DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 02/02/2026 has been entered. Claims 1-3 and 5-19 are pending in the application.
Terminal Disclaimer
The terminal disclaimer filed on 02/27/2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 17/109667 (US PATENT US 11653920 B2) has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7-19, is/are rejected under 35 U.S.C. 103 as obvious over Nicholas et al. (US 20160118201 A1) in view of TAYLOR (US 20140148803 A1) in view of Zimmermann (US 5365155 A).
Regarding claims 7-8 and 15, Nicholas et al. discloses a handle assembly (106/100c) of a surgical instrument system having a surgical end effector (400) having a first jaw (406) and a second jaw (408) movable relative to the first jaw ([0051, 0057, 0077-0079, 0093], figs. 1 and 20-22), the handle assembly comprising: a disposable outer housing (102/106) defining a sterile barrier, the disposable outer housing comprising: a first housing-portion (104); and a second housing-portion (106 or 402) movable relative to the first housing-portion between an open configuration and a closed configuration (fig. 9);
a control inner core (100/142 or 101c) receivable inside the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control inner core within the sterile barrier in the closed configuration ([0052-0053, 0062-0063], fig. 9); and wherein the control inner core comprises a motor assembly (M1, M2, M3 [0052-0061]);
an actuator/pressure-sensitive actuation member (200, 212, switch subassemblies 210, 270, 280)
a magnetic field source (magnet 218/273/288) positionable inside the disposable outer housing; a magnetic field sensor (hall effect sensors 140a, 140b, 140c, 140d) positionable within a sufficient proximity to the magnetic field source to measure at least one parameter of a magnetic field generated by the magnetic field source;
a control circuit (motor controller circuit board 112 and/or printed circuit board 144) configured to: detect changes in the magnitude of an external actuation force applied to the pressure-sensitive actuation member based on measurements by the magnetic field sensor of the at least one parameter of the magnetic field; and adjust drive motions generated by the motor assembly in accordance with the detected changes in the magnitude of the external actuation force, wherein the drive motions generated by the motor assembly are configured to be adjusted proportionally with respect to the detected changes in the magnitude of the external actuation force ([0058-0059, 0064, 0077-0078, 0081-0087, 0093-0095], figs. 2 and 11-17);
the actuator being configured to transfer, across opposite sides of the sterile barrier, actuations applied to the actuator with varying pressures in response to an amount of force applied to the actuator by a user of the surgical instrument system without compromising the sterile barrier to proportionally adjust drive motions of the motor assembly corresponding to the varying pressures (change an intensity of a magnetic flux/ intensity of a magnetic field [0077-0078, 0083-0086, 0093-0095]), the drive motions comprising a closure motion, a firing motion, (actuate first motor M1 to fire and close [0057, 0077-0084, 0093]), an articulation motion or combinations thereof [0066, 0078, 0090-0094].
Nicholas et al. states: “switch subassemblies 210, 270, 280 in operative mechanical and/or electrical communication with motors M1-M3, via hall effect sensors 140a-c” [0064] … alter an intensity of a magnetic field sensed by fourth hall effector sensor 140d. Upon sensing movement of magnet 288, fourth hall effector sensor 140d relays the signal to motor controller circuit board 112 to actuate third motor M3 to rotate end effector 400 [0086] … switch subassemblies 210, 270, 280 can be variously configured, such as, for example, as switches, rockers, flaps, latches, levers, dials, buttons, or touch screens [0087]
Nicholas et al. fails to explicitly disclose the actuator has a pressure-sensitive actuation member, that extends across a cavity defined in a portion of an outer wall of the disposable outer housing defining a sterile barrier, such that edges of the pressure- sensitive actuation member are aligned with sidewalls of the cavity to form a contiguous surface of the outer wall/sterile barrier and a sealed connection with the disposable outer housing and the magnetic field source comprises a wire coil.
TAYLOR teaches an electrosurgical instrument (10) with having a surgical end effector (100) having a first jaw (110) and a second jaw (110) movable relative to the first jaw (both jaws moveable with respect to the other [0045-0046], fig. 2); a disposable outer handle having a disposable outer housing/sterile barrier (20 [0040], fig. 1); an actuator/pressure-sensitive actuation member (40/408) having edges of the actuator/pressure-sensitive actuation member (40) aligned with sidewalls of a cavity to form a contiguous surface of the outer wall defined by a portion of a housing/sterile barrier (20) and a sealed connection with the disposable outer housing (hermetic seal/adhesive layer 541, sealed with housing 20 [0048-0085], figs. 1-10) with actuator/pressure-sensitive actuation member (408) having activation nubs 904 that correspond to switches 404 activated via an external actuation force applied to the pressure-sensitive actuation member [0081-0084] and a flexible circuit board (402) having switch contacts 512 and wired connecting mechanical/electrical interface (510, 520 and wires 754 [0064-0068], figs. 1-7).
