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 .
Notice of Amendment
In response to the amendment filed on 8/12/2026, amended claims 21-23, 26-27, 29-30, and 33-34 and cancelled claims 28 and 32 are acknowledged. Claims 21-27, 29-31, and 33-34 remain pending. The following new and reiterated grounds of rejection are set forth:
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.
Claim(s) 21-27 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Werneth et al. (US Publication No. 2007/0083193 A1) (cited by Applicant).
Regarding claim 21, Werneth et al. discloses a method of controlling a stimulation monitoring system having a stimulation system to stimulate a subject through a stimulation instrument, comprising:
positioning a stimulation instrument (120) within a sterile field (see Figure 3a and [0010] – “According to a third aspect of the invention, a percutaneous catheter for performing a sterile medical procedure is disclosed. The catheter is for inserting into a body cavity such as a vessel of a patient and includes an elongate tubular structure with a proximal end and a distal end. On the proximal end of the tubular structure is a handle that is maintained within a sterile field during the medical procedure. The handle further includes a control assembly for controlling a separate medical device. In a preferred embodiment, the separate medical device is outside of the sterile field”);
positioning a stimulation monitoring system (200) having a stimulation system in a non-sterile field out of the sterile field (see Figure 3a and [0068] – “Remote control 300, in addition to mouse control 111 of ablation catheter 100 allow the clinician operator in the sterile field to modify one or more parameters of RF delivery unit 200, preferably not in the sterile field”);
positioning a monitor assembly within the non sterile field, the monitor assembly configured to generate a stimulation voltage (see [0064] – “RF delivery unit 200 includes user interface 201, such as a user interface including data input devices like touch screens, buttons, switches, keypads, magnetic readers and other input devices; and also including data output devices like data and image screens, lights, audible transducers, tactile transducers and other output devices. User interface 201 is used to perform numerous functions including but not limited to: selecting electrodes to receive energy (electrodes 130 of carrier assembly 120); setting power levels, types (bipolar and monopolar) and durations; setting catheter and other system threshold levels; setting mapping and other system parameters; initiating and ceasing power delivery; deactivating an alarm condition; and performing other functions common to electronic medical devices. User interface 201 also provides information to the operator including but not limited to: system parameter information including threshold information; mapping and ablation information including ablation element temperature and cooling information; and other data common to ablation therapy and other electronic medical devices and procedures” and [0072] – “In a preferred embodiment, parameters associated with the bipolar and monopolar energy delivery are adjusted during the procedure, automatically by the system and/or manually by the operator. The energy delivery parameters are adjusted by measured, calculated or otherwise determined values include those relating to: energy delivered measurements such as voltage or current delivered to an electrode”);
rigidly connecting a remote controller (110) conductively connected to the stimulation instrument within the sterile field adjacent a patient, the remote controller configured to provide an input to control the monitor assembly (see [0010] – “On the proximal end of the tubular structure is a handle that is maintained within a sterile field during the medical procedure”, [0054] – “Handle 110 may include other controls, not shown, to perform numerous functions such as change energy delivery settings”, [0061] – “Coupler 140 can be flexible or rigid, and may contain both rigid and flexible portions along its length”, [0066] – “Handle 110 includes mouse control 111, an adjustable knob that provides two-dimensional control of cursor 230 of user interface 201, similar to mouse-control devices integral to some laptop computers”, and [0068] – “Remote control 300, in addition to mouse control 111 of ablation catheter 100 allow the clinician operator in the sterile field to modify one or more parameters of RF delivery unit 200, preferably not in the sterile field”), and ;
operably connecting the remote controller to the stimulation monitoring system in the non- sterile field (see [0067] – “Mouse control 111 can control cursor 230 via wireless transmissions using a wireless transceiver, not shown, or wired communication utilizing a wire integral to cable 202”); and
remotely controlling at least one operation of the stimulation system with the remote controller to stimulate the subject within the sterile field (see [0054] – “Handle 110 on the ablation catheter includes controls to operate the carrier assembly 120. Handle 110 is constructed of a rigid or semi-rigid material such as Delrin or polycarbonate, and includes button 116 that is connected to switch means, not shown, for starting and/or stopping the delivery of energy to one or more of electrodes 130. Handle 110 may include other controls, not shown, to perform numerous functions such as change energy delivery settings”).
