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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 31, 2025 has been entered.
Response to Amendment
In the amendment filed on October 31, 2025, the following has occurred: claim(s) 21-24, 26, 29-32, 34, 37 have been amended. Now, claim(s) 21-37 are pending.
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.
Claim(s) 21-37 is/are rejected under 35 U.S.C. 101 because the claimed invention is
directed to an abstract idea without significantly more.
Claims 21-28: Step 2A Prong One
Claim 21 recite(s)
creating a profile for the participant including a first biometric sample identifying the participant, wherein the first biometric sample includes a selfie of the participant;
opening instructions for performing testing during the clinical trial being conducted of a test product;
performing testing of the test product based on the instructions, wherein the testing includes:
creating a first self-verifying data set comprising a plurality of data subsets, wherein the plurality of data subsets includes:
(i) a first data subset including the first biometric sample;
(ii) a second data subset including a time stamp marking a time of creation of the first self-verifying data set;
(iii) a third data subset including an internet protocol (IP) address associated with the smartphone; and
(iv) a fourth data subset including test data points identified for storing based on the instructions, wherein the test data points represent a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior or
relationships or interactions between people (including social activities, teaching, and following
rules or instructions) which is a subgrouping of Certain Methods of Organizing Human
Activity. That is, other than reciting, “a smartphone”, “a testing module including”, “from the smartphone” to perform these functions, nothing in the claim precludes the limitations from practically being performed by a person following rules or instructions to conduct a test. For example, the claims encompass a user following instructions to create a profile for the participant including a first biometric sample identifying the participant, a user following instructions to open instructions for performing testing during the clinical trial, and a user following instructions to performing testing of the test product based on the instructions.
Claims 22-28 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, claim 22 recites an additional generic computer component, “a server”, and describes instructions to follow before opening the generic computer component, the testing module. Similarly, claim 23 recites a step to communicate an encrypted version of the data set. Similarly, claim 24 recites steps to create a second self-verifying data set, and transmit from the smartphone the second self-verifying data set. Similarly, claims 25-26, 28 further describe the first self-verifying data set. Finally, claim 27 further describes the biometric sample. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 21-28: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining
elements amount to no more than general purpose computer components programmed to perform the abstract idea and adding insignificant extra-solution activity.
Claims 21-28, directly or indirectly, recite the following generic computer components, “a testing module including”, “from the smartphone”, and “a server” (i.e., “Types of test data points may be generated by a computing device such a smart phone and can include but are not limited images showing administration of serialized test products, health measurements that may be entered into the application running the test module or included within an image, audio recordings that cover the users breathing of speech patterns, and users responses to questionnaires.” (See Specification in Paragraph [0045]) and “In other embodiments, the CD 102 may connect to the network 114 via a Wi-Fi connection. Once connected to the network 114, the CD 102 may download an application from a server 116 within the network 114. In other embodiments, the application may be downloaded from a third party server such as the Google App store. The server 116 may further include one or more trial modules 118. Each trial module 118 within the server 116 may correspond to a different trial that can be run by the application.” (See Specification in Paragraph [0017]).) As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “receiving to the smartphone an indication of whether the first self-verifying data set is valid and in compliance with the testing of the test product based on the instructions” and “transmitting the first self-verifying data set for determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions” that does not integrate the judicial exception into a practical application because they merely recite insignificant, extra-solution activity of data gathering of the abstract idea (See MPEP 2106.05(g)).
Claims 21-28: Step 2B
The claim(s) does/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 computer
configured to perform above identified functions amounts to no more than mere instructions to
apply the exception using generic computer components. Mere instructions to apply an exception
using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at
223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.")
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2016.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Additionally, receiving or transmitting data over a network, (Symantec, 838 F.3d at 1321,
120 USPQ2d at 1362 (utilizing an intermediary computer to forward information). Merely adding well-understood, routine, and conventional activity of a general-purpose computing device to a judicial exception is insufficient to transform the claim into patent-eligibility.
