DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed February 27, 2026 has been entered. Claims 1, 3, 5-8, 21, 23-24 and 26-34 remain pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-7, 23 and 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks et al. (US 2015/0005765 A1) (“Hendriks”) in view of Podhajsky (US 7749217 B2) ("Podhajsky") in further view of Stone et al. (US 2018/0256051 A1) ("Stone").
Regarding claims 1, 23 and 27 Hendriks discloses A method/system of using a patient monitoring system during surgery, the method comprising (Abstract and entire document):
attaching a probe to the patient monitoring system, wherein the probe includes a plurality of probe portions disposed therein including a monopolar probe portion, an emitter, and a detector (FIG. 2 and associated paragraphs see [0065], “an electro-surgical device 105 with comprises a handling portion 130 for handling by a surgeon or a robotic device (neither shown), and an electrode portion 110, the electrode portion being electrically connected, as indicated with arrow 151, to the electro-surgical power source ESG 150” and [0066], “Additionally, the electro-surgical device has an optical guide 114, the optical guide being integrated into said electrode portion so that an optical exit and exit position 115 from the optical guide are positioned with least a part of said electrode portion between the handling portion and said optical entry and exit position.” And [0026] discussing monopolar and bipolar configurations. The probe has both monopolar probe portion, emitter and detectors. Claims 9 and 23 recite different combinations of monopolar, bipolar, all of which are disclosed by Hendriks),
wherein a distal end of the emitter and a distal end of the detector terminate at a distal end of the monopolar probe portion, thereby enabling the emitter, the detector, and the monopolar probe portion to contact a nerve simultaneously (FIG. 2 and [0066], “Additionally, the electro-surgical device has an optical guide 114, the optical guide being integrated into said electrode portion so that an optical exit and exit position 115 from the optical guide are positioned with least a part of said electrode portion between the handling portion and said optical entry and exit position.” The emitter and detector terminate near the distal end of the probe portion as shown in fig 2. See further FIG. 3A. The distal end of the emitter and the distal end of the detector and the distal end of the electrode all terminate at the end, as is also shown in FIG. 3B);
applying a ground electrode to a non-innervated, electrically neutral anatomical area of a patient ([0026], “Electro-surgery may be performed in at least two different ways; dipolar where two electrode portions are in contact with the tissue to be impacted, and monopolar where an electrode portion is applied on the tissue of a subject, and a more remote electrode on the subject, e.g. so-called dispersive pads, are used for the return circuit. The present invention may be implemented in both ways.”);
inserting the attached probe into a patient undergoing surgery ([0019 – 0022] discussing surgery and insertion and cutting);
using a distal end of the attached probe to bluntly dissect tissue by separating apart fibrous tissue to gain access to the nerve ([0019 – 0022] discussing surgery and insertion and cutting);
selecting the monopolar probe portion from the plurality of probe portions to apply diagnostic electrical stimulation to at least one of the fibrous tissue or the nerve ([0069], “The electrode 110 is electrically connected to the electrical console 150 capable of sending electrical signal to the blade inducing various treatments such as to cut, coagulate, desiccate, or fulgurate tissue. The electrode 110 is capable of performing these treatments to the tissue 200.”);
selecting the emitter to apply excitation radiation to the nerve to induce autofluorescence of the nerve for optical identification ([0067], “The optical unit comprises an optical radiation source 160b capable of emitting radiation, and a corresponding spectrometer 160b capable of receiving corresponding radiation from the tissue and further arranged for performing an analysis of the tissue type and/or condition, as will be explained in more detail below.”);
simultaneously contacting the nerve with the emitter, the detector, and the monopolar probe portion (See FIG. 3A. The distal end of the emitter and the distal end of the detector and the distal end of the electrode all terminate at the end, as is also shown in FIG. 3B and [0086], “For instance, it allows for monitoring the progress of treatment in a volume traversed by radiation R1 (bold dashed arrow exiting from exit position 115a, entering entry position 115b) close to the blade, with the optical signal changing during the treatment. At the same time, a tissue volume traversed by radiation R2 (bold dashed arrow exiting also from exit position 115a, but entering entry position 115c) further away from the electrode portion 110 is not, or not significantly, affected by the treatment and gives information from the untreated tissue nearby. This allows the physician to decide when and where to continue the treatment in nearby tissue and/or to switch to a different operation mode if necessary.” Monopolar electrode and the emitter/detector can be used simultaneously);
