DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/28/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/28/2026 with respect to the rejection of Independent Claims 1, 14 and 19 under pre-AIA 35 USC 102(a) have been fully considered but they are not persuasive. Applicant argues that Independent Claims 1, 14 and 19 under pre-AIA 35 U.S.C. 102(a) are not anticipated by US 2010/0106217 A 1 to Colborn ("Colborn") because Colborn (1) Colborn does not disclose such an "index" as claimed and (2) Colborn does not disclose such an "index range" as claimed. Applicant’s characterization of the term “index” upon which its arguments rely is in contradiction to the plain meaning of the term, Applicant’s own previous characterizations, and – most decisively – the Present Specification. Despite the fact that Colborn and Claim 1 use different words, both Colborn and Claim 1 are doing the same thing based on the same information: heart rate. Applicant’s arguments are, accordingly, not persuasive. The rejection is maintained.
Applicant’s precise arguments in Applicant’s response filed 1/28/2026 were addressed in the Advisory Action dated 9/30/2025 (compare Applicant’s Response after Final dated 9/19/2025 at Pg. 8-9 with Applicant’s Remarks filed 1/28/2026 at Pg. 8-9). For brevity, the Examiner’s response to Applicant’s arguments (which was two single-spaced pages in length) is not rehashed herein, but is instead incorporated by reference. The Examiner’s response herein elaborates on the single most determinative factor: the Present Specification.
As mentioned above, Applicant's argument that Colborn does not disclose such an "index" as claimed is the same as Applicant's argument addressed in the Final Office Action dated 8/5/2025 and in the Advisory Action dated 9/30/2025. Applicant argues that Colborn's “cardiac parameter” that is “determin[ed]. .. from [Colborn's] sensed cardiac data” (Colborn at Para. [0042]) is not such a “first body index” as claimed because “a parameter and an index have two different definitions” (Applicant's Remarks filed 1/28/2026).
The Examiner respectfully disagrees that Colborn's "cardiac parameter" "determin[ed]. .. from [Colborn's] sensed cardiac data" is not such an "first body index" as claimed. Colborn's "cardiac parameter"is number indicative of heart condition, and is thus such an "index" as claimed. Applicant's position to the contrary is based on an interpretation of the term "first body index" that is narrower than the broadest reasonable interpretation. Although a parameter and an index do indeed "have two different definitions" as Applicant asserts, this is immaterial to the Examiner's position that Colborn's particular "cardiac parameter" is a species included in the broad genus "index" as the term "index" is used in the Present Specification: both describe heart rate.
"During patent examination, the pending claims must be 'given their broadest reasonable interpretation consistent with the specification."' MPEP 2111. "Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification." MPEP 2111.01 (I). "In the absence of an express intent to impart a novel meaning to the claim terms, the words are presumed to take on the ordinary and customary meanings attributed to them by those of ordinary skill in the art." MPEP 2111.01 (Ill), quoting Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298, 67 USPQ2d 1132, 1136 (Fed. Cir. 2003).
The Present Specification decisively supports the Examiner’s position. Colborn's "cardiac parameter" at issue is heart rate (see, e.g., Colborn at Para. [0070]).1 The Present Specification explicitly states that heart rate is a body index, and is consistent in this characterization throughout its entirety:
Para. [0031] of the Present Specification states that "heart rate" is a body index:
The medical device 200 may also comprise a body index range module 260, configured to determine body index ranges of the patient, based at least in part on the activity level determined by the activity level module 250. In some embodiments, the body index range module 260 may determine a reference value range for a certain body index (e.g., heart rate). … Thus, body index range module 260 may determine that the same body index value (e.g., the same heart rate) in the same patient is either pathological or non-pathological based on the activity level, activity type, or other variables (e.g., fitness level). (Present Specification at Para. [0037], emphasis added).
Para. [0037] of the Present Specification explicitly states that "heart rate" is a body index:
The body index may be heart rate (instantaneous or in a short-term or long-term time window), heart rate rhythm, heart rate variability, blood pressure, blood pressure variability, respiratory rate, respiratory rhythm, respiratory rate variability, end tidal C02, kinetic activity, cognitive activity, dermal (including electro-dermal) activity, chemical (including electro-chemical) activity, arterial pH, cortisol level, catecholamine level, or blood oxygen saturation, among others. For example, the body index may be heart rate. (Present Specification at Para. [0037], emphasis added).
Para. [0041] of the Present Specification states that "heart rate" is a body index:
However, other measures of work level may be also used, including the classic reference to work level involving amount of force used, displacement, etc. For example, if the body index is heart rate, an activity level indicative of vigorous aerobic exercise may be related to a non- pathological heart rate range of 120-140 BPM. (Present Specification at Para. [0041], emphasis added).
Para. [0047] of the Present Specification states that "heart rate" is a body index:
Although non-pathological activity level is shown in Figure 3A as a single continuous parameter, a plurality of discrete activity levels or states may also be used to correlate heart rate (or another body index) to activity levels in some embodiments of the invention. (Present Specification at Para. [0047], emphasis added).
Para. [0054] of the Present Specification states that "heart rate" is a body index:
Figures 3A and 3B together show that a non-pathological heart rate (or other body index) range may be established for a given activity level of the patient. (Present Specification at Para. [0054], emphasis added).
Para. [0062] of the Present Specification states that “heart rate” is a body index:
The non-pathological range for the at least one body index may be based upon work level data and patient or environmental conditions, according to some embodiments. First, 1000, patient activity data may be received at 710. This received data may be related to the origin(s), type, or magnitude of the activity, i.e., may provide a qualitative, semi-quantitative, or quantitative measure of the kinetic, emotional, and/or cognitive contributions to the patient's activity level. A non-pathological range (e.g., a non-ictal heart rate range) for the at least one body index may be determined at 720, based on the patient's activity. (Present Specification at Para. [0062], emphasis added).
The plain meaning of the term "index" includes Colborn's "cardiac parameter" that is "determin[ed]. .. from [Colborn's] sensed cardiac data.” Both are heart rate. The Present Specification explicitly supports this interpretation (see above). Applicant's argument that Colborn does not disclose such an "index" as claimed because Colborn's "cardiac parameter" that is "determin[ed]. .. from [Colborn's] sensed cardiac data" is not such an "first body index" as claimed is not persuasive. Both Colborn’s “cardiac parameter” and the “first body index” of Claim 1 are heart rate. Both Colborn and Claim 1 do the same thing based on the same information: heart rate. That two different terms are used to describe this information is immaterial: based on the context of their use, they are the same.
It is unclear from Applicant's arguments why Applicant considers the very specific "cardiac parameter" "determin[ed]... from ... sensed cardiac data" described by Colborn to be different than the "first body index" of the independent Claims in the particular context of either the invention or the claims. Both pertain to the same piece of information: heart rate. Applicant’s arguments discuss only the dictionary definitions of the terms at issue without regard for inventive context. Context makes clear that despite the use of different terminology, Colborn’s “cardiac parameter” and Applicant’s “body index” are the same thing: heart rate.
From the phrasing of Applicant's arguments, it appears that Applicant has misinterpreted the Examiner's position. The Examiner does not disagree that the terms average and range have different meanings. Instead, the Examiner is of the position that Colborn's "compar[ing] the moving average of the patient's heart rate to the heart rate threshold value" as specifically described at Colborn's Para. [0072] is such "comparing the first body index to the non-pathological range for the first body index" as claimed because the comparison results in range of acceptable values. The Examiner notes that this is precisely what described at Para. [0055] of the Present Specification ("By monitoring the patient's activity level and heart rate, it is possible to determine when the patient's heart rate falls outside the non-pathological ranges as the patient's activity levels change over time."). Applicant's arguments are therefore not persuasive.
