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 .
Status of Claims
This office action for the 18/205744 application is in response to the communications filed August 06, 2025.
Claims 1 and 4 were amended August 06, 2025.
Claim 3 was cancelled August 06, 2025.
Claims 21 and 22 were added as new August 06, 2025.
Claims 1, 2 and 4-22 are currently pending and considered below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2 and 4-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
As per claim 1,
Step 1: The claim recites subject matter within a statutory category as a process.
Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A).
Step 2A Prong 1: The claim contains subject matter that recites an abstract idea, with the steps of obtaining information relating to a patient's usage of an implantable medical device in delivering stimulation energy to the patient over a first period of time and determining a likelihood of the patient to adhere to a treatment plan for use of the implantable medical device after the first period of time based upon the obtained information, including: deriving a patient usage pattern of the patient over the first period of time from the obtained information, comparing the patient usage pattern with usage pattern segments of a plurality of previous usage patterns, wherein each of the plurality of previous usage patterns includes usage of an implantable medical device in delivering stimulation energy to a previous patient over a period of time greater than the first period of time, identifying one or more of the plurality of previous usage patterns having a usage pattern segment similar to the patient usage pattern, and predicting the likelihood of the patient to adhere to the treatment plan based upon a treatment plan adherence implicated by the identified one or more usage patterns. These steps, as drafted, under the broadest reasonable interpretation recite:
certain methods of organizing human activity (e.g., fundamental economic principles or practices including: hedging; insurance; mitigating risk; etc., commercial or legal interactions including: agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations; etc., managing personal behavior or relationships or interactions between people including: social activities; teaching; following rules or instructions; etc.) but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from being directed to certain methods of organizing human activity. The identified abstract idea, law of nature, or natural phenomenon identified above, in the context of this claim, encompasses a certain method of organizing human activity, namely managing personal behavior or relationships or interactions between people. This is because each of the limitations of the abstract idea recite a list of rules or instructions that a human person can follow in the course of their personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers at least the recited methods of organizing human activity above, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP 2106.04(a).
Step 2A Prong 2: The claim does not recite additional elements that integrate the judicial exception into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“automatically” and “maintained in a database” which corresponds to mere data gathering and/or output.
Accordingly, this claim is directed to an abstract idea.
Step 2B: The claim does not recite additional elements that amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, see MPEP 2106.05(d)(II), such as:
“automatically” which corresponds to receiving or transmitting data over a network.
“maintained in a database” which corresponds to storing and retrieving information in memory.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 2,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the implantable medical device is one of a fully implantable medical device and an implantable medical device with at least one component external the patient.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 4,
Claim 4 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 4 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the step of determining includes matching the obtained information … to generate an individual adherence prediction for the patient.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“as input patterns into a machine learning model” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception, see MPEP 2106.05(f), such as:
“as input patterns into a machine learning model” which corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 5,
Claim 5 depends from claim 4 and inherits all the limitations of the claim from which it depends. Claim 5 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“reviews relationships of usage patterns over period of time akin to the first period of time and long term adherence to a treatment plan akin to the treatment plan for at least five hundred other patients.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“wherein the machine learning model” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 6,
Claim 6 depends from claim 4 and inherits all the limitations of the claim from which it depends. Claim 6 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the first period of time is less than three months following initial implant of the implantable medical device, and further wherein the step of determining predicts whether the patient will have high or low daily usage, on average, of the implantable medical device in delivering stimulation therapy three months after initial implant.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 7,
Claim 7 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 7 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon the duration of each therapy session occurring over the first period of time” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“wherein the implantable medical device is operable to continuously deliver pulsed stimulation energy to the patient over the course of a therapy session” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 8,
Claim 8 depends from claim 7 and inherits all the limitations of the claim from which it depends. Claim 8 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon the number of pauses in each of the therapy sessions or total pause time over the first period of time.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“wherein the implantable medical device is operable to temporarily pause delivery of stimulation energy to the patient for a pre-determined period of time during a particular therapy session” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 9,
Claim 9 depends from claim 7 and inherits all the limitations of the claim from which it depends. Claim 9 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon an intensity of stimulation energy delivered during each of the therapy sessions.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 10,
Claim 10 depends from claim 7 and inherits all the limitations of the claim from which it depends. Claim 10 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon a maximum amplitude of stimulation energy delivered during each of the therapy sessions.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 11,
Claim 11 depends from claim 7 and inherits all the limitations of the claim from which it depends. Claim 11 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon changes in stimulation intensity as selected by the patient.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 12,
Claim 12 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 12 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the likelihood of the patient adhering to the treatment plan is based, at least in part, on therapy start and stop times, and derived metrics such as total therapy hours of when the patient used the implantable medical device over the first period of time.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 13,
Claim 13 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 13 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: identifying one or more potential causes of a determined low likelihood of the patient to adhere to a treatment plan.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 14,
Claim 14 depends from claim 13 and inherits all the limitations of the claim from which it depends. Claim 14 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the one or more potential causes is selected from the group consisting of patient sleep issue, stimulation-caused patient discomfort, proper sleep remote operation, and efficacy of treatment.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 15,
Claim 15 depends from claim 14 and inherits all the limitations of the claim from which it depends. Claim 15 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the patient sleep issue is selected from the group consisting of insomnia, circadian sleep disorders, irregular timing of sleep, and irregular length of sleep.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 16,
