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 .
Election/Restrictions
Applicant’s election without traverse of Species D and Species IV (directed to claims 1 and 12-24) in the reply filed on 07/06/2026 is acknowledged. Claims 2-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Information Disclosure Statement
The Information Disclosure Statement (IDS) dated 12/13/2023 has been considered by the Examiner.
Claim Objections
Claim 20 objected to because of the following informalities: ‘wherein the articulating portion and the second articulating bother have’ should read ‘wherein the articulating portion and the second articulating both have’. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 12, 13, 15-17, 19, 22, and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Traina (US 20200345435 A1).
Regarding claim 1, Traina teaches surgical device (200) comprising:
a shaft (204) comprising a sheath,
an internal torque transmission shaft within the sheath (203), and
an articulating portion (see Figs. 5-6; articulating joints 210 and 212) comprising an articulating sheath forming a portion of the sheath (Fig. 5-6) and
an articulating wrist (203b) within the articulating sheath and forming a portion of the torque transmission shaft (see Fig. 10, [0058]; firing assembly 203b of drive assembly 203 comprising drive shaft 220, ball shaft 222, first bearing 224, first ball housing 226, first dual ball shaft 228, second bearing 230, second ball housing 232, second dual ball shaft 234, third bearing 236, and drive coupler 238),
wherein the articulating portion defines one or more degrees of rotational freedom so that the shaft may rotate around one or more axes at the articulating portion to bend the shaft (see Fig. 16; where the articulating portion defines one or more degrees of rotational freedom);
a base unit (202/203) coupled to a proximal end of the shaft (see Fig. 2, [0044]; surgical instrument 200 includes housing 202 at the proximal end of the elongated shaft 204), wherein the base unit is configured to cause the torque transmission shaft to rotate relative to the sheath (see [0045-0048]; housing 202 supports drive assembly 203 which allows for an articulation/rotation/pitch/yaw of wrist assembly 206 and/or end effector 300, [0059]; drive shaft 220 of drive assembly 203 is operably coupled to one or more motors 50 in order to enable drive shaft 220 to rotate about longitudinal axis L-L), and
wherein the base unit (202/203 is configured to actuate the articulating portion (210, 212) to cause the shaft to bend around the one or more axes (see [0070]; one or more cables 205 of cable drive assembly 203a of drive assembly 203 are axially translated to cause one or both of first and second joints 210, 212 of wrist assembly 206 to rotate and/or articulate) while the torque transmission shaft is rotating (see [0070]; one or more components of the firing assembly 203b, 226/228/232/234 may pivot, rotate, and/or articulate as first and second joints 210, 212 pivot, rotate, and/or articulate); and
an end effector (300) coupled to the shaft (204), wherein the end effector is configured to be rotated by rotation of the torque transmission shaft (see [0066]; end effector 300 can rotate with firing assembly 203b of drive assembly 203).
Regarding claim 12, Traina teaches the surgical device of claim 1, wherein the articulating portion defines exactly two degrees of rotational freedom (see [0048]; drive cables 205 of drive assembly 203 of wrist 206 are positioned such that they may provide articulation in multiple axes, e.g. two; see also Fig. 16 which pictures wrist 206 defining exactly two degrees of rotational freedom).
Regarding claim 13, Traina teaches the surgical device of claim 12, wherein the articulating sheath comprises:
a distal portion (212b) defining a first pair of projections (212k);
a proximal portion (210a) defining a second pair of projections (210k); and
a central portion (210b and 212a) defining a first pair of axles (212r) and a second pair of axles (210r) around a central opening (210m/212m);
wherein the first pair of axles (212r) are rotationally coupled to the first pair of projections (212k) and the second pair of axles (210r) are rotationally coupled to the second pair of projections (210k) to define the two degrees of rotational freedom (see [0051]; proximal portion 210 includes a proximal segment 210a and a distal segment 210b which are pivotable coupled together by links 210c, 210d, [0055-0056]; links 210c, 210d of the proximal portion 210 receive projections 210k and axles 210r to secure the portions together and enable the segments to articulate relative to one another; distal portion 212 of wrist assembly 206 is identical to proximal portion 210, but is angularly displaced 90 degrees so that the distal and proximal portions can interconnect and articulate/pivot relative to one another), and
wherein the articulating wrist (203b) extends between first pair of projections (212k), through the central opening (210m/212m), and between the second pair of projections (210k). See annotated Fig. 5 below and Fig. 7 for exploded view.