If amendment were made to more narrowly reflect the definition of index that Applicant purports to govern its interpretation, the Examiner’s position may merit reconsideration. With such an amendment in mind and in the interest of compact prosecution, Claims 1, 14 and 19 are alternatively rejected herein under pre-AIA 35 USC 103 as unpatentable over Colburn in view of US 20090124923 A1. The rejection uses an alternative interpretation in line with Applicant’s position that the term “index” is itself of decisive significance.
The Examiner additionally notes the relevance of US 8190249 B1, Figs. 9-10 of which as elaborated upon by the Specification appear pertinent.
Applicant's arguments regarding Independent Claims 14 and 19 are similar to Applicant’s arguments regarding Independent Claim 1, and have been fully considered but are not persuasive for the same reasons as explained above.
Applicant's arguments regarding Dependent Claims 4-13, 15-18 and 20 are based on Applicant's arguments regarding Independent Claims 1 , 14 and 19, and have been fully considered but are not persuasive for the same reasons as explained above.
Applicant’s arguments regarding Dependent Claim 3 are persuasive to the extent the Examiner agrees that Applicant’s amendments requiring all of the listed alternatives rather than at least one of such alternatives is not disclosed by Colborn. Accordingly, the rejection is withdrawn. However, upon further search and consideration, new grounds of rejection is made in view of US 2008/0021514 A1, US 2012/0265266 A1 and US 2011/0270095 A1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 6, 9, 11 and 13-19 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by previously cited US 2010/0106217 A1 to Colborn (“Colborn”). The rejection is maintained.
Regarding Independent Claim 1, Colborn discloses:
A method for detecting a pathological body state of a patient, comprising: (Title, “Dynamic cranial nerve stimulation based on brain state determination from cardiac data;” Para. [0067], “The unstable brain state declaration module 280 is capable of declaring an unstable brain state of a patient from said at least a first cardiac parameter and said at least a first value;” Para. [0068], “An “unstable brain state” is used herein to refer to the state of the brain during an epileptic seizure…”);
See Para. [0002] of the Present Specification in support of this interpretation (“This disclosure relates to medical device systems and methods capable of detecting a pathological body state of a patient, which may include epileptic seizures….”).
receiving a first body signal of the patient; (Para. [0069], “The cardiac module 296 is capable of determining at least a first cardiac parameter based upon sensed cardiac data from the patient, as discussed above;” Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data.”);
determining a first body index from the first body signal; (Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data.”);
Colborn’s “cardiac parameter” is such a “first body index” as claimed.
Colborn describes several such “cardiac parameter” at Paras. [0043] through [0058].
determining an activity level of the patient; (Para. [0084], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module (not shown) capable of detecting an activity level of the patient.”);
determining a non-pathological range for the first body index, based at least in part on the activity level; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM);” Para. [0096], “In embodiments wherein the unstable brain state declaration module 280 further comprises a non-cardiac parameter detection module, the value setting module 282 may be capable of setting at least a second value, and the unstable brain state declaration module 280 is capable of declaring an unstable brain state of the patient from both said at least one non-cardiac parameter and said at least a second value;” Para. [0094], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting at least one non-cardiac parameter selected from the group consisting of an activity level of the patient…”).
comparing the first body index to the non-pathological range for the first body index; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM). At a predetermined sampling rate, by way of example, from about 100 times per second to about once per five seconds, the cardiac module 296 determines the moving average of the patient's heart rate and the unstable brain state declaration module 280 compares the moving average of the patient's heart rate to the heart rate threshold value.”);
detecting an indication of a pathological body state when the first body index is outside the non-pathological range; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM).”);
and initiating an electrical therapy based on the indication of the pathological body state (Para. [0103], “In one embodiment, the method can further comprise generating and applying 462 a first electrical signal to the vagus nerve if an unstable brain state has not been declared, and generating and applying 464 a second electrical signal to the vagus nerve if an unstable brain state has been declared. FIG. 5 shows this embodiment.”).
Regarding Claim 6, Colburn ‘217 discloses the entirety of Claim 1 as explained above.
Colburn ‘217 additionally discloses:
wherein determining the non-pathological body index range is further based at least in part on one or more of a time of day, an environmental condition, a patient's body weight and height, a patient's body mass index, a patient's gender, a patient's age, an indicator of the patient's overall health, or an indicator of the patient's overall fitness. (Para. [0087], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting the time of day. The parameter detection module of this embodiment may be a clock or a module capable of querying a clock for the current time.”).
Regarding Claim 9, Colburn ‘217 discloses the entirety of Claim 1 as explained above.
Colburn ‘217 additionally discloses:
wherein the pathological state is an epileptic event (Para. [0068], “An “unstable brain state” is used herein to refer to the state of the brain during an epileptic seizure…”).
Regarding Claim 11, Colburn ‘217 discloses the entirety of Claim 1 as explained above.
Colburn ‘217 additionally discloses:
wherein determining a non-pathological range for the first body index comprises determining the non-pathological range for the first body index for a first time point based on the patient's activity in a first time window prior to the first time point (Para. [0047], “For example, a baseline heart rate may be defined as a 30-beat moving average heart rate, or longer moving average such as a 5 minute average heart rate, and the elevation may be the difference between an instantaneous heart rate and the baseline rate. Cardiac module 296 may further be capable of determining a difference between a first moving average and a second moving average. The first and second moving averages may be based upon a particular number of beats, for example a 3 beat moving average and a 30 beat moving average, or upon particular time periods, for example a 10 second moving average and a 5 minute moving average. In another embodiment, cardiac module 296 may be capable of determining a first cardiac parameter consisting of a duration of an elevation of the patient's heart rate above the patient's baseline heart rate;” Para. [0095], “However if an accelerometer indicates high activity level and then heart rate begins to increase rapidly, a logical value boolHeartRateIncreaseWithoutActivity may be set to false, and the unstable brain state declaration module 280 may not declare an unstable brain state from the logical value being false. More aggressive users may desire a logical value boolHeartRateIncrease=true or one of a pair of logical values (boolHeartRateIncrease=true or boolActivity=true) to be sufficient for the unstable brain state declaration module 280 to declare an unstable brain state.”).
Colborn determines its non-pathological range by taking “a 30-beat moving average heart rate, or longer moving average such as a 5 minute average heart rate,” and considers activity as indicated by Colborn 217’s accelerometer in confirming that range. Colborn thus determines its non-pathological range for the first body index in the manner claimed.
Regarding Claim 13, Colborn discloses the entirety of Claim 1 as explained above.
Colborn additionally discloses:
wherein determining a first body index from the first body signal comprises determining a change in the first body index, (Para. [0047], “For example, a baseline heart rate may be defined as a 30-beat moving average heart rate, or longer moving average such as a 5 minute average heart rate, and the elevation may be the difference between an instantaneous heart rate and the baseline rate. Cardiac module 296 may further be capable of determining a difference between a first moving average and a second moving average. The first and second moving averages may be based upon a particular number of beats, for example a 3 beat moving average and a 30 beat moving average, or upon particular time periods, for example a 10 second moving average and a 5 minute moving average. In another embodiment, cardiac module 296 may be capable of determining a first cardiac parameter consisting of a duration of an elevation of the patient's heart rate above the patient's baseline heart rate.”);
and wherein detecting the pathological body state when the first body index is outside the non-pathological range comprises determining if the change in the first body index is commensurate with the determined activity level (Para. [0095], “However if an accelerometer indicates high activity level and then heart rate begins to increase rapidly, a logical value boolHeartRateIncreaseWithoutActivity may be set to false, and the unstable brain state declaration module 280 may not declare an unstable brain state from the logical value being false. More aggressive users may desire a logical value boolHeartRateIncrease=true or one of a pair of logical values (boolHeartRateIncrease=true or boolActivity=true) to be sufficient for the unstable brain state declaration module 280 to declare an unstable brain state.”).
