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 .
DETAILED ACTION
In the amendments filed 09 July 2026:
Claims 18-20 are new
Claims 1,6,8,15-17 are pending
Claims 1-20 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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1,16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a system, method and non-transitory computer readable medium, which are within a statutory category.
Step 2A1
The limitations of:
Claim(s) 1,16-17 (Claim 1 being representative)
Receive a request for a risk prediction for a future endoscopic procedure, wherein the request includes procedural information related to at least one of historical endoscopic procedure information or proposed endoscopic procedural information for the future endoscopic procedure;
and output a risk prediction alert associated with performance of the future endoscopic procedure, wherein the risk prediction is based on risk information associated with one or more risks to at least one of a patient, a physician, or an additional healthcare professional based on at least one of biographical information or the proposed endoscopic procedural information, wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks,
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a medical alert system comprising memory and processor, and non-transitory computer-readable medium, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the medical alert system comprising memory and processor, and non-transitory computer-readable medium, this claim encompasses receiving requests for a risk prediction and outputting said risk prediction, in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a medical alert system comprising memory and processor, and non-transitory computer-readable medium that implement the identified abstract idea. The medical alert system comprising memory and processor, and non-transitory computer-readable medium are not described by the applicant and is recited at a high-level of generality (i.e., a generic server performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional element of a communication interface. The communication interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a medical alert system comprising memory and processor, and non-transitory computer-readable medium to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of a communication interface was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claims are not patent eligible.Claims 2-15,18-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2 merely describe(s) using a model based on historical data, which further defines the abstract idea.
Claim(s) 3 merely describe(s) what the model comprises, which further defines the abstract idea.
Claim(s) 3 also includes “training a machine learning model.” When given its broadest reasonable interpretation in light of the disclosure, the training of a machine learning model by supervised learning represents the creation of mathematical interrelationships between data. As such, the training of the machine learning model represents a mathematical concept that is interpreted to be part of the identified abstract idea, supra. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Claim(s) 4 merely describe(s) receiving feedback, which further defines the abstract idea.
Claim(s) 5 merely describe(s) receiving and displaying feedback information, which further defines the abstract idea.
Claim(s) 5 also includes the additional elements of a “device” and “user interface” which is analyzed the same as the “a communication interface” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 6 merely describe(s) what the feedback information contains, which further defines the abstract idea.
Claim(s) 2,6 also includes the additional element of using a trained machine learning model to generate a risk prediction. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). Alternatively, or in addition, the implementation of the trained machine learning model to generate a risk prediction merely confines the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use (neural network) and thus fails to add an inventive concept to the claims.
Claim(s) 6 also includes the additional elements of a “camera” which is analyzed the same as the “a communication interface” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 7 merely describe(s) receiving risk tolerances or goals of the procedure, which further defines the abstract idea.
Claim(s) 8 merely describe(s) outputting recommendation, which further defines the abstract idea.
Claim(s) 9-11 merely describe(s) the ergonomic interventions, which further defines the abstract idea.
Claim(s) 12-14 merely describe(s) the biographic information, which further defines the abstract idea.
Claim(s) 15 merely describe(s) receiving the biographic information, which further defines the abstract idea.
Claim(s) 18 merely describe(s) outputting the risk prediction alert, which further defines the abstract idea.
Claim(s) 19 merely describe(s) the risk prediction, which further defines the abstract idea.
Claim(s) 20 merely describe(s) the risks, which further defines the abstract idea.
Claim Rejections - 35 USC § 103
The Examiner notes that the rejection will reference the translated documents (attached) corresponding to any foreign documents recited in the rejection.
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.
Claims 1-4,6,12-17,19 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf et al (US Publication No. 20200273575) in view of BALASUBRAMANIAN et al (US Publication No. 20170154162) in view of WOLF’216 et al (Foreign Publication WO-2021207016-A1) in view of SCHOLL et al (US Publication No. 20230207110).
