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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
Status of Claims
This Office Action is in response to the remarks and amendments filed on February 3rd, 2026. Claims 4, 15, and 22 have been canceled and claim 23 has been added as such claims 1-3, 5-14, 16-21, and 23 are pending consideration in this Office Action.
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 19 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.
Claim 19 is recites the limitation "the perceived patient effort" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, "the perceived patient effort” is being treated as “a perceived patient effort”.
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 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bassi (US 20190038894) in view of Evans (US 20190001127) and further in view of Göbel (US 20230191054) and JP674 (JP 6740526) and its translation (EspaceNet Translation of JP 6740526).
Regarding claim 1, Bassi discloses
an esophageal balloon catheter (Figs. 1 and 3A; esophageal catheter 210 with inflatable member 250; [0059]) comprising:
a catheter that carries a nutrient substance to sustain a patient (“the esophageal catheter may include a feeding tube for administration of substances including food stuff and nutrients”; [0068]);
an inflatable balloon positioned along a length of the catheter (Fig. 3A; “inflation member 250 runs along a length of the tubular esophageal catheter”; [0059]) ,
the inflatable balloon having an exterior surface (see Fig. 3A; inflatable member 250 has exterior surface);
a set of electrodes on the exterior surface of the inflatable balloon (see Fig. 3A; electrodes 220 are positioned on inflatable member 250; [0059] and [0060]),
the set of electrodes including a first electrode and a second electrode (see Fig. 3A; electrodes 220; 4 electrodes 220a-d; [0060]),
Bassi does not disclose the set of electrodes capable of stimulating a phrenic nerve of the patient when positioned in lower thoracic esophagus of the patient; at least one wire capable of providing power to the set of electrodes; and a connector comprising: a balloon port, fluidly coupled to the inflatable balloon, to receive gases for inflating the inflatable balloon: an injection port, fluidly coupled to the catheter, to receive the nutrient substance and a power port electrically coupled to the set of electrodes via the at least one wire.
Evans discloses a similar catheter and inflatable balloon with a set of electrodes 48 and where
the set of electrodes (Fig. 8; electrodes 48; [0127]) capable of stimulating a phrenic nerve (electrodes stimulate phrenic nerves; Paragraph 0127, Lines 11-16) of the patient when positioned in an esophagus of the patient (see Fig. 8 of the electrodes inserted into the patient’s esophagus);
at least one wire (one or more conducting wires; [0127]) capable of providing power ([0123], Lines 9-22; Claim 59, Lines 6-9) to the set of electrodes (Fig. 8; electrodes 48; Paragraph 0127, lines 1-6).
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 esophageal catheter of Bassi with the esophageal catheter and electrodes of Evans to provide a phrenic nerve stimulation thereby reducing the likelihood of trauma from ventilation (Evans: [0062]).
The modified device of Bassi does not disclose the set of electrodes positioned in a lower thoracic esophagus and a connector comprising: a balloon port, fluidly coupled to the inflatable balloon, to receive gases for inflating the inflatable balloon: an injection port, fluidly coupled to the catheter, to receive the nutrient substance and a power port electrically coupled to the set of electrodes via the at least one wire.
Göbel discloses an analogous esophageal balloon catheter where
the set of electrodes are positioned in a lower thoracic esophagus (fig. 4; electrodes 12 are positioned in so that they come to rest on both sides of the diaphragm, i.e., transdiaphragmally and measures electrical signals of the diaphragm where an appropriate stimulus reaches the diaphragm ZF via the phrenic nerve; [0170] and [0191]; the esophageal balloon can be positioned in the upper or lower half of the thoracic esophagus; [0022]).
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 balloon with electrodes on the esophageal catheter of the modified device of Bassi to be positioned further down in the lower thoracic esophagus of the patient as disclosed in Göbel to be able to derive electrical signals from the diaphragm and from structures that innervate the diaphragm which are important for optimizing the synchronization of the ventilator and the patient (Göbel: [0051]).
