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 .
Drawings
The drawings are objected to because the following figures are not described in the detailed description of the specification: Figs. 7B, 15B, 19A, and 19B. The drawings are objected to because the following figures contain letters that do not label anything: "a" in Fig. 1B, "d" in Fig. 7A, "c" in Fig. 7B, "b" in Fig. 13, "d" in Fig. 14, "c" in Fig. 15A, "a" in Fig. 15B, "e" in Fig. 16, "b" in Fig. 19A, "e" in Fig. 19B, and "d" in Fig. 20. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 4 and 19 are objected to because of the following informalities:
In claim 4, line 4, “to maintain the heart rate of the subject” should read “to maintain a heart rate of the subject”.
In claim 19, line 2, “configured to: determining a target heart rate” should read “configured to determine a target heart rate”.
In claim 19, line 3, “determines a level of stimulation” should read “determine a level of stimulation”.
In claim 19, line 3, “to maintain the heart rate of the subject” should read “to maintain a heart rate of the subject”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “a wearable device configured to…” in claims 16-17, 22, and 26-27, and “a controller device configured to…” in claims 16 and 19-21.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (See Paragraphs 0072-0074 of the Applicant’s Specification).
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 12, 21, and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claims 6 and 21 recite a “data-driven model”. The specification does not provide any written description for what a “data-driven model” is, and only says that “the adjusting is performed by a model in the CCU” (Paragraph 0105). It is unclear whether the Applicant is referring to a computer algorithm, such as a machine-learning model, or if the Applicant is referring to something else entirely. Furthermore, if the Applicant is referring to a machine-learning model, the model is not described in the specification, which renders the claim scope unclear and indefinite.
Claims 12 and 27 recite a “coronary care unit (CCU)”. The specification does not provide any written description for what a “coronary care unit” is, and only says that “the wearable device includes a coronary care unit” (Paragraph 0071). The common meaning of a coronary care unit is a specialized hospital ward dedicated to patients with serious or acute heart conditions. Therefore, it is unclear how a specialized hospital ward could be included in a coronary care unit. Furthermore, it is unclear if the Applicant is referring to another structure entirely, which renders the claim scope unclear and indefinite.
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.
Claims 10 and 25 are 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 10 recites that “the control device comprises an electrocardiogram (ECG) machine”. It is unclear if the Applicant is referring to the previously described “controller device”, or if they are referring to a new device entirely. Therefore, the scope of the claim is unclear and the claim is indefinite. For examination purposes, “the control device” is being interpreted as the previously described “controller device”. Claim 25 is rejected for the same reasoning as claim 10.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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 1-3, 5-7, 9, 12-13, 15-18, 20-22, 24, 27-28, and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zitnik et al. (U.S. Patent No. 11,471,681).
Regarding claim 1, Zitnik teaches a method for vagus nerve stimulation (Col. 7,
lines 35-37) using at least one wirelessly powered stimulator (Fig. 24A, Col. 24, lines 38-39 and 66, 2403), the method comprising: implanting at least one wirelessly powered stimulator proximate to a vagus nerve of a subject (Fig. 24A, Col. 24, lines 61-65), each wirelessly powered stimulator comprising an implantable pulse generator (Col. 26, line 59) comprising: a receive antenna (Col. 31, line 48); a rectifier (Fig. 60B, Col. 47, lines 26-27); an energy storage capacitor (Col. 41, lines 8-10); a demodulator (Fig. 60B, Col. 47, lines 23-24); and an output voltage regulator (Fig. 60B, Col. 47, lines 27-28); receiving, at a wearable device (Fig. 24B, Col. 25, lines 7-9, 2405), a control input describing stimulation data from (Col. 41, lines 36-43) a controller device (Fig. 24B, Col. 25, lines 9-13, 2407); providing a radio frequency (RF) signal from the wearable device to the stimulator based on the control input (Col. 41, lines 43-47 and Col. 47, lines 29-33); receiving and recovering power from the RF signal using the stimulator (Col. 47, lines 29-38); outputting a stimulation that releases energy stored in the energy storage capacitor (Col. 47, lines 57-63) on a plurality of electrodes (Col. 26, line 61) in an output pulse having characteristics based on the received RF signal (Col. 47, lines 29-33); generate monitoring results by monitoring, at the wearable device, at least one vital sign of the subject while outputting the stimulation (Col. 52, lines 58-60); and adjusting the outputting the stimulation based on the monitored at least one vital sign (Col. 52, lines 60-62).
