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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/06/2026 has been entered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 31, 39, and 41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al. (US 20080029576 A1).
Regarding claims 21 and 41, Shelton et al. discloses a method of operating a surgical stapler (10/1500, [0123], figs. 1-7 and 49-56) having a body (cylinder assembly 501/ first cylinder housing 510) that houses a linear channel (axial passage 516) and a slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547 or knife indicator 1780 for distal limit switch 1770), a shaft (distal spine segment 110/elongate channel 20), distal to the body (cylinder assembly 501/ first cylinder housing 510, figs. 1-11);
a motor (618 and/or 1730/1740, [0207-0208], figs. 1 and 49-56), a linear channel (23/54), a slider (E-beam firing mechanism 30 with slider 35/547), and
having a body (70/74, figs. 1-6) that houses a linear channel (knife channel in cartridge 74) and a slider (86/83), a shaft (distal tip of 74), distal to the body (figs. 6-10);
a electrical circuit (electrical switches and battery connected forming circuit, digital circuitry [0165-0169, 0219]) including a motor direction switch (546 or distal limit switch 1770), the method comprising:
(a) operating the motor in a first direction to fire a plurality of staples (staple cartridge 50 with staples 70) from the surgical stapler (10) and simultaneously drive the slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547) along the linear channel (axial passage 516) within the body (cylinder assembly 501/ first cylinder housing 510) from a proximal position to a distal-most position; and
(b) as a result of sliding the slider (35/547) along the linear channel, engaging the motor direction switch (546) with the slider at the distal-most position to thereby automatically reverse the motor into a second direction, the second direction being opposite from the first direction ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56). Shelton et al. also discloses distal limit switch (1770) on shaft (1754) inside the handle housing body (300/340, figs. 1, 7, and 49-56) which forms a channel there inside for inner shaft 1754 and a shaft (100) distal to the body the switch (1770) activated by a slider (knife indicator 1780) when the slider moves a distal most position on shaft 1754 ([0216-0217], figs. 49-56).
Regarding claim 31, Shelton et al. discloses a method of operating a surgical stapler (10/1500, [0123], figs. 1-7 and 49-56) having a motor (618 and/or 1730/1740, [0207-0208], figs. 1 and 49-56) a longitudinal moving member (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547 or knife indicator 1780 for distal limit switch 1770), and a circuit (electrical switches and battery connected forming circuit [0169]) including motor direction switch (546 or distal limit switch 1770), the method comprising:
(a) with a firing trigger (310) of the surgical stapler in a first trigger state applying a first electrical current through the motor direction switch in a first switch orientation and through the motor; the firing trigger being externally exposed for actuation by an operator between the first trigger state and a second trigger state (figs. 1-7, and 49-56);
(b) distally advancing the slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547 or knife indicator 1780 for distal limit switch 1770) towards the motor direction switch in the first switch orientation while the first electrical current remains applied to the motor; (c) firing a plurality of staples from the surgical stapler while the first electrical current remains applied to the motor;(d) after firing the staples, engaging the motor direction switch with the slider to thereby transition the motor direction switch from the first switch orientation to a second switch orientation ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56); and
(e) with the firing trigger in the second trigger state applying a second electrical current through the motor direction switch in the second switch orientation and through the motor, wherein the first trigger state and the second trigger state are different, wherein the first current and the second current are in opposite directions, and wherein the first switch orientation and the second switch orientation are different ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56). Shelton et al. also discloses distal limit switch (1770) on shaft (1754) inside the handle housing body (300/340, figs. 1, 7, and 49-56) which forms a channel there inside for inner shaft (1754) and a shaft (100) distal to the body the switch (1770) activated by a slider (knife indicator 1780) when the slider moves a distal most position on shaft 1754 ([0216-0217], figs. 49-56).
Regarding claim 39, Shelton et al. discloses a method of operating a surgical stapler surgical stapler (10/1500, [0123], fig. 1) having a motor (618 and/or 1730/1740, [0207-0208], figs. 1 and 49-56), a slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547 or knife indicator 1780 for distal limit switch 1770), and a circuit electrical switches and battery connected forming circuit [0169]) including motor direction switch (546 or distal limit switch 1770), the method comprising:
(a) in response to a trigger of the surgical stapler being in a first trigger state and the motor direction switch being in a first switch orientation, preventing the motor from energizing;(b) in response to the trigger transitioning from the first trigger state to a second trigger state with the motor direction switch in the first switch orientation, energizing the motor to operate in a first direction ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56); (c) advancing the slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547 or knife indicator 1780) towards the motor direction switch using the motor operating in the first direction ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56);
(d) engaging the motor direction switch (546 or distal limit switch 1770) with the slider to thereby transition the motor direction switch from the first switch orientation to a second switch orientation; and (e) in response to the trigger transitioning from the second trigger state to the first trigger state while the motor direction switch is in the second switch orientation, retracting the slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547 or knife indicator 1780 for distal limit switch 1770) away from the motor direction switch using the motor operating in a second direction, wherein the first trigger state and the second trigger state are different, and wherein the first switch orientation and the second switch orientation are different, wherein the trigger in the first trigger state, depending on the orientation of the motor direction switch, is configured to prevent the motor from energizing and to operate the motor in the second direction ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56).
