DETAILED ACTION
Response to Amendments
The amendment filed on 10/23/2025 has been entered.
Claims 1-28 remain pending in the application.
Allowable Subject Matter
Claims 7-8, 11, 15-17, 20-21 and 24-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. See Office Action dated 9/16/2025 for Reasons for Allowance.
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.
Claims 1, 4, 9-10, 12-14, 18, 22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over USPGP# 20190200986 of Shelton, IV et al. (henceforth Shelton).
Regarding claim 1, Shelton teaches
A staple cartridge (150304), comprising:
a cartridge body (150194) comprising a deck (top surface of 150194) and staple cavities (150195) defined in said deck;
staples (150191) removably stored in the staple cavities, wherein the staples are ejected from the staple cavities during a staple firing stroke (para 0397);
a sensing array (28102, 28104, please note para 0653 states “the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects”) configured to assess a parameter of patient tissue (para 0608-0609) supported by the cartridge body and generate one or more signals indicative (inherent signal generated by the sensors 28102, 28104) thereof;
a temperature sensor circuit (27004, para 0562) in the cartridge body (see fig. 88), the temperature sensor circuit comprising a temperature sensor (27004, para 0562) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0562);
a data transmission antenna (27202, para 0581 radio frequency antenna of RFID tag. Please note para 0653 states “the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects”); and
a control system (27012) in communication with the temperature sensor circuit (para 0561), wherein the control system comprises a processor (inherent in order to perform the functions described in para 0561) configured to process the one or more signals from the sensing array (para 0561) and further configured to modify an operation of the staple cartridge to control the amount of heat generated by the staple cartridge (para 0561, control circuit 27012 at least turns on/off the heating element 27002).
Shelton does not explicitly teach
the control system is, additionally, in communication with the sensing array and the data transmission antenna.
Shelton teaches (in a different embodiment)
a similar control system (461) that is in communication with multiple sensors (472, 474, 476, fig. 12).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control system of the embodiment of 27012 such that it is communication with multiple sensors and sensory arrays (such as sensor array 28102) and transmission antenna (of sensor RFID tag 27202), as taught by a different embodiment of Shelton, in order to provide the predictable result of reducing the number of processors needed to processes signals from various sensors. This makes the staple cartridge less complex, cheaper to produce and/or more compact.
Regarding claim 4, as shown in claim 1, Shelton teaches
wherein the temperature sensor comprises the cartridge body (see fig. 88, 27004 is part of the cartridge body).
Regarding claim 9, as shown in claim 1, Shelton teaches
wherein the operation of the staple cartridge modified by the processor includes(para 0561, i.e. “the control circuit 27012 can be configured to activate the active element 27002” and para 0562, i.e. “the active element 27002 comprises a heating element”), or a combination thereof.
Regarding claim 10, as shown in claim 9, Shelton teaches
wherein the processor is configured to modify the operation of the staple (para 0561, i.e. “the control circuit 27012 can be configured to activate the active element 27002” and para 0562, i.e. “the active element 27002 comprises a heating element”), or a combination thereof.
Regarding claim 12, as shown in claim 1, Shelton teaches
wherein the processor is further configured to receive, from another temperature sensor (see fig. 88, there are two temperature sensors 27004), a signal generated based on a temperature sensed thereby indicative of the amount of heat generated by the staple cartridge (para 0562), the processor being further configured to modify the operation of the staple cartridge to control the amount of heat generated by the staple cartridge based on the signals from the temperature sensor and the other temperature sensor (para 0561).
Regarding claim 13, as shown in claim 12, Shelton teaches
wherein the other temperature sensor is located in the staple cartridge (see fig. 88, both sensors are in the cartridge).
Regarding claim 14, as shown in claim 12, Shelton teaches
wherein the other temperature sensor is located in an instrument in which the staple cartridge is installed (the other temperature sensor is on the staple cartridge and since the staple cartridge is installed on the instrument, the other temperature sensor is also located on the instrument).