Regarding Claim 1
WOLF teaches a medical alert system for predicted risks in endoscopic procedures, comprising:
a communication interface [Wolf at Para. 0218 teaches the request of the user may be received from a computing device which may include a user interface enabling the user to make the request];
memory; and at least one processor coupled to the memory and configured to [Wolf at Para. 0314 teaches similarly, systems and devices consistent with the present disclosure may include at least one processor and memory, and the memory may be a non-transitory computer-readable storage medium. As used herein, a non-transitory computer-readable storage medium refers to any type of physical memory on which information or data readable by at least one processor can be stored]:
[ … ] … wherein the request includes procedural information related to at least one of historical endoscopic procedure information or proposed endoscopic procedural information for the future endoscopic procedure [Wolf at Para. 0010 teaches the embodiments may further include accessing historical data associated with historical surgical footage of prior surgical procedures, wherein the historical data includes information that distinguishes portions of the historical surgical footage into frames associated with intraoperative surgical events and frames not associated with surgical activity];
WOLF does not teach receive, at the communication interface of the medical alert system, a request for a risk prediction for a future endoscopic procedure, … [ … ]
and output, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure, wherein the risk prediction is based on risk information associated with one or more risks to at least one of a patient, a physician, or an additional healthcare professional based on at least one of biographical information or the proposed endoscopic procedural information, wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
BALASUBRAMANIAN teaches receive, at the communication interface of the medical alert system, a request for a risk prediction for a future endoscopic procedure [BALASUBRAMANIAN at Para. 0018 teaches the system further includes a risk assessment unit programmed to compute a risk of an adverse reaction in the patient based on the information about the patient and the information about the upcoming medical procedure acquired by the data acquisition unit. The system also includes a risk alert unit programmed to present an indication of the risk in a visually perceptible form in advance of the medical procedure (interpret to combine with endoscopic procedure of Wolf); BALASUBRAMANIAN at Para. 0042 teaches assessment can be done automatically once the information is collected, or it can be done at a later time, such as upon request of a user], … [ … ]
[ … ] … wherein the risk prediction is based on risk information associated with one or more risks to at least one of a patient, a physician, or an additional healthcare professional based on at least one of biographical information or the proposed endoscopic procedural information [BALASUBRAMANIAN at Para. 0013 teaches in some non-limiting embodiments, the information about the patient includes one or more of a patient's age, sex, underlying medical conditions, hematologic conditions, medications, and history of adverse reactions to contrast media. Further, the patient information may be acquired from a hospital system selected from a radiology information system, an electronic medical record system, and a laboratory information system; BALASUBRAMANIAN at Para. 0014 teaches in certain non-limiting embodiments, the risk is predicted by comparing the information about the patient and the medical procedure to one or more risk factors stored in memory; BALASUBRAMANIAN at Para. 0056 teaches in certain embodiments, system 10 can access the outcome information to help assess the risks involved in future procedures and to alert of risks associated therewith.], … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine processor of Wolf with the prediction of BALASUBRAMANIAN with the motivation to improve the effectiveness of risk assessments.
Wolf/BALASUBRAMANIAN do not teach and output, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure, … [ … ]
[ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
WOLF’016 teaches and output, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure [WOLF’016 at Para. 000233 teaches some aspects of the disclosure may involve operations may include triggering an intra- surgical warning of a risk in an upcoming portion of the ongoing surgical procedure (interpret to correspond with risk prediction alert and future procedure of BALASUBRAMANIAN and endoscopic procedure of WOLF)], … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN with the alert of WOLF’016 with the motivation to improve efficiency and accuracy in data analysis.
Wolf/BALASUBRAMANIAN/WOLF’016 do not teach [ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
SCHOLL teaches [ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks [SCHOLL at Para. 0067 teaches for example, a wearable sensor 310 at the lower back of medical staff 102 may alert medical staff 102 to adjust their posture to relieve lower back strain, or a medical tool or instrument may vibrate to indicate that greater or lesser force is required or that a different tool may be required. Lights/sounds/vibrations/equipment controls 510 may include, for example, an adjustment to a table height, movement of a position of medical robot 105, adjustment of a support for a portion of medical staff 102's body, or adjustment of the patient's position, etc].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf/BALASUBRAMANIAN/WOLF’016 with the intervention of SCHOLL with the motivation to improve ergonomics of medical staff.
