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 implant