Regarding claim 18, Shelton teaches
A method of operating a staple cartridge (150304) of a surgical instrument (150010), the staple cartridge comprising a cartridge body (150194) including a deck (top surface of 150194) and staple cavities (150195) defined in said deck, staples (150191) removably stored in the staple cavities, wherein the staples are ejected from the staple cavities during a staple firing stroke (para 0397), a sensing array (28102, 28104, please note para 0653 states “the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects”) configured to assess a parameter of patient tissue supported by the cartridge body and generate one or more signals indicative thereof (para 0608-0609), a temperature sensor circuit (27004, para 0562) in the cartridge body, the temperature sensor circuit comprising a temperature sensor (27004) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0562), and a control system (27012) in communication with the temperature sensor circuit (para 0561), the method comprising:
processing, by a processor (inherent in order to perform the functions described in para 0561) of the control system, the one or more signals from the temperature sensor circuit (para 0561); and
modifying, by the processor, an operation of the staple cartridge to control the amount of heat generated by the staple cartridge (para 0561, control circuit 27012 at least turns on/off the heating element 27002).
Shelton does not explicitly teach
the control system is, additionally, in communication with the sensing array and processing, by the processor of the control system, the one or more signals from the sensing array.
Shelton teaches (in a different embodiment)
a similar control system (461) that is in communication with multiple sensors (472, 474, 476, fig. 12).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control system of the embodiment of 27012 such that it is communication with multiple sensors and sensory arrays (such as sensor array 28102) and processes the signal generated by the sensor array, as taught by a different embodiment of Shelton, in order to provide the predictable result of reducing the number of processors needed to processes signals from various sensors. This makes the staple cartridge less complex, cheaper to produce and/or more compact.
Regarding claim 22, as shown in claim 18, Shelton teaches
wherein the operation of the staple cartridge modified by the processor includes (para 0561, i.e. “the control circuit 27012 can be configured to activate the active element 27002” and para 0562, i.e. “the active element 27002 comprises a heating element”), or a combination thereof.
Regarding claim 28, Shelton teaches
A surgical stapling system (150010), comprising:
an end effector (150300) including a staple cartridge (150304) seated in a jaw (150302) thereof and having a cartridge body (150194), comprising:
a deck (top surface of 150194); and
staple cavities (150195) defined in said deck;
staples (150191) removably stored in said staple cavities, wherein said staples are ejected from said staple cavities during a staple firing stroke (para 00397);
a staple firing drive (150172) configured to produce said staple firing stroke (para 0397);
a tissue sensing array (28102, 28104, please note para 0653 states “the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects”);
a temperature sensor (27004, para 0562) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0562); and
a control system (27012) in communication with the temperature sensor (para 0561), wherein the control system comprises a processor (inherent in order to perform the functions described in para 0561) configured to process the one or more signals and further configured to modify the operation of the staple cartridge to control the amount of heat generated by the staple cartridge (para 0561, control circuit 27012 at least turns on/off the heating element 27002).
Shelton does not explicitly teach
the control system is, additionally, in communication with the tissue sensing array and the processor is configured to process the one or more signals from the sensing array.
Shelton teaches (in a different embodiment)
a similar control system (461) that is in communication with multiple sensors (472, 474, 476, fig. 12) and a processor (462) of the control system is configured to process signals from said sensors (para 0273).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control system of the embodiment of 27012 such that it is communication with multiple sensors and sensory arrays (such as sensor array 28102), as taught by a different embodiment of Shelton, in order to provide the predictable result of reducing the number of processors needed to processes signals from various sensors. This makes the staple cartridge less complex, cheaper to produce and/or more compact.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton (alternate interpretation).