Regarding Independent Claim 14, Colborn discloses:
A method of determining a pathological state in a patient, comprising: (Title, “Dynamic cranial nerve stimulation based on brain state determination from cardiac data;” Para. [0067], “The unstable brain state declaration module 280 is capable of declaring an unstable brain state of a patient from said at least a first cardiac parameter and said at least a first value;” Para. [0068], “An “unstable brain state” is used herein to refer to the state of the brain during an epileptic seizure…”);
See Para. [0002] of the Present Specification in support of this interpretation (“This disclosure relates to medical device systems and methods capable of detecting a pathological body state of a patient, which may include epileptic seizures….”).
receiving data relating to an activity level of the patient; (Para. [0084], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module (not shown) capable of detecting an activity level of the patient.”);
determining an activity level of the patient based on the data relating to an activity level; Para. [0094], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting at least one non-cardiac parameter selected from the group consisting of an activity level of the patient…”).
receiving at least one body signal of the patient; (Para. [0069], “The cardiac module 296 is capable of determining at least a first cardiac parameter based upon sensed cardiac data from the patient, as discussed above;” Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data.”);
determining at least a first body index based on the at least one body signal; (Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data.”);
Colborn’s “cardiac parameter” is such a “first body index” as claimed.
Colborn describes several such “cardiac parameter” at Paras. [0043] through [0058].
dynamically determining a reference value range for the at least a first body index based on the activity level; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM);” Para. [0096], “In embodiments wherein the unstable brain state declaration module 280 further comprises a non-cardiac parameter detection module, the value setting module 282 may be capable of setting at least a second value, and the unstable brain state declaration module 280 is capable of declaring an unstable brain state of the patient from both said at least one non-cardiac parameter and said at least a second value;” Para. [0094], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting at least one non-cardiac parameter selected from the group consisting of an activity level of the patient…”);
Colborn 217’s use of a “moving average” is such “dynamically determining” as claimed when the term is afforded its broadest reasonable interpretation.
Alternatively, Colborn discloses adjustment of “the at least a first value, the at least a second value, or both” using “the at least one non-cardiac parameter and the at least a second value” at Para. [0097], which adjustment is additionally such “dynamically determining” as claimed.
determining that the patient is in one of a non-pathological state and a pathological state, wherein the patient is determined to be in a non-pathological state if the at least a first body index is within the reference value range for the activity level, and the patient is indicated to be in a pathological state if the at least a first body index is outside the reference value range; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM). At a predetermined sampling rate, by way of example, from about 100 times per second to about once per five seconds, the cardiac module 296 determines the moving average of the patient's heart rate and the unstable brain state declaration module 280 compares the moving average of the patient's heart rate to the heart rate threshold value.”);
initiating an electrical therapy based on the indication of the pathological body state (Para. [0103], “In one embodiment, the method can further comprise generating and applying 462 a first electrical signal to the vagus nerve if an unstable brain state has not been declared, and generating and applying 464 a second electrical signal to the vagus nerve if an unstable brain state has been declared. FIG. 5 shows this embodiment.”);
and taking at least one further action based on determining that the patient is in a pathological state, wherein the further action is selected from, issuing a warning to the patient or a caregiver regarding the pathological state, logging the occurrence of the pathological state, logging the response to the initiated electrical therapy, or logging a severity of the pathological state. (Para. [0071], “In one embodiment, the memory 217 is capable of storing a timestamp associated with a declaration of an unstable brain state by the unstable brain state declaration module 280. The memory 217 may also be capable of storing a time series of the at least one cardiac parameter and/or the at least a first value. The unstable brain state declaration module 280, or another module in the IMD 200 or in an apparatus in communication with the IMD 200 (such as the computer 150), may create a log of times at which a patient experiences an unstable brain state.”).
Regarding Claim 15, Colborn discloses the entirety of Claim 14 as explained above.
Colborn additionally discloses:
wherein the reference value range comprises one of a non-pathological range and a pathological range (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM);” Para. [0096], “In embodiments wherein the unstable brain state declaration module 280 further comprises a non-cardiac parameter detection module, the value setting module 282 may be capable of setting at least a second value, and the unstable brain state declaration module 280 is capable of declaring an unstable brain state of the patient from both said at least one non-cardiac parameter and said at least a second value;” Para. [0094], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting at least one non-cardiac parameter selected from the group consisting of an activity level of the patient…”).
Regarding Claim 16, Colborn discloses the entirety of Claim 14 as explained above.
Colborn additionally discloses:
wherein the pathological state is an epileptic seizure. (Para. [0068], “An “unstable brain state” is used herein to refer to the state of the brain during an epileptic seizure…”).
Regarding Claim 17, Colborn discloses the entirety of Claim 14 as explained above.
Colborn additionally discloses:
wherein the at least one body signal is selected from a cardiac signal, a respiratory signal, a blood signal, a dermal signal and an endocrine signal (Para. [0067], “The unstable brain state declaration module 280 is capable of declaring an unstable brain state of a patient from said at least a first cardiac parameter and said at least a first value.”).
Regarding Claim 18, Colborn discloses the entirety of Claim 14 as explained above.
Colborn additionally discloses:
wherein the first body index is selected from: a cardiac index based on the cardiac signal, wherein the cardiac index is selected from a heart rate, heart rhythm, a heart rate variability, and a blood pressure; a respiratory index based on the respiratory signal, wherein the respiratory index is selected from a respiratory rate, respiratory rhythm, blood oxygen saturation, and an end tidal CO2 concentration; a dermal index based on the dermal signal, wherein the dermal index is selected from a skin resistivity and a skin conductivity; a blood index based on the blood signal, wherein the blood index is selected from an arterial pH and a lactic acid concentration; and an endocrine index based on the endocrine signal, wherein the endocrine signal is selected from a cortisol level and a catecholamine level. (Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data;” (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM).”).
Regarding Independent Claim 19, Colborn discloses:
A medical device system, comprising: (Title, “Dynamic cranial nerve stimulation based on brain state determination from cardiac data;” Para. [0067], “The unstable brain state declaration module 280 is capable of declaring an unstable brain state of a patient from said at least a first cardiac parameter and said at least a first value;” Para. [0068], “An “unstable brain state” is used herein to refer to the state of the brain during an epileptic seizure…;” Abstract, “In addition, the implantable medical device used in the method.”);
at least one kinetic sensor, each the sensor configured to collect at least one kinetic signal from a patient; (Para. [0085], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting an output of an accelerometer. The accelerometer may be worn on the patient's person or implanted in the patient's body.”);
an activity level module configured to determine an activity level of the patient, based at least in part on the at least one kinetic signal; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM);” Para. [0096], “In embodiments wherein the unstable brain state declaration module 280 further comprises a non-cardiac parameter detection module, the value setting module 282 may be capable of setting at least a second value, and the unstable brain state declaration module 280 is capable of declaring an unstable brain state of the patient from both said at least one non-cardiac parameter and said at least a second value;” Para. [0094], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting at least one non-cardiac parameter selected from the group consisting of an activity level of the patient…”).
at least one sensor configured to sense a body signal; (Para. [0069], “The cardiac module 296 is capable of determining at least a first cardiac parameter based upon sensed cardiac data from the patient, as discussed above;” Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data.”)
