Prosecution Insights
Last updated: July 17, 2026
Application No. 19/074,278

CAUSAL DISCOVERY AND INFERENCING FOR MEDICAL SYSTEMS

Final Rejection §101
Filed
Mar 07, 2025
Priority
Mar 11, 2024 — provisional 63/563,901
Examiner
HUYNH, EMILY
Art Unit
3683
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Auris Health Inc.
OA Round
2 (Final)
20%
Grant Probability
At Risk
3-4
OA Rounds
2y 1m
Est. Remaining
62%
With Interview

Examiner Intelligence

Grants only 20% of cases
20%
Career Allowance Rate
31 granted / 151 resolved
-31.5% vs TC avg
Strong +42% interview lift
Without
With
+41.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
27 currently pending
Career history
190
Total Applications
across all art units

Statute-Specific Performance

§101
26.4%
-13.6% vs TC avg
§103
68.4%
+28.4% vs TC avg
§102
2.9%
-37.1% vs TC avg
§112
1.9%
-38.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 151 resolved cases

Office Action

§101
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 . Notice to Applicant This communication is in response to the amendment filed 06/03/2026. Claims 1, 3-5, 11- 13, 15, 17-20 have been amended. Claims 2, 16 have been canceled. Claims 21-22 have been added. Claims 1, 3-15, 17-22 have been presented for examination. Subject Matter Free of Prior Art Claim(s) 1, 3-15, 17-22 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular: “mapping the plurality of clinical metrics to a directed acyclic graph (DAG) based on a causal discovery operation that identifies one or more causal relationships between pairs of clinical metrics of the plurality of clinical metrics, wherein the causal discovery operation includes: determining whether each pair of clinical metrics of the plurality of clinical metrics is statistically correlated; generating one or more edges for the DAG, wherein each edge of the one or more edges connects a respective pair of clinical metrics of the plurality of clinical metrics that is statistically correlated; and determining at least a directionality for each of the one or more edges based at least in part on an order of the phases in the sequence of phases; and generating one or more inferences associated with the robotic system based at least in part on the directionality for each of the one or more edges.” Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in independent claims 1, 15, claims 1, 15 are hereby deemed to be allowable over prior art. Originally numbered dependent claims 3-14, 17-22 incorporate the allowable features of originally numbered independent claims 1, 15, through dependency, respectively. However, the claims are still rejected under 101. 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 1, 3-15, 17-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis: Claim 1 is drawn to a method which is within the four statutory categories (i.e., method). Claim 15 is drawn to a system which is within the four statutory categories (i.e., machine). Independent claim 15 (which is representative of independent claim 1) recites…receive telemetry data generated…during a medical procedure performed by the robotic system; segmenting the telemetry data based on a sequence of phases associated with the medical procedure; determining a plurality of clinical metrics based at least in part on the telemetry data, wherein each clinical metric of the plurality of clinical metrics is associated with a respective phase in the sequence of phases; mapping the plurality of clinical metrics to a directed acyclic graph (DAG) based on a causal discovery operation that identifies one or more causal relationships between pairs of clinical metrics of the plurality of clinical metrics, wherein the causal discovery operation includes: determining whether each pair of clinical metrics of the plurality of clinical metrics is statistically correlated; generating one or more edges for the DAG, wherein each edge of the one or more edges connects a respective pair of clinical metrics of the plurality of clinical metrics that is statistically correlated; and determining at least a directionality for each of the one or more edges based at least in part on an order of the phases in the sequence of phases; and generating one or more inferences associated with the robotic system based at least in part on the directionality for each of the one or more edges. Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output based on the analysis accordingly (i.e., ¶ 0004 describes “provide greater insights about medical procedures using the data that is captured or recorded from the medical procedures” as a human activity performed by a “physician”) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea. Claim 1 recites additional elements (i.e., computer to implement the method; a robotic system). Claim 15 recites additional elements (i.e., A causal inferencing system comprising: a processing system; and a memory storing instructions; a robotic system). Looking to the specifications, a computer having a processing system, a memory storing instructions is described at a high level of generality (¶ 0042-0044; ¶ 0204), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “a robotic system” is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., generating, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only generally links the claimed invention to a particular technological environment or field of use (i.e., robotics), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea. Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computer having a processing system, a memory storing instructions) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “a robotic system” is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., generating, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only generally links the claimed invention to a particular technological environment or field of use (i.e., robotics), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception. Dependent claims 3-14, 17-22 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein. Claims 3-14, 17-20 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.” Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims. Response to Arguments Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 06/03/2026. In the remarks, Applicant argues in substance that: Regarding the 101 rejections, “The human mind is not equipped to receive or process such robotic telemetry data. These operations are fundamentally tied to robotic medical systems and cannot be performed as a human activity. Furthermore, processing robotic telemetry data does not manage personal behavior or interactions between people”; “By reciting that the telemetry data is segmented based on a sequence of phases associated with the medical procedure, and that the causal discovery operation includes generating edges based on statistical correlations and then determining a directionality for each of the one or more edges based on an order of the phases in the sequence of phases, Applicant's claim 1 provides a particular, non-abstract solution to the technological problem of extracting accurate causal relationships from medical procedure-based telemetry… Applicant's claim 1 is not directed to a general algorithm on a generic computer, but rather to a specific technique of segmenting telemetry data generated by a robotic system based on a sequence of phases and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases, which constitutes an improvement to how the causal inferencing system operates. For at least the foregoing reasons, claim 1 reflects an improvement in computer functionality and technology”; and “Under Step 2B, a claim is eligible if its elements, considered individually or as an ordered combination, are not well-understood, routine, and conventional in the relevant field... the specific ordered combination of steps- segmenting telemetry data based on a sequence of phases associated with a medical procedure, and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases to generate one or more inferences-provides a specific technical solution for analyzing telemetry data generated by a robotic system during a medical procedure that was not previously available. The unconventional nature of this specific ordered combination is evidenced by the absence of prior art demonstrating this solution…The Examiner has not provided evidence demonstrating that determining a directionality for each of one or more edges for a DAG based at least in part on an order of the phases in the sequence of phases was well-understood, routine, or conventional in the art.” Regarding the 103 rejections, the cited prior art reference(s) fails to teach the amended claim limitations. It is respectfully submitted that Examiner has considered Applicant’s arguments and does not find them persuasive. Examiner has attempted to address all of the arguments presented by Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons: In response to Applicant’s argument that (a) regarding the 101 rejections, “The human mind is not equipped to receive or process such robotic telemetry data. These operations are fundamentally tied to robotic medical systems and cannot be performed as a human activity. Furthermore, processing robotic telemetry data does not manage personal behavior or interactions between people”: It is respectfully submitted that Applicant argues “The human mind is not equipped to receive or process such robotic telemetry data. These operations…cannot be performed as a human activity. Furthermore, processing robotic telemetry data does not manage personal behavior or interactions between people.” However, Applicant fails to specify how “processing robotic telemetry data does not manage personal behavior or interactions between people.” Furthermore, per broadest reasonable interpretation of the claim in light of the specification, the claims of the present invention encompass the activity of (to paraphrase) rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output based on the analysis accordingly, which covers the sub-grouping of managing personal behavior or relationships or interactions between people in the “Certain Methods of Organizing Human Activity” grouping of abstract ideas, and not a concept performed in the human mind in the “Mental Processes” grouping, as Applicant now argues. Put another way, the claimed invention amounts to a series of rules or steps that a user (i.e., physician) would follow to analyze data to determine correlations and trends. For example, the specification describes “provide greater insights about medical procedures using the data that is captured or recorded from the medical procedures” as a human activity performed by a “physician” (¶ 0004) and “review each of the identified metrics to determine how they can improve the outcome” as a human activity performed by a “physician or user of the medical system” (¶ 0049). This is an abstract idea. That the steps are performed on a well-known, general purpose computer (i.e., a computer having a processing system, a memory storing instructions) does not remove the invention from being directed to an abstract idea. Applicant argues “These operations are fundamentally tied to robotic medical systems.” However, the “robotic system” is interpreted as an additional element to be interpreted in Step 2A, Prong Two, which is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., generating, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only generally links the claimed invention to a particular technological environment or field of use (i.e., robotics), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims are directed to an abstract idea. “By reciting that the telemetry data is segmented based on a sequence of phases associated with the medical procedure, and that the causal discovery operation includes generating edges based on statistical correlations and then determining a directionality for each of the one or more edges based on an order of the phases in the sequence of phases, Applicant's claim 1 provides a particular, non-abstract solution to the technological problem of extracting accurate causal relationships from medical procedure-based telemetry… Applicant's claim 1 is not directed to a general algorithm on a generic computer, but rather to a specific technique of segmenting telemetry data generated by a robotic system based on a sequence of phases and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases, which constitutes an improvement to how the causal inferencing system operates. For at least the foregoing reasons, claim 1 reflects an improvement in computer functionality and technology”: Applicant argues “By reciting that the telemetry data is segmented based on a sequence of phases associated with the medical procedure, and that the causal discovery operation includes generating edges based on statistical correlations and then determining a directionality for each of the one or more edges based on an order of the phases in the sequence of phases, Applicant's claim 1 provides a particular, non-abstract solution to the technological problem of extracting accurate causal relationships from medical procedure-based