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 12/16/2025 has been entered. Claims 20, 22-31, 33-39 are pending in the application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20, 22-31 and 33-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-15 of U.S. Patent No. US 12161341 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a surgical stapling device having a staple magazine/reload, anvil, transmission assembly movable by a motor; the anvil assembly movable relative to the reload; a strain sensor configured to monitor operation of the transmission assembly and output sensor data; and a controller comprising a processor and a memory and configured to: operate the motor to advance the transmission assembly to eject the plurality of staples for stapling the tissue; stop the motor for a preset hold period of time after the plurality of staples are ejected; determine an imparted force on the transmission assembly based on the sensor data; compare, during the preset hold period of time, the imparted force on the transmission assembly with a threshold; and determine that the stapled tissue is coming apart when the imparted force exceeds the threshold during the preset hold period.
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) 20, 22-31 and 33-39 is/are rejected under 35 U.S.C. 103 as obvious over WILLIAMS et al. (WO 2020014056 A1) in view of MODZIERZ et al. (EP 3412225 A1) and further in view of Shelton, IV et al. (US 20220104820 A1).
Regarding claims 1, 24, and 30-31, WILLIAMS et al. discloses a surgical device (200, figs. 1 and 12-98), comprising: a power source (144); a motor (152) coupled to the power source ([00349], fig. 89); an effector (anvil 510/reload 400), an annular reload (400, [00189, 00349], figs. 1 and 12-98) including a plurality of staples (S, [00237, 00320-00324], figs. 66-67) 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]);
an anvil assembly (510) movable relative to the reload; and configured to clamp tissue therebetween ([0221-0226], figs. 71-75 and 90-92);
a sensor (strain gauge 320) configured to output sensor data indicative of a sensed force on the transmission assembly ([00351-00352], figs. 29-33 and 51-56); and
a controller (142/147) comprising a processor and a memory (141, Chip 464c [00328], fig. 89) and configured to: operate the motor to advance the transmission assembly to eject the plurality of staples for stapling the tissue [00256, 00324, 00358];
stop the motor for a preset hold period of time after the plurality of staples are ejected ([00256, 00350-00385, 00390-00391], figs. 82-83); determine an imparted force on the transmission assembly based on the sensor data; compare, during the preset hold period of time ([00354-00366, 00372-00384, 00391], figs. 82-83), the imparted force on the transmission assembly with a threshold [00355-00358, 00370-00377, 00385]; and determine that the stapled tissue is coming apart when the imparted force exceeds the threshold during the preset hold period (monitor forces for force limits, strain on the driver, and formation of staples for “different indications of tissue” [00256, 00363-00366, 00372-00384, figs. 82-85). WILLIAMS et al. also teaches overriding a motor stop when detecting force exceeds maximum [00381] and;
determine the rate of change in the measured values (CTC progress, travel distance over time, monitor a relaxation of tissue, samples a plurality of strain gauge values over period of time [0256-0258, 0350, 0358-0373, 0383 figs. 83-85].
WILLIAMS et al. states: “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].
WILLIAMS et al. fails to explicitly disclose to determine during the preset hold period of time, rate of change of the imparted force, to determine whether the stapled tissue is coming apart when the rate of change of the imparted force is nonzero such that the imparted force is not stable, based on the force measure during the preset hold period of time.
