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.
Claims 3-11, 13, & 14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the multiple test persons" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the slow wave sleep information…" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the template" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the whole head topographies" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the first regressor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the slow oscillation power of the template correlation" in line & 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the variance of the slow oscillation power of the template correlation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the second regressor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the average global gamma p" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the correlation of the whole head topographies" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the template" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the SO power of the template correlation" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the variance of SO power of the template correlation" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the percentage of power in SO frequency band" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the limitation "the average global gamma power" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the presence of artifacts/arousals" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the artifact/arousal detection process" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the voltage range" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the amplitude" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the frontal power" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the average global gamma power" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the frontal amplitude" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the frontal delta power" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the average global gamma power" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 11-15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 13 recites the limitation "the randomized noise stimulation" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the line increase of volume" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0092600 hereinafter Simons.
In regards to Claim 1: A sleep-based detection and intervention system (1) for treatment of major depressive disorder comprising:
an electroencephalography cap with multiple electrodes configured for recording an electroencephalogram of a patient's brain (Simons, Paragraph 8; “head cap”),
an earphone device configured for an ear or the ears of the patient (Simons, Paragraph 30 & 43),
a processing unit being connected to the electroencephalography cap and to the earphone device (Simons, Paragraph 49; Figure 2-6 Item 212), wherein the processing unit includes
a template-based algorithm configured for detecting slow wave sleep of the patient based on the electroencephalogram recorded by the multiple electrodes of the electroencephalography cap (Simons, Paragraph 42 & 43; Figure 1 Item 116), and
an acoustic intervention protocol configured for providing a noise stimulation to the patient via the earphone device when slow wave sleep is detected by the template-based algorithm (Simons, Paragraph 30 & 43; Figure 1 Item 130).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2009/0192556 hereinafter Wu.
In regards to Claim 2: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the template-based algorithm is based on a template referring to averaged slow wave sleep information of multiple test persons.
Wu teaches wherein the template-based algorithm is based on a template referring to averaged slow wave sleep information of multiple test persons (Wu, Paragraph 146; based on data gathered from more than one patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the test information taught in Wu to the device of Simons, the motivation being to provide useful information to the clinician to determine different patient sleep stages so they may calibrate and adjust the system.
Claim(s) 3, 6, 9, & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2019/0126033 hereinafter Pradeep.
In regards to Claim 3: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the slow wave sleep information used for creating the template is in the form of multiple whole head topographies from each of the multiple test persons recorded at the time-point of a frontal slow wave peak in the electroencephalogram.
Pradeep teaches wherein the slow wave sleep information used for creating the template is in the form of multiple whole head topographies from each of the multiple test persons recorded at the time-point of a frontal slow wave peak in the electroencephalogram (Pradeep, Paragraph 84; participants learned 120 non-sense words and hypnograms were created as templates with one older fig. 2c and one younger fig. 2d participant provided).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the whole head topographies taught in Pradeep to the device of Simons, the motivation being to provide a readable representation of the users brain activities.
In regards to Claim 6: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the first regressor includes the slow oscillation power of the template correlation, the variance of the slow oscillation power of the template correlation and a relative percentage of the slow oscillation power of the template correlation.
Pradeep teaches wherein the first regressor includes the slow oscillation power of the template correlation, the variance of the slow oscillation power of the template correlation and a relative percentage of the slow oscillation power of the template correlation (Pradeep, Paragraph 149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the slow oscillation power of the template taught in Pradeep to the device of Simons, the motivation being to provide a further analysis of the user’s brain activity.
In regards to Claim 9: Simons teaches of the sleep-based detection and intervention system according to any one of claim 1, but does not teach wherein the template-based algorithm is configured to determine the presence of artifacts/arousals based on an artifact/arousal detection process running parallel to slow wave sleep detection.
Pradeep teaches wherein the template-based algorithm is configured to determine the presence of artifacts/arousals based on an artifact/arousal detection process running parallel to slow wave sleep detection (Pradeep, Paragraph 51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the determination of arousal taught in Pradeep to the device of Simons, the motivation being to provide a more data about the user’s state of sleep.
In regards to Claim 11: Simons teaches of the sleep-based detection and intervention system according to claim 10, wherein the frontal amplitude and the frontal delta power and the average global gamma power of the electroencephalogram are preferably determined across a 4 s moving window and preferably checked every 0.5 s.
Pradeep teaches wherein the frontal amplitude and the frontal delta power and the average global gamma power of the electroencephalogram are preferably determined across a 4 s moving window and preferably checked every 0.5 s (Pradeep, Paragraph 45; Examiner interprets the device of Pradeep to be capable of identifying average gamma & delta).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the determination of arousal taught in Pradeep to the device of Simons, the motivation being to provide a more data about the user’s state of sleep.
Claim(s) 4 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2019/0126033 hereinafter Pradeep in view of US 2009/0192556 hereinafter Wu.
In regards to Claim 4: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the template-based algorithm is configured to determine a correlation of whole head topographies of the patient with the template in order to detect slow wave sleep.
Wu teaches wherein the template-based algorithm is configured to determine a correlation of the patient with the template in order to detect slow wave sleep (Wu, Paragraph 210).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the correlation of the patient with the template taught in Wu to the device of Simons, the motivation being to provide a further analysis of the user’s sleep.
Pradeep teaches of whole head topographies (Pradeep, Paragraph 84).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the whole head topographies of Pradeep to the device of a modified Simons, the motivation being to provide a readable view of the user.