a body index determination module configured to determine at least a first body index based on the sensed body signal; (Para. [0069], “The cardiac module 296 is capable of determining at least a first cardiac parameter based upon sensed cardiac data from the patient, as discussed above.”);
a body index range module, configured to determine a non-pathological body index range for the at least a first body index, based at least in part on the activity level; (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM);” Para. [0096], “In embodiments wherein the unstable brain state declaration module 280 further comprises a non-cardiac parameter detection module, the value setting module 282 may be capable of setting at least a second value, and the unstable brain state declaration module 280 is capable of declaring an unstable brain state of the patient from both said at least one non-cardiac parameter and said at least a second value;” Para. [0094], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting at least one non-cardiac parameter selected from the group consisting of an activity level of the patient…”);
and a pathological state determination module, configured to determine an indication that the patient is in one of a non-pathological state and a pathological state, wherein the patient is indicated to be in a non-pathological state if the at least a first body index is within the non-pathological body index range for the at least a first body index, and the patient is indicated to be in a pathological state if the at least a first body index is outside the non-pathological body index range for the at least a first body index. (Para. [0070], “The value setting module 282 sets at least a first value to be used by the unstable brain state declaration module 280. The at least a first value, along with the at least a first cardiac parameter determined by the cardiac module 296, is used by the unstable brain state declaration module 280 to declare or not declare the occurrence of an unstable brain state. For example, the at least a first cardiac parameter may be a moving average of the patient's heart rate (by way of example only, having a baseline value of 60-75 BPM) and the at least a first value may be a heart rate threshold value (by way of example only, 120 BPM). At a predetermined sampling rate, by way of example, from about 100 times per second to about once per five seconds, the cardiac module 296 determines the moving average of the patient's heart rate and the unstable brain state declaration module 280 compares the moving average of the patient's heart rate to the heart rate threshold value. ”);
and initiating an electrical therapy based on the indication of the pathological body state (Para. [0103], “In one embodiment, the method can further comprise generating and applying 462 a first electrical signal to the vagus nerve if an unstable brain state has not been declared, and generating and applying 464 a second electrical signal to the vagus nerve if an unstable brain state has been declared. FIG. 5 shows this embodiment.”).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over previously cited US 2010/0106217 A1 to Colborn (“Colborn”) as applied to Claims 1 and 19, respectively, and further in view of US 2008/0021514 A1 to Pless (“Pless”), US 2012/0265266 A1 to Colburn (“Colburn ‘266”) and US 2011/0270095 A1 to Bukhman (“Bukhman”).
Regarding Claim 3, Colburn ‘217 discloses the entirety of Claim 1 as explained above.
Colburn ‘217 additionally discloses:
further comprising: in response to detecting the indication of the pathological state … logging a time of occurrence of the detecting… (Para. [0071], “In one embodiment, the memory 217 is capable of storing a timestamp associated with a declaration of an unstable brain state by the unstable brain state declaration module 280. The memory 217 may also be capable of storing a time series of the at least one cardiac parameter and/or the at least a first value. The unstable brain state declaration module 280, or another module in the IMD 200 or in an apparatus in communication with the IMD 200 (such as the computer 150), may create a log of times at which a patient experiences an unstable brain state.”).
Colburn does not disclose:
issuing a notice of the detecting,
issuing a warning,
logging a response to a therapy,
and logging a severity of the pathological state.
Pless describes “An implantable neurostimulator system … capable of responsively treating epileptiform activity with electrical stimulation and other therapies and … further configured to detect periods of increased susceptibility to clinical seizures” (Abstract). Pless is analogous art.
Pless teaches:
issuing a notice of the detecting (Para. [0001], “The invention relates to systems and methods for detecting and treating epileptic seizures, and more particularly to detecting, treating, and providing notice of recurring epileptiform seizure-like activity…;” Para. [0021]).
issuing a warning, (Para. [0016], “ When a period of increased therapy activity is observed, it would be advantageous to be able to warn the patient to take protective measures or take in increased dose of an anticonvulsant medication, or to automatically provide additional therapy (above and beyond the responsive therapy already being applied) to reduce the impact or likelihood of a clinical seizure;” Para. [0021], “In a system according to the invention, warnings and other messages to the patient may be provided by an audio transducer within the implanted device or via telemetry to a piece of external equipment, such as a personal computer.”).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the device of Colburn with the teachings of Pless (i.e., to modify the device of Colburn such that it additionally issues a notice of the detecting in the manner of Pless and issues a warning in the manner of Pless) in order to allow the patient to take protective measures prior to seizure onset (Pless at Para. [0016]).
Colborn ‘266 describes “A system and method for estimating the longevity of an implantable medical device (IMD)” (Abstract), which implantable medical device “…may deliver a stimulation burst in response to detection of an impending or already-occurring seizure based on one or more of the patient's cardiac parameters (e.g., heart rate, rate of change of heart rate, heart rate variability, etc.” (Para. [0033]). Colborn ‘266 is analogous art.
Colborn ‘266 teaches:
logging a response to a therapy, (Para. [0027], “Storage 280 may be used for storing various program codes, starting data, and the like. More specifically, the storage 280 stores the parameter values that govern the rate and level of stimulation provided by the stimulation logic 255. The stored parameter values also enable delivery and/or logging of stimulation administered or events detected based on the different categories of stimulation (e.g., open-loop, automatically-initiated, manually-initiated). Information regarding the stimulation administered and/or stimulation trigger events detected is stored as stimulation data and counts 282 in the storage 280. The stimulation data and counts 282 may comprise a count of open-loop stimulations administered, a count of automatic stimulation trigger events detected, a count of automatic stimulation events administered, a count of received manually-initiated stimulation requests, and a count of manually-initiated stimulations delivered.”).
As Colborn ‘266’s stimulation is administered in a closed-loop fashion, Colborn ‘266’s stored “[i]nformation regarding the stimulation administered and/or stimulation trigger events detected” which “may comprise a count of open-loop stimulations administered, a count of automatic stimulation trigger events detected, a count of automatic stimulation events administered, a count of received manually-initiated stimulation requests, and a count of manually-initiated stimulations delivered” necessarily contains information pertaining to a patient’s response to therapy, and thus entails such “logging a response to a therapy” as claimed.
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the device of combined Colborn and Pless with the teachings of Colborn ‘266 (i.e., to modify the device of combined Colborn and Pless such that it additionally logs such information as described by Colborn ‘266 at Para. [0027], thereby logging a response to a therapy” as claimed) in order to “ facilitate prediction of the operational life” of the device (Colborn ‘266 at Para. [0027]).
Bukhman describes “methods, systems, and apparatus for detecting an epilepsy event in a patient using a medical device” (Abstract). Bukhman is analogous art.
Bukhman teaches:
and logging a severity of the pathological state (Para. [0204], “Alternatively or in addition, the medical device 200 may provide a warning to the patient or his or her caregivers, physician, etc. (block 1575); log a time of seizure (block 1577); or compute and store one or more seizure severity indices (block 1579);” Para. [0081]).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the device of combined Colborn, Pless and Colborn ‘266 with the teachings of Bukhman (i.e., to additionally log a severity of the pathological state in the manner of Bukhman) in order to facilitate treatment by the appropriate techniques (Bukhman at Paras. [0081] through [0083]).
Claims 4 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2010/0106217 A1 to Colborn (“Colborn”) as applied to Claims 1 and 19, respectively, and further in view of US 6,658,287 B1 to Litt et al. (“Litt”).
Regarding Claim 4, Colborn discloses the entirety of Claim 1 as explained above.
Colborn does not disclose:
wherein the first body index is a catecholamine level
Litt describes “…a method, and system for predicting the onset of a seizure prior to electrograph onset in an individual” (Abstract). Litt is analogous art.
Litt teaches:
wherein the first body index is a catecholamine level (Col. 27, Ln. 16-23, “For example, the modalities of intervention measures (and parameters thereof) may track algorithms which predict EEG and/or clinical onset of seizures based upon multiple features of a feature set, such as the EEG and/or a variety of other physiological parameters including electrocardiogram and other features derived from it (e.g. heart rate variability), pupillary diameter, skin resistance, respiratory rate, serum catecholamines.”).
