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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 recites the limitation "…step c')…" in the last line of claim 4. There is insufficient antecedent basis for this limitation in the claim.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The judicial exception being an abstract idea. The claim(s) recite(s) transferring, identifying and detecting data that is then analyzed similar Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) which was directed to organizing information and manipulating information through mathematical correlations which is found to be patent ineligible. This judicial exception is not integrated into a practical application because when the claims are considered as a whole, there is no element or combination of elements in the claims that are sufficient to ensure that the claims amount to significantly more that the abstract idea itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims fail to recite any improvements to another technology or technical field, improvements to the functioning of the processor itself, and/or meaningful limitation beyond generally link the use of an abstract idea to a particular environment (i.e. there is not structural relationship between the abstract idea of organizing and analyzing data through mathematical correlations). The use of a data processing unit is merely generic. Therefore, because there is no meaningful limitations in the claim to transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim is rejected under 35 USC 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-9, 12-13, 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolea (US 20140228905).
Regarding claim 1, Bolea discloses a computer-implemented method for quantification of a level of response to nerve stimulation, the method comprising the following steps: transferring a stimulation parameter data to a data processing unit 30, 40 (Fig. 1, section 0127, a neurostimulator system 10 including implanted components 20, physician programmer 30 and patient controller 40); transferring at least a subgroup of physiological data corresponding to a subject to the data processing unit (Section 0151, the respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link. The respiratory sensor(s) may detect respiration directly or a surrogate thereof. The respiratory sensor(s) may measure, for example, respiratory airflow, respiratory effort (e.g., diaphragmatic or thoracic movement), intra-pleural pressure, lung impedance, respiratory drive, upper airway EMG, changes in tissue impedance in and around the lung(s) including the lungs, diaphragm and/or liver, acoustic airflow or any of a number other parameters indicative of respiration); identifying at least one physiological signal of the physiological data corresponding to the therapy's impact on the subject's airway opening (Section 0151, The respiratory sensor(s) may measure, for example, respiratory airflow, respiratory effort (e.g., diaphragmatic or thoracic movement), intra-pleural pressure, lung impedance, respiratory drive, upper airway EMG, changes in tissue impedance in and around the lung(s) including the lungs, diaphragm and/or liver, acoustic airflow or any of a number other parameters indicative of respiration); detecting ON-instants and OFF-instants in a defined time segment of the physiological data, wherein each ON-instant corresponds to an instant of time in which the subject was stimulated and wherein each OFF-instant corresponds to an instant of time in which the subject was not stimulated (Fig. 80I trace 3-4, Section 0508, 0509, a subset of ABAB mode known as A0A0 mode, wherein the B breath is not stimulated. A may be 2.0 mA and B may be 0 mA. A0B0 mode, wherein a first breath is stimulated at level "A," followed by a second breath that is unstimulated, followed by a third breath that is stimulated at level "B," followed by a fourth breath that is unstimulated, (e.g., A is 2.0 mA and B is 1.8 mA). This allows for simultaneous assessment of two different levels (A and B) when compared to adjacent non-stimulated breaths); detecting at least one breath cycle (Section 0515, providing the patient with stimulation during an entire respiratory cycle); for each breath cycle detected, analyzing an airflow segment and checking if it was synchronized with an ON-instant or with an OFF-instant (Fig. 80I trace 3-4, Section 0508, 0509, a subset of ABAB mode known as A0A0 mode, wherein the B breath is not stimulated. A may be 2.0 mA and B may be 0 mA. A0B0 mode, wherein a first breath is stimulated at level "A," followed by a second breath that is unstimulated, followed