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 14 August 2025 has been entered. Claims 1-2, 4, and 11-20 are currently amended. Claims 1-20 are pending in the application.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
In claim 1, “one to the end effector” should read --on to the end effector--.
In claim 13, “the pair of plungers” in line 3 should read --each plunger of the pair of plungers--.
Appropriate correction is required.
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 5, 10, 13-19 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.
In claim 13, the limitation “the nub recess” is unclear because multiple nub recesses are recited in amended claim 11, upon which claim 13 depends, which renders the scope of the claim unclear. For examination purposes, the claim will be read as wherein the second end of each plunger extends into the respective nub recess and does not extend from the respective nub recess. Dependent claims 14-19 are necessarily rejected as depending on a rejected base claim.
Claims 5 and 15 recite the limitation “the printed circuit board” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim after the most recent amendments to claims 4 and 14. For examination purposes, these claims will be read with an additional limitation of wherein each button is electrically coupled to a printed circuit board.
In claim 10, the limitation “the switch” is unclear because multiple switches are recited in amended claim 1, upon which claim 10 depends, which renders the scope of the claim unclear. For examination purposes, this limitation will be read as --each switch--.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-5, 11-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Devengenzo et al. (US PGPub. No. 2007/0119274), hereinafter Devengenzo, in view of Cooper et al. (US PGPub. No. 2016/0199138), hereinafter Cooper, and Vannus et al. (US Patent No. 5,116,329), hereinafter Vannus, and further in view of Johnson et al. (US PGPub No. 2013/0053831), hereinafter Johnson.
Regarding claims 1-2, 11-12, and 20, Devengenzo teaches a robotic surgical system (Fig. 1: robotic surgical system 1) comprising:
an electrosurgical energy source (Figs. 1 and 3: surgical tool 5; par. 0045: “the surgical tool may comprise an electrosurgical probe for ablating, resecting, cutting or coagulating tissue;” examiner notes that an electrosurgical energy source must be present in order to operate an electrosurgical probe);
a sterile interface module (Figs. 5D-5E1: instrument sterile adaptor 109);
and a surgical instrument for selective connection to the sterile interface module (par. 0044: “Tool 5 has a proximal housing 24 which interfaces with a tool holder or instrument interface of the manipulator, generally providing a quick release mounting engagement through a sterile adapter or interface”) having a housing (Fig. 3: housing 24) and an elongated shaft that extends distally from the housing to an end effector (Fig. 3: elongated shaft 23, end effector 28),
the housing supporting an electrical connector assembly and an electrical switch assembly (Figs. 16C-16D: instrument electrical contacts 255 on housing of surgical instrument 5),
the electrical switch assembly positioned to enable electrical communication between the end effector of the surgical instrument and the robotic surgical system when the sterile interface module is engaged with the surgical instrument and the electrical switch assembly (Figs. 16C-16D and par. 0071: “As ISA 109 is swung down into position, electrical contacts 310 engage electrical contacts 510 (e.g., pogo pins) such that an initially open circuit on the manipulator 8 is closed, which activates the ISA engagement sequence. It is noted that the insert-molded contact 310 in housing 302 may have multiple electrical paths (vias) which engage with contacts on the adaptor receiving portion 101, and which are also used to establish communication with a surgical instrument 5 via instrument electrical contacts 255 (FIGS. 16C and 16D)”),
and the electrical switch assembly positioned to prevent electrical communication between the surgical instrument and the robotic surgical system when the sterile interface module is disengaged from the switch (electrical communication is not established when instrument electrical contacts 255 are not engaged with ISA electrical contacts 310).
Devengenzo teaches wherein the sterile interface module has a distal portion and the housing has a proximal end portion, but does not teach wherein the proximal end portion of the housing secures to the distal portion of the sterile interface module such that the sterile interface module and the surgical instrument are disposed in a colinear relationship when the surgical instrument is connected to the sterile interface module. Rather, as shown in Figs. 5E-5E1, Devengenzo teaches wherein lateral portions of the sterile interface module and surgical instrument housing are connected to each other. However, as demonstrated in Cooper, it is known in the art to secure a proximal end portion of a surgical instrument housing to a distal portion of a sterile interface module such that the sterile interface module and the surgical instrument are disposed in a colinear relationship (Figs. 2-3: sterile adapter assembly 250, surgical instrument 260, proximal/distal directions 390). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to rearrange the connection orientation of Devengenzo’s sterile interface module and surgical instrument housing such that the distal end of the sterile interface module connects to the proximal end of the surgical instrument housing, as taught by Cooper, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Devengenzo further does not explicitly teach wherein the electrosurgical energy source is coupled to the surgical instrument to transmit electrical energy from the electrosurgical energy source to the electrical switch assembly, or wherein the electrical switch assembly specifically enables or prevents transmission of the electrical energy from the electrosurgical energy source to the end effector of the surgical instrument. However, it is well within the level of ordinary skill in the robotic surgical art to prevent surgical instruments from operating when not fully or properly connected. For example, Vannus teaches a medical system with an energy source (col 2, lines 25-26: “a socket interconnect assembly 15 for connecting the plug assembly 13 to a radiation beam generator (not shown)”) and a medical instrument configured for coupling to the energy source (Fig. 1: laser catheter system 11), wherein activation of the medical instrument is selectively permitted only when the parts are properly coupled (col 1, lines 47-51: “Mechanically-actuated sensors on the socket assembly are included to prevent the laser from firing until the plug assembly is fully inserted and properly positioned in the socket assembly”). Additionally, automation of a manual process is an obvious modification (see MPEP 2144.04(III)), where in this case the manual process is preventing a surgical instrument from operating when it is not properly connected to a robotic surgical system. It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system and instrument of Devengenzo by configuring the existing electrical switch to automatically prevent operation of the surgical instrument when the parts of the system are not connected, as taught by Vannus, including preventing transmission of electrical energy from the energy source to the surgical instrument end effector when the instrument is disengaged from the sterile interface module, to produce the predictable result of preventing damage to the system or harm to an operator, patient, or bystander, as well as preventing undesired operation of the system when the parts are not connected in a functional manner.