Claim 16 depends from claim 13 and inherits all the limitations of the claim from which it depends. Claim 14 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the step of identifying includes applying at least one of a group analysis, cohort analysis, and a cluster analysis to the obtained information.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 17,
Claim 17 depends from claim 13 and inherits all the limitations of the claim from which it depends. Claim 17 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the step of identifying includes identifying two or more potential causes, the method further comprising automatically prioritizing the identified two or more causes.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 18,
Claim 18 depends from claim 13 and inherits all the limitations of the claim from which it depends. Claim 18 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further where a patient usage session begins when the implantable medical device is transitioned from the therapy off state to the therapy on state and ends when the implantable medical device is subsequently transitioned to the therapy off state, and further wherein the step of identifying includes: determining a sleep apnea severity value for at least some of the patient usage sessions occurring over the first period of time; recording a maximum stimulation amplitude for at least some of the patient usage sessions occurring over the first period of time; and correlating the determined sleep apnea severity value with the maximum stimulation amplitude for the corresponding patient usage sessions.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“wherein the implantable medical device is operable in a therapy on state which stimulation energy is delivered to at least one stimulation site of the patient and a therapy off state in which stimulation energy is not delivered to the at least one stimulation site, the therapy on state including an optional therapy pause mode in which delivery of stimulation energy is temporarily paused” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 19,
Claim 19 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 19 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the sleep apnea severity value is at least one of: an Apnea Hypopnea Index (AHI); an Oxygen Desaturation Index (ODI); minutes of snoring; number of snoring occurrences per hour; a patient-reported measurement of sleepiness; and a patient-reported measurement of daytime activity.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 20,
Claim 20 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 20 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the step of correlating includes determining a correlation coefficient to measure a linear relationship between the determined sleep apnea severity value and the recorded maximum stimulation amplitude over time.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 21,
Claim 21 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 21 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further wherein the derived patient usage pattern includes: the duration of each therapy session occurring over the first period of time; the number of pauses in each of the therapy sessions or total pause time during the first period of time; an intensity of stimulation energy delivered during each of the therapy sessions over the first period of time; a maximum amplitude of stimulation energy delivered during each of the therapy sessions over the first periods of time; changes in stimulation intensity as selected by the patient during each of the therapy sessions over the first period of time; start and stop times of each of the therapy sessions over the first period of time; and total therapy hours of when the patient used the implantable medical device over the first period of time.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“wherein the implantable medical device is operable to continuously deliver pulsed stimulation energy to the patient over the course of a therapy session, and to temporarily pause delivery of stimulation energy to the patient for a pre-determined period of time during a particular therapy session” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h), such as “wherein the implantable medical device is operable to continuously deliver pulsed stimulation energy to the patient over the course of a therapy session, and to temporarily pause delivery of stimulation energy to the patient for a pre-determined period of time during a particular therapy session”
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the examiner as being well‐understood, routine, and conventional functions in light of the prior art, wherein the examiner has provided multiple references as evidence as required by Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018), see MPEP 2106.05(d)(I), such as:
Rondoni et al. (US 2023/0095780; herein referred to as Rondoni) which teaches upon detecting such a trend some example methods may comprise decreasing stimulation intensity gradually, such as via a ramp, which may increase patient comfort upon termination of the treatment period and/or during brief awakenings. In addition, upon resuming stimulation after a brief awakening, the stimulation intensity may be increased gradually (e.g. via a ramp). As noted elsewhere, a change in stimulation intensity may comprise a change in an amplitude, frequency, pulse width, etc. of electrical stimulation signal. See Paragraph [0062] of Rondoni.
Bolea (US 2016/0089540) which teaches stimulation duty cycle may vary to meet efficacy and safety requirements. Generally, the stimulation duty cycle is used to determine the stimulation period as a percentage of the predicted respiratory period (stimulation period=duty cycle.times.predicted respiratory period). After a stimulation period is started, stimulation continues until the end of the stimulation period as set by the stimulation duty cycle, or until the next actual peak is detected, whichever occurs first. See Paragraph [0469] of Bolea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
Claim 22
Claim 22 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 22 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: delivering stimulation energy to the patient over a second period of time based upon the determined likelihood of the patient to adhere to the treatment plan.” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h), such as “further comprising: delivering stimulation energy to the patient over a second period of time based upon the determined likelihood of the patient to adhere to the treatment plan.”
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the examiner as being well‐understood, routine, and conventional functions in light of the prior art, wherein the examiner has provided multiple references as evidence as required by Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018), see MPEP 2106.05(d)(I), such as:
Rondoni et al. (US 2023/0095780; herein referred to as Rondoni) which teaches upon detecting such a trend some example methods may comprise decreasing stimulation intensity gradually, such as via a ramp, which may increase patient comfort upon termination of the treatment period and/or during brief awakenings. In addition, upon resuming stimulation after a brief awakening, the stimulation intensity may be increased gradually (e.g. via a ramp). As noted elsewhere, a change in stimulation intensity may comprise a change in an amplitude, frequency, pulse width, etc. of electrical stimulation signal. The teaching further describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. See Paragraphs [0057], [0062] and [0324] of Rondoni.
Bolea (US 2016/0089540) which teaches stimulation duty cycle may vary to meet efficacy and safety requirements. Generally, the stimulation duty cycle is used to determine the stimulation period as a percentage of the predicted respiratory period (stimulation period=duty cycle.times.predicted respiratory period). After a stimulation period is started, stimulation continues until the end of the stimulation period as set by the stimulation duty cycle, or until the next actual peak is detected, whichever occurs first. A feature common to the predictive algorithms is illustrated in FIG. 64D. This feature provides a sequence of predicted respiratory periods in case the respiration impedance signal (“Z”) is temporarily lost (e.g., due to change in respiratory effort). Until a subsequent respiratory peak is detected, stimulation parameters which are based on the measured respiratory period (e.g., stimulation period) are unchanged. Thus, stimulation timing remains synchronous to the last detected peak. See Paragraphs [0468] and [0469] of Bolea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claims 1, 2, 4 and 7-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rondoni et al. (US 2023/0095780; herein referred to as Rondoni).