Claim Rejections - 35 USC § 102/103
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.
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) 21 and 40-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hooven (US 5518164 A) or, in the alternative, under 35 U.S.C. 103 as obvious over Hooven (US 5518164 A) in view of Shelton et al. (US 20080029576 A1) in view of Viola et al. (US 20060278680 A1) and further in view of Roth et al. (US 20050256533 A1).
Regarding claims 21 and 41, Hooven discloses a method of operating a surgical stapler (30, figs. 1-3) having a body (70/74, figs. 1-6) that houses a linear channel (knife channel in cartridge 74) and a slider (86/83), a shaft (distal tip of 74), distal to the body (figs. 6-10);
a motor (45, col. 4, line 8-col. 5, line 13, figs. 1-5), and an electrical circuit (electrical switches and controller, col. 5, lines 50-col. 6, lines 1-53) including a motor direction switch (87, figs. 6-10), the method comprising:
(a) operating the motor in a first direction to fire a plurality of staples (staple cartridge 80 with staples 81) from the surgical stapler (30) and simultaneously drive the slider (86/83) along the linear channel (knife channel in cartridge 74) within the body (70/74, figs. 1-6) from a proximal position (diameter portion 72 adjacent the shaft 61) to a distal-most position (end of 71/end of smaller diameter portion 73); and
(b) as a result of sliding the slider (86/83) along the linear channel, engaging the motor direction switch (87) with the slider at the distal-most position (fig. 9) to thereby automatically reverse the motor into a second direction, the second direction being opposite from the first direction (col. 5, lines 14-col. 6, line 53, figs. 1-10)
Hooven states: “Another configuration would be to locate contacts in the handle portion of the instrument and use a follower nut on the rotating shaft to monitor position. It should be pointed out that it is desirable to locate as many as possible of the contacts and sensors in the handle portion of the instrument so that the head or business end can be maintained as small as possible…reversal of the motor may also be sensed as well as the movement of the stop member to open the anvil portion etc.” (col. 6, lines 1-53)
In the alternative, if it can be argued that Hooven fails to disclose having a circuit including a motor direction switch, the stapler does not drive the slider along the linear channel within the body from a proximal position to a distal-most position and there is not a shaft distal to the body wherein the circuit comprises an electrical circuit -
Viola et al. teaches a method of operating a surgical stapler (10) having a motor (66), a longitudinal moving member (74 or resistor strip 102 or magnetic member 112 figs. 11-12) in a linear channel (76), and a circuit (controller 28 [0049-0057, 0086-008]) including motor direction switch (80/82, [0077-0084], figs. 1-8 and/or resistor strip 102 and hall sensor 106 with magnetic member 112 [0089-0095], figs. 11-12), the method comprising:(a) operating the motor in a first direction to fire a plurality of staples (158) from the surgical stapler and simultaneously drive the slider from a proximal position to a distal-most position; and(b) engaging the motor direction switch with the slider at the distal-most position to thereby automatically reverse the motor into a second direction, the second direction being opposite from the first direction [0056-0084], figs. 1-8). Viola et al. also teaches using Hall sensor switches or resistor switches (resistor strip 102 and hall sensor 106 with magnetic member 112) to control the motor [0089-0095], figs. 11-12) and teaches having a slider (magnetic member 112 or 106 – teaches either on the piston drive) in the housing proximal to the shaft with a slider on a piston (“magnetic member 112 may be disposed on a suitable drive piston instead of the drive screw 66” [0094]) that slides in a channel of the handle housing ([0076, 0094], fig. 12) wherein the circuit comprises an electrical circuit [0049-0057, 0086-0091] and a digital display 62 [0072-0074].
