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.
Claims 12-21 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.
In re claim 12, the limitation, “the user” lacks antecedent basis.
Appropriate correction is required.
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)(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 2-5, 7-10, 12-13, 15-19, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben Ezra et al. (US 2005/0065553).
In re claim 2, Ben Ezra discloses a stimulation system (fig. 2: 20; [0383]: antiarrhythmic vagal stimulation; [0332]) for enhancing a pharmacologic agent for treatment of cardiac arrhythmia ([0383]: antiarrhythmic vagal stimulation may be applied in combination with antiarrhythmic drug therapy which results in a synergistic effect that is interpreted as enhancing a pharmacologic agent; [0054, 0101]),
the stimulation system comprising:
one or more peripheral nerve effectors (fig. 1: two electrode device 20; [0332-0333]: may comprise two electrode devices for stimulating the vagus nerve, which would be peripheral nerve stimulation; [0111]);
at least one biomedical sensor (fig. 1: any one of sensors 38, 39, and 40; [0418]: control unit continuously monitoring heart rate is also interpreted as a biomedical sensor; [0341, 0421, 0155]); and
a controller (control unit 32; [0341]),
wherein the biomedical sensor is configured to receive data related to one or more cardiac parameters of a user ([0421]: physiological parameters sensed using a sensor is related to heart rate and used to determine if heart rate needs to be lowered; [0418]),
wherein the biomedical sensor is configured to transmit the data to the controller [0341, 0418];
wherein the controller is configured to adjust a nerve stimulation signal based on the data ([0418]: heart rate can be used as a feedback loop to adjust stimulation parameters; [0421]: determination of whether heart rate should be lowered may be dependent on physiological parameters from sensor 39; [0187, 0189]),
wherein the one or more peripheral nerve effectors is configured to deliver stimulation to one or more peripheral nerves based on the adjusted nerve stimulation signal ([0418]: stimulation is updated based on feedback; [0422]: electrodes are used to provide stimulation to vagus nerve; [0187, 0189]),
wherein the delivered stimulation enhances a response of the user to an administered pharmacologic agent for treating cardiac arrhythmia ([0385-0387]: applying vagal stimulation prevents side effects by improving a safety of a drug (including antiarrhythmic drugs) administered to a patient and may even allow for lower dosages).
In re claim 3, Ben Ezra discloses
wherein
the enhanced response comprises reducing a dose of the pharmacologic agent ([0385-0386]: applying signals to the vagus nerve improves a safety of a drug administered, and may allow for lower dosages of the drug, including for antiarrhythmic drugs) or
a frequency of administration of the pharmacologic agent or
by reducing a side effect of the pharmacologic agent ([0385-0386]: safety of drug administered is improved by applying signals to vagus nerve, which prevents adverse effects caused by the drug), and
wherein the one or more peripheral nerves comprises a median nerve or a vagus nerve ([0385-0386]: vagal stimulation; also see in re claim 2 above, where stimulation is provided to a vagus nerve).
In re claim 4, regarding the limitations, “wherein
the enhanced response comprises reducing a dose of the pharmacologic agent or
a frequency of administration of the pharmacologic agent”,
see in re claim 3 above, which discloses reducing a dose of the pharmacologic agent.
In re claim 5, regarding the limitations, “wherein the enhanced response comprises reducing a side effect of the pharmacologic agent”, see in re claim 3 above.
In re claim 7, regarding the limitations, “wherein the one or more peripheral nerves comprises a vagus nerve”, see in re claim 3 above.
In re claim 8, Ben Ezra discloses wherein the pharmacologic agent comprises one or more of
a cardiac glycoside ([0008]: drugs may include digoxin, which is a known cardiac glycoside),
a beta-blocker ([0386]: antiarrhythmic drugs may cause a prolongation of a QT interval when provided without vagal stimulation; [0008]: an example of an antiarrhythmic drug includes beta-blockers), and
a calcium-channel blocker ([0008]: drugs may also include calcium channel antagonists).
In re claim 9, Ben Ezra discloses wherein the pharmacologic agent comprises an anti-arrhythmic agent ([0008]: antiarrhythmic drugs include beta-blockers, sotalol, dofetilide, etc.; [0386]).
In re claim 10, Ben Ezra discloses wherein the one or more cardiac parameters comprise at least one of
a heart rate ([0418]: heart rate used to adjust stimulation parameters; [0421]: physiological parameters may provide an indication on heart rate;),
a heart rate variability, or
a galvanic skin response.
In re claim 12, regarding the limitations, “a stimulation system for enhancing a pharmacologic agent for treatment of cardiac arrhythmia,
the stimulation system comprising:
one or more peripheral nerve effectors;
at least one data input source; and
a controller,
wherein the data input source is configured to receive data related to a user event,
wherein the data input source is configured to transmit the data to the controller,
wherein the controller is configured to adjust a nerve stimulation signal based on the data,
wherein the one or more peripheral nerve effectors is configured to deliver stimulation to one or more peripheral nerves based on the adjusted nerve stimulation signal,
wherein the delivered stimulation enhances a response of the user to an administered pharmacologic agent for treating cardiac arrhythmia”,
see in re claim 2 above, where the recited “at least one data input source” is interpreted as “at least one biomedical sensor” and “receive data related to one or more cardiac parameters” is interpreted as “receive data related to a user event”, since the change in heart rate of Ben Ezra (see in re claim 2 above) would be a user event.