As per claim 1,
Rondoni discloses automatically obtaining information relating to a patient's usage of an implantable medical device in delivering stimulation energy to the patient over a first period of time:
(Paragraphs [0048] and [0049] of Rondoni. The teaching describes sleep disordered breathing (SBD) care, which may comprise monitoring, diagnosis, and/or stimulation therapy. At least some examples may comprise implantable devices and/or methods comprising use of implantable devices. In some such examples, SDB care may comprise automatically determining a sleep-wake status, which may in turn comprise detecting sleep and/or detecting wakefulness. In some examples, detecting sleep comprises detecting an onset of sleep and/or detecting on-going sleep after the onset of sleep. In some such examples, the sleep-wake determination may be used to initiate (and/or maintain) a treatment period in which neurostimulation therapy is used to treat sleep disordered breathing. In some examples, such automatic detection of wakefulness (as part of an automatic sleep-wake determination) may be used to terminate a treatment period.)
Rondoni further discloses determining a likelihood of the patient to adhere to a treatment plan for use of the implantable medical device after the first period of time based upon the obtained information:
(Paragraphs [0057] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care.)
Rondoni further discloses including: deriving a patient usage pattern of the patient over the first period of time from the obtained information, comparing the patient usage pattern with usage pattern segments of a plurality of previous usage patterns maintained in a database, wherein each of the plurality of previous usage patterns includes usage of an implantable medical device in delivering stimulation energy to a previous patient over a period of time greater than the first period of time, identifying one or more of the plurality of previous usage patterns having a usage pattern segment similar to the patient usage pattern and predicting the likelihood of the patient to adhere to the treatment plan based upon a treatment plan adherence implicated by the identified one or more usage patterns:
(Paragraphs [0054] and [0163] of Rondoni. The teaching describes that the automatic determination of a sleep-wake status may be customized automatically according to a particular patient's breathing patterns, activity patterns (e.g. ways and times in which they are active), sleeping patterns (e.g. time of day, days of week, etc.), and the like. For instance, sensing an upright posture typically is associated with a wakeful state, such as standing or walking. However, as noted elsewhere, a person could be in an upright sitting position and still be in a sleep state (e.g. sleeping a chair). Accordingly, posture may be just one parameter used in determining a sleep-wake state, along with at least some other parameters described in association with sensing portion 2000 of FIG. 24 and/or care engine 2500 in FIG. 27A. Conversely, sensing a supine or lateral decubiitis (i.e. laying on a side) posture typically is associated with a sleep state. However, a patient might be in such a position without being asleep, such that other parameters (e.g. FIGS. 24, 27A) in addition to, or instead of, posture may significantly enhance determination of sleep-wake status.)
As per claim 2,
Rondoni discloses the limitations of claim 1.
Rondoni further discloses wherein the implantable medical device is one of a fully implantable medical device and an implantable medical device with at least one component external the patient:
(Paragraph [0064] of Rondoni. The teaching describes In some examples, the accelerometer may be implanted at the chest, neck, and/or head, while in some examples, the accelerometer may be secured externally on the patient's body at such locations.)
As per claim 4,
Rondoni discloses the limitations of claim 1.
Rondoni further discloses wherein the step of determining includes matching the obtained information as input patterns into a machine learning model to generate an individual adherence prediction for the patient:
(Paragraphs [0057] and [0358] of Rondoni. The teaching describes that FIG. 35 is a diagram schematically representing an example method 7600 (and/or example device) for using a trained machine learning model 7631 for determining sleep-wake state using internal measurements, such as via an implanted accelerometer in some examples. As shown in FIG. 35 , currently sensed inputs 7611 are fed into the trained machine learning model 7631, which then produces a determinable output 7641, such as a current sleep-wake state determination 7643, which is based on the current inputs 7611. In some examples, the current inputs 7611 correspond to the same type and/or number of known inputs 7510 (FIG. 34 ) used to train the machine learning model. As part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes.)
As per claim 7,
Rondoni discloses the limitations of claim 1.
Rondoni further discloses wherein the implantable medical device is operable to continuously deliver pulsed stimulation energy to the patient over the course of a therapy session, and further wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon the duration of each therapy session occurring over the first period of time:
(Paragraphs [0057], [0065], [0275] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period)
As per claim 8,
Rondoni discloses the limitations of claim 7.
Rondoni further discloses wherein the implantable medical device is operable to temporarily pause delivery of stimulation energy to the patient for a pre-determined period of time during a particular therapy session, and further wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon the number of pauses in each of the therapy sessions or total pause time over the first period of time:
(Paragraphs [0057], [0065], [0275], [0309] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period. The pause parameter 5080 (white bar) represents a period of time in which a treatment period is paused or suspended, such as when a patient is temporarily awake to use the lavatory, get a snack, etc. In some examples, as shown in FIG. 31A, after such a pause (5080), the treatment period resumes in the on mode (5075). The treatment period may be resumed via automatic initiation upon detecting sleep by the patient or by the patient re-initiating the treatment period via remote control or other means (e.g. physical control).)
As per claim 9,
Rondoni discloses the limitations of claim 7.
