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 9 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. The claim recites the term “preferably.” It is unclear if the biphasic rectangular wave following the term is required by the claim limitations or not.
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 1-4, 5, 8, 10-11, 13, 16-17, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No 2016/0310730 granted to Martins et al (hereinafter “Martins”).
In reference to claims 1 and 23, Martins discloses a system for electrically stimulating a nerve to cause muscle contraction [e.g. “…an electrode array of a first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve…” (abstract)], comprising: a plurality of electrodes configured to be positioned in electrical contact with the skin simultaneously, the electrodes being configured to allow electrical stimulation to be directed independently towards a plurality of different stimulation regions below the skin via a corresponding plurality of combinations of the electrodes [e.g. “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” (paragraph 0148)]; and a controller [e.g. controller 1350] configured to: for each combination of electrodes, apply a test stimulation using the combination of electrodes and measure a response to the test stimulation [e.g. “…the system or the clinician may proceed to test electrodes of that particular region of the electrode array as follows: electrode pairs 3-5, then 4-5, then 3-4, then 4-6, then 5-6. The testing may also include inversion of which electrode gives a better response as an anode or cathode…” (paragraph 0164)]; select one or a subset of stimulation regions based on the measured responses [e.g. “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc., then testing can focus on the electrodes of that particular region of the electrode array…” (paragraph 0164)]; and apply a therapy stimulation to each selected stimulation region using the combination of electrodes corresponding to the selected stimulation region [e.g. “…The stimulator may be capable of stimulating for example in five different stimulation modes (SMs) as will be discussed below although other modes of operation are also envisioned. After the electrode combination that provides better results is determined (e.g., better contraction of the diaphragm and/or little or no collateral contraction of collateral muscles), three amplitudes for example may be established to support different modes of operation as described herein …” (paragraph 0168)].
In reference to claim 2, Martins discloses wherein each measured response comprises information about a physiological response to the corresponding test stimulation [e.g. “…During use, testing (e.g., in accordance with the EPTM discussed above) can start with electrodes 1 (cathode) and 4 (anode). The stimulus amplitude can be set to a value that typically generates a contraction that is visible and/or measurable, although it doesn't have to generate a full-breath contraction. The desired contraction may be some contraction that is visible and/or can be measurable (e.g., through use of a motion sensor)…”(paragraph 0163)].
In reference to claim 3, Martins discloses wherein the physiological response comprises a physiological response of the diaphragm [e.g. “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc…” (paragraph 0164)].
In reference to claim 4, Martins discloses wherein the controller is configured such that the selection of the one or a subset of the stimulation regions comprises selecting the stimulation region for which the measured response to the respective test stimulation is the highest [e.g. “…if it is determined that electrode pair 1-4 gives better stimulation than electrode pair 3-6, then the system or the clinician (for example by pressing a key that selects the next pair of electrodes of the same group) may proceed testing electrodes within that particular region (e.g., in the region of electrode pair 1-4) of the electrode array such as electrode pairs 1-3, then 1-2, then 2-3, then 2-4, and then 3-4. If, on the other hand, the electrode pair 3-6 is determined to give better stimulation than electrode pair 1-4, the system or the clinician may proceed to test electrodes of that particular region…” (paragraph 0164)].
In reference to claim 5, Martins discloses wherein the controller is configured such that the selection of the one or a subset of the stimulation regions is performed based on whether the respective measured response is, or respective measured responses are, higher than a predetermined response threshold [e.g. “…after the electrode combination that provides better results is determined; e.g. better contraction of the diaphragm…” (paragraph 0168)].
In reference to claim 8, Martins discloses wherein: the therapy stimulations are applied at intervals separated by one or more breathing cycle periods [e.g. “…It is also envisioned that stimulation may also occur for one period of time and thereafter be discontinued for another period of time which periods may be the same or different..” (paragraph 0183)]; and a separate instance of the test stimulation is performed before each application of the therapy stimulation [e.g. “…if it is determined that electrode pair 1-4 gives better stimulation than electrode pair 3-6, then the system or the clinician (for example by pressing a key that selects the next pair of electrodes of the same group) may proceed testing electrodes within that particular region…” (paragraph 0164)].
In reference to claim 10, Martins discloses wherein the test stimulation is applied using each of the combinations of electrodes one after another [e.g. “…if it is determined that electrode pair 1-4 gives better stimulation than electrode pair 3-6, then the system or the clinician (for example by pressing a key that selects the next pair of electrodes of the same group) may proceed testing electrodes within that particular region…” (paragraph 0164)].
In reference to claim 11, Martins discloses wherein each application of the therapy stimulation comprises applying a plurality of therapy waveforms [e.g. “…shows a graph 1800A of a breathing waveform (BW) and a corresponding stimulation waveform SW in accordance with embodiments of the present system…” (paragraph 0170)].
