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 .
Drawings
The drawings filed on 12/16/2024 are accepted by the examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 18 is objected to because of the following informalities: a surgical instrument in line 1 should be the surgical instrument. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US20230027210 to Shelton, IV et al. (hereinafter “Shelton”), in view of US20150272571 to Leimbach et al. (hereinafter “Leimbach”), further in view of US20210378700 to Houser.
As for claim 1, Shelton substantially discloses a surgical data system (Shelton, see Fig. 6 and [0111]-[0114]), comprising:
a surgical instrument configured to, during performance of a surgical procedure on a patient, receive at least two data streams available to the surgical instrument from an external source, each of the at least two data streams including data collected in real time with the performance of the surgical procedure (Shelton, see Fig. 6 and [0111]-[0114]),
the data from any of the at least two data streams are feedback data (Shelton, see Fig. 6 and [0111]-[0114]).
Shelton does not explicitly disclose data discrimination system, data streams regarding a same measured parameter, wherein a controller of the surgical instrument is configured to control performance of a function of the surgical instrument in an open loop configuration or in a closed loop configuration; in the open loop configuration, the controller is configured to control the performance of the function without using the feedback data; and in the closed loop configuration, the controller is configured to control the performance of the function using the data of a one of the at least two data streams selected by the controller.
However, Leimbach in an analogous art discloses data discrimination system (Leimbach, see [0102] for ignoring the data signals based on range of data), data streams regarding a same measured parameter (Leimbach, see [0101] and [0104] for redundant sensors detecting the same condition), wherein a controller of the surgical instrument is configured to control performance of a function of the surgical instrument in a closed loop configuration, in the closed loop configuration, the controller is configured to control the performance of the function using the data of a one of the at least two data streams selected by the controller (Leimbach, see [0102]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
The combination of Shelton and Leimbach does not explicitly discloses wherein a controller of the surgical instrument is configured to control performance of a function of the surgical instrument in an open loop configuration; in the open loop configuration, the controller is configured to control the performance of the function without using the feedback data.
However, Houser in an analogous art discloses wherein a controller of the surgical instrument is configured to control performance of a function of the surgical instrument in an open loop configuration; in the open loop configuration, the controller is configured to control the performance of the function without using the feedback data (Houser, see [0103]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Houser into the above combination of Shelton and Leimbach. The modification would be obvious because one of the ordinary skill in the art would want to provide an ultrasonic end effector blade that is capable of generating adequate heat for hemostatis, coagulation, and/or anastomoses tissue but that quickly cools when it is not in use (Houser, see [0008]).
As per claim 2, the rejection of claim 1 is incorporated, Shelton further discloses wherein the external source includes at least two different surgical system sources being used in relation to the performance of the surgical procedure (Shelton, see Fig. 6 and [0111]-[0114]).
As per claim 3, the rejection of claim 2 is incorporated, Shelton further discloses wherein each of the at least two different surgical system sources is a surgical instrument (Shelton, see Fig. 6 and [0111]-[0114], it is noted that “each of the at least two different surgical system sources is one of a hospital network, a database, a surgical instrument, or a surgical cart” can be interpreted as “each of the at least two different surgical system sources is a surgical instrument” because of the usage of “one of”).
As per claim 4, the rejection of claim 1 is incorporated, Leimbach further discloses wherein the parameter regards at least one of the patient and the surgical procedure (Leimbach, see [0100]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 5, the rejection of claim 1 is incorporated, Leimbach further discloses wherein the selection by the controller of the one of the at least two data streams is based on which of the at least two data streams improves operational behavior of the surgical instrument in either stability or outcome (Leimbach, see [0102], it is noted that the outcome of the surgical instrument’s operation using the non-fault sensor’s data would be better than the outcome of the surgical instrument’s operation using the faulty sensor’s data).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 6, the rejection of claim 1 is incorporated, Leimbach further discloses wherein the controller is configured to base the selection by the controller of the one of the at least two data streams based on a trustworthiness of each of the at least two data streams (Leimbach, see [0102], faulty sensor’s out of range data can be interpreted as non-trustworthy).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 7, the rejection of claim 6 is incorporated, Shelton further discloses criteria of data includes the hierarchy of the at least two data streams (Shelton, see [0197]). Leimbach further discloses wherein the controller is configured to base the selection by the controller of the one of the at least two data streams based on a criteria (Leimbach, see [0102]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 8, the rejection of claim 6 is incorporated, Leimbach further discloses wherein the controller is configured to base the selection by the controller of the one of the at least two data streams based on the trustworthiness of each of the at least two data streams (Leimbach, see [0102], faulty sensor’s out of range data can be interpreted as non-trustworthy).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 9, the rejection of claim 6 is incorporated, Shelton further discloses criteria of data includes the time-dependability of each of the at least two data streams (Shelton, see [0017]). Leimbach further discloses wherein the controller is configured to base the selection by the controller of the one of the at least two data streams based on a criteria (Leimbach, see [0102]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 10, the rejection of claim 1 is incorporated, Shelton further discloses the controller is configured to identify data streams available to the surgical instrument to identify the at least two data streams (Shelton, see [0207]-[0208]).
As per claim 11, the rejection of claim 10 is incorporated, Shelton further discloses wherein the controller is configured to identify the available data streams based on the external source being communicatively coupled by a user with the surgical instrument (Shelton, see Fig. 3 and [0082]).
As per claim 12, the rejection of claim 10 is incorporated, Shelton further discloses wherein the external source includes at least two different surgical systems; and the controller is configured to identify each of the available data streams based on either the surgical system broadcasting data stream identification to the surgical instrument or the controller causing the surgical instrument to interrogate the surgical system for available data stream information (Shelton, see Fig. 4 and [0101]-[0105]).
