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 .
Information Disclosure Statement
The information disclosure statement filed 16 January 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The Examiner notes that a copy of foreign patent documents DE-2831313-A1 [listed as #751 in the IDS; the Examiner notes that a corresponding file name is listed in the Electronic Filing System Acknowledgement Receipt dated 16 January 2025 (“CAD-CAD605_CON-Foreign-751-FOR.pdf”); the Examiner further notes that foreign patent document DE-8803153-U1 is attached twice] and JP-2000590531-A [listed as #823 in the IDS; the Examiner notes that a corresponding file name is listed in the EFS Acknowledgement Receipt dated 16 January 2025 (“CAD-CAD605_CON-Foreign-823-FOR.pdf”); the Examiner further notes that foreign patent document JP-2003524452-A is attached twice] are not provided.
Drawings
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: “A” [Fig. 6]; “B” [Fig. 7]. The Examiner notes that the use of reference characters “A” and “B” to show continuity between sheets of the same figure may be interpreted as an additional step between the corresponding steps that “A” and “B” are used to connect in sequence.
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 Objections
Claim(s) 28 is/are objected to because of the following informalities:
Claim 28 should read “wherein the probe port comprises first and second outputs for connect [[of]] to the anode and the cathode of the at least one probe” [lines 3-4].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 21, 23, and those dependent therefrom is/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 21 recites the limitation “at least one of a strip electrode and a grid electrode, wherein the at least one probe and/or at least one strip electrode and grid electrode are configured…” [lines 5-6], which is considered indefinite, as it is not clear whether “at least one of” is meant to describe both the strip electrode and the grid electrode due to later reference to “at least one strip electrode and grid electrode”, such that the recited limitation is meant to refer to at least one strip electrode AND at least one grid electrode, or refer to at least one of a strip electrode AND/OR a grid electrode, or refer to at least one of a strip electrode AND wherein there is a grid electrode [wherein the grid electrode is not described by the recitation of “at least one of”]. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any art applied under § 102 or § 103. The Examiner notes that similar subject matter is recited in claim 34, which clearly refers to at least one of a strip electrode and a grid electrode [wherein “at least one of” refers to at least one of a strip electrode and/or a grid electrode].
Claim 23 recites the limitation “a second plurality of probe ports” [line 2], which lacks antecedent basis is considered indefinite, as there is no previously recited “first plurality” of probe ports. For examination purposes, the Examiner has interpreted the indefinite limitation to read “a [including subsequent recitations of the indefinite limitation in any dependent claims].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 21-42 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-20 and 22-23 of U.S. Patent No. 11,992,339, herein after Kirkup. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Conflicting claim 1 of Kirkup is considered to anticipate each and every limitation of instant claim 21 [see comparison below]. The Examiner notes that despite Kirkup disclosing a different statutory category [method] from the instant invention [system], Kirkup is considered to anticipate the instant invention due to the particular disclosure of structural elements and method steps of using said structural elements being similar to the instant claimed functionality of elements of the instant system. Conflicting claim(s) 2-12 are considered to anticipate instant claims 22-32.
Claim 21 of the Instant Application
Claim 1 of Conflicting Patent No. 11,992,339, herein after Kirkup
An intraoperative neurophysiological monitoring (IONM) system for using cortical stimulation to assess neural structures during a surgical procedure, the system comprising:
A method of using cortical stimulation to assess neural structures during a surgical procedure, the method comprising: providing an intraoperative neurophysiological monitoring (IONM) system [Kirkup Col 17:16-20]
at least one reference electrode positioned in a perimeter of a surgical field of a patient;
at least one reference electrode [Kirkup Col 17:20-21]
placing the at least one reference electrode in a perimeter of a surgical field of a patient [Kirkup Col 17:34-35]
at least one probe;
at least one probe [Kirkup Col 17:20]
at least one of a strip electrode and a grid electrode, wherein the at least one probe and/or the at least one strip electrode and grid electrode are configured to be positioned at target locations on the anatomy of said patient;
at least one strip electrode or grid electrode [Kirkup Col 17:21-22]
positioning the at least one probe and/or the at least one strip electrode or grid electrode at target locations on the anatomy of said patient [Kirkup Col 17:36-38]
at least one sensing electrode adapted to be positioned on said patient's anatomy and configured to sense the patient's responses to stimulation;
at least one sensing electrode [Kirkup Col 17:22]
preparing for recordation of said patient's responses to stimulation by positioning said at least one sensing electrode on said patient's anatomy [Kirkup Col 17:39-41]
a stimulation module; and
a stimulation module [Kirkup Col 17:22-23]
a handle having a proximal end configured to connect to the stimulation module and a distal end configured to attach to the at least one probe, wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode, and wherein the stimulation module is configured to initiate a stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation and adjust stimulation parameters of the stimulation protocol to determine a threshold response.
a handle having a proximal end configured to connect to the stimulation module and a distal end configured to attach to the at least one probe, wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, and wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode [Kirkup Col 17:23-33]
initiating a stimulation protocol in accordance with the automatically selected first mode of operation or second mode of operation; adjusting stimulation parameters of the stimulation protocol to determine a threshold response [Kirkup Col 17:42-46]
Conflicting claim 13 of Kirkup is considered to anticipate each and every limitation of instant claim 33 [see comparison below]. The Examiner notes that despite Kirkup disclosing a different statutory category [method] from the instant invention [system], Kirkup is considered to anticipate the instant invention due to the particular disclosure of structural elements and method steps of using said structural elements being similar to the instant claimed functionality of elements of the instant system. Conflicting claim(s) 14-20 and 22-23 are considered to anticipate instant claims 34-42.
