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 .
Information Disclosure:
The information disclosure statements (IDS) submitted on 06/25/2026 is in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 17, 2026 has been entered.
Applicant Argument Response
The examiner considers all applicant arguments about objections to the claims remark filed on 06/17/2026 page 6 and are persuasive, applicant remove objections languages for claims 21, 23, 24, 25 and 26.
The examiner considers all applicant arguments about 35 U.S.C 112(b) to the claims remark filed on 06/17/2026 page 6 and are persuasive, applicant remove indefinite languages for claims 7, 11-12, 14-16, 18-20, 22, and 27-30.
The examiner considers all applicant arguments about 35 U.S.C 102 to the claims remark filed on 06/17/2026 page 7 and are persuasive, applicant language overcome 35 U.S.C 102 in view of Karlin for claims 1-3, 5-7, 9, 11-12, 14-16, 18, 21-23, 25-27, and 29-30.
The examiner considers all applicant arguments about 35 U.S.C 103 to the claims remark filed on 06/17/2026 page 8-12 and are persuasive, applicant language overcome 35 U.S.C 103 in view of Karlin in combination with Kim for claims 1-3, 5-7, 9, 11-12, 14-16, 18-23, 25-27, and 29-30 for the reasons below.
Allowable Subject Matter -Subject Matter Free from Prior Art
The following is a statement of reasons for the indication of subject matter free from the prior art: The prior art of record fails to expressly teach or suggest, either alone or in combination, each and every feature of independent claims 1 and 19. In particular, the prior art fails to teach or suggest generating a corresponding report whose corresponding file size is proportional to a number of images and to a frequency of bowel movements of the user, and, based on that corresponding file size exceeding a threshold, generating an alert related to the frequency of the bowel movements of the user over a period of time to a caregiver device. Upon completion of an updated prior art search, the examiner submits that the closest related art includes:
● Reference A -Karlin (US 2020/0395124 A1), disclosing a smartphone-based stool image monitoring system that determines stool characteristics, visualizes classified stool data on a timeline to derive a frequency of a patient’s bowel movements, determines disease risk, and communicates detected adverse events to a responsible party ( 0066- 0070, 0086, 0097-0099), but failing to explicitly disclose a report whose file size is proportional to the number of images and to the frequency of bowel movements, or the generation of a caregiver alert triggered by that report file size exceeding a threshold;
● Reference B -Kim (US 2006/0128407 A1), disclosing calculating the total size of selected photos, comparing that aggregate size to a transmittable/allowable size (e.g., 400 Kbyte), and, when the size is exceeded, lowering image resolution or outputting a message so the photos can be transmitted by MMS ( 0032-0035, 0040), but failing to explicitly disclose any relationship between that file size and bowel-movement frequency -Kim’s threshold governs whether images are too large to transmit, not the generation of an alert related to the frequency of a user’s bowel movements;
● Reference C -Guillemette (US 11,540,760 B1), disclosing receiving bowel-event images, comparing prior and recent data to generate trends and risk indicators, and alerting caregivers for high bathroom frequency (Col. 10, ll. 1-25; Col. 17, ll. 1-30; Col. 20, ll. 25- 40), but failing to explicitly disclose a report file size proportional to the number of images and to bowel-movement frequency, or an alert triggered by that report file size exceeding a threshold;
and ● Reference D -Thakkar (US 2014/0254954 A1), disclosing a container file for large format imagery in which, for each image file in a sequence, there is one corresponding fixed-length record having a reserved size that is the same for all records (0096), but failing to explicitly disclose a report file size proportional to bowel-movement frequency.
Though many aspects of the independent claims are individually disclosed in the prior art, it would not have been obvious to one of ordinary skill in the art to combine the disparate features into the invention of the instant claims. In particular, it would not have been obvious to modify Karlin’s clinical stool-monitoring system so as to (i) generate a report whose file size is deliberately made proportional to the number of images and to the frequency of the user’s bowel movements, and (ii) use that report file size exceeding a threshold as the condition for generating an alert related to bowel-movement frequency to a caregiver device. Accordingly, the prior art, either alone or in combination, does not disclose or render obvious all the features of independent claims 1 and 19, and they are found to recite subject matter free from the prior art, as are the claims depending therefrom.
The examiner considers all applicant arguments about 35 U.S.C 101 subject matter eligibility to the claims remark filed on 06/17/2026 page 12-16 and are not persuasive, applicant language does not overcome 35 U.S.C 101 for claims 1-3, 5-7, 9, 11-12, 14-16, and 18-30 for the reasons below.