It would have been obvious for a person of ordinary skill in the art at the time the invention was made to modify the method of Colborn with the teachings of Litt (i.e., to modify the method of Colborn such that catecholamine level is used as the first body index as taught by Litt) in order to facilitate “predicting seizures with such accuracy that the activity of the brain can be monitored by an implantable device to warn a patient of the likelihood of an impending seizure, and/or to take preventative actions through application of intervention measures to abort or modulate the seizure prior to clinical onset.” (Litt at Col. 1, Ln. 44-50).
Regarding Claim 20, Colborn discloses the entirety of Claim 19 as explained above.
Colborn does not disclose:
wherein the body signal is a catecholamine level
Litt describes “…a method, and system for predicting the onset of a seizure prior to electrograph onset in an individual” (Abstract). Litt is analogous art.
Litt teaches:
wherein the body signal is a catecholamine level (Col. 27, Ln. 16-23, “For example, the modalities of intervention measures (and parameters thereof) may track algorithms which predict EEG and/or clinical onset of seizures based upon multiple features of a feature set, such as the EEG and/or a variety of other physiological parameters including electrocardiogram and other features derived from it (e.g. heart rate variability), pupillary diameter, skin resistance, respiratory rate, serum catecholamines.”).
It would have been obvious for a person of ordinary skill in the art at the time the invention was made to modify the method of Colborn with the teachings of Litt (i.e., to modify the method of Colborn such that catecholamine level is used as the first body index as taught by Litt) in order to facilitate “predicting seizures with such accuracy that the activity of the brain can be monitored by an implantable device to warn a patient of the likelihood of an impending seizure, and/or to take preventative actions through application of intervention measures to abort or modulate the seizure prior to clinical onset.” (Litt at Col. 1, Ln. 44-50).
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2010/0106217 A1 to Colborn (“Colborn”) as applied to Claim 1 above, and further in view of US 5,995,868 A to Dorfmeister et al. (“Dorfmeister”).
Regarding Claim 5, Colborn discloses the entirety of Claim 1 as explained above.
Colborn additionally discloses:
wherein determining the activity level comprises analyzing a body signal of the patient (Para. [0069], “The cardiac module 296 is capable of determining at least a first cardiac parameter based upon sensed cardiac data from the patient, as discussed above;” Para. [0042], “In one embodiment, the sensor 295 may be capable of sensing cardiac data and the cardiac module 296 may be capable of determining at least one cardiac parameter of the patient from the sensed cardiac data.”)
Colborn does not disclose:
wherein the analyzing is performed on sensed data from a lactic acid accumulation sensor
Dorfmeister describes a “System for the prediction, rapid detection, warning, prevention, or control of changes in activity states in the brain of a subject” (Title). Dorfmeister is analogous art.
Dorfmeister teaches:
wherein the analyzing is performed on sensed data from a lactic acid accumulation sensor (Col. 9, Ln. 40-62, “Those skilled in the art will recognize that changes in cerebral state are highly correlated with changes in level and type of activity of other organ systems (e.g., heart, etc.) and as such these signals, may be useful for detection and prediction or validation of seizures or of other changes in brain state. The following signals (not annotated in FIG. 1) may be used in conjunction with EEG and ECoG signals to further improve performance of the system: … 5) Signals representative of concentrations in the blood or other peripheral tissues of gases, substances, or chemicals such as lactic acid, etc….”).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the method of Colborn with the teachings of Dorfmeister (i.e., to modify the method of Colborn such that data sensed from a lactic acid accumulation sensor is analyzed in the manner taught by Dorfmeister) in order to improve detection and prediction of seizures or other changes in brain state (Dorfmeister at Col. 9, Ln. 40-45).
Claims 7 and 8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2010/0106217 A1 to Colborn (“Colborn”) as applied to Claim 1 above, and further in view of US 2010/0298656 A1 to McCombie et al. (“McCombie”).
Regarding Claim 7, Colborn discloses the entirety of Claim 1 as explained above.
Colborn does not disclose:
wherein the activity level is an activity level for a time window
McCombie describes “Alarm system that processes both motion and vital signs using specific heuristic rules and thresholds” (Title). McCombie is analogous art.
McCombie teaches:
wherein the activity level is an activity level for a time window (Para. [0131]; McCombie uses a N samples in a buffer in order to calculate the various variables used to determine the activity level of the person from the accelerometers [0131]. The N samples in the buffer with its corresponding sampling rate are the equivalent of a time window in that they are samples taken over a span of time.)
It would have been obvious for a person of ordinary skill in the art at the time the invention was made to modify the method of Colborn with the teachings of McCombie (i.e., to modify the method of Colborn such that a time window is used for activity level as taught by McCombie) in order to “reduce the occurrence of false alarms” (McCombie at Para. [0128]).
Regarding Claim 8, Colborn discloses the entirety of Claim 1 as explained above.
Colborn does not disclose:
wherein determining the activity level occurs in real time
McCombie describes “Alarm system that processes both motion and vital signs using specific heuristic rules and thresholds” (Title). McCombie is analogous art.
McCombie teaches:
wherein determining the activity level occurs in real time (Abstract, “A software framework generates alarms/alerts based on threshold values that are either preset or determined in real time.”)
It would have been obvious for a person of ordinary skill in the art at the time the invention was made to modify the method of Colborn with the teachings of McCombie (i.e., to modify the method of Colborn such that activity level is determined in real time as taught by McCombie) in order to “reduce the occurrence of false alarms” (McCombie at Para. [0128]).
Claims 10 and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2010/0106217 A1 to Colborn (“Colborn”).
Regarding Claim 10, Colborn discloses the entirety of Claim 1 as explained above.
Colborn additionally discloses:
further comprising repeating the steps of determining an activity level of the patient and determining a non-pathological range for the first body index at a time interval ranging from about 100 times per second to about once every four hours (Para. [0070], “At a predetermined sampling rate, by way of example, from about 100 times per second to about once per five seconds, the cardiac module 296 determines the moving average of the patient's heart rate and the unstable brain state declaration module 280 compares the moving average of the patient's heart rate to the heart rate threshold value;” Para. [0078], “In one embodiment, the adjustment may be made by a unit of the value setting module 282 on a determination of an unstable brain state from other data, such as other cardiac data (e.g., an elevation of heart rate above the patient's baseline heart rate for a predetermined or adjustable duration, or a difference between a first moving average and a second moving average, among others) or other data (e.g., an output from an accelerometer….”).
Colborn’s disclosed range of “100 times per second to about once per five seconds” overlaps the claimed range of “about 100 times per second to about once every four hours.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05. Although Colborn does not disclose the precise range claimed, it would have been obvious for a person of ordinary skill in the art at the time the invention was made to select the claimed range of “about 100 times per second to about once every four hours” based on Colborn’s disclosure because doing so would be likely to result in success.
Regarding Claim 12, Colborn discloses the entirety of Claim 1 as explained above.
Colborn additionally discloses:
wherein the duration of the first time window is from 1 second to 2 hours (Para. [0047], “For example, a baseline heart rate may be defined as a 30-beat moving average heart rate, or longer moving average such as a 5 minute average heart rate, and the elevation may be the difference between an instantaneous heart rate and the baseline rate. Cardiac module 296 may further be capable of determining a difference between a first moving average and a second moving average. The first and second moving averages may be based upon a particular number of beats, for example a 3 beat moving average and a 30 beat moving average, or upon particular time periods, for example a 10 second moving average and a 5 minute moving average.”).
Colborn’s disclosed range of “a 10 second moving average and a 5 minute moving average” overlaps the claimed range of “from 1 second to 2 hours.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05. Although Colborn does not disclose the precise range claimed, it would have been obvious for a person of ordinary skill in the art at the time the invention was made to select the claimed range of “from 1 second to 2 hours” based on Colborn’s disclosure because doing so would be likely to result in success.