The modified device of Bassi does not disclose a connector comprising: a balloon port, fluidly coupled to the inflatable balloon, to receive gases for inflating the inflatable balloon: an injection port, fluidly coupled to the catheter, to receive the nutrient substance and a power port electrically coupled to the set of electrodes via the at least one wire.
JP 674 discloses a similar balloon catheter with multiple ports
a connector (see Fig. 3; connector comprising ports 112, 113, and 114) comprising:
a balloon port (Fig. 3; air supply port 112; [0030]), fluidly coupled to the inflatable balloon, to receive gases for inflating the inflatable balloon (Fig. 3; air supply port 112 communicates with balloons 21 and 22 to inflate said balloons; [0030]):
an injection port fluidly coupled to the catheter (Fig. 3; injection port 113; coupled to the catheter segment 11; [0030]), to receive the nutrient substance and
a power port (Fig. 3; electrically conductive port 114 with metal wire 115 to provide electric current via an external pulse generator) electrically coupled to the set of electrodes via the at least one wire.
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 esophageal balloon catheter with electrodes and feeding tube of the modified device of Bassi with the connector comprising the different ports and cavities of JP 674 such that the air supply port 112 is connected with the inflatable member 250 of Bassi, the feeding tube of Bassi is connected via the injection port 113, and the one or more conductive wires with the electrodes of Bassi are connected via the electrically conductive port 114 in order to provide a stable structure which allows different mediums (nutrients, electricity, air, etc.; JP 674: [0030]) and prevents them from mixing (JP 674: see Fig. 4 which shows different cavities preventing mixing).
Regarding claim 2, Bassi further discloses
the balloon catheter (esophageal catheter 210) of claim 1,
wherein the first electrode and the second electrode are spaced apart on the exterior surface of the inflatable balloon (Fig. 3A; electrode 220a and 220c are spaced apart on the surface of inflatable member 250; [0060]).
Regarding claim 3, Bassi further discloses
the balloon catheter (esophageal catheter 210) of claim 2,
wherein the first electrode and the second electrode are spaced apart radially on the surface of the inflatable balloon (Fig. 3A; electrode 220a and 220c are radially spaced apart on the surface of inflatable member 250; [0060]).
Regarding claim 8, Bassi further discloses
the balloon catheter (esophageal catheter 210) of claim 1,
wherein the first electrode and the second electrode are independently controllable (“All electrodes 220 may be independently controlled to transmit different electrical signals”; [0060]).
Claims 5-7, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bassi (US 20190038894) in view of Evans (US 20190001127) and further in view of Göbel (US 20230191054), JP674 (JP 6740526) and its translation (EspaceNet Translation of JP 6740526), and Golanov (US 20200360683).
Regarding claim 5, the modified device of Bassi discloses
the balloon catheter (esophageal catheter 210) of claim 2,
wherein the set of electrodes further includes a third electrode and a fourth electrode (Fig. 3A; electrodes 220a-d comprises a third electrode 220b and fourth electrode 220d).
The modified device of Bassi doesn’t explicitly disclose wherein the first electrode, the second electrode, the third electrode, and the fourth electrode are aligned and substantially evenly spaced apart radially on the exterior surface.
Golanov discloses an inflatable cuff with an electrode array to selectively target vagus nerve activity
wherein the first electrode, the second electrode, the third electrode, and the fourth electrode (see figs. 1a-1b; electrode array 106 is arranged on the inflatable cuff 104; [0038]; at least six electrodes 106a are shown on the first row) are aligned and substantially evenly spaced apart radially on the exterior surface (see fig. 1a-1b; the electrodes 106a can be form a spiral, concentric, annular, or curved pattern on the exterior surface of the inflatable cuff 104; [0039]; the electrode array 106 is spaced similar to a grid, see figs. 1a-1b, such that the electrodes 106a in the first row are evenly spaced from each other).