Zimmermann teaches having a similar actuator/pressure-sensitive actuation member (push-button 3) with either a protruding actuator/pressure-sensitive actuation member (push-button 3) or an actuator/pressure-sensitive actuation member (push-button 3) having edges (19) of the actuator/pressure-sensitive actuation member (3/19) aligned with sidewalls of a cavity (cavity in housing 2) to form a contiguous surface of the outer wall defined by a portion of a housing/sterile barrier (fig. 3b) using hall sensors and magnets (5/9) or pressure sensor (17) with variable resistance value to control speed, and a magnetic field source (inductive sensor 13/inductive sensor 23, figs. 2, 4b and 5) comprises a wire coil (15/15’/36) for current to flow (col. 3, lines 53-col. 8, line 22, claims 1-5 and 16-18, figs. 1-5).
Given the teachings of Nicholas et al. to have a disposable housing having a sterile barrier with actuators/switches having magnetic sensors and touch screen switches, 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 Nicholas et al.’s actuator to be a pressure-sensitive actuation member , that extends across a cavity defined in a portion of an outer wall of the disposable outer housing defining a sterile barrier, such that edges of the pressure- sensitive actuation member are aligned with sidewalls of the cavity to form a contiguous surface of the outer wall/sterile barrier and a sealed connection with the disposable outer housing and the magnetic field source comprises a wire coil for better magnetic field conduction, having a protective sheath/cover for the button, improved variable adjustment of power/speed, and/or for having flush surface for ergonomic purposes as taught by TAYLOR and Zimmermann.
Regarding claim 9, Nicholas et al. discloses the actuator comprises a stem (214/272) extending from the pressure-sensitive actuation member (toggle button 212/ switch subassembly 270). Zimmermann also teaches the actuator (push-button 3) comprises a stem (20) extending from the pressure-sensitive actuation member (19, fig. 3b) and TAYLOR teaches actuator/pressure-sensitive actuation member (408) comprises a stem (nubs 904).
Regarding claim 10, Nicholas et al. fails to discloses the stem is configured to abut against a rigid surface of the control inner core when the control inner core is properly assembled with the disposable outer housing.
Zimmermann teaches stem (20) is configured to abut against a rigid surface of a control inner core (2, “pressure sensor 17 is, in this embodiment, rigidly connected to pressure plate 19…displacement-free activation of pressure sensor 17”, col. 3, lines 53-col. 8, line 22, figs. 1-4).
TAYLOR teaches stem (nubs 904) is configured to abut against a rigid surface (510) of a control inner core (internal space 120 defined by the housing 20) when the control inner core (20) is properly assembled with a disposable outer housing (80 [0048, 0056-0067], figs. 1-7).
Given the teachings of Nicholas et al. to have a disposable housing having a sterile barrier with actuators/switches having magnetic sensors, switches with stems and touch screen switches, 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 Nicholas et al.’s actuator stem configured to abut against a rigid surface of the control inner core when the control inner core is properly assembled with the disposable outer housing for better magnetic field conduction, having a protective sheath/cover for the button, improved variable adjustment of power/speed, and/or for having flush surface for ergonomic purposes as taught by TAYLOR and Zimmermann.
Regarding claim 11, Nicholas et al. fails to discloses a wire coil is wound around the stem.
Zimmermann teaches a wire coil (15/15’/36) for current to flow and teaches wire coil (15) is wound around a stem (14, col. 3, lines 53-col. 8, line 22, claims 1-5 and 16-18, figs. 1-5).
Given the teachings of Nicholas et al. to have a disposable housing having a sterile barrier with actuators/switches having magnetic sensors, switches with stems and touch screen switches, 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 Nicholas et al.’s actuator stem with a wire coil wound around the stem for better magnetic field conduction, having a protective sheath/cover for the button, improved variable adjustment of power/speed, and/or for having flush surface for ergonomic purposes as taught by Zimmermann.
Regarding claims 11-12 and 16-19, Nicholas et al. discloses the actuator/pressure-sensitive actuation member having a stem (210/272/214, figs. 2 and 10-19), a magnetic sensor (hall effect sensors 140a, 140b, 140c, 140d , magnet 218/273) on a first side of the sterile barrier and a second side of the sterile barrier and a control circuit in communication with the magnetic sensor adjust drive motions generated by the motor assembly in accordance with the changes in the actuation force, wherein the control circuit (motor controller circuit board 112) is further configured to adjust the drive motions in accordance with the changes in the actuation force up to a predetermined threshold ([0077-0078, 0083-0086], figs. 2 and 11-17).
Nicholas et al. fails to discloses the control inner core power source is configured to energize a wire coil on the stem, the actuator comprises: a ferromagnetic member on a first side of the sterile barrier; and wherein the control circuit is configured to: detect changes in an actuation force applied to the ferromagnetic member based on measurements by the magnetic sensor; and wherein the ferromagnetic member is aligned with the magnetic sensor when the disposable outer housing is properly assembled with the control inner core and the magnetic field source comprises a wire coil.
