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
Receipt is acknowledged of an amendment, filed 06 July 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 1, and 5-23 are pending.
Claims 1 and 19 are amended.
Claims 2-4 are canceled.
Specification and Drawings:
Amendments to the specification and drawings have not been submitted in the amendment filed 06 July 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-9, 11, 15, and 19-20, 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott et al. (US Patent Publ. No. 2015/0250474) in view of Burbank et al. (US Patent Publ. No. 2017/0265954).
With respect to claim 1, Abbott et al. disclose a medical device for tissue fastening (an apparatus 1000 for delivering a surgical implant 10 for sealing tissue with fasteners 32, figs. 28, 50), the medical device comprising: an end effector (end effector 502, fig. 50) having a cartridge (jaw 504b that receives deployment member 14 of the implant 10, fig. 50); a sled positioned in the cartridge (driver 542 actuatable for distal and proximal movement along the jaw and for deployment of the fasteners 32, fig. 54B, [0217]); a first control member coupled to the sled (return cable 546 may be looped around posts of the driver 542 or anchored to the driver 542, [0215]-[0217], figs. 53A, 53B); and a second control member coupled to the sled (drive cable 544 may be looped around posts of the driver 542 or anchored to the driver 542, [0215]-[0217], figs. 53A, 53B); wherein a distal end of the first control member is coupled to a distal end of the second control member (“the cables 544 and/or 546 may be anchored, pinned, or otherwise secured to the driver 542 without looping about the posts 560 and 562, such that one end of each of the cables 544 and/or 546 terminates at the driver 542”, thus each distal end of cables 544 and 546 are fixed to the driver 542, and each distal end of the cables 544, 546 are coupled to each other via the driver 542, [0217]); a shaft coupled to the end effector (flexible shaft 508, fig. 50, [0205], [0206]; and an operation portion coupled to the shaft (proximal assembly 506, fig. 50), wherein the operation portion is configured to remain outside of a body of a subject upon insertion of the end effector into the subject (proximal assembly 506 includes a handle and trigger for operation by the user outside of a subject, [0209], fig. 50), wherein the operation portion includes an actuator that is configured to actuate at least the first control member or the second control member, wherein proximal actuation of the first control member moves the sled proximally (proximal actuation of the return cable 546 pulls the driver 542 proximally, [0218]) and proximal actuation of the second control member moves the sled distally (proximal actuation of the drive cable 544 pulls the driver 542 distally, [0218], trigger 514 and end effector driving assembly 540 to operate the apparatus and move the driver 542 proximally and distally, fig. 50, [0209], [0214]), wherein each of the first control member and the second control member extends through the shaft (cables 544, 546 extend through the shaft, [0216]), and wherein a proximal end of each of the first control member and the second control member is coupled to a portion of the actuator (ends of cables 544, 546 terminate at the spools 548 and are fastened to spools 548 via fasteners 564, fig. 51C, [0217]).
Abbott et al. fail to disclose a distal end of the first control member is directly coupled to a distal end of the second control member, such that the first control member and the second control member are portions of a single wire or cable.
Burbank et al. disclose in a similar type of system that it is old and well known to have first and second control members (first cable segment 110) coupled to a sled (cable driven slider beam 104), wherein a distal end of the first control member is directly coupled to a distal end of the second control member, such that the first control member and the second control member are portions of a single wire or cable (“although in one embodiment, the first pitch/slider cable 110 includes a single unitary cable secured at the first crimp surface 402 to the first cantilever beam 274, in an alternative embodiment, the first pitch/slider cable 110 includes two segments, extending longitudinally from opposite sides of the first cantilever beam 274”, [0043], figs. 10-12).
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 Abbott et al. device by substituting first and second control members that are directly coupled such that that control members are portions of a single wire or cable, suggested by Burbank et al., for the two separate control members that are fixed to the sled of Abbott et al., in order to have fewer points of coupling for ease of manufacture. In this instance, a skilled artisan would have recognized that the substitution of the directly coupled first and second control members from the Burbank et al. reference for the two separate control members of the Abbott 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 5, Abbott et al. disclose wherein the first control member extends along a top surface of a wall of a body of the end effector (return cable 546 extends along the top surface of the longitudinal walls of the frame 552 of jaw 504b, fig. 53A), and wherein the second control member extends along a bottom surface of the wall of the body (drive cable 544 extends along the bottom surface of the longitudinal walls of the frame 552 of the jaw 504b, fig. 53A).
