DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 55 and 70 are objected to because of the following informalities:
Regarding claim 55, add –to—between “configured” and “supply” in line 5 of the claim
Regarding claim 70, “recommendation” should be –recommended--
Appropriate correction is required.
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.
Claim 55 is directed to a judicial exception (i.e. a low of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 55-74 are directed to a system for determining insomnia using an algorithm which is an abstract idea. Claims 55-59 and 63-74 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below.
The analysis of claim 55 is as follows:
Step 1: Claim 55 is drawn to a product which is one of the statutory categories.
Step 2A -Prong one: Claim 55 recites an abstract idea. In particular, claim 1 recites the following limitations:
-determine a sleep-wake signal
- determine one or more sleep related parameters
-determine the user experienced insomnia
-identify a type of insomnia experienced by the user
These elements of claim 55 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgement, and opinion.
Step 2A – Prong 2: Claim 55 recites the following limitations that are beyond the judicial exception: a therapy system including sensors, a respiratory device, a user interface, memory, and control system.
These elements do not integrate the exception into a practical application of the exception. In particular, the element of a control system is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea.
Step 2B: Claim 55 does not recite additional elements that amount to significantly more than the judicial exception itself.
The additional elements of sensors, therapy device, and user interface do not qualify as significantly more because these limitations are simply appending well understood, routine and conventional activities previously known in the industry specified at a high level of generality, to the judicial exception. Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 55 and the dependent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above judicial exception. Looking at the limitations as a whole 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 the computer, for example or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer based problem or a particular way to achieve a desired computer based outcome. Rather the collective function of the claimed invention merely provides conventional computer implementation as a tool to perform the process.
Claims 56-59 and 63-74 depend from claim 55 and recite the same abstract idea as claim 55. Furthermore, these claims only contain recitations that further limit the abstract idea. Each of these claims merely are insignificant extrasolution activity to the judicial exception, e.g. mere data gathering in conjunction with the abstract idea that uses convention, routine and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known element.
Claims 60-62 provide steps which provide significantly more and thus are not rejected under U.S.C. 101.
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.
Claims 55-56 and 60-70 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al (US 2017/0239433), hereinafter Martin in view of Naujokat et al (US 2012/0238800), hereinafter Naujokat.
Regarding claim 55, Martin teaches a system (Fig. 1, Abstract, Paragraph 57, paragraph 82) comprising:
one or more sensors configured to generate first physiological data associated with the user during a first sleep session (paragraph 86, pressure and flow transducers, paragraph 99, movement sensor, paragraph 198, flow sensor determines sleep state, paragraph 208, pulse oximeter, accelerometer, activity sensor, audio sensor);
a therapy system (Fig. 1) including;
a respiratory device configured to supply pressurized air (paragraph 57, RPT device 4000); and
a user interface coupled to the respiratory device via a conduit (Fig. 1, paragraph 57, patient interface 3000, air circuit 4170), the user interface being configured to engage a portion of the user during the first sleep session to aid in directing the supplied pressurized air to an airway of the user (Fig. 1, paragraph 57, delivers air via mask to the airway of the patient);
a memory storing machine-readable instructions (Paragraph 122, one or more computer programs stored in a non-transitory computer readable storage medium such as memory 4260); and
a control system including one or more processors configured to execute the machine-readable instructions (paragraph 88, RPT device has a controller, a therapy device controller, paragraph 122, implement the one or more algorithms) to:
determine, based at least in part on the physiological data, a sleep-wake signal for the user during the first sleep session (Paragraph 198, the sleep state determination algorithm may monitor and analyze a signal representative of the patient to determine sleep state. The physiological parameter is the respiratory flow rate, paragraph 208 other sensors such as a pulse oximetry signal may be used or an accelerometer, or activity signal);
determine, based at least in part on the sleep-wake signal, one or more sleep-related parameters for the user during the first sleep session (paragraph 199, paragraph 200, detects SDB events or an absence of disturbances, Paragraph 208, may look at pulse oximetry signal or activity signal) ;
determine based at least in part on the one or more sleep-related parameters, that the user experienced insomnia during the first sleep session (Paragraph 232, periodic spikes in the EEG represent arousal, increased activity indicates arousal, paragraph 282, an increase in breathing rate indicates arousal).
Martin teaches that there are different types of insomnia (Paragraphs 292-294) but does not explicitly state that responsive to determining that the user experienced insomnia during the first sleep session identify a type for the insomnia.
