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 .
Priority
This application is a continuation of US Application no. 17/870,097, now US Patent no. 12,076,170, filed 21 July 2022.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osorio (US Publication no. 2015/0080670).
In regard to claim 1, Osorio discloses a method for determining a status relating to a patient with epilepsy (para 8, an increased risk of death from epilepsy is disclosed), comprising:
receiving cardiac data into a medical device (para 8, the method includes receiving cardiac data into a medical device);
determining, using the medical device, a cardiac index from the received cardiac data (para 8, determining, using the medical device, at least one cardiac index);
determining whether the cardiac index is an extreme cardiac index by determining whether the cardiac index is below a low cardiac threshold value or above a high cardiac threshold value (para 8, an increased risk of death is associated with epilepsy if the at least one cardiac index is an extreme value; para 157, the cardiac index may be a heart rate; para 172, the cardiac index such as heart rate above a pre-determined threshold can indicate seizure severity (SSI), additionally heart rate value indicates the SSI which can indicate increased risk when the SSI is either above or below a threshold);
determining, using the medical device, the increased risk of medical issues associated with epilepsy in response to a determination that the cardiac index is the extreme cardiac index (para 8, an increased risk of death associated with epilepsy if the at least one cardiac index is an extreme value);
implementing one or more therapeutic actions based on the occurrence of the increased risk of the increase in the medical issues (para 93, the controller 210 is capable of causing a therapy unit 220 to take responsive action in response to the identification of one or more various extreme or non-extreme epileptic events by the medical device); and
logging information related to the increased risk of the medical issues (para 8, logging automatically information related to the increased risk of death).
In regard to claim 2, Osorio teaches that providing the one or more therapeutic actions comprises providing at least one of an electrical therapy, a chemical therapy, a thermal therapy, a cardiac defibrillation, a cardiac pacing, or a support treatment (para 93, the responsive action may comprise generating and delivering an electrical signal to target tissues of the patient's body for treating a medical condition. In one or more embodiments, the responsive action may comprise drug treatments, oxygen treatments, cooling and/or the like).
In regard to claim 3, Osorio teaches that comprising determining a further increase in the risk of the medical issues (para 8, in another aspect of the present invention, a method for determining and responding in real-time to an increased risk of death relating to a patient with epilepsy is provided);
wherein logging comprises (para 130) logging at least one of a time when the increased risk of the medical issues is identified, a time when the further increased risk of the medical issues is identified, a time when the warning is issued, a type of warning issued, a body organ index relating to the determined at least one cardiac index and associated with at least one of the increased risk of the medical issues or the further increased risk of the medical issues, a classification of at least one of the increased risk of the medical issues or the further increased risk of the medical issues, one or more environmental factors, one or more patient conditions, one or more patient activity factors, or one or more patient circumstances associated with the increased risk of the medical issues (para 130, the logging includes if a seizure event or other event of interest occurs within a given time window which is considered to include a time when the increased risk of the medical issues is identified); and
wherein the one or more environmental factors, the one or more patient activity factors, the one or more patient conditions, and the one or more patient circumstances are based upon at least one of a level of consciousness of the patient, a level, a type and a duration of the activity of the patient, a body posture of the patient, a time of day, a type of seizure activity, a site of origin of the seizure activity, a frequency of seizure activity, an intensity, a duration of seizure activity, an extent of spread of seizure activity, one or more brain regions engaged in seizure activity or involved by the severity of seizure activity, or a time spent in seizure, a seizure burden on the patient, a seizure density, an age of the patient, a physical fitness/integrity of the patient, an impact of seizure activity on the patient, or types of patient medications (para 45, 99, 100, 105, 110, 151, 157, these paragraphs describe various aspects related to the feature above including seizure severity, patient activity, body posture, stress markers, seizure origin, brain regions etc.).
In regard to claim 4, Osorio teaches that the one or more therapeutic actions comprises providing at least one of an electrical therapy, a chemical therapy, a thermal therapy, a cardiac defibrillation, a cardiac pacing, or a support treatment (para 93, the responsive action may comprise generating and delivering an electrical signal to target tissues of the patient's body for treating a medical condition. In one or more embodiments, the responsive action may comprise drug treatments, oxygen treatments, cooling and/or the like).
