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 .
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement(s) (IDS), filed 23 April 2026, which have been placed of record in the file. An initialed, signed, and dated copy of each PTO-1449 or PTO-SB-08 form is attached to the Office action.
Response to Preliminary Amendment
Receipt is acknowledged of a preliminary amendment, filed 15 April 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 21-40 are pending.
Claims 21-40 are new.
Claims 1-20 are canceled.
Specification and Drawings:
Amendments to the specification have been submitted in the amendment filed 15 April 2026.
Amendments to the drawings have been submitted in the amendment filed 15 April 2026.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The title “Staple Cartridge Comprising a Seating Cam” is not descriptive of the current claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 recites the limitation "the opposing end" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation “the opposing end” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 38-39 depend from claim 37, and are likewise indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 21-26, 28-31, and 36-40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wellman (US Patent Publ. No. 2022/0346790).
With respect to claim 21, Wellman discloses an apparatus, comprising: (a) a first jaw extending longitudinally along a first jaw axis (jaw 111, fig. 1A); (b) a second jaw extending longitudinally along a second jaw axis (jaw 112), the second jaw being selectively actuatable relative to the first jaw to clamp tissue (jaw 112 is movable from the position of fig. 1A to the position of fig. 5); (c) a plurality of surgical fasteners supported by one of the first jaw or the second jaw (staples 124, fig. 1C); (d) a firing driver actuatable through a firing stroke to deploy the surgical fasteners into the clamped tissue (firing driver 190, fig. 4A); (e) a motor (operated by a motor, [0090]); and (f) a controller operable to activate the motor (motor is operated by a control device, [0090]) to: (i) before initiation of the firing stroke, approximate the second jaw toward the first jaw from an open position to a first clamped position in which the first and second jaw axes are substantially parallel (the position of the jaws when the jaws are closed onto the tissue), and (ii) before completion of the firing stroke, further approximate the second jaw toward the first jaw from the first clamped position to a second clamped position (the position of the jaws during movement of the sled and when the staples are driven into the tissue). Wellman disclose that “drive member 150 is advanced distally through end effector 110 to move jaws 111, 112 from the open position to the closed position, after which shuttle 123 and knife 128 are advanced distally through cartridge 122 to staple and cut tissue grasped between jaws 111, 112”, ([0086]) (emphasis added). The advancement of the shuttle and knife through the cartridge to staple and cut tissue is considered to be the firing stroke. Accordingly, the jaws are approximated before initiation of the firing stroke, and are further approximated during the firing stroke.
With respect to claim 22, Wellman discloses the controller is configured to approximate the second jaw toward the first jaw from the first clamped position to the second clamped position during the firing stroke (control device, [0090]). Wellman disclose that “drive member 150 is advanced distally through end effector 110 to move jaws 111, 112 from the open position to the closed position, after which shuttle 123 and knife 128 are advanced distally through cartridge 122 to staple and cut tissue grasped between jaws 111, 112”, ([0086]) (emphasis added). The advancement of the shuttle and knife through the cartridge to staple and cut tissue is considered to be the firing stroke. Accordingly, the jaws are the second jaw is approximated toward the first jaw from the first clamped position to the second clamped position during the firing stroke.
With respect to claim 23, Wellman discloses in the first clamped position the second jaw is spaced apart from the first jaw by a gap distance that is substantially uniform along a length of the first and second jaws (fig. 5).
With respect to claim 24, Wellman discloses that in the second clamped position the second jaw is spaced apart from the first jaw by a minimum gap distance less than the gap distance of the first clamped position (the jaws 111, 112 are approximated further during movement of the sled and upper and lower shoes 152, 154 to apply force and clamp tissue, and when the staples are driven into the tissue, [0092]).
With respect to claim 25, Wellman discloses the second jaw extends longitudinally between a hinged end and an opposed end (fig. 2), the firing driver being advanceable through the firing stroke in a longitudinal direction from the hinged end toward the opposed end (fig. 5).
With respect to claim 26, Wellman discloses in the first clamped position the opposing end of the second jaw is spaced apart from the first jaw by a first gap distance (the position of the jaws when the jaws are closed onto the tissue), wherein in the second clamped position the opposing end is spaced apart from the second jaw by a second gap distance less than the first gap distance (the position of the jaws during movement of the sled and when the staples are driven into the tissue).
With respect to claim 28, Wellman discloses the motor comprises a first motor, wherein the apparatus further comprises a second motor operable to actuate the firing driver through the firing stroke (the device includes a plurality of motors for actuating closing and stapling, [0079], [0080]).
With respect to claim 29, Wellman discloses the first and second motors are independently operable (powered surgical system includes robotic surgical systems that utilize drive cables connected to a system of motors and pulleys for various functions including opening and closing of jaws, as well as for movement and actuation of end effectors, [0080]).
