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 .
Response to Arguments
Double Patenting
This Non-final Rejection is made to include the Nonstatutory Double Patenting rejections as detailed in the rejection below.
Claim Rejections - 35 USC § 102/103
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive.
Amendment to claim 1 was made including the limitation: “…wherein a responsiveness parameter includes a magnitude of a change in the patient's responsiveness”, which was taken from claim 15. Applicant argues:
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Examiner respectfully disagrees. As stated in the rejection below, Nicolelis teaches a system which uses first and second implanted electrodes to obtain field potential signals indicative of a patient’s responsiveness (paragraph 0008 – “An intelligent brain pacemaker for mammals having a cranial nerve not associated with an autonomic function is disclosed. In a preferred embodiment, the intelligent brain pacemaker comprises (a) one or more electrodes adapted to acquire field potential measurements indicative of a mammal's brain activity in real-time…”; paragraph 0081 – “In this embodiment, signals from a subject's brain, which can comprise data related to the nature and quality of a subject's seizure attack…”). Nicolelis further teaches a responsiveness test in the form of a seizure detection module, which uses band-pass filtered signals collected from a subject’s brain to identify patterns of brain activity that characterize a seizure activity, and further uses a responsiveness parameter such as the signal derivative and its magnitude to further identify seizure activity, as detailed in paragraph 0134 – “A seizure detection module of an ASD device employs a signal that has been filtered by a band-pass filter in order to identify patterns of brain activity that characterize a seizure activity. Such a seizure detection module can employ any of a number of algorithms to identify a seizure. Such algorithms can be adapted to identify signals components such as the magnitude of the signal, the dominant frequency component of the signal, or the magnitude of the derivative of the signal in order to identify seizure activity”.
The claim recites, “…wherein a responsiveness parameter includes a magnitude of a change in the patient's responsiveness”; the field potential signals are indicative of a patient’s responsiveness when the signals are collected from the implanted electrodes, and the magnitudes of the signal derivatives (also known as the rate of change of the signal's amplitude with respect to time) can be used to determine seizure activity, as disclosed by paragraph 0134 of Nicolelis. Therefore, it is considered by the Examiner that “magnitude of a change in the patient's responsiveness” is sufficiently taught under the “magnitude of the derivative of the signal” as taught by Nicolelis paragraph 0134. Furthermore, additional paragraph 0138 of Nicolelis details seizure identification by changes in voltage values in a field potential voltage profile, as stated in the rejection below. Therefore, the changes in the signal amplitudes as taught in paragraph 0138 of Nicolelis represent changes in magnitude of a patient’s responsiveness.
Therefore, claim 1, and subsequently dependent claims 2-15 remain rejected.
Specification
Applicant’s arguments, filed 06/03/2026, with respect to the abstract objection have been fully considered and are persuasive. The abstract objection of 03/03/2026 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, filed 06/03/2026, with respect to the 35 USC § 112 rejections to claims 6, 8 and 13 have been fully considered and are persuasive. The 35 USC § 112 rejections to claims 6, 8 and 13 of 03/03/2026 have been withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,607,547 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claim 1 is broader than the corresponding claim 1 in the reference patent, as shown in the table below. It has been held that if the claims of the generic invention are “anticipated” by the species of the reference patent, a rejection of the generic claims under on the grounds of nonstatutory double patenting may be made, as per in re Goodman, 11 F.3d 1046, 1053, 29 USPQ2d 2010, 2016 (Fed. Cir. 1993), see MPEP 806.04(i). Furthermore, dependent claims 2-15 of the instant application and reference patent are not patentably distinct as shown in the table below.
U.S. Application 18/740,099
U.S. Patent 11,607,547 B2
A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including
a first electrode coupled to a first cranial nerve structure and a second electrode coupled to a second cranial nerve structure,
the method comprising:
providing a first electrical signal to the first cranial nerve structure of the patient;
providing a second electrical signal to the second cranial nerve structure of the patient;
administering to the patient a responsiveness test and comparing a result of the responsiveness test to a baseline responsiveness test;
and initiating a second therapy or issuing a warning based on the comparison of the result of the responsiveness test to the baseline responsiveness test;
wherein a responsiveness parameter includes a magnitude of a change in the patient's responsiveness.