Regarding claim 2, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1
wherein adjusting the outputting the stimulation based on the monitored at least vital sign (Col. 52, lines 60-62) further comprises: transmitting the monitoring results from the wearable device to the controller device (Col. 41, lines 36-47); adjusting, at the controller device, the control input based on the monitoring results (Col. 52, lines 60-62); adjusting, at the wearable device, the RF signal based on the adjusted control input (Col. 52, lines 60-62); and providing the adjusted RF signal to the stimulator (Col. 52, lines 60-62).
Regarding claim 3, Zitnik teaches the method (Col. 7, lines 35-37) of claim 2, further comprising: outputting a stimulation that releases the energy stored in the energy storage capacitor (Col. 47, lines 57-63) on the plurality of electrodes (Col. 26, line 61) in an output pulse having characteristics based on the received adjusted RF signal (Col. 46, lines 46-67).
Regarding claim 5, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1, wherein the adjusting of input is performed dynamically based on the monitoring results (Col. 52, lines 60-62).
Regarding claim 6, Zitnik teaches the method (Col. 7, lines 35-37) of claim 5, wherein the dynamic adjustment of input (Col. 52, lines 60-62) is performed using a data-driven model (Col. 52, lines 62-65).
Regarding claim 7, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1, wherein the at least one vital sign of the subject monitored by the wearable device is the subject’s heart rate (Col. 52, lines 58-60).
Regarding claim 9, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1, wherein the wirelessly powered stimulator is located within 5 cm of the wearable device (Col. 40, lines 31-38, 2 inches ~ 5 cm).
Regarding claim 12, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1, wherein the monitoring results are provided to a coronary care unit (CCU) (Col. 27, lines 28-37) through the wearable device (Col. 52, lines 62-65).
Regarding claim 13, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1, wherein the wearable device is rechargeable (Col. 37, lines 22-28).
Regarding claim 15, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1, wherein the characteristics of the output pulse determined by the RF signal (Col. 47, lines 29-33) are voltage (Col. 14, lines 3-5), frequency (Col. 26, lines 19-25 and 30-31), and pulse width (Col. 26, lines 19-25 and 27-30).
Regarding claim 16, Zitnik teaches a system for vagus nerve stimulation (Col. 13, lines 25-27), comprising: at least one wirelessly powered stimulator (Fig. 24A, Col. 24, lines 38-39 and 66, 2403), each wirelessly powered stimulator comprising an implantable pulse generator (Col. 26, line 59) comprising: a receive antenna (Col. 31, line 48); a rectifier (Fig. 60B, Col. 47, lines 26-27); an energy storage capacitor (Col. 41, lines 8-10); a demodulator (Fig. 60B, Col. 47, lines 23-24); and an output voltage regulator (Fig. 60B, Col. 47, lines 27-28); where each implantable pulse generator is configured to: receive and recover power from a radio frequency (RF) signal (Col. 47, lines 29-38); and output a stimulation that releases energy stored in the energy storage capacitor (Col. 47, lines 57-63) on a plurality of electrodes (Col. 26, line 61) in an output pulse having characteristics based on the received RF signal (Col. 47, lines 29-33); a wearable device (Fig. 24B, Col. 25, lines 7-9, 2405) configured to: receive a control input describing stimulation data (Col. 41, lines 36-43); provide a radio frequency (RF) signal from the wearable device to the wirelessly powered stimulator based on the control input (Col. 41, lines 43-47 and Col. 47, lines 29-33); and generate monitoring results by monitoring at least one vital sign of a subject implanted with at least one wirelessly powered stimulator while outputting the stimulation (Col. 52, lines 58-60); and a controller device (Fig. 24B, Col. 25, lines 9-13, 2407) configured to: provide the control input describing stimulation data to the wearable device (Col. 41, lines 36-43); and adjust the control input describing stimulation data based on the monitored at least one vital sign (Col. 52, lines 60-62).