identifying the nerve using radiation captured from the nerve that has been stimulated by the applied excitation radiation, and confirming the identification by comparing a detected fluorescence signal to a threshold corresponding to a reference nerve ([0071], “Here the light is spectrally analysed. From the spectral signatures the tissue type and/or condition in front of the electrode portion 110 can be determined. For instance using a white light source and detecting the diffuse reflected light it is possible to detect the presence and concentration of various chromophores such as water, lipid blood, blood oxygenation, bile, beta-carotene etc. These parameters are then used to identify the tissue such a nerve tissue, blood vessel, muscle tissue etc.” see also [0026] discussing reference tissue analyzed. It is interpreted that the radiation signal and tissue properties are compared to known or reference values to identify the nerve/tissue inherently at some level of threshold degree of comparison), and
Hendriks fails to disclose actuating a switch disposed on the probe to initiate, during a single continuous actuation of the switch, delivery of the diagnostic electrical stimulation by the monopolar probe portion and application of the excitation radiation by the emitter;
maintaining, during the single continuous actuation of the switch, simultaneous activation of the monopolar probe portion and the emitter while the emitter, the detector, and the monopolar probe portion are simultaneously contacting the nerve;
during the single continuous actuation of the switch, determining a location and/or integrity of the nerve using stimulated response signals from the fibrous tissue and/or the nerve in response to diagnostic electrical stimulation delivered by the monopolar probe portion and configured to evoke EMG activity; during the single continuous actuation of the switch and while performing the determining electrically, simultaneously performing the identifying by radiation captured from the nerve that has been stimulated by the applied excitation radiation,
terminating, in response to release of the switch, delivery of the diagnostic electrical stimulation and application of the excitation radiation.
However, in the same field of endeavor, Podhajsky teaches actuating a switch disposed on the probe to initiate, during a single continuous actuation of the switch, delivery of the diagnostic electrical stimulation by the monopolar probe portion and application of the excitation radiation by the emitter (FIG. 1-2 and associated paragraphs, “control button 24”, for controlling the electrosurgical energy which includes both monopolar and bipolar circuitry and light emitter/sensor, see at least col. 5 lines 48-52 and col. 9 lines 19 – 40, “Accordingly, the handpiece 12A provides the surgeon with the ability to control the amount of tissue cutting, coagulating, etc. as the system 10 concurrently detects the amount of blood.”);
maintaining, during the single continuous actuation of the switch, simultaneous activation of the monopolar probe portion and the emitter while the emitter, the detector, and the monopolar probe portion are simultaneously contacting the nerve (FIG. 1-2 and associated paragraphs, “control button 24”, for controlling the electrosurgical energy which includes both monopolar and bipolar circuitry and light emitter/sensor, see at least col. 5 lines 48-52 and col. 9 lines 19 – 40, “Accordingly, the handpiece 12A provides the surgeon with the ability to control the amount of tissue cutting, coagulating, etc. as the system 10 concurrently detects the amount of blood.”);
terminating, in response to release of the switch, delivery of the diagnostic electrical stimulation and application of the excitation radiation (FIG. 1-2 and associated paragraphs, “control button 24”, for controlling the electrosurgical energy which includes both monopolar and bipolar circuitry and light emitter/sensor, see at least col. 5 lines 48-52 and col. 9 lines 19 – 40, it is interpreted that the select control includes both the start and stop of the controls/stimulation/radiation).
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 as taught by Hendriks to include actuating a switch disposed on the probe to initiate, during a single continuous actuation of the switch, delivery of the diagnostic electrical stimulation by the monopolar probe portion and application of the excitation radiation by the emitter; maintaining, during the single continuous actuation of the switch, simultaneous activation of the monopolar probe portion and the emitter while the emitter, the detector, and the monopolar probe portion are simultaneously contacting the nerve; terminating, in response to release of the switch, delivery of the diagnostic electrical stimulation and application of the excitation radiation as taught by Podhajsky to have simultaneous control (col. 9 lines 19 – 40, “Accordingly, the handpiece 12A provides the surgeon with the ability to control the amount of tissue cutting, coagulating, etc. as the system 10 concurrently detects the amount of blood.”).
