Prosecution Insights
Last updated: August 06, 2026
Application No. 18/278,210

A Privacy Enabled System And Method For Managing Logistics For Clinical Study Participants

Non-Final OA §101§112
Filed
Aug 22, 2023
Priority
Nov 18, 2021 — provisional 63/281,046 +1 more
Examiner
SINGH, RUPANGINI
Art Unit
3628
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Gray Consulting Inc.
OA Round
3 (Non-Final)
36%
Grant Probability
At Risk
3-4
OA Rounds
12m
Est. Remaining
88%
With Interview

Examiner Intelligence

Grants only 36% of cases
36%
Career Allowance Rate
91 granted / 255 resolved
-16.3% vs TC avg
Strong +53% interview lift
Without
With
+52.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
21 currently pending
Career history
283
Total Applications
across all art units

Statute-Specific Performance

§101
35.2%
-4.8% vs TC avg
§103
32.9%
-7.1% vs TC avg
§102
3.7%
-36.3% vs TC avg
§112
23.8%
-16.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 255 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 Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 29, 2026 has been entered. Status of the Claims Claims 1-9 were previously pending and subject to a final rejection dated January 9, 2026. In the RCE, submitted on June 29, 2026 claim 1 was amended. Therefore, claims 1-9 are currently pending and rejected in the non-final rejection below. Response to Arguments Applicant’s remarks on Page 8 of the Response, regarding the previous rejection of claims 1-9 under 35 U.S.C. 112(a) have been fully considered and are found persuasive in view of the claim amendments. Applicant’s remarks on Pages 8-11 of the Response, regarding the previous rejection of claims 1-9 under 35 U.S.C. 101 have been fully considered but are not found persuasive. On Page 9 of the Response, in discussing Step 2A, Prong One, Applicant argues that claim 1 “explicitly require[s] a non-generic hardware configuration that structurally prevents non-volatile data caching, combined with a specific state-machine comparator algorithm that reverts the GUI to a prior state (e.g., step) upon a travel policy compliance failure. This is a specific technological improvement and not an abstract …The amendments to claim 1 recite a specific configuration of the computer hardware memory used in the remote workstation and the server, as well as a specific automated operational workflow for the GUI. Under the Alice/Mayo framework, amended Claim 1 is patent-eligible because it integrates the alleged abstract idea into a practical application (Step 2A, Prong 2) and recites an inventive concept (Step 2B). Accordingly, the Applicant respectfully submits that the rejection of currently pending Claims 20-25 under 35 U.S.C. § 101 is now moot and should be withdrawn.” Examiner respectfully disagrees and notes the high-level recitation of the additional elements (i.e., using volatile memory for specific data, GUI displaying data) amount to apply it or merely using a computer as a tool to perform the concept. On Pages 9-10 of the Response, Applicant further argues that the claims “fundamentally alters how the claimed computer hardware operates. Specifically, it forces the system to rely only on volatile computer memory (e.g., RAM) to transmit and display highly sensitive data (e.g., obfuscated personal information). Accordingly, the claimed system does not utilize the ‘conventional’ or ‘generic’ data caching in non-volatile and instead explicitly prevents this standard hardware operation. This is a specific, hardware-level reconfiguration that solves a technical vulnerability (local data leakage via disk caching) inherent in distributed network systems. It is not a mere instruction to perform an abstract idea. The specification explicitly supports this as a specific measure for ‘added privacy protection and data security’ given the inherent security risks of accessing sensitive Personal Information (PI) over public networks and on insecure devices. Paragraph [0008] notes the complexity of securing data accessed by ‘thousands of individuals... over public networks, and in insecure locations’. Standard computing systems cache data to non-volatile storage by default, creating a risk that sensitive data remains on a device after use. Claim 1 as amended provides a technological solution to data leakage by ensuring data physically vanishes upon power loss or session termination, a security feature generic computers do not enforce by default... Accordingly, the claim as amended recites a specific technical solution (disabling non-volatile caching for specific obfuscated datasets) to a technical problem (data security on a networked workstation) and it constitutes an improvement to computer functioning pursuant to Step 2A, Prong 2.” Examiner respectfully disagrees that using “volatile computer memory (e.g., RAM) to transmit and display … data” verses caching is “a technological solution to data leakage” as alleged, rather it amounts to apply it. That the data itself is highly sensitive data (e.g., obfuscated personal information) merely reflects the abstract idea. Applicant alleges “hardware-level reconfiguration” however, nothing in the claims or specification