In regard to claim 5, Osorio teaches the steps comprising at least one of: automatically performing at least one of determining, classifying, ranking, reporting, or logging at least one of an autonomic index from a group consisting of a respiratory rate, a respiratory rhythm, a respiratory pattern, a cardiac rate, and a cardiac rhythm over a predetermined period of time relating to the increased risk of the medical issues; automatically performing at least one of reporting or logging at least one autonomic index over a predetermined time period before the increased risk of the medical issues is determined; and determining a time when the increased risk of returns to a baseline value (para 54, 63, 64 (discuss changes in autonomic indices), Claim 33 recites return to baseline).
In regard to claim 6, Osorio teaches the cardiac index is selected from a group consisting of a heart rate, a heart rhythm, an EKG complex morphology, and a blood pressure (para 157).
In regard to claim 7, Osorio teaches determining at least one additional index from at least one of a metabolic index, an endocrine index, a tissue stress index, a neurologic index, and a physical fitness/integrity index, the at least one additional index being based upon body data (para 64 and 67-81, 99, 102).
In regard to claim 8, Osorio teaches determining the increased risk of the medical issues associated with epilepsy comprises identifying at least one of: at least one of a decreasing heart rate variability of pulmonary hypertension over a macroscopic time scale (para 53, 40-41); at least one of pulmonary edema or respiratory distress syndrome over a mesoscopic time scale (para 51 and 83, 40-41), and at least one of an ST complex depression, an ST complex elevation, a QT elongation, multifocal premature ventricular contractions, a ventricular tachycardia, a fibrillation, over a microscopic time scale (para 40-41).
In regard to claim 9, Osorio teaches automatically issuing a warning comprises indicating a severity indication commensurate with the increased risk of the medical issues (para 8, 52, 55, 57); and wherein automatically logging information comprises logging information indicative of the severity indication commensurate with the increased risk of the medical issues (para 152, the severity indication of the risk of death (provided in step 825) may be logged).
In regard to claim 10, Osorio teaches the severity indication is based on at least one of one or more environmental factors, one or more patient activity factors, and one or more patient conditions (para 11, the increased risk and the increasing risk is associated with at least one patient condition, patient activity, or environmental circumstance; para 104, a severity index value may be determined based on body data that includes aspect of one or more patient conditions.
In regard to claim 11, Osorio discloses a non-transitory computer readable medium (abstract) for determining a status relating to a patient with epilepsy (para 8, an increased risk of death from epilepsy is disclosed), comprising:
receiving cardiac data into a medical device (para 8, the method includes receiving cardiac data into a medical device);
determining, using the medical device, a cardiac index from the received cardiac data (para 8, determining, using the medical device, at least one cardiac index);
determining whether the cardiac index is an extreme cardiac index by determining whether the cardiac index is below a low cardiac threshold value or above a high cardiac threshold value (para 8, an increased risk of death is associated with epilepsy if the at least one cardiac index is an extreme value; para 157, the cardiac index may be a heart rate; para 172, the cardiac index such as heart rate above a pre-determined threshold can indicate seizure severity (SSI), additionally heart rate value indicates the SSI which can indicate increased risk when the SSI is either above or below a threshold);
determining, using the medical device, the increased risk of medical issues associated with epilepsy in response to a determination that the cardiac index is the extreme cardiac index (para 8, an increased risk of death associated with epilepsy if the at least one cardiac index is an extreme value);
implementing one or more therapeutic actions based on the occurrence of the increased risk of the increase in the medical issues (para 93, the controller 210 is capable of causing a therapy unit 220 to take responsive action in response to the identification of one or more various extreme or non-extreme epileptic events by the medical device); and
logging information related to the increased risk of the medical issues (para 8, logging automatically information related to the increased risk of death).
In regard to claim 12, Osorio teaches that providing the one or more therapeutic actions comprises providing at least one of an electrical therapy, a chemical therapy, a thermal therapy, a cardiac defibrillation, a cardiac pacing, or a support treatment (para 93, the responsive action may comprise generating and delivering an electrical signal to target tissues of the patient's body for treating a medical condition. In one or more embodiments, the responsive action may comprise drug treatments, oxygen treatments, cooling and/or the like).
