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 .
Status of Claims
This action is in reply to Applicant’s communication filed on February 23, 2026.
Claims 1-5 and 11-19 have been amended and are hereby entered.
Claims 1-20 are currently pending and have been examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest priority date is: December 28, 2017.
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 an abstract idea without significantly more.
Step 1 analysis:
Claims 1 and 13 are each directed to a system and Claim 18 is directed to a method and therefore all fall into one of the four statutory categories. (Step 1: Yes, the claims fall into one of the four statutory categories).
Step 2A analysis - Prong one:
The substantially similar independent system and method claims, taking claim 18 as exemplary, recite the following limitations: A method comprising: receiving…perioperative data…, wherein the surgical instrument is actuatable to perform a tissue altering function,…, and wherein the perioperative data corresponds to a first actuation of the surgical instrument during a procedure to perform the tissue altering function; inferring a surgical context based, at least in part, on the received…perioperative data…; correlating the surgical context to a plurality of surgical outcomes…; identifying a pattern associated with the surgical context and the plurality of surgical outcomes based, at least in part, on the correlation; and updating the control program based, at least in part, on the identified pattern,…
The series of steps as recited above describe managing personal behavior or relationships or interactions between people including following rules or instructions and are thus are grouped as certain methods of organizing human activity which are abstract ideas. (Step 2A – Prong 1: Yes, the claims are abstract).
Step 2A analysis - Prong two:
Claims 1, 13 and 18 recite additional elements beyond the abstract idea. Claims 1, 13 and 18 recite a signal generated by a surgical instrument, a plurality of surgical hubs, a medical record database, a surgical instrument, “wherein the tissue altering function is executed according to a control program” and “cause the first surgical instrument to execute a second actuation according to the updated control program during the procedure to perform the tissue altering function”. Claim 1 further recites a plurality of surgical instruments, a cloud-based analytics subsystem, a control circuit, and autonomously inferring a surgical context. Claim 13 further recites a cloud-based analytics system, a control circuit and autonomously inferring a surgical context. The claims are applying generic computer components to the recited abstract limitations. The recited control program appears to be software.
This judicial exception is not integrated into a practical application. In particular, the claims recite a signal generated by a surgical instrument, a plurality of surgical hubs, a medical record database, a control program, a plurality of surgical instruments, a first surgical instrument, a cloud-based analytics subsystem, a control circuit, a cloud-based analytics system and autonomously inferring a surgical context which are all recited at a high-level of generality (i.e., as a generic processor performing generic computer functions) such that it amounts to no more than mere instructions to apply the exceptions using a generic computer component. Applicant’s specification explains that the control circuit merely reads instructions, executes control functions, etc., like a generic processor. For example, para 2037 states that the circuit may be “a general-purpose computer configured by a computer program which at least partially carries out processes and/or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and/or devices described herein” (see Applicant’s spec. paras 2037). Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 1, 13 and 18 are directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional claimed elements are not integrated into a practical application).
Step 2B analysis:
The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i) receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)); iv) storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. See MPEP §2106.05(d)(II).
This listing is not meant to imply that all computer functions are well‐understood, routine, conventional activities, or that a claim reciting a generic computer component performing a generic computer function is necessarily ineligible. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). On the other hand, courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. See MPEP §2106.05(d)(II) – emphasis added.
Here, the steps are receiving or transmitting data over a network (MPEP 2106.05(d)(II)); storing and retrieving information in memory (MPEP 2106.05(d)(II)) – all of which have been recognized by the courts as well-understood, routine and conventional functions.
The claims are directed to an abstract idea with additional generic computer elements that do not add meaningful limitations to the abstract idea because they require no more than a generic computer to perform generic computer functions that are well-understood, routine, and conventional activities previously known in the industry.
For the next step of the analysis, it must be determined whether the limitations present in the claims represent a patent-eligible application of the abstract idea. A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.
For the role of a computer in a computer implemented invention to be deemed meaningful in the context of this analysis, it must involve more than performance of well-understood, routine, and conventional activities previously known to the industry. Further, the mere recitation of a generic computer cannot transform a patent ineligible abstract idea into a patent-eligible invention. See MPEP 2106.05(d).