describes reconfiguring hardware. Paragraph [0081] merely states “security workstation 40, internet gateway 7, server 3, and other devices within system 1, may be configured to prevent caching personal information to non-volatile storage (e.g., disk, ROM) and instead use only volatile computer memory (e.g., RAM) to transmit/display personal information”, however nothing in the claims or specification describes a “reconfiguration” of hardware as alleged. Similarly, Applicant alleges “disabling non-volatile caching for specific obfuscated datasets”, however, nothing in the claims or specification describes a disabling step as alleged. Thus, Applicant’s arguments are not found persuasive. On Page 10 of the Response, Applicant argues that the claim recites “this exact state-machine logic. The system executes a specific technical process: routing data to an automated workflow and, based on the output, automatically triggers a state transition in the GUI to revert to a previous data-entry state. This physical manipulation of the graphical user interface based on algorithmic output further grounds the claim in a practical, technological application rather than a purely abstract concept.” Examiner respectfully disagrees and notes that “routing data to an automated work flow” and “GUI…configured to return the… interface…to a previous step allowing modification of the…information” amounts to apply it or merely using a computer as a tool to perform the concept. That is, “physical manipulation of the graphical user interface based on algorithmic output” amounts to apply it or merely using a computer as a tool to perform the concept. Thus, Applicant’s arguments are not found persuasive. On Page 11 of the Response, in discussing Step 2B, Applicant further argues “the combination of (1) randomly generating anonymous unique identifiers for obfuscated personal data, (2) disabling standard non-volatile hardware caching to exclusively utilize volatile memory during the transit of this specific data, and (3) enforcing programmatic state-reversions within a GUI upon algorithmic rule failure provide detailed and specific architecture that is neither generic nor well-understood. There is no evidence in the record that configuring a networked workstation to intentionally bypass its own non-volatile storage caching mechanisms while processing anonymous identifiers for obfuscated personal data was a well-understood, routine, or conventional activity at the time of the invention. Any assertion that this specific ordered combination of hardware memory reconfiguration and automated GUI state transitions is merely well-understood, routine, and conventional, must be supported with objective evidence in pursuant to MPEP § 2106.07(a)(III). Absent such factual evidence on the record, any continued subject matter eligibility rejection under Step 2B cannot be sustained.” Examiner notes the features upon which applicant relies (i.e., “disabling standard non-volatile hardware caching to exclusively utilize volatile memory during the transit of this specific data”, “configuring a networked workstation to intentionally bypass its own non-volatile storage caching mechanisms”) are not recited in the rejected claims. Lastly, Examiner notes that Examiner has not indicated that any of the claimed additional elements are “was a well-understood, routine, or conventional activity at the time of the invention” as alleged. Therefore, the evidentiary requirement of Berkheimer is not triggered, and Applicant’s arguments are moot. 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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Step 1 Claims 1-9 recite a system comprising a server (i.e., a machine). Therefore, the claims all fall within one of the four statutory categories of invention. Step 2A, Prong One Claim 1 recites a privacy enabled system for secure visualization and enforcement of a travel policy for a clinical study by: storing data records with randomly generated unique identifiers to obfuscate personal information; providing a study dataset comprising a first travel policy condition, and a study travel policy dataset comprising a main travel policy and a specialized travel policy; transmit and display the obfuscated personal information; wherein the first travel policy condition is selected from the group consisting of a country, a clinical site, a traveler policy label, a visit attribute, a visit policy label, and combinations thereof; wherein the specialized travel policy is associated with the first travel policy condition via a unique identifier corresponding to the first travel policy condition; wherein the system is configured to apply the main travel policy to the trip segment by default, and to apply the specialized travel policy to override the main travel policy only when the trip segment matches the first travel policy condition; wherein the system is configured to receive a booking request for the trip segment comprising segment booking information; wherein responsive to receiving the booking request the system executes a comparator algorithm to compare the segment booking information against the main travel policy by default or against the specialized travel policy when the specialized travel policy overrides the main travel policy; wherein the system is configured to invoke an approval workflow if the comparator algorithm determines the segment booking information is non-compliant with one or more of the main travel policy or the specialized travel policy; wherein, responsive to the approval workflow resulting in a rejection, allowing modifying of the segment booking information; wherein the specialized travel policy is selected from a country policy, a site policy, a first visit policy, a second visit policy, a custom policy, and combinations thereof; receiving the travel policy condition and study travel policy dataset using the unique identifier for a query; displaying the travel policy condition, the main travel policy, and the specialized travel policy; visually associate the first travel policy condition with the specialized travel policy; enable modifying the specialized travel policy; and, wherein responsive modifying the specialized travel policy, is configured to (a) receive a modified specialized travel policy, (b) store the modified specialized travel policy replacing the specialized travel policy, (c) associate the modified specialized travel policy with the first travel policy condition by linking the modified specialized travel policy to the unique identifier, and (d) visually associate the travel policy condition with the modified specialized travel policy. The claim as a whole recites a certain method of organizing human activity. The limitations recited above, under broadest reasonable interpretation, recite the abstract idea of a certain method of organizing human activity, e.g., commercial interactions or fundamental economic practices. Therefore, the claim recites an abstract idea. Step 2A, Prong Two The judicial exception is not integrated into a practical application. Claim 1 as a whole amounts to: “apply it” (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. Claim 1 recites the additional elements of: (i) a server secured within a private cloud, the server in communication with a networked workstation via an internet gateway; (ii) prevent caching of information to non-volatile storage and using only volatile computer memory to transmit and display information; (iii) a database (to programmatically associate data; for being queried); (iv) a GUI (for updating interfaces) comprising a travel policies interface and a travel policy control, wherein the GUI is configured to be displayed on the networked workstation, and the GUI is configured to return the travel policies interface to a previous step; and (v) automated enforcement, and programmatically associate data. The above additional elements of: (i) –(v) are recited at a high-level of generality such that, when viewed as whole/ordered combination, it amounts to no more than mere instructions to apply the judicial exception using generic computer components (See MPEP 2106.05(f)). Accordingly, these additional elements, when viewed as a whole/ordered combination (See Figs. 1 and 4) do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea. Step 2B As discussed above with respect to Step 2A Prong Two, the additional elements amount to no more than reciting the words “apply it” (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea; or generally link the use of a judicial exception to a particular technological environment or field of use. The same analysis applies here in 2B, i.e., reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, does not integrate the abstract idea into a practical application at Step 2A or provide an inventive concept at Step 2B. Therefore, the additional elements discussed above do not integrate the abstract idea into a practical application at Step 2A or provide an inventive concept at Step 2B. Thus, even when viewed as a whole/ordered combination, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea. Thus, the claim is ineligible. Dependent claims 2-5, and 8-9 further recite details which merely narrow the previously recited abstract idea limitiaitions. For these reasons, as described above with respect to claim 1, these judicial exceptions are not meaningfully integrated into a practical application or significantly more than the abstract idea. Thus, claims 2-5 and 8-9 are also ineligible. Claim 6 describes wherein the clinical dataset further comprises a second participant dataset; receiving and displaying the second participant dataset; associating the second participant dataset with the second travel policy condition; and, responsive to associating the second participant dataset with the second travel policy condition: associate the new specialized travel policy with the second participant dataset – which merely narrows the previously recited abstract idea. The claim adds the additional element of a participant travel policies interface having a participant policy control, wherein using the participant policy control the GUI is configured to cause the database to programmatically associate data with the second participant dataset. The abstract idea is not integrated into a