CTNF 19/070,036 CTNF 84876 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 21-33 and 35-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2019/0059997 to Frushour in view of U.S. Patent Application Publication 2017/0140134 to Brough further in view of U.S. Patent Application Publication 2013/0041355 to Heeren . As per claim 2 1, Furshour teaches a surgical hub comprising a control circuit configured to (see: Furshour, Fig. 1-2, ele. 200; paragraph 30-33, is met by is met by local area device configured to receive, store, and/or transmit the surgical instrument information, patient information, and procedure information): receive an request signal from a surgical instrument communicably coupled to the surgical hub (see: Frushour, Fig. 1-2, ele. 100, 200; and paragraph 29, 31-34, 41, and 56-57, is met by surgical information obtained communicated upon occurrence of a particular event, where surgical instrument information may be relayed from each of a plurality of surgical instruments or combination of surgical instruments to the local area device, where surgical instrument information includes identifying information of the surgical instrument(s)); forward the request signal to a cloud server (see: Frushour, Fig. 1-2, ele. 200, 300; and paragraph 30-33, 41, 44, and 56-57, is met by remote area including one or more devices such as servers configured to receive, process, manipulate, store, and/or output information, where surgical instrument information may be relayed through the local area device to the remote area device); receive a update signal from the cloud server based on forwarding the request signal to the cloud server, wherein the update signal comprises an updated for the surgical instrument, and (see: Frushour, paragraph 33, 52-54, and 58, is met by correlating surgical instrument information and outcome information from prior similar cases and presenting the same facilitates the determination of what surgical instrument(s) to utilize and in what manner to utilize them, where the output may be to the local area device); and . Frushour fails to specifically teach that the surgical information includes an authentication request signal , wherein the authentication request signal comprises an authentication credential associated with the surgical instrument ; however, Brough teaches a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), and if the authentication was successful, allows the user to use and control the medical device (see: Brough, paragraph 78 and 80). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical information as taught by Frushour to incorporate a communication from a medical device to a server device including an authentication request including a user identification and credential as taught by Brough with the motivation that it may be beneficial to store a measurement of a physiological parameter of a patient captured by a medical device in an electronic health record associated with the patient that is stored on a health information system (HIS) server, and/or it may be beneficial to alert a billing server of various measurements that have been taken using a medical device in order to facilitate billing and collecting payments for the measurement (see: Brough, paragraph 18). Frushour teaches obtaining and recording instrument information, determination of what surgical instrument(s) to utilize and in what manner to utilize them based on a comparison to previous similar cases, and input/output also enables the input of configuration information within a surgical instrument including software updates (see: Frushour, paragraph 33, 41, 50-51, and 54), but Frushour fails to specifically teach wherein the updated control program is executable by the surgical instrument to perform a surgical function such that the hub may forward the control program update signal to the surgical instrument causing the surgical instrument to execute the updated control program to perform the surgical function ; however, Heeren teaches adjusting a parameter of a surgical device based on a characteristic such that the operational parameters can be adjusted (see: Heeren, paragraph 6, 23, and 31-33). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the recommendation and procedure information and the input of configuration information including software updates within a surgical instrument as taught by Frushour and Brough to include adjusting a parameter of a surgical device based on a characteristic such that the operational parameters can be adjusted as taught by Heeren with the motivation of preventing or reducing damage to a biological organ at the surgical site (see: Heeren , paragraph 5-6 and 26-27). As per claim 22 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 21, and further teach : wherein the surgical function comprises any one or more of tissue clamping, tissue cutting, and tissue sealing, and wherein the control program update comprises a modification to an operational parameter implemented by the surgical instrument for performing the surgical function (see: Heeren, paragraph 24 and 34, is met by during a surgery, vaporizing a small amount of tissues at the surgical site to facilitate the removal of the extracted tissues by ensuring sufficient flow and achieving low traction). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the recommendation and procedure information and the input of configuration information including software updates within a surgical instrument as taught by Frushour, Brough, and Heeren to include adjusting a parameter of a surgical device to vaporize a small amount of tissues at the surgical site to facilitate the removal of the extracted tissues by ensuring sufficient flow and achieving low traction as taught by Heeren with the motivation of preventing or reducing damage to a biological organ at the surgical site (see: Heeren , paragraph 5-6 and 26-27). As per claim 23 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 22, and further teach : wherein the control circuit is configured to: receive a data transmission readiness signal from the surgical instrument, wherein the data transmission readiness signal indicates that the surgical instrument has transitioned to a configuration for receiving the control program update signal (see: Heeren, paragraph 23 and 32, is met by in a stopped state, analyze the input data and based on one or more determined characteristics, adjust operational parameters, and after the operational parameters have been properly adjusted, continuing surgery). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical process as taught by Frushour, Brough, and Heeren to include, from stopped state, analyze the input data and based on one or more determined characteristics, adjust operational parameters, and after the operational parameters have been properly adjusted, continuing surgery as taught by Heeren with the motivation of preventing or reducing damage to a biological organ at the surgical site (see: Heeren , paragraph 5-6 and 26-27). As per claim 24 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 23, and further teach : wherein the control circuit is configured to: transmit perioperative data corresponding to performance of the surgical function by the surgical instrument to the cloud server for storage in an aggregated medical database (see: Frushour, Fig. 1; and paragraph 29-33 and 41, is met by one or more surgical areas across a hospital network, each including a plurality or surgical instruments that are configured to obtain, store, and or/transmit surgical instrument information such as: identifying information; number, pattern, sequence, and/or density of activations such as energy activations, firings, articulations, rotations; modes of operation; time duration; electrical parameters; pressure, temperature; and/or other operation data, usage data, status data, notifications; where each local area includes one or more computer/server devices configured to receive, store, and/or transmit the surgical instrument information, patient information, and procedure information, and associate all the information to store in one or more searchable databases). As per claim 25 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 21, and further teach : wherein the control circuit is configured to: receive a second request signal from a second surgical instrument (see: Frushour, Fig. 1-2, ele. 100, 200; and paragraph 29, 31-34, 41, and 56-57, is met by surgical information obtained communicated upon occurrence of a particular event, where surgical instrument information may be relayed from each of a plurality of surgical instruments or combination of surgical instruments to the local area device, where surgical instrument information includes identifying information of the surgical instrument(s)); forward the second request signal to the cloud server (see: Frushour, Fig. 1-2, ele. 200, 300; and paragraph 30-33, 41, 44, and 56-57, is met by remote area including one or more devices such as servers configured to receive, process, manipulate, store, and/or output information, where surgical instrument information may be relayed through the local area device to the remote area device); and receive a instruction signal associated with the second instrument from the cloud server based on forwarding the second request signal (see: Frushour, paragraph 33, 52-54, and 58, is met by correlating surgical instrument information and outcome information from prior similar cases and presenting the same facilitates the determination of what surgical instrument(s) to utilize and in what manner to utilize them, where the output may be to the local area device). Frushour fails to specifically teach that the surgical information includes a second authentication request signal , wherein the second authentication request signal comprises a second authentication credential associated with the second surgical instrument , such that the instruction is a lockout instruction; however, Brough teaches a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), and if the authentication was successful, allows the user to use and control the medical device (see: Brough, paragraph 78 and 80). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical information as taught by Furshour, Brough, and Heeren to incorporate a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), and if the authentication was successful, allows the user to use and control the medical device as taught by Brough with the motivation that it may be beneficial to store a measurement of a physiological parameter of a patient captured by a medical device in an electronic health record associated with the patient that is stored on a health information system (HIS) server, and/or it may be beneficial to alert a billing server of various measurements that have been taken using a medical device in order to facilitate billing and collecting payments for the measurement (see: Brough, paragraph 18). As per claim 26 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 25, and further teach : wherein the control circuit is configured to: block signal communications between the second surgical instrument and the cloud server based on receiving the lockout instruction (see: Brough, paragraph 78 and 80, is met by a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), which prevents further login attempts for a predetermined duration of time or until an administrator performs an unlock operation, and if the authentication was successful, allows the user to use and control the medical device). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical information as taught by Furshour, Brough, and Heeren to incorporate a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), which prevents further login attempts for a predetermined duration of time or until an administrator performs an unlock operation, and if the authentication was successful, allows the user to use and control the medical device as taught by Brough with the motivation that it may be beneficial to store a measurement of a physiological parameter of a patient captured by a medical device in an electronic health record associated with the patient that is stored on a health information system (HIS) server, and/or it may be beneficial to alert a billing server of various measurements that have been taken using a medical device in order to facilitate billing and collecting payments for the measurement (see: Brough, paragraph 18). As per claim 27 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 25, and further teach : wherein the control circuit is configured to: receive an authentication credential update signal from the cloud server, wherein the authentication credential update signal comprises a new authentication credential associated with locking out the second surgical instrument (see: Brough, paragraph 78 and 80, is met by a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), which prevents further login attempts for a predetermined duration of time or until an administrator performs an unlock operation, and if the authentication was successful, allows the user to use and control the medical device). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical information as taught by Furshour, Brough, and Heeren to incorporate a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), which prevents further login attempts for a predetermined duration of time or until an administrator performs an unlock operation, and if the authentication was successful, allows the user to use and control the medical device as taught by Brough with the motivation that it may be beneficial to store a measurement of a physiological parameter of a patient captured by a medical device in an electronic health record associated with the patient that is stored on a health information system (HIS) server, and/or it may be beneficial to alert a billing server of various measurements that have been taken using a medical device in order to facilitate billing and collecting payments for the measurement (see: Brough, paragraph 18). Claims 28-33, 35-37, and 39 repeat the subject matter of claims 21-27, which have been shown to be fully disclosed by the cited prior art in the rejections above; as such, claims 28-33, 35-37, and 39 are rejected here for the same reasons given in the above rejections of claims 21-27, which are incorporated herein. As per claim 38 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 37, and further teach : wherein the surgical instrument comprises an end effector configured to interact with patient tissue, wherein the surgical function comprises any one or more of tissue clamping, tissue cutting, and tissue sealing (see: Frushour, paragraph 29, 35, and 40, is met by surgical stapler including an end effector) , and Frushour teaches a surgical stapler including an end effector as a surgical instrument (see: Frushour, paragraph 29, 35, and 40) and a determination of what surgical instrument(s) to utilize and in what manner, such as using a first surgical instrument rather than using a second surgical instrument (see: Frushour, paragraph 53-54), but Frushour fails to specifically teach the following limitations met by Heeren as cited: wherein the control program update comprises a modification to an operational parameter implemented by the surgical instrument for performing the surgical function (see: Heeren, paragraph 24 and 34, is met by during a surgery, vaporizing a small amount of tissue at the surgical site to facilitate the removal of the extracted tissues by ensuring sufficient flow and achieving low traction). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the recommendation and procedure information and the input of configuration information including software updates within a surgical instrument as taught by Frushour, Brough, and Heeren to include adjusting a parameter of a surgical device to vaporize a small amount of tissues at the surgical site to facilitate the removal of the extracted tissues by ensuring sufficient flow and achieving low traction as taught by Heeren with the motivation of preventing or reducing damage to a biological organ at the surgical site (see: Heeren , paragraph 5-6 and 26-27) . As per claim 40 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 37, and further teach : a wireless transceiver for transmitting signals to and receiving signals from the surgical hub (see: Furshour, paragraph 41, is met by input/output may be configured for wired or wireless communication and may communicate the surgical instrument information in real-time, periodically, upon occurrence of a particular event, and/or upon request ) . 