With respect to claim 6, Abbott et al. disclose the body (jaw 504b) is configured to removably receive the cartridge (jaw 504b receives deployment member 14 of the implant 10, and deployment member 14 is removed from jaw after tissue is fastened, figs. 28, 50)
With respect to claim 7, Abbott et al. disclose the first control member is fixedly coupled to a bottom surface of the sled (end of return cable 546 terminates at the driver 542 and is anchored, [0217]). The end effector is hand-held and thus may be positioned in any orientation in space, such that the coupling between the end of the return cable 546 and the driver 542 is at a bottom surface of the driver. Therefore, the first control member is considered to be fixedly coupled to a bottom surface of the sled.
With respect to claim 8, Abbott et al. disclose the sled includes a blade and a slider, and wherein the slider is configured to deliver a fastener to a tissue of a subject (a surface of the driver 542 slides along the bottom surface of the frame 552 and is thus a slider, the driver 542 includes a cutting blade, the driver 542 installs the fasteners 32 of the implant 10, fig. 53B, [0010], [0219]).
With respect to claim 9, Abbott et al. disclose the actuator is a first actuator (trigger 514 and end effector driving assembly 540 to operate the apparatus and move the driver 542 proximally and distally, fig. 50, [0209], [0214]), wherein the operation portion includes a second actuator, and wherein the second actuator is configured to articulate the shaft (articulation actuator 528, 530, fig. 51C, [0212]).
With respect to claim 11, Abbott et al. disclose the operation portion includes a motor, and wherein the actuator is controlled by the motor (motor to drive the spools 548, [0242]).
With respect to claim 15, Abbott et al. disclose the operation portion is releasably coupled to the shaft (the proximal assembly 506 is connected to the end effector 502 via the flexible shaft 508, figs. 50, 52C, 52D, [0209]). As shown in figures 52C, 52D, the shaft 508 is a member separate from the rotation actuator 522 of the proximal assembly 500, and thus the operation portion is considered to be releasably coupled to the shaft.
With respect to claim 19, Abbott et al. disclose a medical device for tissue fastening (an apparatus 1000 for delivering a surgical implant 10 for sealing tissue with fasteners 32, figs. 28, 50), the medical device comprising: an end effector (end effector 502, fig. 50) having an anvil (jaw 504a, fig. 50); and a cartridge that contains a plurality of fasteners (jaw 504b that receives deployment member 14 of the implant 10, deployment member 14 contains fasteners 32, fig. 50); a flexible shaft coupled to the end effector (flexible shaft 508, fig. 50, [0205], [0206]; a wire extending through at least a portion of the flexible shaft (cables 544, 546 extend through the shaft, [0216]) and having a first portion with a threaded post or a protrusion (“the cables 544 and 546 are fastened to their respective one of the drive spools 548 via one or more fasteners 564”, “the cables 544 and/or 546 may be anchored, pinned, or otherwise secured to the driver 542 without looping about the posts 560 and 562, such that one end of each of the cables 544 and/or 546 terminates at the driver 542”, the ends may include a knot, bulge, protuberance, or loop and fastener 564 to fasten the cable to the driver 542, [0217]) and a second portion with a threaded receptacle or a loop, respectively (“the cables 544 and 546 are fastened to their respective one of the drive spools 548 via one or more fasteners 564”, “the cables 544 and/or 546 may be anchored, pinned, or otherwise secured to the driver 542 without looping about the posts 560 and 562, such that one end of each of the cables 544 and/or 546 terminates at the driver 542”, the ends may include a knot, bulge, protuberance, or loop and fastener 564 to fasten the cable to the driver 542, [0217]); wherein the first portion and second portion are coupled to each other by the respective (a) threaded post or protrusion and (b) threaded receptacle or loop (since each distal end of cables 544 and 546 is fixed to the driver 542, then the distal ends of the cables are considered to be coupled to each other via the driver 542, [0217]), and an operation portion releasably coupled to the flexible shaft by the wire (proximal assembly 506 is an operation portion, ends of cables 544, 546 terminate at the spools 548 and are fastened to spools 548 via fasteners 564, figs. 50, 51C, [0217]). Abbott et al. disclose that the terminal ends of the cables are fastened to the proximal assembly 506 by fasteners 564 and/or loops, and thus also may be unfastened. Therefore, the operation portion is considered to be releasably coupled to the shaft by the wire.