A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including
a first electrode coupled to a first cranial nerve structure and a second electrode coupled to a second cranial nerve structure,
where the first cranial nerve structure is a left portion of a cranial nerve and the second cranial nerve structure is a right portion of the cranial nerve, the method comprising:
providing a first electrical signal to the first cranial nerve structure of the patient
using a first polarity configuration in which the first electrode functions as a cathode and the second electrode functions as an anode, the first electrical signal is configured to induce action potentials in the first cranial nerve structure, wherein a charge accumulates at the anode and the cathode as a result of the first electrical signal; switching from the first polarity configuration to a second polarity configuration upon termination of the first electrical signal where the first electrode functions as the anode and the second electrode functions as the cathode in the second polarity configuration;
providing a second electrical signal to the second cranial nerve structure
in the second polarity configuration,
the second electrical signal is configured to induce action potentials in the second cranial nerve structure where at least a portion of the second electrical signal comprises the accumulated charge from the first electrical signal;
administering to the patient a responsiveness test and comparing a result of the responsiveness test to a baseline responsiveness test;
and initiating a second therapy or issuing a warning based on the comparison of the result of the responsiveness test to the baseline responsiveness test.
15. …wherein at least one responsiveness parameter includes at least one of…(ii) a magnitude of a change in the patient's responsiveness…
The method of claim 1, wherein one or more processors are configured to
increase a sympathetic tone to increase the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to
increase a sympathetic tone to increase a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a parasympathetic tone to increase the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a parasympathetic tone to increase a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a sympathetic tone to decrease the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a sympathetic tone to decrease a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to increase a parasympathetic tone to decrease the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to increase a parasympathetic tone to decrease a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, further comprising a seizure detection unit capable of analyzing at least one body data stream to determine an epileptic seizure status.
The method of claim 1, further comprising a seizure detection unit capable of analyzing at least one body data stream to determine an epileptic seizure status.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals, respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals, respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in the neurologic autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in a neurologic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration.
The method of claim 1, wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.
The method of claim 1, wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.
The method of claim 1, further comprising, based on the patient's responsiveness, instructing an external device to change an operating state thereof.
The method of claim 1, further comprising, based on the patient's responsiveness, instructing an external device to change an operating state thereof.
The method of claim 1, wherein the test of responsiveness further comprises a test to determine a patient's capacity to perform a response.
The method of claim 1, wherein the test of responsiveness further comprises a test to determine a patient's capacity to perform the purposeful response.
The method of claim 1, wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient.
The method of claim 1, wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient.
The method of claim 1, wherein at least one responsiveness parameter includes at least one of: (i) a duration of a change in the patient's responsiveness; (ii) a magnitude of a change in the patient's responsiveness, (ii) a time interval from the indication of the detection of the epileptic seizure to a change in the patient's responsiveness, (iii) a type of change in the patient's responsiveness, (iv) an estimation of a seizure severity; (v) a classification of a seizure into clinical or subclinical; (vi) a classification of a clinical seizure into simple partial, complex partial, or generalized; (vii) an assessment of efficacy of a therapy for the patient's medical condition; (viii) an assessment of the state of the disease and formulation of a prognosis for the patient; (ix) an estimation of a risk of injury or death for the patient; and (x) two or more thereof.
The method of claim 1, wherein at least one responsiveness parameter includes at least one of: (i) a duration of a change in the patient's responsiveness; (ii) a magnitude of a change in the patient's responsiveness, (iii) a time interval from an indication of the detection of the epileptic seizure to a change in the patient's responsiveness, (iv) a type of change in the patient's responsiveness, (v) an estimation of a seizure severity; (vi) a classification of a seizure into clinical or subclinical; (vii) a classification of a clinical seizure into simple partial, complex partial, or generalized; (viii) an assessment of efficacy of a therapy for the patient's medical condition; (ix) an assessment of the state of the disease and formulation of a prognosis for the patient; (x) an estimation of a risk of injury or death for the patient; and (xi) two or more thereof.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,023,500 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claim 1 is broader than the corresponding claim 1 in the reference patent, as shown in the table below. It has been held that if the claims of the generic invention are “anticipated” by the species of the reference patent, a rejection of the generic claims under on the grounds of nonstatutory double patenting may be made, as per in re Goodman, 11 F.3d 1046, 1053, 29 USPQ2d 2010, 2016 (Fed. Cir. 1993), see MPEP 806.04(i). Furthermore, dependent claims 2-15 of the instant application are not patentably distinct from claims 1-14 of the reference patent as shown in the table below.
