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 12/19/2025 has been entered. Claims 1, 4-9, 11, and 14-20 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) 1, 4-9, 11, and 14-20 is/are rejected under 35 U.S.C. 103 as obvious over ZEMLOK et al. (AU 2018202629 A1) in view of Shelton, IV et al. (US 20190314015 A1) in view of ZEMLOK et al. (US 20130168431 A1).
Regarding claims 1, 8, 11, 15, 18, and 20, ZEMLOK et al. discloses a computer-implemented method with a non-transitory computer-readable medium storing instructions which, when executed by a processor (microcontroller 405/500/600), cause the processor to perform a method for controlling a surgical stapling instrument (10/169), comprising: activating a motor (200) to cause rotation of a lead screw (firing rod 220 with threaded portion 226, which extends through an internally-threaded portion 212 of drive tube 210, [0092]) to cause advancing advancement of a pusher (213/drive beam 266/sled74/pushers 68) towards an anvil assembly (162) of the surgical stapling instrument from a first position to a second position ([0094-0101], figs. 7-8), the pusher configured to concurrently eject a plurality of staples (66) from a staple cartridge (164) of the surgical stapling instrument (10) toward corresponding staple forming surfaces of the anvil assembly (162) to define formed staples ([0095-0101], figs. 1, 9, 17, and 33-39);
determining that the pusher (213/drive beam 266/sled74/pushers 68) has stopped advancing towards the annular anvil assembly prior to reaching the second position (stall/malfunction [0137, 0224-0231]; based on determining that the pusher has stopped advancing towards the anvil assembly prior to reaching the second position: measuring a strain imparted on the lead screw to determine a force of staple compression (strain sensor 185, [0165, 0220], fig. 6); and comparing the force to thresholds to determine if firing should be enabled and based on the formed staples being not suitably formed: preventing a cutting mode from being entered (firing stroke stopped [0013]); and at least one of: exiting a firing mode of the surgical stapling instrument, or outputting an alert indicative of the formed staple not being suitably closed formed ([0013, 0137, 0170, 0212-0231], claims 6 and 18, figs. 1, 9, 17, and 33-39). ZEMLOK et al. also teaches having light sensor (914) and processor (918) and detection assembly (920) that monitors tissue attributes to predetermined accepted values before and/or during actuation of the knife (906) to preventing a cutting mode from being entered and provide alerts indicative of tissue attributes within the predetermined range of values “(e.g., a green light, a go ahead tone, a go icon, a go light pattern, an audible go pattern, etc.)” ([0207-0219], figs. 33-40).
ZEMLOK et al.’2629 fails to disclose the surgical stapling instrument (10) is a circular surgical stapling instrument with an annular staple cartridge and annular anvil assembly.
However, ZEMLOK et al. ’2629 teaches the stapler can have a circular surgical stapling instrument loading unit (169) with an annular staple cartridge and annular anvil assembly [0065], teaches to stop firing if staples encounter an obstruction [0228] and wait/pause during firing depending on feedback with “predictive style adaptive stapling algorithm that optimizes staple formation…minimizes the percentage of malformed staples.” [0231]. ZEMLOK et al. also teaches the controller configured to stop the motor “in response to the measured clamping force being greater than a first threshold clamping force” [0008-0010], pause if current is past a threshold, firing rod stalled/locked then a malfunction is occurring [0137] and controlling clamping force with strain gauges 187 and 189 [0224-0227].
ZEMLOK et al. ’2629 also fails comparing the force of staple compression of formed staples after ejection with a predetermined range of staple compression; determining that the formed staples are not suitably closed formed based on the force of staple compression being outside of the predetermined range of staple compression; and based on the formed staples being not suitably formed: preventing a cutting mode from being entered; and at least one of: exiting a firing mode of the surgical stapling instrument, or outputting an alert indicative of the formed staple not being suitably closed formed.
Shelton, IV et al. teaches a staple formation sensing system (1020 [0253]) for determining whether a staple is properly formed and “to determine if the staples are being malformed and/or underformed and adapt the operation of the surgical stapling instrument to improve the deformation of the staples into a desired shape” [0246], strain gauges can be mounted to the firing member [0265], and comparing the force of staple compression of formed staples after ejection with a predetermined range of staple compression (current exceeds a threshold, malformation of two consecutive staples, voltage outputs of Hall Effect sensors compared to a range of acceptable outputs/range, evaluate the firing force/strain exceeds a predetermined threshold); determining that the formed staples are not suitably closed formed based on the force of staple compression being outside of the predetermined range of staple compression (determines proper, malformed, partially malformed, fig. 12); and based on the formed staples being not suitably formed: preventing a cutting mode from being entered (firing stroke stopped [0245]); and at least one of: exiting a firing mode of the surgical stapling instrument, or outputting an alert indicative of the formed staple not being suitably closed formed (retracted to home position [0245], stop/prevented if there is something wrong with the surgical stapling system, display feedback [0288]). Shelton, IV et al. also teaches correct ranges of compression and determining whether a functionally closed staple formation has been achieved [0258-0259, 0265-0269, 0279-0281, 0289-0291, 0304-0310], claims 35-40).