Shelton et al. also teaches a method of operating a surgical stapler (10/1500, [0123], fig. 1) having a body (cylinder assembly 501/ first cylinder housing 510) that houses a linear channel (axial passage 516) and a slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547), a shaft (distal spine segment 110/elongate channel 20), distal to the body (cylinder assembly 501/ first cylinder housing 510, figs. 1-11);
a motor (618 and/or 1730/1740, [0207-0208], figs. 1 and 49-56), a linear channel (23/54), a slider (E-beam firing mechanism 30 with slider 35/547), and
having a body (70/74, figs. 1-6) that houses a linear channel (knife channel in cartridge 74) and a slider (86/83), a shaft (distal tip of 74), distal to the body (figs. 6-10);
a electrical circuit (electrical switches and battery connected forming circuit, digital circuitry [0165-0169, 0219]) including a motor direction switch (546), the method comprising:
(a) operating the motor in a first direction to fire a plurality of staples (staple cartridge 50 with staples 70) from the surgical stapler (10) and simultaneously drive the slider (second cylinder housing 520 and/or E-beam firing mechanism 30 with slider 35/547) along the linear channel (axial passage 516) within the body (cylinder assembly 501/ first cylinder housing 510) from a proximal position to a distal-most position; and
(b) as a result of sliding the slider (35/547) along the linear channel, engaging the motor direction switch (546) with the slider at the distal-most position to thereby automatically reverse the motor into a second direction, the second direction being opposite from the first direction ([0156-0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56). Shelton et al. also discloses distal limit switch (1770) on shaft (1754) inside the handle housing body (300/340, figs. 1, 7, and 49-56) which forms a channel there inside for inner shaft 1754 and a shaft (100) distal to the body the switch (1770) activated by a slider (knife indicator 1780) when the slider moves a distal most position on shaft 1754 ([0216-0217], figs. 49-56).
Further/Alternatively, Roth teaches having a shaft (atraumatic tip 562) distal to a cartridge body to prevents injury to tissue [0157-0158], figs. 28-31) and also teaches stapler (600) with adding a nose cone (632) at end of frame 602 or the anvil portion 610 [0162], fig. 32) and teaches attaching a shaft (411) to both of a cartridge and anvil “incorporate a tapered end 411 positioned at a distal end of either cartridge 392, anvil 394, or both ([0139], figs. 20-22).
Given the teachings of Hooven to have a slider to activate a reverse/retract switch and electronics/electrical switches working in conjunction with a slider switch, 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 electronics with having a electrical circuit including a motor direction switch and the slider moving along the linear channel within the body from a proximal position to a distal-most position (slider/switch assembly in handle portion) to the body to have precise adjustment of speed/torque of the firing member, more compact design, smaller effector with slider in the body/handle portion, for more precise operation/better control of the stapler and/or circuitry for feedback purposes as taught by Viola et al. and Shelton et al. and/or to have a shaft distal to the cartridge body having the linear channel (rather than move slider/switch assembly into the handle body) for better entry, preventing tissue injury as further taught by Roth.
Regarding claim 40, Hooven fails to teach maintaining the slider/longitudinal moving member in a fixed position relative to the motor while the motor is operating in the first direction or the second direction.
Viola et al. also teaches retracting the slider/longitudinal moving member (74 or strip 102 or magnetic member 112 figs. 11-12) to the proximal position, a rack (100 [0059-0061]), the method further comprising:(a) moving the rack relative to the motor; and(b) sliding the slider (resistor strip 102 or magnetic member 112) along the rack (plunger 100 with resistor strip 102 or magnet 112 moves along rack 74) and maintaining the slider/longitudinal moving member (74 or strip 102 or magnetic member 112 figs. 11-12) in a fixed position relative to the motor while the motor is operating in the first direction or the second direction (figs. 11-12).
Given the teachings of Hooven to have a slider to activate a reverse/retract switch and electronics/electrical switches working in conjunction with a slider switch, 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 electronic control with maintaining the slider/longitudinal moving member in a fixed position relative to the motor while the motor is operating in the first direction or the second direction to have precise adjustment of speed/torque of the firing member, more precise operation/better control of the stapler and/or for feedback purposes as taught by Viola et al.
Claim(s) 22-23, 29, 32, 38, and 40-41 is/are rejected under 35 U.S.C. 103 as obvious over Shelton et al. (US 20080029576 A1) in view of Viola et al. (US 20060278680 A1) and further in view of Smith et al. (US 20070270884 A1).
Regarding claims 22-23, 29, 32, 38, and 40-41, Shelton et al. discloses retracting the slider (35/547) to the proximal position with motor direction switch (546) wherein reversing the motor into the second direction includes transitioning the switch ([0156, 0169, 0175, 0180, 0207-0208], figs. 1-15 and 49-56). Shelton et al. also teaches distal limit switch (1770) on shaft (1754) inside the handle housing body (300/340, figs. 1, 7, and 49-56) which forms a channel there inside for inner shaft 1754 and a shaft (100) distal to the body the switch (1770) activated by a slider (knife indicator 1780) when the slider moves a distal most position on shaft 1754 ([0216-0217], figs. 49-56).
