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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/29/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 21, “a blocker movable . . . at least partially out of the lock cavity” and “a blocking position at least partially out of the lock cavity” fails to comply with the written description requirement because the disclosure does not support these limitations. The specification and drawings do not describe the blocker being moved at least partially out of the lock cavity.
Regarding claims 22-31, claims 22-31 are rejected because they depend from rejected claim 21.
Regarding claim 32, “a spring-loaded blocker movable . . . at least partially out of the lock cavity” and “a blocking position at least partially out of the lock cavity” fails to comply with the written description requirement because the disclosure does not support these limitations. The specification and drawings do not describe the blocker being moved at least partially out of the lock cavity.
Regarding claims 33-40, claims 33-40 are rejected because they depend from rejected claim 32.
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.
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.
Claims 21, 23-25, 27-29, 31-35, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Baxter et al (US 2020/0222044), hereinafter Baxter, in view of Shelton et al (US 2021/0186495), hereinafter Shelton, in view of Williams et al (US 2014/0263567), hereinafter Williams.
Regarding claim 21, Baxter discloses a surgical tool (Fig. 83, item 8410), comprising:
an end effector (Fig. 84, item 8412) comprising an elongate channel (Fig. 84, end effector 8412 has channel running along axis DD) and an anvil (Fig. 84, item 8420), wherein a lock cavity (Fig. 84, lock cavity is where blocker 8991, 8992 is located in end effector 8412) is defined into the elongate channel;
an shaft (Fig. 83, item 8500) defining a longitudinal axis (Fig. 83, item DD/PD), wherein a yaw axis (Fig. 83) (Para. 0415) and a pitch axis (Fig. 83) (Para. 0415) are oriented transverse to the longitudinal axis;
a joint (Fig. 86, item 8510);
a beam head (Fig. 84, item 8973) movable distally through a closure stroke (Para. 0424-0426) from a proximal position (Para. 0424-0426) to an intermediate position (Para. 0424-0426) to close the end effector (Para. 0424-0426) and movable distally through a firing stroke (Para. 0424-0426) from the intermediate position (Para. 0424-0426) to a distal position (Para. 0424-0426), the beam head comprising:
a first cam (Fig. 84, item 8977) positioned to cammingly engage the elongate channel (Para. 0424-0426); and
a second cam (Fig. 84, item 8977’) positioned to cammingly engage the anvil (Para. 0424-0426); and
a blocker (Fig. 84, item 8991, 8992) movable relative to the beam head and the lock cavity (Fig. 84) (Para. 0427), wherein the blocker is movable between a blocking position (Para. 0427) and an unblocking position (Para. 0427), and wherein the blocker, in the blocking position, is positioned to block (Para. 0427) distal advancement of the beam head (Para. 0427) through the firing stroke (Para. 0427).
Baxter is silent about wherein the end effector is articulatable about the yaw axis and the pitch axis at the joint.
However, Shelton teaches an end effector (Fig. 1, item 1200) articulable about a yaw axis (Fig. 1, item AA1) (Para. 0594) and a pitch axis (Fig. 1, item AA2) (Para. 0594) at the joint.
It would have been obvious to a person of ordinary skill in the art at the effective filing date of the invention having the teachings of Baxter and Shelton to modify the surgical tool of Baxter to include the multiple articulation axis of Shelton. A person of ordinary skill in the art would have been motivated to make such change in order to permit the user to more precisely position the end effector during use (Para. 0594).
Baxter in view of Shelton is silent about the lock cavity defined within an inside bottom surface of the elongate channel; the blocker movable into and at least partially out of the lock cavity, wherein the blocker is movable between a blocking position at least partially out of the lock cavity and an unblocking position within the lock cavity.
However, Williams teaches a surgical tool (Williams, Fig. 1), comprising: a lock cavity (Williams, Fig. 6, item 130) defined within an inside bottom surface (Williams, Para. 0196) of the elongate channel (Williams, Para. 0196); a blocker (Williams, Fig. 7, item 132) movable into and at least partially out of the lock cavity (Williams, Para. 0196-0202), wherein the blocker is movable between a blocking position (Williams, Para. 0196-0202) at least partially out of the lock cavity (Williams, Para. 0196-0202) and an unblocking position (Williams, Para. 0196-0202) within the lock cavity (Williams, Para. 0196-0202).
It would have been obvious to a person of ordinary skill in the art at the effective filing date of the invention having the teachings of Baxter, Shelton, and Williams to modify the surgical tool of Baxter in view of Shelton to include the lock cavity and blocker configuration of Williams. A person of ordinary skill in the art would have been motivated to make such change in order to prevent inadvertent firing of the knife of the surgical stapler when a staple cartridge is not installed or is spent (Williams, Para. 0006).