Alternative Rejection of Independent Claims 1, 14 and 19
Claim Rejections - 35 USC § 103
Claims 1, 14 and 19 are alternatively rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US20090124923A1 to Sackellares et al. (“Sackellares”) in view of previously cited US 2010/0106217 A1 to Colborn (“Colborn”)
Regarding Independent Claim 1, Sackellares discloses:
A method for detecting a pathological body state of a patient, comprising: (Claim 1, “A system for monitoring brain pathological conditions and detecting critical neurological events of a patient in real time from a series of analyses on scalp or intracranial brain electrical activity, such as multi-channel EEG signals, comprising:”)
receiving a first body signal of the patient; (Claim 1, “a. an amplifier configured to receive and amplify the EEG signals;”);
determining a first body index from the first body signal; (Claim 1, “c. a signal processor configured to process the digital signals and to provide outputs indicative of the brain pathological conditions, wherein the processor is programmed to perform analyses for each EEG channel as follows: … 1.c-4. calculate a seizure susceptibility index (SSI) based on a distribution of STLmax, and PMRS as well as respective convergence measures T-index1 and T-index2 outputs;”);
determining an activity level of the patient; Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts.”);
determining a non-pathological range for the first body index, based at least in part on the activity level; (Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;” Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts.”);
comparing the first body index to the non-pathological range for the first body index; (Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…” Para. [0049]; Para. [0050]);
detecting an indication of a pathological body state when the first body index is outside the non-pathological range; (Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;” Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…” Para. [0049]; Para. [0050]).
Sackellares does not disclose:
and initiating an electrical therapy based on the indication of the pathological body state
Colborn describes “Dynamic cranial nerve stimulation based on brain state determination from cardiac data.” Colborn is analogous art.
Colborn teaches:
and initiating an electrical therapy based on the indication of the pathological body state (Para. [0103], “In one embodiment, the method can further comprise generating and applying 462 a first electrical signal to the vagus nerve if an unstable brain state has not been declared, and generating and applying 464 a second electrical signal to the vagus nerve if an unstable brain state has been declared. FIG. 5 shows this embodiment.”).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the method of Sackellares with the teachings of Colborn (i.e., to initiate an electrical therapy based on the indication of the pathological body state in the manner of Colborn) in order to treat the pathological body state (Colborn at Para. [0011]).
Regarding Independent Claim 14, Sackellares discloses:
A method of determining a pathological state in a patient, comprising: (Claim 1, “A system for monitoring brain pathological conditions and detecting critical neurological events of a patient in real time from a series of analyses on scalp or intracranial brain electrical activity, such as multi-channel EEG signals, comprising:”);
receiving data relating to an activity level of the patient; (Claim 1, “a. an amplifier configured to receive and amplify the EEG signals;”);
determining an activity level of the patient based on the data relating to an activity level; (Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts.”);
receiving at least one body signal of the patient; (Claim 1, “a. an amplifier configured to receive and amplify the EEG signals;”);
determining at least a first body index based on the at least one body signal; (Claim 1, “c. a signal processor configured to process the digital signals and to provide outputs indicative of the brain pathological conditions, wherein the processor is programmed to perform analyses for each EEG channel as follows: … 1.c-4. calculate a seizure susceptibility index (SSI) based on a distribution of STLmax, and PMRS as well as respective convergence measures T-index1 and T-index2 outputs;”);
dynamically determining a reference value range for the at least a first body index based on the activity level; (Claim 1, “c. a signal processor configured to process the digital signals and to provide outputs indicative of the brain pathological conditions, wherein the processor is programmed to perform analyses for each EEG channel as follows: … 1.c-4. calculate a seizure susceptibility index (SSI) based on a distribution of STLmax, and PMRS as well as respective convergence measures T-index1 and T-index2 outputs;” Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;” Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts;” Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…;” Para. [0049]; Para. [0050]);
determining that the patient is in one of a non-pathological state and a pathological state, wherein the patient is determined to be in a non-pathological state if the at least a first body index is within the reference value range for the activity level, and the patient is indicated to be in a pathological state if the at least a first body index is outside the reference value range; (Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…” Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;” Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts;” Para. [0049]; Para. [0050]);
and taking at least one further action based on determining that the patient is in a pathological state, wherein the further action is selected from, issuing a warning to the patient or a caregiver regarding the pathological state, logging the occurrence of the pathological state, logging the response to the initiated electrical therapy, or logging a severity of the pathological state. (Para. [0095], “After a seizure is detected in step 126, the SMDS 10 proceed to steps 128. It is envisioned that the SMDS 10 can also sequentially process evaluating left, right and bilateral seizure detection criteria. At step 128, the SMDS 10 may (1) alert the user(s) that a seizure is being detected, (2) output a seizure alarm on the EEG monitor, and/or (3) save the detection information including the detection time and type of EEG seizure onset in the profile for post hoc analysis.”)
Sackellares does not disclose:
initiating an electrical therapy based on the indication of the pathological body state
Colborn describes “Dynamic cranial nerve stimulation based on brain state determination from cardiac data.” Colborn is analogous art.
Colborn teaches:
initiating an electrical therapy based on the indication of the pathological body state (Para. [0103], “In one embodiment, the method can further comprise generating and applying 462 a first electrical signal to the vagus nerve if an unstable brain state has not been declared, and generating and applying 464 a second electrical signal to the vagus nerve if an unstable brain state has been declared. FIG. 5 shows this embodiment.”);
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the method of Sackellares with the teachings of Colborn (i.e., to initiate an electrical therapy based on the indication of the pathological body state in the manner of Colborn) in order to treat the pathological body state (Colborn at Para. [0011]).
Regarding Independent Claim 19, Sackellares discloses:
A medical device system, comprising: (Claim 1, “A system for monitoring brain pathological conditions and detecting critical neurological events of a patient in real time from a series of analyses on scalp or intracranial brain electrical activity, such as multi-channel EEG signals, comprising:”);
an activity level module configured to determine an activity level of the patient, based at least in part on the at least one kinetic signal; (Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts.”);
at least one sensor configured to sense a body signal; (Claim 1, “a. an amplifier configured to receive and amplify the EEG signals;”);
a body index determination module configured to determine at least a first body index based on the sensed body signal; (Claim 1, “c. a signal processor configured to process the digital signals and to provide outputs indicative of the brain pathological conditions, wherein the processor is programmed to perform analyses for each EEG channel as follows: … 1.c-4. calculate a seizure susceptibility index (SSI) based on a distribution of STLmax, and PMRS as well as respective convergence measures T-index1 and T-index2 outputs;”);
a body index range module, configured to determine a non-pathological body index range for the at least a first body index, based at least in part on the activity level; (Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…” Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;” Para. [0053], “ The STD and STX can reject the false detections caused by the muscle activity, significant movement activity, electrode artifacts, and recording system artifacts;” Para. [0050]);
and a pathological state determination module, configured to determine an indication that the patient is in one of a non-pathological state and a pathological state, wherein the patient is indicated to be in a non-pathological state if the at least a first body index is within the non-pathological body index range for the at least a first body index, and the patient is indicated to be in a pathological state if the at least a first body index is outside the non-pathological body index range for the at least a first body index. (Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;” Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…;” Claim 1, “…1.c-5. determine whether an impending seizure is susceptible based on SSI values; and…” Para. [0049], “ As a result, when the SSI is close to 1, the patient is at great risk of having a seizure, and when close to 0, the patient is not likely to have a seizure;”).
Sackellares does not disclose:
at least one kinetic sensor, each the sensor configured to collect at least one kinetic signal from a patient;
and initiating an electrical therapy based on the indication of the pathological body stat
Colborn describes “Dynamic cranial nerve stimulation based on brain state determination from cardiac data.” Colborn is analogous art.
