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 .
Status of Claims
This Office Action is in response to the remarks and amendments filed on August 20th, 2025. Claims 4 and 15 have been canceled and claims 21 and 22 have been added. As such, claims 1-3, 5-14, and 16-22 are pending consideration in this Office Action.
Response to Amendments
The objections to the claims are withdrawn in light of the amendments.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9-11, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans (US 20190001127).
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).
Regarding claim 10, Evans further discloses
The method (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) 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 (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) 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 14, Evans further discloses
The method (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) 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 15, Evans further discloses
The method (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) of claim 9,
the method (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) further comprising:
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) while maintaining phrenic nerve stimulation (stimulation of phrenic nerves; Paragraph 0063, Lines 1-12) based on the breathing parameter (pace diaphragm muscle; Paragraph 0062, Lines 1-12; contracting/activating of diaphragm muscle is inhaling or a 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 1-5 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 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 inserted within an 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 inserted within 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 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, the feeding tube is connected via the injection port 113, and the one or more conductive wires with the electrodes 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 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 5, Bassi further discloses
the balloon catheter (esophageal catheter 210) of claim 1,
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).
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 6-7 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 JP674 (JP 6740526) and its translation (EspaceNet Translation of JP 6740526) and a second embodiment of Evans (US 20190001127).
Regarding claim 6, the modified device of Bassi discloses
the balloon catheter (esophageal catheter 210) of claim 5,
The modified device of Bassi does not disclose wherein the balloon catheter further includes four of the sets of electrodes.
However, a second embodiment of Evans discloses
wherein the balloon catheter (catheter 12; Paragraph 0112, Lines 8-10) further includes four sets of electrodes (Fig, 9; “stimulation array may include multiple sets of electrodes” and “more than 2 electrode combinations (e.g. 3, 4, or more)”; [0111], Lines 1-16 and [0132], Lines 1-18).
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 electrode configuration and inflatable member of the Bassi to have a balloon with four electrode combinations/sets as taught in the second embodiment of Evans to be able to stimulate more targeted nerves or muscles (second embodiment of Evans 0132, Lines 10-18).
Regarding claim 7, the modified device of Bassi further discloses
the balloon catheter (esophageal catheter 210) of claim 6,
wherein the four sets of electrodes (Evans: Fig, 9; “stimulation array may include multiple sets of electrodes” and “more than 2 electrode combinations (e.g. 3, 4, or more)”; [0111], Lines 1-16 and [0132], Lines 1-18) are distributed along the surface of the inflatable balloon (Bassi: Fig. 3A; electrodes 220 on inflatable member; inflatable member modified to have 4 sets of electrodes).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Bhattacharya (US 20200406034)
Regarding claim 12, Evans discloses
The method (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) of claim 10,
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 discloses a system for stimulating phrenic nerves
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).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Karamanoglu (US 8504158)
Regarding claim 16, Evans discloses
the method (Paragraph 0043, Lines 1-12 and Paragraph 0046, Lines 1-9) of claim 9,
Evan does not disclose wherein a frequency of the phrenic nerve stimulation is based on the detected patient effort.
Karamanoglu discloses a method for selectively adjusting the length of phrenic nerve electrical stimulation
wherein a frequency of the phrenic nerve stimulation (Col. 12, Lines 49-56; processor initiates stimulation) is based on the detected patient effort (respiratory-based indication; Col. 12, Lines 49-56).
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 initiate phrenic stimulation based on a respiratory indication to begin to treat breathing abnormalities not normally treated if a single missed breath becomes a pattern. (Karamanoglu: Col. 16, Lines 66-67 and Col. 17, Lines 1-17).
Claims 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Fell (DE 102006013304) and its translation (EspaceNet Translation Fell) and further in view of Bhattacharya (US 20200406034).
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 disclose a nerve stimulation port; providing power to a set of electrodes coupled via the nerve stimulation port based on the breathing parameter of the patient, adjusting at least one of the frequency, the amplitude, or both.
