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 .
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 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 4, the limitation “wherein the at least one sense electrode comprises the at least one stimulation electrode” renders the claim indefinite as the number of sense electrodes and stimulation electrodes are not required to match, and it is unclear how one sense electrode could comprise three stimulation electrodes.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 1-9, 12-13, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20150374991 awarded to Morris et al.
Regarding Claims 1, 18, and 20, Morris teaches a system, device, and method of use comprising: one or more electrodes disposed on a transesophageal stimulation device (Para. 0088, “Although the examples disclosed herein are generally described in the context of stimulating vagal nerves in the neck of patient 12, lead 29 and electrodes attached thereto may also be arranged for vagal nerve stimulation in, e.g., the thorax, and/or adjacent to the esophagus”), the one or more electrodes comprising at least one sense electrode (Para. 0108, “For example, to determine the response to stimulation of vagus nerve 150, ECG, heart rate, blood pressure, blood flow, cardiac output, and/or breathing, of patient 12 can be sensed or observed. These and other physiological signals may be detected in a variety of ways including sensing the signals using sense electrodes, pressure sensors, ultrasound sensors, motion sensors or other devices. In other examples, physiological reactions of patient 12 may be observed or measured by, e.g., a clinician. In one example, efficacy may be measured by a sensor including, e.g., an accelerometer that determines if stimulation of the neck muscles or phrenic nerve of patient 12 is occurring with or instead of stimulation of vagus nerve 150. In another example, a pressure sensor arranged coincident with or connected to lead 29 may measure blood pressure by detecting the pressure within jugular vein 158. A pressure sensor, or other type of physiological feedback sensor, may also, in some examples, be connected to catheter 220 to measure, e.g., blood pressure within vein 158”); sensing circuitry configured to generate a signal of a patient via the at least one sense electrode (Para. 0108); one or more stimulation elements (Para. 0088) configured to deliver transesophageal stimulation to anatomy of the patient (Para. 0086); and processing circuitry communicatively coupled to the sensing circuitry, the processing circuitry being configured to: obtain the signal from the sensing circuitry and determine, based on the signal, a location within an esophagus of at least one stimulation element of the one or more stimulation elements (Para. 0056, “Various physiological signals may be observed to measure the efficacy of the test stimulation, and thereby the need to reposition lead 28 relative the target nerve tissue. In some examples, test treatment efficacy may be indicated by, e.g., ECG, heart rate, blood pressure, blood flow, blood oxygen content, blood biomarker content, cardiac output, and/or breathing, of patient 12. Additionally, T-wave morphology, heart rate variability, contractility, and atrioventricular (AV) intervals may be observed as an indication of test treatment efficacy”); and output an indication of the location (Para. 0061, “As another example, programmer 24 may be used by a user, e.g., a clinician while a medical lead is placed within patient in accordance with this disclosure to retrieve or view sensor feedback during the implantation of the lead. In one example, a physician uses programmer 24 to retrieve and/or view physiological signals sensed by one or more sensors in response to test electrical stimulation pulses delivered to patient 12 during the placement of lead 12 adjacent a vagus nerve. In this manner, the physician employs programmer 24 to determine the efficacy of the test stimulation delivered by lead 28, and thereby the position of lead 28 relative to the vagus nerve. In another example, the physician may also use programmer 24 to view an imaging field produced by an IVUS imaging system connected to a delivery catheter used to place lead 28, and electrodes connected thereto intra or transvascularly within patient 12. In this manner, the physician may employ programmer 24 to view, in real time, the placement of lead 28 within patient 12 relative to target nerve tissue and a blood vessel in which or through which the lead is placed”).
Regarding Claim 2, Morris teaches the system of claim 1, wherein the one or more stimulation elements comprise at least one of a stimulation electrode (Para. 0035).
Regarding Claim 3, Morris teaches the system of claim 1, wherein the one or more stimulation elements comprise at least one stimulation electrode (Para. 0035), wherein the stimulation comprises a transesophageal stimulation signal (Para. 0086), the system further comprising one or more memories configured to store stimulation parameters that at least partially define the transesophageal stimulation signal, the one or more memories being communicatively coupled to the processing circuitry (Para. 0035).
Regarding Claim 4, Morris teaches the system of claim 3, wherein the at least one sense electrode comprises the at least one stimulation electrode (Para. 0115, “Electrode 229 is also connected to a distal end of catheter 220 and may be advanced toward the wall of the lumen of jugular vein 158 to deliver test stimulation pulses to vagus nerve 150 through the wall of vein 158. Electrode 229 may therefore be employed in addition to or in lieu of sensor 222 to detect the relative position of vagus nerve 150 outside of jugular vein 158. During test stimulation of vagus nerve 150, electrode 229 may be connected to a conductor connected, e.g., transcutaneously to an external neurostimulation device that is configured to deliver electrical stimulation to the target nerve tissue, e.g., vagus nerve 150. After electrode 229 is connected to the neurostimulator, the device, either automatically or as partially or completely commanded by a programmer, such as programmer 24, may deliver electrical stimulation therapy to and/or receive sensor feedback from vagus nerve 150”).
Regarding Claim 5, Morris teaches the system of claim 1, wherein as part of determining the location, the processing circuitry is configured to: determine a morphology of the signal (Para. 0056); and at least one of compare at least one value associated with the morphology of the signal to at least one threshold or compare the morphology of the signal to a template (Para. 0055, “The electrical nerve signal may be sensed between two or more electrodes of lead 28. IMD 16 may analyze the electrical nerve signal for a response, for example, by measuring an amplitude of the electrical nerve signal and comparing the determined value to a threshold value. In this case, the electrical nerve signal may have a baseline amplitude value and a response to the stimulation signal may be characterized by a spike in amplitude. The nerve response may be characterized by an amplitude or other characteristics of a sensed electrical signal”).