U.S. Application 18/740,099
U.S. Patent No. 12,023,500 B2
A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including
a first electrode coupled to a first cranial nerve structure and a second electrode coupled to a second cranial nerve structure, the method comprising:
providing a first electrical signal to the first cranial nerve structure of the patient;
providing a second electrical signal to the second cranial nerve structure of the patient;
administering to the patient a responsiveness test and comparing a result of the responsiveness test to a baseline responsiveness test;
and initiating a second therapy or issuing a warning based on the comparison of the result of the responsiveness test to the baseline responsiveness test;
wherein a responsiveness parameter includes
a magnitude of a change in the patient's responsiveness.
A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including
a first electrode coupled to a first cranial nerve structure and a second electrode coupled to a second cranial nerve structure, the method comprising:
providing a first electrical signal to the first cranial nerve structure of the patient;
providing a second electrical signal to the second cranial nerve structure of the patient;
administering to the patient a responsiveness test and comparing a result of the responsiveness test to a baseline responsiveness test;
and initiating a second therapy or issuing a warning based on the comparison of the result of the responsiveness test to the baseline responsiveness test;
wherein at least one responsiveness parameter includes
at least one of: (i) a duration of a change in the patient's responsiveness;
(ii) a magnitude of a change in the patient's responsiveness,
(iii) a time interval from an indication of the detection of the epileptic seizure to a change in the patient's responsiveness, (iv) a type of change in the patient's responsiveness, (v) an estimation of a seizure severity; (vi) a classification of a seizure into clinical or subclinical; (vii) a classification of a clinical seizure into simple partial, complex partial, or generalized; (viii) an assessment of efficacy of a therapy for the patient's medical condition; (ix) an assessment of the state of the disease and formulation of a prognosis for the patient; (x) an estimation of a risk of injury or death for the patient; and (xi) two or more thereof.
The method of claim 1, wherein one or more processors are configured to
increase a sympathetic tone to increase the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to
increase a sympathetic tone to increase a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a parasympathetic tone to increase the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a parasympathetic tone to increase a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a sympathetic tone to decrease the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to decrease a sympathetic tone to decrease a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to increase a parasympathetic tone to decrease the heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, wherein one or more processors are configured to increase a parasympathetic tone to decrease a heart rate of the patient via at least one of the second therapy and a third therapy.
The method of claim 1, further comprising a seizure detection unit capable of analyzing at least one body data stream to determine an epileptic seizure status.
The method of claim 1, further comprising a seizure detection unit capable of analyzing at least one body data stream to determine an epileptic seizure status.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals, respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof.
A method of treating a medical condition in a patient using an implantable medical device…
…collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals, respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof.
The method of claim 1, further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor; determining an autonomic index; and detecting a change in a neurologic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration.
The method of claim 1, wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration.
The method of claim 1,
wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.
A method of treating a medical condition in a patient using an implantable medical device…
…wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.
The method of claim 1, further comprising, based on the patient's responsiveness, instructing an external device to change an operating state thereof.
The method of claim 1, further comprising, based on the patient's responsiveness, instructing an external device to change an operating state thereof.
The method of claim 1, wherein the test of responsiveness further comprises a test to determine a patient's capacity to perform a response.
The method of claim 1, wherein the test of responsiveness further comprises a test to determine a patient's capacity to perform the purposeful response.
The method of claim 1, wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient.
The method of claim 1, wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient.
The method of claim 1,
wherein at least one responsiveness parameter includes at least one of: (i) a duration of a change in the patient's responsiveness; (ii) a magnitude of a change in the patient's responsiveness, (ii) a time interval from the indication of the detection of the epileptic seizure to a change in the patient's responsiveness, (iii) a type of change in the patient's responsiveness, (iv) an estimation of a seizure severity; (v) a classification of a seizure into clinical or subclinical; (vi) a classification of a clinical seizure into simple partial, complex partial, or generalized; (vii) an assessment of efficacy of a therapy for the patient's medical condition; (viii) an assessment of the state of the disease and formulation of a prognosis for the patient; (ix) an estimation of a risk of injury or death for the patient; and (x) two or more thereof.
