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 .
Response to Amendment
The amendment filed 03/31/2026 has been entered. Claims 1-20 are pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 16-20, 22-27, and 37 is/are rejected under 35 U.S.C. 103 as obvious over HART et al. (WO 2022125397 A1) in view of Morgan et al. (US 20150054753 A1) and further in view of SMITH et al. (US 20100096431 A1).
Regarding claims 16, HART et al. discloses a surgical stapler (1), comprising: an end effector (300) configured to receive a staple cartridge (400/420) including staples ([0025, 0038], fig. 1); a trocar (270) movable relative to the end effector; an anvil (500) removably coupleable to the trocar, wherein the anvil is movable relative to the end effector based on movement of the trocar [0033], and wherein the anvil is configured to apply a force to tissue positioned between the anvil and the end effector [0033-0036];
a sensor (sensors 408a-n include a strain gauge) configured to sense the force [0030, 0036]; a firing drive (staple driver assembly) to fire the staples [0033-0034]; a housing (10) comprising a display (146); and a control circuit (147) operably coupled to the sensor and the display ([0030, 0053]) wherein the control circuit is configured to: interrogate the sensor to determine the force (controlled tissue compression (“CTC”), strain gauge measurements, calculate loads [0030-0032-0057]); display a representation of the determined force on the display/gauge 700 [0053], fig. 8), wherein the representation comprises: a visual guide bar (700 zones 1/2/3), defining: an unacceptable zone extending along a first portion of the visual guide bar to designate forces that are unacceptable for firing staples from the staple cartridge; an acceptable zone extending along a second portion of the visual guide bar to designate forces that are acceptable for firing staples from the staple cartridge (three zones, zone 700a/b/c and high force caution graphic on 700c, target clamping force, pressure limit, fig. 8); and
a force indicator (progress bar) movable along the visual guide bar to a position that represents the determined force ([0030-0032-0057], fig. 8); and a tissue compression countdown to determine correct compression force [0008, 0030, 0036, 0040, 0047, 0053-0055].
HART et al. states: “as the anvil assembly 510 is being moved to compress the tissue under the CTC, the gauge 700, the anvil animation 702, and the distance traveled by the anvil assembly 510 as progress percentage 704 are updated continuously to provide real time feedback regarding the CTC progress [0053]…clamp extremely thick tissue without overcompressing and damaging the tissue… tracking the position of the trocar member 274 and calculating the ratio of current position to target position and increasing the pressure in proportion to that ratio until a pressure limit is reached” [0057].
HART et al. fails to explicitly disclose the stapler configured to initiate a tissue compression countdown based on the force indicator moving within the acceptable zone, wherein the tissue compression countdown includes a timer to allow the tissue captured between anvil and the end effector to relax; display a firing readiness indicator based on a completion of the tissue compression countdown;
allow the firing drive to fire the staples from the staple cartridge based on the completion of the tissue compression countdown; and prevent the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone and wherein the force indicator is movable along the visual guide bar based on the anvil moving relative to the end effector and prior to the firing drive firing the staples
Morgan et al. teaches a stapler (10) that measures force on tissue and force and position on an anvil [0272-0274, 0321-0324, 0398-0402], detect force and movement of the trigger [0370], the stapler configured to initiate a count (display percentages feedback as function of time [0399]), pause [0415], based on a force indicator moving within an acceptable zone (visual indicator); display a firing readiness indicator (visual indicator, start period 5057 [0326, 0380, 401-409], figs. 75-92) and prevent the firing drive from firing the staples from the staple cartridge based on a force indicator being location within a unacceptable zone ([0271, 0299, 0236, 0375, 0415-0417], figs. 1-6), wherein a force indicator (moving arrow 5054, fig. 79, anvil display 10390 indicators 10391-10395 that depict anvil position, [0282-0286], figs. 121-124, graphical representation [0410], fig. 75 shows needle graph, “a scale and/or a ruler, which can illustrate the detected tissue thickness” [0401-0402], progression bar 5480, fig. 92) is movable along the visual guide bar based on the anvil or knife moving relative to the end effector and prior to the firing drive firing the staples [0282-0286, 0401-0410], figs. 75-92 and 121-124).
Morgan et al. states: “as the DLU 5022 is manipulated around the surgical site, the DLU 5022 may move around the display 5002. In such embodiments, the feedback related to the DLU 5022, such as the jaw position and/or the articulation data, for example, can move along with the DLU 5022. Movement of the relevant feedback may ensure the feedback remains in the operator's field of vision [0403]…user may desire to observe the clamping force exerted on the tissue T along the length and/or width of the end effector jaws 5024” [0410].