Zimmermann teaches a control inner core power source (semiconductor layer 6/Printed circuit board 7 provides current) is configured to energize a wire coil (15) on the stem (14, fig. 2), and teaches having a ferromagnetic member (9/9’) on a first side of a sterile barrier (2); and wherein a control circuit is configured to: detect changes in an actuation force applied to the ferromagnetic member based on measurements by a magnetic sensor (5); and wherein the ferromagnetic member is aligned with the magnetic sensor (col. 3, lines 53-col. 8, line 22, claims 1-5 and 16-18, figs. 1-5).
TAYLOR teaches stem (nubs 904) is configured to abut against a rigid surface (510) of a control inner core (internal space 120 defined by the housing 20) when the control inner core (20) is properly assembled with a disposable outer housing (80 [0048, 0056-0067], figs. 1-7).
Given the teachings of Nicholas et al. to have a disposable housing having a sterile barrier control inner core inside with actuators/switches having magnetic sensors, switches with stems and touch screen switches, 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 Nicholas et al.’s control inner core power source configured to energize a wire coil on the stem, the actuator comprise a ferromagnetic member on a first side of the sterile barrier; and wherein the control circuit is configured to: detect changes in an actuation force applied to the ferromagnetic member based on measurements by the magnetic sensor; and wherein the ferromagnetic member is aligned with the magnetic sensor when the disposable outer housing is properly assembled with the control inner core and the magnetic field source comprises a wire coil for better magnetic field conduction, having a protective sheath/cover for the button, improved variable adjustment of power/speed, and/or for having flush surface for ergonomic purposes as taught by TAYLOR and Zimmermann.
Regarding claims 13-14, Nicholas et al. discloses the control circuit
is further configured to adjust the drive motions in accordance with the changes in the external actuation force up to a predetermined threshold
(change an intensity of a magnetic flux/ intensity of a magnetic field [0077-0078, 0083-0086, 0093-0095]), wherein the disposable outer housing comprises a flexible display (touch screen and/or wireless modules 114, 116 (e.g., an RF module), and/or a flex circuit 118 [0052-0053, 0086-0087], figs. 2-5 and 9). TAYLOR teaches also teaches the outer housing comprises a flexible display (1002/clock 1014 - digital signal processor, microprocessor [0085-0088] and additional electrical devices 756 [0093], figs. 1-10).
Allowable Subject Matter
Claims 1-3 and 5-6 are allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a loading unit for a handle assembly for use with a surgical instrument system comprising all the structural and functional limitations and further comprising a disposable outer housing defining a sterile barrier, the disposable outer housing comprising: a first housing-portion; and a second housing-portion movable relative to the first housing-portion between an open configuration and a closed configuration; a control inner core receivable inside the disposable outer housing in the open configuration, wherein the disposable outer housing is configured to isolate the control inner core within the sterile barrier in the closed configuration; a wireless electrical interface assembly configured to effect at least one wireless transmission of at least one of data and power through the sterile barrier, the wireless electrical interface assembly comprising: a first wireless-interface portion on a first side of the sterile barrier; and a second wireless-interface portion on a second side of the sterile barrier opposite the first side, wherein the first wireless-interface portion is configured to cooperate with the second wireless-interface portion to facilitate the at least one wireless transmission of the at least one of data signal and power through the sterile barrier; and a wired electrical interface assembly configured to effect at least one wired transmission of the at least one of data and power through the sterile barrier, the wired electrical interface assembly comprising: a first wired-interface portion on the first side of the sterile barrier; a second wired-interface portion on the second side of the sterile barrier opposite the first side; and a connector, comprising: a body extending through an outer wall of the disposable outer housing; a first contact extending from the body, wherein the first contact is releasably attachable to the first wired-interface portion; and a second contact extending from the body, wherein the second contact is releasably attachable to the second wired-interface portion wherein the first wireless-interface portion and the first wired-interface portion are defined in an outer wall of the control inner core wherein the first wireless-interface portion is magnetically couplable to the second wireless-interface portion. Though Nicholas et al. (US 20160118201 A1) teaches a similar disposable sterile outer housing, it would not be obvious to modify the disposable sterile outer housing with having the wireless electrical interfaces on the inner core member inside the disposable sterile outer housing and communicating with wireless electrical interfaces on disposable sterile outer housing along with having wired connections wherein the first wireless-interface portion is magnetically couplable to the second wireless-interface portion since the housing and switches of Nicholas et al. uses mechanical switches and one of ordinary skill would recognize that a wireless interface on both the inner core and outer housing to be magnetically coupled could not be done without having to add other electronics to function with the two wireless electrical interface system. Having the sterile protection along with electronic communication provides and effective protective outer sheath/housing with electronic communication.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
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.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 5-19 have been considered but are moot because the new ground of rejection does not rely on all references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Also, the phrase “when the control inner core is properly assembled with the disposable outer housing” (claims 10 and 19) is not limiting and “properly assembled” is not limited to any structural or functional limitation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20180325517 A1 –housing with wireless interface & inner core
US 20160310134 A1 – core 101, housing 10a/10b, display 146
US 20130168435 A1- button 152 flush with housing 103 [0174] and see references cited, form 892.
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 ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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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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/ROBERT F LONG/ Primary Examiner, Art Unit 3731