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 (IDS) submitted on June 11, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Amendment
The amendment filed June 10, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112, 101, and 103 rejections previously set forth in the Non-Final Office Action mailed April 30, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 102 Rejections below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180078195 A1 (Sutaria et al.).
Regarding claim 1, Sutaria teaches a computer-implemented method of assessing tissue contact/proximity status for a plurality of electrodes located on a medical device ([0185] “This feeding tube 102 contains impedance sensors 1101-1108 that are positioned on the outside of the tube 102 and along the tube section that is located in the esophagus 101. In an exemplary embodiment, there are eight impedance sensors 1101-1108 that comprise a conductive electrode in order to measure the impedance between two different sensors. When reflux material spans two sensors, the electrical impedance between the two sensors is reduced. This difference in measured impedance is captured by the monitor 110 via a cable 108 and electrical connector 106 that connects the impedance sensors 1101-1108 on the feeding tube 102 to the monitor 110”), the method comprising:
measuring, using a first electrical sensing channel of impedance measurement circuitry, a first electrode impedance signal associated with a first electrode located on a spline of the medical device ([0302] “If the GRV sensor is composed of just two electrodes, this will be referred to as a bipolar impedance sensor/measurement. With two electrodes, impedance may be measured by injecting a current between the two electrodes and simultaneously measuring the resulting voltage on the same two electrodes”; The spline is interpreted to be the feeding tube 102; [0304] “a tetrapolar conductivity sensor at the distal end of the feeding tube 102. It is composed of source electrodes, 2201 and 2202, and two sensing electrodes, 2203 and 2204.”);
measuring, using a second electrical sensing channel of impedance measurement circuitry, a second electrode impedance signal associated with at least a second and third electrode located on the spline ([0302] “Two or more electrodes may be ganged together to form a single electrode. For example, two or more electrodes on a conductivity sensor may function as a single electrode for the GRV sensor by electrically connecting these electrodes”),
wherein the second and third electrodes are electrically connected to each other but not to the first electrode ([0302] “GRV sensor is composed of three electrodes”; “impedance may also be measured by applying a voltage to the source electrodes and measuring the resulting current on the sensing electrodes in bipolar, tripolar, and tetrapolar impedance measurement configurations. Two or more electrodes may be ganged together to form a single electrode”; A first electrode may be measured independently and the second and third electrodes are ganged together, not electrically connected to the first electrode),
wherein the second and third electrodes are connected in parallel with one another to the second sense channel such that the second electrode impedance signal is measured as a combined value associated with the second and third electrodes ([0302] “impedance may also be measured by applying a voltage to the source electrodes and measuring the resulting current on the sensing electrodes in bipolar, tripolar, and tetrapolar impedance measurement configurations. Two or more electrodes may be ganged together to form a single electrode. For example, two or more electrodes on a conductivity sensor may function as a single electrode for the GRV sensor by electrically connecting these electrodes”; The second and third electrodes are ganged, and therefore in parallel, measuring a combined impedance for the ganged electrode functioning as a single electrode.); and
assessing tissue contact/proximity status of the spline, the tissue contact/proximity status indicating whether the spline is in contact with or proximate to tissue, based on the first electrode impedance signal and the second electrode impedance signal ([0317] “The location of the impedance sensor in the patient's body may be monitored consistently by monitor 110.”; [0320] “The conductivity measurement from the conductivity sensor (2201-2204) at the distal tip of the feeding tube 102 in FIGS. 22A-22E may also be used to determine feeding tube placement. The conductivity sensor can identify the tissues that it is in contact with because each tissue has different conductivity.”).
Regarding claim 11, Sutaria teaches the computer-implemented method of claim 1, wherein the first, second and third electrodes are located on a single spline of the medical device ([0302] “a sensor located at the distal end of the feeding tube is used to measure GRV … three electrodes”; )
Regarding claim 12, Sutaria teaches the computer-implemented method of claim 11, further including generating an output indicating the tissue contact/proximity status of the spline based on the measured first electrode impedance signal and the measured second electrode impedance signal ([0320-0321] “If the monitor detects that the conductivity sensor is in the lower respiratory tract with a probability above a certain threshold, it will alert the clinician to remove the feeding tube and try to insert it again.”).