Applicant’s specification discloses the following:
Applicant describes embodiments of the disclosure at a very high level to include the use of a wide variety of databases (see paras 621, 690, 794, 875), monitoring devices (see para 650), sensors (e.g., light sensors, non-contact inductive sensors, image sensors, etc.) (see paras 153, 212, 237), machine learning systems (see para 795), computers, control circuits, processors, computer-readable medium, memories, software/programs, networks, etc. (see paras, 2036-2042). The invention may use any computer via any transmission medium (a communication network or broadcast waves) capable of transmitting data.
Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. The collective functions appear to be implemented using conventional computer systemization.
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 identified additional elements used to perform all of the steps discussed above amount to no more than mere instructions to apply the exceptions using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims do not provide an inventive concept significantly more than the abstract idea. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. (Step 2B: No, the claims do not provide significantly more).
Dependent Claims 2-12, 14-17 and 19-20 further define the abstract idea that is presented in independent Claims 1, 13 and 18 respectively, and are further grouped as certain methods of organizing human activity and are abstract for the same reasons and basis as presented above. Further, Claims 5-7, 9, 17 and 20 recite additional elements beyond the abstract idea. Claims 5 and 17 recite using a robotic instrument. Claims 6 and 20 recite a machine learning algorithm. Claim 7 recites an artificial neural network. Claim 9 recites using a subset of a plurality of surgical staplers. These additional elements are recited at a high level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. For example, as noted above, the Applicant’s specification indicates the use of known machine learning systems. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims do not recite additional elements that integrate the judicial exception into a practical application when considered both individually and as an ordered combination. Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-20 are rejected under 35 U.S.C. 101 as being directed to abstract ideas without significantly more.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grantcharov et al. (WO 2016149794) in view of Stulen et al. (US 20170000516).
Regarding Claim 1, Grantcharov discloses the following limitations:
A surgical system comprising: a medical record database configured to store a plurality of surgical outcomes associated with historical procedures performed throughout a medical network; (Grantcharov discloses a multi-channel recorder/encoder for collecting, integrating, synchronizing and recording medical or surgical data received as independent live or real-time data streams from a plurality of hardware units. The real-time medical or surgical data streams are used to generate session container files on network accessible storage devices such as a central content server (a medical record database). The session container files are processed to identify root causes of adverse patient outcomes (a plurality of surgical outcomes associated with historical procedures). The ability to model, recognize and predict the relevant patterns has tremendous potential…for historical data. – abstract; paras 54, 106, 116, 161, 302)
a plurality of surgical hubs distributed across the medical network, wherein the plurality of surgical hubs is communicably coupled to the medical record database and configured to be coupled to a plurality of surgical instruments, (Grantcharov discloses a media management hub (surgical hubs) in communication with the Central Content Server (CCS) (coupled to the medical record database) and there may be communication with client sit hubs indicating multiple hubs may be present (a plurality of surgical hubs). The media management hub performs translating, connecting, formatting, and recording the real-time medical or surgical data streams to generate session container files on network accessible storage devices, wherein these data streams originate from a plurality of hardware units (coupled to a plurality of surgical instruments) – abstract; paras 34, 54, 106, 257, 261-262; FIG 1, 5-8)
wherein a surgical hub of the plurality of surgical hubs is configured to be communicably coupled to a surgical instrument of the plurality of surgical instruments, (Grantcharov discloses that the media management hub (a surgical hub of the plurality of surgical hubs) performs translating, connecting, formatting, and recording the real-time medical or surgical data streams to generate session container files on network accessible storage devices. The data streams originate from a plurality of hardware units (the plurality of surgical instruments). The hardware units may gather or collect one or more independent data streams from different devices, and in turn each data stream provided by the hardware unit may be independent of other data streams provided by other hardware units (communicably coupled to a surgical instrument). – abstract; paras 34, 54, 106, 257, 261-262; FIG. 1, 16)
and a cloud-based analytics subsystem communicably coupled to the medical record database and the plurality of surgical hubs, wherein the cloud-based analytics subsystem comprises a control circuit configured to: receive, from the surgical hub, a signal comprising perioperative data…; (Grantcharov discloses a cloud based system for collecting and processing medical or surgical data incorporating an encoder (a cloud-based analytics subsystem) including a processor (a control circuit). Wireless network infrastructure provides a secure network connection between the encoder, the smart devices (i.e., the hardware units) (the surgical instrument) and the media management hub server (from the surgical hub) for communication of (receive a signal comprising) the real-time medical or surgical data streams (perioperative data). – paras 34, 54, 200; FIG. 10B, 11)
