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
Response to Amendment
In the amendment dated 04/29/2026, the following occurred: Claim 1, 4, 7, 9, 12 and 15 were amended.
Claims 1-16 are currently 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 1-16 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 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method and a system for inter-connectivity of data flows between independent smart systems, which are within a statutory category.
Regarding claims 1 and 9, the limitation of (claim 1 being representative) determining capability information associated with a surgical environment, wherein the capability information indicates information, wherein the information comprises at least a list associated with the surgical environment; receiving first data indicated in the information, wherein the first data comprises first metadata that indicates the first data is control data or response data; selecting an operation configuration based on the first metadata, wherein the operation configuration is the first operation configuration or a second operation configuration; operating in accordance with the selected operation configuration, wherein operating in accordance with the selected operation configuration comprises refraining from switching the operating configuration when the first metadata indicates response data, and applying a different operating configuration when the first metadata indicates control data; generating second data based on the selected operation configuration; determining in the list associated with the surgical environment to send a portion of the second data; and sending, via data stream, the portion of the second data, wherein the data stream comprises second metadata that indicates that the at least a portion of the second data is control data or response data as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to determining capability information, receiving first data comprising first metadata that indicates the first data is control data or response data, selecting an operation configuration based on the first metadata, operating in accordance with the selected operation configuration, generating second data, send at least a portion of the second data comprising second metadata that indicates that the at least a portion of the second data is control data or response data in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “determining…receiving…selecting…operating… generating… determining…and sending the portion of the second data” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., surgical system, a first surgical system, a second surgical system and a third surgical system (in claim 1) and a processor, a surgical system, a first surgical system, a second surgical system and a third surgical system (in claim 9), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). 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 – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a surgical system, a first surgical system, a second surgical system and a third surgical system. Claim 9 recites the additional elements of a processor, a surgical system, a first surgical system, a second surgical system and a third surgical system. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server for enabling access to medical information or generic computer components for performing generic computer functions. See specification at para. [0029], [0030], [0045], [0055] that describe generic surgical systems) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
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 elements of the processor, surgical system, first surgical system, second surgical system and the third surgical system 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”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
The Examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-8 and 10-16 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 and 10 further merely describe(s) the selection of second operation configuration. Claim(s) 3 and 11 further merely describe(s) the first and second operation configuration. Claim(s) 4 and 12 further merely describe(s) portion of the second data. Claim(s) 5 and 13 further merely describe(s) receiving surgical environment information, and performing discovery associated with the surgical environment. Claim(s) 6 and 14 further merely describe(s) the capability information. Claim(s) 7 and 15 further merely describe(s) the list of surgical systems and determining first data. Claim(s) 8 and 16 further merely describe(s) the first type of data, the second type of data and the indication indicating that the second type of data is missing. As can be seen, claims 2-8 and 10-16 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1 and 9.
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 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.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (US 2021/0315580).
REGARDING CLAIM 1
Shelton discloses a method for operating a first surgical system using a first operation configuration, comprising: determining capability information associated with a surgical environment, wherein the capability information indicates surgical system information, wherein the surgical system information comprises at least a list of surgical systems associated with the surgical environment (Shelton at [0116] teaches a list of surgical items and [0991] teaches a list of medical supplies to be used in the procedure (interpreted by Examiner as the list of surgical systems associated with the surgical environment). [0957] teaches the surgical hub can be configured to compare the list of items for the procedure and/or a list of devices paired with the surgical hub to a recommended or anticipated manifest of items and/or devices for the given surgical procedure (interpreted by Examiner as determining capability information that indicates surgical system information that comprises at least a list of surgical systems)); receiving first data from a second surgical system indicated in the surgical system information, wherein the first data comprises first metadata that indicates the first data is control data or response data ([0014] teaches receiving first usage data (interpreted by Examiner as the first data), from a first subset of surgical hubs of the surgical system (interpreted by Examiner as the second surgical system indicated in the surgical system information) [0476] teaches a cloud service provider that coordinates the usage and control of the devices 1a-1n/2a-2m located in one or more operating theaters and [1393] teaches generating self-describing data (e.g., metadata) including identification of notable features or configuration and that the data collection and aggregation module can generate aggregated metadata or other organized data based on raw data received from the surgical hubs (interpreted by Examiner as wherein the first data comprises first metadata that indicates the first data is control data or response data)); selecting an operation configuration based on the first metadata, wherein the operation configuration is the first operation configuration or a second operation configuration ([0542] teaches the control circuit may be programmed to select a firing control program or closure control program based on tissue conditions (interpreted by Examiner as selecting an operation configuration)); operating the first surgical system in accordance with the selected operation configuration, wherein operating the first surgical system in accordance with the selected operation configuration comprises refraining from switching the operating configuration when the first metadata indicates response data, and applying a different operating configuration when the first metadata indicates control data (Fig. 17 teaches a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure. [0444] teaches permitting a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example and [0524] teaches a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions. In certain instances, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain instances, the plurality of motors of robotic surgical instrument 600 can be individually activated to cause firing, closure, and/or articulation motions in the end effector. The firing, closure, and/or articulation motions can be transmitted to the end effector through a shaft assembly, for example (interpreted by Examiner as operating the first surgical system in accordance with the selected operation configuration)); generating second data based on the selected operation configuration ([0014] teaches receiving second usage data (interpreted by Examiner as generating second data based on the selected operation configuration)); determining a third surgical system in the list of surgical systems associated with the surgical environment to send a portion of the second data ([0524] teaches a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions. In certain instances, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain instances, the plurality of motors of robotic surgical instrument can be individually activated to cause firing, closure, and/or articulation motions in the end effector (interpreted by Examiner as determining a third surgical system in the list of surgical systems associated with the surgical environment)); and sending, via a data stream, the portion of the second data, wherein the data stream comprises second metadata that indicates that the at least a portion of the second data is control data or response data ([0015] teaches transmitting first and second usage data, [0613] teaches using data streams, [1393] teaches generating self-describing data (e.g., metadata) including identification of notable features or configuration and that the data collection and aggregation module can generate aggregated metadata or other organized data based on raw data received from the surgical hubs, and [1887] teaches transmit a control signal to the detected surgical device to transmit to the surgical hub surgical parameter data associated with the detected surgical device (interpreted by Examiner as sending, via a data stream, the at least a portion of the second data, wherein the data stream comprises second metadata that indicates that the at least a portion of the second data is control data or response data)).