Hendriks as modified fails to disclose during the single continuous actuation of the switch, determining a location and/or integrity of the nerve using stimulated response signals from the fibrous tissue and/or the nerve in response to diagnostic electrical stimulation delivered by the monopolar probe portion and configured to evoke EMG activity; during the single continuous actuation of the switch and while performing the determining electrically, simultaneously performing the identifying by radiation captured from the nerve that has been stimulated by the applied excitation radiation
However, in the same field of endeavor, Stone teaches during the single continuous actuation of the switch, determining a location and/or integrity of the nerve using stimulated response signals from the fibrous tissue and/or the nerve in response to diagnostic electrical stimulation delivered by the monopolar probe portion and configured to evoke EMG activity; during the single continuous actuation of the switch and while performing the determining electrically, simultaneously performing the identifying by radiation captured from the nerve that has been stimulated by the applied excitation radiation (As discussed above Hendriks teaches disclosing the identification by radiation and Podhajsky teaches the use of the switch to activate the emitter, detector and probe portions, Stone in Para. [0004] discussed structure and integrity of nerves. And para. [0080], “The surgical system 10 does so by electrically stimulating nerves via one or more stimulation electrodes at the distal end of the surgical access components 25-28 while monitoring the EMG responses of the muscle groups innervated by the nerves.” And para. [0085], “The EMG responses provide a quantitative measure of the nerve depolarization caused by the electrical stimulus.” See also [0030], “The presently disclosed and taught neurophysiological monitoring system provides the surgeon with information regarding the status of various nerves or other neural structures within the patient as well as other information useful in obtaining a successful surgical outcome—e.g., positional information indicating the distance between one or more surgical accessories and one or more nerves which, when brought to the attention of the surgeon or other operating room participant, enhances the likelihood that the surgical accessories do not interfere (structurally or functionally) with one or more of the patient's nerves or other neural structures.” Stone further teaches in [0006], “interprets the data of multiple modalities of information being aggregated through such neural monitoring, and communicates such interpreted information to the surgeon and/or others in the operating chamber in a reliable and consistent manner. It is to such a neurophysiological monitoring system that the presently disclosed and claimed inventive concept(s), process(es), methodology(ies) and/or outcome(s) is directed.” See also [0030], “The neurophysiological monitoring system is connected to the patient prior to spine surgery and permits a surgeon to monitor multiple neural monitoring modalities simultaneously during the entirety of the spine surgery—e.g., from patient positioning to final closure of the surgical wound or access point.” And [0067] and [0075], “FIGS. 3-16 show exemplary embodiments of status screens generated by a control unit of the surgical system of FIG. 1 in which multiple neural monitoring modalities are simultaneously being monitored in accordance with the present disclosure.” Simultaneously monitoring multiple modalities for the identification of the nerves);
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 as taught by Hendriks as modified to include determining a location and/or integrity of the nerve using stimulated response signals from the fibrous tissue and/or the nerve in response to diagnostic electrical stimulation delivered by the monopolar probe portion and configured to evoke EMG activity; while performing the determining electrically, simultaneously performing the identifying by radiation as taught by Stone to avoid interfering with nerves or other structured during surgery ([0030], “The presently disclosed and taught neurophysiological monitoring system provides the surgeon with information regarding the status of various nerves or other neural structures within the patient as well as other information useful in obtaining a successful surgical outcome—e.g., positional information indicating the distance between one or more surgical accessories and one or more nerves which, when brought to the attention of the surgeon or other operating room participant, enhances the likelihood that the surgical accessories do not interfere (structurally or functionally) with one or more of the patient's nerves or other neural structures.”).
Regarding claim 3, Hendriks as modified discloses The method of claim 1, further comprising positioning monitoring electrodes on the patient to receive the stimulated response signals (Hendriks [0026], “Electro-surgery may be performed in at least two different ways; dipolar where two electrode portions are in contact with the tissue to be impacted, and monopolar where an electrode portion is applied on the tissue of a subject, and a more remote electrode on the subject, e.g. so-called dispersive pads, are used for the return circuit. The present invention may be implemented in both ways.”).