Fell discloses a three-lumen catheter with a balloon with
a nerve stimulation port (Figs. 1a-1h; lumen 5; Paragraph 0033, Line 2-4);
providing power (Paragraph 0033, Line 2-5) to a set of electrodes (Figs. 1a-2c; electrodes 6; Paragraph 0033, Lines 2-5 and Paragraph 0036, Lines 1-4) coupled via the nerve stimulation port (Figs. 1a-1h; lumen 5; Paragraph 0033, Line 2-4)
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 catheter of Evans with the lumens of Fell in order to be able to have a lumen where the wire goes through to allow the electrodes to receive power (Fell: Paragraph: 0033, Lines 2-5).
The modified device of Evans does not disclose based on the breathing parameter of the patient, adjusting at least one of the frequency, the amplitude, or both.
Bhattacharya discloses a system for stimulating phrenic nerves where
based on the breathing parameter of the patient (Fig. 5; step 520; measure tidal volume; Paragraph 0055, Lines 20-28), adjusting at least one of the frequency, the amplitude, or both (at least one parameter; step 528; Paragraph 0055, Lines 28-33).
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 adjust parameters based on tidal volumes as taught in Bhattacharya to achieve a desired contraction and corresponding tidal volume depending on the patient (Bhattacharya: Paragraph 0056, Lines 1-5).
Regarding claim 19, the modified device of Evans further discloses
The ventilator (Evans: external respiratory support; Bhattacharya: adjust parameters) of claim 17,
wherein adjusting at least one of the frequency, 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; measure tidal volume; Paragraph 0055, Lines 20-28).
Regarding claim 20, Evans further discloses
The ventilator (external respiratory support) 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).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 20190001127) in view of Fell (DE 102006013304) and its translation (EspaceNet Translation Fell) and further in view of Bhattacharya (US 20200406034) and Govari (US 20220193353).
Regarding claim 18, the modified device of Evans discloses
the ventilator (Evans: external respiratory support; Bhattacharya: adjust parameters) of claim 17,
the set of operations further comprising:
pausing providing power (Bhattacharya: Paragraph 0055, Lines 16-20) to the set of electrodes (Evans: Fig. 8; electrodes 48, Paragraph 0127, Lines 1-3); and
while pausing providing power (Bhattacharya: Paragraph 0055, Lines 16-20),
detecting a patient effort (Bhattacharya: Fig. 5; step 520; measure tidal volume; 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 (Bhattacharya: Fig. 5; step 520; measure tidal volume; Paragraph 0055, Lines 20-28).
Govari discloses a patient ventilation system where the processor 44 detects whether the patient makes
an unassisted patient effort (self-breathing; Paragraph 0050, Lines 1-13)
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 modified device of Evans to be able to detect when the patient is self-breathing as taught in Govari to be able to predict when the patient is trying or will soon be trying to breathe independently (Govari: Paragraph 0017, Lines 3-13) and adjust based on those parameters.
Claim 21 is 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 JP674 (JP 6740526) and its translation (EspaceNet Translation of JP 6740526) and Golanoz (WO 2019094698).
Regarding claim 21, the modified device of Bassi discloses
the balloon catheter (esophageal catheter 210) 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.
Golanoz discloses an inflatable cuff with an electrode array to selectively target vagus nerve activity (Abstract)
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 [0073]) 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 of Golanoz 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 (Golanoz: [0073]).
Claim 22 is 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 JP674 (JP 6740526) and its translation (EspaceNet Translation of JP 6740526) and Bly (US 20080183253).
Regarding claim 22, the modified device of Bassi discloses
The balloon catheter (esophageal catheter 210) of claim 1,
The modified device of Bassi does not disclose wherein the first electrode and the second electrode have opposite polarities.
Bly discloses a neurostimulation lead with electrodes for stimulating a phrenic nerve [0017]
wherein the first electrode and the second electrode have opposite polarities (“the electrodes 56 can have differing polarities” and can be individually addressed electrodes; [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 the electrodes of the modified device of Bassi to have differing polarities as taught in Bly to have individually addressable electrodes 56 allow for flexibility in electrode selection providing for greater control over the current field and the direction of stimulation as well as allowing for multiple options for stimulation and sensing (Bly: [0026]).
Response to Arguments
Applicant’s arguments, see page 7, filed August 20th, 2025, with respect to the 101 rejections of Claims 9-20 have been fully considered and are persuasive. The 101 rejections of Claims 9-20 has been withdrawn.