Rondoni further discloses wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon an intensity of stimulation energy delivered during each of the therapy sessions:
(Paragraphs [0057], [0065], [0275] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period)
As per claim 10,
Rondoni discloses the limitations of claim 7.
Rondoni further discloses wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon a maximum amplitude of stimulation energy delivered during each of the therapy sessions:
(Paragraphs [0057], [0065], [0275] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period)
As per claim 11,
Rondoni discloses the limitations of claim 7.
Rondoni further discloses wherein the likelihood of the patient to adhere to the treatment plan is based, at least in part, upon changes in stimulation intensity as selected by the patient:
(Paragraphs [0057], [0065], [0275] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period)
As per claim 12,
Rondoni discloses the limitations of claim 1.
Rondoni further discloses wherein the likelihood of the patient adhering to the treatment plan is based, at least in part, on therapy start and stop times, and derived metrics such as total therapy hours of when the patient used the implantable medical device over the first period of time:
(Paragraphs [0057], [0065], [0275], [0319] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period. In some examples the user metrics portion 5300 may comprise an automatic element 5310 to track and/or report instances in which the treatment is automatically started (5312), automatically stopped (5314), and automatically paused 5316. In some examples, these automatic implementations (e.g. start, stop, pause) are triggered or caused by an automatic determination of a sleep-wake status as described throughout the present disclosure. For instance, in some examples the user metrics portion 5300 may comprise an elective element 5320 to track and/or report instances in which the treatment is electively started (5322), electively stopped (5324), and electively paused 5326. In some examples, these elective implementations (e.g. start, stop, pause) are caused by a user operating a remote control, app on a mobile device, etc. Each of the respective automatic and elective functions (e.g. start, stop, pause) may be tracked and/or reported according to observable patterns (5330), averages (5340), and trends (5350).)
As per claim 13,
Rondoni discloses the limitations of claim 1.
Rondoni further discloses further comprising: identifying one or more potential causes of a determined low likelihood of the patient to adhere to a treatment plan:
(Paragraphs [0051]-[0054] of Rondoni. The teaching describes determining sleep-wake status comprises detecting sleep upon: (1) a time of day; and (2) detection of a lack of bodily motion indicative of sleep over a selectable, predetermined period of time. The time-of-day may be selectable and/or based on patient data. To the extent that some sleep periods are unintended or occur due to an irregular schedule, at least some example methods of automatic sleep detection (and/or wakefulness detection) may enhance SDB care. In contrast, initiating SDB care solely according to preset times and/or according to manual control may miss opportunities to provide SDB care, whereas automatic sleep detection may increase the number and/or type of situations in which SDB care may be implemented. In some examples, determination of the sleep-wake status also may comprise determining sleep stages of the patient, which may in turn enable modifying stimulation (e.g. increasing, reducing, etc.) within a treatment period.)
As per claim 14,
Rondoni discloses the limitations of claim 13.
Rondoni further discloses wherein the one or more potential causes is selected from the group consisting of patient sleep issue, stimulation-caused patient discomfort, proper sleep remote operation, and efficacy of treatment:
(Paragraphs [0051]-[0054] of Rondoni. The teaching describes determining sleep-wake status comprises detecting sleep upon: (1) a time of day; and (2) detection of a lack of bodily motion indicative of sleep over a selectable, predetermined period of time. The time-of-day may be selectable and/or based on patient data. To the extent that some sleep periods are unintended or occur due to an irregular schedule, at least some example methods of automatic sleep detection (and/or wakefulness detection) may enhance SDB care. In contrast, initiating SDB care solely according to preset times and/or according to manual control may miss opportunities to provide SDB care, whereas automatic sleep detection may increase the number and/or type of situations in which SDB care may be implemented. In some examples, determination of the sleep-wake status also may comprise determining sleep stages of the patient, which may in turn enable modifying stimulation (e.g. increasing, reducing, etc.) within a treatment period.)
As per claim 15,
Rondoni discloses the limitations of claim 14.
Rondoni further discloses wherein the patient sleep issue is selected from the group consisting of insomnia, circadian sleep disorders, irregular timing of sleep, and irregular length of sleep:
(Paragraphs [0051]-[0054] of Rondoni. The teaching describes determining sleep-wake status comprises detecting sleep upon: (1) a time of day; and (2) detection of a lack of bodily motion indicative of sleep over a selectable, predetermined period of time. The time-of-day may be selectable and/or based on patient data. To the extent that some sleep periods are unintended or occur due to an irregular schedule, at least some example methods of automatic sleep detection (and/or wakefulness detection) may enhance SDB care. In contrast, initiating SDB care solely according to preset times and/or according to manual control may miss opportunities to provide SDB care, whereas automatic sleep detection may increase the number and/or type of situations in which SDB care may be implemented. In some examples, determination of the sleep-wake status also may comprise determining sleep stages of the patient, which may in turn enable modifying stimulation (e.g. increasing, reducing, etc.) within a treatment period.)
As per claim 16,
Rondoni discloses the limitations of claim 13.
Rondoni further discloses wherein the step of identifying includes applying at least one of a group analysis, cohort analysis, and a cluster analysis to the obtained information:
(Paragraphs [0051]-[0054] and [0292] of Rondoni. The teaching describes determining sleep-wake status comprises detecting sleep upon: (1) a time of day; and (2) detection of a lack of bodily motion indicative of sleep over a selectable, predetermined period of time. The time-of-day may be selectable and/or based on patient data. To the extent that some sleep periods are unintended or occur due to an irregular schedule, at least some example methods of automatic sleep detection (and/or wakefulness detection) may enhance SDB care. In contrast, initiating SDB care solely according to preset times and/or according to manual control may miss opportunities to provide SDB care, whereas automatic sleep detection may increase the number and/or type of situations in which SDB care may be implemented. In some examples, determination of the sleep-wake status also may comprise determining sleep stages of the patient, which may in turn enable modifying stimulation (e.g. increasing, reducing, etc.) within a treatment period. It will be understood that the various parameters, functions, portions, etc. shown and described in association with FIG. 27A are not limited to the particular groupings, relationships, etc. shown in FIG. 27A, but may be arranged in groupings, relationships, etc. other than shown in FIG. 27A.)
