Prosecution Insights
Last updated: July 17, 2026
Application No. 18/732,403

SYSTEMS AND METHODS FOR MAINTAINING DATA INTEGRITY IN A HEALTH ANALYSIS PLATFORM BY ASSESSING AND MODIFYING PHYSIOLOGICAL MEASUREMENTS BASED ON FILTERED HEALTHCARE DATA

Final Rejection §101§103§112
Filed
Jun 03, 2024
Examiner
SANGHERA, STEVEN G.S.
Art Unit
3684
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Medidata Solutions Inc.
OA Round
2 (Final)
30%
Grant Probability
At Risk
3-4
OA Rounds
1y 9m
Est. Remaining
59%
With Interview

Examiner Intelligence

Grants only 30% of cases
30%
Career Allowance Rate
51 granted / 170 resolved
-22.0% vs TC avg
Strong +29% interview lift
Without
With
+29.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
44 currently pending
Career history
234
Total Applications
across all art units

Statute-Specific Performance

§101
15.4%
-24.6% vs TC avg
§103
80.9%
+40.9% vs TC avg
§102
1.2%
-38.8% vs TC avg
§112
2.1%
-37.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 170 resolved cases

Office Action

§101 §103 §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 . Response to Amendment In light of the amendments, the previous claim objections have been withdrawn. In light of the amendments, the previous 112(b) rejections have been withdrawn. In light of the amendments, the claims are rejected under 35 U.S.C. 101. In light of the amendments, the claims are rejected under 35 U.S.C. 103. Notice to Applicant In the amendment dated 04/21/2026, the following has occurred: claims 38, 43-44, 46, 48, and 50-57 have been amended; claims 39-42, 45, 47, and 49 remain unchanged; and no new claims have been added. Claims 38-57 are pending. Effective Filing Date: 06/03/2024 Response to Arguments Claim Objections: Applicant canceled the previous limitation which had a claim objection. Examiner withdraws this objection. 35 U.S.C. 112(b) Rejections: Applicant has overcome the 112(b) issues via amendment. Examiner withdraws these rejections. 35 U.S.C. 101 Rejections: Applicant argues that the claims are not directed towards a mathematical concept. Examiner agrees. The claims are directed towards certain methods of organizing human activity. Applicant further states that the claims are not directed towards certain methods of organizing human activity (CMOHA), more specifically fundamental economic practices. Examiner however respectfully disagrees as the claims are indeed directed towards CMOHA, but under managing personal behavior or relationships or interactions between people (including following rules or instructions). Lastly, Applicant argues that the claims are not directed towards mental processes. Examiner agrees. 35 U.S.C. 103 Rejections: Examiner withdraws the previous 103 art rejections in view of the amendments requiring an unreasonable combination of references in order to reject these claims. Claim Rejections - 35 USC § 112(b) 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. Claims 38-57 are 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. Claims 38, 52, and 57 each recite “a bus system” twice and “a data store” three times. Examiner is unsure if these are supposed to be the same components for each recitation or if they are supposed to be different, leading to the claims being indefinite. Examiner is interpreting that, for each claim, all recitations of “a bus system” are referring to the same system and all recitations of “a data store” are referring to the same store. Claim 38 also recites “at least one processor” twice in the claim (in the 3rd line of the claim and the 4th-to-last line of the claim). Examiner is unsure if these are supposed to be the same components, leading to the claims being indefinite. Examiner is interpreting that these components are the same. Claims 39-51 and 53-56 are rejected based on their dependency on claims 38 and 52. 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 38-57 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. Claims 38-51 are drawn to a system, claims 52-56 are drawn to a method, and claim 57 is drawn to a media, each of which is within the four statutory categories. Claims 38-57 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES). Step 2A: Prong One: Claim 38 recites a system for maintaining data integrity in a computerized health analysis platform, the system comprising: a) at least one processor; and b) a memory subsystem communicatively coupled to the at least one processor, the memory subsystem storing instructions which, when executed by the at least one processor, cause the at least one processor to perform operations comprising: 1) accessing, by c) a bus system from d) a data store, one or more first data structures comprising: a plurality of first data sets regarding a plurality of entities, wherein each of the first data sets represents measurements of one or more physiological parameters of the plurality of entities, and one or more health-related attributes of the plurality of entities; 2) reading, from a data store, e) executable measurement unit determination software comprising f) a data filtration tool and g) a unit determination tool; 3) executing, by the at least one processor, the measurement unit determination software to perform operations comprising: 3a) determining, by the data filtration tool of the executable measurement unit determination software, a first subset of the first data sets based on the one or more health-related attributes of the plurality of entities; and 3b) based on one or more measurements of the one or more health-related attributes, generating, by the data filtration tool of the executable measurement unit determination software in one or more measurement units, a reference measurement range of the one or more physiological parameters represented in the first subset determining based on the one or more health-related attributes; 4) accessing, a bus system from a data store, one or more second data structures comprising: one or more second data sets regarding one or more target entities, wherein the one or more second data sets represent one or more measurements of