As per claim 13, the rejection of claim 10 is incorporated, Shelton further discloses wherein the controller is configured to identify the available data streams based on an introduction of a surgical system to a same space as the surgical instrument (Shelton, see Fig. 2 and [0067]-[0069]).
As per claim 14, the rejection of claim 13 is incorporated, Shelton further discloses herein the space is a physical operating room space (Shelton, see Fig. 2 and [0067]-[0069]).
As per claim 15, the rejection of claim 1 is incorporated, Leimbach further discloses the function of the surgical instrument is stapling tissue of the patient (Leimbach, see [0069] and [0094]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 16, the rejection of claim 1 is incorporated, Leimbach further discloses the surgical instrument is a surgical stapler (Leimbach, see [0069] and [0094]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As for claim 17, Shelton substantially discloses a surgical data system (Shelton, see Fig. 6 and [0111]-[0114]), comprising:
a processor (Shelton, see Fig. 6 element 20222);
a memory storing instructions that, when executed by the processor, cause the processor to perform operations (Shelton, see Fig. 6 element 20223 and [0304]) comprising:
using data from any of at least two data stream available to the surgical instrument from an external source, each of the at least two data streams include data collected in real time with the performance of the surgical procedure (Shelton, see Fig. 6 and [0111]-[0114]),
the data from any of the at least two data streams are feedback data (Shelton, see Fig. 6 and [0111]-[0114]).
Shelton does not explicitly disclose data discrimination system, data streams regarding a same measured parameter, controlling performance of a function of a surgical instrument in an open loop configuration or in a closed loop configuration; in the open loop configuration, the controller is configured to control the performance of the function without using the feedback data; and in the closed loop configuration, the controller is configured to control the performance of the function using the data of selected one of the at least two data stream.
However, Leimbach in an analogous art discloses data discrimination system (Leimbach, see [0102] for ignoring the data signals based on range of data), data streams regarding a same measured parameter (Leimbach, see [0101] and [0104] for redundant sensors detecting the same condition), controlling performance of a function of a surgical instrument in a closed loop configuration, in the closed loop configuration, the controller is configured to control the performance of the function using the data of selected one of the at least two data stream (Leimbach, see [0102]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
The combination of Shelton and Leimbach does not explicitly discloses controlling performance of a function of a surgical instrument in an open loop configuration; in the open loop configuration, the controller is configured to control the performance of the function without using the feedback data.
However, Houser in an analogous art discloses controlling performance of a function of a surgical instrument in an open loop configuration; in the open loop configuration, the controller is configured to control the performance of the function without using the feedback data (Houser, see [0103]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Houser into the above combination of Shelton and Leimbach. The modification would be obvious because one of the ordinary skill in the art would want to provide an ultrasonic end effector blade that is capable of generating adequate heat for hemostatis, coagulation, and/or anastomoses tissue but that quickly cools when it is not in use (Houser, see [0008]).
Claim 20 is a method claim corresponds to the system claim 17, it is therefore rejected under similar reasons set forth in the rejection of claim 17.
As per claim 18, the rejection of claim 17 is incorporated, Shelton further discloses wherein a surgical instrument includes the processor and the memory (Shelton, see Fig. 6 element 20221). Leimbach further discloses the surgical instrument is a surgical stapler (Leimbach, see [0069] and [0094]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate teaching of Leimbach into the system of Shelton. The modification would be obvious because one of the ordinary skill in the art would want to deactivate and/or modify certain functions of the surgical instrument when the processor detects that one or more of the sensors may be faulty (Leimbach, see [0106]).
As per claim 19, the rejection of claim 17 is incorporated, Shelton further discloses wherein a surgical hub includes the processor and the memory, the surgical hub being configured to be communicatively coupled with each of the surgical instrument and the external source (Shelton, see Fig. 1A and [0042]-[0045]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US20190201129 discloses a computer system, such as a surgical hub, can be configured to be communicably coupled to a surgical device and a camera configured to view an operating room. The computer system can be programmed to receive images of surgical staff members and surgical devices within the operating room during a surgical procedure. The computer system can further determine conditions or characteristics associated with the surgical staff members and surgical devices, such as whether a surgical staff member is performing a particular gesture or the pose of a surgical device, such as a surgical instrument, during a surgical procedure. The computer system can then control the paired surgical devices accordingly.
US20190206216 discloses a surgical instrument includes a surgical end effector, a communication module configured to wirelessly pair the surgical instrument to the surgical hub, and a control circuit. The control circuit is configured to detect a first security violation, cause the surgical instrument to generate a first response to the first security violation, store a record of the first security violation, detect a second security violation, and cause the surgical instrument to generate a second response to the second security violation, wherein the second response is escalated from the first response.
US20180122506 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 medical or surgical data relating to a live or real-time medical procedure. Example hardware units include a control interface, cameras, sensors, audio devices, and patient monitoring hardware. Further example systems may include a cloud based platform incorporating the encoder.
US20190333626 discloses an artificial agent based cognitive operating room system and a method thereof providing automated assistance for a surgical procedure are disclosed. Data related to the surgical procedure from multiple data sources is fused based on a current context. The data includes medical images of a patient acquired using one or more medical imaging modalities. Real-time quantification of patient measurements based on the data from the multiple data sources is performed based on the current context. Short-term predictions in the surgical procedure are forecasted based on the current context, the fused data, and the real-time quantification of the patient measurements. Suggestions for next steps in the surgical procedure and relevant information in the fused data are determined based on the current context and the short-term predictions. The suggestions for the next steps and the relevant information in the fused data are presented to an operator.
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/JASON LIN/
Primary Examiner, Art Unit 2117
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