Claim 33 of the Instant Application
Claim 13 of Conflicting Patent No. 11,992,339, herein after Kirkup
An intraoperative neurophysiological monitoring (IONM) system adapted to deliver direct nerve stimulation to identify nerve fibers and nerve pathways during a surgical procedure, the system comprising:
A method of using direct nerve stimulation to identify nerve fibers and nerve pathways during a surgical procedure, the method comprising: providing an intraoperative neurophysiological monitoring (IONM) system [Kirkup Col 18:43-47]
at least one probe positioned at a first target location on the patient;
at least one probe [Kirkup Col 18:47]
positioning the at least one probe at a first target location on the patient [Kirkup Col 18:61-62]
at least one sensing electrode positioned at a second target location in the patient;
at least one sensing electrode [Kirkup Col 18:47-48]
positioning the at least one sensing electrode at a second target location in the patient [Kirkup Col 18:63-64]
a stimulation module, wherein the stimulation module comprises at least twelve output connectors and a plurality of probe ports; and
a stimulation module [Kirkup Col 18:48]
wherein the stimulation module comprises at least twelve output connectors and a plurality of probe ports [Kirkup Col 18:51-53]
a handle having a proximal end configured to connect to the stimulation module and a distal end configured to attach to the at least one probe, wherein the handle comprises a first visual indicator, a second visual indicator, and a controller configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode, wherein the stimulation module is configured to initiate a direct nerve stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation, adjust stimulation parameters of the direct nerve stimulation protocol to determine a threshold motor response, and identify at least one of the nerve fibers and the nerve pathways based on the threshold motor response.
a handle having a proximal end configured to connect to the stimulation module and a distal end configured to attach to the at least one probe [Kirkup Col 18:49-51]
wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, and wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode [Kirkup Col 18:53-60]
initiating a direct nerve stimulation protocol in accordance with the automatically selected first mode of operation or second mode of operation; adjusting stimulation parameters of the direct nerve stimulation protocol to determine a threshold motor response; and identifying the nerve fibers and nerve pathways based on the threshold motor response [Kirkup Col 18:65-19:5]
Claim Rejections - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 21 and 33 each recite a judicial exception [“determine a threshold response” (claim 21); “determine a threshold motor response, and identify at least one of the nerve fibers and the nerve pathways based on the threshold motor response” (claim 33)] at Step 2A Prong 1, which is considered to be an abstract idea that may be performed in the mind or by hand with the assistance of pen and paper by merely observing a reaction and drawing mental conclusions therefrom. However, the Examiner further notes that claim(s) 21 and 33 recite limitations directed towards additional elements [reference electrode, probe, strip electrode, grid electrode, sensing electrode, stimulation module, handle, actuator of claim 21; probe, sensing electrode, stimulation electrode, handle, controller of claim 33] that is considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 21, 33, and those dependent therefrom is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 21 recites the limitation “at least one reference electrode positioned in a perimeter of a surgical field of a patient” [line 3], which is considered to positively recite the human body [see emphasized portion]. The Examiner suggests amending the limitation to read “at least one reference electrode configured to be positioned in a perimeter of a surgical field of a patient”.
Claim 33 recites the limitation “at least one probe positioned at a first target location on the patient” [line 4], which is considered to positively recite the human body [see emphasized portion]. The Examiner suggests amending the limitation to read “at least one probe configured to be positioned at a first target location on the patient”.
Claim 33 recites the limitation “at least one sensing electrode positioned at a second target location on the patient” [line 4], which is considered to positively recite the human body [see emphasized portion]. The Examiner suggests amending the limitation to read “at least one sensing electrode configured to be positioned at a second target location on the patient”.
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) 21-25, 29-31, 33-35, and 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziobro (US-20050182456-A1, cited by Applicant) in view of Wallace (US-20110004207-A1, cited by Applicant) and Rupp (US-20180042659-A1).
Regarding claim 21, Ziobro teaches
An intraoperative neurophysiological monitoring (IONM) system for using cortical stimulation to assess neural structures during a surgical procedure, the system comprising:
at least one reference electrode positioned in a perimeter of a surgical field of a patient [Optionally, reference sensors may be utilized, including a ground electrode inserted subcutaneously between stimulating electrode contacts 21 and recording sensors 41, a reference sensor inserted into a heel pad (Ziobro ¶0046)];
at least one probe [Various types of probes may be used as EMG sensors. For example, FIGS. 12A-16 illustrate exemplary mono-polar, bi-polar, and tri-polar type probes, as well as a sphere type electrode, any of which may be selected for particular applications (Ziobro ¶0070); probe that may be formed in any of a mono-, bi-, or tri-polar configuration (Ziobro ¶0073); see probes 2-9 of Ziobro Figs. 12-16];
at least one of a strip electrode and a grid electrode, wherein the at least one probe and/or the at least one strip electrode and grid electrode are configured to be positioned at target locations on the anatomy of said patient [subdural/cortical strip electrode grid 70 or grid 80 is in place along the desired portion of the patient's brain in a known manner (Ziobro ¶0066, Figs. 3-4)];
at least one sensing electrode adapted to be positioned on said patient's anatomy and configured to sense the patient's responses to stimulation [Muscle activity of the patient is monitored by EMG sensors 41 that provide detection signals to a signal conditioning and processing section 43 in the input portion of EMG 40… Signal processor 43 automatically determines whether a stimulus applied to a pair of the electrodes 21 has caused a muscle reaction, by detecting a muscle contraction in the signal(s) from sensors 41 and correlating the detected contraction with a particular stimulus (Ziobro ¶0039)];
a stimulation module [Cortical stimulator 20 contains a signal generator 29 operative to output stimulation signals and selectively change various parameters thereof (Ziobro ¶0040)]; and