the one or more physiological parameters of the one or more target entities, wherein the one or more target entities exhibit the one or more health-related attributes, and wherein the one or more measurements of the one or more target entities lack a measurement unit or exhibit a mislabeling error regarding the measurement unit; 5) based on execution of the measurement unit determination software, determining, by the unit determination tool of the measurement unit determination software and based on the reference measurement range, the measurement unit for the one or more measurements that lack the measurement unit or exhibit the mislabeling error regarding the measurement unit; 6) generating, by the at least one processor, a third data structure representing the measurement unit; 7) storing, by at least one processor, the third data structure in h) a hardware storage device; and 8) outputting, by an input/output (I/O) interface to an I/O device, a graphical user interface of the third data structure in a display format. Claim 38, in part, performing the steps of 1) accessing one or more first data structures comprising: a plurality of first data sets regarding a plurality of entities, wherein each of the first data sets represents measurements of one or more physiological parameters of the plurality of entities, and one or more health-related attributes of the plurality of entities, 3) perform operations comprising: 3a) determining, by the data filtration tool (when not software), a first subset of the first data sets based on the one or more health-related attributes of the plurality of entities and 3b) based on one or more measurements of the one or more health-related attributes, generating, by the data filtration tool in one or more measurement units, a reference measurement range of the one or more physiological parameters represented in the first subset determining based on the one or more health-related attributes, 4) accessing one or more second data structures comprising: one or more second data sets regarding one or more target entities, wherein the one or more second data sets represent one or more measurements of the one or more physiological parameters of the one or more target entities, wherein the one or more target entities exhibit the one or more health-related attributes, and wherein the one or more measurements of the one or more target entities lack a measurement unit or exhibit a mislabeling error regarding the measurement unit, 5) determining, by the unit determination tool and based on the reference measurement range, the measurement unit for the one or more measurements that lack the measurement unit or exhibit the mislabeling error regarding the measurement unit, 6) generating a third data structure representing the measurement unit, and 7) storing the third data structure. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes how one could organize data. Independent claims 52 and 57 recite similar limitations and are also directed to an abstract idea under the same analysis. Depending claims 39-51 and 53-56 include all of the limitations of claims 38 and 52, and therefore likewise incorporate the above described abstract idea. Depending claim 39 adds the additional step of “providing the third data structure to the computerized health analysis platform”; claim 42 adds the additional steps of “comparing measurement values of the one or more physiological parameters of the first subset of the first data sets with each other” and “converting different measurement units of the one or more physiological parameters of the first subset to the one or more measurement units”; claims 43 and 53 add the additional steps of “comparing one or more values of the one or more measurements to the reference measurement range” and “determining, based on the comparison, that the one or more measurements exhibit the mislabeling error or lack the measurement unit”; claims 44 and 54 add the additional steps of “determining a frequency of the one or more values of the one or more measurements that fall within the reference measurement range” and “determining the mislabeling error based on the frequency”; claims 45 and 55 add the additional step of “generating a score based on the comparison of the one or more values of the one or more measurements to the reference measurement range”; claim 46 adds the additional step of “based on comparing the score to a threshold score, determining the one or more measurements exhibit the mislabeling error”; claim 47 adds the additional step of “outputting the measurement unit to a display of a user interface”; claims 48 and 56 add the additional step of “generating, on the display of the user interface, an indication of whether one or more measurements exhibit the mislabeling error or lack the measurement unit”; claim 49 adds the additional step of “generating a frequency graph that represents a relationship between a frequency of the one or more measurements and a plurality of measurement units”; claim 50 adds the additional step of “utilizing a machine learning classifier to determine the measurement unit, wherein the machine learning classifier is trained based on z-score probability and one or more of frequency features, wherein the frequency features comprise a unit frequency by study, a unit frequency by site, and a unit frequency by subject, and wherein utilizing a machine learning classifier to determine the measurement unit comprises utilizing logistic regression model to predict, based on the z-score probability derived from the reference measurement range and the frequency features, a binary outcome that indicates a possibility of the one or more measurements being measured in one or more respective measurement units”; and claim 51 adds the additional step of “modifying, based on the third data structure, the one or more second data sets, wherein modifying the one or more second data sets improves data integrity by preventing processing of incomplete or erroneous second data sets, and wherein the measurement unit (i) is incorporated into the