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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/3/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6-8, 12-17 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim now recites the step of determining a patient fitness value but the specification does not disclose determining a patient fitness level. ¶22, 29, 45, 53 disclose using the fitness level in selecting the heart rate values but do not disclose anything about how the determination of the fitness level is made.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6-8, 12-17 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, claims 1, 7 and 15 recite modifying a threshold value of the indication based on a patient fitness level. It is unclear what the patient fitness level indication or metric is. The specification does not provide clarification reciting only “a fitness level” without any description of what that might entail. It is also unclear when and where the fitness level is determined and how it is used to modify the determination. Claim 1 recites “modify a threshold value” but it is unclear where this threshold is used as the determination is based on a comparison of the change in heart rate to the reserve heart rate without a recitation of a specific threshold. It is assumed this comparison has some difference threshold that it is compared to.
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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 6, 7, 12, 15-17 and 21 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Colborn US 2012/0277605.
Regarding claim 1, Colborn discloses a non-transitory computer readable program storage unit encoded with instructions that, when executed by a medical device, perform a method for indicating an epileptic seizure, comprising:
determining a patient fitness value ([¶69] an exercise level is determined which under a BRI is considered a fitness value as fitness value is not further defined)
receiving heart data of a patient;
determining a maximal heart rate and a resting heart rate;
calculating a reserve heart rate by subtracting the resting heart rate from the maximal heart rate ([¶58-59]);
receiving a heart rate of a patient;
determining via one or more processors a change in the heart rate ([¶28,31]);
comparing the change in heart rate to the reserve heart rate ([¶58-59]);
detecting via the one or more processors the indication of the epileptic seizure based on the comparison of the change in heart rate to the reserve heart rate ([¶58-59] the foreground heart rate change is compared to the reserve heart rate and if it exceeds that a seizure detection is triggered); and
in response to the indication of the epileptic seizure delivering an electrical therapy to a nerve and taking a responsive action selected from one of. issuing a warning; determining a seizure severity; and logging one of a date and a time of occurrence of the epileptic seizure, an epileptic seizure severity, a type of therapy delivered, and a delivered therapy effect ([¶34,38-39] in response to determining a seizure the device logs the event and generates a warning or initiates a stimulus)
modifying a threshold value for epileptic seizure indication based on a patient fitness level ([¶52-64] the dynamic threshold is adjusted based on activity level and background heart rate. Similarly, using the heart rate itself is an indication of fitness).
Regarding claims 7 and 15, Colborn discloses a medical device system, comprising:
at least one sensor configured to collect at least one cardiac signal from a patient ([¶25]); and
a medical device, comprising:
one or more processors configured to receive a heart rate value of the patient, based at least in part on the cardiac signal ([¶30]);
the one or more processors configured to provide a patient's maximal heart rate based on a patient's age and to calculate a change of the heart rate in reference to the patient's maximal heart rate ([¶58-59][¶50] max heart rate is determined based on age);
the one or more processors configured to detect an indication of an epileptic seizure if the change in the heart rate reaches a threshold value ([¶58-59] the foreground heart rate change is compared to the reserve heart rate and if it exceeds that a seizure detection is triggered. The threshold being the change that exceeds the reserve heart rate beats);
a therapy unit configured to deliver via the one or more processors an electrical therapy to a nerve for the epileptic seizure based on the seizure indication ([¶21-22]); and
modifying a threshold value for epileptic seizure indication based on a patient fitness level ([¶52-64] the dynamic threshold is adjusted based on activity level and background heart rate. Similarly, using the heart rate itself is an indication of fitness) and
Regarding claim 6, 12 and 21, Colborn discloses the method further comprises modifying a threshold value for epileptic seizure detection based on at least one of a time of day, a state of the patient, a patient health status, a patient fitness level, at least one environmental condition, a patient emotional status, or at least one medication prescribed to the patient ([¶46-52] the dynamic threshold is adjusted based on activity level and background heart rate).
Regarding claim 16, Colborn discloses the seizure is an epileptic seizure or a non-epileptic seizure ([¶19,40]).
Regarding claim 17, Colborn discloses the change is expressed as a percentile value change ([¶51]).