It is noted Werneth et al. does not specifically teach the remote controller is removably connected to the stimulation instrument. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to removably connect the remote controller to the stimulation instrument, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 22, Werneth et al. teaches removably and rigidly connecting the remote controller to the stimulation instrument within the sterile field includes connecting (via coupler 140 and shaft 150) a housing (110) of the remote controller to the stimulation instrument (see Figure 3a and [0061] – “Coupler 140 can be flexible or rigid, and may contain both rigid and flexible portions along its length. Coupler 140 may provide electrical connection means to connect wires extending from the handle to wires from carrier assembly 120 electrodes”).
Regarding claim 23, Werneth et al. teaches removably and rigidly connecting the controller to the stimulation instrument within the sterile field includes interconnecting a housing of the remote controller with the stimulation instrument with a conductor (see Figure 3a and [0061] – “Coupler 140 can be flexible or rigid, and may contain both rigid and flexible portions along its length. Coupler 140 may provide electrical connection means to connect wires extending from the handle to wires from carrier assembly 120 electrodes”).
Regarding claim 24, Werneth et al. teaches remote controlling operation of the stimulation system with the remote controller to stimulate the subject within the sterile field includes operating the remote controller to transmit a signal with a conductor from the remote controller in the sterile field to the stimulation system in the non-sterile field (see [0067] – “Mouse control 111 can control cursor 230 via wireless transmissions using a wireless transceiver, not shown, or wired communication utilizing a wire integral to cable 202”).
Regarding claim 25, Werneth et al. teaches connecting a conductor between the stimulation instrument and the remote controller and between the remote controller and the monitoring system (see Figure 3A and [0061] – “Coupler 140 may provide electrical connection means to connect wires extending from the handle to wires from carrier assembly 120 electrodes” and [0067] – “Mouse control 111 can control cursor 230 via wireless transmissions using a wireless transceiver, not shown, or wired communication utilizing a wire integral to cable 202”)
Regarding claim 26, Werneth et al. teaches a conductor (202) is physically connected to the monitoring system (see Figure 3a).
Regarding claim 27, Werneth et al. teaches the stimulation monitoring system further comprises a monitor having at least one monitor electrode, the monitor configured to be positioned within the sterile field, the monitor conductively connected to the stimulation monitoring system to provide monitored information from a patient (see Figure 1 and [0046] – “Each of the electrodes 130 is attached via connecting wires to an energy delivery apparatus, RF delivery unit 200, which is also attached to patch electrode 25, preferably a conductive pad attached to the back of the patient”).
Regarding claim 29, Werneth et al. teaches the stimulation monitoring system includes a processor configured to receive a signal from the input to control at least one operation of the stimulation monitoring system, wherein the at least one operation of the stimulation monitoring system includes at least one of changing a stimulation period, changing a stimulation voltage, starting stimulation, stopping stimulation, capturing a screen shot, controlling a threshold limit, or changing a message volume (see [0047] – “In another preferred embodiment, RF delivery unit 200 is configured to accept a signal from one or more sensors integral to ablation catheter 100, not shown, such that the energy delivered can be modified via an algorithm which processes the information received from the one or more sensors” and [0072] – “In a preferred embodiment, parameters associated with the bipolar and monopolar energy delivery are adjusted during the procedure, automatically by the system and/or manually by the operator. The energy delivery parameters are adjusted by measured, calculated or otherwise determined values include those relating to: energy delivered measurements such as voltage or current delivered to an electrode; force or pressure measurement such as the force exerted by the carrier assembly as measured by an integral strain gauge; other ablation catheter or ablation system parameter; temperature of tissue; rate of change of temperature of tissue; temperature of an electrode or other ablation element; rate of change of temperature of an electrode or other ablation element; ECG; tissue thickness; tissue location; cardiac flow-rate; other patient physiologic and other patient parameters; and combinations thereof. The energy delivery drive parameters may be adjusted by a combination of these determined values. In order to automatically modify an energy delivery parameter, or to notify an operator of a condition, these determined values are compared to a threshold, such as via a threshold comparator integral to the interface unit of the present invention. Threshold values can be calculated by the system or can be entered by the operator into a user interface of the system”).
Regarding claim 30, Werneth et al. teaches the input includes at least one switch configured to be operated by the user within the sterile field (see [0054] – “Handle 110 is constructed of a rigid or semi-rigid material such as Delrin or polycarbonate, and includes button 116 that is connected to switch means, not shown, for starting and/or stopping the delivery of energy to one or more of electrodes 130”).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Werneth et al., further in view of Hausman et al. (US Publication No. 2011/0060242 A1) (previously cited).
