DETAILED ACTION
This action is pursuant to claims filed on 6/5/2025. Claims 1-17 are pending. A first action on the merits of claims 1-17 is as follows.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the insulating sleeve of claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 590. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 11-17 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 11 is rejected because the single jaw wire in light 8 cannot also be multiple wires as required in lines 12-14. It can either be a single jaw wire or a plurality of jaw wires, but not both. For the purposes of compact prosecution, this will be interpreted as a plurality of jaw wires.
Claims 12-17 are rejected due to their dependance on claim 11.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Worrell (US 20220133388 A1).
Regarding independent claim 1, Worrell discloses a surgical instrument (Fig. 2) comprising:
an end tool (end effector 204 which includes jaws 210 and 212 and jaw holders 414a and 414b) rotatable in at least one direction ([0026]: end effector can rotate) and including a first jaw and a second jaw opposite to the first jaw (opposed jaws 210 and 212 that include 414a,b of Figs. 5-8);
a manipulation part (drive housing 208) configured to control a rotational motion of the end tool ([0026]: The housing 208 includes (contains) various mechanisms designed to control operation of various features associated with the end effector 204 (e.g., clamping, firing, rotation, articulation, energy delivery, etc.)), connected to an external power supply ([0033]: the surgical tool may be supplied with power via a cable 214; this cable is connected to the housing as seen in Fig. 2), and further configured to transmit an electrical energy provided by the external power supply to the end tool ([0034]: the power cable places the surgical tool in communication with the generator that supplies energy, particularly to the end effector 204; [0048]: the power cable 214 is electrically coupled to the conductor 418 that supplied energy to the end effector at the drive housing); and
a connection part (shaft 202) configured to connect the end tool to the manipulation part (connects end effector 204 to drive housing 208 as seen in Fig. 2),
wherein the end tool further includes a coupling hub (wrist 206) connected to one end of the connection part (connected onto end of shaft 202 as seen in Fig. 2), and
the first jaw includes a first jaw electrode part ([0035]: the jaws can contain or serve as the electrodes) electrically connected to the external power supply and configured to receive the electrical energy ([0055]: the electrical conductor energizes one or both jaws 210 and 212 for operation), and a first jaw insulating part (first jaw holder 414a; [0055]: the jaw holders may be made of non-conductive material) disposed between the first jaw electrode part and the coupling hub (disposed between conductive jaw portion 210 and the hub as seen in Figs. 7 and 8a) and configured to insulate the first jaw electrode part (the non-conductive material provides for insulation around the base of conductive jaw portion as seen in Fig. 8a).
Regarding claim 2, Worrell discloses the surgical instrument of claim 1, wherein
the coupling hub is electrically connected to the external power supply and receives the electrical energy ([0055]: the conductor adapter 426 may contact and otherwise been in electrical engagement with the distal clevis 402a, which transmits the electrical energy supplied by the electrical conductor 418 to at least one of the jaws; the conductor adapter and the distal clevis are part of the coupling hug as seen in Figs. 4-6), and
the second jaw receives the electrical energy through the coupling hub ([0055]: energy is supplied to at least one of the jaws to energize one or both of the jaws; thus the second jaw can receive the electrical energy).
Regarding claim 3, Worrell discloses the surgical instrument of claim 2, wherein at least a portion of the second jaw, which is in contact with the coupling hub, is formed of a conductive material ([0037]: wrist includes the axle 404a connected to distal clevis 402a; electrical energy is conducted to the jaws 210, 212 through the first axle 404a; thus there is contact with the portion of the second jaw 212 and the coupling hub portion 404a and the jaw portion that contacts the axle is made of a conductive material since that is how the jaw is energized by the axle; [0035]: the jaws serve as the electrodes – thus 210 and 212 must be made of conductive material in order to serve as the electrodes).