However, Naujokat teaches a system for assessment of a sleep problem (Abstract) which determines based on one or more sleep related parameters for the user during the first sleep session that a user experienced insomnia (Paragraph 88, sleep pattern data includes wake time, patient’s sleep efficiency, sleep onset latency) and
responsive to the determining that the user experienced insomnia during the first sleep session, identify, based at least in part on the one or more sleep related parameters, a type for the insomnia experienced by the user. (Paragraph 92, sleep classifier unit, Paragraph 93, estimates sleep onset latency, wake after sleep onset, paragraph 123, identifying the type of insomnia)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included the classification of the type of insomnia as taught by Naujokat in the device of Martin in order to determine a proper course of treatment. (paragraphs 123, 175)
Regarding claim 56, Martin in view of Naujokat teaches the system of claim 55, and Martin further teaches wherein the one or more sensors includes a first sensor configured to generate at least a portion of the first physiological data, wherein the first sensor is coupled to or integrated in the therapy system. (Paragraph 86, flow sensor and pressure sensors in therapy device 4000, paragraph 198)
Regarding claim 60, Martin in view of Naujokat teaches the system of claim 55, and Martin further teaches wherein the control system is further configured to adjust one or more settings of the therapy system based at least in part on the determined type of insomnia. (Paragraph 258, adjusts EPAP during inspiration only to prevent arousals, paragraph 275, the gain of the control equation may be variable depending on the sleep state, Fig. 10, paragraph 277 specialized acclimatation therapy for insomnia patients, paragraph 278 paced breathing)
Regarding claim 61, Martin in view of Naujokat teaches the system of claim 60, and Martin further teaches wherein the adjusting the one or more settings of the therapy system includes adjusting a pressure setting of the respiratory device. (paragraphs 258, 275, 277, 278)
Regarding claim 62, Martin in view of Naujokat teaches the system of claim 61, and Martin further teaches wherein the adjusting the pressure setting includes reducing the pressure setting, increasing the pressure setting, adjusting a pressure ramp up, or prolonging the delivery of pressurized air. (Fig. 10, paragraph 281, starts with smooth and comfortable waveform template, paragraph 282 if the patient’s breathing rate is greater than the interim breathing rate target the pressure is increased)
Regarding claim 63, Martin in view of Naujokat teaches the system of claim 55, and Martin further teaches wherein the sleep-wake signal is indicative of one or more sleep stages during the first sleep session, the one or more sleep stages including a wakefulness stage, a first non-REM stage, a second non-REM stage, a third non-REM stage, a REM stage, or any combination thereof. (paragraph 66)
Regarding claim 64, Martin in view of Naujokat teaches the system of claim 55, but Martin does not teach wherein the one or more sleep related parameters includes a total includes a total sleep time, a total time in bed, a go-to-sleep time, an initial sleep time, a sleep onset latency, a persistent sleep onset latency, a wake-after-sleep-onset parameter, a persistent wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof.
However, Naujokat teaches wherein the one or more sleep related parameters includes a total includes a total sleep time, a total time in bed, a go-to-sleep time, an initial sleep time, a sleep onset latency, a persistent sleep onset latency, a wake-after-sleep-onset parameter, a persistent wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof. (Paragraph 90, a total wake time, a sleep efficiency, sleep onset latency, a total sleep time, awakenings after sleep onset)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Martin with the details of the sleep related parameters as taught by Naujokat in order to determine the severity of the user’s insomnia. (paragraph 123)
Regarding claim 65, Martin in view Naujokat teaches the system of claim 64, and Naujokat teaches wherein the sleep onset latency is determined as a function of the go-to-sleep time and the initial sleep time. (paragraph 90, the sleep onset latency is the time between the patient getting into bed and first falling asleep)
Regarding claim 66, Martin in view of Naujokat teaches the system of claim 65, and Naujokat further teaches wherein the identified type of insomnia is a sleep-onset insomnia and the identifying the type of insomnia includes determining that the sleep onset latency is equal to or greater than a predetermined threshold. (Paragraph 93, measures of insomnia may be compared to a standard threshold for example the sleep onset latency threshold is set to 30 minutes)
Regarding claim 67, Martin in view of Naujokat teaches the system of claim 64, and Naujokat further teaches wherein the type of insomnia is a sleep-maintenance insomnia and the identifying the type of insomnia includes determining that the wake-after-sleep-onset parameter is equal to or greater than a predetermined threshold or determining that the sleep efficiency is equal to or less than a predetermined threshold. (paragraph 93, sleep efficiency may be compared to standard thresholds such as 90% to assess whether or not the patient sleeps in a consolidated way)