one or more measurements that lack the measurement unit or (ii) replaces respective measurement unit of the one or more measurements that exhibit the mislabeling error”. Additionally, the limitations of depending claims 40-41 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 39-51 and 53-56 are nonetheless directed towards fundamentally the same abstract idea as independent claims 38 and 52 (Step 2A (Prong One): YES). Prong Two: This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) at least one processor, b) a memory subsystem communicatively coupled to the at least one processor, the memory subsystem storing instructions which, when executed by the at least one processor, cause the at least one processor to perform operations, c) a bus system from d) a data store, e) executable measurement unit determination software comprising f) a data filtration tool and g) a unit determination tool, h) a hardware storage device, i) an electronic device (from claims 52 and 56), and j) a user interface (from claims 47, 48, and 56) to perform the claimed steps. The claims also include the additional element steps of 2) “reading, from a data store, executable measurement unit determination software comprising a data filtration tool and a unit determination tool”, 3) “executing, by the at least one processor, the measurement unit determination software”, and 8) “outputting, by an input/output (I/O) interface to an I/O device, a graphical user interface of the third data structure in a display format”. The a) at least one processor, b) memory subsystem, c) a bus system from d) a data store, e) executable measurement unit determination software comprising f) a data filtration tool and g) a unit determination tool, h) a hardware storage device, i) an electronic device, and j) a user interface in these steps and the additional element steps of 2) “reading, from a data store, executable measurement unit determination software comprising a data filtration tool and a unit determination tool” and 3) “executing, by the at least one processor, the measurement unit determination software” are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraphs [0083] and [0098] where these components are recited as being generic, see MPEP 2106.05(f)). Additionally, the additional element step of 8) “outputting, by an input/output (I/O) interface to an I/O device, a graphical user interface of the third data structure in a display format” adds insignificant extra-solution activity to the abstract idea which amounts to insignificant application, see MPEP 2106.05(g). Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application. Accordingly, these 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. The claims are directed to an abstract idea (Step 2A (Prong Two): NO). Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) at least one processor, b) a memory subsystem communicatively coupled to the at least one processor, the memory subsystem storing instructions which, when executed by the at least one processor, cause the at least one processor to perform operations, and c) a hardware storage device to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of mere instructions to apply the exception using generic computer components that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d) and MPEP 2106.05(f) recites that the following limitations are not significantly more: Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)). The current invention generates and stores a data structure utilizing a) at least one processor, b) a memory subsystem, c) a bus system from d) a data store, e) executable measurement unit determination software comprising f) a data filtration tool and g) a unit determination tool, h) a hardware storage device, i) an electronic device, and j) a user interface and the additional element steps of 2) “reading, from a data store, executable measurement unit determination software comprising a data filtration tool and a unit determination tool” and 3) “executing, by the at least one processor, the measurement unit determination software”, thus these computing components and steps are adding the words “apply it” with mere instructions to implement the abstract idea on a computer. Additionally, the additional element step of 8) “outputting, by an input/output (I/O) interface to an I/O device, a graphical user interface of the third data structure in a display format” adds insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives third structure data, and transmits the data to a device over a network, for example the Internet. Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO). Claims 38-57 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. No Art Rejections Claims 38-57 do not have art rejections applied based on the prior art references which could be used to reject these claims not being reasonable to reject with, alone or in combination. Conclusion 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 THREE-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 final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri). 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, Shahid Merchant can be reached at 571-270-1360. 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. /STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
Read full office action

Prosecution Timeline

Jun 03, 2024
Application Filed
Feb 11, 2026
Non-Final Rejection mailed — §101, §103, §112
Apr 01, 2026
Interview Requested
Apr 08, 2026
Applicant Interview (Telephonic)
Apr 08, 2026
Examiner Interview Summary
Apr 21, 2026
Response Filed
Jun 26, 2026
Final Rejection mailed — §101, §103, §112 (current)

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

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Prosecution Projections

3-4
Expected OA Rounds
30%
Grant Probability
59%
With Interview (+29.1%)
3y 10m (~1y 9m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 170 resolved cases by this examiner. Grant probability derived from career allowance rate.

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