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 of the modified device of Bassi with the electrode pattern and arrays of Golanov to create a concentric distribution of surface electrodes that expand with the cuff thus creating a near uniform distribution of sensing and stimulating electrode recovery and provide a coverage of electrodes that are designed to fit patients of various sizes such that the location and/or size of the region of interest, which varies from patient-to-patient, can be targeted in each particular patient (Golanov: [0037] and [0069]).
Regarding claim 6, the modified device of Bassi further discloses
the balloon catheter (Bassi: esophageal catheter 210; Evans: electrodes stimulating phrenic nerve; Golanov: electrode array) of claim 5,
wherein the balloon catheter (Bassi: Figs. 1 and 3A; esophageal catheter 210 with inflatable member 250; [0059]) further includes four sets of electrodes (Golanov: see figs. 1a-1b; electrode array 106 is arranged on the inflatable cuff 104; [0037]-[0039]; see figs. 1a-1b which shows that electrode array 106 comprises at least 8 rows/sets of electrodes 106a; therefore, includes four sets of electrodes).
Regarding claim 7, the modified device of Bassi further discloses
the balloon catheter (Bassi: esophageal catheter 210; Evans: electrodes stimulating phrenic nerve; Golanov: electrode array) of claim 6,
wherein the four sets of electrodes (Golanov: see figs. 1a-1b; electrode array 106 is arranged on the exterior of the inflatable cuff 104; [0037]-[0039]; see figs. 1a-1b which shows that electrode array 106 comprises at least 8 rows/sets of electrodes 106a; therefore, includes four sets of electrodes) are distributed evenly along the exterior surface of the inflatable balloon (Golanov: see fig. 1a-1b; the electrodes 106a can be form a spiral, concentric, annular, or curved pattern on the exterior surface of the inflatable cuff 104; [0039]; the electrode array 106 is spaced similar to a grid, see figs. 1a-1b, such that the electrodes 106a are evenly spaced from each other radially in rows and columns).
Regarding claim 21, the modified device of Bassi discloses
the balloon catheter (Bassi: esophageal catheter 210; Evans: electrodes stimulating phrenic nerve) of claim 1,
The modified device of Bassi does not disclose wherein the set of electrodes are spaced along the exterior surface in one of a spiral pattern or a helical pattern.
Golanov discloses an inflatable cuff with an electrode array to selectively target vagus nerve activity
wherein the set of electrodes are spaced along the exterior surface in one of a spiral pattern (Fig. 2; “flexible electrodes can form an annular, spiral, concentric, or curved pattern on the exterior surface of the inflatable cuff”; [0005] and [0039]) or a helical pattern.
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 of the modified device of Bassi with the electrode patterns and arrays of Golanov to create a concentric distribution of surface electrodes that expand with the cuff thus creating a near uniform distribution of sensing and stimulating electrode recovery and provide a coverage of electrodes that are designed to fit patients of various sizes such that the location and/or size of the region of interest, which varies from patient-to-patient, can be targeted in each particular patient (Golanov: [0037] and [0069]).
Regarding claim 23, the modified device of Bassi discloses
the balloon catheter (Bassi: esophageal catheter 210; Evans: electrodes stimulating phrenic nerve) of claim 1,
wherein the inflatable balloon is a first inflatable balloon (Bassi: Fig. 3A; “inflation member 250 runs along a length of the tubular esophageal catheter”; [0059]).
The modified device of Bassi does not disclose wherein the esophageal balloon catheter further comprises a second inflatable balloon positioned along the length of the catheter, and wherein the second inflatable ballon includes at least one electrode.
Golanov discloses an inflatable cuff with an electrode array to selectively target vagus nerve activity
wherein the esophageal balloon catheter further comprises a second inflatable balloon positioned along the length of the catheter (figs. 1a-1b; elongate tubular member 102 includes inflatable cuff 104a and further includes holding inflatable cuff 104b distal to cuff 104a; [0038]), and
wherein the second inflatable ballon includes at least one electrode (figs. 1a-1b; the exterior surface of the inflatable cuff 104A and/or the holding cuff 104B can be covered with a matrix of elastic or flexible electrodes 106a; [0039]).