Regarding Claim 2
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the at least one processor is further configured to:
generate the risk prediction using a model based on historical endoscopic procedural information [WOLF’016 at Para. 000233 teaches Some aspects of the disclosure may involve operations may include triggering an intra- surgical warning of a risk in an upcoming portion of the ongoing surgical procedure. The warning may be triggered using artificial intelligence by predicting a future event in the ongoing surgical procedure that may be associated with increased probabilities of patient complications; WOLF’016 at Para. 000345 teaches a process of analyzing video frames may be performed by a suitable machine-learning model such as an image recognition algorithm, as described herein. In various embodiments, information obtained from stored historical data based on prior surgical procedures may be used to train the image recognition algorithm to assess aspects of surgical procedures by recognizing and comparing specific intraoperative events, actions, timings, etc. base on accessed frames of surgical footage, as described herein].
Regarding Claim 3
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 2,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the model comprises an artificial intelligence (AI) or machine learning (ML) model that is trained based on the historical endoscopic procedural information [Wolf at Para. 0198 teaches in accordance with embodiments of the present disclosure, the historical data may include information that distinguishes portions of surgical footage into frames associated with intraoperative surgical events and frames not associated with surgical activity. The information may distinguish the portions of surgical footage in various ways. For example, in connection with historical surgical footage, frames associated with surgical and non-surgical activity may already have been distinguished. This may have previously occurred, for example, through manual flagging of surgical activity or through training of an artificial intelligence engine to distinguish between surgical and non-surgical activity. The historical information may identify, for example, a set of frames (e.g., using a starting frame number, a number of frames, an end frame number, etc.) of the surgical footage].
Regarding Claim 4
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 3,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the at least one processor is configured to:
receive, via the communication interface, feedback information for an endoscopy procedure of the patient including one or more of outcome information for the patient, the physician, or the additional healthcare professional [WOLF’016 at Para. 000274 teaches disclosed embodiments may involve updating a personnel record of the subject with a competency score. For example, an evaluation section of the subject in a personnel record of the subject may be updated based on the at least one competency score. Similarly, the method may include causing a competency score to populate an evaluation form of the subject. An evaluation form may permit a subject to receive feedback on his or her performance in a surgical procedure. An evaluation form may be related to an evaluation of a particular surgical procedure, a series of surgical procedures, intern rotation, etc].
Regarding Claim 6
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach medical alert system of claim 4,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the feedback information comprises video from a camera at a treatment room for the endoscopy procedure, and wherein the model is configured to associate a behavior, posture, or positioning identified from the video with a potential injury risk to the physician or the additional healthcare professional [SCHOLL at Para. 0025 teaches anthropometric data may be used to provide recommendations for modular attachments for instruments, robots, tables, etc. that could support an improved position or posture of medical staff 102. Anthropometric data may be gathered from medical staff 102, technicians, support staff, and patients within the medical suite, and may be captured, for example, from motion capture cameras or other devices or may be directly measured with analog devices, such as devices worn by medical staff 102; SCHOLL at Para. 0051 teaches patient demographic information may also be considered during the medical procedure, such as to optimize positioning of medical staff 102 in order to reduce the risk of injury].
Regarding Claim 12
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the biographical information of the patient comprises information related to one or more of physical features of the patient, medical conditions of the patient, or surgical history of the patient [Wolf at Para. 0126 teaches for example, patient characteristics (such as a patient's medical condition, age, weight, medical history, or other characteristics), surgeon skill level, difficulty of the procedure, type of procedure, or other factors may be considered in determining the estimated outcomes].
Regarding Claim 13
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the biographical information of the physician comprises information related to one or more of physical conditions of the physician, medical conditions of the physician, or experience of the physician in performing multiple endoscopic procedures [Wolf at Para. 0128 teaches these characteristics may include, but are not limited to, the medical professional's age, medical background, experience level (e.g., the number of times the surgeon has performed this or similar surgical procedures, the total number of surgical procedures the surgeon has performed, etc.), skill level, training history, success rate for this or other surgical procedures, or other characteristics that may be relevant].
Regarding Claim 14
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the biographical information of the additional healthcare professional comprises information related to physical conditions of the additional healthcare professional, medical conditions of the additional healthcare professional, or experience of the additional healthcare professional in performing multiple endoscopic procedures [Wolf at Para. 0126 (see Claim 12 for explanation)].
Regarding Claim 15
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach further comprising: receiving, via the communication interface of the medical alert system, the biographical information related to at least one of the patient, the physician, or the additional healthcare professional involved in the endoscopic procedure [Wolf at Para. 0180 teaches in another example, the stored event characteristic may include a patient characteristic. The term “patient characteristic” refers to any physical, sociological, economical, demographical or behavioral characteristics of the patient, and to characteristics of the medical history of the patient].
Regarding Claim 16
WOLF teaches a method for providing a medical alert via a medical alert system for endoscopic procedures, comprising:
[ … ] … wherein the risk prediction alert is based on risk information associated with one or more risks to at least one of a patient, a physician, or an additional healthcare professional based on at least one of biographical information or the proposed endoscopic procedural information [Wolf at Para. 0010 (see Claim 1 for explanation)], … [ … ]
WOLF does not teach receiving, at a communication interface of the medical alert system, proposed endoscopic procedural information for a future endoscopic procedure;
and outputting, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure, … [ … ]
[ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
BALASUBRAMANIAN teaches receiving, at a communication interface of the medical alert system, proposed endoscopic procedural information for a future endoscopic procedure [BALASUBRAMANIAN at Para. 0018, 0042 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine processor of Wolf with the prediction of BALASUBRAMANIAN with the motivation to improve the effectiveness of risk assessments.
Wolf/BALASUBRAMANIAN do not teach and outputting, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure, … [ … ]
[ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
WOLF’016 teaches and outputting, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure [WOLF’016 at Para. 000233 (see Claim 1 for explanation)], … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN with the alert of WOLF’016 with the motivation to improve efficiency and accuracy in data analysis.
Wolf/BALASUBRAMANIAN/WOLF’016 do not teach [ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
SCHOLL teaches [ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks [SCHOLL at Para. 0067 (see Claim 1 for explanation)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf/BALASUBRAMANIAN/WOLF’016 with the intervention of SCHOLL with the motivation to improve ergonomics of medical staff.
Regarding Claim 17
WOLF teaches a non-transitory computer-readable medium storing code for a medical alert system for endoscopic procedures, the code when executed by one or more processors causes the one or more processors to:
[ … ] … wherein the risk prediction alert is based on risk information associated with one or more risks to at least one of a patient, a physician, or an additional healthcare professional based on at least one of biographical information or the proposed endoscopic procedural information [Wolf at Para. 0010 (see Claim 1 for explanation)], … [ … ]
WOLF does not teach receive, at a communication interface of the medical alert system, proposed endoscopic procedural information for a future endoscopic procedure;
and output, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure, … [ … ]
[ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
BALASUBRAMANIAN teaches receive, at a communication interface of the medical alert system, proposed endoscopic procedural information for a future endoscopic procedure [BALASUBRAMANIAN at Para. 0018, 0042 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine processor of Wolf with the prediction of BALASUBRAMANIAN with the motivation to improve the effectiveness of risk assessments.
Wolf/BALASUBRAMANIAN do not teach and output, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure, … [ … ]
[ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
WOLF’016 teaches and output, via the communication interface, a risk prediction alert associated with performance of the future endoscopic procedure [WOLF’016 at Para. 000233 (see Claim 1 for explanation)], … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN with the alert of WOLF’016 with the motivation to improve efficiency and accuracy in data analysis.
Wolf/BALASUBRAMANIAN/WOLF’016 do not teach [ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks.
SCHOLL teaches [ … ] … wherein the risk prediction alert identifies one or more ergonomic interventions to be implemented for the future endoscopic procedure based on identification of the one or more risks [SCHOLL at Para. 0067 (see Claim 1 for explanation)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf/BALASUBRAMANIAN/WOLF’016 with the intervention of SCHOLL with the motivation to improve ergonomics of medical staff.
Regarding Claim 19
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach wherein the risk prediction is based on a combination of information about a particular physician, information about a particular patient, and information about a particular additional healthcare professional for the future endoscopic procedure, to predict a potential risk specific to the future endoscopic procedure [SCHOLL at Para. 0028 teaches patient demographics that may be employed in such analysis may include, for example, patient height, weight, muscle strength, bone mineral density, age, type of disease, etc; SCHOLL at Para. 0030 teaches such a model may, for example, correlate reported difficulty level with procedure type, changes to the conditions of the medical procedure made by one of medical staff 102, technicians and support staff during the procedure, demographic, anthropometric, and biometric data of medical staff 102, technicians, support staff, and patients, etc. and may individualize such predictions for each individual among medical staff 102, technicians, and support staff.].
Claims 5,8,11 rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL as applied to claim 1, 16-17 above, and further in view of SHELTON et al (Foreign Publication WO-2022249093-A2).
Regarding Claim 5
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach medical alert system of claim 4,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL do not teach wherein the feedback information is received at a device at or near a treatment room for the endoscopy procedure via a user interface that displays a question about one or more of whether manual pressure was used, whether the patient was repositioned, or an effect on the physician or the additional healthcare professional.
SHELTON teaches wherein the feedback information is received at a device at or near a treatment room for the endoscopy procedure via a user interface that displays a question about one or more of whether manual pressure was used, whether the patient was repositioned, or an effect on the physician or the additional healthcare professional [SHELTON at Para. 00420 teaches for example, based on the monitored data and the determined recommended position of the patient, the surgical computing system may determine whether the current patient position is proper. The surgical computing system may determine feedback based on the determination of whether the current patient position is proper. For example, feedback to change (e.g., and how to change) the patient positioning may be determined based on an improper positioning. Feedback confirming proper patient positioning may be determined if the monitored data indicates proper positioning].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL with the feedback of SHELTON with the motivation to improve the wear and fatigue on the HCPs.
Regarding Claim 8
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL do not teach wherein the at least one processor is further configured to: output a recommendation of the one or more ergonomic interventions to be implemented by at least one of the patient, the physician, or the additional healthcare professional for the endoscopic procedure based on the identification of the one or more risks.
SHELTON teaches wherein the at least one processor is further configured to: output a recommendation of the one or more ergonomic interventions to be implemented by at least one of the patient, the physician, or the additional healthcare professional for the endoscopic procedure based on the identification of the one or more risks [SHELTON at Para. 0052 teaches systems, methods, and instrumentalities are disclosed for monitoring HCPs in a surgical procedure and providing parameters associated with improving wear on HCPs. The parameters may be indicated in control signals, recommendations, adjustments, and/or feedback. The parameters may be associated with ergonomic positioning. For example, a computing system may monitor surgeon motion, posture, and surgical access to create recommendations to improve wear on HCP; SHELTON at Para. 0053, 00306 (see Claim 6 for explanation)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL with the output of SHELTON with the motivation to improve surgical outcomes, and improve experience and/or wellbeing of the patient and the healthcare professional.
Regarding Claim 11
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL/SHELTON teach the medical alert system of claim 8,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL/SHELTON further teach wherein the one or more ergonomic interventions comprises at least one of the additional healthcare professional utilizing assistive equipment to assist in an application of external pressure on the patient or repositioning of the patient [SCHOLL at Para. 0067 (see Claim 1 for explanation; interpreted as repositioning of the patient utilizing assistive equipment)].
Claim 7 rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL as applied to claim 1, 16-17 above, and further in view of Srivastava et al (US Publication No. 8655682).
Regarding Claim 7
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL further teach [ … ] … wherein the risk prediction alert is based on the preference information received at the communication interface [WOLF’016 at Para. 000233 (see Claim 2 for explanation)].
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL do not teach wherein the at least one processor is further configured to: receive, via the communication interface, preference information related to risk tolerances or goals of an endoscopy procedure, … [ … ]
Srivastava teaches wherein the at least one processor is further configured to: receive, via the communication interface, preference information related to risk tolerances or goals of an endoscopy procedure [Srivastava at Para. 89 teaches the system illustratively queries the patient with a patient preference tool specific to the question, and assesses a patient preference score for each option. The patient preference score may be based on, for example, the patient's risk tolerance, lifestyle values, and cost considerations. In addition, the patient preference score may be computed at least in part using a risk tolerance score (RTS). Specifically, the RTS assesses how the patient judges and prioritizes the inherent risks and benefits of each of the options. The RTS is a score/value designed to understand the general risk tolerance of the patient to each option], … [ … ]
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL with the preference of Srivastava with the motivation to improve treatment decisions.
Claim 9 rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL, SHELTON as applied to claim 8 above, and further in view of HATHORN et al (US Publication No. 20170042752).