Regarding claim 5, Hendriks as modified discloses The method of claim 1, wherein the at least one emitter comprises a solid state laser or a laser diode (Hendriks [0104], “This is understood to be commonly known by the skilled person. It is also possible to modulate the various wavelength bands with different modulation frequencies at the source and demodulate these at the detector, (this technique is described in the published patent application WO2009/153719 which is hereby incorporated by reference in its entirety). Various other modifications can be envisioned without departing from the scope of the invention for instance using more than one spectrometer 160b comprising one or more detectors or using more than one light source with different wavelength band, such as Light Emitting Diodes (LEDs) or LASER sources.”).
Regarding claim 6, Hendriks as modified discloses The method of claim 1, wherein a filter is used to limit emitter bandwidth from the at least one emitter (Hendriks [0104], “It is noted that the measurement of data representative of optical spectra of the associated tissue 200 can be carried out in various ways, such as by means of various filter systems in different positions of the optical path,”).
Regarding claims 7, Hendriks as modified discloses The method of claim 1, wherein the captured radiation is the fluorescence from the nerve (Hendriks FIG. 2 and [0066], “Additionally, the electro-surgical device has an optical guide 114, the optical guide being integrated into said electrode portion so that an optical exit and exit position 115 from the optical guide are positioned with least a part of said electrode portion between the handling portion and said optical entry and exit position.” The emitter and detector terminate near the distal end of the probe portion as shown in fig 2);
wherein the monitoring system includes at least one optical fiber extending through at least a portion of the probe to the distal end of the probe when wherein the detector is separate from the probe (Hendriks FIG. 2 and [0066], “Additionally, the electro-surgical device has an optical guide 114, the optical guide being integrated into said electrode portion so that an optical exit and exit position 115 from the optical guide are positioned with least a part of said electrode portion between the handling portion and said optical entry and exit position.” The emitter and detector terminate near the distal end of the probe portion as shown in fig 2); and
further comprising transferring the fluorescence from the distal end of the probe to the at least one detector via the at least one optical detector optical fiber to facilitate identification by the at least one detector (Hendriks FIG. 2 and [0066], “Additionally, the electro-surgical device has an optical guide 114, the optical guide being integrated into said electrode portion so that an optical exit and exit position 115 from the optical guide are positioned with least a part of said electrode portion between the handling portion and said optical entry and exit position.” The emitter and detector terminate near the distal end of the probe portion as shown in fig 2).
Regarding claim 28, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the emitter is configured to deliver the excitation radiation through an optical fiber extending along the probe (Hendriks FIG. 1-5 and [0031] – 0032]).
Regarding claim 29, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the detector unit includes a photodetector configured to detect fluorescence emitted by nerve tissue (Hendriks FIG. 1-5 and [0067], “An optical unit 160 for optical characterization of tissue type and/or condition is optically connected to the optical guide for transmitting optical radiation and receiving corresponding optical radiation, to and from, respectively, as indicated with double dashed arrow 120, the tissue 200 of the subject. The optical unit comprises an optical radiation source 160b capable of emitting radiation, and a corresponding spectrometer 160b capable of receiving corresponding radiation from the tissue and further arranged for performing an analysis of the tissue type and/or condition, as will be explained in more detail below.”).
Regarding claim 30, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the processor is further configured to generate a visual indication of nerve identification based on the detected fluorescence signal (Hendriks [0028]).
Regarding claim 31, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the processor is further configured to generate an auditory indication of nerve identification based on the detected fluorescence signal (Hendriks [0028]).
Regarding claim 32, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the electrical stimulation probe portion includes a monopolar electrode (Hendriks [0026]).
Regarding claim 33, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the processor is further configured to measure an amplitude or latency of the EMG activity to assess the integrity of the nerve (Stone [0060]).
Regarding claim 34, Hendriks as modified discloses The patient monitoring system of claim 27, Hendriks as modified further discloses wherein the excitation radiation includes visible or near-infrared radiation (Hendriks [0024]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Podhajsky in further view of Stone in further view of Nie et al. (US 9345389 B2) (hereinafter – Nie).
Regarding claim 8, Hendriks as modified discloses The method of claim 7, Hendriks as modified fails to disclose wherein the at least one detector is a near infrared camera with a highpass filter, and wherein the highpass filter is configured to pass optical wavelengths above emitted wavelengths of the radiation used to stimulate the nerve.