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 esophageal catheter of Bassi with the holding inflatable cuff and electrode patterns/arrays of Golanov to be able to secure the elongate tubular member in place within the subject, create a concentric distribution of surface electrodes that expand with the cuff thus creating a near uniform distribution of sensing and stimulating electrode recovery and provide a coverage of electrodes that are designed to fit patients of various sizes such that the location and/or size of the region of interest, which varies from patient-to-patient, can be targeted in each particular patient (Golanov: [0037]-[0039] and [0069]).
Claims 9-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Thakkar (US 20190175908) and further in view of Bhattacharya (US 20200406034).
Regarding claim 9, Evans discloses
a method for stimulating a nerve (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9), comprising:
providing first nerve stimulation (electrodes; Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9; Paragraph 0072, Lines 2-6) to a patient under mechanical ventilation (mechanical ventilation; Paragraph 0043, Lines 1-12),
wherein the first nerve stimulation (electrodes; Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9; Paragraph 0072, Lines 2-6) is based on first values for a set of stimulation parameters (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9; Paragraph 0064, Lines 6-10); after providing the first nerve stimulation (electrodes; Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9; Paragraph 0072, Lines 2-6) to the patient, receiving a breathing parameter of the patient (detection of breathe; Paragraph 0072, Lines 29-33 and Paragraph 0046, Lines 1-9);
determining second values for the set of stimulation parameters (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9),
based on the breathing parameter (contraction of respiratory muscle; Paragraph 0046, Lines 1-9; Paragraph 0072, Lines 29-33 and Last sentence of Paragraph 0072); and
providing second nerve stimulation to the patient (electrodes; Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9; Paragraph 0072, Lines 2-6),
based on the second values for the set of stimulation parameters (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9), reducing delivery of ventilation (pressure/time of mechanical ventilation are reduced; Paragraph 0063, Lines 1-12; Paragraph 0004, Lines 1-6; Paragraph 0006; Paragraph 0007) based on the breathing parameter (pace diaphragm muscle; Paragraph 0062, Lines 1-12; contracting/activating of diaphragm muscle is inhaling or a patient effort).
Evans does not explicitly disclose reducing delivery of ventilation while maintaining phrenic nerve stimulation based on the breathing parameter; and after reducing delivery of ventilation, temporarily pausing nerve stimulation for at least one breath of the patient while determining a patient effort.
Thakkar discloses methods and systems for stimulating a respiratory muscle or nerve of a patient comprising
reducing delivery of ventilation while maintaining phrenic nerve stimulation (figs. 1-2; continuing stimulation to hold open portions of the lung at the end of inspiration after the completion of the inspiration cycle from the external respiratory support (reducing ventilation); [0088]; system/method further discloses subsequent to administering at least some stimulation therapy, the level of external respiratory support may be reduced, as the patient's respiratory muscle begins strengthening from the stimulation and stimulation therapy may be continued after removal of the external respiratory support; [0104]) based on the breathing parameter (figs. 1-2; respiratory muscle stimulator, external respiratory support 88, and controller system 64 manages the delivery of stimulation and ventilation assistance in proportion to and in synchrony with the patient's respiratory efforts and in consideration of pain receptor signaling; [0090]).
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 of Evans to be able to control the ventilation and stimulation therapy as disclosed in Thakkar such that stimulation may be continued after reducing ventilation to provided negative end expiratory pressure (NEEP) that may mitigate de-recruitment of the lung tissue and prevent atelectasis and reduce external support, as the patient's respiratory muscle begins strengthening from the stimulation (Thakkar: [0088] and [0104]).
The modified method of Evans does not explicitly disclose after reducing delivery of ventilation, temporarily pausing nerve stimulation for at least one breath of the patient while determining a patient effort.