SMITH et al. also teaches a stapler (1) that measures force on tissue (strain gauge, force measurements, force switch 400, optimal tissue compression (OTC) [0010, 0097, 0107-0114, 0132, 0137], a force/compression indicator (14 [0076, 0079]), the stapler configured to initiate a tissue compression countdown (countdown sequence) based on a force indicator moving within the acceptable zone (firing of staples only occurs within the OTC range [0137]), wherein the tissue compression countdown includes a timer (staple control assembly 200/microcontroller [0097, 0103-0114, 0135]) to allow the tissue captured between anvil and the end effector to relax (allowed to desiccate); display a firing readiness indicator (14/blinking fire button LED) based on a completion of the tissue compression countdown; allow the firing drive to fire the staples from the staple cartridge based on the completion of the tissue compression countdown; and prevent the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone (desired pressure range/OTC range [0113-0114, 0129-0135]).
SMITH et al. states: “staple firing countdown sequence because it is understood that the tissue needs to be compressed and allowed to desiccate before staple firing should occur. Thus, after the staple firing switch 22 is activated, the anvil 60 closes upon the interposed tissue and begins to compress the tissue. The staple firing sequence includes an optimal tissue compression (OTC) measurement and a feedback control mechanism that causes staples to be fired only when the compression is in a desired pressure range, referred to as the OTC range, and a sufficient time period has elapsed to allow fluid removal from the compressed tissue” [0130]
Given the teachings of HART et al. to have force indicator (progress bar) movable along the visual guide bar to a position that represents the determined force and a tissue compression countdown to determine proper force, 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 stapler to be configured to initiate a tissue compression countdown based on the force indicator moving within the acceptable zone, wherein the tissue compression countdown includes a timer to allow the tissue captured between anvil and the end effector to relax; display a firing readiness indicator based on a completion of the tissue compression countdown; allow the firing drive to fire the staples from the staple cartridge based on the completion of the tissue compression countdown; and prevent the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone and wherein the force indicator is movable along the visual guide bar based on the anvil moving relative to the end effector and prior to the firing drive firing the staples to have precise adjustment of speed/torque for more precise operation on the tissue (avoid overshoot/damage or under clamping to the tissue) and/or for feedback purposes as taught by Morgan et al. and SMITH et al.
Regarding claim 23, HART et al. discloses a surgical stapler (1), comprising: an end effector (300) configured to receive a staple cartridge (400/420) including staples ([0025, 0038], fig. 1); a trocar (270) movable relative to the end effector; an anvil (500) removably coupleable to the trocar, wherein the anvil is movable relative to the end effector based on movement of the trocar [0033], and wherein the anvil is configured to apply a force to tissue positioned between the anvil and the end effector [0033-0036];
a position sensor (plurality of sensors 408a ... 408n) configured to sense a position of the anvil relative to the end effector (samples position, counting revolutions of the motor, [0010-0014, 0030-0031, 0041-0044, 0050-0055] display fig. 8);
a force sensor (sensors 408a-n include a strain gauge) configured to sense the force [0030, 0036]; a firing drive (staple driver assembly) to fire the staples [0033-0034];
a housing (10) comprising a display (146) and a rotary actuator (motor 152/motor controller 143) configured to move the trocar relative to the end effector ([0028-0033, 0044, 0057], claims 1 and 13), and a control circuit (143/147) operably coupled to the position and force sensors and the display ([0030-0055]), wherein the control circuit is configured to: interrogate the position sensor to determine the position of the anvil (samples position, counting revolutions of the motor, [0010-0014, 0030-0031, 0041-0044, 0050-0055] display fig. 8);
interrogate the force sensor to determine the force (controlled tissue compression (“CTC”), strain gauge measurements, calculate loads [0030-0032-0057]); and display a representation of the determined position and force on the display [0053-0055], wherein the representation comprises
a visual guide, defining: a first unacceptable zone corresponding to positions of the anvil that are unacceptable for firing staples from the staple cartridge (misalignment, not reach minimum travel distance); a first acceptable zone corresponding to positions of the anvil that are acceptable for firing staples from the staple cartridge ([0044], reaches distance 604 or minimum travel distance [0050]);
a second unacceptable zone corresponding to forces that are unacceptable for firing staples from the staple cartridge (minimum force not reached, high force caution graphic on 700c, target clamping force, pressure limit, fig. 8); and a second acceptable zone corresponding to forces that are acceptable for firing staples from the staple cartridge (“verifies whether the measured force is within predefined parameters to determine if the measured force exceeds a high force threshold limit” [0044]);
a first position indicator (progress percentage 704) configured to traverse the visual guide to a position that represents the determined position (progress updated until distance 606 reached); and a second force indicator (progress bar) configured to traverse the visual guide to a position that represents the determined force (three zones, zone 700a/b/c and high force caution graphic on 700c, target clamping force, pressure limit, fig. 8), and a tissue compression countdown to determine correct compression force [0008, 0030, 0036, 0040, 0047, 0053-0055].