Regarding claim 4, Worrell discloses the surgical instrument of claim 3, wherein
the coupling hub includes an end tool hub coupled to one end of the end tool (end tool hub is the distal clevis 402a and the axle 404a coupled to end tool as seen in Fig. 4), and a pitch hub (remainder of wrist 206 comprising pulleys coupled to axles 404c and 404b) configured to connect the end tool hub to the connection part (connects the distal clevis 402a and the shaft 202 as seen in Fig. 4) and disposed to at least partially overlap the end tool hub (the distal clevis 402a overlaps with the axle 404b as seen in Fig. 4),
wherein at least one of the end tool hub and the pitch hub comprises conductive material ([0055]: electrical energy is conducted to the jaws through axle 404a; thus the axle 404a must be made of a conductive material in order to conduct the energy and axle 404a is part of the end tool hub).
Claim(s) 1, 7, 10-13, and 15-17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Murrell et al. (hereinafter ‘Murrell’, US 20250025224 A1).
Regarding independent claim 1, Murrell discloses a surgical instrument (Fig. 2) comprising:
an end tool (end effector 204) rotatable in at least one direction ([0025]: end effector can rotate) and including a first jaw and a second jaw opposite to the first jaw (opposed jaws 210 and 212 including molded components 512 in Figs. 5-8);
a manipulation part (drive housing 208) configured to control a rotational motion of the end tool ([0025]: The housing 208 includes (contains) various mechanisms designed to control operation of various features associated with the end effector 204 (e.g., clamping, firing, rotation, articulation, energy delivery, etc.)), connected to an external power supply ([0031]: the surgical tool may be supplied with power via a cable 214 coupled to housing 208), and further configured to transmit an electrical energy provided by the external power supply to the end tool ([0032]: the power cable places the surgical tool in communication with the generator that supplies energy, particularly to the end effector 204); and
a connection part (shaft 202) configured to connect the end tool to the manipulation part (connects end effector 204 to drive housing 208 as seen in Fig. 2),
wherein the end tool further includes a coupling hub (wrist 206) connected to one end of the connection part (connected onto end of shaft 202 as seen in Fig. 2), and
the first jaw includes a first jaw electrode part ([0033]: the jaws can contain or serve as the electrodes) electrically connected to the external power supply and configured to receive the electrical energy ([0033]: the electrodes of the jaws receive current from the power cable), and a first jaw insulating part (first jaw holder 414a; [0052]: the jaw holders are configured to encapsulate and insulate the supply conductor and are made of a non-conductive material) disposed between the first jaw electrode part and the coupling hub (disposed between conductive jaw portion 210 and the hub as seen in Fig. 4) and configured to insulate the first jaw electrode part (the non-conductive material provides for insulation around the base of conductive jaw portion as seen in Fig. 5).
Regarding claim 7, Murrell discloses the surgical instrument of claim 1, wherein the second jaw includes a second jaw electrode part [0033]: the jaws can contain or serve as the electrodes) electrically connected to the external power supply and configured to receive the electrical energy ([0033]: the electrodes of the jaws receive current from the power cable), and a second jaw insulating part (jaw holder 414b; [0052]: the jaw holders are configured to encapsulate and insulate the supply conductor and are made of a non-conductive material; [0048]: the description of the fist jaw holder is equally applicable to the second jaw and the second jaw holder) disposed between the second jaw electrode part and the coupling hub (disposed between conductive jaw portion 212 and the hub as seen in Fig. 4) and configured to insulate the second jaw electrode part (the non-conductive material provides for insulation around the base of conductive jaw portion as seen in Fig. 5).
