DETAILED ACTION
The present office action represents a nonfinal action on the merits.
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 .
Priority
This application claims the priority date of a foreign application JP2022-082495 dated May 19, 2022.
Status of Claims
Claims 3-4 and 10-11 are withdrawn and claims 1-13 are pending.
Election/Restrictions
Claims 3-4 and 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species B and C, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/12/2026.
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 1-2, 5-9, and 12-13 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 1-2 are drawn to a device, which is within the four statutory categories (i.e., machine). Claims 5-9 and 12-13 are drawn to a method, which is within the four statutory categories (i.e., process).
Claims 1-2 recite a device comprising:
a user input interface;
a display;
a first interface with a surgical device to send control information indicative of a therapeutic treatment;
a second interface to receive, from a surgical monitoring device, a medical data stream with information indicative of operation of the surgical device; and
a processor configured to:
receive, via the user input interface, a therapeutic treatment selected by a user;
retrieve, from a therapeutic treatment database, therapeutic treatment information associated with the selected therapeutic treatment;
select the surgical monitoring device, from a monitoring device database, based on the therapeutic treatment information, wherein the surgical monitoring device monitors medical data, included in the medical data stream, relevant to efficacy of the therapeutic treatment;
generate a therapy profile based on the therapeutic treatment information and the surgical monitoring device, wherein the therapy profile comprises a graphical representation of progress of the therapeutic treatment;
output the therapy profile to the display;
receive, over the first interface, the medical data stream;
determine, based on the medical data, qualitative feedback information about the therapeutic treatment determine a threshold value associated with the medical data and the therapeutic treatment;
compare the medical data to the threshold value determined from the therapy profile; and
on a condition that the medical data exceeds the threshold value, adjust, over the first interface, the therapeutic treatment.
Claims 5-9 and 12-13 recite a method comprising:
selecting a therapeutic treatment from a database of a plurality of therapeutic treatments;
selecting a corresponding medical data stream relevant to the therapeutic treatment, wherein the medical data stream is produced by a surgical monitoring device; and
determining, based on the medical data stream, qualitative feedback information about the therapeutic treatment.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components. The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 2, 6-9, and 12-13 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 an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The dependent claims include additional limitations but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 5.
The additional elements from claim 1 include:
a device (apply it, MPEP 2106.05(f)).
a user input interface (apply it, MPEP 2106.05(f)).
a display (apply it, MPEP 2106.05(f)).
a first interface (apply it, MPEP 2106.05(f)).
a surgical device (apply it, MPEP 2106.05(f)).
a second interface (apply it, MPEP 2106.05(f)).
a surgical monitoring device (apply it, MPEP 2106.05(f)).
a processor configured to (apply it, MPEP 2106.05(f)).
a therapeutic treatment database (apply it, MPEP 2106.05(f)).
a monitoring device database (apply it, MPEP 2106.05(f)).
The additional elements from claim 5 include:
a database (apply it, MPEP 2106.05(f)).
a surgical monitoring device (apply it, MPEP 2106.05(f)).
The dependent claims contain additional elements including:
an implant (generally linking, MPEP 2106.05(h)).
a surgical instrument (generally linking, MPEP 2106.05(h)).
Claims 1-2, 5-9, and 12-13 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a “a device”, “a user input interface”, “a display”, “a first interface”, “a surgical device”, “a second interface”, “a surgical monitoring device”, “a processor”, “a therapeutic treatment database”, “a monitoring device database”, “a database”, “a surgical monitoring device”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see Specification Paragraphs [0024], [0027], [0034], [0056]-[0058], and [0060]-[0063] (see MPEP 2106.05(f)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Paragraphs [0024], [0027], [0034], [0056]-[0058], and [0060]-[0063] of the Specification discloses that the additional elements (i.e., a device, a user input interface, a display, a first interface, a surgical device, a second interface, a surgical monitoring device, a processor configured to, a therapeutic treatment database, a monitoring device database, a database, a surgical monitoring device) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives patient medical data.
Dependent claims 2, 6-9, and 12-13 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the coordinated control of therapeutic treatment effects.