Claims 29-36 and 37 recite the same functions as claims 21-28, but in device and computer program product forms. Therefore, these claims also recite abstract ideas that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas as explained above. These claims also do not integrate the abstract idea into a practical application for the same reasons as explained above because they merely include instructions to implement the abstract idea on a computer. The addition of “processing circuitry; and a non-transitory computer readable memory coupled to the processing circuitry, wherein the smartphone is configured to:” in claim 29 and “a non-transitory computer readable medium storing a computer program product comprising instructions which, when executed on processing circuitry, cause the processing circuitry to:” in claim 37 recites generic computer components (See Specification in Paragraph [0062]: “In embodiments where PC 502 includes a programmable processor, a computer readable storage medium (CRSM) 542 may be provided. CRSM 542 may store a computer pro- gram (CP) 543 comprising computer readable instructions (CRI) 544.CRSM 542 may be a non- transitory computer readable medium, such as, magnetic media (e.g., a hard disk), optical media, memory devices (e.g., random access memory, flash memory), and the like.”)
Therefore, whether considered alone or in combination, the additional elements do not
amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-37 are rejected under 35 U.S.C. 103 as being unpatentable over Sillay et al. (U.S. Patent Pre-Grant Publication No. 2014/0257047) in view of Pulitzer et al. (U.S. Patent Pre-Grant Publication No. 2019/0027258).
As per independent claim 21, Sillay discloses a smartphone-enabled method for use in a clinical trial for integrated real- time data acquisition, validation, and compliance for a participant, wherein during the method the participant uses a smartphone, the method comprising:
creating a profile for the participant including a first biometric sample identifying the participant (See Paragraphs [0151]-[0154], [0160], [0196]: An individual with disease or a caregiver or assistant may use the device, or a different device such as a desktop or laptop computer, tablet, or smart phone, to access a server computer in order to control access to stored information about or derived from the individual with disease, which the Examiner is interpreting stored information about or derived from the individual with disease to encompass creating a profile for the participant, and the Examiner is interpreting the Client Interface Device's communications or networking component(s) can, under the direction of a stored program executed by the processor, upload data to a medical records system implemented, by example, on a Server or other computer or computer system adapted to receive the data into an individual with disease's file via a communications interface to encompass a first biometric sample identifying the participant), wherein the first biometric sample includes a selfie of the participant captured by the smartphone (See Paragraph [0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting the Client Interface Device to encompass the smartphone, and still or motion image data to encompass a selfies of the participant);
opening a testing module including instructions for performing testing during the clinical trial being conducted of a test product (See Paragraphs [0285]-[0286]: Combined with known stimulation or other therapy metrics, and computation of recommended further adjustment or therapy will be made and an alert given to the user or to the relevant care provider, in the case of a fluid filled delivery pump, the pump will be instructed or instructions displayed for increasing or decreasing the level of delivered therapy, which the Examiner is interpreting the pump to encompass a test product, therapy to encompass the clinical trial, and instructions displayed to encompass a testing module including instructions);
performing testing of the test product based on the instructions, wherein the testing includes:
creating a first self-verifying data set comprising a plurality of data subsets (See Paragraphs [0158]-[0163], [0173]-[0178]: The system, has at any given time, a state, which is determined by the totality of the stored individual with disease-related data, and implements a method to select a subset of the data for further processing (cohort data) based upon one or more criteria such as the age, gender, ethnicity, geographic location, disease status, treatment or treatments applied, service provider(s), services rendered, participation in a program, duration and type(s) of data stored, devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program, for each individual with disease for which data are stored, which the Examiner is interpreting devices or protocols used to gather data to encompass creating a first self-verifying data set comprising a plurality of data subset), wherein the plurality of data subsets includes:
(i) a first data subset including the first biometric sample (See Paragraphs [0195]-[0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting the image data to encompass a first data subset including the first biometric sample);
(ii) a second data subset including a time stamp marking a time of creation of the first self-verifying data set (See Paragraphs [0153], [0158]-[0163], [0173]-[0178]: The system, has at any given time, a state, which is determined by the totality of the stored individual with disease-related data, and implements a method to select a subset of the data for further processing (cohort data) based upon one or more criteria such as the age, gender, ethnicity, geographic location, disease status, treatment or treatments applied, service provider(s), services rendered, participation in a program, duration and type(s) of data stored, devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program, for each individual with disease for which data are stored, which the Examiner is interpreting devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program to encompass a time stamp marking a time of creation of the first self-verifying data set);
(iii) a third data subset including an internet protocol (IP) address associated with the smartphone (See Paragraphs [0232]-[0233]: One could then determine the frequency of twitter feed and Internet searches based upon location by IP address or GPS location during the search and process the relationship between cost, quality, and travel for the cohort); and