MODZIERZ et al. teaches a surgical device/powered stapler (100/200, [0086], fig. 1) comprising: a power source (144 [0113], figs. 12-13, 17, and 89); a motor (152/154) coupled to the power source; a reload (400) including a plurality of staples [0280]; a transmission assembly (250/255) including a stapler driver (434) movable by the motor [0123, 0178]; a sensor (strain gauge 320) configured to monitor operation of the transmission assembly and output sensor data [0280-0283]; a controller (143/147) configured to: determine a position of the transmission assembly [0253, 0280-0289]; and operate the motor based on the position of the transmission assembly [0253-0255 and 0280-0289] to advance the transmission assembly to eject the plurality of staples from the reload ([0280-285], figs. 84-85); and stop the motor once the plurality of staples are ejected from the reload for a preset period of time (“period of time” overly broad and when motor changes direction to retract driver 434 this would be a stop for a period of time, [0283-0285]) and activating the motor (152/154) coupled to the transmission assembly (250/255); advancing the transmission assembly (250/255) including the stapler driver (434) configured to engage the reload; ejecting a plurality of staples from the reload by the stapler driver [0280-285]; and stopping the motor after the plurality of staples are ejected from the reload for a preset hold period of time (motor changes direction to retract driver 434 this would be a stop/hold period of time and stops if force above threshold to indicate staples formation in error and user can continue ignoring force limit with control button, [0278, 0283-0285]) and;
determine force based on the sensor data imparted on the transmission assembly during the preset hold period of time; and determine whether the plurality of staples is properly formed during the preset hold period of time based on the force (stops if force above threshold to indicate staples formation in error and user can continue ignoring force limit with control button and displays staple formation process with indicating proper [0077, 0153, 0263-0267, 0274, 0281-0289]) and MODZIERZ et al. teaches the controller is further configured to determine whether the plurality of staples is properly formed during the preset period of time and the controller is configured to determine that the plurality of staples are ejected from the reload based on at least one of the position of the position of the transmission assembly and based on the force and whether the stapled tissue is coming apart/cut based on the force measure during the preset hold period of time [0280-285].
MODZIERZ et al. states: “controller is configured to stop the motor in response to the measured strain exceeding the maximum stapling force [0077] … monitors forces during a firing and formation of the staples as the staples are being ejected from reload 400” [0153] … “after the stapling sequence is complete…force imparted on the third rotation transmitting assembly 260 is monitored by the strain gauge assembly 320. The process is deemed complete once the third rotation transmitting assembly 260 reaches a hard stop corresponding to a force threshold and detected by the strain gauge assembly 320” [0282].
Shelton, IV et al. teaches a similar movable indicator needle, determine force/load on the effector, tissue compression force F [0245-0247, 0308-0310], staple height operating range 210160 display (figs. 23 and 59-60), a timer (wait time) to clamp the tissue and to prevent a firing drive from firing the staples from the staple cartridge based on a force indicator being location within a unacceptable zone (firing lockout, increase the wait time, and/or warning, [0293-0314], fig. 64), wherein the control circuit is further configured to: display a first color in the portion based on the indicator indicating that the determined force is within the unacceptable zone; and display a second color in the portion based on the indicator indicating that the determined force is within the acceptable zone (yellow and green zone [0408, 0448-0454) and teaches having a sensor (torque sensor 744/ position sensor 784) configured to sense attachment of the anvil with the trocar (verification zone, process 201720 verifies 201130 and/or RFID scanner [0044, 0245-0247, 0264, 0322-0333, 04222], fig. 34) and determine force and determine if there is an error/problem with tissue, tissue creep, tissue stabilized, acceptable staple height to controls a wait period [0314-0317, 0458, 0472-0473].
Given the teachings of WILLIAMS 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 determine during the preset hold period of time, rate of change of the imparted force, to determine whether the stapled tissue is coming apart when the rate of change of the imparted force is nonzero such that the imparted force is not stable, based on the force measure during the preset hold period of time to have precise speed/torque for compressing the tissue correctly, not overload/stress the tissue, monitor stapling progress for correct completion, and/or for feedback monitoring purposes as taught by MODZIERZ et al. and Shelton, IV et al.
Regarding claims 22-23 and 33-34, WILLIAMS et al. teaches threshold comprises a maximum rate of increase, and wherein the controller is further configured to determine a rate of increase of the imparted force exceeds the maximum rate of increase, wherein the maximum rate of increase is zero (protect against exceeding a predetermined maximum firing force, [00256, 00350-0353, 00370-00371, 00380-00382, 00392]) wherein the preset hold period of time is between 1-10 seconds (every 1 millisecond [00369] and verify proper time to verify if anvil detachment has occurred [00400]).
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]
WILLIAMS et al. fails to explicitly disclose the controller is further configured to determine that the stapled tissue is coming apart when the rate of increase of the imparted force exceeds the maximum rate of increase wherein, during the preset hold period of time, imparted force on the transmission assembly increases when the stapled tissue is coming apart.