Abbott et al. fail to disclose wherein the first portion and the second portion are directly coupled to each other.
Burbank et al. disclose in a similar type of system that it is old and well known to have first and second control members (first cable segment 110) coupled to a sled (cable driven slider beam 104), wherein the first portion and the second portion are directly coupled to each other (“although in one embodiment, the first pitch/slider cable 110 includes a single unitary cable secured at the first crimp surface 402 to the first cantilever beam 274, in an alternative embodiment, the first pitch/slider cable 110 includes two segments, extending longitudinally from opposite sides of the first cantilever beam 274”, [0043], figs. 10-12).
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 Abbott et al. device by substituting first and second control members that are directly coupled to each other, suggested by Burbank et al., for the two separate control members that are fixed to the sled of Abbott et al., in order to have fewer points of coupling for ease of manufacture. In this instance, a skilled artisan would have recognized that the substitution of the directly coupled first and second control members from the Burbank et al. reference for the two separate control members of the Abbott 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 20, Abbott et al. disclose the operation portion includes at least one motor for controlling the end effector (motor to drive the spools 548, [0242]).
With respect to claim 21, Abbott et al. disclose the actuator is configured to actuate each of the first control member and the second control member (trigger 514 and end effector driving assembly 540 operate the apparatus to actuate the drive cable 544 and the return cable 546, and move the driver 542 proximally and distally, fig. 50, [0209], [0214]).
With respect to claim 22, Abbott et al. disclose the distal end of the first control member and the distal end of the second control member are coupled to one another so as to form a loop (“the cables 544 and/or 546 may be anchored, pinned, or otherwise secured to the driver 542 without looping about the posts 560 and 562, such that one end of each of the cables 544 and/or 546 terminates at the driver 542”, thus each distal end of cables 544 and 546 are fixed to the driver 542, and each distal end of the cables 544, 546 are coupled to each other via the driver 542, [0217]). The drive cable 544 and the return cable 546, with the driver 542 therebetween, form a loop.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott et al. in view of Burbank et al. as applied to claim 11, and further in view of Spivey et al. (US Patent Publ. No. 2014/0291383).
With respect to claim 12, Abbott et al. disclose a first motor (motor to drive the spools 548, [0242]) and a first actuator configured to actuate the first control member (trigger 514 and end effector driving assembly 540 to operate the apparatus and move the driver 542 and cables 544, 546 proximally and distally, fig. 50, [0209], [0214]).
Abbott al. fail to disclose a second motor that controls a second actuator, wherein the second actuator is configured to actuate the second control member.
Spivey et al. disclose a plurality of motors that control a plurality of actuators for actuating end effector closing, transmission, and staple deployment (fig. 58, [0216], [0265], [0270]).
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 Abbott et al. medical device to include a second motor and actuator as taught by Spivey et al., since including a second motor and actuator would involve only a duplication of parts, and absent a new and unexpected result, there does not appear to be any particular advantage to having a plurality of motors and actuators. MPEP 2144.04 VI. B.
With respect to claim 13, Abbott et al. disclose a control member coupled to the end effector to close the end effector (advancement of the driver actuates the jaws to close shut, [0214], 0222]).
Abbott et al. fail to disclose a third motor that controls a third actuator, wherein the third actuator is configured to actuate a third control member that is coupled to the end effector to close the end effector.
Spivey et al. disclose a plurality of motors that control a plurality of actuators for actuating end effector closing, transmission, and staple deployment (fig. 58, [0216], [0265], [0270]).