(iv) a fourth data subset including test data points identified for storing based on the instructions (See Paragraphs [0158]-[0163], [0173]-[0178]: The system, has at any given time, a state, which is determined by the totality of the stored individual with disease-related data, and implements a method to select a subset of the data for further processing (cohort data) based upon one or more criteria such as the age, gender, ethnicity, geographic location, disease status, treatment or treatments applied, service provider(s), services rendered, participation in a program, duration and type(s) of data stored, devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program, for each individual with disease for which data are stored, which the Examiner is interpreting duration and type(s) of data stored to encompass a fourth data subset including test data points identified for storing based on the instructions), wherein the test data points represent a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant (See Paragraphs [0195]-[0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting acquire either still or motion (video) image data to encompass a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant when combined with Pulitzer described below);
transmitting from the smartphone the first self-verifying data set for determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions (See Paragraphs [0245]-[0246], [0280]-[0286]: The metrics may be stored in one or more Servers, which may communicate with Client Interface Devices or other computers or computer systems or devices to implement upload, download, viewing, and access control features of the method such as authentication, granting and revocation of access privileges, non-repudiation, logging, and audit trail records, which the Examiner is interpreting communicate with Client Interface Devices or other computers or computer systems or devices to encompass transmitting from the smartphone the first self-verifying data set, interpreting a drop-out rate is calculated at different points in therapy and in follow-up, and methods including telephone calls, reminder e-mails, and direct mailings are used both the attempt to assess the reasons for follow-up loss, make changes to ensure compliance and retention, and add feedback to the improvement of the system to encompass determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions); and
receiving to the smartphone an indication of whether the first self-verifying data set is valid and in compliance with the testing of the test product based on the instructions (See Paragraphs [0286]-[0288]: Should other testing be indicated, an alert will sound asking the user to perform a test or take a measurement, which the Examiner is interpreting an alert to encompass an indication of whether the first self-verifying data set is valid and in compliance with the testing of the test product based on the instructions as if other testing should be indicated the first self-verifying data set may not be valid or in compliance with the testing of the test product based on the instructions.)
While Sillay discloses the method wherein the test data points represent a second biometric sample including a selfie comprising the participant, Sillay may not explicitly teach wherein the test data points represent a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant.
Pulitzer teaches a method wherein the test data points represent a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant (See Paragraphs [0109], [0134]: The user performs a self-diagnostic medical test and uses a mobile application running on a mobile device 802 to capture an image of the test product, the diagnostic test identifier allows for the type of test being used by the user of the mobile device to be determined, the identifier may be a number associated with the test, or any other means of identifying the test being performed by the user of the mobile device, which the Examiner is interpreting the identifier may be a number associated with the test to encompass a first serialized test.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Sillay to include an image of a first serialized test product administered to the participant as taught by Pulitzer. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sillay with Pulitzer with the motivation of provide clinical health care from a distance (See Background of Pulitzer in Paragraph [0003]).
Claim(s) 29 and 37 mirrors claim 21 only within (a) different statutory category, and is rejected for the same reason as claim 21. The addition of “processing circuitry; and a non-transitory computer readable memory coupled to the processing circuitry, wherein the smartphone is configured to” in claim 29 and “a non-transitory computer readable medium storing a computer program comprising instructions which, when executed on processing circuitry, cause the processing circuitry to:” in claim 37 is encompassed by Sillay in Paragraphs [0158]: “Multiple computer systems or processors may be utilized to implement the server; for example, a processor may be used to execute a stored program and implement the method to select, and a second processor may be used to manage the storage of data.”
As per claim 22, Sillay/Pulitzer discloses the method of claim 21 as described above. Sillay further teaches the method further comprising:
prior to opening the testing module, downloading the testing module from a server (See Fig. 8 and Paragraph [0294]: The individual with disease or the doctor may store/download to the local device (FIG. 8) what medication treatment protocol the individual with disease is personally using to be able to develop a true cohort database with other similarly situated individuals diagnosed with a disease); and
prior to creating the first self-verifying data set, uploading the profile for the participant to the server, wherein at least one of the IP address and the first biometric sample is assigned to the profile (See Paragraphs [0151]-[0153]: The invention utilizes personal devices such as smart phones (FIG. 8) or other wearable computers (FIG. 105), which may contain data acquisition components such as gyroscopes, accelerometers, a universal time clock, a GPS receiver coupled to the clock, and wireless network transceivers (FIG. 52, FIG. 102), to acquire/transmit data using these data acquisition components or other components such as a touch screen 1020, physical or virtual buttons, a keyboard, a temperature sensor, or an antenna (all collectively referred to herein as "input components") and provide control data to an individual user or an associated wireless device, which the Examiner is interpreting personal devices to encompass prior to creating the first self-verifying data set since the device is a personal device and the information can be sent to a server computer.)