Therefore, whether taken individually or as an ordered combination, claims 1-2, 5-9, and 12-13 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roh I (U.S. Pub. No. 2023/0059343 A1).
Regarding claim 1, Roh I discloses a device comprising:
a user input interface (Paragraphs [0004] and [0086] discuss an input interface and a digital assistant interface in an operating room.);
a display (Paragraph [0085] discusses the operating room includes high-definition monitor display.);
a first interface (Examiner notes that the prior art does not include “first”, “second”, etc.) with a surgical device to send control information indicative of a therapeutic treatment (Paragraph [0004] discusses a system for telemetry-based control for a surgical procedure includes a surgical consulting network, a hospital with an operating room for the surgical procedure, a digital assistant interface in the operating room, at least one consultant user device.);
a second interface to receive, from a surgical monitoring device, a medical data stream with information indicative of operation of the surgical device (Paragraphs [0004], [0127], [0131]-[0132], [0159] discuss a surgical consulting network, a hospital with an operating room for the surgical procedure, a digital assistant interface in the operating room, at least one consultant user device, a database of available consultants, and a database of surgical procedures, wherein at least one consultant user device can be connected to the operating room to allow a remote user to interact with the people or equipment in the operating room for the surgical procedure; the communication module enables one or more consultant user devices to connect to one or more sensors, a digital assistant interface, or the medical equipment in the operating room.); and
a processor configured to (Paragraph [0100] discusses processors.):
receive, via the user input interface, a therapeutic treatment selected by a user (Paragraphs [0123]-[0124], [0131]-[0133] discuss operation of the medical equipment is controlled by the user device based on received consultant inputs in compliance with a stored access control list for the surgical consultant.);
retrieve, from a therapeutic treatment database, therapeutic treatment information associated with the selected therapeutic treatment (Paragraphs [0005] and [0123]-[0125] discuss in response to receiving a prompt indicating a surgical procedure from a computer device at a medical facility, a computer system schedules the surgical procedure based on patient data retrieved from an electronic health records database. The computer system receives a surgical consulting requirement of the medical facility for the surgical procedure, receives a message that the surgical procedure has been initiated, establishes a communication channel between the computer device at the medical facility.);
select the surgical monitoring device, from a monitoring device database, based on the therapeutic treatment information, wherein the surgical monitoring device monitors medical data, included in the medical data stream, relevant to efficacy of the therapeutic treatment (Paragraphs [0029], [0117]-[0125], and [0197] discuss provide best practice for surgery and a computer device at a medical facility and the consultant user device of a surgical consultant and provide medical advice related to the present surgical procedure using the surgery module based on patient data enabling surgical consultants to interact with a surgical procedure in the operating room, for example, the surgical consultant can be an anesthesiologist remotely monitoring and controlling the medical equipment, such as an anesthesiology machine in some embodiments using the surgery module.);
generate a therapy profile based on the therapeutic treatment information and the surgical monitoring device, wherein the therapy profile comprises a graphical representation of progress of the therapeutic treatment (Paragraphs [0190] discuss the consultant device can display procedure information from the surgery room, equipment controls, and other data disclosed herein, the consultant device can display a graphical user interface (“GUI”), imaging equipment can automatically capture images for surgical side viewing via a display, includes a procedure progress that can be updated to show completed progress for the procedure, and controls can be used to operate machines/applications.);
output the therapy profile to the display (Paragraph [0190] discusses the consultant device can display procedure information from the surgery room, equipment controls, and other data disclosed on a graphical user interface (“GUI”).);
receive, over the first interface, the medical data stream (Paragraph [0190] discusses the GUI displays procedure and patient data, imaging equipment can automatically capture images for surgical side viewing via a display, a procedure progress that can be updated to show completed progress for the procedure, and controls can be used to operate machines/applications.);
determine, based on the medical data, qualitative feedback information about the therapeutic treatment (Paragraphs [0190]-[0194] discuss GUI includes a procedure progress, consultant monitors progress, for example, if an adverse event occurs, the consultant can request access to the additional equipment (e.g., robotic arms of surgical robot, breathing machine, heart rate monitor, etc.) provide dynamic update of the procedure.);