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Regarding claim 15, Traina teaches the surgical device of claim 1, wherein the shaft (204) comprises a second articulating portion (212) comprising a second articulating sheath (212a, 212b) and a second articulating wrist (232, 234, 236). See annotated Fig. 5 below where joint 210 is considered the first articulating portion having a first wrist (203b comprising 222, 224, 226, 228, 230 seen in Figs. 7 and 11) and joint 212 is considered the second articulating portion having a second wrist (203b comprising 232, 234, 236) wherein each articulating portion defines one degree of rotational freedom.
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Regarding claim 16, Traina teaches the surgical device of claim 15, the second articulating sheath is identical to the articulating sheath (see [0056]; second joint 212 of wrist assembly 206 is identical to the first joint 210), and the second articulating wrist is identical to the articulating wrist (see Fig. 8 wherein the first and second articulating wrists are identical to one another).
Regarding claim 17, Traina teaches the surgical device of claim 15, wherein the second articulating portion is directly coupled to the articulating portion (see annotated Fig. 5 above where the second articulating portion 212 is directly coupled to the articulating portion 210).
Regarding claim 19, Traina teaches the surgical device of claim 15, wherein an axis of a degree of freedom of the second articulating portion and is perpendicular to an axis of a degree of freedom of the articulating portion (see [0056]; second joint 212 of wrist assembly 206 is identical to first joint 210 but is angularly displaced, e.g. 90 degrees, relative to the first joint 210 so that the first and second joints 210, 212 can interconnect and articulate/pivot relative to one another).
Regarding claim 22, Traina teaches a system comprising:
the surgical device (200) of claim 1 (see above);
a controller (4); and
a user interface (5) coupled to the controller (see [0040]; operating console 5 couples with control device 4) and
configured to allow a user to control actuation of the articulating portion, wherein the user interface comprises at least one 2 degree of freedom knob, or 2 degree of freedom joystick (see [0041]; operating console 5 includes a display device 6 and manual input devices 7, 8, which allow a clinician to telemanipulate the robotic arms which may be composed of any number of members, which may be connected through any number of joints).
Regarding claim 24, the claimed limitation of ‘where the user interface is configured to be draped while allowing the user to control actuation of the articulating portion during a surgical procedure so that the user interface remains sterile’ is identified as the recitation of the intended use of the claimed invention and does not result in a structural difference between the claimed invention and the prior art that patentably distinguishes the claimed invention from the prior art. The structure of the prior art is capable of performing the intended use, wherein the user interface is draped while allowing the user to control actuation of the articulating portion during a surgical procedure so that the user interface remains sterile and there is no suggestion that any structural limitation of the prior art device would preclude this function.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Traina (US 20200345435 A1) in view of Burbank (US 20110118707 A1).
Regarding claim 14, Traina teaches the surgical device of claim 13, wherein the articulating wrist comprises a universal joint comprising a distal shaft portion (distal portion 226i of housing 226 annotated in Fig. 11 below); a proximal shaft portion (proximal portion 226a of housing 226 annotated in Fig. 11 below); first central portion (228a) pivotably coupled to the distal shaft portion (see Traina [0063]; pin hole 228m of ball pin 228k and elongated slot 228n of ball member 228a are configured to receive pin 226m of first ball housing 226 to rotatably/articulatably couple first dual ball shaft 228 to first ball housing 226); and
a second central portion (222h) pivotably coupled to the proximal shaft portion (see Traina [0061]; first ball housing 226 of firing assembly 203b of drive assembly 203 has a proximal shell 226a that rotatably received ball member 222h).
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Traina is silent regarding wherein the first central portion comprises a first projection and the second central portion comprises a pair of second projections defining a slot;
wherein the first projection is received within the slot to form a sliding joint configured to allow a transfer of rotation of the torque transmission shaft between the first central portion and the second central portion.