a handle having a proximal end configured to connect to the stimulation module and a distal end configured to attach to the at least one probe [see handles 93, 103, 113, 123, 133, 143, 153 of Ziobro Figs. 12-15; Instrument 60 has a cortical stimulator 20 that provides stimulation pulse trains to a probe output module 39 that is adaptable to accept leads, tails, wires, and various connectors for monopolar straight electrodes, bipolar straight electrodes, bipolar angled electrodes, bipolar straight sheathed electrodes, bipolar Y-tip electrodes, tripolar straight electrodes, tripolar angled electrodes, one, two or three-dimensional electrode arrays, ball electrodes, etc. Such adaptation may be provided by use of plug-in adapters (not shown) (Ziobro ¶0055), wherein a proximal end of the corresponding handle(s) are considered to be connected to the stimulation module via cable(s) 92, 102, 112, 122, 132, 142, 152, respectively; and wherein a distal end of the corresponding handle(s) are considered to be connected to the corresponding probes via conductive metal shaft 94, 104, 114, 124, 134, 144, 154, respectively], and wherein the stimulation module is configured to initiate a stimulation protocol and adjust stimulation parameters of the stimulation protocol to determine a threshold response [A first mapping pass is performed at step 160. Signal generator 29 outputs a set of pulse trains for a first pass of a mapping session, according to the stimulation pattern and associated waveform parameters. The pulse trains may be fed to a multiplexer section of signal generator 29 for distribution of individual pulse trains to corresponding pairs of subdural electrodes 21, via output ports 26 and tail(s) 73, 83 (Ziobro ¶0083); When controller 23 determines that an EMG detection event is not conclusive, the parameters for stimulating the particular electrode pair are evaluated and modified in step 210 if controller 23 determines that, for example, a higher stimulation voltage should be used in a subsequent pass. In addition, when the EMG detection event is inconclusive, detection parameters such as IIR filtering and spatial alignment may be adjusted for improving detection accuracy corresponding to a subsequent pass (Ziobro ¶0084)].
However, while Ziobro discloses a handle with monopolar or bipolar probes [Ziobro ¶¶0032-0033, Figs. 12-13], Ziobro fails to explicitly disclose wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode; and wherein the stimulation module is configured to initiate a stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation.
Wallace discloses systems for neural stimulation, wherein Wallace discloses a handle coupled to a probe, wherein the handle comprises a first visual indicator, a second visual indicator [The nerve localization devices and systems described herein may include one or more indicators or outputs. The detectors may provide a user-identifiable signal to indicate the location of the nerve or the status of the system. For example, the nerve localization devices may include one or more light emitting diodes (LEDs), buzzers (or other sound output), a video display, or the like. An LED may be illuminated based on signals generated by, received by, or generated in response to the energized electrode(s) as discussed above. In some variations the system or devices create a vibration or sound that a user manipulating the device 20 may feel or hear. The intensity of the output may vary as a function of detected signal (Wallace ¶0180); For example, FIGS. 31A-31C illustrate a handle 3101 of a neural localization device. In this example, the handle includes a window 3109 on one or more sides of the device that indicates visually where and when stimulation is being applied… The window may alternatively show other suitable indicators such as a graphic, including a color, an alphanumeric message, a symbol, or the like (Wallace ¶0228), wherein any first and second indicator may be considered to read on the claimed first visual indicator and second visual indicator], and an actuator configured to switch a stimulation module between a first mode of operation and a second mode of operation, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode [The neural stimulation device may be used to stimulate either the dorsal or ventral device surfaces (e.g., "top" or "bottom" of the ribbon structure). A control (e.g., the slider switch 3105 on the handle) may be used to determine the stimulation surface (top/bottom) and/or the mode (monopolar/bipolar, etc). In the example shown in FIGS. 32A-32B, an indicator on the handle indicates the mode of operation (Wallace ¶0232, Figs. 32A-C)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro to employ wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to switch the stimulation module between a first mode of operation and a second mode of operation, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode, so as to allow for user control of the type of operation and to indicate to a user of the handle which mode of operation is being employed.
However, the combination of Ziobro in view of Wallace fails to explicitly disclose wherein the actuator is configured to automatically switch the stimulation module between the first mode of operation and the second mode of operation depending upon a type of the at least one probe; and wherein the stimulation module is configured to initiate a stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation.
Rupp discloses systems for operating electrosurgical instruments, wherein Rupp discloses an actuator that is configured to automatically switch a stimulation module between a first mode of operation and a second mode of operation depending upon a type of instrument being coupled to the stimulation module [The switch 300 controls which control signal (i.e., electrosurgical control signals or ultrasonic control signals) to pass to control the amplifier 228 and/or power supply 227. Control signals may be pulse width modulated signals as described in further detail below. The switch 300 can either be manually set by a user by selecting a desired output on the user interface 241 of the generator 200, or automatically by the controller 224, which may be based on a type of instrument being coupled to the generator 200. In embodiments, if the ultrasonic instrument 40 is coupled to port 260, the switch 300 is activated to pass ultrasonic control signals from the ultrasonic controller 304. Alternatively, if a monopolar electrosurgical instrument 20 or electrosurgical forceps 30 are coupled to ports 256 and 258, respectively, switch 300 is activated to pass electrosurgical control signals from electrosurgical controller 302 (Rupp ¶0034)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace to employ wherein the actuator is configured to automatically switch the stimulation module between the first mode of operation and the second mode of operation depending upon a type of the at least one probe; and wherein the stimulation module is configured to initiate a stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation, so as to ensure proper operation of the system based on the coupled at least one probe, and as this modification further amounts to merely automating a manual activity [In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)].