In regard to claim 13, Osorio teaches that comprising determining a further increase in the risk of the medical issues (para 8, in another aspect of the present invention, a method for determining and responding in real-time to an increased risk of death relating to a patient with epilepsy is provided);
wherein logging comprises (para 130) logging at least one of a time when the increased risk of the medical issues is identified, a time when the further increased risk of the medical issues is identified, a time when the warning is issued, a type of warning issued, a body organ index relating to the determined at least one cardiac index and associated with at least one of the increased risk of the medical issues or the further increased risk of the medical issues, a classification of at least one of the increased risk of the medical issues or the further increased risk of the medical issues, one or more environmental factors, one or more patient conditions, one or more patient activity factors, or one or more patient circumstances associated with the increased risk of the medical issues (para 130, the logging includes if a seizure event or other event of interest occurs within a given time window which is considered to include a time when the increased risk of the medical issues is identified); and
wherein the one or more environmental factors, the one or more patient activity factors, the one or more patient conditions, and the one or more patient circumstances are based upon at least one of a level of consciousness of the patient, a level, a type and a duration of the activity of the patient, a body posture of the patient, a time of day, a type of seizure activity, a site of origin of the seizure activity, a frequency of seizure activity, an intensity, a duration of seizure activity, an extent of spread of seizure activity, one or more brain regions engaged in seizure activity or involved by the severity of seizure activity, or a time spent in seizure, a seizure burden on the patient, a seizure density, an age of the patient, a physical fitness/integrity of the patient, an impact of seizure activity on the patient, or types of patient medications (para 45, 99, 100, 105, 110, 151, 157, these paragraphs describe various aspects related to the feature above including seizure severity, patient activity, body posture, stress markers, seizure origin, brain regions etc.).
In regard to claim 14, Osorio teaches that the one or more therapeutic actions comprises providing at least one of an electrical therapy, a chemical therapy, a thermal therapy, a cardiac defibrillation, a cardiac pacing, or a support treatment (para 93, the responsive action may comprise generating and delivering an electrical signal to target tissues of the patient's body for treating a medical condition. In one or more embodiments, the responsive action may comprise drug treatments, oxygen treatments, cooling and/or the like).
In regard to claim 15, Osorio teaches the steps comprising at least one of: automatically performing at least one of determining, classifying, ranking, reporting, or logging at least one of an autonomic index from a group consisting of a respiratory rate, a respiratory rhythm, a respiratory pattern, a cardiac rate, and a cardiac rhythm over a predetermined period of time relating to the increased risk of the medical issues; automatically performing at least one of reporting or logging at least one autonomic index over a predetermined time period before the increased risk of the medical issues is determined; and determining a time when the increased risk of returns to a baseline value (para 54, 63, 64 (discuss changes in autonomic indices), Claim 33 recites return to baseline).
In regard to claim 16, Osorio teaches the cardiac index is selected from a group consisting of a heart rate, a heart rhythm, an EKG complex morphology, and a blood pressure (para 157).
In regard to claim 17, Osorio teaches determining at least one additional index from at least one of a metabolic index, an endocrine index, a tissue stress index, a neurologic index, and a physical fitness/integrity index, the at least one additional index being based upon body data (para 64 and 67-81, 99, 102).
In regard to claim 18, Osorio teaches determining the increased risk of the medical issues associated with epilepsy comprises identifying at least one of: at least one of a decreasing heart rate variability of pulmonary hypertension over a macroscopic time scale (para 53, 40-41); at least one of pulmonary edema or respiratory distress syndrome over a mesoscopic time scale (para 51 and 83, 40-41), and at least one of an ST complex depression, an ST complex elevation, a QT elongation, multifocal premature ventricular contractions, a ventricular tachycardia, a fibrillation, over a microscopic time scale (para 40-41).
In regard to claim 19, Osorio teaches automatically issuing a warning comprises indicating a severity indication commensurate with the increased risk of the medical issues (para 8, 52, 55, 57); and wherein automatically logging information comprises logging information indicative of the severity indication commensurate with the increased risk of the medical issues (para 152, the severity indication of the risk of death (provided in step 825) may be logged).
In regard to claim 20, Osorio teaches the severity indication is based on at least one of one or more environmental factors, one or more patient activity factors, and one or more patient conditions (para 11, the increased risk and the increasing risk is associated with at least one patient condition, patient activity, or environmental circumstance; para 104, a severity index value may be determined based on body data that includes aspect of one or more patient conditions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,076,170. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘170 patent anticipates each and every limitation of the present invention. For instance, the conflict between the claims of the ‘170 patent and the present invention is illustrated below.