MODZIERZ et al. teaches determine force based on the sensor data imparted on the transmission assembly during the preset hold period of time and control the motor speed (stops if force above threshold to indicate staples formation in error and user can continue ignoring force limit with control button and displays staple formation process with indicating proper [0077, 0153, 0263-0267, 0274, 0281-0289]) and the controller is further configured to determine whether the plurality of staples is properly formed during the preset period of time and the controller is configured to determine that the plurality of staples are ejected from the reload based on at least one of the position of the position of the transmission assembly and based on the force and whether the stapled tissue is coming apart/cut based on the force measure during the preset hold period of time [0280-285].
Shelton, IV et al. also teaches a circular stapler that determines force and determine if there is an error/problem with tissue, tissue creep, tissue stabilized, acceptable staple height to controls a wait period [0314-0317, 0458, 0472-0473].
Given the teachings of WILLIAMS 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 further be configured to determine that the stapled tissue is coming apart when the rate of increase of the imparted force exceeds the maximum rate of increase wherein during the preset hold period of time, imparted force on the transmission assembly increases when the stapled tissue is coming apart to have precise speed/torque for compressing the tissue correctly, monitor stapling progress for correct completion, and/or for feedback monitoring purposes as taught by MODZIERZ et al. and Shelton, IV et al.
Regarding claims 25-27 and 35-37, WILLIAMS et al. teaches 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 the controller is further configured to monitor the sensor data and determine the imparted force during advancement of the staple driver between the second position and the third position, and to compare the imparted force during advancement with a stapling force threshold [00377-00385]. MODZIERZ et al. also control the motor speed or changing speed of motor to eject the staples and stopping if threshold met (stops if force above threshold to indicate staples formation in error and user can continue ignoring force limit with control button and displays staple formation process with indicating proper [0077, 0153, 0263-0267, 0274, 0281-0289]) and the controller is further configured to determine whether the plurality of staples is properly formed during the preset period of time and the controller is configured to determine that the plurality of staples are ejected from the reload based on at least one of the position of the position of the transmission assembly and based on the force and whether the stapled tissue is coming apart/cut based on the force measure during the preset hold period of time [0280-285]. Shelton, IV et al. also teaches a circular stapler (surgical instrument 215000 [0464], fig. 82) having a strain gage (215910) to determine of tissue is being over-stressed/coming apart and stopping the motor or changing speed of motor to eject the staples ([0475], figs. 82-89).
Regarding claims 28-29 and 38-39, WILLIAMS et al. teaches the controller is further configured to stop the motor when the imparted force exceeds the stapling force threshold during advancement and when the imparted force does not exceed the threshold during the preset hold period (protect against exceeding a predetermined maximum firing force [00256, 00350-0353, 00370-00371, 00380-00382, 00392]).
WILLIAMS et al. fails to explicitly disclose the controller is further configured to stop the motor when the imparted force exceeds the stapling force threshold during advancement and wherein the controller is further configured to determine that the stapled tissue is not coming apart when the imparted force does not exceed the threshold during the preset hold period.
MODZIERZ et al. teaches the controller is further configured to stop the motor when the imparted force exceeds the stapling force threshold during advancement and wherein the controller is further configured to determine that the stapled tissue is not coming apart when the imparted force does not exceed the threshold during the preset hold period [0077, 0153, 0263-0267, 0274, 0281-0289]) and whether the stapled tissue is coming is cut based on the force measure during the preset hold period of time [0280-285].
Shelton, IV et al. also teaches a circular stapler that determines force and determine if there is an error/problem with tissue, tissue creep, tissue stabilized, acceptable staple height to controls a wait period [0314-0317, 0458, 0472-0473].
Given the teachings of WILLIAMS 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 further be configured to stop the motor when the imparted force exceeds the stapling force threshold during advancement and wherein the controller is further configured to determine that the stapled tissue is not coming apart when the imparted force does not exceed the threshold during the preset hold period to have precise speed/torque for compressing the tissue correctly, monitor stapling progress for correct completion, and/or for feedback monitoring purposes as taught by MODZIERZ et al. and Shelton, IV et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20, 22-31, 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. Also, a Terminal Disclaimer for U.S. Patent No. US 12161341 B2 has not been filed.
Conclusion
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.
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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/ROBERT F LONG/Primary Examiner, Art Unit 3731