by a third breath that is stimulated at level "B," followed by a fourth breath that is unstimulated, (e.g., A is 2.0 mA and B is 1.8 mA). This allows for simultaneous assessment of two different levels (A and B) when compared to adjacent non-stimulated breaths); sorting each airflow segment into one of two groups (examiners broadest reasonable interpretation sees that first group of Bolea is a first breath is stimulated at level "A," and the second group is a second breath that is unstimulated “0” shown in Fig. 80l) based on its respectively checked synchronization with an ON/OFF-instant (section 0508-0509, a subset of ABAB mode known as A0A0 mode, wherein the B breath is not stimulated. A may be 2.0 mA and B may be 0 mA. A0B0 mode, wherein a first breath is stimulated at level "A," followed by an second breath that is unstimulated) the two groups being an ON-group comprising airflow signals that are synchronized with ON-instants (a first breath is stimulated at level "A,") and an OFF-group comprising airflow signals that are synchronized with OFF-instants (followed by an second breath that is unstimulated) (Fig. 80I trace 3-4, sections 0508-0509, a subset of ABAB mode known as A0A0 mode, wherein the B breath is not stimulated. A may be 2.0 mA and B may be 0 mA. A0B0 mode, wherein a first breath is stimulated at level "A," followed by an second breath that is unstimulated)); for each of the two groups, separately determining an airflow curve from all airflow segments of each respective group (Fig. 80I trace 9 show the airflow with respect to a first breath is stimulated at level "A," and an second breath that is unstimulated “0”); calculating a volume of air for each of the two airflows (section 0489, 0635, FIG. 80A, the bio-impedance respiration signal ("Z"), which is generated by dividing the change in measured voltage ("V") by the excitation current ("I"), tracks with diaphragm movement (DM) over time and therefore is a good measure of respiratory activity, and may be used to measure respiratory effort, respiratory rate, respiratory (tidal) volume, minute volume. ABAB, ramps may also be useful in determining absolute flow (e.g., tidal volume, minute volume, etc.) and determining what level of stimulation reduces or eliminates respiratory events, since stimulation is delivered every breath); and determining an impact of stimulation based on visualization of the two airflows and/or on a ratio of the two volumes (section 0505 FIG. 80I (traces 1-9), illustrates some commonly used modes, all of which are inspiratory synchronous, meaning stimulation is automatically delivered according to an algorithm that predicts the inspiratory phase and initiates stimulation delivery at a desired time relative to inspiration, such as centered on the predicted inspiration. Inspiration is shown in FIG. 80I (trace 9) in the upward direction. This Figure 80I shows the airflow trace 9 with respect to the on (wherein a first breath is stimulated at level "A,") and off airflow signal (a second breath that is unstimulated) of trace 3).
Regarding claim 2, Bolea discloses the physiological data comprises PSG data (Section 0297, 0505, The data 484 utilized in implementing the algorithm may include patient specific data derived from a sleep study i.e., PSG data. These modes may be used as standard therapy as well as to determine device settings during a PSG).
Regarding claim 5, Bolea discloses co-aligning all detected breath cycles within respiration cycles in the defined time segment (section 0498, the stimulation duty cycle is set using to programmer system 2100 to a fixed percentage value. This fixed value may be increased when the respiratory signal is lost, increasing the likelihood of aligning with actual inspiration. In adaptive mode, the duty cycle is allowed to vary as a function of a characteristic of respiration).
Regarding claim 6, Bolea discloses the ON-instants and the OFF-instants detected are each detected based on EMG signals of the physiological data (Section 0151, 0412, 0523, The respiratory sensor(s) may measure, for example, respiratory airflow, respiratory effort (e.g., diaphragmatic or thoracic movement), intra-pleural pressure, lung impedance, respiratory drive, upper airway EMG. The system described above may modulate electrical stimulation intensity proportion based on electromyogram (EMG) feedback from the muscles in the upper airway being stimulated or others in the area. Signals from the INS 1100 (such as sensed respiration impedance and stimulation output amplitude) can be represented by these outputs to allow simultaneous recording with other standard PSG signals (flow, belts, EMG/ECG).