Regarding claim 17, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the wearable device (Fig. 24B, Col. 25, lines 7-9, 2405) is further configured to: transmit the monitoring results from the wearable device to the controller device (Col. 41, lines 36-47); adjust the RF signal based on an adjusted control input provided by the controller device (Col. 52, lines 60-62); and provide the adjusted RF signal to the wirelessly powered stimulator (Col. 52, lines 60-62).
Regarding claim 18, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the stimulator (Fig. 24A, Col. 24, lines 38-39 and 66, 2403) is further configured to: output a stimulation that releases energy stored in the energy storage capacitor (Col. 47, lines 57-63) on the plurality of electrodes (Col. 26, line 61) in an output pulse having characteristics based on the received adjusted RF signal (Col. 46, lines 46-67).
Regarding claim 20, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the controller device (Fig. 24B, Col. 25, lines 9-13, 2407) is further configured to adjust the control input dynamically based on the monitoring results (Col. 52, lines 60-62).
Regarding claim 21, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the controller device (Fig. 24B, Col. 25, lines 9-13, 2407) is further configured to adjust the control input dynamically (Col. 52, lines 60-62) using a data-driven model (Col. 52, lines 62-65).
Regarding claim 22, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the wearable device (Fig. 24B, Col. 25, lines 7-9, 2405) is further configured to monitor the subject’s heart rate (Col. 52, lines 58-60).
Regarding claim 24, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the wirelessly powered stimulator is located within 5 cm of the wearable device (Col. 40, lines 31-38, 2 inches ~ 5 cm).
Regarding claim 27, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the wearable device (Fig. 24B, Col. 25, lines 7-9, 2405) is further configured to provide the monitoring results to a coronary care unit (CCU) (Col. 27, lines 28-37 and Col. 52, lines 62-65).
Regarding claim 28, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the wearable device is rechargeable (Col. 37, lines 22-28).
Regarding claim 30, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16, where the characteristics of the output pulse determined by the RF signal (Col. 47, lines 29-33) are voltage (Col. 14, lines 3-5), frequency (Col. 26, lines 19-25 and 30-31), and pulse width (Col. 26, lines 19-25 and 27-30).
Claim Rejections - 35 USC § 103
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 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zitnik et al. (U.S. Patent No. 11,471,681) in view of Libbus et al. (U.S. PGPub No. 2015/0321001).
Regarding claim 4, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1 that includes adjusting, at the controller device, the control input based on the monitoring results (Col. 52, lines 60-62). Zitnik does not teach that adjusting the control input based on the monitoring results comprises: determining a target heart rate; and determining a level of stimulation to maintain the heart rate of the subject at the target heart rate.
Libbus, however, teaches a method for delivering neurostimulation therapy to patients for treating chronic heart failure that uses an implantable vagus stimulation system (Fig. 1, Paragraph 0026, line 1, 11). Libbus teaches that the implantable vagus stimulation system includes an implantable pulse generator (Fig. 1, Paragraph 0026, line 2, 12). Libbus also teaches an external control system that comprises an external programmer (Fig. 3, Paragraph 0026, line 12, 40) that communicates wirelessly with the implantable system (Paragraph 0026, lines 30-32) and a programming wand (Fig. 3, Paragraph 0041, line 1, 42).
Furthermore, Libbus teaches that the control system determines a target heart rate (Paragraph 0058, lines 1-12 and Paragraph 0060, lines 14-19), and determines a level of stimulation to maintain the heart rate of the subject at the target heart rate (Paragraph 0091, lines 5-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Libbus to include that adjusting the control input based on the monitoring results comprises: determining a target heart rate; and determining a level of stimulation to maintain the heart rate of the subject at the target heart rate. Doing so would ensure that stimulation is delivered at a desired level to maintain a target heart rate (Paragraph 0091, lines 5-9), which in turn would allow tachycardia-inducing stimulation effects to be offset by bradycardia-inducing effects (Paragraph 0058, lines 8-12), as recognized by Libbus.