Colborn teaches:
at least one kinetic sensor, each the sensor configured to collect at least one kinetic signal from a patient; (Para. [0085], “In one embodiment, the unstable brain state declaration module 280 may further comprise a non-cardiac parameter detection module capable of detecting an output of an accelerometer. The accelerometer may be worn on the patient's person or implanted in the patient's body.”);
and initiating an electrical therapy based on the indication of the pathological body state (Para. [0103], “In one embodiment, the method can further comprise generating and applying 462 a first electrical signal to the vagus nerve if an unstable brain state has not been declared, and generating and applying 464 a second electrical signal to the vagus nerve if an unstable brain state has been declared. FIG. 5 shows this embodiment.”).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the device of Sackellares with the teachings of Colborn (i.e., to initiate an electrical therapy based on the indication of the pathological body state in the manner of Colborn) in order to treat the pathological body state (Colborn at Para. [0011]).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the device of Sackellares with the teachings of Colborn (i.e., to include such an accelerometer for collecting kinetic signal as taught by Colborn) in order to facilitate relating multiple sets relevant parameters (e.g., Sackellares’s exclusion criteria based on movement) more accurately (Colborn at Para. [0095]).
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).
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Claims 1, 3-10 and 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 10-12, 15-18 and 21 of U.S. Patent No. US 11,083,407 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4-8, 10-12, 15-18 and 21 of U.S. Patent No. US 11,083,407 B2 encompass the entirety of Claims 1, 3-10 and 12-19 of the present application, as explained below:
17/372,716
US 11,083,407 B2
Explanation
Claim 1
A method for detecting a pathological body state of a patient, comprising:
receiving a first body signal of the patient;
determining a first body index from the first body signal;
determining an activity level of the patient;
determining a non-pathological range for the first body index, based at least in part on the activity level;
comparing the first body index to the non-pathological range for the first body index;
detecting an indication of a pathological body state when the first body index is outside the non-pathological range.
and initiating an electrical therapy based on the indication of the pathological body state.
Claim 1
A method for detecting an epileptic seizure of a patient, comprising:
receiving by a medical device a first body signal of the patient;
receiving by the medical device a second body signal of the patient;
determining by the medical device a first body index from the first body signal;
determining by the medical device a second body index from the second body signal;
determining by the medical device an activity level of the patient based on sensed data from one or more sensors selected from a group consisting of one or more kinetic sensors, one or more muscle temperature sensors, one or more oxygen measuring devices, one or more lactic acid accumulation sensors, one or more sweat sensors, or one or more neurogram sensors;
determining by the medical device a first non-pathological range for the first body index based on the activity level of the patient via a work level look-up table where the work level look-up table contains information relating the first non-pathological body index range to the activity level of the patient where the first non-pathological range has a first lower limit value or a first number and a first upper limit value or a second number;
determining by the medical device a second non-pathological range for the second body index based on the activity level of the patient via the work level look-up table where the work level look-up table contains information relating the second non-pathological body index range to the activity level of the patient where the second non-pathological range has a second lower limit value or a third number and a second upper limit value or a fourth number, the third number being different than the first number and the fourth number being different than the second number;
comparing by the medical device the first body index to the first non-pathological range for the first body index;
comparing by the medical device the second body index to the second non-pathological range for the second body index;
and detecting by the medical device the epileptic seizure when the first body index reaches a first value that is outside the first non-pathological range for the first body index and the second body index reaches a second value that is outside the second non-pathological range for the second body index; and
initiating one or more therapeutic actions based on a detection of the epileptic seizure.
Both claims are directed to the same method
Both claims recite receipt of the same information
Both claims recite determining the same first body index in the same manner
Both claims recite determining the same activity level
Both claims recite determining the same range based on the same information
Both claims recite the same comparison
Both claims recite making the same detection based on the same information
Both claims recite initiating treatment based on the same information.
Claim 3
The method of claim 1, further comprising: in response to detecting the indication of the pathological state, issuing a notice of the detecting, issuing a warning, logging a time of occurrence of the detecting, logging a response to a therapy, and logging a severity of the pathological state.
Claim 1
… initiating one or more therapeutic actions based on a detection of the epileptic seizure.
Claim 4
The method of claim 1, further comprising:
in response to detecting the epileptic seizure, performing by the medical device at least one further action selected from issuing a notice of an epileptic seizure detection, delivering a therapy, issuing a warning, logging a time and a date of occurrence of the epileptic seizure detection, logging a response to the therapy, and logging a severity of the epileptic seizure.
All three claims recite the same response upon detection of the same event
Claim 4
The method of claim 1, wherein the first body index is a catecholamine level.
Claim 5
The method of claim 1, wherein the first body index is selected from a heart rate, a heart rate rhythm, a heart rate variability, a blood pressure, and the second body index is selected from one of a respiratory rate, a respiratory rhythm, an end-tidal CO2, a cognitive activity, a dermal activity, an arterial pH, a cortisol level, a catecholamine level, or a blood oxygen saturation.
Both claims further limit the recited first body index in the same manner
Claim 5
The method of claim 1, wherein determining the activity level comprises analyzing a body signal of the patient, wherein the analyzing is performed on sensed data from a lactic acid accumulation sensor.
Claim 1
… determining by the medical device an activity level of the patient based on sensed data from one or more sensors selected from a group consisting of one or more kinetic sensors, one or more muscle temperature sensors, one or more oxygen measuring devices, one or more lactic acid accumulation sensors, one or more sweat sensors, or one or more neurogram sensors;…
Both claims recite determining the recited activity level using information from a lactic acid accumulation sensor
Claim 6
The method of claim 1, wherein determining the non-pathological body index range is further based at least in part on one or more of a time of day, an environmental condition, a patient's body weight and height, a patient's body mass index, a patient's gender, a patient's age, an indicator of the patient's overall health, or an indicator of the patient's overall fitness
Claim 6
The method of claim 1, wherein determining by the medical device the first non-pathological range for the first body index and the second non-pathological range for the second body index are further based at least in part on one or more of a time of day, an environmental condition, a patient's body weight and height, a patient's body mass index, a patient's gender, a patient's age, an indicator of a patient's overall health, or an indicator of a patient's overall fitness.
Both claims further limit the recited determining of the first body index in the same way
Claim 7
The method of claim 1, wherein the activity level is an activity level for a time window.
Claim 7
The method of claim 1, wherein the first activity level is an activity level for a time window.
Both claims further limit the recited activity level in the same manner.
Claim 8
The method of claim 1, wherein determining the activity level occurs in real time.
Claim 8
The method of claim 1, wherein determining by the medical device the first activity level occurs in real time.
Both claims further limit determining the recited activity level in the same manner.
Claim 9
The method of claim 1, wherein the pathological state is an epileptic event.
Claim 1
Claim 1 further limits the pathological state to an epileptic event throughout
Both claims limit the pathological state to an epileptic event
Claim 10
The method of claim 1, further comprising repeating the steps of determining an activity level of the patient and determining a non-pathological range for the first body index at a time interval ranging from about 100 times per second to about once every four hours.
Claim 10
The method of claim 1, wherein determining by the medical device the first non-pathological range for the first body index comprises determining the first non-pathological range for the first body index for a first time point based on a patient's activity in a first time window and determining by the medical device the second non-pathological range for the second body index comprises determining the second non-pathological range for the second body index for the first time point based on the patient's activity in a second time window.
Both claims further limit the recited activity level determination in the same manner
Claim 12
The method of claim 11, wherein the duration of the first time window is from 1 second to 2 hours.
Claim 11
The method of claim 10, wherein a duration of the first time window is from 1 second to 2 hours and a duration of the second time window is from 1 second to 2 hours.
Both claims further limit the recited time window in the same manner
Claim 13
The method of claim 1 wherein determining a first body index from the first body signal comprises determining a change in the first body index, and wherein detecting the pathological body state when the first body index is outside the non-pathological range comprises determining if the change in the first body index is commensurate with the determined activity level.
