DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 22, 31, and 36 are currently amended.
Claims 1-21 and 28-30 are cancelled
Terminal Disclaimer
The terminal disclaimer filed on 7/3/2026 disclaiming the terminal portion of any patent
granted on this application which would extend beyond the expiration date of U.S. Patent Number: US 10743817 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 7/3/2026, with respect to the rejection(s) of claim(s)
22-36 under 35 U.S.C. 102 and 103 rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hadani.
35 U.S.C. 102 and 103:
Regarding claim 22, applicant argues that Goldstone, alone or in combination with the prior art,
does not teach “wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes.” After further search and consideration, the examiner will now rely on Hadani to teach this limitation (fig. 2; paragraph 54-58). The magnetic marking 132 can be relatively easily identified from outside the patient, are positioned on or near one or more of the electrodes within the patient. When electrification is required, a physician can use an external sensor to determine the position of one or more of the electrodes within the patient.
Therefore, 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 exterior surface of the endotracheal tube from Goldstone to add the external sensor and magnetic markings from Hadani for the benefit of indicating the position of the electrodes along the esophagus of a patient (paragraph 55).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-27 and 31-36 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.
Regarding claims 22, 31, and 36, the limitation “wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes”, as well as specifically the limitation "wherein the magnetic indicator cooperating with a magnetic pick-up sensor," renders the claim indefinite because it is unclear whether the limitation(s) following “wherein” are part of the claimed invention. See MPEP § 2173.05(d).
It is not clear if a magnetic indicator is actually required based on the fact that it’s introduced for the first time in a wherein clause. See MPEP § 2111.01. The examiner suggests removing the “wherein” language and recite “a magnetic indicator” if this element is required. Similarly, it’s unclear if a pick-up sensor is required, based on the “cooperating” language. Specifically, does a first element cooperating with a second element positively require the second element or just the ability/capability of the first element to cooperate with the second element. The language of the claim should clearly reflect whether the pick-up sensor is actually required or just a functional limitation related to the indicator. Functional language is generally recited as, e.g. “the magnetic indicator configured to cooperate with a magnetic pick up sensor.”
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness
rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31-34 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Goldstone
et al. US Pat.: US 5125406 A, hereinafter Goldstone in view of Hadani US Pub.: US 20080249507 A1.
Regarding claim 31, Goldstone teaches a system, comprising: an endotracheal tube (10) having
an exterior surface and at least one piece of tape disposed thereon, the at least one piece of tape including a plurality of electrodes (16A-D), the plurality of electrodes (16A-D) including at least one stimulating electrode (16A-D) configured to stimulate tissue of a patient and at least one monitoring electrode (16A-D) configured to monitor at least one nerve of the patient (fig. 1-4; col. 4-5, lines 64-68 and 1-24; col. 6, lines 34-57); The electrodes 16A-D may be metallic tape that is configured to adhere to the exterior surface of the endotracheal tube. Changes in voltage can be caused by electrical stimulation to the nerve controlling that tissue site or by contact or manipulation of that nerve.
and a nerve integrity monitor device (57) configured to send a stimulation signal to the corresponding at least one stimulating electrode (16A-D) and configured to receive a monitoring signal from the corresponding at least one monitoring electrode (16A-D) (fig. 1-4 and 7; col. 6, lines 34-57). Changes in voltage can be caused by electrical stimulation to the nerve controlling that tissue site or by contact or manipulation of that nerve.
However, Goldstone does not teach wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes.
Hadani teaches an emergency electrode on medical tube and further teaches wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes (fig. 2; paragraph 54-58). The magnetic marking 132 can be relatively easily identified from outside the patient, are positioned on or near one or more of the electrodes within the patient. When electrification is required, a physician can use an external sensor to determine the position of one or more of the electrodes within the patient.
Therefore, 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 exterior surface of the endotracheal tube from Goldstone to add the external sensor and magnetic markings from Hadani for the benefit of indicating the position of the electrodes along the esophagus of a patient (paragraph 55).