Bhattacharya discloses a system for stimulating phrenic nerves where
temporarily pausing nerve stimulation for at least one breath of the patient while determining a patient effort (fig. 5; falling edge of the electrical pulse reaches zero, the phrenic nerve may no longer be stimulated by the pacing module 304 and the diaphragm muscle may relax, thereby shrinking the chest cavity and forcing the air, or gas, out of the lungs. A tidal volume may be measured based on the inspiration and exhalation caused by the contraction of the side of the diaphragm stimulated by the phrenic nerve; [0055]; therefore, allowing for at least one parameter, such as a voltage, pulse frequency, pulse duration, duty cycle, pulse shape, rising edge, and/or falling edge may be adjusted).
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 external respiratory system of Evans with the ability to pause nerve stimulations as disclosed Bhattacharya after reducing ventilation as disclosed in Thakkar such that the stimulation parameters may be adjusted based on tidal volumes to achieve a desired contraction and corresponding tidal volume depending on the patient (Bhattacharya: [0055]-[0056]).
Regarding claim 10, Evans further discloses
the method (Evans: method for stimulating the phrenic nerve; Thakkar: reducing ventilation while stimulating; Bhattacharya: pausing nerve stimulation) of claim 9,
wherein the set of stimulation parameters (stimulation parameters; Paragraph 0085, Lines 1-5) includes a frequency of stimulation, or an amplitude of stimulation, or both (stimulation charge and frequency of pulses in a stimulation; Paragraph 0085, Lines 1-5).
Regarding claim 11, Evans further discloses
the method (Evans: method for stimulating the phrenic nerve; Thakkar: reducing ventilation while stimulating; Bhattacharya: pausing nerve stimulation) of claim 10,
wherein the breathing parameter of the patient (delivered breath; Paragraph 0074, Lines 18-25) includes at least one of a tidal volume of the patient (Paragraph 0074, Lines 18-25; “e.g., pressure, flow, tidal volume, etc.”), an end-tidal CO2, or a patient effort.
Regarding claim 12, the modified method of Evans discloses
the method (Evans: method for stimulating the phrenic nerve; Thakkar: reducing ventilation while stimulating; Bhattacharya: pausing nerve stimulation) of claim 10,
The modified method of Evans does not disclose the method further comprising: determining that the breathing parameter exceeds a threshold; and based on determining that the breathing parameter exceeds the threshold, changing at least one of the frequency of stimulation or the amplitude of stimulation.
Bhattacharya further discloses a system for stimulating phrenic nerves where
the method (method 500; Paragraph 0054, Lines 1-9) further comprising:
determining that the breathing parameter exceeds a threshold (Table 1; contraction threshold; Paragraph 0054, Lines 1-9); and
based on determining that the breathing parameter exceeds the threshold (Table 1; contraction threshold; Paragraph 0025, Lines 13-20 and Paragraph 0054, Lines 1-9), changing at least one of the frequency of stimulation or the amplitude of stimulation (amplitude of voltage of pacing signal; Paragraph 0025, Lines 13-20).
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 of Evans with the contraction threshold of Bhattacharya to help utilize the phrenic pacing system to assist a patient with breathing (Bhattacharya: Paragraph 0054, Lines 9-13).
Regarding claim 13, the modified method of Evans discloses
the method (Evans: method for stimulating the phrenic nerve; Thakkar: reducing ventilation while stimulating; Bhattacharya: pausing nerve stimulation) of claim 9,
wherein the method (Evans: method for stimulating the phrenic nerve; [0043], [0049]; Bhattacharya: Fig. 5; method 500; Paragraph 0054, Lines 1-13) further comprises:
implementing a weaning maneuver (Thakkar: system/method further discloses subsequent to administering at least some stimulation therapy, the level of external respiratory support may be reduced; [0104]Bhattacharya: Fig. 5; method 500; Paragraph 0054, Lines 1-13),
wherein the weaning maneuver (Bhattacharya: Fig. 5; method 500; Paragraph 0054, Lines 1-13) includes:
pausing providing nerve stimulation (Bhattacharya: Paragraph 0055, Lines 16-20); and
during the pause, receiving an indication of a patient effort (Bhattacharya: Fig. 5; step 520; measure tidal volume; Paragraph 0055, Lines 20-28),
wherein the second values for the set of stimulation parameters (Bhattacharya: at least one parameter; step 528; Paragraph 0055, Lines 28-33) is based on the patient effort (Bhattacharya: Fig. 5; step 520; measure tidal volume; Paragraph 0055, Lines 20-28).