REGARDING CLAIM 2
Shelton further discloses:
The method of claim 1, wherein based on a determination that the first metadata indicates the first data is control data, the second operation configuration is selected as the operation configuration, and wherein based on a determination that the first metadata indicates the first data is response data, the first operation configuration is selected as the operation configuration ([0818] teaches the control circuit is configured to select one of a master mode of operation or a slave mode of operation in the master-slave arrangement. [1163] teaches a surgeon to select, operate and control a plurality of different surgical devices through a common input device. [1204] teaches changing configurations and [1331] teaches adjust one or more of their operating parameters thereby allowing them to optimize their manipulation of the tissue (interpreted by Examiner as wherein based on a determination that the first metadata indicates the first data is control data, the second operation configuration is selected as the operation configuration, and wherein based on a determination that the first metadata indicates the first data is response data, the first operation configuration is selected as the operation configuration)).
REGARDING CLAIM 3
Shelton further discloses:
The method of claim 1, wherein the method further comprises: determining the second operation configuration based on the first data, wherein the first operation configuration is associated with performing an action based on a first parameter, wherein the second operation configuration is associated with performing an action based on a second parameter, and wherein the second parameter is determined based on the first data ([0014] teaches operational parameter of a surgical system and [1330] teaches determine parameters associated with the function of the instruments (interpreted by Examiner as the first/second operation configuration is associated with performing an action based on a first/second parameter)).
REGARDING CLAIM 4
Shelton further discloses:
The method of claim 1, wherein the third surgical system is the first surgical system, wherein based on a determination that the first metadata indicates the first data is control data, and wherein the method further comprises: determining that the portion of the second data is response data based on the determination that the first metadata indicates that the first data is control data, wherein the second metadata indicates that the portion of the second data is response data ([0544] teaches response of an instrument and based on the response of the robotic surgical instrument during the open-loop portion of the stroke, the control circuit may select a firing control program in a closed-loop configuration. [0557] teaches the control circuit can be configured to simulate the response of the actual system of the instrument in the software of the controller (interpreted by Examiner as determining that the at least a portion of the second data is response data based on the determination that the first metadata indicates that the first data is control data, wherein the second metadata indicates that the at least a portion of the second data is response data)).
REGARDING CLAIM 5
Shelton further discloses:
The method of claim 1, wherein the method further comprises: receiving surgical environment information, wherein the surgical environment information indicates surgical system information associated with a default surgical system environment; and performing discovery associated with the surgical environment to determine discovered surgical environment information, wherein the capability information comprises the default surgical system environment and the discovered surgical environment information ([0890] teaches interaction with an interactive surgical system environment including a surgical hub, in one aspect, self-describing data packets as shown in FIG. 69 are generated at an issuing instrument, or device or module located in or in communication with the operating theater, and include identifiers for all devices that handle the packet along a communication path (interpreted by Examiner as wherein the surgical environment information indicates surgical system information associated with a default surgical system environment) [1415] teaches based on all of the data, trends may be determined, and here, it may be discovered that there is a small window of the number of firings that results in the best performance outcomes, at interval “a” as shown. The magnitude of this performance compared to the most common number of firings is shown as interval “b.” Because the number of firings that results in the best outcomes may not be what is commonly practiced, it may not be readily easily to have discovered these outcomes without the aggregation and analytical abilities of the cloud system and [1459] teaches the cloud-based system may first provide a baseline recommendation for how a smart instrument should be used, based on best practices discovered in the aggregate data (interpreted by Examiner as performing discovery associated with the surgical environment to determine discovered surgical environment information)).