Zemlok et al.’8431 teaches a similar surgical stapler (10) with a staple formation recognition system (30), staple trace system (170/210/250) to determine correct or incorrect formation of crimped legs with display screen (40) and having a controller (CPU 36) that stops advancement of a knife blade 110 [0062, 0101] if staple formation/knife progression fall outside a predetermined tolerance and “notify the clinician of an error state, signal the clinician to stop, or any combination thereof” [0101-0107].
Given the teachings of ZEMLOK et al.’2629 to have a strain gauge to measure strain measurements during clamping, having a pressure sensor to determine strain, circuits in the pockets to detect malformed staples and other sensors for measuring other operational parameters including firing current and anvil strain and having a circular effector, 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 surgical stapling instrument with having a circular surgical stapling instrument with an annular staple cartridge and annular anvil assembly and the processor and sensor system with comparing the force of staple compression of formed staples after ejection with a predetermined range of staple compression; determining that the formed staples are not suitably closed formed based on the force of staple compression being outside of the predetermined range of staple compression; and based on the formed staples being not suitably formed: preventing a cutting mode from being entered; and at least one of: exiting a firing mode of the surgical stapling instrument, or outputting an alert indicative of the formed staple not being suitably closed formed to have precise adjustment of clamping, prevent malformation of a staple, perform maintenance/repair, and/or for feedback purposes as taught by Shelton, IV et al. and Zemlok et al.’8431
Regarding claims 4-5, and 14, ZEMLOK et al.’2629 teaches the force of staple compression is measured based on a current of a motor configured to advance the pusher (213/drive beam 266/sled74/pushers 68), wherein the force of staple compression is greater than the predetermined range (current sensor 430, voltage sensor 428, and/or torque sensors 431 [0166, 0171, 0184, 0221-0223], figs. 1, 9, 17, and 33-39). ZEMLOK et al. also teaches using a strain gauge (strain sensor 185, fig. 6, jaw members may include strain gauges 187 and 189 fig. 17) to monitor forces on the jaws, motor, and/or firing rod [0011,0164-0168, 0185, 0222-0223], microcontroller 405/500/600, with a screen (122) for displaying feedback/alerts (monitor to optimize staple formation and prevent staple malformation by stopping [0074, 0227-0231], figs. 1-43) and preventing staple firing in response to the force of staple compression being greater than the predetermined range (locked, stalled, stop points, etc. identifier 442 reports malfunction/position, status, [0116, 0125, 0135-0138, 0143-0146, 0220-0221].
Regarding claims 6-7, 9, 16-17, and 19, ZEMLOK et al.’2629 teaches having a display/user interface (120) displaying a warning in response to the force of staple compression being greater than the predetermined range (microcontroller 405/500/600, with a screen (122) for displaying feedback/alerts (monitor to optimize staple formation and prevent staple malformation by stopping [0074, 0227-0231], figs. 1-43), wherein the displayed warning includes at least one of a warning to inspect a surgical site or to unclamp tissue and generating an audio warning in response to the force of staple compression being greater than the predetermined range ([0072-0082, 0115-0130, 0142-0170, 0207, 0218-0224], Table 1, figs. 1-40). Zemlok et al.’8431 teaches a similar surgical stapler (10) with a staple formation recognition system (30), staple trace system (170/210/250) to determine correct or incorrect formation of crimped legs with display screen (40) and having a controller (CPU 36) that stops advancement of a knife blade 110 [0062, 0101] if staple formation/knife progression fall outside a predetermined tolerance and “notify the clinician of an error state, signal the clinician to stop, or any combination thereof” [0101-0107]. Shelton, IV et al. also teaches having a display/user interface (75044) displaying a warning in response to the force of staple compression being greater than the predetermined range, wherein the displayed warning includes at least one of a warning to inspect a surgical site or to unclamp tissue and generating an audio warning in response to the force of staple compression being greater than the predetermined range ([0267-0270, 0288-0289, 0316], fig. 12) and Shelton, IV et al. also teaches correct ranges of compression and determining whether a functionally closed staple formation has been achieved [0258-0259, 0265-0269, 0279-0281, 0289-0291, 0304-0310], claims 35-40).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-9, 11, and 14-20 have been considered but are moot because the new ground of rejection does not rely on any/all 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 20180116667 A1 – sensor drive (400) with strain sensor 500 on circular stapler driver assembly 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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/ROBERT F LONG/Primary Examiner, Art Unit 3731