Claim 1 of the ‘170 patent:
A method for determining an increased risk of death relating to a patient with epilepsy, comprising:
receiving cardiac data into a medical device;
determining, using the medical device, a cardiac index from the received cardiac data; determining whether the cardiac index is an extreme cardiac index by determining whether the cardiac index is below a low cardiac threshold value or above a high cardiac threshold value; determining, using the medical device, the increased risk of death associated with epilepsy in response to a determination that the cardiac index is the extreme cardiac index;
implementing one or more therapeutic actions based on the occurrence of the increased risk of death; and
logging information related to the increased risk of death.
Claim 1 of the present invention:
A method for determining a status relating to a patient with epilepsy, comprising:
receiving cardiac data into a medical device;
determining, using the medical device, a cardiac index from the received cardiac data; determining whether the cardiac index is an extreme cardiac index by determining whether the cardiac index is below a low cardiac threshold value or above a high cardiac threshold value; determining, using the medical device, the increased risk of medical issues associated with epilepsy in response to a determination that the cardiac index is the extreme cardiac index; implementing one or more therapeutic actions based on the occurrence of the increased risk of the increase in the medical issues; and logging information related to the increased risk of the medical issues.
The overlap in recited features is substantial. The present invention is observed to be drafted in broader form reciting increased risk associated with “status” or “medical issues” relating to epilepsy as opposed to the narrower drafting of the ‘170 patent reciting an increased risk “of death” from epilepsy. The narrower form of the ‘170 anticipate the broader medical issues of the present invention as the risk of death may be properly construed to comprise a medical issue.
Additionally, similar overlap is exhibited between claims 2-20 of the ‘170 patent over claims 2-20 of the present invention.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 9,808,207. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘207 patent anticipates each and every limitation of the present invention. For instance, the conflict between the claims of the ‘207 patent and the present invention is illustrated below.
Claim 1 of the ‘207 patent:
A method for determining and responding in real-time to an increased risk of death relating to a patient with epilepsy, comprising:
receiving cardiac data into a medical device; determining,
at least one cardiac index based upon said cardiac data;
determining whether said cardiac index is an extreme cardiac index by determining whether said cardiac index is below a low cardiac threshold value or above a high cardiac threshold value;
determining, using the medical device, the increased risk of death associated with epilepsy in response to a determination that said cardiac index is the extreme cardiac index; and performing a responsive action based upon an occurrence of the increased risk of death, said responsive action comprises at least one of issuing automatically a warning; providing a therapy, or logging automatically information related to the increased risk of death.
Claim 1 of the present invention:
A method for determining a status relating to a patient with epilepsy, comprising:
receiving cardiac data into a medical device;
determining, using the medical device, a cardiac index from the received cardiac data; determining whether the cardiac index is an extreme cardiac index by determining whether the cardiac index is below a low cardiac threshold value or above a high cardiac threshold value; determining, using the medical device, the increased risk of medical issues associated with epilepsy in response to a determination that the cardiac index is the extreme cardiac index;
implementing one or more therapeutic actions based on the occurrence of the increased risk of the increase in the medical issues; and logging information related to the increased risk of the medical issues.
The overlap in recited features is substantial. The present invention is observed to be drafted in broader form reciting increased risk associated with “status” or “medical issues” relating to epilepsy as opposed to the narrower drafting of the ‘207 patent reciting an increased risk “of death” from epilepsy in “real-time”. The narrower form of the ‘207 anticipates the broader medical issues of the present invention present invention as the risk of death may be properly construed to comprise a medical issue. Additionally, the “performing a responsive action” recitation of the ‘207 patent is construed to be similar in force as to “implementing” and action as presently claimed. Moreover, the responsive actions performed by the ‘207 include applying a therapeutic action and logging information as presently recited.
Additionally, similar overlap is exhibited between claim 9 of the ‘207 patent over claim 11 of the present invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent nos. 9,504,390 and 8,562,524 pertain to similar inventions for determining risk of medical issues, particularly increased risk of death from epilepsy, from cardiac index based analysis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 9 July 2026
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