Burbank teaches systems for surgical tools having two degree-of-freedom wrist articulation by linked tension members, and mechanisms for transmitting torque through an angle (Burbank, Abstract),
wherein the articulating wrist comprises a double hinge sliding joint comprising a distal shaft portion, a proximal shaft portion (see annotated Burbank Fig. 19c below),
a first central portion (396) pivotably coupled to the distal shaft portion and comprising a pair of first projections defining a slot (434, see annotated Burbank Fig. 19c below); and
a second central portion (392) pivotably coupled to the proximal shaft portion and comprising a second projection (432);
wherein the second projection is received within the slot to form a sliding joint configured to allow a transfer of rotation of the torque transmission shaft between the first central portion and the second central portion (see annotated Burbank Fig. 19c below, [0157-0158]).
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It can be appreciated that in the prior art device of Burbank, the first central portion pivotably coupled to the distal shaft portion comprises the pair of projections defining a slot and the second central portion pivotably coupled to the proximal shaft portion comprises a projection received within the slot, which mirrors the configuration of the claimed invention. This can be held to be a mere rearrangement/reversal of parts that would not modify the operation of the device and therefore does not create any patentable difference between the claimed device and the prior art device. The matter of arrangement of the first and second projections would have been an obvious matter of design choice. See MPEP 2144.04(VI), In re Gazda, 219 F.2d 449, In re Japikse, 181 F.2d 1019.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the articulating wrist as taught by Traina with the first and second projections configured to couple to one another as disclosed by Burbank. One of ordinary skill in the art would have been motivated to make this modification in order to provide a desired shaft angle constraint via the joint configuration for increased control of the joint articulation (Burbank [0157]).
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Traina (US 20200345435 A1) in view of Cooper et al (US 20170056118 A1).
Regarding claim 18, Traina teaches the surgical device of claim 15. Traina is silent regarding wherein the shaft comprises a rigid sheath portion and a rigid torque transmission shaft portion between the second articulating portion and the articulating portion.
Cooper teaches a surgical device comprising a shaft comprising a sheath (916) and an articulating portion (914) wherein the articulating portion defines one or more degrees of rotational freedom so that the shaft may rotate around one or more axes at the articulating portion to bend the shaft (see Cooper Fig. 17, [0120]),
wherein the shaft comprises a rigid sheath portion (918) and a rigid torque transmission shaft portion (919) between the second articulating portion (912) and the articulating portion (910, see Figs. 16-17, [0118]; parallel motion mechanism 910 may include a straight shaft section 916 that separates a proximal joint mechanism 912 from a distal joint mechanism 914).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Traina’s surgical device having an articulating portion and a second articulating portion with a section of rigid shaft in between the articulating portions as taught by Cooper. One of ordinary skill in the art would have been motivated to make this modification in order to utilize a parallel motion mechanism to control the relative orientations of the articulating portions in two or more dimensions (Cooper [0119-0121]).
Regarding claim 20, Traina teaches the surgical device of claim 15. Traina is silent regarding wherein the articulating portion and the second articulating portion both have exactly two degrees of freedom.
Cooper teaches wherein the articulating portion and the second articulating portion both have exactly two degrees of freedom (see Cooper [0112]; a wrist comprising a series of connected disks in an ABAB configuration with two degrees of freedom, and Fig. 16 wherein articulating portion 914 and second articulating portion 912 comprise a series of connected disks in an ABAB configuration, resulting in two degrees of freedom, which can be seen in Fig. 17 which pictures both articulating portions capab;e of articulation in the X-Y space).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Traina’s surgical device having an articulating portion and a second articulating portion with an articulating portion and second articulating portion both having exactly two degrees of freedom as taught by Cooper. One of ordinary skill in the art would have been motivated to make this modification in order to utilize a parallel motion mechanism to control the relative orientations of the articulating portions in the X-Y space but minimize or prevent bending motion along an arc (Cooper [0121]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Traina (US 20200345435 A1) in view of Saadat et al (US 20080009747 A1).
Regarding claim 21, Traina teaches the surgical device of claim 1. Traina is silent regarding the surgical device further comprising an anchoring system coupled to the shaft,
wherein the anchoring system comprises a plurality of beams,
wherein the beams are configured to be bowed and pressed against bodily tissue during a procedure in order to maintain a position of a distal portion of the articulating portion
so that the end effector can be moved by the articulating portion relative to the anchor.