As per claim 17,
Rondoni discloses the limitations of claim 13.
Rondoni further discloses wherein the step of identifying includes identifying two or more potential causes, the method further comprising automatically prioritizing the identified two or more causes:
(Paragraphs [0051]-[0054] of Rondoni. The teaching describes determining sleep-wake status comprises detecting sleep upon: (1) a time of day; and (2) detection of a lack of bodily motion indicative of sleep over a selectable, predetermined period of time. The time-of-day may be selectable and/or based on patient data. To the extent that some sleep periods are unintended or occur due to an irregular schedule, at least some example methods of automatic sleep detection (and/or wakefulness detection) may enhance SDB care. In contrast, initiating SDB care solely according to preset times and/or according to manual control may miss opportunities to provide SDB care, whereas automatic sleep detection may increase the number and/or type of situations in which SDB care may be implemented. In some examples, determination of the sleep-wake status also may comprise determining sleep stages of the patient, which may in turn enable modifying stimulation (e.g. increasing, reducing, etc.) within a treatment period.)
As per claim 18,
Rondoni discloses the limitations of claim 13.
Rondoni further discloses wherein the implantable medical device is operable in a therapy on state which stimulation energy is delivered to at least one stimulation site of the patient and a therapy off state in which stimulation energy is not delivered to the at least one stimulation site, the therapy on state including an optional therapy pause mode in which delivery of stimulation energy is temporarily paused, and further where a patient usage session begins when the implantable medical device is transitioned from the therapy off state to the therapy on state and ends when the implantable medical device is subsequently transitioned to the therapy off state and further wherein the step of identifying includes: determining a sleep apnea severity value for at least some of the patient usage sessions occurring over the first period of time; recording a maximum stimulation amplitude for at least some of the patient usage sessions occurring over the first period of time; and correlating the determined sleep apnea severity value with the maximum stimulation amplitude for the corresponding patient usage sessions:
(Paragraphs [0057], [0065], [0185], [0275], [0319] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period. In some examples the user metrics portion 5300 may comprise an automatic element 5310 to track and/or report instances in which the treatment is automatically started (5312), automatically stopped (5314), and automatically paused 5316. In some examples, these automatic implementations (e.g. start, stop, pause) are triggered or caused by an automatic determination of a sleep-wake status as described throughout the present disclosure. For instance, in some examples the user metrics portion 5300 may comprise an elective element 5320 to track and/or report instances in which the treatment is electively started (5322), electively stopped (5324), and electively paused 5326. In some examples, these elective implementations (e.g. start, stop, pause) are caused by a user operating a remote control, app on a mobile device, etc. Each of the respective automatic and elective functions (e.g. start, stop, pause) may be tracked and/or reported according to observable patterns (5330), averages (5340), and trends (5350). In some examples, the EMG information sensed via one of the electrodes (e.g. 2120, 2112, etc.) may comprise detecting upper airway patency to assess obstruction (e.g. degree, location, etc.) and/or assess stimulation effectiveness, as well as detecting (and/or assessing) inhalation/exhalation during respiration. In some examples, the sensed EMG information may comprise sensing intercostal muscle activity in order to identify respiratory cyclical information (e.g. inspiration, expiration, expiratory pause) and/or identify or differentiate between central sleep apnea and obstructive sleep apnea.)
As per claim 19,
Rondoni discloses the limitations of claim 18.
Rondoni further discloses wherein the sleep apnea severity value is at least one of: an Apnea Hypopnea Index (AHI); an Oxygen Desaturation Index (ODI); minutes of snoring; number of snoring occurrences per hour; a patient-reported measurement of sleepiness; and a patient-reported measurement of daytime activity:
(Paragraphs [0229] of Rondoni. The teaching describes that care engine 2500 comprises a snoring parameter 2545 to direct sensing of, and/or to receive, track, evaluate, etc. snoring information, which in some examples may be detected and obtained via motion sensing. This sensed snoring information may be used, in some examples, to at least partially determine a sleep-wake status. In one aspect, snoring may be defined as noise associated with each exhalation when respiratory periods are relatively stable and with stable frequency content. Conversely, talking lacks stable respiratory periods and frequency content, and therefore would not be detected as snoring. As noted elsewhere, in some examples the snoring is sensed via acoustic sensor 2039 (FIG. 24 ) and/or acoustic parameter 2539 (FIG. 27A).)
As per claim 20,
Rondoni discloses the limitations of claim 18.