Regarding claim 22, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 21, wherein the stimulation protocol is a motor cortex stimulation protocol, a speech stimulation protocol, or a language stimulation protocol [The memory requirements may also depend on the types of filtering used for detecting barely discernable muscle response signals above background noise, a number of EMG electrodes 41, stimulus repetition rate(s), length of procedure and associated number of mapping sessions, complexity of expert system, data storage requirements, real-time processing requirements, etc. For example, EMG signals may be simultaneously monitored for detection events for ten, twenty or more different muscles (Ziobro ¶0082)].
Regarding claim 23, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 21, wherein said stimulation module comprises a first plurality of output connectors [The mapping stimulator 10 includes a cortical stimulator 20, a number of subdural electrodes 21 connected to corresponding output ports 26 of cortical stimulator 20 (Ziobro ¶0037); Electrode strip 70 has a tail portion formed of a small-diameter, elongate, cylindrical, flaccid, flexible, electrically insulating material such as a silicone material or a polyurethane as the tail body 73. The body 73 has collar-like, tubular electric contacts 74 closely fitted around its outside surface (Ziobro ¶0051); A number of tails 83 depends on the electrode configuration. Here, subdural electrode grid 80 has two tails 83 of ten contacts 84 each (Ziobro ¶0052)] and a second plurality of probe ports [input channels 46 of EMG 40 (Ziobro ¶0037); Various types of probes may be used as EMG sensors (Ziobro ¶0070)].
Regarding claim 24, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 23, wherein the first plurality of output connectors are configured to enable connection to the at least one of the strip electrode and the grid electrode, wherein the at least one of the strip electrode and the grid electrode comprises a plurality of contacts and wherein a total number of the plurality of contacts does not exceed a total number of the first plurality of output connectors [Ziobro ¶¶0051, 0052, Figs. 3-4; wherein each of the contacts 74, 84 corresponding to a respective electrode, wherein the entire strip/grid electrode being coupled to the cortical stimulator 20 is considered to read on the number of contacts not being greater than the amount of output connectors].
Regarding claim 25, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 23, wherein the second plurality of probe ports comprises a first probe port and a second probe port, wherein each of the first probe port and the second probe port is configured to connect to the at least one probe [wherein as depicted in at least Ziobro Figs. 13A-B, the probe(s) is/are coupled to two probe ports via plugs 1111, 121], wherein the at least one probe comprises at least one of a monopolar probe and a bipolar probe [Ziobro ¶0070, Figs. 12-16].
Regarding claim 29, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 21, wherein the at least one sensing electrode comprises an electromyography needle electrode [An exemplary EMG system 40 detects the electrical response of a muscle using pairs of noninsulated electroencephalography-type needle electrodes 41 that are placed subcutaneously overlying each target muscle (Ziobro ¶0044)].
Regarding claim 30, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 21, wherein the stimulation protocol comprises a multi-pulse train having 2 to 10 pulses and wherein each of the pulses is defined by a pulse width in a range of 50 μsec to 1000 μsec, an inter-stimulus interval in a range of 0.5 to 10 milliseconds, and a pulse amplitude in a range of 0.01 mA to 20 mA [Pulse trains may be formed for one to twenty pulses (Ziobro ¶0043); Pulse width for such pulses may be adjusted, for example, from 10 .mu.sec to 3.0 msec/phase, where a pulse width of approximately 0.4-0.6 msec may be selected as a nominal value (Ziobro ¶0043); 0.1 msec to 4 msec between adjacent pulses being typical (Ziobro ¶0043); an stimulation output adjustable between 0-36 mA, peak-to-peak, in 0.1 mA increments. Other selectable ranges may include, for example, 0-10 mA, 0-1 mA, 0-100 .mu.A, etc. (Ziobro ¶0042)].
Regarding claim 31, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 21, wherein the first visual indicator is configured to indicate at least one of the first mode of operation, the second mode of operation, a connection state of the at least one probe and what part of the at least one probe is active [Wallace ¶0232, Figs. 32A-C].