autonomously infer a surgical context based, at least in part, on the received signal comprising the perioperative data; (Grantcharov discloses that the encoder detects clinical events within the surgical data streams (autonomously infer a surgical context). – paras 42, 45-46, 159; FIG. 26)
correlate the surgical context to the plurality of surgical outcomes stored in the medical record database; (Grantcharov discloses that all identified crisis scenarios (e.g., adverse outcomes) (the plurality of surgical outcomes) may be stored in a database (stored in the medical record database). The significant events (the surgical context) are detected from the surgical data and the processing of the data includes identifying underlying factors and/or patterns of events that led up to adverse outcome (correlate the determined surgical context to the plurality of surgical outcomes). – paras 159-161, 177)
identify a pattern associated with the surgical context and the plurality of surgical outcomes based, at least in part, on the correlation; (Grantcharov discloses that the network server or encoder identifies frequent temporal events (associated with the surgical context) as patterns (identify a pattern) leading to adverse events or errors (and the plurality of surgical outcomes) in the timeline and develops predictive models that can identify critical events during the real-time medical procedures. Analyzing these underlying factors according to some embodiments may allow identification of performance deficiencies of medical/surgical devices (the surgical instrument) – to curb the rate of risk factors in future procedures and/or ultimately to improve patient safety outcomes and clinical costs. – paras 68, 161, 303)
Grantcharov does not discloses the following limitations taught by Stulen:
and wherein the surgical instrument is actuatable to perform a tissue altering function, wherein the tissue altering function is executed according to a control program; (Stulen teaches a method for dynamically changing the energy delivered to a surgical instrument 108 based on a determination of tissue type being treated by the surgical instrument 108. During the treatment of the tissue, the processor 502 continues to calculate and monitor 2720 the tissue coefficient of friction μ and the rate of change of the tissue coefficient of friction μ (according to a control program) to allow the processor 502 to dynamically update the power delivery profile (the surgical instrument is actuatable to perform a tissue altering function). If an error is found, the power delivery profile is modified 2724 (the tissue altering function is executed according to a control program). The processor 502 then determines 2722 if the correct pattern of power and delivery profile is being used. If no error is found, the current power delivery profile continues 2726. – paras 219, 221)
…perioperative data corresponding to a first actuation of the surgical instrument during a procedure to perform the tissue altering function; (Stulen teaches a method for dynamically changing the energy delivered to a surgical instrument 108 based on a determination of tissue type being treated by the surgical instrument 108 (corresponding to a first actuation of the first surgical instrument during a procedure to perform the tissue altering function). The tissue coefficient of friction μ and the processor 502 measures 2706 the rate of change (e.g., rate of rise) of the tissue coefficient of friction μ over a short period of time (perioperative data). The processor 502 compares 2708 the measured tissue coefficient of friction μ and the rate of change of the tissue coefficient of friction μ to values stored in a tissue information database 2714. – paras 219-220; FIG. 48)
and update the control program during the procedure based, at least in part, on the identified pattern, to control the surgical instrument to execute a second actuation according to the updated control program during the procedure to perform the tissue altering function. (Stulen teaches that if an error is found, the power delivery profile is modified 2724 (update the control program during the procedure). The processor 502 then determines 2722 if the correct pattern of power and delivery profile is being used (based, at least in part, on the identified pattern). If no error is found, the current power delivery profile continues 2726. Otherwise, the processor 502 modifies 2724 the power and delivery profile. The processor 502 continues the process of verification and correction of the power delivery profile during the entire surgical procedure (control the surgical instrument to execute a second actuation according to the updated control program during the procedure to perform the tissue altering function) to optimize the energy being delivered to the surgical instrument 108 based on the type of tissue being treated. – para 221; FIG. 48) (Examiner notes that, based on broadest reasonable interpretation, the limitations “and update the control program during the procedure based, at least in part, on the identified pattern, to control the surgical instrument to execute a second actuation according to the updated control program during the procedure to perform the tissue altering function.” may be interpreted to encompass updating an algorithm for any instrument-related implementation during a procedure based on an identified pattern.)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surgical data collected by the hardware units relating to a live or real-time medical procedure as disclosed by Grantcharov to incorporate dynamically updating the power delivery profile of the surgical instrument during the entire surgical procedure as taught by Stulen in order to optimize the energy being delivered to the surgical instrument (see Stulen para 221).
