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 16-18, 24-28, and 30-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea: Claims 16 and 30: “detect occurrence of a nonspecific reaction with a nonspecific substance during the immunoassay of the biological sample” provides an evaluation (detecting involves making determinations based on data or experience) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea. “applying a calibration curve to the change of absorption of the emission of light to calculate a concentration of the specific substance in the measurement sample” provides a mathematical calculation (calculating concentration using a calibration curve) that is considered a mathematical concept, which is an abstract idea. “determining if the calculated concentration of the specific substance exceeds a threshold concentration” and “determine if the estimated likelihood exceeds a threshold likelihood” provides an evaluation (determining if a value exceeds a threshold involves a comparison) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea. Claim 17: “determine the change of absorption of the emission of light” provides an evaluation (determining a change in light absorption involves comparing two or more data values) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea. Claim 24: “the report includes at least one previously reported concentration of the specific substance for comparison with the calculated concentration of the specific substances and/or the clinical diagnosis history of the patient related to the specific substance” provides an evaluation (comparing concentration values involves evaluating data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea. These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claim 16 recites performing some aspects of the analysis on “a controller programmed to analyze”, there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental processes” grouping of abstract ideas. As such, claims 16-18, 24-28, and 30-34 recite an abstract idea (Step 2A, Prong 1: YES). Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements: Claims 16 and 30: “performing immunoassay to invoke an antigen-antibody reaction with a specific substance contained in a biological sample” provides insignificant extra-solution activities (performing an immunoassay is a pre-solution activity involving sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. “preparing a measurement sample containing the biological sample and a measurement reagent that is mixed with the biological sample to induce the antigen-antibody reaction” provides insignificant extra-solution activities (preparing a sample for measurement is a pre-solution activity involving sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. “applying an emission of light to the measurement sample” provides insignificant extra-solution activities (applying light to a sample is a pre-solution activity involving sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. “receiving the emission of light that has passed through the measurement sample and converting, at a regular interval, the received emission of light into a set of detection signals” and “receiving the set of detection signals and generating a sequence of intensity signals” provides insignificant extra-solution activities (receiving and measuring light as a digital signal is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application. “training a deep learning algorithm that has a neural network structure with training data for detection of occurrence of the nonspecific reaction, wherein the training data is obtained from analyses of a plurality of samples for which occurrence or non-occurrence of the nonspecific reaction is determined” provides insignificant extra-solution activities (obtaining data and training a deep learning algorithm are pre-solution activities involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. “running the trained deep learning algorithm on the sequence of intensity signals to estimate a likelihood that the nonspecific reaction occurred in the measurement sample” provides insignificant extra-solution activities (running a model on obtained data is a pre-solution activity involving data manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. “preparing a report that reports the calculated concentration of the specific substance and the determination” provides insignificant extra-solution activities (preparing a report is a post-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. Claim 24: “access a medical record of a patient that provided the biological sample” provides insignificant extra-solution activities (accessing patient medical records is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application. Claim 26: “the controller is programmed to prepare a user interface designed to prompts for input of an instruction to perform the re-analysis of the biological sample, and the controller is programmed to, in response to a receipt of the instruction to perform the re-analysis through the user interface, control the analyzer to perform the re-analysis of the biological sample” provides insignificant extra-solution activities (performing a reanalysis of a sample based on user input is a post-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. Claim 28: “dilute the biological sample at a dilution rate to prepare the measurement sample and dilute the biological sample at a different rate to prepare a new measurement sample for the re-analysis” provides insignificant extra-solution activities (making a dilution series is a pre-solution activity involving sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application. Claim 32-34: “the determination in the report is reported with a statistical probability indicative of the likelihood that the nonspecific reaction has occurred during the immunoassay of the biological sample”, “the determination in the report is reported with a symbol representative of the likelihood that the nonspecific reaction has occurred during the immunoassay of the biological sample”, and “the determination in the report is reported with a word indicative of the likelihood that the nonspecific reaction has occurred during the immunoassay of the biological sample” provides insignificant extra-solution activities (reporting probabilities is outputting data which is a post-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application. The steps for applying a light source to a sample, preparing and/or diluting a biological sample for measurement, and detecting light from the sample; and receiving, inputting, outputting, and storing information are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data gathering, data manipulation, and sample manipulation steps (see MPEP 2106.04(d)(2)). Furthermore, the limitations regarding implementing program instructions do not indicate that they require anything other than mere instructions to implement the abstract idea in a generic way or in a generic computing environment. As such, this limitation equates to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Therefore, claims 16-18, 24-28, and 30-34 are directed to an abstract idea (Step 2A, Prong 2: NO). Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. As discussed above, there are no additional elements to indicate that the claimed “controller programmed to analyze” requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for applying a light source to a sample, preparing and/or diluting a biological sample for measurement, and detecting light from the sample; and receiving, inputting, outputting, and storing information are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are well-understood, routine, and conventional. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 16-18, 24-28, and 30-34 are not patent eligible. Response to Arguments under 35 USC § 101 Applicant’s arguments filed 1/20/2026 are fully considered but they are not persuasive. Applicant asserts that "Claims 16-18, 24-28, and 30 Are Not Directed to an Abstract Idea" because "claim 16 is directed to an analyzer [] compris[ing] a sample preparator, a plurality of light sources, a detector and a controller" (Remarks 1/20/2026 Pages 5-7). Applicant's argument hinges on the key term "practically", with respect to the memorandum from August 4, 2025, Applicant asserts that "the controller limitation cannot be practically performed in human mind" (Remarks 1/20/2026 Page 8). Applicant further asserts that claim 16 "recites processed performed by the controller" which "cannot be practically performed it the human mind" (Remarks 1/20/2026 pages 8-9. Examiner notes that for the reasons listed above in the section "Claim Rejections - 35 USC 101", the claims in question do indeed recite abstract ideas, and further that the processed performed by the controller are identified as additional elements not judicial exceptions of an abstract idea performed in the human mind. With respect to the August 4, 2025 memo cautioning that limitations encompassing AI in a way that cannot be practically performed in the human mind do not fall within this grouping, there are no limitations in independent claims 16 or 30 precluding the human mind from "detect occurrence of a nonspecific reaction with a nonspecific substance during the immunoassay of the biological sample". The fact that an AI model is applied is moot, as its training by the obtained data and application to the received data is simply an additional element that is an insignificant extra-solution activity and does not serve to integrate the recited judicial exceptions into a practical application (nor do any other of the identified additional elements of the claims). Furthermore, no inventive concept is claimed by this amendment as all additional elements are well-understood, routine, and conventional. The Examiner also notes that MPEP 2106(I) states that if the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). In the “search for an ‘inventive concept’” (the second part of the Alice/Mayo test), the additional elements identified do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception because they are all well-understood, routine, and conventional techniques that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Therefore, combining insignificant extra-solution activities with any of the identified judicial exceptions would not result in patent eligible subject matter because integrating well-understood, routine, and conventional techniques does not yield “significantly more” to a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon. Finally, Applicant argues that claim 16 provides an improvement to technology via the deep learning algorithm "determin[ing] how likely it is that the nonspecific reaction occurred" (Remarks 1/20/2026 page 10. Examiner notes that there is no improvement to existing technology as the suggested improvement is not enabled for the reasons outlined above (see section "Claim Rejection - 35 USC 112" subsection 112(a)). Therefore, the rejection of claims 16-18 and 24-28 under 35 USC 101 is maintained. All other claims depend from these independent claims; therefore, their rejection is likewise maintained. Additionally, newly added claims 30-34 are also rejected under 35 USC 101 for the reasons outlined above. Citation of Pertinent Prior Art The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20200378891, Andrecka et al.; para.0015 "the present invention enables absolute concentration measurement of a particle in solution by analysis of the changes or decay in binding rate of the particle to a surface as detected by light scattering over time" US-20190162666, Akasaka et al.; Re-analysis message/display US-20200132687, El-Dweik et al.; antibody detection apparatus with light source Banaei et al. "Machine learning algorithms enhance the specificity of cancer biomarker detection using SERS-based immunoassays in microfluidic chips." RSC advances 9.4 (2019): 1859-1868; evaluating immunoassay data using machine learning algorithms Malmborg et al. "Real time analysis of antibody‐antigen reaction kinetics." Scandinavian journal of immunology 35.6 (1992): 643-650; Antigen-antibody measurements over time Yakes et al. "Surface plasmon resonance biosensing: Approaches for screening and characterising antibodies for food diagnostics." Talanta 156 (2016): 55-63; Surface plasmon resonance for screening and characterising antibodies Conclusion No claims are allowed. It is noted that claims 16-18, 24-28, and 30-34 as currently recited are not enabled nor do they have adequate written description in the instant specification, rendering a meaningful search of the art not possible at this moment. Insofar as prior art is not applied to claims 16-18, 24-28, and 30-34 in the instant rejection, prior art will be re-assessed upon any amendment. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the TH REE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this finaI action. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert A. Player whose telephone number is (571)272-6350. The examiner can normally be reached Mon-Fri, 8am-5pm. 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, Larry D. Riggs can be reached on 571-270-3062. 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. /R.A.P./Examiner, Art Unit 1686 /LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
Read full office action

Prosecution Timeline

Mar 31, 2022
Application Filed
Apr 01, 2025
Response after Non-Final Action
Sep 29, 2025
Non-Final Rejection — §101, §112
Jan 07, 2026
Examiner Interview Summary
Jan 20, 2026
Response Filed
Mar 13, 2026
Final Rejection — §101, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12584180
Methods and Systems for Determining Proportions of Distinct Cell Subsets
2y 5m to grant Granted Mar 24, 2026
Patent 12571054
Methods and Systems for Determining Proportions of Distinct Cell Subsets
2y 5m to grant Granted Mar 10, 2026
Study what changed to get past this examiner. Based on 2 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
25%
Grant Probability
99%
With Interview (+85.7%)
1y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 8 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month