DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 08/27/26 has been entered in the case. Claims 21-40 are pending for examination and claims 1-20 are cancelled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-28, 30-38 & 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ternes et al. (US 2018/0153460).
Regarding claim 21, Ternes discloses a processor-implemented method comprising:
receiving body movement information (via epileptic monitoring device 222, Fig. 2 & para [0008]);
determining, based on the body movement information, that a body motion or a pattern of body motions of a user is symptomatic of an illness, disease (epileptic seizure types), or health condition (wellness indicator) that influences a physiological characteristic response of a user
Note: in para [0047], the IDM 112 senses physiological and functional signals in a patient, and predicts an impending epileptic event; para [0053], confirm or reject the detection of the epileptic event. In addition, in para [0058], the sensor circuit 210 may include sense amplifiers coupled to two or more sensors, such as a first sensor 202 and a second sensor 204, to sense multiple physiological or functional signals in the patient. The physiological signals may include cardiac, pulmonary, hemodynamic, neural, or biochemical signals.... Examples of the functional signals may include a posture, a gait, a balance indicator, a locomotion pattern, a physical activity intensity or duration, or a grip strength signal, among others. In para [0069], the user interface 240 may include an input device 241 and an output unit 242. In an example, at least a portion of the user interface 240 may be implemented in the external system 130. The input device 241 may enable a user to provide parameters for sensing physiological or functional signals, parameters for detecting epileptic events, or parameters for trending the physiological or functional signals during and after the detected epileptic events);
identifying the physiological characteristic response of the user that historically results from the illness, disease, or health condition indicated by the body motion or the pattern of body motion.
Note: Para [0008] discloses monitoring epilepsy by recognizing a pattern of repeated body or limb movements. These devices are well-suited for convulsive seizures, such as tonic-clonic seizures, or other types of generalized seizures involving moderate to vigorous body or limb movements.
Paras [0017–0018] disclose classifying the detected epileptic event into one of a plurality of epilepsy types using the one or more epileptic characteristics.
In para [0072], FIG. 3 illustrates generally an example of a portion of an epilepsy management system for classifying an epileptic seizure into different categories and managing the patient with the classified epileptic seizure. The categories of epilepsy may include two or more of a generalized seizure, a partial seizure, an absence seizure, a tonic seizure, a clonic seizure, and an atonic seizure, among others. Partial seizures, also known as “focal” or “local” seizures, begin in one location of the brain. Generalized seizures, which may begin everywhere in the brain at once, may be further classified into various types including absence seizures, tonic seizures, clonic seizures, tonic-clonic seizures, and atonic seizures. Absence seizures may begin suddenly but have a short duration of around 10–20 seconds, and they are typically not accompanied by body or limb movements. A tonic seizure may manifest as the muscles in the chest, arms, and legs contract and the back arches due to muscle stiffness, which may be accompanied by a loss of consciousness. As the chest muscles tighten, it becomes harder for the patient to breathe. A clonic seizure is typically accompanied by muscle jerking; the elbows, legs, and head will flex and then relax rapidly at first, but the frequency of the spasms will gradually subside until they cease altogether. A tonic seizure followed by a clonic seizure may be categorized as a tonic-clonic seizure. Atonic seizures cause the muscles to go limp, which may cause the patient's body to slump or crumple to the ground, potentially resulting in injury.
Based on the statements above, Ternes clearly discloses the limitation of determining, based on the body movement information (e.g., tonic seizures, clonic seizures, tonic-clonic seizures, and atonic seizures), that a body motion or a pattern of body motions of a user (e.g., muscle contraction in the chest, arms, and legs, arching of the back due to muscle stiffness, and loss of consciousness; or tightening of the chest muscles making it harder to breathe) has occurred.
automatically delivering medication to the user based on the identified physiological characteristic response by changing at least one therapy-altering factor of a therapy control algorithm to compensate for the identified physiological characteristic response.
Note: e.g., see step 550 in Fig. 5 & para [0081]; para [0049], ... the antiepileptic therapy is delivered in a closed-loop fashion, where one or more therapy parameters may be adjusted or drug dosage titrated according to an efficacy of the antiepileptic therapy delivered. The therapy efficacy may be assessed based on sensor feedback, such as the physiological or functional signals sensed during or after the epilepsy event.
Regarding claim 22, further comprising: automatically delivering the medication to the user in a first mode of operation (e.g., see step 550 in Fig. 5 & para [0081]); and
transitioning from the first mode of operation to a second mode of operation in response to identifying the physiological characteristic response, wherein automatically delivering the medication to the user based on the identified physiological characteristic response includes operating in the second mode of operation (e.g., para [0049 & 0070], the antiepileptic therapy may be delivered in a closed-loop fashion, where one or more therapy parameters may be adjusted or drug dosage titrated according to an efficacy of the antiepileptic therapy delivered. The therapy efficacy may be assessed based on sensor feedback, such as the physiological or functional signals sensed during or after the epilepsy event; also see paras [0075, 0081].