Regarding claim 19, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16 that includes the controller device (Fig. 24B, Col. 25, lines 9-13, 2407). Zitnik does not teach that the controller device is further configured to: determining a target heart rate; and determines a level of stimulation to maintain the heart rate of the subject at the target heart rate.
Libbus, however, teaches a system for delivering neurostimulation therapy to patients for treating chronic heart failure that uses an implantable vagus stimulation system (Fig. 1, Paragraph 0026, line 1, 11). Libbus teaches that the implantable vagus stimulation system includes an implantable pulse generator (Fig. 1, Paragraph 0026, line 2, 12). Libbus also teaches an external control system that comprises an external programmer (Fig. 3, Paragraph 0026, line 12, 40) that communicates wirelessly with the implantable system (Paragraph 0026, lines 30-32) and a programming wand (Fig. 3, Paragraph 0041, line 1, 42).
Furthermore, Libbus teaches that the control system determines a target heart rate (Paragraph 0058, lines 1-12 and Paragraph 0060, lines 14-19), and determines a level of stimulation to maintain the heart rate of the subject at the target heart rate (Paragraph 0091, lines 5-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Libbus to include that adjusting the control input based on the monitoring results comprises: determining a target heart rate; and determining a level of stimulation to maintain the heart rate of the subject at the target heart rate. Doing so would ensure that stimulation is delivered at a desired level to maintain a target heart rate (Paragraph 0091, lines 5-9), which in turn would allow tachycardia-inducing stimulation effects to be offset by bradycardia-inducing effects (Paragraph 0058, lines 8-12), as recognized by Libbus.
Claims 8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Zitnik et al. (U.S. Patent No. 11,471,681) in view of Leyde (U.S. PGPub No. 2008/0114417).
Regarding claim 8, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1. Zitnik does not teach that at least one wirelessly powered stimulator includes a plurality of wireless powered stimulators and the vagus nerve stimulation is performed in more than one location by the plurality of wireless powered stimulations.
Leyde, however, teaches a neurological stimulation method that utilizes a system (Fig. 1, Paragraph 0041, line 1, 2) that includes a controller (Fig. 1, Paragraph 0041, line 2, 4), a sensing assembly (Fig. 1, Paragraph 0041, lines 2-3, 6), and a stimulation assembly (Fig. 1, Paragraph 0041, line 3, 8). Leyde teaches that the system can include a plurality of wireless powered (Paragraph 0070, lines 1-11) stimulators (Paragraph 0046, lines 6-7) that can provide stimulation to the vagus nerve (Paragraph 0046, lines 1-5). Furthermore, Leyde teaches that the plurality of stimulators can be implanted in more than one location (Paragraph 0046, lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Leyde to include that at least one wirelessly powered stimulator includes a plurality of wireless powered stimulators and the vagus nerve stimulation is performed in more than one location by the plurality of wireless powered stimulations. Doing so would ensure that stimulation can be provided to multiple locations along a vagus nerve (Paragraph 0046, lines 6-9) to optimize patient therapeutic outcomes, as recognized by Leyde.
Regarding claim 23, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16. Zitnik does not teach that at least one wirelessly powered stimulator includes a plurality of wireless powered stimulators and the vagus nerve stimulation is performed in more than one location by the plurality of wireless powered stimulations.
Leyde, however, teaches a neurological stimulation system (Fig. 1, Paragraph 0041, line 1, 2) that includes a controller (Fig. 1, Paragraph 0041, line 2, 4), a sensing assembly (Fig. 1, Paragraph 0041, lines 2-3, 6), and a stimulation assembly (Fig. 1, Paragraph 0041, line 3, 8). Leyde teaches that the system can include a plurality of wireless powered (Paragraph 0070, lines 1-11) stimulators (Paragraph 0046, lines 6-7) that can provide stimulation to the vagus nerve (Paragraph 0046, lines 1-5). Furthermore, Leyde teaches that the plurality of stimulators can be implanted in more than one location (Paragraph 0046, lines 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Leyde to include that at least one wirelessly powered stimulator includes a plurality of wireless powered stimulators and the vagus nerve stimulation is performed in more than one location by the plurality of wireless powered stimulations. Doing so would ensure that stimulation can be provided to multiple locations along a vagus nerve (Paragraph 0046, lines 6-9) to optimize patient therapeutic outcomes, as recognized by Leyde.