Regarding Claim 9
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL/SHELTON teach the medical alert system of claim 8,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL/SHELTON do not teach wherein the one or more ergonomic interventions comprises at least one of the patient utilizing a compression device during the endoscopic procedure, receiving a sedation, or physical manipulation.
HATHORN teaches wherein the one or more ergonomic interventions comprises at least one of the patient utilizing a compression device during the endoscopic procedure, receiving a sedation, or physical manipulation [HATHORN at Para. 0027 teaches compression may be applied to the abdomen of the patient using various compression devices. One example of a compression device that may be used to apply constant pressure to the abdomen of the patient during withdrawal of an endoscope is an elongated elastic band that is wrapped around the abdomen of the patient and secured].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL, SHELTON with the compression device of HATHORN with the motivation to improve adenoma detection during an endoscopy procedure.
Claim 10 rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL, SHELTON as applied to claim 8 above, and further in view of Kaforey et al (US Publication No. 10188570).
Regarding Claim 10
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL/SHELTON teach the medical alert system of claim 8,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL/SHELTON do not teach wherein the one or more ergonomic interventions comprises at least one of the physician utilizing hand dials, an anti-fatigue mat, or increasing a scheduled time duration for the endoscopic procedure.
Kaforey teaches wherein the one or more ergonomic interventions comprises at least one of the physician utilizing hand dials, an anti-fatigue mat, or increasing a scheduled time duration for the endoscopic procedure [Kaforey at Para. 3 teaches this application relates generally to absorbent, anti-fatigue, disposable floor mats for use during medical procedures, specifically absorbent, anti-fatigue, disposable floor mats that can be used during surgical procedures for the absorption of bodily fluids or medical liquids over the course of a surgical procedure, which fluids or liquids must be sanitarily contained and later removed from the procedural area (interpreted as anti-fatigue mat)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL, SHELTON with the anti-fatigue mat of Kaforey with the motivation to increase energy and awareness for the medical personnel during the medical or surgical procedure.
Claim 18 rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL as applied to claim 1, 16-17 above, and further in view of Polese et al (Patient Position in Operative Endoscopy).
Regarding Claim 18
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teaches wherein the risk prediction alert is output in advance of the future endoscopic procedure [BALASUBRAMANIAN at Para. 0013, 0056 (see Claim 1 for explanation)], … [ … ]
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL does not teach [ … ] … and wherein the one or more risks include an ergonomic risk to the physician or the additional healthcare professional associated with at least one of applying manual pressure to the patient or repositioning the patient during the future endoscopic procedure.
Polese teaches [ … ] … and wherein the one or more risks include an ergonomic risk to the physician or the additional healthcare professional associated with at least one of applying manual pressure to the patient or repositioning the patient during the future endoscopic procedure [Polese at Page 8 Section 5.3 teaches according to the authors, a risk factor is represented by the patient’s position during the procedure [ 13] (interpreted as repositioning of patient; interpreted to correspond with future endoscopic procedure of BALASUBRAMANIAN)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL with the risk of Polese with the motivation to improve understanding of the positioning of the patient during procedures.
Claim 20 rejected under 35 U.S.C. 103(a) as being unpatentable over Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL as applied to claim 1, 16-17 above, and further in view of CHOI et al (Foreign Publication WO-2014110118-A1).
Regarding Claim 20
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL teach the medical alert system of claim 1,
Wolf/BALASUBRAMANIAN/WOLF’016/SCHOLL do not teach wherein the one or more risks include a predicted likelihood of a need for manual abdominal pressure or repositioning of the patient to address looping during the future endoscopic procedure.
CHOI teaches wherein the one or more risks include a predicted likelihood of a need for manual abdominal pressure or repositioning of the patient to address looping during the future endoscopic procedure [CHOI at Para. 0053 teaches however, if the percentage of the partial loop formed is more than the threshold value, then the processing system 14 is configured to notify the operator of its prediction that endoscopic looping may occur; CHOI at Para. 0054 teaches in addition, the CPU 38, having recognized the partial loop, recalls from the memory 40 an escape technique unique to that particular partial loop. The escape technique is then visualized on the display 42 for the convenience of the operator … Additional abdominal pressure may be required (interpreted to correspond with future endoscopic procedure of BALASUBRAMANIAN)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Wolf, BALASUBRAMANIAN, WOLF’016, SCHOLL with the prediction of CHOI with the motivation to improving a patient's experience and safety to encourage routine colonoscopy procedures.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
The Office Action alleges that the additional elements "are not described by the applicant" and are recited at a high level of generality as "a generic server performing generic computer functions." See Office Action, page 4. Applicant respectfully submits that this characterization is factually incorrect. The specification describes the system in detail: a risk analysis system 212 comprising one or more processors 220, memory 222, and a communication interface 224, implementing an AI/ML model, e.g., including a convolutional neural network (CNN), with a model training/update component 218 and a model inference component 217 (FIG. 2). See As-Filed Specification, FIG. 2 and accompanying description. The output is provided to a user device 250 having a display 260. Id. In some aspects, the risk analysis system 212 is provided at a central server accessed by one or more remote terminals, with AI/ML inference performed at the server (FIG. 7). See As-Filed Specification, FIG. 7 and accompanying description. The additional elements are therefore not a generic computer performing generic functions; they are a specifically described AI/ML-based risk analysis system that predicts endoscopy-specific risks and outputs an alert enabling ergonomic interventions to reduce injury.
Regarding (a), the Examiner respectfully disagrees. The claim recites the processor performing these limitations, which, under broadest reasonable interpretation, represents a generic computer. The Examiner notes that if the features of the claim are not generic computer components, Applicant likely has an insurmountable 112(a)-written description problem. However, the Examiner has fount that these features are generic computer components and no 112(a) issue currently exist.
Receiving a request for a risk prediction for a future endoscopic procedure and outputting an AI/ML-generated risk prediction alert that identifies ergonomic interventions is not the management of personal behavior, relationships, or following rules or instructions. Rather, the claims recite a specific technical system that processes procedural and biographical information through an AI/ML model to predict risks specific to endoscopic procedures and output an alert enabling physical interventions to reduce injury. This is not an activity that could be performed through human interaction or by following rules. It is a technology-driven prediction and alert system directed to a concrete safety improvement in the field of endoscopy.
Regarding (b), the Examiner respectfully disagrees. Initially, the independent claims do not recite “an AI/ML model.” In any event, the performance of risk prediction represents a series of rules or steps for a human to follow. The use of machine learning represents the application of a technology (AI/ML) via a computer was evaluated as an additional element; it is an “apply it” step. Applicant did not invent AI/ML and is merely using it as a tool to perform the noted abstract idea. Further, Applicant is not claiming the entire field of endoscopy; applicant is claiming a computer that performs a prediction.
Even if the claims were considered directed to an abstract idea, the specific combination of elements, e.g., a risk analysis system that predicts endoscopy-specific risks and outputs an alert enabling ergonomic interventions to be implemented for the future endoscopic procedure, amounts to significantly more than mere instructions to apply an idea on a generic computer. The claims do not merely recite a processor and memory performing a generic function; they recite a medical alert system that receives procedural and biographical information, generates a risk prediction for a future endoscopic procedure, and outputs an alert that identifies concrete physical interventions to reduce injury to the patient, physician, and additional healthcare professional.
Dependent claim 3, as an example, further includes "an [AI/ML] model that is trained based on the historical endoscopic procedural information."
The Office Action cites Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 (Fed. Cir. April 18, 2025), for the proposition that claims applying established methods of machine learning to a new data environment are ineligible. See Office Action, page 5. However, unlike the claims in Recentive, claims 1, 16, and 17, as amended, arc not directed to applying generic machine learning to a new data set. Rather, the claims recite a specific medical alert system that identifies endoscopy-specific ergonomic risks and outputs an alert to apply concrete physical interventions, e.g., such as use of a compression device, assistive equipment for applying external pressure or repositioning, hand dials, an anti-fatigue mat, or adjusting scheduled procedure time, to reduce injury during endoscopic procedures. This is an improvement in the practical performance of endoscopic procedures, not an abstract machine-learning output confined to a field of use.