A method of treating a medical condition in a patient using an implantable medical device…
wherein at least one responsiveness parameter includes at least one of: (i) a duration of a change in the patient's responsiveness; (ii) a magnitude of a change in the patient's responsiveness, (iii) a time interval from an indication of the detection of the epileptic seizure to a change in the patient's responsiveness, (iv) a type of change in the patient's responsiveness, (v) an estimation of a seizure severity; (vi) a classification of a seizure into clinical or subclinical; (vii) a classification of a clinical seizure into simple partial, complex partial, or generalized; (viii) an assessment of efficacy of a therapy for the patient's medical condition; (ix) an assessment of the state of the disease and formulation of a prognosis for the patient; (x) an estimation of a risk of injury or death for the patient; and (xi) two or more thereof.
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.
Claim(s) 1-6, 12 and 15 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Nicolelis (US 20030083716 A1 – hereinafter Nicolelis).
Re. claim 1, Nicolelis teaches a method of treating a medical condition in a patient using an implantable medical device (paragraph 0007 – “What is needed, therefore, is an apparatus and method of detecting and ameliorating epileptic seizures by stimulation of the trigeminal nerve, either alone or in combination with stimulation of other cranial nerves. Preferably, the apparatus is adapted to be chronically implanted in a subject”), the implantable medical device including
a first electrode coupled to a first cranial nerve structure (paragraph 0207 – “The infraorbital nerve (or nerves) was stimulated unilaterally or bilaterally via chronically implanted nerve cuff electrodes”) and a second electrode coupled to a second cranial nerve structure (paragraph 0161 – “However, implantation of a nerve cuff electrode on two or more branches of a nerve present in a subject can facilitate bilateral stimulation of that nerve”; paragraph 0029 – “As used herein, the term "bilateral stimulation" and grammatical derivatives thereof means stimulation of two different sites”),
the method comprising:
providing a first electrical signal to the first cranial nerve structure of the patient and providing a second electrical signal to the second cranial nerve structure of the patient (paragraph 0162 – “FIG. 5 depicts the effects of bilateral stimulation versus unilateral stimulation of the IO nerve…5A2 depicts application of bilateral stimulation”);
administering to the patient a responsiveness test and comparing a result of the responsiveness test to a baseline responsiveness test (paragraph 0042 – “A seizure detection algorithm can comprise, for example, the steps of comparing brain activity of a subject to a database of brain activity known to be associated with seizure activity. A seizure detection algorithm can also comprise, for example, the steps of comparing brain activity of a subject to a threshold voltage value, above which seizure activity is known to be occurring”);
and initiating a second therapy or issuing a warning based on the comparison of the result of the responsiveness test to the baseline responsiveness test (paragraph 0067 – “The data presented in FIGS. 7A-7D was acquired without human intervention. In FIGS. 7B-7D, the dotted lines represent data acquired without human intervention. That is, the seizure detector automatically detected the presence of a seizure and automatically sent a TTL pulse to the nerve stimulator which applied an electrical pulse to the nerve in contact with the nerve contact electrode”),
wherein a responsiveness parameter includes a magnitude of a change in the patient's responsiveness (paragraph 0134 – “A seizure detection module of an ASD device employs a signal that has been filtered by a band-pass filter in order to identify patterns of brain activity that characterize a seizure activity. Such a seizure detection module can employ any of a number of algorithms to identify a seizure. Such algorithms can be adapted to identify signals components such as the magnitude of the signal, the dominant frequency component of the signal, or the magnitude of the derivative of the signal in order to identify seizure activity”; paragraph 0138 also details seizure identification by changes in voltage values in a field potential voltage profile, “An algorithm can be employed to identify pre-seizure activity. As noted hereinabove, a hallmark of seizure-related brain activity is the appearance of signals comprising large changes in voltage values (i.e. spikes) in a field potential voltage profile. Such spikes can arise by hypersynchronization of brain activity and will quantitatively exceed those voltage measurements associated with normal, non-seizure related brain activity”).
Re. claim 2, Nicolelis teaches the processor (figure 1, nerve stimulator 18) delivering at least second and third therapies (paragraph 0191 – “FIG. 2C depicts the EKG traces and instantaneous heart rate over a 15-minute period during which stimulation was twice provided continuously for 1 minute as well as five times for shorter bursts”), but is silent with respect to one or more processors are configured to increase a sympathetic tone to increase the heart rate of the patient via at least one of the second therapy and a third therapy. However, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04 I).