Claims 10-11 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Zitnik et al. (U.S. Patent No. 11,471,681) in view of Srivastava et al. (U.S. PGPub No. 2022/0401739).
Regarding claim 10, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1.
Zitnik also teaches that a separate sensor, such as an ECG device, can be worn to continuously measure heart rate and heart rate variability (Col. 43, lines 59-62). Zitnik does not teach that the control device comprises an electrocardiogram (ECG) machine.
Srivastava, however, teaches a method for remote monitoring and managing of patients with chronic pain, which can be used for vagus nerve stimulation (Paragraph 0103, lines 5-9). Srivastava teaches a patient monitoring and management system (Fig. 1, Paragraph 0105, lines 2-3, 100) that includes an implantable system (Fig. 1, Paragraph 0106, lines 2-3, 110), a wearable device (Fig. 1, Paragraph 0106, lines 4-5, 120), and a controller device (Fig. 1, Paragraph 0101, lines 17-22 and Paragraph 0106, line 6, 140). Srivastava teaches that the implantable system can include an implantable pulse generator (Fig. 1, Paragraph 0106, lines 8-10, 112). Srivastava also teaches that the controller device can include one or more physiological sensors (Paragraph 0152, lines 11-14), such as an electrocardiogram (ECG) sensor (Paragraph 0152, line 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Srivastava to include that the control device comprises an electrocardiogram (ECG) machine. Doing so would ensure that ECG signals can be collected to accurately measure a patient heart rate (Paragraph 0152, line 22), as recognized by Srivastava.
Regarding claim 11, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1.
Zitnik also teaches that a separate sensor, such as an ECG device, can be worn to continuously measure heart rate and heart rate variability (Col. 43, lines 59-62). Zitnik does not teach that the monitoring results comprise an ECG signal of the subject.
Srivastava, however, teaches a method for remote monitoring and managing of patients with chronic pain, which can be used for vagus nerve stimulation (Paragraph 0103, lines 5-9). Srivastava teaches a patient monitoring and management system (Fig. 1, Paragraph 0105, lines 2-3, 100) that includes a controller device with one or more physiological sensors (Paragraph 0152, lines 11-14), such as an electrocardiogram (ECG) sensor to sense an ECG signal (Paragraph 0152, lines 21-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Srivastava to include that the monitoring results comprise an ECG signal of the subject. Doing so would ensure that ECG signals can be collected to accurately measure a patient heart rate (Paragraph 0152, line 22), as recognized by Srivastava.
Regarding claim 25, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16. Zitnik also teaches that a separate sensor, such as an ECG device, can be worn to continuously measure heart rate and heart rate variability (Col. 43, lines 59-62). Zitnik does not teach that the control device comprises an electrocardiogram (ECG) machine.
Srivastava, however, teaches a system (Fig. 1, Paragraph 0105, lines 2-3, 100) for remote monitoring and managing of patients with chronic pain, which can be used for vagus nerve stimulation (Paragraph 0103, lines 5-9). Srivastava teaches that the system includes an implantable system (Fig. 1, Paragraph 0106, lines 2-3, 110), a wearable device (Fig. 1, Paragraph 0106, lines 4-5, 120), and a controller device (Fig. 1, Paragraph 0101, lines 17-22 and Paragraph 0106, line 6, 140). Srivastava teaches that the implantable system can include an implantable pulse generator (Fig. 1, Paragraph 0106, lines 8-10, 112). Srivastava also teaches that the controller device can include one or more physiological sensors (Paragraph 0152, lines 11-14), such as an electrocardiogram (ECG) sensor (Paragraph 0152, line 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Srivastava to include that the control device comprises an electrocardiogram (ECG) machine. Doing so would ensure that ECG signals can be collected to accurately measure a patient heart rate (Paragraph 0152, line 22), as recognized by Srivastava.
Regarding claim 26, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16. Zitnik also teaches that a separate sensor, such as an ECG device, can be worn to continuously measure heart rate and heart rate variability (Col. 43, lines 59-62). Zitnik does not teach that the monitoring results comprise an ECG signal of the subject.