Regarding claim 33, Ziobro teaches
An intraoperative neurophysiological monitoring (IONM) system adapted to deliver direct nerve stimulation to identify nerve fibers and nerve pathways during a surgical procedure, the system comprising:
at least one probe positioned at a first target location on the patient [Various types of probes may be used as EMG sensors. For example, FIGS. 12A-16 illustrate exemplary mono-polar, bi-polar, and tri-polar type probes, as well as a sphere type electrode, any of which may be selected for particular applications (Ziobro ¶0070); probe that may be formed in any of a mono-, bi-, or tri-polar configuration (Ziobro ¶0073); see probes 2-9 of Ziobro Figs. 12-16];
at least one sensing electrode positioned at a second target location in the patient [Muscle activity of the patient is monitored by EMG sensors 41 that provide detection signals to a signal conditioning and processing section 43 in the input portion of EMG 40… Signal processor 43 automatically determines whether a stimulus applied to a pair of the electrodes 21 has caused a muscle reaction, by detecting a muscle contraction in the signal(s) from sensors 41 and correlating the detected contraction with a particular stimulus (Ziobro ¶0039)];
a stimulation module, wherein the stimulation module comprises output connectors and a plurality of probe ports [Cortical stimulator 20 contains a signal generator 29 operative to output stimulation signals and selectively change various parameters thereof (Ziobro ¶0040); The mapping stimulator 10 includes a cortical stimulator 20, a number of subdural electrodes 21 connected to corresponding output ports 26 of cortical stimulator 20… input channels 46 of EMG 40 (Ziobro ¶0037); Electrode strip 70 has a tail portion formed of a small-diameter, elongate, cylindrical, flaccid, flexible, electrically insulating material such as a silicone material or a polyurethane as the tail body 73. The body 73 has collar-like, tubular electric contacts 74 closely fitted around its outside surface (Ziobro ¶0051); A number of tails 83 depends on the electrode configuration. Here, subdural electrode grid 80 has two tails 83 of ten contacts 84 each (Ziobro ¶0052); Various types of probes may be used as EMG sensors (Ziobro ¶0070)]; and
a handle having a proximal end configured to connect to the stimulation module and a distal end configured to attach to the at least one probe [see handles 93, 103, 113, 123, 133, 143, 153 of Ziobro Figs. 12-15; Instrument 60 has a cortical stimulator 20 that provides stimulation pulse trains to a probe output module 39 that is adaptable to accept leads, tails, wires, and various connectors for monopolar straight electrodes, bipolar straight electrodes, bipolar angled electrodes, bipolar straight sheathed electrodes, bipolar Y-tip electrodes, tripolar straight electrodes, tripolar angled electrodes, one, two or three-dimensional electrode arrays, ball electrodes, etc. Such adaptation may be provided by use of plug-in adapters (not shown) (Ziobro ¶0055), wherein a proximal end of the corresponding handle(s) are considered to be connected to the stimulation module via cable(s) 92, 102, 112, 122, 132, 142, 152, respectively; and wherein a distal end of the corresponding handle(s) are considered to be connected to the corresponding probes via conductive metal shaft 94, 104, 114, 124, 134, 144, 154, respectively], wherein the stimulation module is configured to initiate a direct nerve stimulation protocol, adjust stimulation parameters of the direct nerve stimulation protocol to determine a threshold motor response, and identify at least one of the nerve fibers and the nerve pathways based on the threshold motor response [A first mapping pass is performed at step 160. Signal generator 29 outputs a set of pulse trains for a first pass of a mapping session, according to the stimulation pattern and associated waveform parameters. The pulse trains may be fed to a multiplexer section of signal generator 29 for distribution of individual pulse trains to corresponding pairs of subdural electrodes 21, via output ports 26 and tail(s) 73, 83 (Ziobro ¶0083); When controller 23 determines that an EMG detection event is not conclusive, the parameters for stimulating the particular electrode pair are evaluated and modified in step 210 if controller 23 determines that, for example, a higher stimulation voltage should be used in a subsequent pass. In addition, when the EMG detection event is inconclusive, detection parameters such as IIR filtering and spatial alignment may be adjusted for improving detection accuracy corresponding to a subsequent pass (Ziobro ¶0084)].
However, while Ziobro discloses a plurality of output connectors, and further depicts connecting at least 20 electrodes via respective electrode contacts [see Ziobro ¶¶0051-0052, Figs. 3-4], Ziobro fails to explicitly disclose wherein the stimulation module comprises at least twelve output connectors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro to employ wherein the stimulation module comprises at least twelve output connectors, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [connect the stimulation module to an electrode] [MPEP § 2143(I)(D)].
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) of at least 12 output connectors is/are somehow ‘critical’ or lead to unexpected results.
However, while Ziobro discloses a handle with monopolar or bipolar probes [Ziobro ¶¶0032-0033, Figs. 12-13], Ziobro fails to explicitly disclose wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode; and wherein the stimulation module is configured to initiate a stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation.
Wallace discloses systems for neural stimulation, wherein Wallace discloses a handle coupled to a probe, wherein the handle comprises a first visual indicator, a second visual indicator [The nerve localization devices and systems described herein may include one or more indicators or outputs. The detectors may provide a user-identifiable signal to indicate the location of the nerve or the status of the system. For example, the nerve localization devices may include one or more light emitting diodes (LEDs), buzzers (or other sound output), a video display, or the like. An LED may be illuminated based on signals generated by, received by, or generated in response to the energized electrode(s) as discussed above. In some variations the system or devices create a vibration or sound that a user manipulating the device 20 may feel or hear. The intensity of the output may vary as a function of detected signal (Wallace ¶0180); For example, FIGS. 31A-31C illustrate a handle 3101 of a neural localization device. In this example, the handle includes a window 3109 on one or more sides of the device that indicates visually where and when stimulation is being applied… The window may alternatively show other suitable indicators such as a graphic, including a color, an alphanumeric message, a symbol, or the like (Wallace ¶0228), wherein any first and second indicator may be considered to read on the claimed first visual indicator and second visual indicator], and an actuator configured to switch a stimulation module between a first mode of operation and a second mode of operation, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode [The neural stimulation device may be used to stimulate either the dorsal or ventral device surfaces (e.g., "top" or "bottom" of the ribbon structure). A control (e.g., the slider switch 3105 on the handle) may be used to determine the stimulation surface (top/bottom) and/or the mode (monopolar/bipolar, etc). In the example shown in FIGS. 32A-32B, an indicator on the handle indicates the mode of operation (Wallace ¶0232, Figs. 32A-C)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro to employ wherein the handle comprises a first visual indicator, a second visual indicator, and an actuator configured to switch the stimulation module between a first mode of operation and a second mode of operation, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode, so as to allow for user control of the type of operation and to indicate to a user of the handle which mode of operation is being employed.
However, the combination of Ziobro in view of Wallace fails to explicitly disclose wherein the controller configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the stimulation module is configured to initiate a direct nerve stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation.