Claim(s) 30 mirrors claim 22 only within (a) different statutory category, and is rejected for the same reason as claim 22.
As per claim 23, Sillay/Pulitzer discloses the method of claims 21-22 as described above. Sillay further teaches the method further comprising: sending an encrypted version of the first self-verifying data set to the server, wherein the server is configured to decrypt the encrypted version of the first self-verifying data set (See Paragraphs [0153]-[0157], [0199]: Security may be carefully controlled through both authentication of the individual with disease or individual with disease's representative to each server computer and encryption of data during transmission between devices (whether server computers, devices under the control or used by the individual with disease, or devices used by other individuals such as personnel at a hospital or a clinic, in order to ensure that access or use of the data is not consistent with the individual with disease's directives), which the Examiner is interrupting the encryption of data during transmission between devices to encompass sending an encrypted version of the first self-verifying data set to the server), and the decryption described in [0199] to encompass the server is configured to decrypt the encrypted version of the first self-verifying data set) and assign the first self-verifying data set to the profile for the participant based on at least one of the IP address and the first biometric sample within the first self-verifying data set (See Paragraphs [0153]-[0157]: Such a public/private key pair may be utilized to maintain sensitive data that are stored on the server in an encrypted form, where the key data that are necessary to decrypt the information are stored only by the owner of the data, which is normally the individual with disease who is associated with that data, which the Examiner is interpreting the information are stored only by the owner of the data to encompass assign the first self-verifying data set to the profile for the participant based on at least one of the IP address and the first biometric sample within the first self-verifying data set as the user profile would be linked to the owner of the data.)
Claim(s) 31 mirrors claim 23 only within (a) different statutory category, and is rejected for the same reason as claim 23.
As per claim 24, Sillay/Pulitzer discloses the method of claim 21 as described above. Sillay further teaches the method further comprising:
creating a second self-verifying data set comprising a plurality of data subsets (See Paragraphs [0158]-[0163], [0173]-[0178]: The system, has at any given time, a state, which is determined by the totality of the stored individual with disease-related data, and implements a method to select a subset of the data for further processing (cohort data) based upon one or more criteria such as the age, gender, ethnicity, geographic location, disease status, treatment or treatments applied, service provider(s), services rendered, participation in a program, duration and type(s) of data stored, devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program, for each individual with disease for which data are stored, which the Examiner is interpreting devices or protocols used to gather data to encompass creating a second self-verifying data set), wherein the plurality of data subsets includes:
(i) a first data subset including the first biometric sample (See Paragraphs [0195]-[0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting the image data to encompass the first biometric sample);
(ii) a second data subset including a time stamp marking a time of creation of the second self-verifying data set (See Paragraphs [0153], [0158]-[0163], [0173]-[0178]: The system, has at any given time, a state, which is determined by the totality of the stored individual with disease-related data, and implements a method to select a subset of the data for further processing (cohort data) based upon one or more criteria such as the age, gender, ethnicity, geographic location, disease status, treatment or treatments applied, service provider(s), services rendered, participation in a program, duration and type(s) of data stored, devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program, for each individual with disease for which data are stored, which the Examiner is interpreting devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program to encompass a second data subset including a time stamp marking a time of creation of the second self-verifying data set);
(iii) a third data subset including an internet protocol (IP) address associated with the smartphone (See Paragraphs [0232]-[0233]: One could then determine the frequency of twitter feed and Internet searches based upon location by IP address or GPS location during the search and process the relationship between cost, quality, and travel for the cohort); and