Regarding claim 3, Shelton teaches
A staple cartridge (150304), comprising:
a cartridge body (150194) comprising a deck (top surface of 150194) and staple cavities (150195) defined in said deck;
staples (150191) removably stored in the staple cavities, wherein the staples are ejected from the staple cavities during a staple firing stroke (para 0397);
a sensing array (28102, 28104, please note para 0653 states “the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects”) configured to assess a parameter of patient tissue (para 0608-0609) supported by the cartridge body and generate one or more signals indicative (inherent signal generated by the sensors 28102, 28104) thereof;
a temperature sensor circuit (27002 and circuit wiring connecting 27002, 27004 and 27012, para 0562) in the cartridge body (see fig. 88), the temperature sensor circuit comprising a temperature sensor (27004, para 0562) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0562);
a data transmission antenna (27202, para 0581 radio frequency antenna of RFID tag. Please note para 0653 states “the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects”); and
a control system (27012, 27004 para 0562) in communication with the temperature sensor circuit (para 0561), wherein the control system comprises a processor (para 0406) configured to process the one or more signals from the sensing array (para 0406) and further configured to modify the operation of the staple cartridge to control the amount of heat generated by the staple cartridge (para 0561, control circuit 27012 at least turns on/off the heating element 27002).
Shelton does not explicitly teach
the control system is, additionally, in communication with the sensing array and the data transmission antenna.
Shelton teaches (in a different embodiment)
a similar control system (461) that is in communication with multiple sensors (472, 474, 476, fig. 12).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control system of the embodiment of 27012 such that it is communication with multiple sensors and sensory arrays (such as sensor array 28102) and transmission antenna (of sensor RFID tag 27202), as taught by a different embodiment of Shelton, in order to provide the predictable result of reducing the number of processors needed to processes signals from various sensors. This makes the staple cartridge less complex, cheaper to produce and/or more compact.
wherein the temperature sensor is internal to the processor (the processor is being interpreted as the combination of 27012 and 27004).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of USPGP 20150122870 of Zemlok et al. (henceforth Zemlok).
Regarding claim 2, as shown in claim 1, Shelton does not explicitly teach
wherein the temperature sensor comprises a thermistor, thermocouple, and/or resistance temperature detector.
Zemlok teaches
a temperature sensor (403) in communication with a control system (405); wherein the temperature sensor comprises a thermistor (para 0119), thermocouple (para 0119), and/or resistance temperature detector (para 0119).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the temperature sensor of Shelton with a thermistor, thermocouple, and/or resistance temperature detector, as taught by Zemlok in order to allow usage of existing, commercially available technology to detect the desired target temperature. This makes it cheaper to produce the device since new temperature sensors don’t have to be created. Additionally, both Shelton and Zemlok teach temperature sensors for detecting temperature, it would have been obvious to one skilled in the art, ore the effective filing date of the claimed invention, to substitute one temperature sensor (unknown type of Shelton) for the other (thermistor, thermocouple, and/or resistance temperature detector of Zemlok) to achieve the predictable result of reliably and effectively measuring the temperature. KSR Int’l Co. V. Teleflex Inc. 550 U.S.
Claims 5-6, 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of USPGP 20140276719 of Parihar (henceforth Parihar).
Regarding claim 5, as shown in claim 4, Shelton does not teach
wherein the cartridge body comprises a positive temperature coefficient material.
Parihar teaches
A cartridge (182) comprising a deck (top surface of 182); the cartridge comprising
a control system (104)
a temperature sensor circuit (189, para 0057) in the cartridge body (see fig. 9), the temperature sensor circuit comprising a temperature sensor (189) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0057); wherein the cartridge body comprises a positive temperature coefficient material (para 0057).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the temperature sensor of Shelton with a thermistor that uses a positive temperature coefficient material, as taught by Parihar in order to efficiently and quickly detect the temperature of the tissue and/or the cartridge (Parihar: para 0057). This allows the cartridge to adjust the power supplied to the heating element to prevent overheating (and thus damage) to the tissue and/or cartridge (Parihar: para 0057).
Regarding claim 6, as shown in claim 1, Shelton does not explicitly teach
wherein the processor is further configured to determine when the amount of heat generated by the staple cartridge exceeds a first threshold and modify the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge.
Parihar teaches
a cartridge (182) comprising a deck (top surface of 182); the cartridge comprising
a control system (104) with a processor (inherent part of 104)
a temperature sensor circuit (189, para 0057) in the cartridge body (see fig. 9), the temperature sensor circuit comprising a temperature sensor (189) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0057); wherein the processor is further configured to determine when the amount of heat generated by the staple cartridge exceeds a first threshold and modify the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge (para 0057).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the processor of Shelton such that it is further configured to determine when the amount of heat generated by the staple cartridge exceeds a first threshold and modify the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge, as taught by Parihar in order to effectively prevent overheating (and thus damage) to the tissue and/or cartridge (Parihar: para 0057).