With respect to claim 30, Wellman disclose the surgical fasteners comprise surgical staples (staples 124).
With respect to claim 31, Wellman discloses a method of operating a surgical instrument end effector having a first jaw (jaw 111, fig. 1A), a second jaw (jaw 112), and a firing driver (firing driver 190, fig. 4A), the method comprising: activating a motor to approximate the second jaw toward the first jaw from an open position to a first clamped position in which a gap distance defined between the first and second jaws is substantially uniform along a length of the first and second jaws (motor, [0090], the position of the jaws when the jaws are closed onto the tissue); actuating the firing driver through a firing stroke to deploy a plurality of surgical fasteners from one of the first jaw or the second jaw (shuttle 123 and knife 128 are advanced distally through cartridge 122 to staple and cut tissue grasped between jaws 111, 112”, [0086]); and during the firing stroke, activating the motor to further approximate the second jaw toward the first jaw from the first clamped position to a second clamped position in which a minimum gap distance defined between the first and second jaws is less than the gap distance of the first clamped position (the position of the jaws during movement of the sled and upper and lower shoes 152, 154 to apply force and clamp tissue, and when the staples are driven into the tissue, [0092]). Wellman disclose that “drive member 150 is advanced distally through end effector 110 to move jaws 111, 112 from the open position to the closed position, after which shuttle 123 and knife 128 are advanced distally through cartridge 122 to staple and cut tissue grasped between jaws 111, 112”, ([0086]) (emphasis added). The advancement of the shuttle and knife through the cartridge to staple and cut tissue is considered to be the firing stroke. Accordingly, the jaws are further approximated during the firing stroke.
With respect to claim 36, Wellman discloses the surgical instrument further includes a controller (control device, [0090]), wherein activating the motor to approximate the second jaw from the open position to the first clamped position and from the first clamped position to the second clamped position includes activating the motor with the controller (motor is operated by a control device, [0090]).
With respect to claim 37, Wellman discloses the second jaw extends longitudinally between a hinged end and an opposed end (jaw 112 and jaw 111 are hinged, fig. 2), the firing driver being advanceable through the firing stroke in a longitudinal direction from the hinged end toward the opposing end (firing driver 190 is advanceable, fig. 5).
With respect to claim 38, Wellman discloses that in the second clamped position the minimum gap distance is defined between the opposed end of the second jaw and the first jaw (when firing driver reaches the distalmost position, minimum gap distance is defined between opposed ends of the jaws, figs. 5, 6, 8).
With respect to claim 39, Wellman discloses that the hinged end comprises a proximal end and the opposed end comprises a distal end (proximal hinged end and distal opposed end, fig. 1).
With respect to claim 40, Wellman discloses actuating the firing driver through the firing stroke includes deploying the surgical fasteners successively along a length of the end effector (staples are deployed successively along the length of the end effector, figs. 1A, 5, 6).
Claim Rejections - 35 USC § 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.
Claims 21, and 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan et al. (US Patent Publ. No. 2016/0058441).
With respect to claim 21, Morgan et al. disclose an apparatus, comprising: (a) a first jaw extending longitudinally along a first jaw axis (bottom jaw 4002, fig. 78); (b) a second jaw extending longitudinally along a second jaw axis (upper jaw 4004), the second jaw being selectively actuatable relative to the first jaw to clamp tissue (the end effector is closed to clamp tissue, figs. 78-80, [0349]); (c) a plurality of surgical fasteners supported by one of the first jaw or the second jaw (staple cartridge 1112 seated in the lower jaw, fig. 3); (d) a firing driver actuatable through a firing stroke to deploy the surgical fasteners into the clamped tissue (drive rod 1076 and sled 1078, fig. 23); and (f) a controller (device’s handle that actuates actuator 4006, fig. 78, [0351]) operable to: (i) before initiation of the firing stroke, approximate the second jaw toward the first jaw from an open position to a first clamped position in which the first and second jaw axes are substantially parallel (jaw 4004 is moved from open position of fig. 78 to intermediate position of fig. 79), and (ii) before completion of the firing stroke, further approximate the second jaw toward the first jaw from the first clamped position to a second clamped position (jaw 4004 is moved from intermediate position of fig. 79 to closed position of fig. 80 in which the upper jaw proximal end is forced “in an upward direction, and the upper jaw distal end is forced “in a downward direction”, [0353]). Morgan et al. disclose that the jaws are moved from the intermediate position to the closed position before initiation of the firing stroke, and thus the jaws are moved from the intermediate position to the closed position before completion of the firing stroke. The claim does not require the second jaw is further approximated after initiation of the firing stroke.
In the embodiment of figs. 78-80, Morgan et al. fail to disclose a motor.