Regarding claim 14, Evans further discloses
The method (Evans: method for stimulating the phrenic nerve; Thakkar: reducing ventilation while stimulating; Bhattacharya: pausing nerve stimulation) of claim 9,
wherein the breathing parameter of the patient (“sigh” breath; Paragraph 0046, Lines 1-9 and Paragraph 0084, Lines 3-11) is based on the stimulation parameters (stimulate with longer duration; Paragraph 0084, Lines 3-11), and
wherein the first nerve stimulation (electrodes 34; Paragraph 0046, Lines 1-9 and Paragraph 0084, Lines 3-11) and the second nerve stimulation (electrodes 34; Paragraph 0046, Lines 1-9 and Paragraph 0084, Lines 3-11) stimulate a phrenic nerve (phrenic nerve 26, 28; Paragraph 0084, Lines 3-11) and are provided from inside an esophagus of the patient (Fig. 8; transesophageal tube 46 with electrodes; Paragraph 0031, Lines 1-6Paragraph 0127, Lines 11-16).
Regarding claim 16, the modified method of Evans discloses
the method (Evans: method for stimulating the phrenic nerve; Thakkar: reducing ventilation while stimulating; Bhattacharya: pausing nerve stimulation) of claim 9,
wherein a frequency of the phrenic nerve stimulation (Bhattacharya: CPU 332 may configure or generate one or more parameters (such as frequency of the electric pulse signal) to cause a signal to be output and applied to a phrenic nerve of a patient; [0055]) is based on the detected patient effort (Evans: respiratory-based indication; Col. 12, Lines 49-56; Bhattacharya: If, however, the measured tidal volume is not within a desired range, then the method 500 may proceed to step 528 where at least one parameter, such as pulse frequency may be adjusted; [0055]).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Ward (US 6360740).
Regarding claim 17, Evans discloses
A ventilator (Figs. 2 and 8; external respiratory support 88; Paragraph 0092, Lines 3-10) for providing mechanical ventilation (Paragraph 0092, Lines 3-10) and nerve stimulation (Fig. 8; electrodes 48; Paragraph 0046, Lines 1-9; Paragraph 0127, lines 1-6) to a patient, the ventilator (Figs. 2 and 8; external respiratory support 88; Paragraph 0092, Lines 3-10) comprising:
a display (Figs. 2 and 8; graphical user interface (GUI) 21; Paragraph 0079, Last sentence);
an inhalation port (see modified Fig. 8 below) for providing breathing gas to the patient (Paragraph 0092, Lines 1-10);
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a processor (Figs. 2 and 8; computer/control unit 18; Paragraph 0079, Last sentence );
memory storing instructions (Figs. 2 and 8; computer; Paragraph 0079, Last sentence; computers store memory) that, when executed by the processor (Figs. 2 and 8; control unit 18; Paragraph 0079, Last sentence), cause the ventilator (Figs. 2 and 8; external respiratory support 88; Paragraph 0092, Lines 3-10) to perform a set of operations comprising:
detecting a perceived patient effort (detection of breathe; Paragraph 0072, Lines 29-33 and Paragraph 0046, Lines 1-9);
delivering the breathing gas to the patient via the inhalation port (see modified Fig. 8 below), based on the perceived patient effort (Paragraph 0139, Lines 10-16);
providing power (Paragraph 0123, Lines 9-22; Claim 59, Lines 6-9) to a set of electrodes (Fig. 8; electrodes 48, Paragraph 0127, Lines 1-3) coupled to an esophageal tube (Fig. 8; transesophageal tube 46, Paragraph 0127, Lines 1-3), wherein the power has a frequency and an amplitude (Claim 62, Lines 1-7);
measuring a breathing parameter of the patient (Paragraph 0074, Lines 18-25; “e.g., pressure, flow, tidal volume, etc.”; Claim 86, lines 1-3),
wherein the breathing parameter includes a tidal volume of the patient (Paragraph 0074, Lines 18-25; “e.g., pressure, flow, tidal volume, etc.”; Claim 86, lines 1-3), an end-tidal CO2 of the patient, or both; and
Evans does not explicitly disclose a nerve stimulation port; providing power to electrodes via the nerve stimulation port based on the breathing parameter of the patient, based on the breathing parameter of the patient, simultaneously reducing the delivery of breathing gas and at least one of the frequency, the amplitude, or both.