Note: the program in the IMD 12 delivers antiepileptic therapy in a closed-loop fashion, para [0054]. Therefore, a second mode of operation is considered as adjusting the drug based on the sensor feedback after performing the first mode of operation.
Regarding claim 23, further comprising: determining a movement-correlated therapy control algorithm (e.g., classifying an epileptic seizure into different categories, paras [0072 & 0075]) by changing a therapy control algorithm based on the identified physiological characteristic response, wherein automatically delivering the medication to the user in the first mode of operation includes automatically delivering the medication to the user in accordance with the therapy control algorithm, (e.g., They controller 425 may dynamically control the system behavior based on the epilepsy detection, e.g., a presence of an epileptic even, or additionally based on the classification of the epileptic seizure types as generated by the epileptic seizure classifier 326) and wherein automatically delivering the medication to the user in the second mode of operation includes automatically delivering the medication to the user in accordance with the movement-correlated therapy control algorithm, see paras [0049, 0070, 0075, 0079 & 0081].
Regarding claim 24, further comprising: obtaining a confirmation from the user confirming a transition of from the first mode of operation to the second mode of operation, wherein transitioning from the first mode of operation to the second mode of operation in response to identifying the physiological characteristic response is further based on obtaining the confirmation (e.g., para [0045], the antiepileptic therapy may be delivered in a closed-loop fashion, where one or more therapy parameters may be adjusted or drug dosage titrated according to an efficacy of the antiepileptic therapy delivered. The therapy efficacy may be assessed based on sensor feedback, such as the physiological or functional signals sensed during or after the epilepsy event).
Regarding claim 25, wherein determining the body motion or the pattern of body motions comprises: searching a movement correlation database populated with movement-correlated physiological response entries that include body motions or patterns of body motions associated with particular diseases, illnesses, or health conditions that influence the physiological characteristic response of the user (e.g., classifying an epileptic seizure into different categories and managing the patient with the classified epileptic seizure..., para [0072], also see para [0075].
Regarding claim 26, wherein searching the movement correlation database comprises matching the body movement information with the body motion or the pattern of body motions in the movement correlation database, paras [0072, 0075].
Regarding claim 27, wherein the received body movement information comprises descriptive data associated with at least one of: a type of body movement; intensity of movement; duration of movement; frequency of movement events; repetitions of movement events; body part(s) in motion; movement start time; or movement end time (e.g., epilepsy seizures or limb movements, para [0008]; the epileptic seizure classifier 326 may classify the detected epileptic event... The classification is based on intensity, duration or frequency of detected epileptic event, para [0073].
Regarding claim 28, wherein the received body movement information comprises user status data generated by at least one ancillary system that monitors the user (e.g., via electrode 116, sensor circuit 210 or one or more sensors to detect epileptic event).
Regarding claim 30, further comprising: providing an insight message to the user, the insight message including a warning about the disease, the illness, or the health condition indicated by the body motion or the pattern of body motions, para [0052].
Regarding claims 31-38, these claims are rejected using the same analysis as noted above with regard to the claims 21-28.
Regarding claim 40, this claim is rejected using the same analysis as noted above with regard to the claims 21-22.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 29 & 39 are rejected under 35 U.S.C. 103 as being unpatentable over Ternes et al. (US 2018/0153460) in view of Cinar et al. (US 2016/0354543).
. Regarding claims 29 & 39, Ternes discloses all the claimed subject matter as required except for the medication comprises insulin, as required in the claims 29 & 30. It is noted that Ternes discloses that using the infusion pump for drug delivery and it is well-known in the art that using an infusion pump for delivering insulin.
Cinar discloses a method and modules or process for recursive model identification, hypoglycemia or hyperglycemia, plasma insulin concentration, assessment of physical activity for determining a presence of major factors or body movement, e.g., meals physical activity, acute stress, sleep..., para [0009] & abstract). It is noted that hypoglycemia or hyperglycemia causes dizziness, unconsciousness, and seizures if untreated diabetic coma or death. Cinar further discloses that automatically delivery medication, i.e. insulin to the use based on the identified physiological characteristic responses, i.e., a blood glucose concentration response of the user such as seizure in hypoglycemia or hyperglycemia.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Ternes with obtaining module for detecting body movement information, i.e. seizure in hypoglycemia or hyperglycemia and delivering insulin when the patient in serious health condition (seizure), as taught by Cinar, in order to deliver the insulin for controlling blood glucose level in diabetic patient.
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 claims at issue 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-23, 25-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,938,301.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are not structurally distinguishable from the claims in the patent.
