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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites, "Disclosed are...", which is considered implied phraseology and should be avoided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 recites the limitation, "the at least one body data stream". There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation, "the neurologic index". There is insufficient antecedent basis for this limitation in the claim. It is then interpreted by the Examiner that the limitation, “…determining an autonomic index…” in claim 8 to read, “…determining a neurologic index…”.
Claim 13 recites the limitation, "the purposeful response". There is insufficient antecedent basis for this limitation in the claim.
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”).
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: (i) a duration of a change in the patient’s responsiveness; (ii) 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”), (iii) a time interval from the 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 (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”), (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 § 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…”),
PNG
media_image1.png
458
414
media_image1.png
Greyscale
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…”).
PNG
media_image2.png
400
694
media_image2.png
Greyscale
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).
PNG
media_image3.png
602
166
media_image3.png
Greyscale
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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.
/ANH-KHOA N DINH/Examiner, Art Unit 3796