Rupp discloses systems for operating electrosurgical instruments, wherein Rupp discloses an actuator that is configured to automatically switch a stimulation module between a first mode of operation and a second mode of operation depending upon a type of instrument being coupled to the stimulation module [The switch 300 controls which control signal (i.e., electrosurgical control signals or ultrasonic control signals) to pass to control the amplifier 228 and/or power supply 227. Control signals may be pulse width modulated signals as described in further detail below. The switch 300 can either be manually set by a user by selecting a desired output on the user interface 241 of the generator 200, or automatically by the controller 224, which may be based on a type of instrument being coupled to the generator 200. In embodiments, if the ultrasonic instrument 40 is coupled to port 260, the switch 300 is activated to pass ultrasonic control signals from the ultrasonic controller 304. Alternatively, if a monopolar electrosurgical instrument 20 or electrosurgical forceps 30 are coupled to ports 256 and 258, respectively, switch 300 is activated to pass electrosurgical control signals from electrosurgical controller 302 (Rupp ¶0034)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace to employ wherein the controller is configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the stimulation module is configured to initiate a direct nerve stimulation protocol in accordance with the automatically selected first mode of operation or the second mode of operation, so as to ensure proper operation of the system based on the coupled at least one probe, and as this modification further amounts to merely automating a manual activity [In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)].
Regarding claim 34, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33, further comprising at least one of a strip electrode and a grid electrode having a total number of contacts not exceeding a total number of the at least twelve output connectors, wherein the at least twelve output connectors are adapted to connect to the at least one of the strip electrode and the grid electrode [subdural/cortical strip electrode grid 70 or grid 80 is in place along the desired portion of the patient's brain in a known manner (Ziobro ¶0066, Figs. 3-4); wherein each of the contacts 74, 84 corresponding to a respective electrode, wherein the entire strip/grid electrode being coupled to the cortical stimulator 20 is considered to read on the number of contacts not being greater than the amount of output connectors].
Regarding claim 35, Ziobro in view of Wallace and Rupp teaches
The IONM system claim 33, wherein the plurality of probe ports comprises a first probe port and a second probe port and is configured to connect to the at least one probe [wherein as depicted in at least Ziobro Figs. 13A-B, the probe(s) is/are coupled to two probe ports via plugs 1111, 121], wherein the at least one probe comprises at least one of a passive monopolar probe and a passive bipolar probe [Ziobro ¶0070, Figs. 12-16].
Regarding claim 39, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33, wherein the at least one sensing electrode comprises an electromyography needle electrode [Ziobro ¶0044].
Regarding claim 40, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33, wherein the direct nerve stimulation protocol comprises a single pulse stimulation, wherein the single pulse has a frequency of 0.05 Hz to 90 Hz, a pulse width of 50 μsec to 1000 μsec, an interval between pulses of 0.5 millisecond to 10 milliseconds and a pulse amplitude in a range of 0.01 mA to 20 mA [Ziobro ¶¶0042-0043].
Regarding claim 41, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33, wherein the first visual indicator is configured to indicate at least one of the first mode of operation, the second mode of operation, a connection state of the at least one probe and what part of the at least one probe is active [Wallace ¶0232, Figs. 32A-C].
Claim(s) 26-28 and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziobro in view of Wallace and Rupp, as applied to claims 23 and 33 above, in further view of Hacker (US-7216001-B2, cited by Applicant).
Regarding claim 26, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 23.
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein each of the first plurality of output connectors are configurable as either an anode or a cathode through a user interface in data communication with the IONM system.
Hacker discloses systems and methods for intraoperative neural monitoring, wherein Hacker discloses a stimulation module comprising output connectors for electrodes that are configurable as either an anode or a cathode through a user interface of the system [Stim 2 electrical stimulation is delivered to the stimulating output electrode or cathode and flows through the anatomical tissue to the stimulating return electrode or anode. As described further below, depending on the polarity or phase selected for Stim 2 electrical stimulation, the stimulating electrodes 76a, 76b may each function as the output electrode or cathode. For positive phase Stim 2 stimulation, the stimulating electrode 76b functions as the output electrode or cathode with the stimulating electrode 76a functioning as the return electrode or anode. For negative phase Stim 2 stimulation, the stimulating electrode 76a functions as the output electrode or cathode with the stimulating electrode 76b functioning as the return electrode or anode (Hacker Col 13:4-17), wherein the Examiner notes that each electrode 76a, 76b being configurable as an anode or cathode depending on selection as operatively connected to the stimulation module is considered to read on the output connectors of the stimulation module being configurable as either an anode or cathode; initiating delivery of Stim 2 stimulation from the stimulator 16 requires actuation by the user completing performance of a multi-step manual actuation procedure with an activator for the stimulator 16 (Hacker Col 14:11-14); An MEP or Stim 2 monitoring display 153 is shown in FIG. 27 and is accessed by pressing the "MEP" tab on the EMG monitoring display 143. The MEP monitoring display 153 is used when Stim 2 electrical stimulation is to be applied to the patient and comprises channel buttons, a waveform display area for displaying EMG activity detected by the monitoring electrodes for each monitoring channel in use, buttons for "event threshold", "auto", "event capture", "largest", "0", "amplitude", "time", "freeze" and "save", a volume control, and tabs for accessing additional displays as described above for the EMG monitoring display 143 (Hacker Col 21:42-52)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein each of the first plurality of output connectors are configurable as either an anode or a cathode through a user interface in data communication with the IONM system, so as to allow for user control over operation of the output connectors, and as this modification would further amount to mere simple substitution of one known element for another with similar expected results [enable stimulation via electrodes] [MPEP § 2143(I)(B)].