Rondoni further discloses wherein the step of correlating includes determining a correlation coefficient to measure a linear relationship between the determined sleep apnea severity value and the recorded maximum stimulation amplitude over time:
(Paragraphs [0057], [0065], [0185], [0275], [0319] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period. In some examples the user metrics portion 5300 may comprise an automatic element 5310 to track and/or report instances in which the treatment is automatically started (5312), automatically stopped (5314), and automatically paused 5316. In some examples, these automatic implementations (e.g. start, stop, pause) are triggered or caused by an automatic determination of a sleep-wake status as described throughout the present disclosure. For instance, in some examples the user metrics portion 5300 may comprise an elective element 5320 to track and/or report instances in which the treatment is electively started (5322), electively stopped (5324), and electively paused 5326. In some examples, these elective implementations (e.g. start, stop, pause) are caused by a user operating a remote control, app on a mobile device, etc. Each of the respective automatic and elective functions (e.g. start, stop, pause) may be tracked and/or reported according to observable patterns (5330), averages (5340), and trends (5350). In some examples, the EMG information sensed via one of the electrodes (e.g. 2120, 2112, etc.) may comprise detecting upper airway patency to assess obstruction (e.g. degree, location, etc.) and/or assess stimulation effectiveness, as well as detecting (and/or assessing) inhalation/exhalation during respiration. In some examples, the sensed EMG information may comprise sensing intercostal muscle activity in order to identify respiratory cyclical information (e.g. inspiration, expiration, expiratory pause) and/or identify or differentiate between central sleep apnea and obstructive sleep apnea.)
As per claim 21,
Rondoni discloses the limitations of claim 1.
Rondoni further discloses wherein the implantable medical device is operable to continuously deliver pulsed stimulation energy to the patient over the course of a therapy session, and to temporarily pause delivery of stimulation energy to the patient for a pre-determined period of time during a particular therapy session:
(Paragraph [0220] of Rondoni. The teaching describes via at least the sleep state portion 2650 of care engine 2500, the sleep detection method/device may differentiate between wakefulness and sleep disordered breathing (SDB), which occurs during sleep. Among other situations, this differentiation may enable effective neurostimulation therapy such as when a patient is in a sleep position (e.g. laying horizontally or incline position) and the sleep detection arrangement detects a change in sensed data which could possibly be interpreted as a rolling over (e.g. from a supine position onto their side (e.g. lateral decubitus) or vice versa) or as consistent with a SDB behavior. In the case of a bona fide rollover by the patient, such as when getting out of bed, the system will pause the neurostimulation therapy. However, if the detected change may be confirmed as legitimate SDB behavior, then the system/method does not pause the neurostimulation therapy in at least some examples.)
Rondoni further discloses the duration of each therapy session occurring over the first period of time; the number of pauses in each of the therapy sessions or total pause time during the first period of time; an intensity of stimulation energy delivered during each of the therapy sessions over the first period of time; a maximum amplitude of stimulation energy delivered during each of the therapy sessions over the first periods of time; changes in stimulation intensity as selected by the patient during each of the therapy sessions over the first period of time; start and stop times of each of the therapy sessions over the first period of time; and total therapy hours of when the patient used the implantable medical device over the first period of time:
(Paragraphs [0220] and [0230]-[0232] of Rondoni. The teaching describes The teaching describes via at least the sleep state portion 2650 of care engine 2500, the sleep detection method/device may differentiate between wakefulness and sleep disordered breathing (SDB), which occurs during sleep. Among other situations, this differentiation may enable effective neurostimulation therapy such as when a patient is in a sleep position (e.g. laying horizontally or incline position) and the sleep detection arrangement detects a change in sensed data which could possibly be interpreted as a rolling over (e.g. from a supine position onto their side (e.g. lateral decubitus) or vice versa) or as consistent with a SDB behavior. In the case of a bona fide rollover by the patient, such as when getting out of bed, the system will pause the neurostimulation therapy. However, if the detected change may be confirmed as legitimate SDB behavior, then the system/method does not pause the neurostimulation therapy in at least some examples. In some examples, sensing portion 2510 of care engine 2500 may comprise a history parameter 2542 by which a history of sensed physiologic information is maintained, and which may be used via comparison parameter 2544 to compare recent sensed physiologic information with older sensed physiologic information. For example, the inspiration-to-expiration transition associated with respiration portion 2580 of care engine 2500 may be used as a fiducial to detect and/or track a respiratory rate (and respiratory rate variability), which may be indicative of a change in wake-sleep status. At least one such example inspiration-to-expiration transition 180 is shown in FIG. 27C. In some examples, changes in a duration of the inspiration-to-expiration transition, changes in peak-to-peak amplitude, and/or changes in the respiratory rate may be indicative of sleep and/or wakefulness, and therefore used to determine a sleep-wake status.)
As per claim 22,
Rondoni discloses the limitations of claim 1.
Rondini further discloses further comprising: delivering stimulation energy to the patient over a second period of time based upon the determined likelihood of the patient to adhere to the treatment plan:
(Paragraphs [0071], [0220] and [0230]-[0232] of Rondoni. The teaching describes The teaching describes via at least the sleep state portion 2650 of care engine 2500, the sleep detection method/device may differentiate between wakefulness and sleep disordered breathing (SDB), which occurs during sleep. Among other situations, this differentiation may enable effective neurostimulation therapy such as when a patient is in a sleep position (e.g. laying horizontally or incline position) and the sleep detection arrangement detects a change in sensed data which could possibly be interpreted as a rolling over (e.g. from a supine position onto their side (e.g. lateral decubitus) or vice versa) or as consistent with a SDB behavior. In the case of a bona fide rollover by the patient, such as when getting out of bed, the system will pause the neurostimulation therapy. However, if the detected change may be confirmed as legitimate SDB behavior, then the system/method does not pause the neurostimulation therapy in at least some examples. In some examples, sensing portion 2510 of care engine 2500 may comprise a history parameter 2542 by which a history of sensed physiologic information is maintained, and which may be used via comparison parameter 2544 to compare recent sensed physiologic information with older sensed physiologic information. For example, the inspiration-to-expiration transition associated with respiration portion 2580 of care engine 2500 may be used as a fiducial to detect and/or track a respiratory rate (and respiratory rate variability), which may be indicative of a change in wake-sleep status. At least one such example inspiration-to-expiration transition 180 is shown in FIG. 27C. In some examples, changes in a duration of the inspiration-to-expiration transition, changes in peak-to-peak amplitude, and/or changes in the respiratory rate may be indicative of sleep and/or wakefulness, and therefore used to determine a sleep-wake status. With these examples of FIGS. 1-3C in mind, in some examples detecting sleep (and/or wakefulness) in association with delivering a stimulation therapy may comprise the method shown at 540 in FIG. 4A. As shown at 542 in FIG. 4A, the method 540 may comprise detecting sleep upon: (1) a time of day; and (2) detection of a lack of bodily motion indicative of sleep over a selectable, predetermined period of time.)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni.