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 Abbott et al. medical device to include a third motor and actuator as taught by Spivey et al., since including a third motor and actuator would involve only a duplication of parts, and absent a new and unexpected result, there does not appear to be any particular advantage to having a plurality of motors. MPEP 2144.04 VI. B.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 19 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.
Allowable Subject Matter
Claims 10, 14, and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 10, the prior art fails to disclose or teach the device of claim 9, wherein the second actuator is fixedly coupled to a first sheath of the shaft, and wherein at least portions of the first sheath are movable with respect to a second sheath of the shaft.
With respect to claim 14, the prior art fails to disclose or teach the device of claim 12, wherein the operation portion includes a fourth motor that is coupled to the shaft and is configured to rotate the shaft, and wherein one or more of the first, the second, or the third motors is configured to accommodate a changing length of at least one of the first control member, the second control member, or the third control member.
With respect to claim 23, the prior art fails to disclose or teach the device of claim 19, wherein the first portion of the wire is fixedly coupled to a bottom surface of a base of a sled of the end effector, wherein the bottom surface of the sled faces a bottom wall of the cartridge that is opposite a top wall of the cartridge, wherein the top wall of the cartridge includes openings for delivering fasteners of the plurality of fasteners, wherein the first portion of the wire has two proximal ends and a looped distal end, and wherein each proximal end of the first portion of the wire includes a threaded post or a protrusion.
Claims 16-18 are allowed.
Regarding independent claim 16: the subject matter of claim 16 is allowable over the prior art because of the combination of structural limitations and their functional relationship to one another. Claim 16 includes the following limitations which in combination with the other limitations of the claim are not taught or suggested by the prior art:
“a sled positioned in the cartridge, wherein the sled includes an angled actuation portion and a base, wherein the angled actuation portion extends from the base toward a top wall of the cartridge, wherein the top wall of the cartridge defines a plurality of openings for delivering fasteners to tissue; and
a cable fixedly coupled to a bottom surface of the base of the sled, wherein the bottom surface of the sled faces a bottom wall of the cartridge that is opposite the top wall of the cartridge, wherein the cable has two proximal ends and a looped distal end;
a shaft coupled to the end effector; and
an operation portion coupled to the shaft, wherein the operation portion includes an actuator that is coupled to the proximal ends of the cable in order to actuate the sled proximally and distally”.
Spivey et al. (US Patent Publ. No. 2014/0291383) is considered to be the closest prior art. Spivey et al. disclose a medical device for tissue fastening comprising an end effector having a cartridge and a sled, the sled having an angled actuation portion extending from a base, the top wall of the cartridge including fastener openings, a cable coupled to the sled, a shaft, and an operation portion and actuator.
The difference between the claimed subject matter and Spivey et al. is that Spivey et al. do not disclose or teach “a sled positioned in the cartridge, wherein the sled includes an angled actuation portion and a base, wherein the angled actuation portion extends from the base toward a top wall of the cartridge, wherein the top wall of the cartridge defines a plurality of openings for delivering fasteners to tissue; and a cable fixedly coupled to a bottom surface of the base of the sled, wherein the bottom surface of the sled faces a bottom wall of the cartridge that is opposite the top wall of the cartridge, wherein the cable has two proximal ends and a looped distal end; a shaft coupled to the end effector; and an operation portion coupled to the shaft, wherein the operation portion includes an actuator that is coupled to the proximal ends of the cable in order to actuate the sled proximally and distally”.
The difference between the claimed subject matter and Spivey et al. would not have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, since such modifications to the Spivey et al. structure would have gone beyond mere substitution or incorporation of a known structure capable of achieving predictable results. Any modification to the Spivey et al. structure to arrive at the claimed subject matter would have required a reworking of the structure and the principle of operation in a manner which would not have been apparent to a person having ordinary skill in the relevant art, and would have required the improper benefit of the teachings of Applicant’s disclosure.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 17-18 depend from claim 16 and are likewise allowable.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA J. HODGE/Primary Examiner, Art Unit 3731