Shelton et al./modified Shelton et al. fails to disclose, having a rack, the method further comprising:(a) moving the rack relative to the motor; and(b) sliding the slider and the motor direction switch includes a single pole double throw switch, wherein reversing the motor into the second direction includes transitioning the single pole double throw switch from a first pole to a second pole, and maintaining the slider/longitudinal moving member in a fixed position relative to the motor while the motor is operating in the first direction or the second direction wherein the circuit comprises an electrical circuit.
Viola et al. also teaches retracting the slider/longitudinal moving member (74 or strip 102 or magnetic member 112 figs. 11-12) to the proximal position, a rack (100 [0059-0061]), the method further comprising:(a) moving the rack relative to the motor; and(b) sliding the slider (resistor strip 102 or magnetic member 112) along the rack (plunger 100 with resistor strip 102 or magnet 112 moves along rack 74) and maintaining the slider/longitudinal moving member (74 or strip 102 or magnetic member 112 figs. 11-12) in a fixed position relative to the motor while the motor is operating in the first direction or the second direction.
Smith et al. teaches a circuit that comprises an electrical circuit (circuit board 500, processor/microprocessor [0063-0068, 0088-0092, 0096-0106, 0123, 0128-0130, 0151-0153, 0175-0177, 0185-0191], figs. 12 and 34-35) a drive system with limit switches (610, 616, 618, 620 to control the drive system and ranges of travel of each motor 120, 210, [0092-0100]), a rack (217 [0166-0187], figs. 31-34) and moving the rack relative to the motor; and also teaches having single pole double throw switches (1200/1300) to have the motor drive in reverse at the end of firing stroke [0185-0191] and maintaining a slider/longitudinal moving member (encoder 268/threaded rod 266 extend longitudinally from the motor 265 [0248] and/or proportional to the movement of the knife 32 [0288]) in a fixed position relative to the motor while the motor is operating in the first direction or the second direction [0244-0248, 0288], figs. 37-
Smith et al. states: “Placement of an appropriate sensor or switch to indicate the forward-most desired position of the blade 1060 or the sled 102 can be used to control a forward travel limit switch 1220 that interrupts power supply to the motor M and prevents further forward travel [0185]… Placement of an appropriate sensor or switch to indicate the rearward-most desired position of the blade 1060 or the sled 102 can be used to control a rearward travel limit switch 1230 that interrupts power supply to the motor M and prevents further rearward travel [0186]… When this limit is reached, the forward limit switch 1320 is actuated and the switch moves to the second position. In this state, no power can get to the motor for forward movement but power can be delivered to the motor for reverse movement [0190].
Given the teachings of Shelton et al. to have electronics/electrical switches with battery and a longitudinal moving member type slider switch and a firing driver, 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 electronics and the firing driver to a rack, the method further comprising:(a) moving the rack relative to the motor; and(b) sliding the slider and the motor direction switch includes a single pole double throw switch, wherein reversing the motor into the second direction includes transitioning the single pole double throw switch from a first pole to a second pole and circuit comprises an electrical circuit/processor/microprocessor to have precise adjustment of speed/torque of the firing member (rack provides greater adjustment), for more precise operation of the stapler, provide better control, improved computing power, safety and/or for feedback purposes as taught by Viola et al. and Smith et al.
Allowable Subject Matter
Claims 24-28 and 33-37 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.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
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, a surgical stapler having a motor that drive member (rack/slider/firing shaft) in a first direction to drive staples and engaging a motor switch (reverse/retract/return/change direction) with a protrusion/slider/engaging member on the drive member (rack/slider/firing shaft) to reverse the motor in a second direction to return the firing member to a home position a rack, moving the rack relative to the motor; and sliding the slider along the rack wherein the rack includes a channel, wherein sliding the slider along the rack includes sliding the slider within the channel such that the slider moves relative to the rack. Though Viola et al. (US 20060278680 A1) teaches a surgical stapler having a motor that drive member (rack/slider/firing shaft) in a first direction to drive staples and engaging a motor switch (reverse/retract/return/change direction) with a protrusion/slider/engaging member on the drive member (rack/slider/firing shaft) to reverse the motor in a second direction to return the firing member to a home position with a rack, and moving the rack relative to the motor; and(b) sliding the slider along the rack, Viola et al. fails to teach moving the rack relative to the motor; and sliding the slider along the rack wherein the rack includes a channel, wherein sliding the slider along the rack includes sliding the slider within the channel such that the slider moves relative to the rack. Having the efficiency and speed of the rack with slider provides and effective automated switching means with a single switch to have the stapler return the rack/firing member to the proximal ready position and safely ensure the firing member is properly returned after use.
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) 21-29 and 31-40 have been considered but are moot because the new ground of rejection does not rely on all references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: See references cited, form 892.
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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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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/ROBERT F LONG/Primary Examiner, Art Unit 3731