As per claim 5,
Rondoni discloses the limitations of claim 4.
Rondoni further discloses wherein the machine learning model reviews relationships of usage patterns over period of time akin to the first period of time and long term adherence to a treatment plan:
(Paragraphs [0057] and [0358] of Rondoni. The teaching describes that FIG. 35 is a diagram schematically representing an example method 7600 (and/or example device) for using a trained machine learning model 7631 for determining sleep-wake state using internal measurements, such as via an implanted accelerometer in some examples. As shown in FIG. 35 , currently sensed inputs 7611 are fed into the trained machine learning model 7631, which then produces a determinable output 7641, such as a current sleep-wake state determination 7643, which is based on the current inputs 7611. In some examples, the current inputs 7611 correspond to the same type and/or number of known inputs 7510 (FIG. 34 ) used to train the machine learning model. As part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes.)
Rondoni does not explicitly teach akin to the treatment plan for at least five hundred other patients.
However, it would have been obvious to one of ordinary skill in the art before the time of filing that Rondoni would have taught such a limitation. The cited teaching of Rondoni above clearly describes a trained machine learning model to determine the patient’s current medical state. Such a training would have necessarily required a training set that comprises a plurality of data inputs. It would have been obvious to one of ordinary skill in the art through routine optimization of the training model that the training set would have comprised at least 500 other patients. Such optimization would have resulted without unexpected results.
As per claim 6,
Rondoni discloses the limitations of claim 4.
Rondoni further discloses wherein the step of determining predicts whether the patient will have high or low daily usage, on average, of the implantable medical device in delivering stimulation therapy:
(Paragraphs [0057], [0065], [0185], [0275], [0319] and [0324] of Rondoni. The teaching describes that as part of determining sleep-wake status, in some examples, sleep time is collected and provided to a clinician and the patient for diagnostic, adherence monitoring, and patient engagement purposes. The gradual ramped initiation or termination of stimulation therapy may enhance a patient's comfort by avoiding abrupt initiation, pause, or cessation of stimulation therapy. Among other features, the ramped implementation may increase the likelihood of patient compliance and appreciation for SDB care. A sensing element (e.g. accelerometer, impedance, other) may be at least partially incorporated in a microstimulator (or other implantable pulse generator) sized and shaped to be implantable within a blood vessel. The example method may comprise sensing ballistic motion of the blood vessel caused by the heartbeat of the patient. The stimulation portion 2900 comprises an auto-titration parameter 2920 by which an intensity of stimulation therapy can be automatically titrated (i.e. adjusted) to be more intense (e.g. higher amplitude, greater frequency, and/or greater pulse width) or to be less intense (e.g. lower amplitude, lower frequency, and/or lower pulse width) within a treatment period. In some examples the user metrics portion 5300 may comprise an automatic element 5310 to track and/or report instances in which the treatment is automatically started (5312), automatically stopped (5314), and automatically paused 5316. In some examples, these automatic implementations (e.g. start, stop, pause) are triggered or caused by an automatic determination of a sleep-wake status as described throughout the present disclosure. For instance, in some examples the user metrics portion 5300 may comprise an elective element 5320 to track and/or report instances in which the treatment is electively started (5322), electively stopped (5324), and electively paused 5326. In some examples, these elective implementations (e.g. start, stop, pause) are caused by a user operating a remote control, app on a mobile device, etc. Each of the respective automatic and elective functions (e.g. start, stop, pause) may be tracked and/or reported according to observable patterns (5330), averages (5340), and trends (5350). In some examples, the EMG information sensed via one of the electrodes (e.g. 2120, 2112, etc.) may comprise detecting upper airway patency to assess obstruction (e.g. degree, location, etc.) and/or assess stimulation effectiveness, as well as detecting (and/or assessing) inhalation/exhalation during respiration. In some examples, the sensed EMG information may comprise sensing intercostal muscle activity in order to identify respiratory cyclical information (e.g. inspiration, expiration, expiratory pause) and/or identify or differentiate between central sleep apnea and obstructive sleep apnea.)
Rondoni does not explicitly teach “wherein the first period of time is less than three months following initial implant of the implantable medical device, … three months after initial implant”.
However, it would have been obvious to one of ordinary skill in the art before the time of filing that Rondoni would have taught such a limitation. The cited teaching of Rondoni above clearly describes an implanted medical device that collects data and treats a patient over a period of time. It would have been obvious to one of ordinary skill in the art through routine optimization of the timing for the medical device treatment sessions that the period for monitoring would have included a first time period of less than three months and further monitoring of more than three months. This is further underlined with the understanding that most implanted medical devices tend to stay in a patient for more than three months. Such optimization would have resulted without unexpected results.