determine a threshold value associated with the medical data and the therapeutic treatment (Paragraphs [0114] discuss the network can adjust the authentication requirements based on a patient's data/vitals, such as health metrics. For example, if the patient's heart rate is below a threshold level (e.g., indicating the user is experiencing a medical emergency), requires lower levels of authentication or no authentication for a healthcare provider to remotely access and control a machine or application.);
compare the medical data to the threshold value determined from the therapy profile (Paragraph [0114] discusses if the patient's heart rate is below the threshold level, the network adapter requires higher levels of authentication for a healthcare provider to remotely access and control a machine or application. The on-site physicians, nurses, and surgical staff can take over operation of previously remote-controlled equipment. Once the patient is stable, based on a confidence of accuracy score above a threshold value, the system can re-establish the telemedicine session with the remote consultant.); and
on a condition that the medical data exceeds the threshold value, adjust, over the first interface, the therapeutic treatment (Paragraphs [0185]-[0186] discuss the robotic surgical system determines whether a detected event (e.g., operational parameters outside a target range or exceeding a threshold, etc.) is potentially an adverse surgical event based on one or more criteria set by the robotic surgical system, user, or both. The adverse surgical event can be an adverse physiological event of the patient, surgical robotic malfunction, surgical errors, or other event that can adversely affect the patient or the outcome of the surgery, robotic surgical system can take other actions in response to identification of an event, for example determine how to proceed with surgery.).
Regarding claims 2 and 9, Roh I discloses wherein the therapeutic treatment comprises a tumor debulking therapy, the medical data stream comprises a tidal volume of airflow at a given pressure, and the qualitative feedback comprises an indication of whether the tidal volume of airflow has reached a desired amount at the given pressure (Paragraphs [0035], [0052], and [0060] discuss the monitors include an end tidal CO2 monitor for the measurement of applications such as cardiopulmonary resuscitation (CPR), airway assessment, procedural sedation and analgesia, pulmonary diseases such as obstructive pulmonary disease, pulmonary embolism, etc., heart failure, metabolic disorders, etc., the amount of carbon dioxide present can be determined; and surgical procedures require the removal of body tissues and organs, for example, electrocautery instrument can be used in applications such as surgery, tumor removal, the stereotactic navigation system can be used for tumor resection.).
Regarding claim 5, Roh I discloses a method comprising:
selecting a therapeutic treatment from a database of a plurality of therapeutic treatments (Paragraphs [0046], [0173], and [0178] discuss a medical visualization apparatus used for visualization and analysis of objects (preferably three-dimensional (3D) objects) in the operating room, provides the selection of points at surfaces, selection of a region of interest, or selection of objects, and can also be used for diagnosis, treatment planning, intraoperative support, documentation, or educational purposes; for surgical applications, the images could include, but are not limited to, real-time optical images, real-time ultrasound, real-time OCT images and/or other modalities, or could include pre-operative images, such as MRI, CT, PET, etc. and the various imaging modalities can be selectable, further, the surgical robot can operate in different modes selected by a user, set by the surgical plan, and/or selected by the robotic surgical system.);
selecting a corresponding medical data stream relevant to the therapeutic treatment, wherein the medical data stream is produced by a surgical monitoring device (Paragraphs [0178]-[0180] discuss the surgical robot can include various imaging devices and can operate in different modes selected by a user, set by the surgical plan, and/or selected by the robotic surgical system, the configuration, functionality, number of modes, and type of modes can be selected based on the desired functionality and user control of the robotic surgical system and the robotic surgical system can switch between modes based on one or more features, such as triggers, notifications, warnings, events, etc.); and
determining, based on the medical data stream, qualitative feedback information about the therapeutic treatment (Paragraph [0181] discusses the robotic surgical system an automatically generate multi-modality images based on surgical plans and then perform one or more surgical steps of a planned surgical procedure and analyzes a surgical plan for a patient to generate an imaging plan for obtaining patient information for diagnostic purposes, modifying the surgical plan, performing surgical steps (e.g., one surgical step, multiple surgical steps, all surgical steps), etc.).