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 negatived by the manner in which the invention was made.
Claims 8 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Colborn US 2012/0277605 and Osorio US 2011/0251468.
Regarding claim 8, Colburn discloses the device wherein the patient heart rate module comprises: a patient activity unit to provide data relating to a patient's activity level; and a patient HR-reference unit to provide at least one of the maximal heart rate (MHR), the resting heart rate (RHR), the reserve heart rate (RvHR), the activity heart rate (AHR), or the reserve activity heart rate (RAHR) based upon data from at least one of the patient data unit, the cardiac data unit, or the patient activity unit ([¶32,55,66,70-71] resting heart rate is provided).
Colburn does not specifically disclose a patient data unit to provide at least one of patient body data selected from a group consisting of a patient's age, a body weight, a body mass index, a health condition, medication regimens, an autonomic data, a neurological data, an endocrine data, a metabolic data, and a tissue stress marker data. Osorio teaches a similar seizure detection system that has a data unit that provides autonomic data ([¶120]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Colburn with the patient data unit of Osorio in order to determine the patient’s responsiveness or attention ([¶88]) and as Colburn discusses using autonomic data ([¶3]) but does not have an input device for it.
Regarding claim 13, Colburn does not disclose the device further comprising at least one sensor configured to collect body data relating to one or more of a patient's autonomic data, a neurological data, an endocrine data, a metabolic data, and a tissue stress marker data. Osorio teaches a similar seizure detection system that has a data unit that provides autonomic data ([¶120]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Colburn with the patient data unit of Osorio in order to determine the patient’s responsiveness or attention ([¶88]).
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Colborn US 2012/0277605 and Guillory et al US 2008/0091089.
Regarding claim 14, Colburn does not disclose the medical device wherein the patient heart rate module further comprises an environmental unit to provide data relating to at least one of a temperature, a humidity, an altitude, a luminance, an ambient loudness, or an electro-magnetic noise. Guillory teaches a physiological monitor that detects seizures that also has sensors to measure humidity ([¶49]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Colburn with the humidity sensor of Guillory in order to monitor more parameters that may have an effect on the patient’s health status ([¶39]).
Response to Arguments
Applicant's arguments filed 5/3/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 112 rejection, Examiner respectfully disagrees. ¶53 cited by Applicant does not clarify what the fitness level is. The fitness level is presumably some value or parameter used as part of the determination or algorithm seizure detection 8/4but without clarity on what the fitness level actually is or how it is calculated, if it is indeed a numerical value, it makes the rest of the determinations using it indefinite. Similarly, there is no clarification on what the threshold is since the recited determination for the seizure is based on the comparison of the change in heart rate to the reserve heart rate.
Regarding Applicant's arguments, on pgs. 8-18, that neither Colborn or Osorio disclose modifying the threshold based on fitness level, Examiner respectfully disagrees. First, fitness level is not defined in the specification or the claims so under a broadest reasonable interpretation any indicator or metric generally associated with fitness could be considered a fitness level. Colborn does not use the exact term “fitness level” but it does teach using a dynamic threshold based on activity level and exercise level. Specifically, Colborn discloses modifying its detection threshold based on activity or exercise level and the background or resting heart rate which is also an indicator of overall fitness. Applicant points to ¶45 to show that the current device distinguishes activity level from fitness level, however this is not entirely accurate. ¶45 distinguishes activity heart rate from fitness level not activity level and fitness level. Colborn’s activity or exercise level fits the claim language of fitness level.
Applicant argues that Colborn does not disclose determining a maximal heart rate as it is an index and not a parameter, Examiner respectfully disagrees. The current claims and specification make no distinction between maximal heart rate as a parameter or index. Similarly, Colborn determines a maximal heart rate as the maximum the patient’s heart is able to beat in non-pathological conditions and maybe determined several ways ([¶50]). This maximum heart rate is by all definitions a parameter. It is a variable that describes a property or characteristic of a system. Additionally, Colborn does disclose determining a reserve heart rate ([¶59] the threshold determination is same calculation recited in the claim language for the reserve heart rate).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Giftakis US 2010/0121215 also teaches a seizure detection algorithm based on heart rate changes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached on 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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