Regarding Claim 2, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 1, wherein the medical record database is further configured to store contextual metadata associated with historical procedures performed throughout the medical network, (Grantcharov discloses that the time-stamped clinical events within the session container file (historical procedures performed) is stored with associated metadata (store contextual metadata) for duration and frequency of each time-stamped clinical event. The metadata may be stored in various formats. – paras 66, 211, 294)
and wherein the control circuit is further configured to correlate the surgical context to the contextual metadata stored in the medical record database. (Grantcharov discloses that the time-stamped clinical events (the surgical context) within the session container file is stored with associated (correlate) metadata (to the contextual metadata stored) for duration and frequency of each time-stamped clinical event. – paras 66, 211)
Regarding Claim 3, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 2, wherein the contextual metadata comprises at least one of a historical procedure time, a historical procedure type, a historical procedural outcome, a historical procedure cost, or a resource date of acquisition. (Grantcharov discloses that the stored metadata is associated with the time-stamped clinical events (a historical procedure time) within session container files. – para 66)
Regarding Claim 4, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 3, wherein the control circuit is further configured to generate a resource recommendation based, at least in part, on the correlation of the surgical context to the contextual metadata stored in the medical record database. (Grantcharov discloses that the time-stamped clinical events (the surgical context) within the session container file is stored with associated metadata (the correlation of the determined surgical context to the contextual metadata) for duration and frequency of each time-stamped clinical event. By analyzing the underlying factors it’s possible to develop recommendations for improvement and/or design of "intelligent" devices and implants (to generate a resource recommendation) - to curb the rate of risk factors in future procedures and/or ultimately to improve patient safety outcomes and clinical costs. The network server or encoder identifies frequent temporal events as patterns leading to adverse events or errors in the timeline and develops predictive models to identify critical events during the real-time medical procedures. – paras 66, 68, 161, 211, 280)
Regarding Claim 5, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 4, wherein the resource recommendation comprises at least one of a cartridge type, a cartridge color, an adjunct resource usage, or a recommendation to utilize a robotic instrument. (Grantcharov discloses providing recommendations on workflow and human factors impacting timeline and chain of events such as equipment and devices (an adjunct resource usage). – paras 161, 280)
Regarding Claim 6, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 5, wherein the control circuit is configured to generate the updated control program and the resource recommendation based, at least in part, on a machine learning algorithm. (Grantcharov discloses using artificial intelligence, vector machines, neural networks, etc. (a machine learning algorithm). – paras 33, 46, 51)
Regarding Claim 7, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 6, wherein the machine learning algorithm is an artificial neural network. (Grantcharov discloses that the methods may include artificial neural networks (ANN)– paras 282-283)
Regarding Claim 8, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 2, wherein the medical network comprises a plurality of facilities, wherein the plurality of surgical hubs is distributed throughout the plurality of facilities, (Grantcharov discloses that the embodiments, including the client site hubs (the plurality of surgical hubs), may be used in various hospital and clinical facilities (a plurality of facilities). – paras 178, 185, 262)
and wherein the contextual metadata stored by the medical record database is automatically generated by the plurality of surgical hubs upon operation of the plurality of surgical instruments during a plurality of historical procedures. (Grantcharov discloses that the hardware units used (operation of the plurality of surgical instruments) generate the surgical data, transmits the data to the encoder where the encoder processes the time-stamped data and identifies clinical events. And the clinical events may be stored (stored by the medical record database) with associated metadata (the contextual metadata). – paras 33, 42, 66)
Regarding Claim 9, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 8, wherein a subset of the plurality of surgical instruments are surgical staplers, (Grantcharov discloses that the hardware units (the plurality of surgical instruments) may include intelligent surgical devices such as smart staplers (surgical staplers). – paras 132, 234, 311)
and wherein the contextual metadata is automatically generated upon firing the subset of the plurality of surgical instruments that are surgical staplers during the plurality of historical procedures. (Grantcharov discloses that the hardware units used (operation of the plurality of surgical instruments) generate the surgical data, transmits the data to the encoder where the encoder processes the time-stamped data and identifies clinical events. And the clinical events may be stored (stored by the medical record database) with associated metadata (the contextual metadata). – paras 33, 42, 66)
Regarding Claim 11, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 1, wherein the perioperative data corresponding to the first actuation of the surgical instrument comprises at least one of a force to fire, a force to close, a power algorithm, a tissue property, a tissue gap, or a closure rate. (Stulen teaches a surgical instrument including an end effector configured to seal and dissect tissue at a distal end thereof and a generator circuit that is configured to deliver energy to the end effector. A force sensor is in communication with the end effector and is configured to measure a force being applied to the tissue by the end effector (a force to fire, a force to close). The energy delivered to the end effector is dynamic based on a determination of the type of tissue interacting with the end effector. The tissue type is selected 2630 and displayed and used to specify 2632 the power delivery profile (a power algorithm) for delivering energy from the generator 500 to the end effector 125 of the surgical instrument 108. The processor 502 continues the process of verification and correction of the power delivery profile during the entire surgical procedure (the perioperative data corresponding to the first actuation of the first surgical instrument). – abstract; paras 217-218, 221)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surgical data collected by the hardware units relating to a live or real-time medical procedure as disclosed by Grantcharov to incorporate end effector data relating to a power delivery profile as well as energy and force being applied as taught by Stulen in order to minimize patient trauma (see Stulen para 3).