Re. claim 3, Nicolelis teaches the processor (figure 1, nerve stimulator 18) delivering at least second and third therapies (paragraph 0191 – “FIG. 2C depicts the EKG traces and instantaneous heart rate over a 15-minute period during which stimulation was twice provided continuously for 1 minute as well as five times for shorter bursts”), but is silent with respect to one or more processors are configured to decrease a parasympathetic tone to increase the heart rate of the patient via at least one of the second therapy and a third therapy.
However, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04 I).
Re. claim 4, Nicolelis teaches the processor (figure 1, nerve stimulator 18) delivering at least second and third therapies (paragraph 0191 – “FIG. 2C depicts the EKG traces and instantaneous heart rate over a 15-minute period during which stimulation was twice provided continuously for 1 minute as well as five times for shorter bursts”), but is silent with respect to one or more processors are configured to decrease a sympathetic tone to decrease the heart rate of the patient via at least one of the second therapy and a third therapy.
However, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04 I).
Re. claim 5, Nicolelis teaches the processor (figure 1, nerve stimulator 18) delivering at least second and third therapies (paragraph 0191 – “FIG. 2C depicts the EKG traces and instantaneous heart rate over a 15-minute period during which stimulation was twice provided continuously for 1 minute as well as five times for shorter bursts”), but is silent with respect to one or more processors are configured to decrease the heart rate of the patient via at least one of the second therapy and a third therapy.
However, the recited limitation is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04 I).
Re. claim 6, Nicolelis further teaches a seizure detection unit capable of analyzing the at least one body data stream to determine an epileptic seizure status (paragraph 0023 – “FIGS. 7A1-A3 are filtered field potential traces showing seizure activity during three sequential 1 minute periods, demonstrating seizure reduction using the intelligent brain pacemaker… and in FIG. 7A3, representing minute 3, no stimulus is provided; the bars on the line labeled "seizure detector" indicate seizures detected by the seizure detection device.)”; paragraph 0195 – “When the microchip detects seizure activity in the EEG signals, it can trigger an implanted stimulator, which then stimulates one or more nerve contact electrodes”; seizure detection module, paragraph 0136).
Re. claim 12, Nicolelis further teaches the method further comprising, based on the patient's responsiveness, instructing an external device to change an operating state thereof (paragraph 0067 – “The data presented in FIGS. 7A-7D was acquired without human intervention. In FIGS. 7B-7D, the dotted lines represent data acquired without human intervention. That is, the seizure detector automatically detected the presence of a seizure and automatically sent a TTL pulse to the nerve stimulator which applied an electrical pulse to the nerve in contact with the nerve contact electrode”).
Re. claim 15, Nicolelis further teaches wherein at least one responsiveness parameter includes at least one of:
a duration of a change in the patient’s responsiveness;
a time interval from the indication of the detection of the epileptic seizure to a change in the patient’s responsiveness,
a type of change in the patient’s responsiveness (paragraph 0042 – “A seizure detection algorithm can comprise, for example, the steps of comparing brain activity of a subject to a database of brain activity known to be associated with seizure activity. A seizure detection algorithm can also comprise, for example, the steps of comparing brain activity of a subject to a threshold voltage value, above which seizure activity is known to be occurring”),
an estimation of a seizure severity (paragraph 0081 – “Alternatively, the computer can be fitted with internet capability, thereby permitting transmission of data to a computer at a remote location. In this embodiment, signals from a subject's brain, which can comprise data related to the nature and quality of a subject's seizure attack, can be sent via a network (such as an internet) to the subject's physician, who can then evaluate the severity and nature of the seizure”);
a classification of a seizure into clinical or subclinical;
a classification of a clinical seizure into simple partial, complex partial, or generalized;
an assessment of efficacy of a therapy for the patient's medical condition (paragraph 0084 – “Additionally, a handheld computer might be useful for a supervising physician or care provider to monitor an operator's epileptic activity. In practice, it might be desirable to examine field potential data and epileptic activity from an operator. To meet this desire, the data stored on the handheld computer could be downloaded to another computer for analysis. For example, an operator might schedule regular visits with his or her physician to determine the efficacy of the operating parameters (e.g., threshold voltage value, pulse train parameters, etc.) of the present invention”);
an assessment of the state of the disease and formulation of a prognosis for the patient;
an estimation of a risk of injury or death for the patient;
and two or more thereof.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nicolelis (US 20030083716 A1 – hereinafter Nicolelis) in view of Suzuki (US 20080004811 A1 – hereinafter Suzuki).