Regarding claim 68, Martin in view of Naujokat teaches the system of claim 55, and Martin further teaches wherein the control system is further configured to determine that the user experienced a different sleep-related disorder during the sleep session (paragraph 157, determines apnea or hypopnea), wherein the different sleep-related disorder is a central apnea, an obstructive apnea, a mixed apnea, a hypopneas snoring, a periodic limb movement, restless leg syndrome, chocking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof. (paragraph 157, 188, 189)
Regarding claim 69, Martin in view of Naujokat teaches the system of claim 55, and Naujokat further teaches wherein the control system is further configured to receive personal data associated with the user and identifies the type of insomnia based at least in part on the personal data.(Paragraph 122, includes gathering data on the patient’s sleep history, paragraph 123, the patient input data and the sleeping activity data to identify factors contributing to the patient’s insomnia, identifying the type of insomnia)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Martin with the personal data associated with the user as taught by Naujokat in order to assist in identifying the type, cause, and severity of the insomnia. (paragraph 123)
Regarding claim 70, Martin in view of Naujokat teaches the system of claim 55, and Naujokat teaches wherein the control system is further configured to (i) determine a recommended action for the user based on the identified type of insomnia to aid in reducing or preventing insomnia symptoms in a second, subsequent sleep session (paragraph 123, recommendation and (ii) cause indicia indicative of the recommended action to be displayed on a display device, wherein the recommendation action includes a suggested bedtime, a suggested wake-up time, a suggested diet, a suggested exercise routine, a suggested sleep medication, a suggested relaxation program, a suggested masking noise, a suggested breathing program, a suggested bedroom activity change, or any combination thereof. (paragraph 123, recommended course of therapy provided to the patient via the display, paragraph 125, include a sleep scheduling module, relaxation module, lifestyle module, paragraph 156, physical activity coaching, caffeine and alcohol coaching)
Claims 57-59 are rejected under 35 U.S.C. 103 as being unpatentable over Martin in view of Naujokat, and further in view of Kapust et al (US 2010/0252042), hereinafter Kapust.
Regarding claim 57, Martin in view of Naujokat teaches the system of claim 55, and Martin further teaches wherein the one or more sensors includes a first sensor configured to generate at least a portion of the first physiological data (Paragraph 198 flow sensor to determine sleep wake signal) but does not teach a second sensor.
However, Kapust teaches a system for ventilation (Abstract) which includes a second sensor configured to generate a second portion of the first physiological data. (Paragraph 367, may include an additional sensor to classify stages of sleep)
It would have been obvious to a person or ordinary skill in the art to have included the additional sensor as taught by Kapust in order to improve accuracy of sleep stage detection.
Regarding claim 58, Martin in view of Naujokat and Kapust teaches wherein the first sensors is coupled to or integrated in the respiratory device of the therapy system (Martin, paragraph 86, flow sensors part of the RPT device) and the second sensor is coupled to or integrated in a user device. (Martin, paragraph 232, Martin teaches that EEGs are a separate user device)
Regarding claim 59, martin in view of Naujokat and Kapust teaches the system of claim 58, and Martin further teaches wherein the user device is a mobile device, a smart phone, a tablet, a laptop, a television, or a wearable device. (Paragraph 232, the EEG sensor is wearable on the person’s head)
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Martin in view of Naujokat, and further in view of Stahmann et al (US 2006/011561), hereinafter Stahmann.
Regarding claim 71, Martin in view of Naujokat teaches the system of claim 55, but does not teach wherein the one or more sensors are configured to generate (i) second physiological data associated with the user subsequent to the first sleep period session and prior to the second sleep session.
However, Stahmann teaches a patient monitoring system (abstract) wherein the one or more sensors are configured to generate (i) second physiological data associated with the user subsequent to the first sleep period session and prior to the second sleep session (Paragraph 1502, detects data during non-sleep)
Martin teaches (ii) third physiological data associated with the user during a second sleep session. (the device of Martin would collect third physiological data in the following sleep session)
Therefore, the combination of Martin, Naujokat and Stahmann teaches using to generate (i) second physiological data associated with the user subsequent to the first sleep period session and prior to the second sleep session.
It would have been obvious to a person or ordinary skill in the art to include the second physiological data of Stahmann in the device of Martin in view of Naujokat in order to modulate respiration therapy at night. (Paragraph 1503)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785