In re claim 13, regarding the limitations, “wherein the enhanced response comprises at least one of:
reducing a dose of the pharmacologic agent,
reducing a frequency of administration of the pharmacologic agent, or
reducing a side effect of the pharmacologic agent”,
see in re claim 3 above.
In re claim 15, regarding the limitations, “wherein one or more peripheral nerves comprises a vagus nerve”, see in re claim 3 above.
In re claim 16, regarding the limitations, “wherein the pharmacologic agent comprises one or more of
a cardiac glycoside,
a beta-blocker, and
a calcium-channel blocker”,
see in re claim 8 above.
In re claim 17, regarding the limitations, “wherein the pharmacologic agent comprises an anti-arrhythmic agent”, see in re claim 9 above.
In re claim 18, regarding the limitations, “wherein the data input source comprises a biomedical sensor”, see in re claim 2 above.
In re claim 19, Ben Ezra discloses wherein the data input source comprises a motion sensor ([0341]: accelerometer detects motion and can be used to determine if heart rate needs to be lowered [0421]).
Claim Rejections - 35 USC § 102 / 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11 and 21 are rejected under 35 U.S.C. 102(a)(1) / 103 as being unpatentable over Ben Ezra et al. (US 2005/0065553) in view of Franke et al. (US 2015/0157868).
In re claim 11, Ben Ezra discloses further comprising a display screen configured to display information on the delivered stimulation ([0349]: external console is used to program apparatus 20 and receives information regarding initiation of treatment and would have a display for the physician to use to review information and program apparatus 20).
Regarding the above recited limitations, although it’s apparent that the external console would have a display screen configured to display information on the delivered stimulation, it is not explicitly disclosed by Ben Ezra.
Thus, claim 11 is alternatively rejected under 35 U.S.C 103 as follows:
Franke discloses a system for delivering electrical stimulation [0002] comprising of a programming system (fig. 7: 731) that may include a display (fig. 7: “DISPLAY”; [0054]).
Franke further teaches that the display provides an indication to a physician regarding how much stimulation is being delivered over a period of time [0054] as well as how much stimulation will be delivered [0054] so they can confirm the dose [0054].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation system taught by Ben Ezra, to provide a display screen configured to display information on the delivered stimulation, as taught by Franke, because the display can provide an indication to a physician regarding how much stimulation is being delivered over a period of time as well as how much stimulation will be delivered so they can confirm the dose.
In re claim 21, regarding the limitations, “ further comprising a display screen configured to display information on the delivered stimulation”, see in re claim 11 above.
Claim Rejections - 35 USC § 103
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Ezra et al. (US 2005/0065553) in view of De Ridder (US 2011/0184486).
In re claim 6, Ben Ezra fails to disclose wherein the one or more peripheral nerves comprises a median nerve.
De Ridder teaches providing stimulation [0006] to treat a neurological condition [0006], for instance one associated with arrhythmic burst firing [0004, 0118], and teaches
providing stimulation to one or more peripheral nerves [0051],
wherein the one or more peripheral nerves comprises
a median nerve [0051] and
a vagal nerve [0051].
De Ridder further teaches that neuromodulation treats conditions linked to arrhythmic burst firing [0118], which includes stimulating peripheral neuronal tissue [0038, 0051] that includes a variety of locations [0051], including median nerves [0051].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation system taught by Ben Ezra, to provide wherein the one or more peripheral nerves comprises a median nerve, as taught by De Ridder, because treating conditions related to arrhythmia includes stimulating peripheral neuronal tissue, which includes a variety of locations such as median nerves.
In re claim 14, regarding the limitations, “wherein one or more peripheral nerves comprises a median nerve”, see in re claim 6 above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ben Ezra et al. (US 2005/0065553) in view of Franke et al. (US 2015/0157868).
In re claim 20, Ben Ezra fails to disclose wherein the data input source comprises information input by the user.
Franke discloses modifying
neural stimulation for circadian rhythm [0067] that receives a data input source ([0067]: physician or patient input; [0068]),
wherein the data input source comprises information input by the user ([0067-0068]: physician or user input may be used to refine stimulation parameters such as amplitude or modify response for delivering neural stimulation).
Franke further teaches that a patient may indicate amplitudes that are tolerable for stimulation [0067] or modify the response for delivering stimulation [0068].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation system taught by Ben Ezra, to provide wherein the data input source comprises information input by the user, as taught by Franke, because a patient may indicate amplitudes that are tolerable for stimulation or modify a response for delivering stimulation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Dalal et al. (US 2008/0004672) discloses a diabetic therapy delivery system (abstract) which includes anti-arrhythmia therapy (abstract), and wherein parasympathetic stimulation increases an effectiveness of the anti-arrhythmia therapy [0085].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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