Re. claim 7, Nicolelis further teaches collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor (paragraph 0191 – “Additionally, the intelligent brain pacemaker minimizes the risk of cardiovascular damage, which is a consideration in VNS therapy. FIGS. 2A-2C are EKG traces that indicate that EKG activity is not significantly altered during IO nerve stimulation”).
Nicolelis does not explicitly teach determining an autonomic index;
and detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals, respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof.
Suzuki teaches a similar biological monitoring system (paragraph 0003 – “The present invention relates to an apparatus, a method, and a computer program product for monitoring biological information of a target person”), and further teaches the known technique of determining an autonomic index (paragraph 0063 – “The autonomic-nervous-index calculating unit 134 calculates an autonomic nervous index…”),
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And further teaches detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals (paragraph 0058 – “The pulse-wave sensor 200 is made up of, for example, a blue light-emitting diode (LED) (not shown) and a photodiode (not shown)”; figure 9, step 120 of monitoring pulse wave data), respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof (paragraph 0063 – “The average pulse-interval calculating unit 132 calculates the average of the pulse-interval data within a predetermined range, i.e., the average pulse interval. The autonomic-nervous-index calculating unit 134 calculates an autonomic nervous index based on the average pulse interval”; paragraph 0067).
Therefore, 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 Nicolelis, to incorporate the autonomic index determination techniques as taught by Suzuki, since such modification would predictably result in determining and assessing potential autonomic dysfunction.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nicolelis (US 20030083716 A1 – hereinafter Nicolelis) in view of Dittman (US 20020014236 A1 – hereinafter Dittman).
Re. claim 8, Nicolelis further teaches the method further comprising collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor (paragraph 0191 – “Additionally, the intelligent brain pacemaker minimizes the risk of cardiovascular damage, which is a consideration in VNS therapy. FIGS. 2A-2C are EKG traces that indicate that EKG activity is not significantly altered during IO nerve stimulation”).
Nicolelis does not explicitly teach determining a neurologic index;
and detecting a change in the neurologic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof.
Dittman teaches the known technique of determining a neurologic index (bispectral index, abstract – “The numerical value is controlled on the basis of an evaluation of the EEG (electroencephalogram) of the patient (1) by an EEG sensor (2), e.g., by determining the so-called BIS (bispectral index)”),
and detecting a change in the neurologic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof (paragraph 0042 – “FIG. 2 shows as an example the changes in BIS (bispectral index) A over time, based on the EEG of a patient 1…”).
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Therefore, 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 Nicolelis, to incorporate the neurological index determination techniques as taught by Dittman, since such modification would predictably result in determining and assessing potential neurological dysfunction in a patient.
Claim(s) 9-11, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nicolelis (US 20030083716 A1 – hereinafter Nicolelis) in view of Theodoracopulos (US 20030073885 A1 – hereinafter Theodoracopulos).
Re. claim 9, Nicolelis teaches a responsiveness test as stated above in claim 1 (paragraph 0042), but does not explicitly teach wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level.
Theodoracopulos teaches a system for testing cognitive function (paragraph 0020 – “Our invention entails using a computer to show a patient a series of cognitive dysfunction tests, receiving the patient's test responses, and analyzing these responses to assess cognitive dysfunction in the patient, whereby a conclusion regarding whether symptoms of cognitive dysfunction probably exist or are absent in the patient”), and further teaches wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level paragraphs 0067-0073 describes two differing reflex and memory testing protocols, in which a ball is displayed in a square for 1,500 milliseconds, followed by 500 milliseconds; paragraphs 0074-0081 also teach two different incidental learning tests in which pictures are displayed for 2.0 seconds, followed by 1.0 second of blank screen).
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Therefore, 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 Nicolelis, specifically the responsiveness tests, to incorporate the first and second responsiveness tests as taught by Theodoracopulos, since such modification would predictably result in determining and assessing potential neurological dysfunction in a patient.
Re. claim 10, Nicolelis teaches a responsiveness test as stated above in claim 1 (paragraph 0042), but does not explicitly teach wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration.
Theodoracopulos teaches a system for testing cognitive function (paragraph 0020 – “Our invention entails using a computer to show a patient a series of cognitive dysfunction tests, receiving the patient's test responses, and analyzing these responses to assess cognitive dysfunction in the patient, whereby a conclusion regarding whether symptoms of cognitive dysfunction probably exist or are absent in the patient”), and further teaches wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration (paragraphs 0067-0073 describes two differing reflex and memory testing protocols, in which a ball is displayed in a square for 1,500 milliseconds, followed by 500 milliseconds; paragraphs 0074-0081 also teach two different incidental learning tests in which pictures are displayed for 2.0 seconds, followed by 1.0 second of blank screen).