Regarding claim 23, Baxter discloses the surgical tool of claim 21, wherein the blocker comprises a spring-loaded blocker (Fig 84, item 8992) (Para. 0427), and wherein the spring-loaded blocker is biased (Para. 0427) toward the blocking position by a spring (Para. 0427).
Regarding claim 24, Baxter discloses the surgical tool of claim 23, further comprising an unfired staple cartridge (Fig. 84, item 8430) removably positioned in the elongate channel (Para. 0427), wherein the unfired staple cartridge is structured to move the blocker (Para. 0427) from the blocking position (Para. 0427) to the unblocking position (Para. 0427).
Regarding claim 25, Baxter discloses the surgical tool of claim 24, wherein the unfired staple cartridge comprises a plurality of staples (Fig. 84, item 8990) and a sled (Fig. 84, item 8985) comprising a ramp (Fig. 84, item 8988) movable to eject the plurality of staples (Para. 0424-0426), wherein the sled is structured to move the blocker (Para. 0424-0426) from the blocking position to the unblocking position (Para. 0424-0427).
Regarding claim 27, Baxter discloses the surgical tool of claim 21, wherein the beam head further comprises a distal-facing abutment surface (Fig. 84, item 8977) structured to receive a blocking force (Para. 0427) via the blocker to prevent distal advancement (Para. 0427) of the beam head unless an unfired staple cartridge (Para. 0424-0427) is positioned in the end effector (Para. 0424-0427).
Regarding claim 28, Baxter discloses the surgical tool of claim 21, further comprising a plurality of pushers (Fig. 84, item 8971, 8972) to push the beam head (Para. 0428) distally through the closure stroke (Para. 0428) and the firing stroke (Para. 0428), wherein each pusher extends through the joint to the beam head (Para. 0428).
Regarding claim 29, Baxter discloses the surgical tool of claim 28, wherein the plurality of pushers comprises an upper pusher (Fig. 84, item 8971) and a lower pusher (Fig. 84, item 8972).
Regarding claim 31, Baxter discloses the surgical tool of claim 29, wherein the upper pusher and the lower pusher are vertically spaced apart within the shaft (Fig. 84, upper pusher 8971 and lower pusher 8972 are spaced apart when they connect with the upper cam 8977’ and lower cam 8977, respectively).
Regarding claim 32, Baxter discloses a surgical tool (Fig. 83, item 8410), comprising:
a shaft (Fig. 83, item 8500);
an end effector (Fig. 84, item 8412) coupled to the shaft at an articulation joint (Fig. 83) (Para. 0415), wherein the end effector is rotatable (Fig. 83) (Para. 0415) relative to the shaft at the articulation joint (Fig. 83) (Para. 0415), wherein the end effector further comprises a channel (Fig. 84, end effector 8412 has channel running along axis DD) to support a staple cartridge (Fig. 84, item 8430), and wherein a lock cavity (Fig. 84, lock cavity is where blocker 8991, 8992 is located in end effector 8412) is defined in the channel (Para. 0424-0426);
a beam head (Fig. 84, item 8973) comprising an upper cam (Fig. 84, item 8977’) and a lower cam (Fig. 84, item 8977), wherein the beam head is movable distally through a closure stroke (Para. 0424-0426) from a proximal position (Para. 0424-0426) to an intermediate position (Para. 0424-0426) to close the end effector (Para. 0424-0426) and movable distally through a firing stroke (Para. 0424-0426) from the intermediate position (Para. 0424-0426) to a distal position (Para. 0424-0426); and
a spring-loaded blocker (Fig. 84, item 8991, 8992) movable relative to the beam head and the lock cavity (Para. 0427), wherein the spring-loaded blocker is biased toward a blocking position (Para. 0427), and wherein the spring-loaded blocker, in the blocking position, (Para. 0427) is positioned to block distal advancement (Para. 0427) of the beam head through the firing stroke (Para. 0427).
Baxter is silent about the end effector rotatable relative to the shaft at the articulation joint in a plurality of articulation planes.
However, Shelton teaches an end effector (Fig. 1, item 1200) rotatable relative to the shaft (Fig. 1, item 1110) at the articulation joint in a plurality of articulation planes (Fig. 1, item AA1, AA2) (Para. 0594).
It would have been obvious to a person of ordinary skill in the art at the effective filing date of the invention having the teachings of Baxter and Shelton to modify the surgical tool of Baxter to include the multiple articulation axis of Shelton. A person of ordinary skill in the art would have been motivated to make such change in order to permit the user to more precisely position the end effector during use (Para. 0594).
