DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07 January 2026 has been entered.
Response to Amendment
Receipt is acknowledged of an amendment, filed 07 January 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 16-35 are pending.
Claims 16, 28, and 32 are amended.
Claims 1-15 are canceled.
Specification and Drawings:
Amendments to the specification and drawings have not been submitted in the amendment filed 07 January 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-27 and 32-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is inadequate written description of the subject matter of claims 16 and 32.
The amended claims 16 and 32 include the following limitations which are deemed to be unsupported by the disclosure, as originally filed:
Claim 16 recites “the controller being configured to detect at least i) whether tissue is present in the target region and ii) whether the tissue that is targeted to be cut during the procedure present in the target region will be cut in its entirety in a single firing of the end effector, wherein detection of tissue by the one or more external electrical pads positioned externally adjacent to the target region indicates that the tissue targeted to be cut during the procedure will not be cut in its entirety in the single firing of the end effector is contained entirely within the target region and not present external to the target region; and provide an indication of whether the tissue that is targeted to be cut during the procedure will be cut in its entirety in a single firing of the end effector the tissue presence and positioning to a user of the surgical instrument”.
Claim 32 recites “providing, by the controller based on whether tissue is present in the target region and whether tissue is present externally adjacent to the target region, an indication of one or both of i) whether tissue is present in the target region and ii) whether the tissue that is present in the target region will be cut in its entirety in the single firing of the end effector”.
Applicant’s response filed on 07 January 2026 fails to specifically point out in the Remarks where there is support for the limitations, and there appears to be no written description of the claim limitations in the application as filed.
In this regard, applicant argues that paragraphs [0047] and [0071] of the written description provide support for the claim amendments.
However, the written description provides no support for a controller that is configured to detect “whether the tissue that is targeted to be cut during the procedure present in the target region will be cut in its entirety in a single firing of the end effector” and “provide an indication of whether the tissue that is targeted to be cut during the procedure will be cut in its entirety in a single firing of the end effector”.
As disclosed in the written description, paragraph [0071], the “controller 906 may determine that tissue is present in the target region 910” and “that the tissue is not entirely contained within the target region 910”. The “controller 906 may determine that the tissue extends distally outside of the target region 910”. Thus, the controller is disclosed as determining that tissue is present, that tissue is not entirely contained, and that tissue extends distally. Then, “[p]resence of tissue at the location of the source electrical contact 1004-4a may indicate that the tissue may not be cut in its entirety with a single firing of the end effector 912”. Thus, the detected presence “indicates” that tissue may not be entirely cut. There is no disclosure that the controller is configured to detect whether the tissue that is targeted to be cut during the procedure will be cut in its entirety in a single firing of the end effector”. There is no disclosure that the controller is configured to provide an indication of whether the tissue that is targeted to be cut during the procedure will be cut in its entirety in a single firing of the end effector”.
Accordingly, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention.
The subject matter of these elements has not been described in the specification in such a way as to reasonably convey to one skilled in the art how to make and use the invention, and comprise new matter.
Accordingly, applicant is required to respond by: specifically pointing out where adequate written description can be found for the limitations; making an amendment to address the deficiency or making appropriate correction.
Claims 17-27 and 33-35 depend from claims 16 and 32, respectively, and are likewise rejected.
While no prior art has been applied with respect to claims 16-27 and 32-35, this is not an indication of allowable subject matter in claims 16-27 and 32-35.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (US Patent Publ. No. 2019/0201020).
With respect to claim 28, Shelton et al. disclose a surgical instrument (fig. 78), comprising: a shaft (fig. 78); an end effector extending from the shaft (end effector 153470, fig. 78), the end effector comprising: a first jaw 153472; and a second jaw 153474, wherein at least one of the first jaw and the second jaw is movable relative to the other to grasp tissue targeted to be cut during a procedure to be performed using the end effector (second jaw 153474 includes a staple cartridge and firing member including a cutting instrument, figs. 78, 79, 82, [0537]); a plurality of electrical pads (segments 153442a-c of segmented flexible circuit 153440, fig. 76, [0533]) positioned, on one or more tissue engaging surfaces of the end effector (segmented flexible circuit 153468 mounted to jaw 153472, fig. 78), the plurality of electrical pads including i) one or more target electrical pads positioned within a target region defined for placement of the tissue, targeted to be cut during the procedure, between the first jaw and the second jaw of the end effector (segments 1-3 define a target region for tissue 153476 placement between the jaws, fig. 79, [0536]) and ii) one or more external electrical pads positioned externally adjacent to the target region of the end effector (segments 4-5 define a region external to and adjacent the region defined by segments 1-3, fig. 79, [0536]), wherein the target region is a stapling region of the end effector and the one or more external electrical pads are positioned external to the stapling region of the end effector (segments 1-3 extend over the staple cartridge 153474 and thus segments 1-3 define a stapling region, segments 4-5 extend external to the segments 1-3, fig. 79, [0535]); and a controller (control circuit, output device/controller, [0536], [0444], [0445], [0524]) coupled to the plurality of electrical pads so as to receive signals from the plurality of electrical pads (tissue detected by the sensors in segments 1-3 and