Regarding claim 6, Roh I discloses wherein the qualitative feedback information about the therapeutic treatment is indicative of an effectiveness of the therapeutic treatment (Paragraphs [0181] and [0206] discuss robotic surgical system can notify the surgical team to add or replace imaging devices to achieve the desired imaging capability; surgical programs can include feedback about the surgical procedure, the goals can include intraoperative goals, post-operative goals (e.g., target outcomes, metrics, etc.), goal rankings, etc., monitoring equipment or the surgical team can determine goal progress, whether a goal has been achieved, etc. If an intraoperative goal is not met, the surgical plan can be modified in real-time so that, for example, the post-operative goal is achieved. The post-operative goal can be redefined intraoperatively in response to events, such as surgical complications, unplanned changes to patient's vitals, etc.).
Regarding claim 7, Roh I discloses wherein determining, based on the medical data stream, qualitative feedback information about the therapeutic treatment comprises (Paragraphs [0205]-[0206] discuss the surgical robot or other components can communicate to send collected data (e.g., sensor readings, instrument data, surgical robot data, etc.) to the database to be used to, for example, create new training data sets, generate plans, perform future simulations, post-operatively analyze surgical procedures, or the like and the surgical programs can include feedback about the surgical procedure.):
determining an expected effect on a patient receiving the therapeutic treatment (Paragraph [0206] discusses surgical programs can include feedback about the surgical procedure, the goals can include intraoperative goals, post-operative goals (e.g., target outcomes, metrics, etc.), goal rankings, etc., monitoring equipment or the surgical team can determine goal progress, whether a goal has been achieved, etc. If an intraoperative goal is not met, the surgical plan can be modified in real-time so that, for example, the post-operative goal is achieved. The post-operative goal can be redefined intraoperatively in response to events, such as surgical complications, unplanned changes to patient's vitals, etc.);
comparing the medical data stream to the expected effect (Paragraph [0197] discusses mapping can be performed before treatment, during treatment, and/or after treatment. For example, pretreatment and posttreatment mapping can be compared by the surgeon and/or ML/AI system. The comparison can be used to determine next steps in a procedure and/or further train the ML/AI system.); and
determining the qualitative feedback information based on the comparison (Paragraph [0206] discusses surgical programs can include feedback about the surgical procedure, the goals can include intraoperative goals, post-operative goals (e.g., target outcomes, metrics, etc.), goal rankings, etc., monitoring equipment or the surgical team can determine goal progress, whether a goal has been achieved, etc. If an intraoperative goal is not met, the surgical plan can be modified in real-time so that, for example, the post-operative goal is achieved. The post-operative goal can be redefined intraoperatively in response to events, such as surgical complications, unplanned changes to patient's vitals, etc.).
Regarding claim 8, Roh I discloses wherein determining, based on the medical data stream, qualitative feedback information about the therapeutic treatment comprises (Paragraphs [0205]-[0206] discuss the surgical robot or other components can communicate to send collected data (e.g., sensor readings, instrument data, surgical robot data, etc.) to the database to be used to, for example, create new training data sets, generate plans, perform future simulations, post-operatively analyze surgical procedures, or the like and the surgical programs can include feedback about the surgical procedure.):
determining a threshold value associated with the medical data stream and the therapeutic treatment (Paragraphs [0108]-[0114] discuss a surgical plan, for example, if the patient's heart rate is below a threshold level (e.g., indicating the user is experiencing a medical emergency), the network adapter requires lower levels of authentication or no authentication for a healthcare provider to remotely access and control a machine or application.).;
comparing the medical data to the threshold value (Paragraphs [0185] and [0197] discuss determine whether operational parameters outside a target range or exceeding a threshold, etc.; mapping can be performed before treatment, during treatment, and/or after treatment. For example, pretreatment and posttreatment mapping can be compared by the surgeon and/or ML/AI system. The comparison can be used to determine next steps in a procedure and/or further train the ML/AI system.); and
on a condition that the medical data exceeds the threshold value, adjusting the therapeutic treatment (Paragraphs [0185]-[0186] discuss the robotic surgical system determines whether a detected event (e.g., operational parameters outside a target range or exceeding a threshold, etc.) is potentially an adverse surgical event based on one or more criteria set by the robotic surgical system, user, or both and can take other actions in response to identification of an event.).