Therefore, 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 Nicolelis, specifically the responsiveness tests, to incorporate the first and second responsiveness test durations as taught by Theodoracopulos, since such modification would predictably result in determining and assessing potential neurological dysfunction in a patient.
Re. claim 11, Nicolelis teaches a responsiveness test as stated above in claim 1 (paragraph 0042), but does not explicitly teach wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.
Theodoracopulos teaches a system for testing cognitive function (paragraph 0020 – “Our invention entails using a computer to show a patient a series of cognitive dysfunction tests, receiving the patient's test responses, and analyzing these responses to assess cognitive dysfunction in the patient, whereby a conclusion regarding whether symptoms of cognitive dysfunction probably exist or are absent in the patient”), and further teaches wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof (paragraphs 0067-0073 describes two differing reflex and memory (cognitive) testing protocols to test which square the ball previously was; paragraphs 0074-0081 also teach two different incidental learning tests).
Therefore, 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 Nicolelis, specifically the responsiveness tests, to incorporate the visual and memory tests as taught by Theodoracopulos, since such modification would predictably result in determining and assessing potential neurological dysfunction in a patient.
Re. claim 13, Nicolelis teaches a responsiveness test as stated above in claim 1 (paragraph 0042), but does not explicitly teach wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of: an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.
Theodoracopulos teaches a system for testing cognitive function (paragraph 0020 – “Our invention entails using a computer to show a patient a series of cognitive dysfunction tests, receiving the patient's test responses, and analyzing these responses to assess cognitive dysfunction in the patient, whereby a conclusion regarding whether symptoms of cognitive dysfunction probably exist or are absent in the patient”), and further teaches wherein the test of responsiveness further comprises a test to determine a patient’s capacity to perform the purposeful response (paragraphs 0067-0073 describes two differing reflex and memory (cognitive) testing protocols to test which square the ball previously was; paragraphs 0074-0081 also teach two different incidental learning tests; paragraph 0037 – “This version entails having the patient take a series of cognitive dysfunction tests before the patient has been exposed, and receiving the patient's test responses, and analyzing these responses, to form a "baseline" performance level for the patient, and to also--after the patient has been exposed--to have the patient take a series of cognitive dysfunction tests, and to receive the patient's test responses, and analyze these responses to form a new performance level for the patient, and to compare these new responses to the patient's earlier ("baseline") responses to then form a conclusion regarding whether symptoms of probable cognitive dysfunction exist”).
Therefore, 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 Nicolelis, specifically the responsiveness tests, to incorporate the test to measure a patient’s cognitive baseline as taught by Theodoracopulos, since such modification would predictably result in determining and assessing potential neurological dysfunction in a patient.
Re. claim 14, Nicolelis teaches a responsiveness test as stated above in claim 1 (paragraph 0042), but does not explicitly teach wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient.
Theodoracopulos teaches a system for testing cognitive function (paragraph 0020 – “Our invention entails using a computer to show a patient a series of cognitive dysfunction tests, receiving the patient's test responses, and analyzing these responses to assess cognitive dysfunction in the patient, whereby a conclusion regarding whether symptoms of cognitive dysfunction probably exist or are absent in the patient”), and further teaches wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient (paragraphs 0067-0073 describes two differing reflex and memory (cognitive) testing protocols to test which square the ball previously was; paragraphs 0074-0081 also teach two different incidental learning tests; paragraph 0037 – “This version entails having the patient take a series of cognitive dysfunction tests before the patient has been exposed, and receiving the patient's test responses, and analyzing these responses, to form a "baseline" performance level for the patient, and to also--after the patient has been exposed--to have the patient take a series of cognitive dysfunction tests, and to receive the patient's test responses, and analyze these responses to form a new performance level for the patient, and to compare these new responses to the patient's earlier ("baseline") responses to then form a conclusion regarding whether symptoms of probable cognitive dysfunction exist”).
Therefore, 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 Nicolelis, specifically the responsiveness tests, to incorporate the cognitive tests as taught by Theodoracopulos, since such modification would predictably result in determining and assessing potential neurological dysfunction in a patient.
Conclusion
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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