In reference to claim 13, Martins discloses wherein the controller is further configured to synchronize the application of the therapy stimulation with the breathing cycle [e.g. “…shows a graph 1800A of a breathing waveform (BW) and a corresponding stimulation waveform SW in accordance with embodiments of the present system…” (paragraph 0170)].
In reference to claim 16, Martins discloses wherein: the plurality of electrodes comprises a plurality of first electrodes configured to be brought simultaneously into contact with respective different locations on the skin; and one or more second electrodes configured to contact one or more respective further locations on the skin [e.g. “…at least one skin electrode may be placed on the sternum of the patient (e.g., a reference electrode), and two additional skin electrodes, one on each side of the intercostal area of the patient and which may provide information related to potentials across the corresponding areas of the anatomy of the patient in a manner similar to the skin pads…” (paragraph 0246)], and to have different polarity to the first electrodes during operation of the system [e.g. Figure 16A-D depicts cathodes and anodes].
In reference to claim 17, Martins discloses wherein each combination of electrodes corresponding to a stimulation region includes at least one of the first electrodes and one of the second electrodes [e.g. “…at least one skin electrode may be placed on the sternum of the patient (e.g., a reference electrode), and two additional skin electrodes, one on each side of the intercostal area of the patient and which may provide information related to potentials across the corresponding areas of the anatomy of the patient in a manner similar to the skin pads…” (paragraph 0246)].
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.
Claims 18-20, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of WO 2010/067145 granted to Minogue.
In reference to claims 18 and 19, Martins discloses a stimulation device but fails to describe where the second electrode surrounds a skin contact region of the first electrodes. Minogue describes a stimulation apparatus and depicts in Figure 2A, the second electrode 16b partially surrounding first electrode 16a [e.g. page 10: lines 3-5]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Martins to include a second electrode surrounding a first electrode as taught by Minogue, since such a modification would provide the predictable results of being able to maximize stimulation across the skin.
In reference to claim 20, Martins discloses wherein at least one of the combinations of electrodes comprises a plurality of at least the first electrodes, and the controller is configured to drive that combination to provide the therapy stimulation by applying different respective electrical stimulations simultaneously via the plurality of first electrodes, the therapy stimulation resulting from interference between the different respective electrical stimulations [e.g. “…Start with a first electrode pair (e.g., electrode 1 as the cathode and electrode 6 as the anode). Increase stimulation amplitude until a contraction is visible. If the stimulation achieves a discernible contraction, this electrode pair may be selected. If there is collateral stimulation then select another electrode pair using any suitable method such as by selecting another cathode such as by deselecting a current cathode (e.g., electrode 1 in current example) and selecting another electrode (e.g., electrode 2 in the current example) as the cathode…” (paragraph 0158)].
In reference to claims 22 and 24, Martins discloses a system for electrically stimulating a nerve to cause muscle contraction [e.g. “…an electrode array of a first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve…” (abstract)], comprising: a plurality of electrodes configured to be positioned in electrical contact with the skin simultaneously, the electrodes being configured to allow electrical stimulation to be directed independently towards a plurality of different stimulation regions below the skin via a corresponding plurality of combinations of the electrodes [e.g. “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” (paragraph 0148)]; one or more second electrodes to contact locations on the skin and to have different polarity to the first electrodes during operation of the system [e.g. Figure 16A-D depicts cathodes and anodes]. Martins discloses a stimulation device but fails to describe where the second electrode surrounds a skin contact region of the first electrodes. Minogue describes a stimulation apparatus and depicts in Figure 2A, the second electrode 16b partially surrounding first electrode 16a [e.g. page 10: lines 3-5]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Martins to include a second electrode surrounding a first electrode as taught by Minogue, since such a modification would provide the predictable results of being able to maximize stimulation across the skin.
In reference to claim 25, Martins discloses wherein the nerve is a phrenic nerve [e.g. “…a plurality of electrodes configured to stimulate a phrenic nerve of the patient…” (abstract)].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of U.S. Patent Application Publication No 2019/0381313 granted to Lu. Martins discloses stimulation device but fails to describe an automated defibrillation unit to measure output from the heart and deliver a shock to the patient and further stimulate a contraction of the diaphragm. Lu discloses an automated defibrillation unit configured to measure an electrical output from a patient's heart and selectively deliver an electrical shock to the patient to restore normal heart function [e.g. “…An automated external defibrillator (AED) is a portable device that can check the heart rhythm and can send an electric shock to the heart to try to restore a normal rhythm…”(paragraph 0247)] and the system of an claim 1 configured to stimulate contraction of the diaphragm to restore normal breathing function [e.g. “…Electrical stimulation of the dorsal cord at C3/4 resulted in diaphragm EMG bursts and productive inhalation…” (paragraph 0425)]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Martins, to include an automated defibrillation unit as taught by Lu, since such a modification would provide the predictable results of allowing the Martins system to provide multiple functions such as restoring heart and breathing functions.
Allowable Subject Matter
Claims 6-7, 9, 12, 14, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796