practical application because the additional element merely serves as generic computer components on which the abstract idea is implemented. See MPEP 2106.05(f). The claim does not include limitations sufficient, either alone or in combination, to amount to significantly more than the claimed abstract idea because the aforementioned additional elements merely serve as generic computer components on which the abstract idea is implemented. See MPEP 2106.05(f) Dependent claim 7 further recite details which merely narrow the previously recited abstract idea limitiaitions. For these reasons, as described above with respect to claim 6, these judicial exceptions are not meaningfully integrated into a practical application or significantly more than the abstract idea. Thus, claim 7 is also ineligible Allowable over the Prior Art Claims 1-9 are allowable over the prior art because the prior art fails to teach the combination of limitations in claim 1. The closest prior art includes: U.S. Patent Application Publication No. 2015/0046187 to Johnson et al. (hereinafter “Johnson”). Johnson discloses a clinical trial participant transportation system that has a transportation request portal in the form of an online interface. The clinical trial participant transportation system examines the details of the desired transportation and determine whether the specific desired transportation matches up with what would be expected and allowable under the parameters of the clinical trial. U.S. Patent Application Publication No. 2019/0034805 to Cohen-Zur et al. (hereinafter “Cohen-Zur”). Cohen-Zur discloses a user interface where a manager can use on/off switches to control whether a particular criterion is to be used in the determination of the recommended action. U.S. Patent Application Publication No. 2021/0209522 to Shaw et al. (hereinafter “Shaw”). Shaw discloses merging a set of rules, wherein the specified manner of merging the respective policies comprises resolving any conflicts between the policies, wherein: additional travel policy properties of the corporate body override corporate body travel rules, additional travel policies of the travelers override travel policies of the travelers, and corporate body travel rules and additional policies override travel policies and additional policies of the travelers. U.S. Patent Application Publication No. 2014/0019176 to Mandelbaum et al. (hereinafter “Mandelbaum”). Mandelbaum discloses importing information associated with one or more appointments from a traveler's calendar to automatically plan and book a complete itinerary. U.S. Patent Application Publication No. 2018/0182055 to Jepson et al. (hereinafter “Jepson”). Jepson discloses systems and methods for coordinating, arranging and/or managing transportation. These systems and methods can be used and applied in a variety of settings and industries, including healthcare. U.S. Patent Application Publication No. 2014/0278597 to Wilkinson et al. (hereinafter “Wikinson”). Wilkinson discloses an administrator interface in which an administrator accesses the system. An administrator may set a user's travel policy with and may access the administrator module and enter travel policy in the travel policy database. The administrator module provides the ability of the administrator to access and view stored travel search criteria and in-policy booking options (and other information) across the entire organization. “Transportation innovation to aid Parkinson disease trial recruitment” by Frank et al., dated December 2019 (hereinafter “Frank”). Frank discloses pre-arranged rides through a third-party ride sharing service for a clinical trial. “Why both no-cache and no-store should be used in HTTP response?” dated May 6, 2021 by Stackoverflow (hereinafter “Stackoverflow”). Stackoverflow discloses a no-store directive is to prevent the inadvertent release or retention of sensitive information. No-store is effectively the full do not cache directive and is intended to prevent storage of the representation in any form of cache whatsoever. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rupangini Singh whose telephone number is (571)270-0192. The examiner can normally be reached Mon-Fri 9-5. 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, Shannon Campbell can be reached on (571) 272-5587. 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. /RUPANGINI SINGH/Primary Examiner, Art Unit 3628
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Prosecution Timeline

Aug 22, 2023
Application Filed
Jul 15, 2025
Non-Final Rejection mailed — §101, §112
Dec 14, 2025
Response Filed
Jan 09, 2026
Final Rejection mailed — §101, §112
Jun 09, 2026
Response after Non-Final Action
Jun 29, 2026
Request for Continued Examination
Jun 30, 2026
Response after Non-Final Action
Jul 15, 2026
Non-Final Rejection mailed — §101, §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
36%
Grant Probability
88%
With Interview (+52.6%)
3y 11m (~12m remaining)
Median Time to Grant
High
PTA Risk
Based on 255 resolved cases by this examiner. Grant probability derived from career allowance rate.

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