Saadat teaches a surgical device (Figs. 6A-6C) comprising a shaft (16) and an articulatable end effector (imagine assembly 10) further comprising an anchoring system (76) coupled to the shaft
wherein the anchoring system comprises a plurality of beams (see Saadat Figs. 6A-6C, [0185]; to facilitate stabilization of the deployment catheter 16, anchors 76, which may utilize mesh members, malecots, or any other temporary expandable structure)
wherein the beams are configured to be bowed and pressed against bodily tissue during a procedure in order to maintain a position of a distal portion of the articulating portion (see Saadat Figs. 6A-6C, [0185]; the anchors may be deployed in order to stabilize the catheter 16 in a position relative to the heart) so that the end effector can be moved by the articulating portion relative to the anchor (see Saadat Figs. 6A-6C, [0178]; to position the imaging assembly including imaging hood 12 at various regions within the body, a number of articulation and manipulation controls may be utilized, it can be appreciated that in Figs. 6A-6C that the anchoring portions 76 are located so that the imaging assembly can be articulated while the anchoring assembly keeps the catheter in place).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the surgical device of Traina with the anchoring assembly as taught by Saadat. One of ordinary skill in the art would have been motivated to make this modification in order to stabilize the shaft of the device in a desired position near the surgical site while allowing the end effector to remain articulatable (Saadat [0185]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Traina (US 20200345435 A1) in view of Marshall et al (US 20170021508 A1).
Regarding claim 23, Traina the system of claim 22 further comprising a robotic arm coupled to the surgical device (see Traina [0040]; any of the surgical robotic arms 2, 3, may have a robotic surgical assembly 100 and an electromechanical surgical instrument 200 coupled thereto). Traina is silent regarding the system further comprising a first force/torque sensor coupled to the robotic arm and the controller; and
a second force/torque sensor coupled to articulating portion of the surgical device and the controller;
wherein the controller is configured to allow the user to control the surgical device and the robotic arm in a collaborative manner based on signals from the first force/torque sensor and the second force/torque sensor.
Marshall teaches a system comprising a surgical device comprising an articulating portion (5) which allows for the articulation of an attached surgical instrument (see Marshall [0040]; wrist 5 couples one limp 3b to the most distal limb 3c of the arm, limb 3c carries an attachment 8 for a surgical instrument 9), and
a robotic arm (1) coupled to the surgical device (Fig. 1);
a first force/torque sensor (7) coupled to the robotic arm and the controller (see Marshall Fig. 1, [0040]; each joint 4 of the arm has one or more position and/or torque sensors 7, [0041]; the control unit 10 is coupled to the sensors 7); and
a second force/torque sensor (7) coupled to articulating portion of the surgical device and the controller (see Marshall Fig. 1, [0040]; each joint 4 of the arm has one or more position and/or torque sensors 7 including near wrist 5, [0041]; the control unit 10 is coupled to the sensors 7)
wherein the controller (10) is configured to allow the user to control the surgical device and the robotic arm in a collaborative manner based on signals from the first force/torque sensor and the second force/torque sensor (see Marshall [0041]; control unit 10 comprises a processor 11 and memory 12 wherein memory 12 stores instructions executable by the processor to control the operation of the motors to drive in dependence on inputs from the sensors 7).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Traina’s system with Marshall’s torque sensors coupled to the robotic arm and articulating portion and the controller. One of ordinary skill in the art would have been motivated to make this modification in order to control the robotic arm and articulating portion appropriately based on the current configuration and/or load at the joint(s) at any given moment to perform a desired surgical procedure (Marshall [0040-0041]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Light et al (US 20170095922 A1) which teaches medical devices having smoothly articulating multi-cluster joints.
Stroup et al (US 20130267936 A1) which teaches a wrist assembly for articulating laparoscopic surgical instruments.
Vetter et al (US 20200315652 A1) which teaches excisional devices and methods.
Simi et al (US 20180250085 A1) which teaches an articulatable surgical tool comprising a robotic arm and wrist assembly.
Chin et al (US 20200197112 A1) teaches an apparatus comprising a shielded wrist for a robotic arm having an articulatable end effector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