Ward discloses a system for assisted breathing with a ventilator and
a nerve stimulation port (figs. 1-4; nerve stimulation apparatus 10 (has a port) to connect via a stimulation line 12 to the phrenic nerve; col. 3, lines 52-60; nerve stimulation apparatus 10 and the ventilator 6 are interconnected (ventilator comprises the nerve stimulation apparatus) to enable them to operate in synchrony; col. 3, lines 61-62);
providing power to electrodes via the nerve stimulation port (figs. 1-4; delivers a stimulation pulses (provides power) to electrode 12a; col. 5, lines 24-27).
based on the breathing parameter of the patient (figs. 1-4; stimulation and ventilation weaning is varied based off patients attempts to breath spontaneously (patient effort); col. 2, lines 61-67 and col. 3, lines 1-5), simultaneously reducing the delivery of breathing gas (figs. 1-4; stimulation reduces weaking of respiratory muscles, therefore, shortens treatment duration times and weaning times of ventilator; col. 1, lines 57-64 and col. 2, lines 11-20) and at least one of the frequency (figs. 1-4; stimulation can be reduced to from three-breath intervals to once every fifth cycle and further to once every tenth breathing cycle (reduce stimulation frequency) based on improvements to the patients attempt to breath; col. 2, lines 61-67 and col. 3, lines 1-5), the amplitude, or both.
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 external respiratory support of Evans to be interconnected with the nerve stimulation apparatus and vary treatment as disclosed in Ward to enable the ventilator and nerve stimulation apparatus to operate in synchrony with a large number of possible operating modes (Ward: col. 3, lines 52-62) and enable the patient to resume adequate spontaneous breathing more rapidly and be disconnected from the ventilator sooner (Ward: col. 2, lines 18-20).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Ward (US 6360740) and further in view of Bhattacharya (US 20200406034).
Regarding claim 18, the modified device of Evans discloses
the ventilator (Evans: external respiratory support; Ward: nerve stimulation apparatus and adjusting stimulation/ventilation) of claim 17,
wherein adjusting the at least one of the frequency, the amplitude, or both is further based on the unassisted patient effort (figs. 1-4; stimulation can be reduced to from three-breath intervals to once every fifth cycle and further to once every tenth breathing cycle (reduce stimulation frequency) based on improvements to the patient’s spontaneous attempt to breath; col. 2, lines 61-67 and col. 3, lines 1-5)
The modified device of Evans does not disclose the set of operations further comprising: pausing providing powers to the set of electrodes and while pausing providing power detecting a patient effort wherein adjusting the at least one of the frequency, the amplitude, or both is further based on the unassisted patient effort
Bhattacharya discloses a system for stimulating phrenic nerves comprising
pausing providing power (figs. 1 and 5; the falling edge of the electrical pulse reaches zero, the phrenic nerve may no longer be stimulated by the pacing module 304 and the diaphragm muscle may relax; [0055]) to the set of electrodes (figs. 1 and 5; stimulation pulse signals are provided to electrodes placed in proximity to the patient’s phrenic nerves; [0054]-[0055]); and
while pausing providing power (figs. 1 and 5; the falling edge of the electrical pulse reaches zero, the phrenic nerve may no longer be stimulated by the pacing module 304 and the diaphragm muscle may relax; [0055]),
detecting a patient effort (Fig. 5; step 520 measure tidal volume; a tidal volume may be measured based on the inspiration and/or exhalation caused by the contraction of the side of the diaphragm stimulated by the phrenic nerve; Paragraph 0055, Lines 20-28),
wherein adjusting the at least one of the frequency, the amplitude, or both is further based on the patient effort (fig. 5; measured tidal volume 520 is used to adjust at least one parameter, such as a voltage, pulse frequency, pulse duration, duty cycle, pulse shape, rising edge, and/or falling edge may be adjusted, see steps 520-528; [0055]).