Regarding Claim 12, Grantcharov and Stulen disclose all the limitations above and further disclose the following limitations:
The system of claim 11, wherein the updated control program comprises a control setting for the tissue altering function, wherein the control setting comprises at least one a force to fire, a force to close, a power algorithm, and a closure rate. (Stulen teaches dynamically changing the energy delivered (a control setting) to a surgical instrument (force to fire, force to close) based on a determination of tissue type being treated by the instrument. If the force applied to the tissue is below a minimum threshold force, the force applied to the tissue is increased (a force to fire, a force to close – para 215; FIG 47) and is again measured and compared by the processor to the threshold minimum force. Further, the power delivery profile (a control setting…a power algorithm) can be optimized for a particular tissue type and delivered to the surgical instrument. The processor dynamically updates the power delivery profile. If an error is found, the power delivery profile is modified (paras 217-218, 221, 225, 230; FIGs. 48-50). – paras 215, 217-218, 221, 225, 230; FIGs. 47-50)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified developing predictive models to identify critical events during the real-time medical procedures as disclosed by Grantcharov to incorporate dynamically updating end effector controls relating to the power delivery profile, energy and force being applied as taught by Stulen in order to minimize patient trauma (see Stulen para 3).
Regarding Claim 13, it recites substantially similar limitations to those recited in claim 1 above; thus, the same rejection applies.
Regarding Claim 14, it recites substantially similar limitations to those recited in claim 2 above; thus, the same rejection applies.
Regarding Claim 15, it recites substantially similar limitations to those recited in claim 3 above; thus, the same rejection applies.
Regarding Claim 16, it recites substantially similar limitations to those recited in claim 4 above; thus, the same rejection applies.
Regarding Claim 17, it recites substantially similar limitations to those recited in claim 5 above; thus, the same rejection applies.
Regarding Claim 18, it recites substantially similar limitations to those recited in claim 1 above; thus, the same rejection applies.
Regarding Claim 19, it recites substantially similar limitations to those recited in claims 2-4 above; thus, the same rejection applies.
Regarding Claim 20, it recites substantially similar limitations to those recited in claim 6 above; thus, the same rejection applies.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Grantcharov et al. (WO 2016149794), in view of Stulen et al. (US 20170000516), further in view of Alvi et al. (US 9836654).
Regarding Claim 10, Grantcharov and Stulen disclose all the limitations above, however, they do not disclose the following limitations taught by Alvi:
The system of claim 1, wherein the plurality of surgical outcomes comprises a bleeding event or a successful wound closure. (The broadest reasonable interpretation includes alternative form and therefore only a citation to a bleeding event is provided) (Alvi teaches generating variables based on, for example, an outcome of one or more real surgical procedures previously recorded by the system. Direct surgical indicators may include patient blood loss (e.g., blood loss during a specific phase of liver surgery) (a bleeding event). – page 28, col 25 line 65-col 26 line 24)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the data within the session container files used to identify root causes of adverse patient outcomes as disclosed by Grantcharov to incorporate additional outcome data of real surgical procedures such as patient blood loss as taught by Alvi in order to improve procedural consistency (see Alvi page 16, col 1, lines 42-45).