However, in the same field of endeavor, Nie teaches wherein the at least one detector is a near infrared camera with a highpass filter, and wherein the highpass filter is configured to pass optical wavelengths above emitted wavelengths of the radiation used to stimulate the nerve (Col.43: Chart 1 describes the third electronic imaging device 122a as NIR video camera used in conjunction with a long pass filter 118 to pass optical wavelengths greater than 810nm; above the 785 nm stimulation wavelength of the laser diode) – the long pass filter 118 is considered the “highpass filter” as claimed.
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 as taught by Hendriks as modified to include wherein the at least one detector is a near infrared camera with a highpass filter, and wherein the highpass filter is configured to pass optical wavelengths above emitted wavelengths of the radiation used to stimulate the nerve as taught by Nie in order to screen and identify and display in real time (Col. 15 lines 33-39, “In some embodiments, one or more contrast agents may be selected for desired tissue responses to allow for a multiplexed system that can simultaneously identify and display fluorescence in differing types of tissues or pathology. Thus, by selecting the appropriate contrast agent, a user could simultaneously and in real-time screen a targeted tissue for various types of cancer or other cellular pathologies.”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Podhajsky in further view of Stone in further view of Morgan et al. (US 2012/0095457 A1) (hereinafter – Morgan).
Regarding claim 21, Hendriks as modified discloses The method of claim 1, Hendriks as modified fails to disclose wherein the plurality of probe portions and use thereof are interchangeable via a universal mechanical connector.
However, in the same field of endeavor, Morgan teaches wherein the plurality of probe portions and use thereof are interchangeable via a universal mechanical connector (Para. [0082], “Traditional electrosurgical mono-polar devices use what is termed in the industry as a "Universal Connector" 300, which is configured with 3-pole contacts 302 as illustrated in FIG. 6. The purpose of these connector poles is to provide dual functionality of cutting and coagulation at the distal tip of the working device.”).
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 as taught by Hendriks as modified to include wherein the plurality of probe portions and use thereof are interchangeable via a universal mechanical connector as taught by Morgan in order to provide dual functionality (Para. [0082], “Traditional electrosurgical mono-polar devices use what is termed in the industry as a "Universal Connector" 300, which is configured with 3-pole contacts 302 as illustrated in FIG. 6. The purpose of these connector poles is to provide dual functionality of cutting and coagulation at the distal tip of the working device.”).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Podhajsky in further view of Stone in further view of Pracyk et al. (US 2018/0333061 A1) (“Pracyk”).
Regarding claims 24-26, Hendriks as modified discloses The method of claim 1, Hendriks as modified fails to disclose further comprising: inserting the attached probe into a neck region of the patient for monitoring the patient during a thyroid surgery; and using the distal end of the attached probe to bluntly dissect neck muscles to gain access to the patient's thyroid.
However, in the same field of endeavor, Morgan teaches further comprising: inserting the attached probe into a neck region of the patient for monitoring the patient during a thyroid surgery; and using the distal end of the attached probe to bluntly dissect neck muscles to gain access to the patient's thyroid ([0065], “Embodiments of the neural monitoring device can also be used in non-spinal surgical procedures that can risk neural damage, including but not limited to thyroid surgery, hand and other extremity surgeries, trans-orifice surgery, abdominal surgery, free fibular harvesting, parotid dissection, endoscopic carpal tunnel release surgery, and revision hip surgery.”).
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 as taught by Hendriks as modified to include further comprising: inserting the attached probe into a neck region of the patient for monitoring the patient during a thyroid surgery; and using the distal end of the attached probe to bluntly dissect neck muscles to gain access to the patient's thyroid as taught by Morgan to avoid neural damage ([0065], “Embodiments of the neural monitoring device can also be used in non-spinal surgical procedures that can risk neural damage, including but not limited to thyroid surgery, hand and other extremity surgeries, trans-orifice surgery, abdominal surgery, free fibular harvesting, parotid dissection, endoscopic carpal tunnel release surgery, and revision hip surgery.”).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 5-7, 22, 23 and 27-34, and claims 8, 21 and 24-26, have been considered but are moot because the new ground of rejection does not solely rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The amendments including the switches have required new rejections. The newly cited reference, Podhajsky teaches the use of a switch to control the probe portions as claimed. The arguments are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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