HART et al. fails to explicitly disclose the stapler configured to initiate a countdown based on the position indicator moving within the first acceptable zone and the force indicator moving within the second acceptable zone display a firing readiness indicator based on a completion of the countdown allow the firing drive to fire the staples from the staple cartridge based on the completion of the countdown; and prevent the firing drive from firing the staples from the staple cartridge based on the position indicator being located within the first unacceptable zone or the force indicator being within the second unacceptable zone or a combination thereof and display a representation of the determined position and force on the display based on actuation of the rotary actuator and prior to the firing drive firing the staples.
Morgan et al. teaches a stapler (10) that measures force on tissue and force and position on an anvil [0272-0274, 0321-0324, 0398-0402], detect force and movement of the trigger [0370], the stapler configured to initiate a count (display percentages feedback as function of time [0399]), pause [0415], based on a force indicator moving within an acceptable zone (visual indicator); display a firing readiness indicator (visual indicator, start period 5057 [0326, 0380, 401-409], figs. 75-92) and prevent the firing drive from firing the staples from the staple cartridge based on a force indicator being location within a unacceptable zone ([0271, 0299, 0236, 0375, 0415-0417], figs. 1-6), wherein a force indicator (moving arrow 5054, fig. 79, anvil display 10390 indicators 10391-10395 that depict anvil position, [0282-0286], figs. 121-124, graphical representation [0410], fig. 75 shows needle graph, “a scale and/or a ruler, which can illustrate the detected tissue thickness” [0401-0402], progression bar 5480, fig. 92) is movable along the visual guide bar based on the anvil or knife moving relative to the end effector and prior to the firing drive firing the staples [0282-0286, 0401-0410], figs. 75-92 and 121-124).
Morgan et al. states: “as the DLU 5022 is manipulated around the surgical site, the DLU 5022 may move around the display 5002. In such embodiments, the feedback related to the DLU 5022, such as the jaw position and/or the articulation data, for example, can move along with the DLU 5022. Movement of the relevant feedback may ensure the feedback remains in the operator's field of vision [0403]…user may desire to observe the clamping force exerted on the tissue T along the length and/or width of the end effector jaws 5024” [0410].
SMITH et al. also teaches a stapler (1) that measures force on tissue (strain gauge, force measurements, force switch 400, optimal tissue compression (OTC) [0010, 0097, 0107-0114, 0132, 0137], a force/compression indicator (14 [0076, 0079]), the stapler configured to initiate a tissue compression countdown (countdown sequence) based on a force indicator moving within the acceptable zone (firing of staples only occurs within the OTC range [0137]), wherein the tissue compression countdown includes a timer (staple control assembly 200/microcontroller [0097, 0103-0114, 0135]) to allow the tissue captured between anvil and the end effector to relax (allowed to desiccate); display a firing readiness indicator (14/blinking fire button LED) based on a completion of the tissue compression countdown; allow the firing drive to fire the staples from the staple cartridge based on the completion of the tissue compression countdown; and prevent the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone (desired pressure range/OTC range [0113-0114, 0129-0135]).
SMITH et al. states: “staple firing countdown sequence because it is understood that the tissue needs to be compressed and allowed to desiccate before staple firing should occur. Thus, after the staple firing switch 22 is activated, the anvil 60 closes upon the interposed tissue and begins to compress the tissue. The staple firing sequence includes an optimal tissue compression (OTC) measurement and a feedback control mechanism that causes staples to be fired only when the compression is in a desired pressure range, referred to as the OTC range, and a sufficient time period has elapsed to allow fluid removal from the compressed tissue” [0130]
Given the teachings of HART et al. to have force indicator (progress bar) movable along the visual guide bar to a position that represents the determined force and a tissue compression countdown to determine proper force, 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 stapler to be configured to initiate a tissue compression countdown based on the force indicator moving within the acceptable zone, wherein the tissue compression countdown includes a timer to allow the tissue captured between anvil and the end effector to relax; display a firing readiness indicator based on a completion of the tissue compression countdown; allow the firing drive to fire the staples from the staple cartridge based on the completion of the tissue compression countdown; and prevent the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone and display a representation of the determined position and force on the display based on actuation of the rotary actuator and prior to the firing drive firing the staples to have precise adjustment of speed/torque for more precise operation on the tissue (avoid overshoot/damage or under clamping to the tissue) and/or for feedback purposes as taught by SMITH et al. and Morgan et al.