Srivastava, however, teaches a system (Fig. 1, Paragraph 0105, lines 2-3, 100) for remote monitoring and managing of patients with chronic pain, which can be used for vagus nerve stimulation (Paragraph 0103, lines 5-9). Srivastava teaches that the system includes a controller device with one or more physiological sensors (Paragraph 0152, lines 11-14), such as an electrocardiogram (ECG) sensor to sense an ECG signal (Paragraph 0152, lines 21-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Srivastava to include that the monitoring results comprise an ECG signal of the subject. Doing so would ensure that ECG signals can be collected to accurately measure a patient heart rate (Paragraph 0152, line 22), as recognized by Srivastava.
Claims 14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Zitnik et al. (U.S. Patent No. 11,471,681) in view of Goto (U.S. PGPub No. 2013/0238057).
Regarding claim 14, Zitnik teaches the method (Col. 7, lines 35-37) of claim 1.
Zitnik does not teach that the stimulation can be stopped by a fail-safe mechanism when the monitored vital sign indicates extreme heart rate deviations.
Goto, however, teaches a nerve stimulating device (Fig. 1, Paragraph 0027, line 1, 1) that includes an implantable stimulator (Fig. 1, Paragraph 0029, line 1, 3) that provides electrical stimulation to the vagus nerve (Paragraph 0029, lines 1-5). Goto teaches that the nerve stimulating device also includes a control portion (Fig. 1, Paragraph 0027, line 6, 4) and a heart-event detecting portion (Fig. 1, Paragraph 0027, lines 2-3, 2). The heart-event detecting portion detects heartbeats based on ECG signals (Paragraph 0028, lines 1-5). Furthermore, Goto teaches that if the heart rate exceeds a pre-determined threshold (Paragraph 0041, lines 1-3), the control portion provides a command to the stimulator to stop the output of stimulation signals (Paragraph 0041, lines 3-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Goto to include that the stimulation can be stopped by a fail-safe mechanism when the monitored vital sign indicates extreme heart rate deviations. Doing so would allow the system to operate within a patient-safe threshold (Paragraphs 0041 and 0042), and would prevent wasteful power consumption of the device (Paragraph 0045, lines 6-8), as recognized by Goto.
Regarding claim 29, Zitnik teaches the system (Col. 13, lines 25-27) of claim 16. Zitnik does not teach that the stimulation can be stopped by a fail-safe mechanism when the monitored vital sign indicates extreme heart rate deviations.
Goto, however, teaches a nerve stimulating device (Fig. 1, Paragraph 0027, line 1, 1) that includes an implantable stimulator (Fig. 1, Paragraph 0029, line 1, 3) that provides electrical stimulation to the vagus nerve (Paragraph 0029, lines 1-5). Goto teaches that the nerve stimulating device also includes a control portion (Fig. 1, Paragraph 0027, line 6, 4) and a heart-event detecting portion (Fig. 1, Paragraph 0027, lines 2-3, 2). The heart-event detecting portion detects heartbeats based on ECG signals (Paragraph 0028, lines 1-5). Furthermore, Goto teaches that if the heart rate exceeds a pre-determined threshold (Paragraph 0041, lines 1-3), the control portion provides a command to the stimulator to stop the output of stimulation signals (Paragraph 0041, lines 3-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zitnik to incorporate the teachings of Goto to include that the stimulation can be stopped by a fail-safe mechanism when the monitored vital sign indicates extreme heart rate deviations. Doing so would allow the system to operate within a patient-safe threshold (Paragraphs 0041 and 0042), and would prevent wasteful power consumption of the device (Paragraph 0045, lines 6-8), as recognized by Goto.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Terry Jr. et al. (U.S. Patent No. 6,473,644) teaches a method for electrically stimulating the vagus nerve using an implantable stimulator to maintain a patient’s heart rate at a target heart rate (Abstract).
Nijlunsing et al. (U.S. Patent No. 11,198,006) teaches an implantable device and method for vagus nerve stimulation (Col. 47) that uses inductive coupling to transmit energy from an energy transmission device to a wireless implantable device (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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, Carl Layno can be reached at 571-272-4949. 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.
/H.A.H./Patent Examiner , Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights