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 9/3/2024, cancelled claims 1-20 and new claims 21-34 are acknowledged. Claims 21-34 remain pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 26 is 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 26 recites the limitation "the conductor" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is noted claim 26 depends from independent claim 1, whereas a “conductor” is only previously recited in dependent claims 23-25.
Claim Rejections - 35 USC § 102
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.
Claim(s) 21-30 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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”);
operably connecting a remote controller (110, 300) to the stimulation instrument within the sterile field (see [0010] – “On the proximal end of the tubular structure is a handle that is maintained within a sterile field during the medical procedure” and [0068] – “In a preferred embodiment, remote control 300 is sterile and maintained in the sterile field of the patient, for use by one or more sterile operators, during the ablation procedure”).
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” 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”).
Regarding claim 22, Werneth et al. discloses operably connecting the remote controller to the stimulation instrument within the sterile field includes rigidly 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. discloses operably 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. discloses 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” 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”).
Regarding claim 25, Werneth et al. discloses 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. discloses the conductor (202) is physically connected to the monitoring system (see Figure 3a).
Regarding claim 27, Werneth et al. discloses the 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 monitor 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 28, Werneth et al. discloses the remote controller includes an input to remotely control at least one operation of the monitoring system (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” 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”).
Regarding claim 29, Werneth et al. discloses the monitoring system includes a processor configured to receive a signal from the input to control at least one operation of the monitoring system, wherein the at least one operation of the 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. discloses 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”).
Regarding claim 32, Werneth et al. discloses generating a stimulation voltage from the stimulation instrument within the sterile field (see [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”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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).
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 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 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 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 system (20), the signal configured to control at least one operation of the stimulation 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”).
Conclusion
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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/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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