Devengenzo teaches wherein the surgical instrument and sterile interface module are coupled by means of protrusions and recesses, wherein the recesses are configured and sized to receive the protrusions when the surgical instrument is secured to the sterile interface module (Fig. 16E and par. 0073: “FIG. 16E shows instrument disk 251 having a pin 253 which engages with hole 316 of ISA disk 304”), but does not teach wherein the protrusions project from the sterile interface module and the recesses located on the housing of the surgical instrument, and the sterile interface module defines the protrusions, or wherein the electrical switch assembly (that is, the electrical contacts) is located at the coupling area. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the placement of the protrusions and recesses, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167; see also MPEP 2144.04(VI).
Devengenzo further does not teach wherein the housing supports a plunger having a first end operatively associated with a switch and a second end projecting from the housing and located within a nub recess. However, Vannus also teaches a configuration for coupling the surgical instrument to the surgical system comprising a plunger (Figs. 9-10: plunger 171) having a first end operatively associated with a switch (Figs. 9-10: plunger 171 contacting microswitch 185; col 7, lines 42-46: “the distal end 71 of the tooth 67 contacts the closed end 137 of the channel 135, forcing the plunger 171 outward from the packing plate approximately 1/4-inch, thereby actuating the first microswitch 185”) and a second end projecting from the housing and located within a nub recess (Fig. 9: plunger 171 projecting into channel 135; col 6, lines 60-65: “in its relaxed state, […] one end of the plunger 171 extends beyond the closed end 137 of the channel 135”). Vannus teaches this configuration of elements as a feature to minimize risk that the surgical instrument will be energized before it is fully engaged and properly aligned (col 6, lines 21-34: “As a further feature to minimize the risk that a laser beam will be emitted through the interface before the plug assembly 13 is fully engaged, the socket assembly 15 is provided with a first microswitch 185, of a nature well known in the art, which senses that the distal end 71 of the tooth 67 has moved far enough toward the end of the channel 135 to ensure that the optical fiber 79 is properly aligned with the radiation beam. The microswitch 185 is desirably provided with a normally open contact 187 and is secured to the backing plate 127 proximate the mouth 139 of the plunger 171 bore 149. The microswitch 185 operates a control line to a microprocessor (not shown) which disables the beam generator until the force of the plunger 171 closes the contact”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the system of the combined reference by providing the housing of the surgical instrument with a plunger having a first end operatively associated with a switch and a second end projecting from the housing and located within a recess, as taught by Vannus, in order to minimize risk that the surgical instrument will be energized before it is fully engaged and properly aligned, as taught by Vannus.
The combined reference does not explicitly teach wherein the electrical switch assembly includes a pair of switches electrically connected to one another, wherein a first switch of the pair of switches is electrically connected to the electrical connector assembly, and wherein a second switch of the pair of switches is electrically connected to the end effector; the electrosurgical energy source couplable to the electrical connector assembly of the surgical instrument to transmit electrical energy from the electrosurgical energy source to the first switch, the electrical switch assembly positioned to enable the electrical energy to be transmitted to the second switch and on to the end effector of the surgical instrument when the sterile interface module is engaged with the surgical instrument and the electrical switch assembly. However, it is known in the electrosurgical art to provide multi-stage switches between the electrosurgical energy source and the end effector of the surgical instrument as a means of preventing energizing the end effector before it is properly positioned. For example, Johnson teaches an electrosurgical instrument with a plurality of switches that must be closed in order for electrical energy to be transmitted to the end effector (par. 0047: “a plurality of switches can be present within the supply conductor 189 which may need to be closed in order for current to flow through the supply conductor 189. Thus, the supply conductor 189 can comprise a plurality of conductor segments which electrically connect the switches”), which reduces the possibility of inadvertently supplying energy to the end effector (par. 0047: “a surgeon can insert the surgical instrument 100 into a patient with the switch 194 in an open condition and close the switch 194 prior to the operation of the surgical instrument 100 described above. Such a cut-off switch can reduce the possibility of inadvertently supplying energy to the end effector”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by providing a multi-stage switch (that is, a second switch, electrically connected to the first switch, that must be closed in order for electrical energy to be transmitted to the end effector) in the electrical switch assembly, as suggested by Johnson, in order to reduce the possibility of inadvertently supplying energy to the end effector, as taught by Johnson.