Regarding claim 10, Murrell discloses the surgical instrument of claim 7, wherein
the end tool further includes a plurality of pulleys (416a and 416b) disposed on the coupling hub (disposed on clevis 402a as seen in Fig. 4) and configured to transmit power for rotating the end tool ([0044]: the pulleys receive and seat drive cables to effect movement of the end effector),
wherein at least one of the plurality of pulleys guides, to the first jaw electrode part, a first electric wire (first pulley on jaw 210 guides wire 418 to electrode part as seen in Figs. 6a-6d) which is electrically connected to the external power supply and through which the electrical energy is transmitted to the first jaw electrode part ([0045]: cable 418 is electrically coupled to power cable 214 to deliver energy to the end effector; it is connected to the electrode part as seen in Fig. 6C and 7A), and guides, to the second jaw electrode part, a second electric wire which is electrically connected to the external power supply and through which the electrical energy is transmitted to the second jaw electrode part ([0046]: electrical conductor 418 may extend to both jaws; [0050]: in bipolar configuration, a second electrical conductor may extend to and be electrically coupled to the second jaw 212; [0048]: the description of the first jaw and jaw holder is equally applicable to the second jaw and the second jaw holder; thus the structure of the pulley and cable is the same for both jaws).
Regarding independent claim 11, Murrell discloses a surgical instrument (Fig. 2) comprising:
an end tool (end effector 204) rotatable in at least one direction ([0025]: end effector can rotate) and including a first jaw and a second jaw opposite to the first jaw (opposed jaws 210 and 212 including molded components 512 in Figs. 5-8);
a manipulation part (drive housing 208) configured to control a rotational motion of the end tool ([0025]: The housing 208 includes (contains) various mechanisms designed to control operation of various features associated with the end effector 204 (e.g., clamping, firing, rotation, articulation, energy delivery, etc.)), connected to an external power supply ([0031]: the surgical tool may be supplied with power via a cable 214 coupled to housing 208), and further configured to transmit an electrical energy provided by the external power supply to the end tool ([0032]: the power cable places the surgical tool in communication with the generator that supplies energy, particularly to the end effector 204);
a connection part (shaft 202) configured to connect the end tool to the manipulation part (connects end effector 204 to drive housing 208 as seen in Fig. 2); and
a power transmission part (shaft adapter 400) connected to the manipulation part ([0034]: the shaft adapter is connected to the shaft 202; the shaft 202 is connected to the manipulator part as seen in Fig. 2) and including a plurality of jaw wires (includes jaw wires 408a-d and 418) configured to transmit a rotation of the manipulation part to the end tool ([0039]: drive cables 408a-d actuate the end effector),
wherein the end tool further includes a coupling hub (wrist 206) connected to one end of the connection part (connected onto end of shaft 202 as seen in Fig. 2), and
the jaw wire includes a first jaw wire positioned on the coupling hub (wire 418 connected to jaw 210 as seen in Figs. 6a-6d; positioned on coupling hub as seen in Fig. 4) and electrically connected to the first jaw ([0045]: cable 418 is electrically coupled to power cable 214 to deliver energy to the end effector; it is connected to the electrode part as seen in Fig. 6C and 7A), and a second jaw wire positioned on the coupling hub and electrically connected to the second jaw ([0046]: electrical conductor 418 may extend to both jaws; [0050]: in bipolar configuration, a second electrical conductor may extend to and be electrically coupled to the second jaw 212; [0048]: the description of the first jaw and jaw holder is equally applicable to the second jaw and the second jaw holder; thus a second electrical cable can connect to the second jaw in the same manner as the first).
Regarding claim 12, Murrell discloses the surgical instrument of claim 11, wherein
the first jaw includes a first wire-contact part (contact plate 606) that is coupled to the coupling hub (coupled to the coupling hub through the jaw holder 414a which connects to the distal clevis of the coupling hub) and in contact with a portion of a first electric wire part (508) of the first jaw wire (in contact with a portion of the first electric wire part of the first jaw wire as seen in Fig. 6C), and
the second jaw includes a second wire-contact part that is coupled to the coupling hub and in contact with a portion of a second electric wire part of the second jaw wire ([0048]: the description of the first jaw and jaw holder is equally applicable to the second jaw and the second jaw holder; the second jaw and holder comprise the same parts as the first jaw and holder).