Regarding claim 32, Goldstone in view of Hadani teaches the claimed invention and Goldstone
further teaches wherein each electrode of the plurality of electrodes (16A-D) is laterally offset relative to another of the plurality of electrodes (16A-D) along the at least one piece of tape (fig. 1-4; col. 4-5, lines 64-68 and 1-24). The figures show the plurality of electrodes are laterally offset from one another along the circular tube 10.
Regarding claim 33, Goldstone in view of Hadani teaches the claimed invention and Goldstone
further teaches wherein each electrode of the plurality of electrodes (16A-D) is longitudinally offset relative to another of the plurality of electrodes (16A-D) along the at least one piece of tape (fig. 1-4; col. 4-5, lines 64-68 and 1-24). The figures show the plurality of electrodes are laterally offset from one another along the circular tube 10.
Regarding claim 34, Goldstone in view of Hadani teaches the claimed invention and Goldstone
further teaches wherein each electrode of the plurality of electrodes (16A-D) is both laterally and longitudinally offset relative to another of the plurality of electrodes (16A-D) along the at least one piece of tape (fig. 1-4; col. 4-5, lines 64-68 and 1-24). The figures show the plurality of electrodes are laterally offset from one another along the circular tube 10.
Claims 22-23, 25-26, 29-30, and 36 are rejected under pre-AIA 35 U.S.C. 103 as being
unpatentable over Goldstone in view of Hadani in view of Scheiner et al. US Pub.: US 20100191311 A1, hereinafter Scheiner.
Regarding claim 22, Goldstone teaches a system, comprising: an endotracheal tube (10) having
an exterior surface (fig. 1-4; col. 4-5, lines 64-68 and 1-24);
at least one piece of tape adhered to the exterior surface of the endotracheal tube (10), the at least one piece of tape including a plurality of electrodes (16A-D) laterally and longitudinally offset relative to one another on the at least one piece of tape, the plurality of electrodes (16A-D) configured to monitor at least one nerve of a patient (fig. 1-4; col. 4-5, lines 64-68 and 1-24); The electrodes 16A-D may be metallic tape that is configured to adhere to the exterior surface of the endotracheal tube.
wherein the multi-channel nerve integrity monitoring device is configured to receive at least two channels of monitoring signals from the plurality of electrodes (fig. 1-4; col. 7, lines 16-24); Separate channels equate to a multi-channel nerve integrity monitoring device.
However, Goldstone does not teach at least one wireless transmitter operably coupled to the endotracheal tube, the at least one wireless transmitter configured to wirelessly communicate with a multi-channel nerve integrity monitoring device, the multi-channel nerve integrity monitoring device, in turn, configured to wirelessly monitor the plurality of electrodes; wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes.
Scheiner, in the same field of endeavor, teaches at least one wireless transmitter configured to wirelessly communicate with a multi-channel nerve integrity monitoring device, the multi-channel nerve integrity monitoring device, in turn, configured to wirelessly monitor the plurality of electrodes (fig. 1; paragraph 20). Sensors 42 and 44 deployed in operative relation to larynx 48 may be wireless sensors capable of transmitting sensed signal data to IMD 10.
Therefore, 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 electrodes from Goldstone to be wireless sensing electrodes capable of transmitting sensed signal data from Scheiner for the benefit of optimizing electrode sensing analysis and to reduce the risk of electronic communication complications.
Hadani teaches an emergency electrode on medical tube and further teaches wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes (fig. 2; paragraph 54-58). The magnetic marking 132 can be relatively easily identified from outside the patient, are positioned on or near one or more of the electrodes within the patient. When electrification is required, a physician can use an external sensor to determine the position of one or more of the electrodes within the patient.
Therefore, 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 exterior surface of the endotracheal tube from Goldstone to add the external sensor and magnetic markings from Hadani for the benefit of indicating the position of the electrodes along the esophagus of a patient (paragraph 55).
Regarding claim 23, Goldstone in view of Scheiner in view of Hadani teaches the claimed
invention and Goldstone further teaches wherein the at least one piece of tape is a conducting tape formed from a woven material (fig. 1-4; col. 4-5, lines 64-68 and 1-24). The electrodes 16A-D may be metallic tape that is configured to adhere to the exterior surface of the endotracheal tube. The metallic tape is a conducting material.