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 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.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Roh I in view of Roh II (U.S. Pub. No. 2024/0065764 A1).
Regarding claim 12, Roh I does not explicitly disclose wherein the therapeutic treatment comprises designing an implant, the medical data stream comprises a first imaging scan of an anatomical area of a patient associated with the implant and a second imaging scan of the anatomical area of the patient associated with the implant, and the qualitative feedback comprises an indication of whether inconsistencies between the first and second imaging scans exist or whether anomalies exist in either the first or second imaging scans.
Roh II teaches:
wherein the therapeutic treatment comprises designing an implant, the medical data stream comprises a first imaging scan of an anatomical area of a patient associated with the implant and a second imaging scan of the anatomical area of the patient associated with the implant, and the qualitative feedback comprises an indication of whether inconsistencies between the first and second imaging scans exist or whether anomalies exist in either the first or second imaging scans (Paragraphs [0020]-[0021] discuss custom surgical implant design, a computer-implemented digital image analysis method for robotic installation of an implant, a surgical robot for performing digital image analysis for robotic installation of an implant and perform design and installation of customized surgical implants and uses imaging data to identify less-invasive installation paths and determine dimensions of the surgical implant components; the apparatus simulates movement of the surgical implant components through the identified routes and assembly of the surgical implant at the implant site within the patient's body. The apparatus identifies and generates modifications to the surgical implant components when it determines that they are unable to pass through the identified route or be assembled at the surgical implant site within the patient's body.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Roh I to include, wherein the therapeutic treatment comprises designing an implant, the medical data stream comprises a first imaging scan of an anatomical area of a patient associated with the implant and a second imaging scan of the anatomical area of the patient associated with the implant, and the qualitative feedback comprises an indication of whether inconsistencies between the first and second imaging scans exist or whether anomalies exist in either the first or second imaging scans, as taught by Roh II, in order to prevent surgical errors and adverse events during surgery. (Roh II Paragraph [0002].).
Regarding claim 13, Roh I discloses wherein the method further comprises adjusting a parameter of the therapeutic treatment in response to the qualitative feedback information, and wherein the parameter of the therapeutic treatment comprises one of more of (Paragraphs [0130]-[0131], [0159], [0206], [0208] discuss operating room can contain sensors associated with measuring a specific parameter of a patient, such as respiratory rate, blood pressure, blood oxygen level, heart rate, etc. based on the patient data feed an anesthesiologist adjusts the medical equipment, and a change in settings is displayed by the digital assistant interface; Monitoring equipment or the surgical team can determine goal progress, whether a goal has been achieved, etc. If an intraoperative goal is not met, the surgical plan can be modified in real-time so that, for example, the post-operative goal is achieved, If a resource becomes unavailable, the surgical plan can be adjusted for the change in resources.).
Roh I does not explicitly disclose:
a location of the therapeutic treatment;
a drug concentration;
an injection pressure;
a power level of a surgical instrument associated with the therapeutic treatment;
a temperature associated with the surgical instrument; or
a resolution of one or more imaging scans.
Roh II teaches:
a location of the therapeutic treatment (Paragraphs [0020]-[0021] a computer-implemented digital image analysis method for robotic installation of an implant, a surgical robot for performing digital image analysis for robotic installation of an implant and perform design and installation of customized surgical implants and uses imaging data to identify less-invasive installation paths and determine dimensions of the surgical implant components; the apparatus simulates movement of the surgical implant components through the identified routes and assembly of the surgical implant at the implant site within the patient's body. The apparatus identifies and generates modifications to the surgical implant components when it determines that they are unable to pass through the identified route or be assembled at the surgical implant site within the patient's body.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Roh I to include, a location of the therapeutic treatment, as taught by Roh II, in order to prevent surgical errors and adverse events during surgery. (Roh II Paragraph [0002].).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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