Regarding claim 13, Murrell discloses the surgical instrument of claim 12, wherein the end tool further includes an insulating sleeve (sleeve 510) disposed between the first wire-contact part and the second wire-contact part (the sleeve 510 extends up to the contact plate as seen in Fig. 6C; the jaws are opposite each other as seen in Fig. 4, thus a portion of the sleeve is between parts of the two contact plates), and formed of an insulating material ([0050]: sheath 510 is an insulation sheath).
Regarding claim 15, Murrell discloses the surgical instrument of claim 11, wherein the jaw wire includes an electric wire part (portion 508) connected to the external power supply ([0050]: conductor 418 has a conductive part 508 that provides electrical energy to the jaw; [0045]: cable 418 couples to power cable 214) and formed of a conductive material(508 conducts energy and thus is formed of a conductive material), and a cover part surrounding the electric wire part and formed of an insulating material (cover 510; [0050]: 510 is an insulation sheath encasing conductor 508).
Regarding claim 16, Murrell discloses the surgical instrument of claim 15, wherein the cover part is formed as a sheath surrounding the electric wire part ([0050]: 510 is an insulation sheath and surrounds the electric wire part as seen in Fig. 6C).
Regarding claim 17 Murrell discloses the surgical instrument of claim 15, wherein the cover part is formed as a tube coupled to the electric wire part (510 is tubular and coupled to 508 as seen in Figs. 5, 6C, 7A, 7C, and 8A-C).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Worrell as applied to claim 2/1 and described above.
Regarding claim 5, Worrell discloses the surgical instrument of claim 2, wherein the end tool further includes a plurality of pulleys ([0046]: jaw holders 414a,b define pulleys) disposed on the coupling hub (these pulleys are disposed on the distal clevis 402a and on axle 404a as seen in Fig. 4) and configured to transmit power for rotating the end tool ([0046]: the pulleys work with the drive cables to effect rotation of the jaws).
However, Worrell discloses multiple embodiments in which the jaw holders 414a,b may or may not be conductive ([0056]).
Worrell states that 414a,b may be made or conductive material or 414a,b may be made of non-conductive material ([0056]). This creates three possibilities. Namely, both 414a and 414b are conductive, both 414a and 414b are non-conductive, or one is conductive and one is non-conductive. Worrell further states that when the tool functions in a bipolar configuration, the opposing jaws are isolated from one another to control the current pass through the tissue and that one must function as the supply and one must function as the return ([0036]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Worrell such that the jaw holder 414a of the first jaw is non-conductive and 414b of the second jaw is conductive. Doing so is merely one of several possibilities from which one of ordinary skill in the art would select to form the jaw holders in light of the options presented by Worrell and would result in isolation between the jaws in the bipolar configuration as well as the pully of the second jaw holder being made of a conductive material.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Worrell as applied to claim 5/2/1 and described above in view of Lee et al. (hereinafter ‘Lee’, WO 2022177366 A1).
Regarding claim 6, Worrell discloses the surgical instrument of claim 5 as described above. Worrell further states that the jaws are isolated from each other and function as a supply and return in the bipolar configuration ([0036]). Worrell further states that the distal clevis of the wrist can energize at least one of the jaws ([0056]). This indicates that one jaw, in this case the second jaw 212, can be energized by the clevis while the other remains isolated from the current supplied by the distal clevis in order to function in the bipolar configuration.
However, Worrell is silent to the current path of the of the fist jaw when it is not energized by the distal clevis.