Regarding claim 21, US’301 discloses a processor-implemented method comprising, see col. 27, lines 33-37:
receiving body movement information, col. 27, lines 41-44;
determining, based on the body movement information, that a body motion or a pattern of body motions of a user is symptomatic of an illness, disease, or health condition that influences a physiological characteristic response of the user, col. 27, lines 45-49;
identifying the physiological characteristic response of the user that historically results from the illness, disease, or health condition indicated by the body motion or the pattern of body motions, col. 27, lines 50-53; and
automatically delivering medication to the user based on the identified physiological characteristic response by changing at least one therapy-altering factor of a therapy control algorithm to compensate for the identified physiological characteristic response, col. 27, lines 54-59.
Regarding claim 22, see claim 2 in US’301
Regarding claim 23, see claims 2 & 3 in US’301
Regarding claim 25, see claim 7 in US’301
Regarding claim 26, see claim 8 in US’301
Regarding claim 27, see claim 4 in US’301
Regarding claim 28, see claim 5 in US’301
Regarding claims 29 & 39, see claim 6 in US’301
Regarding claim 30, see claim 8 in US’301
Regarding claims 31-38, these claims are rejected using the same analysis as noted above with regard to the claims 21-28.
Regarding claim 40, this claim is rejected using the same analysis as noted above with regard to the claims 21-22.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection applied in this office action.
1) Applicant argues that the prior art does not teach the limitation “determining, based on the body movement information, that a body motion or a pattern of body motions of a user is symptomatic of an illness, disease, or health condition that influences a physiological characteristic response of the user. Applicant argues that Ternes does not disclose any illness, disease, or health condition that influences a physiological characteristic response of the user.
In response, Ternes discloses in para [0008], monitor epilepsy by recognizing a pattern of repeated body or limb movements. These devices are well suited for convulsive seizures, e.g., tonic-clonic seizure, or other types of generalized seizure, with moderate to vigorous body or limb movements.; paras [0017-0018], classify the detected epileptic event into one of a plurality of epilepsy types using the one or more epileptic characteristics; para [0058], ... Examples of the functional signals may include a posture, a gait, a balance indicator, a locomotion pattern, a physical activity intensity or duration, or a grip strength signal, among others;
In para [0072], FIG. 3 illustrates generally an example of a portion of an epilepsy management system for classifying an epileptic seizure into different categories and managing the patient with the classified epileptic seizure. The categories of epilepsy may include two or more of a general seizure, a partial seizure, an absence seizure, a tonic seizure, a clonic seizure, and an atonic seizure, among others. Partial seizures, also known as “focal” or “local” seizures, begin in one location of the brain. Generalized seizures, which may begin everywhere in the brain at once, may be further classified into various types including absence seizures, tonic seizures, clonic seizures, tonic-clonic seizures, and atonic seizures. Absence seizures may begin suddenly but with a short duration of around 10-20 seconds, and typically do not accompanied by body or limb movement. A tonic seizure may be manifested as muscles in the chest, arms and legs contract and the back arches due to muscles stiffness, and loss of consciousness. As the chest muscles tighten, it becomes harder for the patient to breathe. A clonic seizure is typically accompanied by muscles and jerk. The elbows, legs and head will flex, and then relax rapidly at first, but the frequency of the spasms will gradually subside until they cease altogether. A tonic seizure is typically accompanied by a clonic seizure, which may be categorized as tonic-clonic seizures. Atonic seizures cause the muscles to go limp. The patient body may slump or crumple to the ground, possibly causing injury.
For all the statements above, Based on the statements above, Ternes clearly discloses the limitation of determining, based on the body movement information (e.g., tonic seizures, clonic seizures, tonic-clonic seizures, and atonic seizures), that a body motion or a pattern of body motions of a user (e.g., muscle contraction in the chest, arms, and legs, arching of the back due to muscle stiffness, and loss of consciousness; or tightening of the chest muscles making it harder to breathe) has occurred.
2) Applicant argues that Ternes does not discloses the “symptomatic” feature.
In response, having said in the para [0072] above, the symptomatic feature such as: muscles in the chest, arms and legs contract and the back arches due to muscles stiffness, and loss of consciousness. As the chest muscles tighten, the chest muscles tighten, it becomes harder for the patient to breathe. A clonic seizure is typically accompanied by muscles and jerk. The elbows, legs and head will flex, and then relax rapidly at first, but the frequency of the spasms will gradually subside until they cease altogether. A tonic seizure is typically accompanied by a clonic seizure, which may be categorized as tonic-clonic seizures. Atonic seizures cause the muscles to go limp. The patient body may slump or crumple to the ground, possibly causing injury) is symptomatic of an illness (epilepsy seizure), disease (epilepsy seizure), or health condition (abnormal condition).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
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