Regarding claim 19, as shown in claim 18, Shelton does not teach
determining, by the processor, when the amount of heat generated by the staple cartridge exceeds a first threshold and modifying the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge.
Parihar teaches
A method of operating a cartridge (182) comprising a deck (top surface of 182); the cartridge comprising
a control system (104) with a processor (inherent part of 104)
a temperature sensor circuit (189, para 0057) in the cartridge body (see fig. 9), the temperature sensor circuit comprising a temperature sensor (189) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0057);
the method comprising:
processing, by a processor of the control system, the one or more signals from the temperature sensor circuit (para 0057); and
modifying, by the processor, the operation of the staple cartridge to control the amount of heat generated by the staple cartridge (para 0057).
and
determining, by the processor, when the amount of heat generated by the staple cartridge exceeds a first threshold and modifying the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge (para 0057).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of using the processor of Shelton such that it is further configured to determine when the amount of heat generated by the staple cartridge exceeds a first threshold and modify the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge, as taught by Parihar in order to effectively prevent overheating (and thus damage) to the tissue and/or cartridge (Parihar: para 0057).
Regarding claim 23, as shown in claim 22, Shelton does not teach
modifying, by the processor, the operation of the staple cartridge by reducing, by the processor, the sampling rate, the processing rate, the data transfer rate, the power transfer rate, the amount of power transferred to the staple cartridge, or a combination thereof.
Parihar teaches
A method of operating a cartridge (182) comprising a deck (top surface of 182); the cartridge comprising
a control system (104) with a processor (inherent part of 104)
a temperature sensor circuit (189, para 0057) in the cartridge body (see fig. 9), the temperature sensor circuit comprising a temperature sensor (189) configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge (para 0057);
the method comprising:
processing, by a processor of the control system, the one or more signals from the temperature sensor circuit (para 0057); and
modifying, by the processor, the operation of the staple cartridge to control the amount of heat generated by the staple cartridge (para 0057).
and
modifying, by the processor, the operation of the staple cartridge by reducing the amount of power transferred to the cartridge (para 0057).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of using the processor of Shelton such that it is configured to modify the operation of the staple cartridge to reduce the amount of heat generated by the staple cartridge, as taught by Parihar in order to effectively prevent overheating (and thus damage) to the tissue and/or cartridge (Parihar: para 0057).
Response to Arguments
Applicant’s arguments filed on 10/23/2025 have been fully considered:
All claim objections have been overcome.
Amended claims have overcome all previous 112 (b) or second paragraph rejection/s.
Applicant’s arguments regarding claims 1, 18 and 28, have been fully considered but are not persuasive.
Regarding claim/s 1, 18 and 28, Applicant states that Shelton does not teach sensing an amount of heat generated by the staple cartridge itself but rather the temperature of the tissue which absorbs the heat generated by the staple cartridge and sensing the temperature of tissue to which thermal energy is applied is not the same as sensing the temperature of the staple cartridge.
The claim, as recited, does not require measuring a temperature of the staple cartridge itself. The claim recites “a temperature sensor configured to sense a temperature and generate a signal based thereon indicative of an amount of heat generated by the staple cartridge”. In other words, the temperature sensor can sense the temperature of anything (i.e. tissue) that indicates the amount heat generated by the staple cartridge (the heating element 27002 is part of the staple cartridge and therefore the heat generated by the heating elements anticipates the limitation of “amount of heat generated by the staple cartridge”). As such, since the temperature sensor 27004 senses a temperature that indicates how much heat was generated by the heating elements, the claims as recited are anticipated.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOBEEN AHMED whose telephone number is (571) 272-0356. The examiner can normally be reached on M-F (8:30 am to 5 pm).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached on 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A./
Examiner, Art Unit 3731
/ANNA K KINSAUL/Supervisory Patent Examiner, Art Unit 3731