(iv) a fourth data subset including test data points identified for storing based on the instructions (See Paragraphs [0158]-[0163], [0173]-[0178]: The system, has at any given time, a state, which is determined by the totality of the stored individual with disease-related data, and implements a method to select a subset of the data for further processing (cohort data) based upon one or more criteria such as the age, gender, ethnicity, geographic location, disease status, treatment or treatments applied, service provider(s), services rendered, participation in a program, duration and type(s) of data stored, devices or protocols used to gather data, and time(s) or time interval(s) for diagnosis, treatment, or participation in a program, for each individual with disease for which data are stored, which the Examiner is interpreting duration and type(s) of data stored to encompass a fourth data subset including test data points identified for storing based on the instructions), wherein the test data points represent a third biometric sample including a selfie comprising the participant and an image of a second serialized test product administered to the participant (See Paragraphs [0195]-[0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting acquire either still or motion (video) image data to encompass a third biometric sample including a selfie comprising the participant and an image of a second serialized test product administered to the participant when combined with Pulitzer described below);
transmitting from the smartphone the second self-verifying data set for determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions (See Paragraphs [0245]-[0246], [0280]-[0286]: The metrics may be stored in one or more Servers, which may communicate with Client Interface Devices or other computers or computer systems or devices to implement upload, download, viewing, and access control features of the method such as authentication, granting and revocation of access privileges, non-repudiation, logging, and audit trail records, which the Examiner is interpreting communicate with Client Interface Devices or other computers or computer systems or devices to encompass transmitting from the smartphone the second self-verifying data set, interpreting a drop-out rate is calculated at different points in therapy and in follow-up, and methods including telephone calls, reminder e-mails, and direct mailings are used both the attempt to assess the reasons for follow-up loss, make changes to ensure compliance and retention, and add feedback to the improvement of the system to encompass determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions); and
receiving to the smartphone an indication of whether the second self-verifying data set is valid and in compliance with the testing of the test product based on the instructions (See Paragraphs [0286]-[0288]: Should other testing be indicated, an alert will sound asking the user to perform a test or take a measurement, which the Examiner is interpreting an alert to encompass an indication of whether the second self-verifying data set is valid and in compliance with the testing of the test product based on the instructions as if other testing should be indicated the second self-verifying data set may not be valid or in compliance with the testing of the test product based on the instructions.)
While Sillay discloses the method wherein the test data points represent a third biometric sample including a selfie comprising the participant, Sillay may not explicitly teach wherein the test data points represent a third biometric sample including a selfie comprising the participant and an image of a second serialized test product administered to the participant.
Pulitzer teaches a method wherein the test data points represent a third biometric sample including a selfie comprising the participant and an image of a second serialized test product administered to the participant (See Paragraphs [0109], [0134]: The user performs a self-diagnostic medical test and uses a mobile application running on a mobile device 802 to capture an image of the test product, the diagnostic test identifier allows for the type of test being used by the user of the mobile device to be determined, the identifier may be a number associated with the test, or any other means of identifying the test being performed by the user of the mobile device, which the Examiner is interpreting the identifier may be a number associated with the test to encompass a second serialized test.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Sillay to include an image of a second serialized test product administered to the participant as taught by Pulitzer. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sillay with Pulitzer with the motivation of provide clinical health care from a distance (See Background of Pulitzer in Paragraph [0003]).
Claim(s) 32 mirrors claim 24 only within (a) different statutory category, and is rejected for the same reason as claim 24.
As per claim 25, Sillay/Pulitzer discloses the method of claim 21 as described above. Sillay further teaches wherein the first self-verifying data set further includes one or more responses to a questionnaire that was included within the testing module (See Figs. 5-6 and Paragraphs [0028], [0229], [0245]: An individual with disease navigates the questionnaire using a computer or other client device that can communicate with a computer server process such as a web server.)
Claim(s) 33 mirrors claim 25 only within (a) different statutory category, and is rejected for the same reason as claim 25.
As per claim 26, Sillay/Pulitzer discloses the method of claims 21 and 25 as described above. Sillay further teaches wherein each response to the questionnaire further includes a response time that measures an amount of time it took the participant to generate each response to the questionnaire (See Figs. 5-6 and Paragraphs [0028], [0229], [0245], [0286]: An individual with disease navigates the questionnaire using a computer or other client device that can communicate with a computer server process such as a web server, and reaction time can be measured ([0286]).)
Claim(s) 34 mirrors claim 26 only within (a) different statutory category, and is rejected for the same reason as claim 26.