In the embodiment of figs. 96-98, Morgan et al. disclose an end effector closing mechanism that includes a motor ([0371]). Morgan et al. disclose that the closing mechanism may be controlled by a motor, a firing trigger, or manually by hand.
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 device of Morgan et al. to include a motor, as suggested by Morgan et al. in the embodiment of figures 96-98, as a mere matter of providing automatic or mechanical means to replace a manual activity, which is considered a routine expedient requiring only ordinary skill in the art. Providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. MPEP 2144.04 III. In this instance, a skilled artisan would have recognized that the addition of a motor from the embodiment of figs. 96-98 of Morgan et al. for the handle operated control of the embodiment of figs. 78-80 of Morgan et al. involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
With respect to claim 23, Morgan et al. disclose that in the first clamped position the second jaw is spaced apart from the first jaw by a gap distance that is substantially uniform along a length of the first and second jaws (intermediate position, fig. 79).
With respect to claim 24, Morgan et al. disclose that in the second clamped position the second jaw is spaced apart from the first jaw by a minimum gap distance less than the gap distance of the first clamped position (in the closed position of fig. 80 the upper jaw distal end is forced “in a downward direction” from the intermediate position, [0353]).
With respect to claim 25, Morgan et al. disclose the second jaw extends longitudinally between a hinged end and an opposed end (upper jaw 4004 is hinged to lower jaw 4002, fig. 78), the firing driver being advanceable through the firing stroke in a longitudinal direction from the hinged end toward the opposed end (drive rod 1076 and sled 1078 are advanceable in the distal and proximal direction to eject staples, [0295], [0296], figs. 21, 23).
With respect to claim 26, Morgan et al. disclose in the first clamped position the opposing end of the second jaw is spaced apart from the first jaw by a first gap distance (fig. 79), wherein in the second clamped position the opposing end is spaced apart from the second jaw by a second gap distance less than the first gap distance (in the closed position of fig. 80 the upper jaw distal end is forced “in a downward direction” from the intermediate position, [0353]).
With respect to claim 27, Morgan et al. disclose in the second clamped position the first and second jaw axes are angled relative to one another at an acute angle (figs. 80, 81), and appears to show an angle of approximately three degrees.
Insofar as Morgan et al. can be considered not to disclose an angle of approximately three degrees, 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 jaw closing mechanism of Morgan et al. to include an angle of approximately three degrees, for a mechanical expedient such as ease of mounting the lobe cam during assembly, in the absence of any unexpected results of the angle of approximately three degrees. MPEP 2131.03.II. and 2144.05 I.
With respect to claim 28, Morgan et al. disclose a handle to advance the drive beam 1076 through the firing stroke ([0297]).
Morgan et al. fail to disclose a second motor operable to actuate the firing driver through the firing stroke.
In the embodiment of figs. 96-98, Morgan et al. disclose an end effector closing mechanism that includes a motor ([0371]). Morgan et al. disclose that the closing mechanism may be controlled by a motor, a firing trigger, or manually by hand.
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 device of Morgan et al. to include a motor, as suggested by Morgan et al. in the embodiment of figures 96-98, to actuate the firing beam, as a mere matter of providing automatic or mechanical means to replace a manual activity, which is considered a routine expedient requiring only ordinary skill in the art. Providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. MPEP 2144.04 III. In this instance, a skilled artisan would have recognized that the addition of a motor from the embodiment of figs. 96-98 of Morgan et al. for the handle operated control of the embodiment of figs. 78-80 of Morgan et al. involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
With respect to claim 29, Morgan et al. disclose that the closure mechanism and the firing beam advancement mechanism are independently operable (the jaw 4004 is actuated by actuator 4006 and a handle, the firing beam 1076 is actuated by an extension of the firing beam and a handle, fig. 25).
Morgan et al. fail to disclose first and second motors that are independently operable.
In the embodiment of figs. 96-98, Morgan et al. disclose an end effector closing mechanism that includes a motor ([0371]). Morgan et al. disclose that the closing mechanism may be controlled by a motor, a firing trigger, or manually by hand.
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 device of Morgan et al. to include a motor, as suggested by Morgan et al. in the embodiment of figures 96-98, to actuate the firing beam and a motor to actuate the jaw closing mechanism, as a mere matter of providing automatic or mechanical means to replace a manual activity, which is considered a routine expedient requiring only ordinary skill in the art. Providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. MPEP 2144.04 III. In this instance, a skilled artisan would have recognized that the addition of a motor from the embodiment of figs. 96-98 of Morgan et al. for the handle operated control of the embodiment of figs. 78-80 of Morgan et al. involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have provided the known element and the results would have been predictable.