Regarding Claims 6 and 19, Morris teaches the system and method claim 1 and 18, wherein the signal comprises at least one of an electrocardiogram (ECG) signal (Para. 0056).
Regarding Claim 7, Morris teaches the system of claim 1, wherein the indication comprises at least one of an instruction to move the at least one stimulation element with respect to a target stimulation region or an indication that the location is acceptable for stimulation (Para. 0061 and Para. 0109).
Regarding Claim 8, Morris teaches the system of claim 7, wherein the indication that the location is acceptable for stimulation comprises a command to control a start of delivery of the transesophageal stimulation (Para. 0107).
Regarding Claim 9, Morris teaches the system of claim 7, wherein the indication that the location is acceptable for stimulation comprises a message for display to a user via a user interface (Para. 0061).
Regarding Claim 12, Morris teaches the system of claim 1, wherein the processing circuitry is further configured to determine whether the location is within a location range, and wherein the indication comprises a representation of whether the location is within the location range (Para. 0039).
Regarding Claim 13, Morris teaches the system of claim 12, wherein the location range comprises a closest location within the esophagus to a particular anatomy of the patient (Para. 0039).
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 (i.e., changing from AIA to pre-AIA ) 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 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 10 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20150374991 awarded to Morris et al, as shown in Claim 1, in view of U.S. Patent Publication 20080269834 awarded to Byerman et al.
Regarding Claims 10 and 15, Morris teaches the system of claim 7, wherein the indication comprises the instruction to move the at least one stimulation element with respect to the target stimulation region (Para. 0107), and wherein the instruction comprises an instruction to move the stimulation device a set distance (Para. 0117, “In the event the nerve tissue stimulation meets or exceeds the threshold efficacy, lead 29 and electrode 228 may be chronically deployed by advancing the lead from the tip of catheter 220 within jugular vein 158 toward vagus nerve 150. On the other hand, if the nerve stimulation delivered by electrode 229 does not provide the threshold level of efficacy in relieving the symptoms of patient 12, catheter 220 and electrode 229 may be repositioned within jugular vein 158 to improve location with respect to vagus nerve 150. Generally speaking, catheter 220 and electrode 229 may be repositioned by rotating catheter 220 within jugular vein 158 to different incremental positions until an acceptable position for catheter 220 relative to vagus nerve 150 is determined. After repositioning catheter 220 and electrode 229, the process of stimulating vagus nerve 150 and comparing the efficacy of the nerve stimulation to a threshold efficacy may be repeated until the arrangement of catheter 220 with respect to vagus nerve 150 delivers electrical stimulation therapy that meets or exceeds the threshold efficacy level”). Morris does not teach wherein the target stimulation region comprises a region where the esophagus passes a diaphragm, but does teach the need to use vagal stimulation to treat obesity (Para. 0034).
However, in the art of transesophageal electrostimulation (abstract), Byerman teaches using transesophageal electrostimulation at a location past the diaphragm (Para. 0091) for the purposes of treating obesity (Para. 0099).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morris by Byerman, i.e. by treating the area past the diaphragm in using the system of Morris as shown in Byerman, for the predictable purpose of improving Morris’s ability to treat obesity as done in Byerman.
Regarding Claim 16, Morris in view of Byerman makes obvious the system of Claim 15. Morris further teaches wherein the processing circuity is further configured to, in response to user input obtained from a clinician, control a start of delivery of the transesophageal stimulation (Para. 0107).
Regarding Claim 17, Morris in view of Byerman makes obvious the system of Claim 16. Morris further teaches wherein the location for the at least one stimulation element is a first location of a plurality of locations of the at least one stimulation element due to movement of the at least one stimulation element over time, and wherein the processing circuitry is further configured to: determine, based on the signal over time, the plurality of locations; determine, based on the signal over time, a preferred location among the plurality of locations; and output an indication of the preferred location (Paras. 0133-0135).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20150374991 awarded to Morris et al, as shown in Claim 1, in view of U.S. Patent Publication 20080269834 awarded to Byerman et al, further in view of NPL to Haeberlin et al, “The optimal lead insertion depth for esophageal ECG recordings with respect to atrial signal quality”, as cited on Applicant’s IDS dated 4/11/2025.
Regarding Claim 11, Morris modified by Byerman makes obvious the system of Claim 10. Morri does not teach wherein the set distance is in a range of 1 cm to 15 cm, inclusive, but does teach adjusting at set intervals to determine the target location (Para. 0117).
However, in the art of esophageal electrostimulation (title, abstract), Haeberlin teaches an interval adjustment of 2 cm to obtain ECG signals correlated to the position of the device (see “Methods”, subsection “ECG acquisition”, second paragraph, Pg. 159).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morris by Haeberlin, i.e. by setting the increments of Morris’s adjustment to two as in Haeberlin, as Morris already teaches the need to improve positioning of the device and the need to increment the position relative to a target area.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20150374991 awarded to Morris et al, as set forth in Claim 13, in view of U.S Patent Publication 20070156199 awarded to Koh et al.
Regarding Claim 14, Morris teaches the system of Claim 13. Morris does not teach wherein the particular anatomy comprises a left atrium, but does teach a need for cardiac pacing through vagal stimulation (Para. 0044).
However, in the art of vagal stimulation (abstract), Koh teaches wherein a left atrium is the target anatomy (Para. 0026) for the purpose of positioning the stimulation device for improved cardiac pacing (Para. 0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morris by Koh, i.e. by positioning the device of Morris towards the left atrium as in Koh, for the predictable purpose of improving the pacing of Morris as in Koh as taught above.
Conclusion
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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