Claim 12
The method of claim 1, wherein determining by the medical device the first body index from the first body signal comprises determining a change in the first body index, and wherein detecting the epileptic seizure when the first body index reaches the first value that is outside the first non-pathological range comprises determining if the change in the first body index is commensurate with the first activity level.
Both claims further limit the recited manner of determining the first body index in the same way
Claim 14
A method of determining a pathological state in a patient, comprising:
receiving data relating to an activity level of the patient;
determining an activity level of the patient based on the data relating to an activity level;
receiving at least one body signal of the patient;
determining at least a first body index based on the at least one body signal;
dynamically determining a reference value range for the at least a first body index based on the activity level;
determining that the patient is in one of a non-pathological state and a pathological state, wherein the patient is indicated to be in a non-pathological state if the at least a first body index is within the reference value range for the activity level, and the patient is determined to be in a pathological state if the at least a first body index is outside the reference value range;
initiating an electrical therapy based on the indication of the pathological body state; and taking at least one further action based on determining that the patient is in a pathological state, wherein the further action is selected from issuing a warning to the patient or a caregiver regarding the pathological state, logging the occurrence of the pathological state, logging the response to the initiated electrical therapy, or logging a severity of the pathological state.
Claim 15
A method of determining an epileptic seizure in a patient, comprising:
receiving by a medical device data relating to an activity level of the patient, wherein the data is received from a lactic acid accumulation sensor;
determining by the medical device the activity level of the patient based on the data relating to the activity level;
receiving by the medical device at least one body signal of the patient;
determining by the medical device at least a first body index based on the at least one body signal;
dynamically determining by the medical device a reference value range for the at least the first body index based on the activity level;
determining by the medical device that the patient is in one of a non-pathological state or an epileptic seizure state, wherein the patient is determined to be in the non-pathological state if the at least the first body index is within the reference value range for the activity level where the reference value range starts at a first number or a lower limit and ends at a second number or an upper limit, and the patient is determined to be in the epileptic seizure state if the at least the first body index reaches a value that is outside an activity level reference value range;
and taking at least one further action by the medical device based on determining that the patient is in the epileptic seizure state, wherein the further action is treating the epileptic seizure state.
Both claims recite a method for the same determination; pathological events include seizures
Both claims recite receiving the same sort of data for the same purpose;
Both claims recite the same determination based on the same data
Both claims recite receipt of the same data
Both claims recite determining a first body index in the same manner
Both claims recite the same determination based on the same information
Both claims recite the same determination based on the same information
Both claims recite treating the epileptic seizure as a further action taken in response to making the same determination
Claim 15
The method of claim 14, wherein the reference value range comprises one of a non-pathological range and a pathological range.
Claim 16
The method of claim 15, wherein the reference value range comprises one of a non-pathological range and a pathological range for a given activity level.
Both claims further limit the recited reference value in the same manner
Claim 16
The method of claim 14, wherein the pathological state is an epileptic seizure.
Claim 15
Claim 15 requires that the “pathological state” be “an epileptic seizure” in its preamble as well as throughout the claim
Both claims require that the method pertain to epileptic seizures in the same manner
Claim 17
The method of claim 14, wherein the at least one body signal is selected from a cardiac signal, a respiratory signal, a blood signal, a dermal signal and an endocrine signal.
Claim 17
The method of claim 15, wherein the at least one body signal is selected from a cardiac signal, a respiratory signal, a blood signal, a dermal signal and an endocrine signal.
Both claims further limit the recited body signal in the same manner
Claim 18
The method of claim 14, wherein the first body index is selected from:
a cardiac index based on the cardiac signal, wherein the cardiac index is selected from a heart rate, heart rhythm, a heart rate variability, and a blood pressure;
a respiratory index based on the respiratory signal, wherein the respiratory index is selected from a respiratory rate, respiratory rhythm, blood oxygen saturation, and an end tidal CO2 concentration;
a dermal index based on the dermal signal, wherein the dermal index is selected from a skin resistivity and a skin conductivity;
a blood index based on the blood signal, wherein the blood index is selected from an arterial pH and a lactic acid concentration;
and an endocrine index based on the endocrine signal, wherein the endocrine signal is selected from a cortisol level and a catecholamine level.
Claim 18
The method of claim 15, wherein the first body index is selected from:
a cardiac index based on a cardiac signal, wherein the cardiac index is selected from a heart rate, a heart rhythm, a heart rate variability, and a blood pressure;
a respiratory index based on a respiratory signal, wherein the respiratory index is selected from a respiratory rate, a respiratory rhythm, a blood oxygen saturation, and an end tidal CO2 concentration;
a dermal index based on a dermal signal, wherein the dermal index is selected from a skin resistivity and a skin conductivity;
a blood index based on a blood signal, wherein the blood index is selected from an arterial pH and a lactic acid concentration;
and an endocrine index based on a endocrine signal, wherein the endocrine signal is selected from a cortisol level and a catecholamine level.
Both claims further limit the recited first body index in word-for-word the same manner
Claim 19
A medical device system, comprising:
at least one kinetic sensor, each the sensor configured to collect at least one kinetic signal from a patient;
an activity level module configured to determine an activity level of the patient, based at least in part on the at least one kinetic signal;
at least one sensor configured to sense a body signal;
a body index determination module configured to determine at least a first body index based on the sensed body signal;
a body index range module, configured to determine a non-pathological body index range for the at least a first body index, based at least in part on the activity level;
and a pathological state determination module, configured to determine an indication that the patient is in one of a non-pathological state and a pathological state, wherein the patient is indicated to be in a non-pathological state if the at least a first body index is within the non-pathological body index range for the at least a first body index, and the patient is indicated to be in a pathological state if the at least a first body index is outside the non-pathological body index range for the at least a first body index;
and initiating an electrical therapy based on the indication of the pathological body state.
Claim 21
A medical device system, comprising:
at least one kinetic sensor configured to collect at least one kinetic signal from a patient;
an activity level circuit configured to determine an activity level of the patient, based on at least one of the one kinetic signal and a muscle force signal;
at least one sensor configured to sense a non-kinetic signal and a non-muscle body signal;
a body index determination circuit configured to determine at least a first body index based on the body signal;
a body index range circuit, configured to determine a non-pathological body index range for the at least a first body index via a work level look-up table where the work level look-up table contains information relating the non-pathological body index range to the activity level of the patient;
and a pathological state determination circuit, configured to determine that the patient is in one of a non-pathological state or an epileptic seizure state, wherein the patient is determined to be in the non-pathological state if the at least the first body index is within the non-pathological body index range for the at least the first body index, and the patient is determined to be in the epileptic seizure state if the at least the first body index reaches a value that is outside the non-pathological body index range for the at least the first body index;
and a treatment unit configured to initiate one or more therapeutic actions based on a detection of the epileptic seizure state;
wherein the body signal is selected from a heart rhythm, a heart rate variability, a blood pressure, a respiratory rate, a respiratory rhythm, an end tidal CO2, a dermal activity, an arterial pH, a cortisol level, a catecholamine level, or a blood oxygen saturation.
Both claims are directed to the same device
Both claims recite the same variety of sensor for obtaining the same information
Both claims recite the same determination based on the same information
Both claims recite a similar sensor; “at least once sensor configured to sense a body signal” includes a sensor “configured to sense a non-kinetic signal and a non-muscle body signal”
Both claims recite the same component having the same function and use the same information
Both claims recite the same component configured to perform the same function
Both claims recite the same component configured to make the same determination based on the same information
Both claims recite the initiation of treatment based on the same information.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner notes that the term “body index” is not being so-narrowly interpreted as to be limited only to heart rate. Instead, the meaning of the term “body index” is being interpreted in light of its use in the specification, which use shows unambiguously that it includes heart rate. That Colburn’s herein-equated “cardiac parameter” is described similarly in Colburn is strong evidence of their equivalence.