Applicant argues that amended claims 1 and 19 do not recite a judicial exception because a human mental process is insufficient to perform the claimed activity.
Examiner respectfully disagrees that claims 1 and 19 fail Prong One. MPEP 2106.04(a) asks whether the claim recites an exception; claim-as-a-whole direction is evaluated in Prong Two. Under BRI, limitations (a)-(e) require observing stool images, identifying characteristics, evaluating changes, judging disease risk, and communicating that judgment mental observations, evaluations, judgments, and opinions. Limitation (f) recites the mathematical relationship of file size being proportional to a number of images and a frequency of bowel movements. Limitation (g) compares that value with a threshold and communicates the result to a caregiver. The claims therefore recite enumerated abstract ideas.
Applicant argues that human ratings are variable, whereas a processor trained on a standardized rating reduces recall-based variability.
Examiner respectfully disagrees that this alleged implementation narrows claims 1 and 19. MPEP 2111 requires BRI consistent with the specification but prohibits importing unclaimed embodiment details. Neither claim requires a processor located in a user device, training on standardized ratings, rating normalization, or any particular AI mechanism. Claim 19 merely uses processors to perform the same functionally recited evaluations. Under MPEP 2106.04(a)(2)(III), computer implementation does not remove an underlying mental process that remains practically performable by a person.
Applicant argues that claims 1 and 19 integrate the exception into a practical application by improving patient-care monitoring through smartphone stool images and a file-size-triggered caregiver alert that avoids specialized plumbing and clinician involvement in image collection.
Examiner respectfully disagrees that the claims reflect the asserted technological improvement. Claims 1 and 19 recite receiving stool images, determining stool characteristics, generating a historical trend, determining risk, providing risk information, and, in claim 19, using a report file-size threshold to alert a caregiver device. Those limitations apply medical observation and a mathematical/organizational rule to patient monitoring. Under MPEP 2106.04(d)(1) and 2106.05(a), eligibility requires the claim itself to reflect a technological improvement or another meaningful practical application, not merely a useful medical context or convenient data source. The claims do not improve image acquisition, computer operation, storage, transmission, report generation, or AI processing, and they do not require a particular treatment or prophylaxis. The user devices, processors, storage medium, and caregiver device perform generic receiving, analyzing, storing, and transmitting functions. The ordered combination therefore improves the availability of clinical information, not the underlying technology, and does not integrate the judicial exception into a practical application.
Applicant argues that claims 1 and 19 add significantly more because the file-size relationship and threshold-triggered alert are not well-understood, routine, and conventional, as Karlin, Clark, and Kim do not disclose the claimed arrangement.
Examiner respectfully disagrees that the claims add significantly more because step 2B does not ask whether Karlin, Clark, or Kim discloses the claimed abstract relationship; that inquiry belongs to §§ 102 and 103. Step 2B asks whether the claim adds, beyond the identified exception, additional elements that amount to significantly more. The file-size relationship, threshold comparison, and caregiver-alert rule were identified as part of the exception, so they cannot supply the inventive concept. The remaining additional elements are user devices, a caregiver device, processors, storage medium, server/database functionality, and network communication. The specification describes these as generic computer/network components, not as a new device, new image-acquisition method, improved computer operation, or particular treatment step. Individually and as an ordered combination, the additional elements merely receive images, apply the abstract medical/file-size rule, store/report results, and transmit an alert. That is generic computer implementation of the exception, not significantly more.
Applicant argues that claims 2-18 and 20-30 are eligible because they incorporate claims 1 or 19 and add further limitations.
Examiner respectfully disagrees that dependency establishes eligibility. MPEP 2106.07 requires claim-by-claim evaluation. Claims 2-3, 5-6, 9, 11-12, 14-15, 18, 21-25, and 27-29 merely narrow the stool evaluation, disease context, trend, or inflammatory-marker correlation. Claims 7 and 16 recite providing an adjustment to a therapy but require no administration, drug, dose, procedure, or other particular treatment. Claim 20 only places the caregiver device within the user-device environment. Claims 26 and 30 use a trained machine-learning model but recite no architecture, training procedure, or improvement in model or computer operation; paragraph [0027] identifies model types generically. Claims 4, 8, 10, 13, and 17 are canceled. The § 101 rejection is therefore maintained for the pending claims.