Baxter in view of Shelton is silent about the lock cavity defined within an inside bottom surface of the elongate channel; the blocker movable into and at least partially out of the lock cavity, wherein the spring-loaded blocker is movable between a blocking position at least partially out of the lock cavity and an unblocking position within the lock cavity.
However, Williams teaches a surgical tool (Williams, Fig. 1), comprising: a lock cavity (Williams, Fig. 6, item 130) defined within an inside bottom surface (Williams, Para. 0196) of the elongate channel (Williams, Para. 0196); a spring-loaded blocker (Williams, Fig. 7, item 132) movable into and at least partially out of the lock cavity (Williams, Para. 0196-0202), wherein the blocker is movable between a blocking position (Williams, Para. 0196-0202) at least partially out of the lock cavity (Williams, Para. 0196-0202) and an unblocking position (Williams, Para. 0196-0202) within the lock cavity (Williams, Para. 0196-0202).
It would have been obvious to a person of ordinary skill in the art at the effective filing date of the invention having the teachings of Baxter, Shelton, and Williams to modify the surgical tool of Baxter in view of Shelton to include the lock cavity and spring-loaded blocker configuration of Williams. A person of ordinary skill in the art would have been motivated to make such change in order to prevent inadvertent firing of the knife of the surgical stapler when a staple cartridge is not installed or is spent (Williams, Para. 0006).
Regarding claim 33, Baxter discloses the surgical tool of claim 32, further comprising an unfired staple cartridge (Fig. 84, item 8430) removably positioned in the end effector (Para. 0427), wherein the unfired staple cartridge is structured to move the blocker (Para. 0427) from the blocking position (Para. 0427) to the unblocking position (Para. 0427).
Regarding claim 34, Baxter discloses the surgical tool of claim 33, wherein the unfired staple cartridge comprises a plurality of staples (Fig. 84, item 8990) and a sled (Fig. 84, item 8985) comprising a ramp (Fig. 84, item 8988) movable to eject the plurality of staples (Para. 0424-0426), wherein the sled is structured to overcome a spring force (Para. 0424-0426) to shift the spring-loaded blocker (Para. 0424-0426) from the blocking position to an unblocking position (Para. 0424-0426).
Regarding claim 35, Baxter discloses t he surgical tool of claim 34, wherein the spring-loaded blocker is compressed into the lock cavity (Para. 0427) by the sled of the unfired staple cartridge (Para. 0427).
Regarding claim 37, Baxter discloses the surgical tool of claim 33, wherein the beam head further comprises a distal-facing abutment surface (Fig. 84, item 8977) structured to receive a blocking force (Para. 0427) via the spring-loaded blocker to prevent distal advancement (Para. 0427) of the beam head unless an unfired staple cartridge (Para. 0424-0427) is positioned in the end effector (Para. 0424-0427).
Regarding claim 38, Baxter discloses the surgical tool of claim 33, wherein the spring-loaded blocker is resiliently supported in the channel (Para. 0427).
Regarding claim 39, Baxter discloses the surgical tool of claim 33, further comprising a plurality of pushers (Fig. 84, item 8971, 8972) to push the beam head distally through the closure stroke and the firing stroke (Para. 0428), wherein each pusher extends through the articulation joint (Para. 0428) to the beam head (Para. 0428), wherein the plurality of pushers comprises an upper pusher (Fig. 84, item 8971) and a lower pusher (Fig. 84, item 8972), and wherein the upper pusher and the lower pusher are vertically spaced apart within the shaft (Fig. 84, upper pusher 8971 and lower pusher 8972 are spaced apart when they connect with the upper cam 8977’ and lower cam 8977, respectively).
Claims 22, 26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Baxter in view of Shelton further in view of Williams further in view of Shelton et al (US 2018/0168651), hereinafter Shelton ‘651.
Regarding claim 22, Baxter in view of Shelton further in view of Williams is silent about the surgical tool of claim 21, wherein the blocker, in the blocking position, is positioned to block distal advancement of the beam head past the intermediate position such that the beam head is movable through the closure stroke to the intermediate position to close the end effector regardless of the blocker being in the blocking position.
However, Shelton ‘651 teaches a blocker (Shelton ‘651, Fig. 29, item 2182), in the blocking position (Shelton ‘651, Fig. 28), is positioned to block distal advancement (Shelton, ‘651, Para. 0448) of the beam head (Shelton ‘651, Fig. 29, item 1763) past the intermediate position (Shelton, ‘651, Para. 0448) such that the beam head is movable through the closure stroke (Shelton, ‘651, Para. 0448) to the intermediate position (Shelton, ‘651, Para. 0448) to close the end effector regardless of the blocker being in the blocking position (Shelton, ‘651, Para. 0448, after staple cartridge is inserted, closure stroke can be completed by beam head, regardless of blocker position).
