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 06 May 2025, 13 June 2025, 15 July 2025, 06 August 2025, and 03 October 2025, 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 18 July 2025, 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 and drawings have not been submitted in the amendment filed 18 July 2025.
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.
Claims 33-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 recites the limitation "the cavity" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation “inner surface” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the cavity" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 35-40 depend from claim 33, and are likewise rejected.
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 21-34 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Graves et al. (US Patent No. 5,919,198) in view of Chow et al. (US Patent No. 4,633,874).
With respect to claim 21, Graves et al. disclose a surgical instrument comprising an end effector comprising first and second jaws (surgical fastening instrument 20 with jaws, fig. 1), the second jaw having a cavity with an inner surface (cartridge holder 24, fig. 1); a staple cartridge configured for positioning within the cavity of the second jaw (cartridge 30a, fig. 2), the staple cartridge comprising a housing having a longitudinal axis (cartridge 30a comprises a housing, col. 6, l. 17-20), a channel (knife slot 55, fig. 2) and a staple assembly comprising a staple pusher (driver 40a, fig. 9) and a staple (staple 22, fig. 9); and wherein the staple cartridge comprises first and second side walls (sidewalls 34, figs. 5A, 5B) disposed between the staple pusher and a side wall of the second jaw (sidewalls 34 are positioned between the driver 40a and the sidewalls of the cartridge holder 24 when the cartridge is positioned within the cartridge holder, figs. 1, 9) and a bottom portion of the staple pusher is exposed to the inner surface of the second jaw (drivers 40a are exposed, figs. 4, 9).
Graves et al. fail to disclose a drive member configured to translate distally through the end effector, the drive member comprising a central portion for translating through the channel and a lower portion that translates through the cavity of the second jaw between the inner surface and the staple cartridge.
Chow et al. disclose a similar surgical instrument including a drive member configured to translate distally through the end effector (wedge shaped tip 128 on staple pusher bar 124, actuated by actuator knob 114, figs. 10 and 18, col. 12, lines 18-36), the drive member comprising a central portion for translating through the channel (pusher bars 124 are central to pusher block 112, fig. 10) and a lower portion that translates through the cavity of the second jaw between the inner surface and the staple cartridge (lower surface of pusher bar 124 and lower surface of wedge shaped tip 128 translates between the cartridge and the jaw, fig. 4).
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 surgical instrument of Graves et al. to include the drive member as taught by Chow et al. to provide movement to the staple pushers, especially since Graves et al. disclose movement of the pushers to staple tissue (figs. 9 and 10, col. 1, lines 21-31; col. 7, line 65 – col. 8, line 15), show in figure 9 the wedge side of the pusher (driver 40a), and since Graves et al. identifies the Chow et al. reference as a typical surgical fastening instrument utilizing a disposable cartridge (col. 1, lines 33-43).
With respect to claim 22, Graves et al. disclose the inner surface of the second jaw is a bottom surface (bottom surface of holder 24 between the side walls of the holder, fig. 1), and the staple cartridge is positioned between the bottom surface of the second jaw and the first jaw (unnumbered first jaw, fig. 1).
With respect to claim 23, Graves et al. disclose the staple cartridge is devoid of a bottom cover extending between the bottom portion of the staple pusher and the inner surface of the second jaw (cartridge 30a is devoid of a bottom cover, fig. 4).
With respect to claim 24, Graves et al. disclose the staple (staple 22) comprises a backspan (crown 23, fig. 9) and first and second legs extending from the backspan towards the first jaw (unnumbered legs, fig. 9), wherein the first and second side walls of the staple cartridge extend between the backspan of the staple and the side wall of the second jaw (sidewalls 34 extend from top to bottom of cartridge, figs. 5A, 5B).
With respect to claim 25, Graves et al. disclose the housing comprises a coupling portion that retains the staple pusher therein and allows the staple pusher to be driven by the drive member in a direction substantially perpendicular to the longitudinal axis (windows or slots 35 in sidewalls 34, figs. 5A, 5B, 9).
With respect to claim 26, Graves et al. disclose the staple cartridge is devoid of a metal cover (cartridge 30a is devoid of a cover, fig. 4).
With respect to claim 27, Graves et al. disclose a surgical instrument comprising an end effector comprising first and second jaws (surgical fastening instrument 20 with jaws, fig. 1), a staple cartridge coupled to the second jaw (cartridge 30a in cartridge holder 24, figs. 1, 2), the staple cartridge comprising a housing having a longitudinal axis (cartridge 30a comprises a housing, col. 6, l. 17-20), a channel (knife slot 55, fig. 2) and a staple assembly comprising a staple pusher (driver 40a, fig. 9) and a staple (staple 22, fig. 9); and wherein the staple cartridge comprises a coupling portion that retains the staple pusher therein and allows the staple pusher to be driven in a direction substantially perpendicular to the longitudinal axis (windows or slots 35 in sidewalls 34, figs. 5A, 5B, 9).