In regards to Claim 8: Simons teaches of the sleep-based detection and intervention system according to any one of claims 1, but does not teach wherein the correlation of the whole head topographies of the patient with the template is calculated over a moving window, respectively, wherein the SO power of the template correlation, the variance of SO power of the template correlation and the percentage of power in SO frequency band are preferably calculated across a 10 s moving window and wherein the average global gamma power of the encephalogram is preferably calculated across a 4 s moving window.
Wu teaches wherein the correlation of the patient with the template is calculated over a moving window, respectively (Wu, Paragraph 210).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the moving window taught in Wu to the device of Simons, the motivation being to provide a detailed data set of the whole brain.
Pradeep teaches of whole head topographies (Pradeep, Paragraph 84).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the whole head topographies of Pradeep to the device of a modified Simons, the motivation being to provide a readable view of the user sleep condition.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2019/0126033 hereinafter Pradeep in view of US 2012/0159656 hereinafter Gerber.
In regards to Claim 5: Simons teaches all of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the template-based algorithm is configured to use the determined correlation of the whole head topographies of the patient with the template in a linear model including a first regressor and a second regressor.
Pradeep teaches wherein the template-based algorithm is configured to use the determined correlation of the whole head topographies of the patient with the template in a linear model including a first regressor (Pradeep, Paragraph 149; Examiner interprets “performed for every channel separately based on previously established algorithms” to teach multiple regressors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the whole head topographies including a first regressor taught in Pradeep to the device of Simons, the motivation being to provide a readable view of the user sleep condition.
Gerber teaches of a second regressor (Gerber, Paragraph 20 &22; “average power of gamma oscillations”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add a second regressor taught in Gerber to the device of Simons, the motivation being to provide a readable view of the user sleep condition.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2012/0159656 hereinafter Gerber.
In regards to Claim 7: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the second regressor includes the average global gamma power of the electroencephalogram.
Gerber teaches wherein the second regressor includes the average global gamma power of the electroencephalogram (Gerber, Paragraph 20 & 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add a second regressor taught in Gerber to the device of Simons, the motivation being to provide a readable view of the user sleep condition.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2019/0126033 hereinafter Pradeep in view of US 2008/0269630 hereinafter Denison.
In regards to Claim 10: Simons teaches of the sleep-based detection and intervention system according to claim 9, but does not teach wherein the artifact/arousal detection process includes the voltage range of the electroencephalogram, the amplitude and the frontal delta power as well as the average global gamma power of the electroencephalogram.
Pradeep teaches wherein the artifact/arousal detection process includes the amplitude and the frontal delta power as well as the average global gamma power of the electroencephalogram (Pradeep, Paragraph 45; Examiner interprets the device of Pradeep to be capable of identifying average gamma & delta).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the arousal detection process taught in Pradeep to the device of Simons, the motivation being to provide accurate information on the user’s sleep condition.
Denison teaches of wherein the artifact/arousal detection process includes the voltage range of the electroencephalogram (Denison, Paragraph 76).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the arousal detection process taught in Pradeep to the device of Simons, the motivation being to provide accurate information on the user’s sleep condition.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2020/0105398 hereinafter Chen.
In regards to claim 12: Simons teaches of the sleep-based detection and intervention system according to any one of claims 1 to 11, but does not teach wherein the acoustic intervention protocol provides for a randomized noise stimulation, wherein preferably the randomized noise stimulation has a randomized duration of preferably about 50 ms to about 500 ms.
Chen teaches wherein the acoustic intervention protocol provides for a randomized noise stimulation, wherein preferably the randomized noise stimulation has a randomized duration of preferably about 50 ms to about 500 ms (Chen, Paragraph 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the randomized noise stimulation taught in Chen to the device of Simons, the motivation being to keep the user from getting used to one type of stimulation.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2013/0324880 hereinafter Adachi.
In regards to Claim 13: Simons teaches all of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the randomized noise stimulation has a linear increase of volume, preferably from about 40 dB to about 106 dB in preferably about 60s, wherein preferably the randomized noise stimulation has randomized interstimulus intervals of about 1 s to about 4 s.
Adachi teaches wherein the randomized noise stimulation has a linear increase of volume, preferably from about 40 dB to about 106 dB in preferably about 60s, wherein preferably the randomized noise stimulation has randomized interstimulus intervals of about 1 s to about 4 s (Adachi, Paragraph 124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the linear increase in volume taught in Adachi to the device taught in Simons, the motivation being to provide just enough stimulation to affect the user.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2021/0138186 hereinafter O’Neill.
In regards to Claim 14: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the linear increase of volume is combined with random walks between preferably about +/- 2.5 dB.
O’Neill teaches wherein the linear increase of volume is combined with random walks between preferably about +/- 2.5 dB (O’Neill, Paragraph 326).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the random walks taught in O’Neill to the device of Simons, the motivation being to provide just enough stimulation to affect the user.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0092600 hereinafter Simons in view of US 2019/0387335 hereinafter Hughes.
In regards to Claim 15: Simons teaches of the sleep-based detection and intervention system according to claim 1, but does not teach wherein the acoustic intervention protocol is configured to provide that upon artifact/arousal detection noise stimulation is reset and suppressed for a period of time, preferably for about 35 s.
Hughes teaches wherein the acoustic intervention protocol is configured to provide that upon artifact/arousal detection noise stimulation is reset and suppressed for a period of time, preferably for about 35 s (Hughes, Paragraph 9; “the stimulus generation unit being further configured to introduce a delay between the plurality of actuation signals representative of said audio signal and the binaural modified audio signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the delay between stimulations taught in Hughes to the device of Simons, the motivation being to provide time for the conditions to change.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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