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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2022 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 10, 13, 20, 33, 35, and 42 are 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.
Claims 10 and 33 recite the limitation “wherein altering based on determining that the subject is asleep” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The preceding claims recite determining a sleep state of the subject not determining that the subject is asleep.
Claims 13, 20, 35, and 42 recite the term “about” with a range, which makes the claim unclear because it cannot be determined what degree outside of the range is encompassed by the term “about”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 25-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-18 of U.S. Patent No. 11,534,571. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 11-18 of US 11,534,571 disclose a species that anticipates the current genus claims. The claims are mapped as follows:
The limitations of claims 1 and 2 are disclosed by claim 1 of US 11,534,571. The key difference is that claim 1 of US 11,534, 571 recites the generation of physiological data using the sensor and gives more specifics about the vibratory output. There is also a wording difference with providing physiological data from the sensor to a processor vs receiving physiological data of the subject from the processor, which are essentially the same thing but described from sender vs receiver perspectives.
In addition, the limitations in claim 2 are also present in claim 1 of US 11,534, 571. Thus, claim 1 of US 11,534,571 is a species of the current genus claims.
The limitations of claim 3 recites the same limitations as claim 2 of US 11,534,571.
The limitations of claim 4 recites the same limitations as claim 3 of US 11,534,571.
The limitations of claim 5 recites the same limitations as claim 4 of US 11,534,571.
The limitations of claim 6 recites the same limitations as claim 5 of US 11,534,571.
The limitations of claim 7 recites the same limitations as claim 6 of US 11,534,571.
The limitations of claim 8 recites the same limitations as claim 7 of US 11,534,571.
The limitations of claim 9 recites the same limitations as claim 8 of US 11,534,571.
The limitations of claim 25 are all disclosed by claim 11 of US 11,534, 571. The key difference is that claim 11 of US 11,534,571 further includes the presence of a sensor and gives more specifics about the vibratory output. Thus, claim 11 of US 11,534,571 is a species of the current genus claim.
The limitations of claim 26 recites the same limitations as claim 12 of US 11,534,571.
The limitations of claim 27 recites the same limitations as claim 13 of US 11,534,571.
The limitations of claim 28 recites the same limitations as claim 14 of US 11,534,571.
The limitations of claim 29 recites the same limitations as claim 15 of US 11,534,571.
The limitations of claim 30 recites the same limitations as claim 16 of US 11,534,571.
The limitations of claim 31 recites the same limitations as claim 17 of US 11,534,571.
The limitations of claim 32 recites the same limitations as claim 18 of US 11,534,571.
Claim Rejections - 35 USC § 102
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, 2, 4-7, 11, 13, 14, 17, 18, 20, 22, 24, 25, 27-30, 35, 36, 39, 40, and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0110461 (Yamaki et al., hereinafter Yamaki).
In regards to claims 1 and 2, Yamaki discloses a computer-implemented method (paragraphs 16-98 and figures 1-8) comprising the following steps:
configuring a stimulation device comprising a transducer to emit a transcutaneous vibratory output to a body part of a subject (shown in figure 1 and paragraphs 17-67; without further defining how the configuring is done, Yamaki would meet the limitations of the claim);
receiving physiological data of the subject from at least one sensor at a processor (paragraphs 18-19);
providing, with the processor, a stimulation pattern for the transcutaneous vibratory output to be emitted by the transducer, the stimulation pattern comprising a perceived pitch, a perceived beat, and an intensity of the transcutaneous vibratory output (paragraphs 23-24);
causing, by the processor, the transducer to emit the transcutaneous vibratory output in the stimulation pattern (paragraph 24);
determining a sleep state of the subject based on the physiological data (paragraphs 6 and 44); and
altering, by the processor, the stimulation pattern based on the sleep state, wherein altering comprises at least one of (i) reducing a frequency of the perceived pitch, (ii) increasing an interval of the perceived beat, or (iii) reducing the intensity (paragraphs 51-63).
wherein the sleep state is at least one of pre-sleep, almost asleep, disturbed sleep, or asleep (paragraphs 6 and 44).
In regards to claims 4 and 5, Yamaki discloses the limitations of claim 1. Yamaki further discloses reducing the frequency of the perceived pitch to a first reduced frequency and maintaining the first reduced frequency for a selected period of time, and further reducing the first reduced frequency to a second reduced frequency and maintaining the second reduced frequency for a selected period of time (paragraphs 51-54).
In regards to claims 6 and 7, Yamaki discloses the limitations of claim 1. Yamaki discloses increasing the interval of the perceived beat to a first increased interval and maintaining the first increased interval for a selected period of time, and further increasing the first increased interval to a second increased interval and maintaining the second increased interval for a selected period of time (paragraphs 56-62; increasing note values correspond to increased intervals).
In regards to claim 11, Yamaki discloses the limitations of claim 1. In addition, as noted in paragraphs 18 and 19, the sensors are used to acquire breathing rate, which can be considered as respiration rate data.
In regards to claim 13, Yamaki discloses the limitations of claim 1. In addition, as noted in paragraphs 51-54, the pitches used falls within the claimed range.