telemetry… Applicant's claim 1 is not directed to a general algorithm on a generic computer, but rather to a specific technique of segmenting telemetry data generated by a robotic system based on a sequence of phases and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases, which constitutes an improvement to how the causal inferencing system operates. For at least the foregoing reasons, claim 1 reflects an improvement in computer functionality and technology.” However, “extracting accurate causal relationships from medical procedure-based telemetry” does not address a technical problem to any specific devices (i.e., robotics), technology, or computers for that matter, and thus, the claims do not provide a technical solution. Examiner notes that even a technical solution to a nontechnical problem does not integrate the judicial exception into a practical application. Even if the claims provide the aforementioned alleged improvements, these alleged benefits are at best, an improvement to the abstract idea of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output based on the analysis accordingly. However, an improved abstract idea is still an abstract idea. Examiner cannot find any problem caused by the technological environment to which the claims are confined, which per broadest reasonable interpretation of the claim in light of the specification, is a well-known, general purpose computer. The computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined. While the specification need not explicitly set forth the improvement, the disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing any technical improvement or any physical improvement to the computer. See MPEP § 2106.04(d)(1) and 2106.05(a). Furthermore, the claim limitations to which Applicant seem to refer as “the telemetry data is segmented based on a sequence of phases associated with the medical procedure, and that the causal discovery operation includes generating edges based on statistical correlations and then determining a directionality for each of the one or more edges based on an order of the phases in the sequence of phases…a specific technique of segmenting telemetry data generated by a robotic system based on a sequence of phases and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases” are interpreted as rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output based on the analysis accordingly, which is the abstract idea and not additional elements to be interpreted in Step 2A, Prong Two. Also, “a robotic system” is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., generating, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only generally links the claimed invention to a particular technological environment or field of use (i.e., robotics), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claim as a whole does not integrate the recited judicial exception into a practical application. “Under Step 2B, a claim is eligible if its elements, considered individually or as an ordered combination, are not well-understood, routine, and conventional in the relevant field... the specific ordered combination of steps- segmenting telemetry data based on a sequence of phases associated with a medical procedure, and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases to generate one or more inferences-provides a specific technical solution for analyzing telemetry data generated by a robotic system during a medical procedure that was not previously available. The unconventional nature of this specific ordered combination is evidenced by the absence of prior art demonstrating this solution…The Examiner has not provided evidence demonstrating that determining a directionality for each of one or more edges for a DAG based at least in part on an order of the phases in the sequence of phases was well-understood, routine, or conventional in the art”: Applicant argues “Under Step 2B, a claim is eligible if its elements, considered individually or as an ordered combination, are not well-understood, routine, and conventional in the relevant field.” However, whether the elements define only well-understood, routine, conventional activity is not a standalone test for determining eligibility, but an exemplary consideration in a non-limiting list of considerations. Applicant argues “the specific ordered combination of steps- segmenting telemetry data based on a sequence of phases associated with a medical procedure, and determining at least a directionality for each of one or more edges for a directed acyclic graph (DAG) based at least in part on an order of the phases in the sequence of phases to generate one or more inferences-provides a specific technical solution for analyzing telemetry data generated by a robotic system during a medical procedure that was not previously available. The unconventional nature of this specific ordered combination is evidenced by the absence of prior art demonstrating this solution.” However, per MPEP § 2106.05(I): “the search for an inventive concept should not be confused with a novelty or non-obviousness determination…As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter…a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty…Because [novelty and obviousness] are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101.” Applicant argues “The Examiner has not provided evidence demonstrating that determining a directionality for each of one or more edges for a DAG based at least in part on an order of the phases in the sequence of phases was well-understood, routine, or conventional in the art.” However, Examiner did not assert any of the claim limitations were well-understood, routine, conventional activity in Office Action dated 03/12/2026 or above, and thus, no evidence per Berkheimer is required. Thus, Examiner maintains the 101 rejections of claims 1, 3-15, 17-22, which have been updated to address Applicant’s remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance and the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence in the above Office Action. Conclusion THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM. 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, Robert Morgan can be reached on (571) 272-6773.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /EMILY HUYNH/Primary Examiner, Art Unit 3683
Read full office action

Prosecution Timeline

Mar 07, 2025
Application Filed
Mar 12, 2026
Non-Final Rejection mailed — §101
Jun 03, 2026
Response Filed
Jul 02, 2026
Final Rejection mailed — §101 (current)

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