Regarding claim 31, it is noted Werneth et al. does not specifically teach coupling the remote controller to a coupling member configured to enable the remote controller to be carried by a user in the sterile field. However, Hausman et al. teaches coupling the remote controller (22) to a coupling member configured to enable the remote controller to be carried by a user in the sterile field (see Figure 7 and [0069] – “Alternatively, as FIG. 2 shows, the stimulation control device 22 may be housed in a separate case, with its own input/output (I/O) controls 26. In this alternative arrangement, the stimulation control device 22 is sized small enough to be easily removably fastened to a surgeon's arm or wrist during the surgical procedure, or otherwise positioned in close proximity to the surgical location (as shown in FIG. 7), to provide sufficient audio and/or visual feedback to the surgeon. In this arrangement, the separate stimulation control device 22 can be temporarily coupled by a lead to a family of various medical devices for use”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Werneth et al. to include coupling the remote controller to a coupling member configured to enable the remote controller to be carried by a user in the sterile field, as disclosed in Hausman et al., so as to allow the remote controller to be easily removably fastened to a surgeon’s arm or wrist during the surgical procedure to provide sufficient audio and/or visual feedback to the surgeon (see Hausman et al.: [0069]).
Claim(s) 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Werneth et al., further in view of Sterrantino et al. (US Publication No. 2006/0025702 A1) (cited by Applicant).
Regarding claim 33, it is noted Werneth et al. does not specifically teach toggling a toggle switch fixed atop a printed circuit board placed within the housing of the remote controller to generate a signal transmitted to the stimulation monitoring system. However, Sterrantino et al. teaches toggling a toggle switch (78) fixed atop a printed circuit board (114) placed within the housing of the remote controller to generate a signal transmitted to the stimulation monitoring system (20) (see Figures 1-3A and [0032] – “The printed circuit board 114 is electrically connected to the control cable 86 and controls electrical signals sent from the switch 78 to the stimulator circuitry (not shown) housed in the control unit 20 (FIG. 1). In particular, the printed circuit board 114 is electrically coupled to the switch 78 such that the control circuitry 112 prompts delivery of stimulation energy to the stimulus probe 72 in response to movements of the switch 78, as described below” and [0034] – “The stimulator circuitry (not shown) within the control unit 20 interprets the electrical signal and responds with an electrical command that is transferred through the energy supply cable 84 to the stimulus probe 72 and/or to other components (e.g., a printer, additional stimulator probe, other surgical device, etc.). In this manner, movement of the switch 78 at the surgical handpiece 70 triggers a remote response from the stimulator circuitry in the control unit 20”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Werneth et al. to include toggling a toggle switch fixed atop a printed circuit board placed within the housing of the remote controller to generate a signal transmitted to the stimulation monitoring system, as disclosed in Sterrantino et al., so as control electrical signals sent from the switch to the stimulation circuitry housed in the stimulation system (see Sterrantino et al.: [0032]).
Regarding claim 34, Sterrantino et al. teaches receiving the signal from the remote controller via a processor (“stimulation circuitry”) disposed within the stimulation monitoring system (20), the signal configured to control at least one operation of the stimulation monitoring system (see [0032] – “The printed circuit board 114 is electrically connected to the control cable 86 and controls electrical signals sent from the switch 78 to the stimulator circuitry (not shown) housed in the control unit 20 (FIG. 1). In particular, the printed circuit board 114 is electrically coupled to the switch 78 such that the control circuitry 112 prompts delivery of stimulation energy to the stimulus probe 72 in response to movements of the switch 78, as described below”).
Response to Arguments
Applicant's arguments filed 8/12/2026 have been fully considered but they are not persuasive.
Applicant argues that Werneth fails to disclose the step of removably and rigidly connecting a remote controller conductively connected to the stimulation instrument within the sterile field adjacent a patient, the remote controller configured to provide an input to control the monitor assembly. The Examiner respectfully disagrees and notes Werneth describes a handle (110) that is maintained within the sterile field (see [0010]). The handle is rigidly and conductively connected to the stimulation instrument via coupler (140) and control shaft (150) (see [0061]) and includes controls, such as mouse control (111) and buttons (116, 117) to provide inputs to the monitor assembly, such as changing energy delivery settings or controlling cursor (230) of user interface (201) (see [0054], [0066], and [0068]-[0069]). While Werneth et al. does not specifically teach the remote controller is removably connected to the stimulation instrument, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to removably connect the remote controller to the stimulation instrument, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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