Regarding claim 25, Goldstone in view of Scheiner in view of Hadani teaches the claimed
invention and Goldstone further teaches wherein the endotracheal tube includes a flexible tube segment where at least one electrode of the plurality of electrodes is positioned, the flexible tube segment being more flexible than a remainder of the endotracheal tube (fig. 1-4; col. 4-5, lines 64-68 and 1-24). The figures show the flexible tube segments the electrodes are disposed on.
Regarding claim 26, Goldstone in view of Scheiner in view of Hadani teaches the claimed
invention and Goldstone further teaches wherein at least one electrode of the plurality of electrodes has a sinusoidal shape (fig. 1-4; col. 4-5, lines 64-68 and 1-24). The figures show the electrodes to be a circular shape which equates to a sinusoidal shape.
Regarding claim 29, Goldstone in view of Scheiner in view of Hadani teaches the claimed
invention and Goldstone further teaches wherein the multi-channel nerve integrity monitoring device includes at least one of a temperature sensing element, a fiber optic element or a video element (65) (fig. 7; col. 6-7, lines 58-68 and 1-6). A display device is disclosed.
Regarding claim 30, Goldstone in view of Scheiner in view of Hadani teaches the claimed
invention but does not teach wherein the multi-channel nerve integrity monitoring device includes at least one of a strain measurement element, an acceleration measurement element or a piezo electric element.
Scheiner further teaches wherein the multi-channel nerve integrity monitoring device includes at least one of a strain measurement element, an acceleration measurement element or a piezo electric element (fig. 1; paragraph 18). The lead 14 may include an accelerometer.
Therefore, 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 electrodes from Goldstone in view of Hadani to add an accelerometer from Scheiner for the benefit of monitoring cardiac function of the patient, which will increase the safety of the device.
Regarding claim 36, Goldstone teaches a multi-channel nerve integrity monitor device,
comprising: at least one stimulation channel configured to communicate a stimulation signal to at least one stimulating electrode (16A-D) disposed on an endotracheal tube (10) to stimulate tissue of a patient (fig. 1-4; col. 4-5, lines 64-68 and 1-24; col. 7, lines 16-24); The electrodes 16A-D may be metallic tape that is configured to adhere to the exterior surface of the endotracheal tube. Separate channels equate to a multi-channel nerve integrity monitoring device.
and a plurality of monitoring channels configured to receive a plurality of monitoring signals from a plurality of monitoring electrodes (16A-D) disposed on the endotracheal tube, wherein the nerve integrity monitor device (57) is configured to analyze the plurality of monitoring signals received from the corresponding plurality of monitoring electrodes (16A-D) and identify a subset of the plurality of monitoring signals based on the analysis (fig. 1-4 and 7; col. 6, lines 34-57). Changes in voltage can be caused by electrical stimulation to the nerve controlling that tissue site or by contact or manipulation of that nerve.
However, Goldstone does not teach at least one wireless transmitter operably coupled to the endotracheal tube, the at least one wireless transmitter configured to wirelessly communicate with a multi-channel nerve integrity monitoring device, the multi-channel nerve integrity monitoring device, in turn, configured to wirelessly monitor the plurality of electrodes; wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes.
Scheiner, in the same field of endeavor, teaches at least one wireless transmitter configured to wirelessly communicate with a multi-channel nerve integrity monitoring device, the multi-channel nerve integrity monitoring device, in turn, configured to wirelessly monitor the plurality of electrodes (fig. 1; paragraph 20). Sensors 42 and 44 deployed in operative relation to larynx 48 may be wireless sensors capable of transmitting sensed signal data to IMD 10.
Therefore, 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 electrodes from Goldstone to be wireless sensing electrodes capable of transmitting sensed signal data from Scheiner for the benefit of optimizing electrode sensing analysis and to reduce the risk of electronic communication complications.