It would further have been obvious to one of ordinary skill in the art, in view of the teachings of Vannus as described previously, to provide a plunger for the second switch as well as another nub and nub recess and thereby arrive at the claimed invention, having pairs of plungers, nubs, and nub recesses; each plunger having a first end operatively associated with a respective switch and a second end projecting from the housing and located within a respective nub recess.
Regarding claims 3 and 13, the combination teaches the devices of claims 2 and 12 as described previously. Vannus further teaches wherein the second end of each plunger extends into the nub recess and does not extend from the nub recess (Fig. 9: second end of plunger 171 extending into and not protruding from channel 135), and wherein each switch includes a button disposed within the housing (Figs. 9-10: microswitch 185) and wherein each plunger is positioned to selectively engage a respective button (Figs. 9-10: plunger 171 positioned to engage microswitch 185; col 6, lines 28-34: “The microswitch 185 is desirably provided with a normally open contact 187 and is secured to the backing plate 127 proximate the mouth 139 of the plunger 171 bore 149. The microswitch 185 operates a control line to a microprocessor (not shown) which disables the beam generator until the force of the plunger 171 closes the contact”).
Regarding claims 4 and 14, the combination teaches the devices of claims 3 and 13 as described previously. The combination further teaches wherein each button is electrically coupled to one another, whereby, when the electrosurgical energy source is coupled to the electrical connector assembly, and when the surgical instrument is connected to the sterile interface module, the pair of plungers are moved to actuate the pair of switches (Vannus at col 6, lines 32-34, as applied in the rejection of claims 1 and 11) and to establish an electrical pathway from the electrosurgical energy source to the first switch, the second switch, and the end effector of the surgical instrument (Johnson at par. 0047, as applied in the rejection of claims 1 and 11).
Regarding claims 5 and 15, the combination teaches the system and instrument of claims 4 and 14 as described previously. Devengenzo further teaches wherein each button (that is, the electrical contact forming the switch) is coupled to a printed circuit board (Figs. 7A-7C: electrical contacts 510 operably mounted to printed circuit assembly 516). The combination does not specifically teach wherein the printed circuit board (PCB) is configured to flex toward each button when the pair of plungers engages the respective button. However, as flexible PCBs are well known in the electrosurgical art, it would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose a flexible material for the PCB of the combined reference, since Applicant has not disclosed that a flexible PCB solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a rigid PCB as with a flexible one.
Claims 6-10 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Devengenzo in view of Cooper, Vannus, and Johnson, and further in view of Omron Corporation (“White Paper on Basics of Tactile Switches,” 2019), hereinafter Omron.
Devengenzo in view of Cooper, Vannus, and Johnson teaches the devices of claims 1, 3, and 13 as described previously. The combined reference does not explicitly teach a dome switch as each switch, or specifically disclose further structure for each switch.
However, in an overview of tactile switches (another term for dome switches), which are a common component well known in electrically-related arts, Omron teaches that the basic structure of a tactile switch includes a spring (Figure 3: contact dome; examiner interprets the dome as a spring because of its biasing properties; see also the contact dome labeled as spring 106e in Figs. 9-10 of Applicant’s Specification) engaged with a footing (Figures 3 and 6: plunger engaged with contact dome), and a button housing coupled to the footing (Figures 3 and 6: cover and base), the button housing movable relative to the footing (the cover moves relative to the plunger when the plunger is depressed, if the plunger is considered the reference point), wherein the footing includes a flange that limits movement of the button housing relative to the footing (Figure 3: flange around raised portion of plunger). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a tactile switch (dome switch) with the basic structure taught by Omron as each switch in the system and instrument of the combined reference, because the substitution would have been within the level of ordinary skill in the art, and the results (selective transmission of electrical energy when the tactile switch is depressed by the force of physical coupling between the components) would have been predictable.
Omron does not explicitly teach wherein each switch footing is engaged with the housing of a surgical instrument, but since the tactile switch of the combined reference is mounted to the printed circuit board of the combined reference, which is necessarily engaged with the housing of the surgical instrument (see Devengenzo Figs. 7A-7C: printed circuit assembly 516 engaged with housing), the tactile switch footing is considered engaged with the housing in a manner as broadly as claimed.
Response to Arguments
Applicant’s arguments, filed 14 August 2025, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Johnson. As previously described, Johnson teaches that it is known in the art to provide multi-stage switches in electrosurgical instruments to reduce the possibility of inadvertently supplying electrical energy to the end effector of a surgical instrument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./ Examiner, Art Unit 3794
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