Applicant’s arguments regarding 35 U.S.C. 101 and nonstatutory double patenting, presented in the remarks filed June 17, 2026, pages 16-17, have been fully considered.
Applicant argues the amended claims are patentably distinct because the copending claims do not recite the file-size limitation: a report file size proportional to images/bowel-movement frequency and a caregiver alert triggered when that file size exceeds a threshold.
Examiner agrees. The amended file-size limitation makes the pending claims patentably distinct from the copending claims because the copending claims do not recite a report file size proportional to images/bowel-movement frequency or a threshold-triggered caregiver alert based on that file size. The double-patenting rejection is withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5-7, 9, 11-12, 14-16, and 18-30 remain ineligible under 35 U.S.C. 101. The amendments add report/file-size/caregiver-alert detail, but not a practical application or inventive concept.
Step 1.This step confirms whether the pending claims fall within a statutory category before applying the judicial-exception framework to the amended claim language.
Claims 1-3, 5-7, 9, 21, and 23-26 recite methods and fall within the process category. Claims 11-12, 14-16, 18-20, 22, and 27-30 recite systems through claim 19’s “one or more data processors” and “non-transitory computer-readable storage medium.”
Step 1 is satisfied. The analysis proceeds to Step 2A.
Prong One:Prong One identifies whether the claim recites a judicial exception.Independent Claims Analysis:Claims 1 and 19 are grouped because claim 19 recites the same operations as claim 1 and only changes statutory form by adding processors and storage medium.
Representative amended claim 1 recites:
Note: Non-bold claim language identifies the judicial exception; bold claim language identifies additional elements considered separately.
(a) receiving two or more images from one or more a plurality of images from each user device of a plurality of user devices, wherein a first of the plurality of images is captured prior to at least a second of the plurality of images from the each user device;
(b) determining, from stool in the plurality of images, one or more stool characteristics associated with the each user device;
(c) generating a historical trend of a health or disease state of a user based on the two or more plurality of images, wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics;
(d) determining a risk of the health or disease state based at least in part on the historical trend; and
(e) generating and providing information associated with the determined risk of the health or disease state to at least some of the plurality of user devices;
(f) generating a corresponding report associated with a corresponding user device of at least some of the plurality of user devices, wherein a corresponding file size associated with the corresponding report is proportional to a number of images and a frequency of bowel movements of a user of the corresponding user device; and
(g) based on the corresponding file size exceeding a threshold, generating an alert related to the frequency of the bowel movements of the user over a period of time to a careregiver device.
Under BRI, the non-bold language evaluates stool images, determines stool characteristics, generates a disease trend/risk, uses report file size as a numerical proxy for bowel-movement frequency, compares that proxy to a threshold, and triggers caregiver review.
Limitations (a)-(e) recite a mental process under the USPTO “mental processes” grouping because they require observation, evaluation, judgment, and opinion. Limitation (a) receives stool-image observations; limitation (b) identifies stool characteristics; limitation (c) evaluates those characteristics over time to generate a health trend; limitation (d) judges disease risk from that trend; and limitation (e) provides the resulting risk information. These are mental-process subcategories because the claim language tracks medical observation and evaluation of patient information to form a clinical judgment.
Limitation (f) recites a mathematical concept, specifically a mathematical relationship, because it requires the “corresponding file size” to be “proportional to a number of images and a frequency of bowel movements.” Limitation (g) also uses a mathematical comparison because it tests whether that file size exceeds a threshold, and it further recites a certain method of organizing human activity, specifically managing interactions between people, because the threshold result triggers an alert to a caregiver for clinical review.
A clinician can receive stool photos, compare them over time, identify stool features, infer disease progression and risk, and notify a caregiver. The file-size relationship is not treated as mental; it is the claimed mathematical proxy that drives the caregiver-interaction workflow.
Dependent Claims Analysis:Claims 2-3 and 11-12 narrow stool-characteristic evaluation, including Bristol stool scale. Claims 5-6, 9, 14-15, 18, and 21-22 narrow the disease/time context. Claims 7 and 16 add therapy-adjustment advice, not a required treatment. Claims 23-25 and 27-29 add inflammatory-marker/CRP correlations. Claims 26 and 30 add machine-learning analysis at a functional result level.
Thus, the claims recite abstract ideas under Prong One. The analysis proceeds to Prong Two.
Prong Two:Prong Two evaluates whether the additional elements integrate the recited judicial exception into a practical application rather than merely applying it on generic technology.Independent Claims Analysis:The additional elements are user device(s), caregiver device, and, in claim 19, one or more data processors and a non-transitory computer-readable storage medium.