REGARDING CLAIM 6
Shelton further discloses:
The method of claim 1, wherein the capability information further indicates for each surgical system in the list of surgical systems associated with the surgical environment respective surgical system capability information, wherein the respective surgical system capability information indicates at least one type of data that the associated surgical system is capable of generating ([0097] teaches determining type of data and [0105] teaches determining procedure type (interpreted by Examiner as wherein the respective surgical system capability information indicates at least one type of data that the associated surgical system is capable of generating)).
REGARDING CLAIM 7
Shelton further discloses:
The method of claim 1, wherein the list of surgical systems indicates the second surgical system and indicates that the second surgical system is capable of generating a first type of data and a second type of data, and wherein the method further comprises: determining that the first data comprises a first portion of data associated with the first type of data; determining that the first data is missing data associated with the second type of data; and sending an indication to the second surgical system indicating that the second type of data is missing ([0957] teaches the surgical hub can be configured to determine the relative distance or position of the modular devices and patient monitoring devices via proximity sensors, for example. The surgical hub can compare the relative positions of the devices to a recommended or anticipated layout for the particular surgical procedure. If there are any discontinuities between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout for the surgical procedure deviates from the recommended layout and [0958] teaches a situationally aware surgical hub could determine whether the surgeon (or other medical personnel) was making an error or otherwise deviating from the expected course of action during the course of a surgical procedure and provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at the particular step in the surgical procedure (interpreted by Examiner as means to determine that the first data comprises at least a first portion of data associated with the first type of data and to determine that the first data is missing data associated with the second type of data and sending an indication to the second surgical system indicating that the second type of data is missing)).
REGARDING CLAIM 8
Shelton further discloses:
The method of claim 7, wherein the first type of data is processed data, wherein the second type of data is unprocessed data, and wherein the indication indicating that the second type of data is missing further indicates to send data associated with the second type of data ([1527] teaches the cloud system may review the information supplied by the medical device that triggered the suspicious activity, and if the information is unequivocally fraudulent or faulty, an alert and a rejection of the device can occur, such that the medical device will be prevented from operating with the medical hub and/or other medical hubs in the same facility (interpreted by Examiner as wherein the first type of data is processed data, wherein the second type of data is unprocessed data, and wherein the indication indicating that the second type of data is missing further indicates to send data associated with the second type of data)).
REGARDING CLAIMS 9-16
Claims 9-16 are analogous to Claims 1-8 thus Claims 9-16 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1-8.
Response to Arguments
Drawing Objections
Regarding the drawing objection(s), the Applicant has amended the drawings to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 112
Regarding the indefinite rejection of claims 1 and 9, the Examiner has dropped the rejection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-16, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
In the present case, amended claims 1 and 9 recite "refraining from switching the operating configuration when the first metadata indicates response data, and applying a different operating configuration when the first metadata indicates control data." This limitation reflects an improvement to the technical field of inter-connected smart surgical systems that is set forth in the specification… Thus, the specification sets forth an improvement in the technical field of inter-connected smart surgical systems that is also reflected in amended claims 1 and 9. Consequently, amended claims 1 and 9 integrate the judicial exception into a practical application and therefore are not directed to an abstract idea under Step 2A, Prong Two. Therefore, amended claims 1 and 9 and their dependent claims are patent-eligible under Step 2A Prong Two. Accordingly, the Applicant requests withdrawal of the rejections under 35 U.S.C. §101.
Regarding 1, The Examiner respectfully disagrees. The specification at para. [0035] discloses improvements to patient outcomes, para. [0039] discloses improvements to surgical procedure outcomes and [0071] discloses improvements to the conclusions, which are all non-technical improvements.
Rejection under 35 U.S.C. § 102
Regarding the rejection of claims 1-16, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
The cited paragraphs of Shelton do not teach or suggest at least "operat[ing] the first surgical system in accordance with the selected operation configuration, wherein operating the first surgical system in accordance with the selected operation configuration comprises refraining from switching the operating configuration when the first metadata indicates response data, and applying a different operating configuration when the first metadata indicates control data," as recited in amended claims 1 and 9. Accordingly, independent claims 1 and 9, and the claims that depend therefrom, patentably define over Shelton. Reconsideration and withdrawal of the rejections based on this reference is therefore respectfully requested..
Regarding 1, The Examiner respectfully disagrees. Shelton at Fig. 17 teaches a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure. [0444] teaches permitting a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example and [0524] teaches a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions. In certain instances, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain instances, the plurality of motors of robotic surgical instrument 600 can be individually activated to cause firing, closure, and/or articulation motions in the end effector. The firing, closure, and/or articulation motions can be transmitted to the end effector through a shaft assembly, for example, which is interpreted by Examiner as operating the first surgical system in accordance with the selected operation configuration.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP §706.07(a). 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Shelton (US 2022/0233119) discloses method of adjusting a surgical parameter based on biomarker measurements. Juergens (US 2019/0343588) discloses operating method for a medical system, and medical system for performing a surgical procedure.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The Examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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