It would have been obvious to a person of ordinary skill in the art having the teachings of Baxter, Shelton, Williams, and Shelton ‘651 to modify the surgical tool of Baxter in view of Shelton further in view of Williams to include the configuration of Shelton ‘651. A person of ordinary skill in the art would have been motivated to make such change in order to prevent the tool from misfiring before the tool is properly positioned (Shelton ‘651, Para. 0443).
Regarding claim 26, Baxter in view of Shelton further in view of Williams is silent about the surgical tool of claim 21, wherein the intermediate position of the beam head over the lock cavity is maintained regardless of a presence or an absence of an unfired staple cartridge in the elongate channel.
However, Shelton ‘651 teaches the intermedial position of the beam head (Shelton, ‘651, Para. 0447-0049) over the lock cavity (Shelton, ‘651, Para. 0447-0049) is maintained regardless of a presence or an absence (Shelton, ‘651, Para. 0447-0049) of an unfired staple cartridge in the elongate channel (Shelton, ‘651, Para. 0447-0049).
It would have been obvious to a person of ordinary skill in the art having the teachings of Baxter, Shelton, Williams and Shelton ‘651 to modify the surgical tool of Baxter in view of Shelton further in view of Williams to include the configuration of Shelton ‘651. A person of ordinary skill in the art would have been motivated to make such change in order to prevent the tool from misfiring before the tool is properly positioned (Shelton ‘651, Para. 0443).
Regarding claim 36, Baxter in view of Shelton further in view of Williams is silent about the surgical tool of claim 33, wherein the intermediate position of the beam head over the lock cavity is maintained regardless of a presence or an absence of an unfired staple cartridge in the end effector.
However, Shelton ‘651 teaches the intermediate position of the beam head over the lock cavity (Shelton, ‘651, Para. 0447-0049) is maintained regardless of a presence or an absence (Shelton, ‘651, Para. 0447-0049) of an unfired staple cartridge in the end effector (Shelton, ‘651, Para. 0447-0049).
It would have been obvious to a person of ordinary skill in the art having the teachings of Baxter, Shelton, Williams, and Shelton ‘651 to modify the surgical tool of Baxter in view of Shelton further in view of Williams to include the configuration of Shelton ‘651. A person of ordinary skill in the art would have been motivated to make such change in order to prevent the tool from misfiring before the tool is properly positioned (Shelton ‘651, Para. 0443).
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Baxter in view of Shelton further in view of Williams further in view of Wixey et al (US 2022/0061841), hereinafter Wixey.
Regarding claim 30, Baxter in view of Shelton further in view of Williams is silent about the surgical tool of claim 29, wherein the upper pusher and the lower pusher each comprise a pusher coil extending through the joint to the beam head.
However, Wixey teaches a surgical tool (Wixey, Fig. 1) wherein the upper pusher (Wixey, Fig. 7A, item 120) and the lower pusher (Wixey, Fig. 7A, item 120) each comprise a pusher coil (Wixey, Fig. 7A, item 120) (Wixey, Para. 0063) extending through the joint to the beam head (Wixey, Fig. 7A, item 150) (Wixey, Para. 0063).
It would have been obvious to a person of ordinary skill in the art at having the teachings of Baxter, Shelton, Williams and Wixey to modify the surgical tool of Baxter in view of Shelton further in view of Williams to include the pusher coils of Wixey. A person of ordinary skill in the art would have been motivated to make such change in order to enhance the flexibility of the driver (Wixey, Para. 0011).
Regarding claim 40, Baxter in view of Shelton further in view of Williams is silent about the surgical tool of claim 39, wherein the upper pusher and the lower pusher each comprise a pusher coil extending through the articulation joint to the beam head.
However, Wixey teaches a surgical tool (Wixey, Fig. 1) wherein the upper pusher (Wixey, Fig. 7A, item 120) and the lower pusher (Wixey, Fig. 7A, item 120) each comprise a pusher coil (Wixey, Fig. 7A, item 120) (Wixey, Para. 0063) extending through the joint to the beam head (Wixey, Fig. 7A, item 150) (Wixey, Para. 0063).
It would have been obvious to a person of ordinary skill in the art at having the teachings of Baxter, Shelton, Williams and Wixey to modify the surgical tool of Baxter in view of Shelton further in view of Williams to include the pusher coils of Wixey. A person of ordinary skill in the art would have been motivated to make such change in order to enhance the flexibility of the driver (Wixey, Para. 0011).
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731