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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/15/2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 05/15/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12161341 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 102/103
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 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.
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) 20, 22-24, 30-31, and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eschbach et al. (US 20190388091 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Eschbach et al. (US 20190388091 A1) in view of Shelton, IV et al. (US 20190201018 A1).
Regarding claims 20, 22, 24, 30-31, and 33, Eschbach et al. discloses a surgical device (10), comprising: a power source (122/120); a motor (motors 128) coupled to the power source; a reload (340) comprising a plurality of staples ([0042, 0055-0056], figs. 1 and 4); a transmission assembly (motor shafts 129a, 129b, 129c, ring gear and gears [0042-0046]) movable by the motor and having a stapler driver (I-beam 317);
an anvil assembly (330) movable relative to the reload and configured to clamp tissue therebetween;
a sensor/strain gauge (strain gauge 450/550, 240, sensors [0049-0051, 0063]) configured to output sensor data indicative of a force measurement [0383-0393, 0404]; and a controller (microcontroller 350/flex circuit 400/500 [0063-0070]) comprising a processor and a memory (memory chip 354 [0009, 0060-0066], figs. 2-6) and configured to:
operate the motor to advance the transmission assembly to eject the plurality of staples for stapling the tissue; after ejecting the plurality of staples, stop the motor for a preset hold period of time to hold the stapled tissue in a compressed state (controls the wait time);during the preset hold period of time, monitor force measurements from the sensor indicative of imparted force on the transmission assembly (processes the sensor data from strain gauge 450, 550, intermittently monitor); and determine that the stapled tissue is coming apart when the force measurements are not stable while holding the stapled tissue in the compressed state during the preset hold period, wherein, during the preset hold period of time, the force measurements increase when the stapled tissue is coming apart and monitor force measurements from the sensor indicative of imparted force on the transmission assembly while the stapled tissue is held in the compressed state; compare a rate of change of the force measurements with a threshold maximum rate of change; and determine that the stapled tissue is coming apart when the rate of change of the force measurements exceeds the threshold maximum rate of change such that the force measurements are not stable during the preset hold period while holding the stapled tissue in the compressed state, wherein, during the preset hold period of time, the force measurements increase when the stapled tissue is coming apart (excess stress determined, waits till stress on the target tissue is at a value within an acceptable range of value [0068, 0073-0074].
In the alternative, if it can be argued that Eschbach et al. fails to disclose the controller is configured determine that the stapled tissue is coming apart when the force measurements are not stable while holding the stapled tissue in the compressed state during the preset hold period wherein, during the preset hold period of time, the force measurements increase when the stapled tissue is coming apart –
Shelton, IV et al. discloses a surgical device (150010, figs. 8-19, 25-28, 31-38, 44-45, 53, 60-82), comprising: a power source (628/150092/150098); a motor (604/150082) coupled to the power source; a reload (150304/152006) comprising a plurality of staples ([0406, 0470], figs. 16-19 and 53); a transmission assembly (150084/150086, fig. 26) movable by the motor and having a stapler driver (150120);
an anvil assembly (150306/152002) movable relative to the reload and configured to clamp tissue therebetween;
a sensor (152008a/b [0420-0450, 0460-0479], figs. 8-19, 29, and 53) configured to output sensor data indicative of a force measurement [0383-0393, 0404]; and a controller (150716/150717) comprising a processor (462/150717) and a memory (468/624/150721, [0300, 0321-0323, 0419-0432] and configured to:
operate the motor to advance the transmission assembly to eject the plurality of staples for stapling the tissue;after ejecting the plurality of staples, stop the motor for a preset hold period of time to hold the stapled tissue in a compressed state;during the preset hold period of time, monitor force measurements from the sensor indicative of imparted force on the transmission assembly; and determine that the stapled tissue is coming apart when the force measurements are not stable while holding the stapled tissue in the compressed state during the preset hold period wherein, during the preset hold period of time, the force measurements increase (too much force) when the stapled tissue is coming apart ( [0592, 0686, 0694, 0704].
Given the teachings of Eschbach et al. to have a controller stop a motor based on sensed conditions including finishing a staple stroke, measure strain during stapling, and monitor force while formation of staples are ejected, 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 controller to disclose the controller is configured determine that the stapled tissue is coming apart when the force measurements are not stable while holding the stapled tissue in the compressed state during the preset hold period wherein, during the preset hold period of time, the force measurements increase when the stapled tissue is coming apart to have precise speed/torque for compressing the tissue correctly, not overload/stress the tissue, monitor stapling progress for correct staple formation, and/or for feedback monitoring purposes as taught by Shelton, IV et al.
Regarding claims 23 and 34, Eschbach et al. fails to teach the preset hold period of time is between 1-10 seconds.
Shelton, IV et al. teaches clamping for a preset hold period of time is between 1-10 seconds (10-20 seconds during, 3-5 seconds after firing, force plots 153606, 153608 [0450, 0457, 0532-0533, 0588], fig. 83).