the absence of tissue detected by the sensors in segments 4-5 is communicated to a control circuit, [0536], fig. 79), the controller configured to: detect, based on the signals received from the plurality of electrical pads, whether tissue that is present in the target region of the end effector extends outside of the target region of the end effector (the absence of tissue detected by the sensors in segments 4-5 indicates that the tissue present in the target region is contained entirely within the target region and not present external to the target region, the absence of tissue detected by the sensors in segments 4-5 indicates that tissue is not present outside of the target region, [0536], fig. 79), wherein detection of tissue by the one or more external electrical pads positioned externally adjacent to the target region indicates that the tissue targeted to be cut during the procedure i) extends outside of the target region of the end effector (tissue detected by the sensors in segments 4-5 indicates whether tissue extends outside of the target region, [0536], fig. 79) and ii) will not be cut in its entirety in a single firing of the end effector. Shelton et al. disclose that the presence and absence of tissue is detected by the sensors in segments 1-5, that the presence/absence detected by the sensors is communicated to a control circuit via interface circuits, and that the control circuit is connected to an output device/controller for providing feedback and for controlling operations of the surgical instrument, and therefor is considered to disclose that the controller, in response to detecting whether tissue is present outside of the target region, provides an indication to a user of the surgical instrument. Shelton et al. disclose segments 1-3 defining a target region for tissue 153476 placement between the jaws (fig. 79, [0536]) and disclose that segments 1-3 extend over the staple cartridge 153474. Thus, the target region of segments 1-3 is considered to be a stapling region. Shelton et al. disclose segments 4-5 defining a region external to and adjacent the region defined by segments 1-3 (fig. 79, [0536]). Thus, the region of segments 4-5 is considered to be external to the stapling region defined by segments 1-3.
Shelton et al. disclose the controller and one or more external electrical pads positioned externally adjacent to the target region. Thus, detection of tissue by one or more external electrical pads positioned externally adjacent to the target region is fully capable of indicating that the tissue targeted to be cut during the procedure will not be cut in its entirety in a single firing of the end effector.
Detection of the tissue and determination that the tissue extends outside the target region, and what property or circumstance is indicated by the detection of the tissue are separate things. Further, any indication about the tissue in this instance is wholly unrelated to the detection and determination, and to the external electrical pads and the controller. Any indication that the targeted tissue will not be cut in its entirety in a single firing of the end effector is disclosed as a conclusion that one makes based on the detection of the tissue by the electrical pads and the determination by the controller that tissue extends outside of the target region ([0071]).
The intended use recitation language (some of which has been italicized supra) carries no weight in the absence of any distinguishing structure. Shelton et al. disclose the structure as claimed and is thus capable of performing the functions. See MPEP 2114 which states: APPARATUS CLAIMS MUST BE STRUCTURALLY DISTINGUISHABLE FROM THE PRIOR ART While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board's finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210,212-13, 169 USPQ 226,228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528,531 (CCPA 1959). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
In the embodiment of figures 78-79, Shelton et al. fail to disclose in response to detecting that tissue is present outside of the target region, providing an alert signal to a user of the surgical instrument.
In the embodiment of figures 88-102, Shelton et al. disclose a surgical instrument comprising a segmented flexible circuit including zones (fig. 88), and a controller coupled to the circuit that, in response to detecting an irregularity in external tissue zones 1 and 3, provides an alert signal to a user of the surgical instrument (if tissue in zones 1,3 is determined to be irregularly distributed, then instructions are provided to the user for releasing and repositioning the tissue, [0622], tissue may be reclamped, motor speed may be reduced, user may be alerted through a display, [0686]).
It 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 to modify the device of the embodiment of figures 78-79 of Shelton et al. to provide that the controller, in response to detecting that tissue is present outside of the target region, provides an alert signal to a user of the surgical instrument as taught by the embodiment of figures 88-102 of Shelton et al., to prevent tissue damage in the event that tissue is detected by the sensors in the external regions.
With respect to claim 29, Shelton et al. disclose the plurality of electrical pads positioned externally adjacent to the target region comprise: a first electrical pad positioned proximally adjacent to the target region (segment 4 positioned proximally of segments 1-3, fig. 79); and a second electrical pad positioned proximally to the target region (segment 5 positioned proximally of segments 1-3, fig. 79).
In the embodiment of figures 78-79, Shelton et al. fail to disclose the first electrical pad is positioned distally adjacent to the target region.
In the embodiment of figures 88-102, Shelton et al. disclose a surgical instrument comprising a segmented flexible circuit including zones (fig. 88), including a first electrical pad positioned distally adjacent to the target zone (in zone 3 in fig. 88, in zone 1 in fig. 90, adjacent to target zone 2) and a second electrical pad positioned proximally adjacent to the target zone (in zone 1 in fig. 88, in zone 3 in fig. 90, adjacent to target zone 2).
It 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 to modify the device of the embodiment of figures 78-79 to include a first electrical pad positioned distally adjacent to the target zone as taught by Shelton et al. in the embodiment of figures 88-102, for a purpose such as determining whether there is tissue distally of the target zone as well as proximally of the target zone, since moving one of the external proximal electrical pads from the proximal position to a distal position would involve only a repositioning of the elements of the device. MPEP 2144.04 VI. C.