Response to Arguments
Applicant's arguments filed August 06, 2025 have been fully considered:
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 101 are not persuasive:
The Applicant argues that claim 1 is directed to an abstract idea under Alice Step 1. Specifically, the claimed invention is directed to a technological process for assessing and predicting patient adherence to a treatment plan involving an IMD. The steps recited by claim 1 are not involved in a method of organizing human activity. Rather, it is a technical application of machine-based pattern recognition and predictive modeling in a medical context. This technical application improves the field of medical treatment adherence.
The Examiner respectfully disagrees. As a preliminary measure, the argument presented is improperly framed. Step 1 of the Alice framework considers whether a particular claim is categorized within one of the four statutory categories of patentable inventions: process, machine, manufacture or composition of matter. Given that claim 1 is a method claim, the result of Step 1 is YES. We move now to Step 2A. Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A). The question of Step 2A Prong 1 is whether a claim recites a judicial exception. Instant claim 1 recites a list of steps that a human person can follow in the course of their personal behavior. Accordingly, the result of Step 2A Prong 1 is YES and we move to Step 2A Prong 2. This prong determines whether a claim is directed to the recited abstract idea. Here is where the Applicant’s argument should have been framed. The Applicant has argued that claim 1 is a technical application of determining medical treatment adherence in a way that that a human person could not. This assertion is not persuasive at all. First of all, there is no explicit technology claimed anywhere in claim 1. One might infer technology from the “automatically” limitation but this does not amount to a technological application because there is no description of what technology that might involve in the claim. Further, the recitation of “implantable medical device” is not positively recited. Claim 1 does not care about the functions of the IMD, but rather the information gathered from it. Information is inherently abstract. Finally, there is no evidence that the claimed invention would have resulted in an improvement to technology if for no other reason than that there is no discussed about what the technical problem is or how the claimed invention would address that technical deficit with a technical solution. All that is present is a collection of information, an analysis of that collected information, and an output of that analysis. Such functions fall squarely in certain methods of organizing human activity.
The Applicant further argues that claim 1 provides an improvement to technology over manual or heuristic methods.
The Examiner respectfully disagrees with this argument. The question of technical improvement does not lie with comparing a technical process to a manual process but rather comparing technology to technology. The Applicant is seriously asserting that the Examiner should consider the improvements in technology as it relates to a manual analog without considering the vast space of prior art of more similar technology. This is akin to comparing the technical improvements of a generic electronic calculator to an abacus. There are countless prior arts to refer to for the Examiner to assess patient adherence by using specific data input and a defined prediction model. The Examiner is not persuaded by this argument at all.
The Applicant further argues that the claims recite something significantly more under Alice Step 2. Specifically, the adherence prediction claimed is the result of processing large-scale, device level data using a technical model trained on real-world historical usage by identifying patterns over time using prior patient data. This constitutes a solution to a medical problem.
The Examiner respectfully disagrees. The Examiner notes that while this argument is under Step 2, the argument is more accurately placed under Step 2B. The Applicant’s argument here is the basis of all predictive modeling that determines adherence likelihood. The Applicant again asks the Examiner to accept the premise that the inventor alone has invented what has ubiquitously existed for more than a decade. Nearly all predictive models with regard to medical adherence can be described in the way that the Applicant has characterized the argued improvement. Accordingly, the Examiner is not persuaded by this argument at all.
The Applicant further argues that claims 21 and 22 are eligible for patent because they are not directed to an abstract idea under Step 1 and recite significantly more than any alleged abstract idea under Step 2.
The Examiner respectfully disagrees. The Examiner notes that the arguments made under Step 1 are actually made under Step 2A Prong 2 and arguments made under Step 2 are actually made under Step 2B. The Applicant has provided no reasoning as to why the Examiner should accept their position. In contrast, the Examiner has provided a detailed explanation as to why the pending claims are ineligible for patent. Accordingly, these arguments are not persuasive.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 102 are not persuasive.
The Applicant argues that a determination of sleep-wake status of the patient is not usage of an implantable device in of itself because this status is determined independently of whether stimulation is being delivered or not.
The Examiner respectfully disagrees. In the plain text of Rondoni: “the sleep-wake determination may be used to initiate (and/or maintain) a treatment period in which neurostimulation therapy is used to treat sleep disordered breathing”. See Paragraph [0049] of Rondoni. This inarguably links the sleep-wake status to the stimulation therapy. Accordingly, this is “information related to a patient’s usage of an implantable medical device” as claimed.
The Applicant further argues that “sleep time” information cannot be the “obtained information” as claimed because the information in Paragraph [0057] of Rondoni does not necessarily relate to the patient’s usage of the IMD in delivering stimulation energy.
The Examiner respectfully disagrees. In the plain text of Rondoni: “the sleep-wake determination may be used to initiate (and/or maintain) a treatment period in which neurostimulation therapy is used to treat sleep disordered breathing”. See Paragraph [0049] of Rondoni. This inarguably links the sleep-wake status to the stimulation therapy. Accordingly, this is “information related to a patient’s usage of an implantable medical device” as claimed.
The Applicant further argues that Rondoni does not disclose the amended features of claim 1 and new claims 21 and 22.
The Examiner respectfully disagrees. The Examiner has provided a detailed explanation as to why Rondoni discloses the limitations of claims 1, 21 and 22 in the updated rejection above. Accordingly, these arguments are not persuasive.
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 CHAD A NEWTON whose telephone number is (313)446-6604. The examiner can normally be reached M-F 8:00AM-4:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H. CHOI can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD A NEWTON/Primary Examiner, Art Unit 3681
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