Given the teachings of Eschbach et al. to have a controller stop a motor based on sensed conditions including finishing a staple stroke, measure strain during stapling, and monitor force while formation of staples are ejected, 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 controller have the preset hold period of time is between 1-10 seconds to have precise speed/torque for compressing the tissue correctly, obtain optimum blood flow during tissue compression, monitor stapling progress for correct staple formation, and/or for feedback monitoring purposes as taught by Shelton, IV et al.
Claim(s) 25-29, 31, and 35-39, is/are rejected under 35 U.S.C. 103 as obvious over Eschbach et al. (US 20190388091 A1) in view of Shelton, IV et al. (US 20190201018 A1) and further in view of WILLIAMS et al. (WO 2020014056 A1).
Regarding claims 25-29, 31, and 35-39, Eschbach et al. teaches during advancement, the controller is further configured to stop the motor when a force measurement exceeds the stapling force threshold [0007, 0074], wherein the controller is further configured to determine that the stapled tissue is not coming apart when the force measurements/rate of change of the force measurements do not increase/exceed the threshold maximum rate during the maximum rate of change/preset hold period (acceptable range, excess stress determined, waits till stress on the target tissue is at a value within an acceptable range of value [0068, 0073-0074].
Eschbach et al. fails to teach the controller is further configured to operate the motor to advance the staple driver at a first speed from an initial stopped position to a second position, wherein the staple driver makes initial contact with the plurality of staples at the second position, wherein the controller is further configured to operate the motor to advance the staple driver at a second speed, slower than the first speed, from the second position to a third position where the plurality of staples are ejected from the reload, wherein, during advancement of the staple driver between the second position and the third position, the controller is further configured to and to compare the imparted force during advancement force measurements with a stapling force threshold.
Shelton, IV et al. also teaches during advancement, the controller is further configured to stop the motor when a force measurement exceeds the stapling force, force on the instrument/anvil, and articulation thresholds [0378-0383, 0533, 0584-0595, 0812].
WILLIAMS et al. teaches a surgical device (200, figs. 1 and 12-98) with an annular reload (400, [00189, 00349], figs. 1 and 12-98), including a plurality of staples (S, [00237, 00320-00324], figs. 66-67) and the end effector comprises an anvil assembly (figs. 1 and 12-98) for clamping a circular portion of tissue, a transmission assembly (transmitting/converting assembly 240, 250, 260 and 432/434, axially moveable drive shafts, [00221, 00245, 00350, 00363, 00377], figs. 25-26) movable by the motor (fig. 71 and 89); and having a stapler driver (430 [0237]); with a controller (142/147) comprising a processor and a memory (141, Chip 464c [00328], fig. 89) configured to operate the motor to advance the staple driver at a first speed from an initial stopped position to a second position, wherein the staple driver makes initial contact with the plurality of staples at the second position, wherein the controller is further configured to operate the motor to advance the staple driver at a second speed, slower than the first speed, from the second position to a third position where the plurality of staples are ejected from the reload, wherein, during advancement of the staple driver between the second position and the third position, the controller is further configured to and to compare the imparted force during advancement force measurements with a stapling force threshold wherein, during advancement, the controller is further configured to stop the motor when a force measurement exceeds the stapling force threshold wherein the controller is further configured to determine that the stapled tissue is not coming apart when the force measurements do not increase during the preset hold period [00377-00385].
WILLIAMS et al. states: ““main controller 147 may measure time and process the above-described values as a function of time, including integration and/or differentiation, e.g., to determine the rate of change in the measured values [0350] …distance marker 604 is not reached within a predetermined period of time, the main controller 147 then issues an error, including an alarm on the display screen 146 prompting the user to inspect the anvil assembly 510. After inspection and clearance of any obstruction, the user may then restart the clamping process” [0364].
Given the teachings of Eschbach et al. to have a controller stop a motor based on sensed conditions including finishing a staple stroke, measure strain during stapling, and monitor force while formation of staples are ejected, 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 controller is further configured to operate the motor to advance the staple driver at a first speed from an initial stopped position to a second position, wherein the staple driver makes initial contact with the plurality of staples at the second position, wherein the controller is further configured to operate the motor to advance the staple driver at a second speed, slower than the first speed, from the second position to a third position where the plurality of staples are ejected from the reload, wherein, during advancement of the staple driver between the second position and the third position, the controller is further configured to and to compare the imparted force during advancement force measurements with a stapling force threshold to have precise speed/torque for compressing the tissue correctly, obtain optimum blood flow during tissue compression, monitor stapling progress for correct staple formation, and/or for feedback monitoring purposes as taught by Shelton, IV et al. and WILLIAMS et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20, 22-31, and 33-39 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
Additional prior art considered pertinent: US 20170245854 A1 – “limits are reached… pause mode and/or pulse modulation… wait and hold time on the tissue as well as the starting firing speed, and throughout the firing, the surgical instrument has the ability to slow down the firing speed based on force feedback. By controlling the firing speed by the surgical instrument, the above described method optimizes the firing force on target tissue and minimizes the percentage of malformed staples” [0233] see 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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/ROBERT F LONG/Primary Examiner, Art Unit 3731
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