07-21-aia AIA Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2019/0059997 to Frushour in view of U.S. Patent Application Publication 2017/0140134 to Brough in view of U.S. Patent Application Publication 2013/0041355 to Heeren further in view of U.S. Patent Application Publication 2009/0309726 to Fritchie . As per claim 34 , Furshour, Brough, and Heeren teach the invention as claimed, see discussion of claim 32, and further teach : wherein the control circuit is configured to: generate a new authentication credential for the second surgical instrument (see: Brough, paragraph 78 and 80, is met by a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), which prevents further login attempts for a predetermined duration of time or until an administrator performs an unlock operation, and if the authentication was successful, allows the user to use and control the medical device). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical information as taught by Furshour, Brough, and Heeren to incorporate a communication from a medical device to a server device that includes an authentication request, which may include the user identification and credential, where the medical device is configured to perform a locking operation after a failed login attempt(s), which prevents further login attempts for a predetermined duration of time or until an administrator performs an unlock operation, and if the authentication was successful, allows the user to use and control the medical device as taught by Brough with the motivation that it may be beneficial to store a measurement of a physiological parameter of a patient captured by a medical device in an electronic health record associated with the patient that is stored on a health information system (HIS) server, and/or it may be beneficial to alert a billing server of various measurements that have been taken using a medical device in order to facilitate billing and collecting payments for the measurement (see: Brough, paragraph 18). Furshour, Brough, and Heeren fail to specifically teach the following limitations met by Fritchie as cited: based on determining the second surgical instrument is associated with a manufacturing defect (see: Fritchie, paragraph 62, is met by enabling the data relating to the configuration of the medical instrument to be uploaded to a centralized database so as to enable the recall of components, assemblies, or sub-assemblies of the medical instrument if a manufacturing defect is discovered). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surgical system as taught by Furshour, Brough, and Heeren to enable the data relating to the configuration of the medical instrument to be uploaded to a centralized database so as to enable the recall of components, assemblies, or sub-assemblies of the medical instrument if a manufacturing defect is discovered as taught by Fritchie with the motivation of allowing the formation of individualized relationships with customers, with the aim of improving customer satisfaction and optimizing profits, identifying problems of customers, and providing customers the a high level of service (see: Fritchie, paragraph 62 and 74). Conclusion 07-96 The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the attached PTO-892 form and includes: Frederick, T. P. (2016). Miniature in vivo robot for minimally invasive small volume procedure with additional advanced subsystem design for the future (Order No. 10141699). Available from ProQuest Dissertations and Theses Professional. (1822489300). Retrieved from https://dialog.proquest.com/professional/docview/1822489300?accountid=131444 U.S. Patent Application Publication 2013/0253499 to Kimball (see abstract). Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A SOREY whose telephone number is (571)270-3606. The examiner can normally be reached Monday through Friday, 8am to 5pm. 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, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROBERT A SOREY/Primary Examiner, Art Unit 3682 Application/Control Number: 19/070,036 Page 2 Art Unit: 3682 Application/Control Number: 19/070,036 Page 3 Art Unit: 3682 Application/Control Number: 19/070,036 Page 4 Art Unit: 3682 Application/Control Number: 19/070,036 Page 5 Art Unit: 3682 Application/Control Number: 19/070,036 Page 6 Art Unit: 3682 Application/Control Number: 19/070,036 Page 7 Art Unit: 3682 Application/Control Number: 19/070,036 Page 8 Art Unit: 3682 Application/Control Number: 19/070,036 Page 9 Art Unit: 3682 Application/Control Number: 19/070,036 Page 10 Art Unit: 3682 Application/Control Number: 19/070,036 Page 11 Art Unit: 3682 Application/Control Number: 19/070,036 Page 12 Art Unit: 3682 Application/Control Number: 19/070,036 Page 13 Art Unit: 3682 Application/Control Number: 19/070,036 Page 14 Art Unit: 3682
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