Graves et al. fail to disclose a drive member configured to translate distally through the end effector, the drive member comprising a central portion for translating through the channel and first and second outer portions each having an inclined surface for engaging the staple pusher upon distal translation of the drive member through the end effector, wherein the first and second outer portions and the central portion are integrally formed as a single component.
Chow et al. disclose a similar surgical instrument including a drive member configured to translate distally through the end effector (wedge shaped tip 128 on staple pusher bar 124, actuated by actuator knob 114, figs. 10 and 18, col. 12, lines 18-36), the drive member comprising a central portion for translating through the channel (pusher bars 124 are central to pusher block 112, fig. 10) and first and second outer portions each having an inclined surface for engaging the staple pusher upon distal translation of the drive member through the end effector (wedge shaped tips 128 have inclined surfaces 130 and are positioned outward of the longitudinal axis, fig. 10), wherein the first and second outer portions and the central portion are integrally formed as a single component (each pusher bar 124, wedge shape tip 128, and inclined surface 130 is a portion of an integral member, fig. 10).
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 surgical instrument of Graves et al. to include the drive member as taught by Chow et al. to provide movement to the staple pushers, especially since Graves et al. disclose movement of the pushers to staple tissue (figs. 9 and 10, col. 1, lines 21-31; col. 7, line 65 – col. 8, line 15), show in figure 9 the wedge side of the pusher (driver 40a), and since Graves et al. identifies the Chow et al. reference as a typical surgical fastening instrument utilizing a disposable cartridge (col. 1, lines 33-43).
With respect to claim 28, Graves et al. disclose the coupling portion comprises an interference fit between the staple pusher and an internal wall of the housing (force is applied to the driver tabs 41, forcing the sidewalls 34 to deflect and accommodate the drivers 40a, col. 7, l. 1-5).
With respect to claim 29, Graves et al. disclose the coupling portion comprises a snap-fit between the staple pusher and an internal wall of the housing (the cartridge walls 34 may be rigid and the driver tabs 41 may be flexible, col. 7, l. 16-21).
With respect to claim 30, Graves et al. disclose the coupling portion comprises a press-fit between the staple pusher and an internal wall of the housing (the drivers 40a are inserted between the sidewalls 34 in a press-fit manner, col. 7, l. 6-15).
With respect to claim 31, Graves et al. disclose wherein the coupling portion comprises a camming surface between the staple pusher and an internal wall of the housing (driver tab 41 includes an inclined camming surface that engages the internal surface of the sidewall 34, fig. 8).
With respect to claim 32, Graves et al. disclose the staple cartridge comprises first and second side walls (sidewalls 34, figs. 5A, 5B) disposed between the staple pusher and a side wall of the second jaw (sidewalls 34 are positioned between the driver 40a and the sidewalls of the cartridge holder 24 when the cartridge is positioned within the cartridge holder, figs. 1, 9) and a bottom portion of the staple pusher is exposed to the inner surface of the second jaw (drivers 40a are exposed, figs. 4, 9).
With respect to claim 33, Graves et al. disclose a surgical system comprising a surgical instrument comprising an elongate shaft (the handle portion has the shape of an elongate shaft, fig. 1), an end effector coupled to a distal end portion of the elongate shaft (jaws extend from distal end of the elongated handle portion, fig. 1) and comprising first and second opposing jaws (surgical fastening instrument 20 with jaws, fig. 1), a staple cartridge configured for positioning within the cavity of the second jaw (cartridge 30a in cartridge holder 24, figs. 1, 2), the staple cartridge comprising a housing having a longitudinal axis (cartridge 30a comprises a housing, col. 6, l. 17-20), a channel (knife slot 55, fig. 2) and a staple assembly comprising a staple pusher (driver 40a, fig. 9) and a staple (staple 22, fig. 9); and wherein the staple cartridge comprises first and second side walls (sidewalls 34, figs. 5A, 5B) disposed between the staple pusher and a side wall of the second jaw (sidewalls 34 are positioned between the driver 40a and the sidewalls of the cartridge holder 24 when the cartridge is positioned within the cartridge holder, figs. 1, 9) and a bottom portion of the staple pusher is exposed to the inner surface of the second jaw (drivers 40a are exposed, figs. 4, 9).
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. MPEP 2111.02
Graves et al. disclose the surgical instrument in a surgical system. Thus one is fully capable of using the surgical instrument in a robotic surgical system.
The intended use recitation language (some of which has been italicized supra) carries no weight in the absence of any distinguishing structure. Graves et al. disclose the structure as claimed and is thus capable of performing the functions. See MPEP 2114 which states: APPARATUS CLAIMS MUST BE STRUCTURALLY DISTINGUISHABLE FROM THE PRIOR ART While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board's finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210,212-13, 169 USPQ 226,228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528,531 (CCPA 1959). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
In the present case, the statements in the preamble reciting the purpose or intended use of the claimed invention do not result in a structural difference between the claimed invention and the prior art.