Regarding claims 17-20, 24-27, and 37, HART et al. discloses the housing comprises a rotary actuator (motor 152/motor controller 143) configured to move the trocar relative to the end effector ([0028-0033, 0044, 0057], claims 1 and 13), and wherein the rotary actuator comprises the sensor (plurality of sensors 408a ... 408n [0030-0031, 0050]), wherein the trocar comprises the sensor (strain gauge 408b [0036-0039]), wherein the housing comprises a handle (power handle 101), wherein the representation comprises a numerical representation (clamping force percentage and distance progress percentage, fig. 8).
Regarding claim 22, HART et al. discloses the bar defines a portion, and wherein the control circuit is further configured to: display a first portion based on the force indicator indicating that the determined force is within the unacceptable zone; and display the portion based on the force indicator indicating that the determined force is within the acceptable zone (three zones, zone 700a/b/c and high force caution graphic on 700c, target clamping force, pressure limit, fig. 8).
HART et al. fails to explicitly disclose the display with a first and a second color based on the force indicator being in the unacceptable zone and acceptable zone portions wherein the first bar defines a portion, and wherein the control circuit is further configured to: display a first color in the portion based on the first position indicator indicating that the determined position is within the first unacceptable zone; and display a second color in the portion based on the first position indicator indicating that the determined position is within the first acceptable zone.
SMITH et al. teaches having a display with different colors for indicating different zones to blink to convey information with different colors to indicate various states [0111].
Morgan et al. also teaches having an anvil display with indicators 10391-1039 having different colors for indicating different zones to convey information with different colors to indicate various states [0285-0286],figs. 121-124) and teaches having the handle with colored indicators 9190 for indicating errors ([0374], fig. 95).
Given the teachings of HART et al. to have the display bar define a portion, and wherein the control circuit is further configured to: display a first portion based on the force indicator indicating that the determined force is within the unacceptable zone; and display the portion based on the force indicator indicating that the determined force is within the acceptable zone, 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 display with having a first and a second color based on the force indicator being in the unacceptable zone and acceptable zone portions wherein the first bar defines a portion, and wherein the control circuit is further configured to: display a first color in the portion based on the first position indicator indicating that the determined position is within the first unacceptable zone; and display a second color in the portion based on the first position indicator indicating that the determined position is within the first acceptable zone to clear viewing of the different zones, easier identification, and/or for feedback purposes (different data displayed in different colors) as taught by SMITH et al. and Morgan et al.
Allowable Subject Matter
Claims 30-31 and 34 are allowed.
Claims 28-29 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.
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a surgical stapling device comprising all the structural and functional limitations and further comprising, amongst other limitations/features, an effector (anvil/cartridge jaw) with a staple cartridge, clamping tissue to apply a force on the tissue between the anvil and end effector, three sensors configured to sense the force, anvil attached, anvil position and a display; and a control circuit operably coupled to the sensor and the display, wherein the control circuit is configured to: interrogate the sensor to determine the force; display a representation of the determined force on the display to provide visual guide of acceptable and unacceptable force zones and the display is configurable a first state in which the display indicates that no anvil is coupled to the trocar; and a second state in which the display indicates that the anvil is coupled to the trocar; wherein the representation comprises transitioning the display to the second state. Though SMITH et al. (US 20100096431 A1) teaches a similar clamping member with a feedback system having visual display with a sensor and counter for correct tissue compression the feedback system does not prevent the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone one of ordinary skill would recognize that feedback mechanism that prevents the firing drive from firing the staples from the staple cartridge based on the force indicator being location within the unacceptable zone would require substantial modification to the control system. Having the efficiency and speed of the feedback to prevent errors during stapling provides an effective staple monitoring and error prevention.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-20, 22-31, 34, and 37 have been considered but are moot because the new ground of rejection does not rely on all new references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Additional prior art considered pertinent:
US 20210077112 A1 - control module (672) adjusts a minimum wait-time “t” before firing algorithm (2263 [0151])
US 20160374672 A1 – Force/Load indicator panel/display (7192) with force indicator needle/bar (7194, figs. 132-133), anvil position sensor (5532) with anvil gap display member ([0558, 0615-0617] display 5800/6708 figs. 113 and 130-131) and transmitter (5384) is configured to emit visible feedback to an operator indicating proper attachment of anvil (5350) to trocar (330/5350, [0527-0528], anvil attachment indicator (5830) [0558-0561 figs 85-87 and 113).
and see form 892.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
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