Relevant Prior Art of Record Not Currently Being Applied
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure.
Jarc et al. (US 20190090969) discloses that during a surgical procedure, the teleoperated surgical systems (TSS) can provide mechanical actuation and control of a variety of surgical instruments or tools having end effectors that perform various functions for the surgeon, for example, holding or driving a needle, grasping a blood vessel, dissecting tissue, stapling tissue, or the like, in response to manipulation of the master input devices. A surgical input that includes monitored events of the TSS, is received and a current stage of the surgical procedure is autonomously determined based on the surgical input. Surgical instrument 520 can also contain stored (e.g., on a semiconductor memory associated with the instrument) information, which may be permanent or may be updatable by a surgical system configured to operate the surgical instrument 520. (see abstract; paras 3 and 60).
Response to Arguments
Regarding rejections under 35 USC § 101 to Claims 1-20, Applicant’s arguments have been fully considered, and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(a) Applicant submits that claim 1 is not directed to an abstract idea, at least because it reflects an improvement to computer functionality, another technology, or a technical field. Claim 1 reflects an improvement to medical technology that is set forth in the specification. For example, the specification recites "a comprehensive digital medical system capable of spanning multiple medical facilities and configured to provide integrated and comprehensive improved medical care to a vast number of patients. [...] The surgical hubs provide a wide array of functionality to improve the outcomes of medical procedures. Improvements in the techniques used to generate the data may be generated as a result, and these improvements may then be disseminated to the various surgical hubs and surgical devices. Due to the interconnectedness of all of the aforementioned components, improvements in medical procedures and practices may be found that otherwise may not be found if the many components were not so interconnected." Further, based on the gathered information, the context may be autonomously inferred. The specification describes that "[w]ithout knowing the procedural context (e.g., knowing the type of tissue being operated on or the type of procedure being performed), the control algorithm may control the modular device incorrectly or suboptimally given the particular context-free sensed data." Thus, the specification sets forth an improvement in technology that is reflected in claim 1. (p. 7-8; emphasis original).
Regarding (a), Examiner respectfully disagrees. MPEP 2106.04(d)(1) states "the word 'improvements' in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B." Here, the claim recites “update the control program during the procedure based, at least in part, on the identified pattern to control the surgical instrument to execute a second actuation according to the updated control program during the procedure to perform the tissue altering function.” As currently recited, the claim does not define how the surgical device is being changed or adjusted in response to the actuation that is taking place. Further, the claim does not define what the signal(s) entails, how or why the change is happening (e.g., Applicant’s specification in paragraph 1330 states that it may be determined that a particular force to fire is suboptimal), and therefore it’s unclear how the surgical outcome is being improved from the current claims. Examiner further notes that the “interconnectedness” of all the components in the claim is merely allowing for data collection and analysis; it is not being interpreted as a practical application, but rather as an act performed for mere data gathering. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Examiner suggests adding limitations that explicitly recite a specific administration of treatment (e.g., define what control functions of the surgical instrument are being actuated/adjusted, why they’re being adjusted (e.g., if they’re suboptimal) and how they’re being adjusted) in response to the updated configuration of the surgical instrument.
Applicant further argues that the claim represents “Improvements in the techniques used to generate the data”. Examiner notes that there is no specificity in the claim as to how the data is being generated and therefore it is unclear as to how the techniques of gathering the data is being improved. For example, claim 1 recites “the plurality of surgical hubs is communicably coupled to the medical record database and configured to be coupled to a plurality of surgical instruments” and “a cloud-based analytics subsystem communicably coupled to the medical record database and the plurality of surgical hubs, wherein the cloud-based analytics subsystem comprises a control circuit configured to: receive, from the surgical hub, a signal comprising perioperative data corresponding to a first actuation of the surgical instrument during a procedure to perform the tissue altering function;”. Here, the claim recites that the surgical hubs are communicably coupled to the surgical instruments, as well as to a medical record database, to allow for transfer of data. However, there is no specificity as to how the data is being gathered/generated that shows an improvement to data generating techniques in the field. Thus, a practical application is not present.