As per claim 27, Sillay/Pulitzer discloses the method of claim 21 as described above. Sillay further teaches wherein the first biometric sample further includes any one or more of a voice print of the participant, a finger print of the participant, and/or an image of a hand of the participant (See Paragraph [0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting the Client Interface Device may also have a camera, which can acquire either still or motion (video) image data to encompass a finger print of the participant, and/or an image of a hand of the participant)
Claim(s) 35 mirrors claim 27 only within (a) different statutory category, and is rejected for the same reason as claim 27.
As per claim 28, Sillay/Pulitzer discloses the method of claim 21 as described above. Sillay further teaches wherein the first self-verifying data set further includes an image of a health measurement device displaying one or more health measurements of the participant measured by the health measurement device based on the instructions (See Fig. 11 and Paragraphs [0151]-[0152], [0176]-[0181], [0196]: The Client Interface Device may also have a camera, which can acquire either still or motion (video) image data, or both, and one or more stored programs that can be selectively executed by a user to acquire still or motion image data to be used or evaluated, either by a person or using a computer algorithm, and from which objective or subjective measurement data can be derived, which the Examiner is interpreting that the Client Interface Device can acquire image data to encompass the first self-verifying data set further includes an image of a health measurement device displaying one or more health measurements of the participant measured by the health measurement device based on the instructions in Fig. 11 is a separate device that could be imaged.)
Claim(s) 36 mirrors claim 28 only within (a) different statutory category, and is rejected for the same reason as claim 28.
Response to Arguments
In the Remarks filed on October 31, 2025, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), Claim Interpretation(s), 35 U.S.C. 112(b) rejection(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the Claim Objection(s), Claim Interpretation(s), and 35 U.S.C. 112(b) rejection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) Applicant respectfully submits that the "testing module" claim limitations recited in these claims should not properly be interpreted as "means-plus-function" under 35 U.S.C. l 12(f). The "testing module" claim element is recited in the independent claims as "a testing module including instructions for performing testing during the clinical trial being conducted of a test product." The recited "testing" during the clinical trial - specifically, the instructions for performing testing which are included as part of the testing module - are performed using the smartphone, which, Applicant submits, constitutes sufficient structure to perform the claimed "performing testing." Accordingly, for at least this reason, Applicant respectfully submits that the "testing module" claim limitations recited in claims 21, 22, 25, 29, 30, 33, and 37 should not be interpreted as "means-plus-function" under 35 U.S.C. l 12(f);
(2) First, for the reasons explained in Section II. above, Applicant submits that the "testing module" claim limitation should not be interpreted as "means-plus-function" under 35 U.S.C. 112(f). Second, the specification provides an adequate written description of the testing module, in addition to the paragraphs indicated by the Office, describing, for example: “[0064] FIG. 5 is a block diagram of computing device (CD) 102, according to some embodiments. As shown in FIG. 5, CD 102 may comprise: processing circuitry (PC) 502, which may include one or more processors (P) 555 (e.g., one or more general purpose microprocessors and/or one or more other processors, such as an application specific integrated circuit (ASIC), field-programmable gate arrays (FPGAs), and the like); communication circuitry 548, which is coupled to an antenna arrangement 549 comprising one or more antennas and which comprises a transmitter (Tx) 545 and a receiver (Rx) 547 for enabling CD 102 to transmit data and receive data (e.g., wirelessly transmit/receive data); and a storage unit (a.k.a., "data storage system") 108, which may include one or more non-volatile storage devices and/or one or more volatile storage devices. In embodiments where PC 502 includes a programmable processor, a computer readable storage medium (CRSM) 542 may be provided. CRSM 542 may store a computer program (CP) 543 comprising computer readable instructions (CRI) 544. CRSM 542 may be a non-transitory computer readable medium, such as, magnetic media (e.g., a hard disk), optical media, memory devices (e.g., random access memory, flash memory), and the like. In some embodiments, the CRI 544 of computer program 543 is configured such that when executed by PC 502, the CRI causes CD 102 to perform steps described herein (e.g., steps described herein with reference to the flow charts). In other embodiments, CD 102 may be configured to perform steps described herein without the need for code. That is, for example, PC 502 may consist merely of one or more ASICs. Hence, the features of the embodiments described herein may be implemented in hardware and/or software.” Accordingly, for at least the foregoing reasons, Applicant submits that the rejection of claims 21-37 under 35 U.S.C. 112(b) as being indefinite should be withdrawn;