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 external respiratory system of Evans to pause nerve stimulations based on detected patient effort as disclosed Bhattacharya to allow for further stimulation parameters (such as voltage, pulse frequency, pulse duration, duty cycle, pulse shape, rising edge, and/or falling edge) to be adjusted based on tidal volumes and therefore achieve a desired contraction and corresponding tidal volume depending on the patient (Bhattacharya: [0055]-[0056]).
Regarding claim 19, the modified device of Evans further discloses
The ventilator (Evans: external respiratory support; Ward: nerve stimulation apparatus and adjusting stimulation/ventilation; Bhattacharya: pausing stimulation and adjusting parameters) of claim 17,
wherein adjusting at least one of the frequency (Ward: figs. 1-4; stimulation can be reduced to from three-breath intervals to once every fifth cycle and further to once every tenth breathing cycle (reduce stimulation frequency) based on improvements to the patients attempt to breath; col. 2, lines 61-67 and col. 3, lines 1-5), the amplitude, or both (Bhattacharya: at least one parameter; step 528; Paragraph 0055, Lines 28-33) is further based on the perceived patient effort (Bhattacharya: Fig. 5; step 520; measured tidal volume; Paragraph 0055, Lines 20-28; Ward: figs. 1-4; stimulation is varied based off patients attempts to breath spontaneously (patient effort); col. 2, lines 61-67 and col. 3, lines 1-5).
Regarding claim 20, Evans further discloses
The ventilator (Evans: external respiratory support; Ward: nerve stimulation apparatus and adjusting stimulation/ventilation; Bhattacharya: pausing stimulation and adjusting parameters) of claim 17,
wherein the esophageal tube (Fig. 8; transesophageal tube 46, Paragraph 0127, Lines 1-3) includes an inflatable balloon (Fig. 8; inflatable balloon; Paragraph 0127, lines 1-6) and
wherein the set of electrodes (Fig. 8; electrodes 48; Paragraph 0127, lines 1-6) is positioned along the inflatable balloon (surface of the balloon; Paragraph 0127, lines 1-6).
Response to Arguments
Applicant’s arguments with respect to claims 9-11 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 10 of the remarks, Applicant further argues that claims 12, 13, and 16 which depend from claim 9 are allowable for the reasons stated on pages 8-9 of the remarks. However, such arguments have been rendered moot in view of the new grounds of rejections as stated above.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 10 of the remarks, Applicant further argues that claims 2, 3, 5-8, and 21 which depend from claim 1 are allowable for the reasons stated on page 10 of the remarks. However, such arguments have been rendered moot in view of the new grounds of rejections as stated above.
Applicant’s arguments with respect to claim 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 11 of the remarks, Applicant further argues that claims 18-20 which depend from claim 17 are allowable for the reasons stated on pages 10-11 of the remarks. However, such arguments have been rendered moot in view of the new grounds of rejections as stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Govari (US 20220193353) – A patient ventilation system with and endotracheal tube containing electrodes to stimulate the phrenic nerve, where the ventilation system comprises a controller to control said stimulation
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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