In regards to claims 14, Yamaki discloses the limitations of claim 4. In addition, as shown in paragraphs 51-54, the first reduced frequency (the 8-14 Hz in paragraph 52) is less than 40 Hz.
In regards to claim 17, Yamaki discloses the limitations of claim 5. In addition, as shown in paragraphs 51-54, the second reduced frequency (4-8 Hz in paragraph 53) is about 75% of the first reduced frequency (8-14 Hz in paragraph 52).
In regards to claim 18, Yamaki discloses the limitations of claim 5. In addition, as shown in paragraphs 51-54, there is a third reduced frequency (0.5-4 Hz in paragraph 54) that is about 50% of the first reduced frequency.
In regards to claim 20, Yamaki discloses the limitations of claim 1. In addition, as noted in paragraphs 56-62, one of the perceived beat ranges disclosed is from 0.5-4 Hz and from 4-8 Hz, which would include the claimed range.
In regards to claims 22 and 24, Yamaki discloses the limitation of claims 6 and 7. Paragraphs 56-62 further show reducing the perceived beat by about 50% by about 25 % (from 8-14 Hz to 4-8 Hz to 0.5 Hz-4 Hz).
In regards to claim 25, Yamaki discloses a system (paragraphs 16-98 and figures 1-8) with the following components:
a stimulation device comprising:
a transducer (51/52) adapted to emit a transcutaneous vibratory output (paragraphs 17-67); and
a processor (20) in electronic communication with the transducer, the processor receiving physiological data of a subject (paragraphs 18-19 and 69) and programmed to:
cause the transducer to emit stimulation, wherein the stimulation comprises the transcutaneous vibratory output having parameters comprising a perceived pitch, a perceived beat, and an intensity (paragraph 24);
determine a sleep state of the subject based on the physiological data; and alter the transcutaneous vibratory output based on the sleep state (paragraphs 6 and 44), wherein altering comprises at least one of (i) reducing a frequency of the perceived pitch, (ii) increasing an interval of the perceived beat, or (iii) reducing the intensity of the transcutaneous vibratory output (paragraphs 51-63).
In regards to claim 27 and 28, Yamaki discloses the limitations of claim 25. Yamaki further discloses reducing the frequency of the perceived pitch to a first reduced frequency and maintaining the first reduced frequency for a selected period of time, and further reducing the first reduced frequency to a second reduced frequency and maintaining the second reduced frequency for a selected period of time (paragraphs 51-54).
In regards to claims 29 and 30, Yamaki discloses the limitations of claim 25. Yamaki further discloses increasing the interval of the perceived beat to a first increased interval and maintaining the first increased interval for a selected period of time, and further increasing the first increased interval to a second increased interval and maintaining the second increased interval for a selected period of time (paragraphs 56-62).
In regards to claim 35, Yamaki discloses the limitations of claim 25. In addition, as noted in paragraphs 51-54, the pitches used falls within the claimed range.
In regards to claims 36, Yamaki discloses the limitations of claim 27. In addition, as shown in paragraphs 51-54, the first reduced frequency (the 8-14 Hz in paragraph 52) is less than 40 Hz.
In regards to claim 39, Yamaki discloses the limitations of claim 28. In addition, as shown in paragraphs 51-54, the second reduced frequency (4-8 Hz in paragraph 53) is about 75% of the first reduced frequency (8-14 Hz in paragraph 52).
In regards to claim 40, Yamaki discloses the limitations of claim 28. In addition, as shown in paragraphs 51-54, there is a third reduced frequency (0.5-4 Hz in paragraph 54) that is about 50% of the first reduced frequency.
In regards to claim 42, Yamaki discloses the limitations of claim 25. In addition, as noted in paragraphs 56-62, one of the perceived beat ranges disclosed is from 0.5-4 Hz and from 4-8 Hz, which would include the claimed range.
Claim(s) 1, 2, 8, 9, 25, 31, and 32 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2020/0170568 (Mercier et al., hereinafter Mercier).
In regards to claims 1 and 2, Mercier discloses a computer-implemented method (paragraphs 37-252 and figures 1-7) comprising the following steps:
configuring a stimulation device comprising a transducer to emit a transcutaneous vibratory output to a body part of a subject (paragraphs 38 and 147 describe how to set up the device on the patient; figures 1-3);
receiving physiological data of the subject from at least one sensor at a processor (paragraphs 38, 43, 72-74);
providing, with the processor, a stimulation pattern for the transcutaneous vibratory output to be emitted by the transducer, the stimulation pattern comprising a perceived pitch, a perceived beat, and an intensity of the transcutaneous vibratory output (paragraphs 19-23 and 57);
causing, by the processor, the transducer to emit the transcutaneous vibratory output in the stimulation pattern (paragraphs 19-23 and 57);
determining a sleep state of the subject based on the physiological data (paragraphs 91-92 and 109-114); and
altering, by the processor, the stimulation pattern based on the sleep state, wherein altering comprises at least one of (i) reducing a frequency of the perceived pitch, (ii) increasing an interval of the perceived beat, or (iii) reducing the intensity (paragraphs 121, 129-131, and 244).
wherein the sleep state is at least one of pre-sleep, almost asleep, disturbed sleep, or asleep (paragraphs 121 and 129-131).