(3) Applicant respectfully submits that claim 21 is patent-eligible under 35 U.S.C. § 101 because (1) the claim is not directed to a judicial exception (e.g., abstract idea) and (2) the claim includes an inventive concept. Applicant submits that claim 21 does not fall within the "Certain Methods Of Organizing Human Activity" grouping. The subject matter of claim 21 is not directed to "managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)," as the Office contends. See Office Action at pp. 11-12. Specifically, the Office contends that "other than reciting, 'a smartphone' and 'a testing module' to perform these functions, nothing in the claim precludes the limitations from practically being performed by a person following rules or instructions to conduct a test. For example, the claims encompass a user following rules or instructions to create a profile for the participant including a first biometric sample identifying the participant, wherein the first biometric sample includes a selfie of the participant, a user following rules or instructions to performing testing of the test product based on the instructions." Office Action at p. 12. Applicant respectfully disagrees. Specifically, claim 21, as amended, does not recite limitations or functions that can practically be performed by a person following rules or instructions to conduct a test. For example, claim 21 requires: (1) "integrated real-time data acquisition, validation, and compliance for a participant, wherein during the method the participant uses a smartphone"; (2) "a profile for the participant including a first biometric sample identifying the participant, wherein the first biometric sample includes a selfie of the participant captured by the smartphone"; (3) "a first self-verifying data set comprising a plurality of data subsets, wherein the plurality of data subsets includes: (i) a first data subset including the first biometric sample; (ii) a second data subset including a time stamp marking the time of creation of the first self-verifying data set; (iii) a third data subset including an internet protocol (IP) address associated with the smartphone; and (iv) a fourth data subset including test data points identified for storing based on the instructions, wherein the test data points represent a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant"; (4) "transmitting from the smartphone the first self-verifying data set for determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions"; and (5) "receiving to the smartphone an indication of whether the first self-verifying data set is valid and in compliance with the testing of the test product based on the instructions." Applicant respectfully submits that these claimed features cannot practically be performed "by a person following rules or instructions" and do not fall within the "certain method of organizing human activity" grouping of abstract ideas. Claim 21 recites very specific requirements for "integrated real-time data acquisition, validation, and compliance" for a participant participating in a clinical trial that enables the creation of "a self-verifying data set comprising a plurality of data subsets" that are "transmit[ed] from the smartphone for determining, based on the plurality of data subsets, validation of the participant and compliance with the testing of the test product based on the instructions" and "receiv[ed] to the smartphone an indication of whether the first self-verifying data set is valid and in compliance with the testing of the test product based on the instructions." These integrated data subsets are also very specific: "(i) a first data subset including the first biometric sample; (ii) a second data subset including a time stamp marking the time of creation of the first self-verifying data set; (iii) a third data subset including an internet protocol (IP) address associated with the smartphone; and (iv) a fourth data subset including test data points identified for storing based on the instructions, wherein the test data points represent a second biometric sample including a selfie comprising the participant and an image of a first serialized test product administered to the participant. For at least these reasons, Applicant submits that the method of claim 21 cannot practically be performed by a person following rules or instructions to conduct a test and, thus, does not recite a method of organizing human activity;
(4) claim 21 is not directed to an abstract idea for at least the reason that the claim recites additional elements that integrate the allegedly identified abstract idea into a practical application. According to M.P.E.P. § 2106.04, an additional claim element or a combination of claim elements that is directed to "[a]n improvement in the functioning of a computer, or an improvement to other technology or technical field” integrates a judicial exception into a practical application. Applicant respectfully submits that the combination of the features recited in claim 21 is directed to "an improvement to the technology or technical field." Because the combination of the features recited in claim 21 is directed to "an improvement to the technology or technical field," the features integrate the allegedly identified abstract idea into a practical application, and thus claim 21 is not directed to an abstract idea. For at least the foregoing reasons, Applicant respectfully submits that claim 21 is patent eligible under 35 U.S.C. § 101;
(5) Applicant respectfully submits that it is not aware of any prior art that would or could establish that claim 21 as a whole does not include an inventive concept. For the reasons discussed above, the claimed smartphone-enabled method for use in a clinical trial for integrated real-time data acquisition, validation, and