Individual Additional Elements Evaluation:The additional elements do not integrate the exception into a practical application. Paragraph [0022] describes the client device, server, and database as “one or more computer devices and/or networked computer devices” and a smartphone camera. The claim does not recite a file-system improvement, database-storage improvement, compression rule, image-normalization mechanism, AI-model improvement, transformation, or particular treatment/prophylaxis. Under MPEP 2106.04(d) and 2106.05(a), (f), and (h), the devices and report merely apply the abstract analysis in a clinical computer environment.
Combination Additional Elements Evaluation:As a whole, the additional elements receive images, generate medical/risk information, create a report, compare file size to a threshold, and alert a caregiver. That is use of the exception, not integration.
Dependent Claims Analysis:Claims 2-3, 5-6, 9, 11-12, 14-15, 18, 21-25, and 27-29 add no additional elements beyond the abstract analysis identified in Prong One; they only narrow stool features, Bristol scale, disease type, time period, flare-up, gastrointestinal state, inflammatory markers, CRP, or marker-level determination. Claims 7 and 16 recite providing “an adjustment to a therapy” to user devices, but this is advice/output, not a particular treatment or prophylaxis. Claim 20 recites the caregiver device within the user-device set, which only narrows the device environment. Claims 26 and 30 recite a machine-learning model, but not a technical model improvement. These limitations do not integrate the exception into a practical application.
Conclusion:The claims do not integrate the abstract ideas into a practical application. The analysis proceeds to Step 2B.
Step 2B:Step 2B considers whether the additional elements, individually or as an ordered combination, amount to significantly more than the identified judicial exception.Independent Claims Analysis:The same additional elements are considered: user device(s), caregiver device, one or more data processors, and non-transitory computer-readable storage medium.
Individual Additional Elements Evaluation:The additional elements do not provide an inventive concept. Paragraph [0022] describes generic computer/network devices, a smartphone camera, server, and database. Paragraph [0027] describes the AI model generically as a “convolutional neural network, deep learning model, large language model, machine learning model, etc.” Refer to MPEP. 2106.05(f)
Combination Additional Elements Evaluation:The ordered combination does not add significantly more because generic computing components perform the exception by receiving images, storing/reporting information, applying a proportional file-size threshold, and sending a caregiver alert. The combination therefore merely automates the abstract medical evaluation and caregiver-notification workflow in a generic computer environment, which is insufficient under MPEP 2106.05(f) and 2106.05(h).
Dependent Claims Analysis:Claims 2-3, 5-6, 9, 11-12, 14-15, 18, 21-25, and 27-29 add no separate additional elements beyond the abstract medical evaluation addressed in Prong One. Claims 7 and 16 add therapy-adjustment output, but not a nonconventional treatment step. Claim 20 adds only caregiver-device placement within the user-device environment. Claims 26 and 30 add a machine-learning model, but the specification describes model types generically and the claims recite no specific architecture, training technique, or computer-function improvement. Thus, none of the dependent claims adds significantly more than the abstract idea.
The amendments do not overcome the 35 U.S.C. 101 rejection. Claims 1-3, 5-7, 9, 11-12, 14-16, and 18-30 remain directed to abstract ideas without integration into a practical application and without an inventive concept.
Relevant Prior Art:
US11540760B1:
Recites receiving user-associated bowel-event images/video, identifying stool type, blood, and user-specific bathroom data, comparing prior and recent data to generate trends, displaying risk indicators and summaries, and alerting caregivers for high bathroom frequency. Refer to Col. 10, ll. 1-25; Col. 17, ll. 1-25; Col. 20, ll. 25-40; Col. 17, ll. 1-30; Col. 18, ll. 1-30; Col. 13, ll. 1-25; Col. 14, ll. 7-25; Col. 14, ll. 10-25; Col. 20, ll. 40-67; FIGS. 16-19.;
US20140254954A1:
paragraph 0096 states For each image file in the sequence of image files, there is one corresponding record in the container and defines fixed-length records having reserved sizes the same for all records.
US 20220321872 A1
A network edge device may receive one or more images originating from one or more camera devices. The network edge device may further, for respective images of the one or more images, determine a respective image size of the respective image. The network edge device may compare the respective image size to a respective threshold range and generate an alert if the respective image size falls outside of the respective threshold range. refer to abstract, par. 0018-0019, par. 0048
Conclusion
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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