Regarding claim 27, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 23, further comprising a computing device having a processor and a non-volatile memory for storing a plurality of programmatic instructions [the stimulation pattern and associated parameters may be obtained by the cortical stimulator section 20 via an input/output section 24. I/O section 24 may include one or more common interfaces such as wireless (e.g., RF, optical, etc.), USB, serial, parallel, intranet, Internet, or similar technology for externally communicating with controller 23, computer(s) 5, and/or memory device(s) 30, 50… Computer(s) 5 may include, for example, various databases accessed over a computer network. For example, a computer 5 may be configured with a host microprocessor, random access memory (RAM), read-only memory (ROM), input/output (I/O) electronics, a clock, a display screen, and an audio output device (Ziobro ¶0080)] which, when executed, cause the processor to:
provide a user interface in data communication with the IONM system [An exemplary method 100 implementing cortical mapping is now described with reference to FIGS. 10A-10B. A setup menu is first displayed on LCD 31 when turning on or resetting power to mapping stimulator 10, on a computer screen by selection of a pull-down menu bar from an attached PC, or by use of front panel buttons 52, 69 according to a firmware routine operating in communication with CPU 27… For example, a 4.times.5 grid may be identified on LCD 31 along with a prompt asking the user whether the indicated configuration is correct (Ziobro ¶0075)];
receive, via the user interface, user-defined stimuli [In step 140, the stimulation pattern and associated parameters may be obtained by the cortical stimulator section 20 via an input/output section 24 (Ziobro ¶0080)]; and
deliver signals representative of the user-defined stimuli to pairs of the first plurality of output connectors [Ziobro ¶¶0075, 0080].
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein each of the plurality of output connectors is configurable as either an anode or a cathode through the user interface.
Hacker discloses systems and methods for intraoperative neural monitoring, wherein Hacker discloses a stimulation module comprising output connectors for electrodes that are configurable as either an anode or a cathode through a user interface of the system [Hacker Col 13:4-17, 14:11-14, 21:42-52, wherein the Examiner notes that each electrode 76a, 76b being configurable as an anode or cathode depending on selection as operatively connected to the stimulation module is considered to read on the output connectors of the stimulation module being configurable as either an anode or cathode].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein each of the plurality of output connectors is configurable as either an anode or a cathode through the user interface, so as to allow for user control over operation of the output connectors, and as this modification would further amount to mere simple substitution of one known element for another with similar expected results [enable stimulation via electrodes] [MPEP § 2143(I)(B)].
Regarding claim 28, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 23, wherein the second plurality of probe ports comprises a probe port adapted to connect the at least one probe [input channels 46 of EMG 40 (Ziobro ¶0037); Various types of probes may be used as EMG sensors (Ziobro ¶0070), wherein as depicted in at least Ziobro Figs. 13A-B, the probe(s) is/are coupled to two probe ports via plugs 1111, 121], a first pair of connection ports adapted to connect to a power supply [Power to instrument 60 is provided by a low noise AC power supply with an internal battery backup (Ziobro ¶0055)] and a second pair of connection ports adapted to connect to a communication module [In step 140, the stimulation pattern and associated parameters may be obtained by the cortical stimulator section 20 via an input/output section 24. I/O section 24 may include one or more common interfaces such as wireless (e.g., RF, optical, etc.), USB, serial, parallel, intranet, Internet, or similar technology for externally communicating with controller 23, computer(s) 5, and/or memory device(s) 30, 50 (Ziobro ¶0080)].
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein the at least one probe comprises an anode and a cathode and wherein the probe port comprises first and second outputs for connection of to the anode and the cathode of the at least one probe.
Hacker discloses systems and methods for intraoperative neural monitoring, wherein Hacker discloses a stimulation module comprising output connectors for electrodes that are configurable as either an anode or a cathode [Hacker Col 13:4-17, 14:11-14, 21:42-52, wherein the Examiner notes that each electrode 76a, 76b being configurable as an anode or cathode depending on selection as operatively connected to the stimulation module is considered to read on the output connectors of the stimulation module being configurable as either an anode or cathode].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein the at least one probe comprises an anode and a cathode and wherein the probe port comprises first and second outputs for connection of to the anode and the cathode of the at least one probe, so as to allow for user control over operation of the probe port outputs, and as this modification would further amount to mere simple substitution of one known element for another with similar expected results [enable stimulation via electrodes] [MPEP § 2143(I)(B)].
Regarding claim 36, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33.
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein each of the at least twelve output connectors are configurable as either an anode or a cathode.
Hacker discloses systems and methods for intraoperative neural monitoring, wherein Hacker discloses a stimulation module comprising output connectors for electrodes that are configurable as either an anode or a cathode through a user interface of the system [Hacker Col 13:4-17, 14:11-14, 21:42-52, wherein the Examiner notes that each electrode 76a, 76b being configurable as an anode or cathode depending on selection as operatively connected to the stimulation module is considered to read on the output connectors of the stimulation module being configurable as either an anode or cathode].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein each of the at least twelve output connectors are configurable as either an anode or a cathode, so as to allow for user control over operation of the output connectors, and as this modification would further amount to mere simple substitution of one known element for another with similar expected results [enable stimulation via electrodes] [MPEP § 2143(I)(B)].
Regarding claim 37, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33, further comprising a computing device having a processor and a non-volatile memory for storing a plurality of programmatic instructions [Ziobro ¶0080] which, when executed, cause the processor to:
provide a user interface in data communication with the IONM system [Ziobro ¶0075];
receive, via the user interface, user-defined stimuli [Ziobro ¶0080]; and
deliver signals representative of the user-defined stimuli to pairs of the at least twelve output connectors [Ziobro ¶¶0075, 0080].