Regarding claim 7, Bolea discloses at least one breath cycle is detected based on respiratory bands 922 signals of the physiological data (Fig. 51C, Section 0367,0369, a conventional respiratory belt to measure respiratory effort about the abdomen and/or chest. The respiratory sensor 916 may comprise a conventional respiratory belt 922 sensor to measure respiratory effort about the abdomen and/or chest, and sensor signals may be wirelessly transmitted to the remote ENS).
Regarding claim 8, Bolea discloses the determined average airflow of the ON-group in step i) corresponds to the average airflow induced by nerve stimulation (A) and that the determined average airflow of the OFF-group in step i) corresponds to the average airflow without stimulation of the nerve (Fig. 80I trace 3-4, sections 0508-0509, a subset of ABAB mode known as A0A0 mode, wherein the B breath is not stimulated. A may be 2.0 mA and B may be 0 mA. A0B0 mode, wherein a first breath is stimulated at level "A," followed by a second breath that is unstimulated, followed by a third breath that is stimulated at level "B," followed by a fourth breath that is unstimulated, (e.g., A is 2.0 mA and B is 1.8 mA). This allows for simultaneous assessment of two different levels (A and B) when compared to adjacent non-stimulated breaths)
Regarding claim 9, Bolea discloses a baseline is determined in step i), the baseline corresponding to the average airflow determined within the OFF- group (Section 0356, the measurement technique used to acquire the respiratory waveform, and the selection of the threshold, would require calibration based on a baseline related to the normal or usual respiratory effort for the patient, and to account for the configuration of the sensors measuring respiratory effort).
Regarding claim 12, Bolea discloses calculation of a stimulation hit rate (section 0354, First, the implanted neurostimulator may completely cease stimulation until an adequate signal is acquired. Second, the neurostimulator may deliver continuous simulation pulses of predetermined durations (e.g., up to 60 seconds) until an adequate signal is acquired; or if an adequate signal is not acquired in this time, the stimulation will be turned off).
Regarding claim 13, Bolea discloses determining a percentage of an inspiration phase that was in synch with the nerve stimulation, pre-defining a desired threshold; and m) calculate calculating an overall hit rate as a percentage of breath cycles with more than the predefined threshold of their inspiration phase in synch with the nerve stimulation compared to breath cycles with less than said pre-defined threshold. (Section 0469, the stimulation period is centered about a percentage (e.g., 75%) of the predictive respiratory period. The predictive algorithm uses historical peak data (i.e., begin-expiration data) to predict the time to the next peak, which is equivalent to the predicted respiratory period. The stimulation period is centered at 75%, for example, of the predicted respiratory time period. Thus, the stimulation trigger point is calculated by predicting the time to the next peak, adding 75% of that predicted time to the last peak, and subtracting 1/2 of the stimulation period (trigger time=time of last peak+75% of predicted time to next peak-1/2 stimulation period))
Regarding claim 15, Bolea discloses at least one of the following intermediate and/or final results is graphically displayed: - stimulation ON/OFF-instants (Fig. 80I, taces1-8);- breath cycles;- airflow signals;- average airflows - average volume of airs - impact of stimulations - inspiration portion of the airflow;- volume of air inspired with nerve stimulations - volume of air inspired without stimulation of the nerves - hit rate; and- average respiratory rate (Figs. 80A-C).
Regarding claim 16, Bolea discloses the stimulation parameter data and/or the physiological data are continuously obtained in real-time (Section 0297, The sensors and device memory are the sources of real-time data).
Regarding claim 17, Bolea discloses manually or automatically adjusting a nerve stimulation protocol based on the impact of stimulation determined in step j) (Section 0355, 0409, the respiratory waveform, such as the waveform characterized with an impedance value, can be identified and analyzed to determine patient status, sleep-related events, and responsiveness to therapy, and can be used to adjust therapy parameters. The stimulation level (i.e., voltage amplitude, pulse width, frequency) may be adjusted based on changes in respiration rate).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796