Lee teaches a surgical instrument and end tool which can be rotated in multiple directions for electrocautery, similar to the device of Worrell ([Abstract]). Lee further teaches that the jaws are connected to the external power source by wires 411 and 412 ([Page 15 of translation]). As seen in Figs. 8 and 78, the electrical wires route around and are guided by the pulleys to connect to the conductive portion of the jaws. Modifying Worrell such that a wire is used to form the conductive path to the conductive portion of the first jaw would maintain operability since the wire can energize the first jaw or act as a return path and would provide for electrical isolation between the first and second jaws which is required for bipolar operation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Worrell to incorporate the teachings of Lee to route a wire around the pulley to the first electrode. Doing so is merely one of several possibilities from which one of ordinary skill in the art would select to form a conductive path between an electrode and a power supply.
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Murrell as applied to claim 7/1 and 12/11, respectively, and described above in view of Hibner et al. (hereinafter ‘Hibner’, US 20250177033 A1).
Regarding claim 8, Murrell discloses the surgical instrument of claim 7 as described above.
However, Murrell is silent to the coupling hub being formed of an insulative material.
Hibner teaches a surgical tool that includes a drive housing, shaft, wrist, and end effector, similar to the device of Murrell ([Abstract]). The device can further include a protective sleeve 1002 that is configured to insulate live portions of the wrist to protect the patient from stray electrical discharge during operation ([0104]). As seen in Fig. 10A, the sheath 1002 covers the entirety of the wrist assembly. Modifying Murrell to include an insulative sheath over the wrist would be a simply modification to the wrist that would maintain operability of the electrical conduction and the end effector. Furthermore, including an insulative sleeve as part of the coupling hub/wrist would form the coupling hub/wrist of an insulative material because the claim does not clarify which parts of the coupling hub/wrist are composed of non-conductive material or if all components of the coupling hub/wrist are nonconductive. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the insulative sleeve of Hibner with the wrist of Murrell such that the outer surface of the wrist is formed of a non-conductive material to protect the patient from stray electrical discharge during operation.
Regarding claim 14, Murrell discloses the surgical instrument of claim 12 as described above.
However, Murrell is silent to the coupling hub being formed of an insulative material.
Hibner teaches a surgical tool that includes a drive housing, shaft, wrist, and end effector, similar to the device of Murrell ([Abstract]). The device can further include a protective sleeve 1002 that is configured to insulate live portions of the wrist to protect the patient from stray electrical discharge during operation ([0104]). As seen in Fig. 10A, the sheath 1002 covers the entirety of the wrist assembly. Modifying Murrell to include an insulative sheath over the wrist would be a simply modification to the wrist that would maintain operability of the electrical conduction and the end effector. Furthermore, including an insulative sleeve as part of the coupling hub/wrist would form the coupling hub/wrist of an insulative material because the claim does not clarify which parts of the coupling hub/wrist are composed of non-conductive material or if all components of the coupling hub/wrist are nonconductive. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the insulative sleeve of Hibner with the wrist of Murrell such that the outer surface of the wrist is formed of a non-conductive material to protect the patient from stray electrical discharge during operation.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Murrell as applied to claim 7/1 and described above in view of Gutti et al. (US 20230233247 A1).
Regarding claim 9, Murrell discloses the surgical instrument of claim 7 as described above.
Murrell further states that the molded component 512 is overmolded onto the jaw 210 ([0052]).
However, Murrell is silent to the electrode part and insulation part of the jaws being formed using a double injection molding method.
Gutti teaches a surgical instrument including a housing, shaft, and end effector that comprises first and second jaw members ([Abstract]). Gutti further teaches that the jaws comprise insulative components and jaw inserts that can be formed with the sealing plates through a single-shot or a two-shot injection molding process ([0052]). The claimed limitations are product by process limitations. MPEP 2113 states, "The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In the present case, producing the product through the claimed process would not result in a different product because the electrode parts and the insulating parts would still be formed on the jaws. Furthermore, utilizing a two-shot or double injection molding process is a known method in the art for forming conductive and insulative parts of an end effector. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a double injection molding method to form the electrode and insulative parts of the respective jaws since doing so is simply one of many known methods in the art to form the portions of the jaws.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/W.M./ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