With respect to claim 30, Shelton et al. disclose that the first and second electrical pads positioned proximally adjacent to the target region are configured to provide a signal indicative of whether the tissue that is present in the target region extends beyond a proximal end of the target region (the absence of tissue detected by the sensors in segments 4-5 indicates whether the tissue present in the target region extends beyond a proximal end of the target region, [0536], fig. 79).
In the embodiment of figures 78-79, Shelton et al. fail to disclose that the first electrical pad positioned distally adjacent to the target region is configured to provide a signal indicative of whether the tissue that is present in the target region extends beyond a distal end of the target region.
In the embodiment of figures 88-102, Shelton et al. disclose a surgical instrument comprising a segmented flexible circuit including zones (fig. 88), including a first electrical pad positioned distally adjacent to the target zone (in zone 3 in fig. 88, in zone 1 in fig. 90, adjacent to target zone 2) and a second electrical pad positioned proximally adjacent to the target zone (in zone 1 in fig. 88, in zone 3 in fig. 90, adjacent to target zone 2).
It 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 to modify the device of the embodiment of figures 78-79 to include a first electrical pad positioned distally adjacent to the target zone that is configured to provide a signal indicative of whether the tissue that is present in the target region extends beyond a distal end of the target region, as taught by Shelton et al. in the embodiment of figures 88-102, for a purpose such as determining whether there is tissue distally of the target zone as well as proximally of the target zone, since moving one of the external proximal electrical pads from the proximal position to a distal position would involve only a repositioning of the elements of the device. MPEP 2144.04 VI. C.
With respect to claim 31, in the embodiment of figures 78-79, Shelton et al. fail to disclose that the first electrical pad and the second electrical pad are electrically connected with one another to provide a single signal indicative of whether the tissue that is present in the target region extends beyond a distal end or a proximal end of the target region.
In the embodiment of figures 88-102, Shelton et al. disclose that the first electrical pad and the second electrical pad are electrically connected with one another to provide a single signal indicative of whether the tissue that is present in the target region extends beyond a distal end or a proximal end of the target region (process includes steps of averaging the tissue impedances in the outer and inner zones, and if tissue distribution is inadequate sends a single signal to release tissue; if tissue distribution is adequate sends a single signal to continue end effector closure, [0622], [0623]).
It 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 to modify the device of the embodiment of figures 78-79 to include a first electrical pad positioned distally adjacent to the target zone and that the first electrical pad and the second electrical pad are electrically connected with one another to provide a single signal indicative of whether the tissue that is present in the target region extends beyond a distal end or a proximal end of the target region, as taught by Shelton et al. in the embodiment of figures 88-102, for a purpose such as determining whether there is tissue distally of the target zone as well as proximally of the target zone, since moving one of the external proximal electrical pads from the proximal position to a distal position would involve only a repositioning of the elements of the device. MPEP 2144.04 VI. C.
Response to Arguments
With respect to the rejection of claims 16 and 32 under 35 U.S.C. 102(a)(1) over Shelton et al. (US Patent Publ. No. 2019/0201020), applicant argues that Shelton et al. fail to disclose the apparatus and method as claimed in amended claims 16 and 32. In view of the current rejection of claims 16-27 and 32-45 under 35 U.S.C. 112(a), this rejection is not insisted upon at this time.
With respect to the rejection of claim 28 under 35 U.S.C. 103 over Shelton et al., applicant argues that independent claim 28 has been amended in include features consistent with claim 16. In particular, applicant argues that Shelton et al. fail to disclose one or more external electrical pads placed such that the detection of tissue by the electrical pads indicates that the tissue targeted to be cut during a procedure to be performed using an end effector will not be cut in its entirety in a single firing of the end effector.
In response, Shelton et al. disclose the controller and one or more external electrical pads positioned externally adjacent to the target region. Thus, detection of tissue by one or more external electrical pads positioned externally adjacent to the target region is fully capable of indicating that the tissue targeted to be cut during the procedure will not be cut in its entirety in a single firing of the end effector.
Detection of the tissue and determination that the tissue extends outside the target region, and what property or circumstance is indicated by the detection of the tissue are separate things. Further, any indication about the tissue in this instance is wholly unrelated to the detection and determination, and to the external electrical pads and the controller. Any indication that the targeted tissue will not be cut in its entirety in a single firing of the end effector is disclosed as a conclusion that one makes based on the detection of the tissue by the electrical pads and the determination by the controller that tissue extends outside of the target region ([0071]).
The intended use recitation language (some of which has been italicized supra) carries no weight in the absence of any distinguishing structure. Shelton et al. disclose the structure as claimed and is thus capable of performing the functions.
Accordingly, in view of all of the above, the rejection of claim 28 under 35 U.S.C. 103 over Shelton et al. is still deemed proper.
Applicant has provided no arguments pointing out errors with respect to the rejections of dependent claims 29-31, and these rejections are still deemed proper.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA J. HODGE/Examiner, Art Unit 3731