Hadani teaches an emergency electrode on medical tube and further teaches wherein a magnetic indicator disposed on the exterior surface of the endotracheal tube proximate the plurality of electrodes is configured to determine a position of the plurality of electrodes relative to a vocal fold after intubation of the endotracheal tube, the magnetic indicator cooperating with a magnetic pick-up sensor to identify the position of the plurality of electrodes (fig. 2; paragraph 54-58). The magnetic marking 132 can be relatively easily identified from outside the patient, are positioned on or near one or more of the electrodes within the patient. When electrification is required, a physician can use an external sensor to determine the position of one or more of the electrodes within the patient.
Therefore, 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 exterior surface of the endotracheal tube from Goldstone to add the external sensor and magnetic markings from Hadani for the benefit of indicating the position of the electrodes along the esophagus of a patient (paragraph 55).
Claim 24 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Goldstone in
view of Scheiner in view of Hadani in view of Rea et al. US Pat.: US 5178145 A, hereinafter Rea.
Regarding claim 24, Goldstone in view of Scheiner in view of Hadani does not teach wherein the
at least one piece of tape includes an expandable conductive foam that expands upon absorbing moisture.
Rea, in the same field of endeavor, teaches wherein the at least one piece of tape includes an
expandable conductive foam that expands upon absorbing moisture (col. 3-4, lines 37-68 and 1-3). Medical grade foam polyethylene tape may absorb moisture and expand.
Therefore, 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 tape from Goldstone in view of Scheiner in view of Hadani to add medical grade foam polyethylene tape from Rea for the benefit of improving electrode contact the patient tissue. This will in turn increase the accuracy of electrode sensing analysis.
Claims 27-28 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over
Goldstone in view of Scheiner in view of Hadani in view of Hissong et al. US Pub.: US 20080039746 A1, hereinafter Hissong.
Regarding claim 27, Goldstone in view of Scheiner in view of Hadani does not teach further
comprising: markings positioned on the exterior surface of the endotracheal tube, the markings configured to provide an indication of longitudinal and rotational positioning of the endotracheal tube relative to the patient.
Hissong, in the same field of endeavor, teaches further comprising: markings positioned on the exterior surface of the endotracheal tube, the markings configured to provide an indication of longitudinal and rotational positioning of the endotracheal tube relative to the patient (paragraph 210-211). One or more reference sensor coils or marking points may be incorporated into an esophageal tube
Therefore, 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 tube from Goldstone in view of Scheiner in view of Hadani to add the marking points from Hissong for the benefit of providing information of the location or position of the device during procedures and to adjust the tube to the most desired location accurately.
Regarding claim 28, Goldstone in view of Scheiner Hadani does not teach wherein at least one
electrode of the plurality of electrodes is configured to determine the position of the endotracheal tube relative to the patient.
Hissong, in the same field of endeavor, teaches wherein at least one electrode
of the plurality of electrodes is configured to determine the position of the endotracheal tube relative to the patient (129 and 204-206). An electric field guidance device may track the position of up to 10 sensor electrodes simultaneously. Therefore, the electrodes are configured to determine the position of the endotracheal tube.
Therefore, 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 system from Goldstone in view of Scheiner in view of Hadani to add the electric field guidance device from Hissong for the benefit of providing more detailed information on the positioning of the endotracheal tube. The monitored sensor electrodes may be shown on a three axis coordinate grid on a monitor or display.
Claim 35 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Goldstone in view
of Hadani in view of Brunnett et al. US Pub.: US 20100145221 A1, hereinafter Brunnett.
Regarding claim 35, Goldstone in view of Hadani does not teach where at least one of the
plurality of electrodes is a stimulation electrode that includes automatic periodic stimulation.
Brunnett, in the same field of endeavor, teaches where at least one of the plurality of
electrodes is a stimulation electrode that includes automatic periodic stimulation (fig. 8; paragraph 127-127). The surgical procedure is performed on the target tissue while automatically stimulating (via the cuff electrode) the nerve with a stimulation signal at periodic intervals.
Therefore, 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 system from Goldstone in view of Hadani to add the automatic periodic stimulation from Brunnett for the benefit of monitoring differences between the measured neurogenic responses and the baseline neurogenic response pattern relative to a limit.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./
Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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