Applicant’s arguments, see page 8, filed August 20th, 2025, with respect to the rejections of claims 1-8 under 35 USC § 102 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 over Bassi (US 20190038894) in view of Evans (US 20190001127) and further in view of JP674 (JP 6740526) and its translation (EspaceNet Translation of JP 6740526).
Applicant's arguments filed August 20th, 2025 have been fully considered but they are not persuasive.
On pages 8-9 of the remarks, Applicant argues that Evans does not disclose the amended language of claim 9 where after providing the second nerve stimulation to the patient, receiving a second breathing parameter of the patient; and based on the second breathing parameter reducing delivery of ventilation while maintaining the second nerve stimulation”. However, the examiner disagrees because Evans discloses a system that “may include a first nerve stimulator configured to stimulate a first nerve, wherein stimulation of the first nerve assists or causes contraction of a respiratory muscle in the subject ; and a processor configured to: receive a test result of a vagus nerve activity in the subject, and generate a stimulation parameter based on the test result; and a second nerve stimulator configured to stimulate a second nerve based on the stimulation parameter” [0046]. In other words, Evans discloses a method to stimulate a first nerve (based on parameters), receive a breathing parameter (test result of vagus nerve activity referring to active of breathing muscles), determine second values (stimulation parameter) based on the breathing parameter (test result) and provide a second stimulation based on the breathing parameter (stimulation parameter created from the test result). It would have been readily understood by one of ordinary skill in the art that if the processor is configured to receive test results and create stimulation parameters then a second breathing parameter could be received. Evans further states that stimulation of phrenic nerves may pace the diaphragm muscle so that the pressure and time required from the mechanical ventilation are reduced [0063] and that the external respiratory support 88 (ventilator/ventilation) can be reduced or even eliminated during a portion of or all of the deliver of stimulation set or stimulation session [0138]-[0139] (may maintain second stimulation and reduce ventilation during the stimulation session). Therefore, the examiner maintains the rejection of claim 9 and its dependents.
On page 9 of the remarks, Applicant argues the Office Action has not established a prima facie case of obviousness for each of the 103 rejections made (see Non Final Rejection filed May 8th, 2025). However, each of the 103 rejections have established a prima facia case of obviousness where each obvious states starts with It would have been obvious… to modify (art 1) with (art 2) and a reason explaining why. For instance, Evans is modified with an analogous/similar phrenic nerve stimulation system of Bhattacharya where it discloses some of the limitations of claim 17 and then further states that “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 adjust parameters based on tidal volumes as taught in Bhattacharya to achieve a desired contraction and corresponding tidal volume depending on the patient (Bhattacharya: Paragraph 0056, Lines 1-5).” As such applicant’s argument is unpersuasive.
On page 9 of the remarks, Applicant argues that Claims 6-8 ultimately depend from claim 1 and for the reasons above are allowable. This argument is rendered moot in view of new rejections pursuant to claims 1-3, and 5-8.
On page 10 of the remarks, Applicant argues that Claims 12, 13, and 16 ultimately depend from claim 9 and thus are allowable for these reasons. However, the examiner disagrees (see reasonings as discussed above). Further claim 13, has been amended to disclose unassisted breathing, please refer to claim 18 where Govari discloses such limitation and reason to modify.
On page 10 of the remarks, Applicant argues with respect to claim 17 that the cited references fail to teach at least a ventilator for providing mechanical ventilation and nerve stimulation to a patient, the ventilator comprising a nerve stimulation port”. Applicant further argues that none of the features of the catheter of Fell could possibly disclose a ventilator having a nerve stimulation port. However, the catheter of Fell is not being used to disclose the ventilator but rather modify the catheter/esophageal of Evans in order to provide a nerve stimulation port that directs wires from a power source (providing power) to the electrodes (see Non-Final Rejection filed on May 8th, 2025). The external respiratory support 88 (ventilator) of Evans comprises the catheter/esophageal tube and the computer unit 18 (controls power/stimulation, see [0123]) where power is provided to the nerve stimulation port as modified in the rejection above. Therefore, the ventilator comprises the nerve stimulation port through the catheter/esophageal tube.
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 SYDNEY REYES RUSSELL whose telephone number is (703)756-4567. The examiner can normally be reached M-F 730am -5pm.
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, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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