With respect to claim 30, Morgan et al. disclose the surgical fasteners comprise surgical staples (staples 1066, fig. 22).
Claims 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Wellman (US Patent Publ. No. 2022/0346790) in view of Morgan et al. (US Patent Publ. No. 2016/0058441).
With respect to claim 27, Wellman fails to disclose that in the second clamped position the first and second jaw axes are angled relative to one another at approximately three degrees.
Morgan et al. disclose in a similar system that it is old and well known to approximate jaws to a first substantially parallel position (jaw 4004 is moved from open position of fig. 78 to intermediate position of fig. 79), and to further approximate the jaws to a second clamped position (jaw 4004 is moved from intermediate position of fig. 79 to closed position of fig. 80 in which the upper jaw proximal end is forced “in an upward direction, and the upper jaw distal end is forced “in a downward direction”, [0353]). Morgan et al. disclose in the second clamped position the first and second jaw axes are angled relative to one another at an acute angle (figs. 80, 81), and appears to show an angle of approximately three degrees.
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 Wellman method by substituting approximating the jaws to a second position of approximately three degrees as suggested by Morgan et al., for approximating the jaws to a second position of Wellman, in order to avoid undesired bending of the jaws at the distal ends. In this instance, a skilled artisan would have recognized that the substitution of the second non-parallel position from the Morgan et al. reference for the second position of the Wellman et al. reference involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.
With respect to claim 32, Wellman discloses the first jaw includes a first tissue compression surface (tissue compression surface of first jaw 111, fig. 1D) and the second jaw includes a second tissue compression surface (tissue compression surface of second jaw 112, fig. 1A), and wherein in the first clamped position the first and second tissue compression surfaces are substantially parallel (fig. 5).
Wellman discloses a second clamped position (the position of the jaws during movement of the sled and upper and lower shoes 152, 154 to apply force and clamp tissue, and when the staples are driven into the tissue, [0092]).
Wellman fails to disclose that in the second clamped position the first and second tissue compression surfaces are not substantially parallel.
Morgan et al. disclose in a similar system that it is old and well known to approximate jaws to a first substantially parallel position (jaw 4004 is moved from open position of fig. 78 to intermediate position of fig. 79), and to further approximate the jaws to a second clamped position (jaw 4004 is moved from intermediate position of fig. 79 to closed position of fig. 80 in which the upper jaw proximal end is forced “in an upward direction, and the upper jaw distal end is forced “in a downward direction”, [0353]).
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 Wellman method by substituting approximating the jaws to a second non-parallel position as suggested by Morgan et al., for approximating the jaws to a second position of Wellman, in order to avoid undesired bending of the jaws at the distal ends. In this instance, a skilled artisan would have recognized that the substitution of the second non-parallel position from the Morgan et al. reference for the second position of the Wellman et al. reference involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.
Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Wellman (US Patent Publ. No. 2022/0346790).
With respect to claim 33, Wellman discloses the motor comprises a first motor (the device includes a plurality of motors for actuating closing and stapling, [0079], [0080]).
Wellman fails to specifically disclose actuating the firing driver through the firing stroke includes actuating the firing driver with a second motor.
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 Wellman method to include actuating the firing driver through the firing stroke with a second motor since actuating the firing driver with a second motor would provide no particular mechanical disadvantage, would involve only a duplication of the elements of the device, and since there does not appear to be any particular disclosed mechanical advantage to actuating the firing driver with a second motor. MPEP 2144.04 VI A.
With respect to claim 34, Wellman, as modified above, teaches that actuating the firing driver with the second motor includes activating the second motor independently of the first motor (powered surgical system includes robotic surgical systems and controller that utilize drive cables connected to a system of motors and pulleys for various functions including opening and closing of jaws, as well as for movement and actuation of end effectors, [0029], [0080]). The motors are operated at different times and are therefore considered to be operated independently.
With respect to claim 35, Wellman, as modified above, teaches approximating the second jaw toward the first jaw from the first clamped position toward the second clamped position includes activating the first and second motors concurrently (powered surgical system includes robotic surgical systems and controller that utilize drive cables connected to a system of motors and pulleys for various functions including opening and closing of jaws, as well as for movement and actuation of end effectors, [0029], [0080]). At least some of the motors are operated at the same time as the second motor, and are therefore considered to be operated concurrently.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mata et al. (US Patent Publ. No. 2014/0249560) disclose jaws approximated in an overclamped position (6B).
Rethy et al. (US Patent Publ. No. 2005/0222616) disclose jaws approximated in a position with a gap narrower at the distal end than at the proximal end (figs. 64-65).
Vidal et al. (U.S. Patent No. 6,716,232) disclose jaws approximated in a position with a gap narrower at the distal end than at the proximal end (figs. 13-15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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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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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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