(b) Additionally, USPTO guidance emphasizes careful, claim-specific analysis and cautions against oversimplification. For example, the December 5, 2025, USPTO memorandum "Advance notice of change to the MPEP in light of Ex Parte Desjardin" updates the MPEP to reinforce that the examiners should evaluate the claim "as a whole," avoid oversimplifying claims, and recognize technological improvements when the claim and specification together reflect a particular technical solution. The 2025 Memo similarly notes that if eligibility is a "close call," §101 rejections should be made only when it is more likely than not that the claims are ineligible, consistent with the preponderance-of-evidence standard. Accordingly, claim 1 is not directed to an abstract idea, and claim 1 and its dependent claims are patent-eligible under Step 2A, Prong Two. For similar reasons, independent claims 13 and 18, and their respective dependent claims, are also patent-eligible. Applicant therefore respectfully requests the withdrawal of the rejections under 35 U.S.C. §101. (p. 8-9; emphasis original).
Regarding (b), Examiner respectfully disagrees. Desjardins recited a particular method of training a machine learning model that resulted in an improvement to the machine learning model. Desjardins does not necessarily apply to the instant claims because machine learning is only recited in dependent claims 6, 7 and 20 at a very broad and generic level. Further, as noted in response to argument (a) above, the claim does not recite an improvement in the techniques used to generate the data.
Regarding rejections under 35 USC § 103 to Claims 1-20, Applicant’s arguments have been fully considered and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(c) Grantcharov is completely silent on the recited subject matter…detecting events from collected medical or surgical data streams for time-stamping, as described in Grantcharov, is not equivalent to "receiv[ing], from the surgical hub, a signal comprising perioperative data corresponding to a first actuation of the surgical instrument during a procedure to perform the tissue altering function" "autonomously infer[ring] a surgical context based, at least in part, on the received signal...," as recited in claim 1 (emphasis added). Grantcharov describes using the timestamped events to generate an interface indicator showing a visual sequence of clinical events and to support a predictive data model for refining protocol; it does not describe using the data streams or events to "autonomously infer[ring] a surgical context based, at least in part, on the received signal...," as recited in the claims. Accordingly, Grantcharov cannot be said to teach or suggest the recited subject matter. The Office Action does not assert Stulen against the recited subject matter. Therefore, for at least the reasons set forth above, claims 1, 13, and 18 are patentably distinct over the cited references. Moreover, because they depend from their respective independent claims, the dependent claims are also patentable over the cited references. (p. 9-10).
Regarding (c), Examiner respectfully disagrees. Examiner evaluates each argued limitation below. See also updated rejection above.
(1) Claim 1 recites “receive, from the surgical hub, a signal comprising perioperative data corresponding to a first actuation of the surgical instrument during a procedure to perform the tissue altering function;”. Grantcharov is relied upon to disclose “receive, from the surgical hub, a signal comprising perioperative data…”. Grantcharov discloses a wireless network infrastructure that provides a secure network connection between the encoder, the smart devices (i.e., the hardware units) (the surgical instrument) and the media management hub server (the surgical hub) for communication of (receive a signal) the real-time medical or surgical data streams (comprising perioperative data). However, Stulen is relied upon to teach “…perioperative data corresponding to a first actuation of the surgical instrument during a procedure to perform the tissue altering function;”. Stulen teaches a method for dynamically changing the energy delivered to a surgical instrument 108 based on a determination of tissue type being treated by the surgical instrument 108 (corresponding to a first actuation of the surgical instrument during a procedure to perform the tissue altering function). The tissue coefficient of friction μ and the processor 502 measures 2706 the rate of change (e.g., rate of rise) of the tissue coefficient of friction μ over a short period of time (perioperative data). The processor 502 compares 2708 the measured tissue coefficient of friction μ and the rate of change of the tissue coefficient of friction μ to values stored in a tissue information database 2714.
(2) Claim 1 recites “autonomously infer a surgical context based, at least in part, on the received signal comprising the perioperative data;”. Grantcharov discloses that the encoder detects clinical events (autonomously infer a surgical context) within the received surgical data streams (based, at least in part, on the received signal comprising the perioperative data).
Therefore, the referenced prior art references disclose each and every limitation of amended claim 1, as well as similar intendent claims 13 and 18 and all claims depending therefrom.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/K.E.V./ Examiner, Art Unit 3681
/PETER H CHOI/ Supervisory Patent Examiner, Art Unit 3681
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