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein each of the at least twelve output connectors is configurable as either an anode or a cathode through the user interface.
Hacker discloses systems and methods for intraoperative neural monitoring, wherein Hacker discloses a stimulation module comprising output connectors for electrodes that are configurable as either an anode or a cathode through a user interface of the system [Hacker Col 13:4-17, 14:11-14, 21:42-52, wherein the Examiner notes that each electrode 76a, 76b being configurable as an anode or cathode depending on selection as operatively connected to the stimulation module is considered to read on the output connectors of the stimulation module being configurable as either an anode or cathode].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein each of the at least twelve output connectors is configurable as either an anode or a cathode through the user interface, so as to allow for user control over operation of the output connectors, and as this modification would further amount to mere simple substitution of one known element for another with similar expected results [enable stimulation via electrodes] [MPEP § 2143(I)(B)].
Regarding claim 38, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 33, wherein the plurality of probe ports comprises a probe port configured to connect to the at least one probe [Ziobro ¶¶0037, 0070, wherein as depicted in at least Ziobro Figs. 13A-B, the probe(s) is/are coupled to two probe ports via plugs 1111, 121], a first pair of connection ports adapted to connect to a power supply [Ziobro ¶0055] and a second pair of connection ports adapted to connect to a transceiver [Ziobro ¶0080].
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein the at least one probe comprises an anode connection and a cathode connection, and wherein the probe port comprises first and second outputs adapted to connect to the anode and the cathode of the probe port.
Hacker discloses systems and methods for intraoperative neural monitoring, wherein Hacker discloses a stimulation module comprising output connectors for electrodes that are configurable as either an anode or a cathode [Hacker Col 13:4-17, 14:11-14, 21:42-52, wherein the Examiner notes that each electrode 76a, 76b being configurable as an anode or cathode depending on selection as operatively connected to the stimulation module is considered to read on the output connectors of the stimulation module being configurable as either an anode or cathode].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein the at least one probe comprises an anode connection and a cathode connection, and wherein the probe port comprises first and second outputs adapted to connect to the anode and the cathode of the probe port, so as to allow for user control over operation of the probe port outputs, and as this modification would further amount to mere simple substitution of one known element for another with similar expected results [enable stimulation via electrodes] [MPEP § 2143(I)(B)].
Claim(s) 32 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziobro in view of Wallace and Rupp, as applied to claims 31 and 41 above, in further view of Gharib (US-20050075578-A1, cited by Applicant).
Regarding claim 32, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 31.
However, Ziobro in view of Wallace and Rupp fails to explicitly wherein the second visual indicator is configured to provide a first indication signifying that a site of stimulation is at a first distance from a nerve and a second indication signifying that the site of stimulation is at a second distance from the nerve, wherein the first distance is less than the second distance.
Gharib discloses systems for assessing nerves, wherein Gharib discloses a visual indicator configured to provide a first indication signifying that a site of stimulation is at a first distance from a nerve and a second indication signifying that the site of stimulation is at a second distance from the nerve, wherein the first distance is less than the second distance [The step of communicating this relationship to the surgeon in an easy-to-interpret fashion may be accomplished in any number of suitable fashions, including but not limited to the use of visual indicia (such as alpha-numeric characters, light-emitting elements, and/or graphics) and audio communications (such as a speaker element). By way of example only, with regard to surgical access systems, step (d) of communicating the relationship may include, but is not necessarily limited to, visually representing the stimulation threshold of the nerve (indicating relative distance or proximity to the nerve), providing color coded graphics to indicate general proximity ranges (i.e. "green" for a range of stimulation thresholds above a predetermined safe value, "red" for range of stimulation thresholds below a predetermined unsafe value, and "yellow" for the range of stimulation thresholds in between the predetermined safe and unsafe values--designating caution), as well as providing an arrow or other suitable symbol for designating the relative direction to the nerve. This is an important feature of the present invention in that, by providing such proximity and direction information, a user will be kept informed as to whether a nerve is too close to a given surgical accessory element during and/or after the operative corridor is established to the surgical target site. This is particularly advantageous during the process of accessing the surgical target site in that it allows the user to actively avoid nerves and redirect the surgical access components to successfully create the operative corridor without impinging or otherwise compromising the nerves (Gharib ¶0057)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein the second visual indicator is configured to provide a first indication signifying that a site of stimulation is at a first distance from a nerve and a second indication signifying that the site of stimulation is at a second distance from the nerve, wherein the first distance is less than the second distance, so as to indicate to a user of the system a level of safety of stimulation based on proximity to a nerve.
Regarding claim 42, Ziobro in view of Wallace and Rupp teaches
The IONM system of claim 41.
However, Ziobro in view of Wallace and Rupp fails to explicitly disclose wherein the second visual indicator is configured to provide a first indication signifying that a site of stimulation is at a first distance from a nerve and a second indication signifying that the site of stimulation is at a second distance from the nerve, wherein the first distance is less than the second distance.
Gharib discloses systems for assessing nerves, wherein Gharib discloses a visual indicator configured to provide a first indication signifying that a site of stimulation is at a first distance from a nerve and a second indication signifying that the site of stimulation is at a second distance from the nerve, wherein the first distance is less than the second distance [Gharib ¶0057].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ziobro in view of Wallace and Rupp to employ wherein the second visual indicator is configured to provide a first indication signifying that a site of stimulation is at a first distance from a nerve and a second indication signifying that the site of stimulation is at a second distance from the nerve, wherein the first distance is less than the second distance, so as to indicate to a user of the system a level of safety of stimulation based on proximity to a nerve.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
Prosecution Insights