Graves et al. fail to disclose a drive member configured to translate distally through the end effector, and an actuation mechanism operatively coupled to the drive member and configured to translate the drive member distally through the end effector.
Chow et al. disclose a similar surgical instrument including a drive member configured to translate distally through the end effector (wedge shaped tip 128 on staple pusher bar 124, actuated by actuator knob 114, figs. 10 and 18, col. 12, lines 18-36), and an actuation mechanism operatively coupled to the drive member and configured to translate the drive member distally through the end effector (actuator knob 114, fig. 10).
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 surgical instrument of Graves et al. to include the drive member and actuation mechanism as taught by Chow et al. to provide movement to the staple pushers, especially since Graves et al. disclose movement of the pushers to staple tissue (figs. 9 and 10, col. 1, lines 21-31; col. 7, line 65 – col. 8, line 15), show in figure 9 the wedge side of the pusher (driver 40a), show in figure 1 an actuation element, and since Graves et al. identifies the Chow et al. reference as a typical surgical fastening instrument utilizing a disposable cartridge (col. 1, lines 33-43).
With respect to claim 34, Graves et al. fail to disclose the drive member comprises a central portion for translating through the channel and a lower portion that translates through the cavity of the second jaw between the inner surface and the staple cartridge.
Chow et al. disclose a drive member comprising a central portion for translating through the channel (pusher bars 124 are central to pusher block 112, fig. 10) and a lower portion that translates through the cavity of the second jaw between the inner surface and the staple cartridge (lower surface of pusher bar 124 and lower surface of wedge shaped tip 128 translates between the cartridge and the jaw, fig. 4).
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 surgical instrument of Graves et al. to include the drive member as taught by Chow et al. to provide movement to the staple pushers, especially since Graves et al. disclose movement of the pushers to staple tissue (figs. 9 and 10, col. 1, lines 21-31; col. 7, line 65 – col. 8, line 15), show in figure 9 the wedge side of the pusher (driver 40a), and since Graves et al. identifies the Chow et al. reference as a typical surgical fastening instrument utilizing a disposable cartridge (col. 1, lines 33-43).
With respect to claim 39, Graves et al. disclose the housing comprises a coupling portion that retains the staple pusher therein and allows the staple pusher to be driven by the drive member in a direction substantially perpendicular to the longitudinal axis (windows or slots 35 in sidewalls 34, figs. 5A, 5B, 9).
With respect to claim 40, Graves et al. disclose the staple cartridge is devoid of a bottom cover extending between the bottom portion of the staple pusher and the inner surface of the second jaw (cartridge 30a is devoid of a bottom cover, fig. 4).
Claims 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Graves et al. (US Patent No. 5,919,198) in view of Chow et al. (US Patent No. 4,633,874) as applied to claim 33 above, and further in view of Shelton et al. (US Patent Publ. No. 2018/0168650).
With respect to claim 35, Graves et al. fail to disclose a robotic arm assembly coupled to the actuation mechanism and a control device coupled to the robotic arm assembly for remotely controlling the robotic arm assembly.
Shelton et al. disclose a robotic surgical system (surgical systems and end effectors may be manually operated or robotically controlled with a control system, [0552]).
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 Graves et al. device, as modified by Chow, to include a control device and robotic arm as taught by Shelton et al., to provide automatic and controlled operation of the surgical device.
With respect to claim 36, Graves et al. fail to disclose the actuation mechanism is operatively coupled to the control device.
Shelton et al. disclose a robotic surgical system (surgical systems and end effectors may be manually operated or robotically controlled with a control system, [0552]).
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 Graves et al. device, as modified by Chow, to include the actuation mechanism operatively coupled to the control device, as taught by Shelton et al., to provide automatic and controlled operation of the surgical device.
With respect to claim 37, Graves et al. fail to disclose a processor configured to transfer motion of the control device to motion of the robotic arm assembly.
Shelton et al. disclose a robotic surgical system (surgical systems and end effectors may be manually operated or robotically controlled with a control system, [0552]).
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 Graves et al. device, as modified by Chow, to include a processor, as taught by Shelton et al., to provide automatic and controlled operation of the surgical device.
With respect to claim 38, Graves et al. disclose a shaft having a proximal end and a distal end and a housing on the proximal end of the shaft (handle portion is elongated and comprises a shaft, having a proximal end a distal end, housing at the proximal end encasing the actuator, fig. 1),
Graves et al. fail to disclose the actuation mechanism comprises a motor disposed within the housing and coupled to the robotic arm assembly.
Shelton et al. disclose a robotic surgical system (surgical systems and end effectors may be manually operated or robotically controlled with a control system, [0552]) including motors for actuating the end effectors ([0552]).
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 Graves et al. device, as modified by Chow, to include a motor, as taught by Shelton et al., to provide automatic and controlled operation of the surgical device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kostrzewski (US Patent Publ. No. 2014/0021239) disclose a staple cartridge (fig. 7).
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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/LINDA J. HODGE/Examiner, Art Unit 3731