Regarding (c), the Examiner respectfully disagrees. The claims do “merely recite a processor and memory performing a generic function.” The generic functions are receiving and outputting data, while the actual data manipulations are the abstraction. Further, Recentive is most certainly applicable because Applicant is claiming generic AI/ML trained on data. The Examiner is unclear as to how Applicant can argue that this is not the use of generic AI/ML when the Applicant has not even claim what the particular AI/ML is being used or how it is being trained. Finally, there is no improvement to the endoscopy because all the claim does is output information that may or may not be utilized.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Applicant argues:
WOLF’016 does not teach a risk prediction alert for a future endoscopic procedure. Wolf 216 teaches a warning about an upcoming portion of a procedure that is already underway-not a risk prediction alert generated in advance for a future (e.g., not-yet- commenced) endoscopic procedure, as recited by claim 1. The distinction is significant, and claim 1 (emphasis added) requires that the system receive "a request for a risk prediction for a future endoscopic procedure" and output a corresponding alert before the procedure begins, enabling prospective planning and intervention. Wolf'216's intra-surgical warning, by contrast, is reactive and occurs only after the procedure has started. Accordingly, Wolf'216 fails to teach or suggest the claimed risk prediction alert.
Regarding (a), the Examiner respectfully disagrees. In combination with the prior art of Balasubramanian and WOLF teach the limitation. Examiner has updated the rejection to provide further explanation as to how the prior art is being combined.
Balasubramanian Is Directed to Contrast-Media Adverse Reactions, Not Endoscopic Procedure Risk. Balasubramanian is directed to "managing adverse reactions in contrast media- based medical procedures." See Balasubramanian, Title. Balasubramanian computes "a prediction of a risk that the patient will experience an adverse reaction to the contrast media." See Balasubramanian, paragraph [0012] (emphasis added). The risk assessed in Balasubramanian is a patient's physiological reaction to contrast media used in imaging procedures-not the risks to a patient, physician, or additional healthcare professional associated with performance of an endoscopic procedure, as recited by claim 1.
Regarding (b), the Examiner respectfully disagrees. The title provides no evidence as to whether the prior art teaches the claim limitations. Examiner does not rely on Para. 0012 in the rejection and makes clear how the prior art of Balasubramanian is being combined with WOLF’016 to teach the limitation. Furthermore, the claimed limitation does not recite “risks to a patient, physician, or additional healthcare professional associated with performance of an endoscopic procedure”. The limitation “wherein the risk prediction is based on risk information associated with one or more risks to at least one of a patient, a physician, or an additional healthcare professional based on at least one of biographical information or the proposed endoscopic procedural information, … [ … ] ”, meaning that the risks do not have to include any information tied to the endoscopic procedure.
The Motivation to Combine Is Conclusory. Even assuming, arguendo, that the cited references could be combined, the Examiner has not articulated a sufficient rationale for doing so. The stated motivations-"to improve the effectiveness of risk assessments" and "to improve efficiency and accuracy in data analysis"- are generic and conclusory. See Office Action, pages 7-8. These boilerplate rationales provide no explanation as to why a person of ordinary skill in the art would combine (i) Wolf's historical-footage analysis system, (ii) Balasubramanian's contrast-media adverse-reaction predictor, and (iii) Wolf 216's intra-surgical real-time video warning to arrive at the claimed medical alert system that outputs a risk prediction alert for a future endoscopic procedure in response to a request received before the procedure begins.
Regarding (c), the Examiner respectfully disagrees. The motivation to combine being generic and conclusory still provides a motivation to combine, as per the MPEP. There is no requirement in the MPEP on how broad or generic motivation can be.
For example, the cited references further fail to disclose or suggest that "the feedback information is received at a device at or near a treatment room for the endoscopy procedure via a user interface that displays a question about one or more of whether manual pressure was used, whether the patient was repositioned, or an effect on the physician or the additional healthcare professional," as in dependent claim 5 (emphasis added).
Regarding (d), the Examiner respectfully disagrees. Applicant has not provided evidence to support statement.
As another example, the cited references further fail to disclose or suggest "receive, via the communication interface, preference information related to risk tolerances or goals of an endoscopy procedure, wherein the risk prediction alert is based on the preference information received at the communication interface," as in dependent claim 7.
Regarding (e), the Examiner respectfully disagrees. Applicant has not provided evidence to support statement.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Chua et al (US Publication No. 20100070327) discloses systems and methods for self-updating procedure duration estimation for patient scheduling.
MOTESHAREI et al (US Publication No. 20230410993) discloses systems and methods for optimizing medical procedures.
THIS ACTION IS MADE FINAL, necessitated by amendment. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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