Regarding claim 13, Sutaria teaches a non-transitory computer-readable medium storing instructions that, when executed by a processor ([0379-0380]), cause the processor to perform a method of assessing tissue contact/proximity status for a plurality of electrodes located on a medical device ([0185] “This feeding tube 102 contains impedance sensors 1101-1108 that are positioned on the outside of the tube 102 and along the tube section that is located in the esophagus 101. In an exemplary embodiment, there are eight impedance sensors 1101-1108 that comprise a conductive electrode in order to measure the impedance between two different sensors. When reflux material spans two sensors, the electrical impedance between the two sensors is reduced. This difference in measured impedance is captured by the monitor 110 via a cable 108 and electrical connector 106 that connects the impedance sensors 1101-1108 on the feeding tube 102 to the monitor 110”), the method comprising:
measuring, using a first electrical sensing channel of impedance measurement circuitry, a first electrode impedance signal associated with a first electrode located on a spline of the medical device ([0302] “If the GRV sensor is composed of just two electrodes, this will be referred to as a bipolar impedance sensor/measurement. With two electrodes, impedance may be measured by injecting a current between the two electrodes and simultaneously measuring the resulting voltage on the same two electrodes”; The spline is interpreted to be the feeding tube 102; [0304] “a tetrapolar conductivity sensor at the distal end of the feeding tube 102. It is composed of source electrodes, 2201 and 2202, and two sensing electrodes, 2203 and 2204.”);
measuring, using a second electrical sensing channel of impedance measurement circuitry, a second electrode impedance signal associated with at least a second and third electrode located on the spline ([0302] “Two or more electrodes may be ganged together to form a single electrode. For example, two or more electrodes on a conductivity sensor may function as a single electrode for the GRV sensor by electrically connecting these electrodes”),
wherein the second and third electrodes are electrically connected to each other but not to the first electrode ([0302] “GRV sensor is composed of three electrodes”; “impedance may also be measured by applying a voltage to the source electrodes and measuring the resulting current on the sensing electrodes in bipolar, tripolar, and tetrapolar impedance measurement configurations. Two or more electrodes may be ganged together to form a single electrode”; A first electrode may be measured independently and the second and third electrodes are ganged together, not electrically connected to the first electrode),
wherein the second and third electrodes are connected in parallel with one another to the second sense channel such that the second electrode impedance signal is measured as a combined value associated with the second and third electrodes ([0302] “impedance may also be measured by applying a voltage to the source electrodes and measuring the resulting current on the sensing electrodes in bipolar, tripolar, and tetrapolar impedance measurement configurations. Two or more electrodes may be ganged together to form a single electrode. For example, two or more electrodes on a conductivity sensor may function as a single electrode for the GRV sensor by electrically connecting these electrodes”; The second and third electrodes are ganged, and therefore in parallel, measuring a combined impedance for the ganged electrode functioning as a single electrode.); and
assessing the tissue contact/proximity status of the spline based on the first electrode impedance signal and the second electrode impedance signal ([0317] “The location of the impedance sensor in the patient's body may be monitored consistently by monitor 110.”; [0320] “The conductivity measurement from the conductivity sensor (2201-2204) at the distal tip of the feeding tube 102 in FIGS. 22A-22E may also be used to determine feeding tube placement. The conductivity sensor can identify the tissues that it is in contact with because each tissue has different conductivity.”).
Response to Arguments
Applicant's arguments filed June 10, 2026 have been fully considered but they are not persuasive. With respect to the 103 rejection in the Non-Final Office Action (See Pages 9-15 of Applicant’s Response “Claim Rejections - 35 U.S.C. § 103”), Applicant argues that Movesov in view of Sutaria does not teach the amended limitations of independent claims 1 and 13. Applicant argues that the cited portion of Sutaria in the previous rejection is insufficient for the amended claims. The previous 103 rejection has been overcome, however there are new grounds of claim rejections that were necessitated by the claim amendments. Claims 1 and 11-13 are rejected under 35 U.S.C. § 102 as described above.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. The requirements for anticipation are discussed in MPEP § 2131.
Applicant argues that Sutaria does not teach or suggest using a first sense channel connected to a single electrode on a spline and a second sense channel connected in parallel to multiple electrodes on that same spline such that the second impedance signal is a combined grouped-electrode value used together with the first impedance signal to assess tissue contact/proximity status of the spline. Examiner notes that the combined group-electrode value is taught by claims 2 and 14, rather than claims 1 and 13. Claims 1 and 13 recite a spline that may be interpreted under BRI to be a structural member/arm, which is taught by the flexible feeding tube 102 of Sutaria [0013]. Additionally, claim 1 and claim 13 recite the limitation “assessing tissue contact/proximity status of the spline, the tissue contact/proximity status indicating whether the spline is in contact with or proximate to tissue, based on the first electrode impedance signal and the second electrode impedance signal”, which may be interpreted under BRI as using both signals in the assessment process. This does not require that the first impedance signal and second impedance signal are combined, as recited in claims 2 and 14. Therefore, claims 1 and 11-13 are rejected as being anticipated by Sutaria, and claims 2-10 and 14-20 are objected to based on their dependence on claims 1 and 13.
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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/EVELYN GRACE PARK/Examiner, Art Unit 3791
/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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