In regards to claims 8 and 9, Mercier discloses the limitations of claim 1. Mercier further discloses reducing the intensity to a first reduced intensity and maintaining the first reduced intensity for a selected period of time, and further reducing the first reduced intensity to a second reduced intensity and maintaining the second reduced intensity for a selected period of time (paragraph 244).
In regards to claim 25, Mercier discloses a system (paragraphs 37-252 and figures 1-7) with the following components:
a stimulation device (1) comprising:
a transducer (4) adapted to emit a transcutaneous vibratory output (paragraphs 38 and 147); and
a processor in electronic communication with the transducer, the processor receiving physiological data of a subject (paragraphs 32, 43, and 72-74) and programmed to:
cause the transducer to emit stimulation, wherein the stimulation comprises the transcutaneous vibratory output having parameters comprising a perceived pitch, a perceived beat, and an intensity (paragraphs 19-23, 57, and 244);
determine a sleep state of the subject based on the physiological data (paragraphs 91-92, and 109-114); and
alter the transcutaneous vibratory output based on the sleep state, wherein altering comprises at least one of (i) reducing a frequency of the perceived pitch, (ii) increasing an interval of the perceived beat, or (iii) reducing the intensity of the transcutaneous vibratory output (paragraphs 121, 129-131, and 244).
In regards to claims 31 and 32, Mercier discloses the limitations of claim 25. Mercier further discloses reducing the intensity to a first reduced intensity and maintaining the first reduced intensity for a selected period of time, and further reducing the first reduced intensity to a second reduced intensity and maintaining the second reduced intensity for a selected period of time (paragraph 244).
Claim Rejections - 35 USC § 103
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) 3, 12, 15, 16, 19, 21, 23, 26, 34, 37, 38, 41, and 43-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0110461 (Yamaki et al., hereinafter Yamaki) as applied to claims 1, 4, 5, 18, 25, 27, 28, and 40 above, and further in view of US 2018/0099116 (Ashby).
In regards to claims 3 and 26, Yamaki discloses the limitations of claims 1 and 25 but do not state that the step of powering off the stimulation device based on determining that the subject is asleep/in a sleep state. Ashby discloses a similar method and system (Abstract) comprising powering off a stimulation device based on a determination that the subject is in a sleep state in order to avoid influencing heart rate during REM sleep (paragraph 90). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of Yamaki by powering off the therapeutic stimulation device based on a determination that the subject is in a sleep state, as taught by Ashby, state in order to avoid influencing heart rate during REM sleep.
In regards to claims 12, 16, 19, 34, 38, and 41, Yamaki discloses the limitations of claims 1, 5, 18, 25, 28, and 40. In addition, as shown in paragraphs 51-54, the frequency ranges for each time interval. However, Yamaki does not disclose the rates of decrease of the frequency. In a related area, Ashby discloses a system for monitoring and controlling sleep (see title and abstract). Ashby states in paragraphs 88-90 that treatment time increments can vary depending on the state of the user. Depending on the chosen frequencies for each interval and the chosen time increment, the frequency reduction rate would be met. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method and system of Yamaki to arrive at the claimed rate of frequency reduction, because time increments of treatments are varied and are optimized depending on the state of the patient as taught by Ashby.
In regards to claims 15 and 37, Yamaki discloses the limitations of claims 4 and 27 but does not give details about the first selected period of time. In a related area, Ashby discloses a system for monitoring and controlling sleep (see title and abstract). Ashby states in paragraphs 88-90 that treatment time increments can vary depending on the state of the user. Note that one of the time increments mentioned is 1.0 minutes or 60 seconds. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method and system of Yamaki to arrive at the claimed period of time, because time increments of treatments are varied and are optimized depending on the state of the patient as taught by Ashby.
In regards to claims 21 and 23, Yamaki discloses the limitations of claim 1 and 7 but does not state the rate of reduction of the perceived beat. In a related area, Ashby discloses a system for monitoring and controlling sleep (see title and abstract). Ashby states in paragraphs 88-90 that treatment time increments can vary depending on the state of the user. Depending on the chosen beat frequencies for each interval and the chosen time increment, the beat reduction rate would be met. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method and system of Yamaki to arrive at the claimed rate of beat frequency reduction, because time increments of treatments are varied and are optimized depending on the state of the patient as taught by Ashby.
In regards to claims 43, 44, 45, and 46, Yamaki discloses the limitations of claims 25 and 30. Yamaki shows in paragraphs 56-62 reducing the perceived beat by about 50% by about 25 % by increasing the intervals (from 8-14 Hz to 4-8 Hz to 0.5 Hz-4 Hz). However, Yamaki does not disclose the rates of decrease of the perceived beat. In a related area, Ashby discloses a system for monitoring and controlling sleep (see title and abstract). Ashby states in paragraphs 88-90 that treatment time increments can vary depending on the state of the user. Depending on the chosen frequencies for each interval and the chosen time increment, the beat frequency reduction rates would be met. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method and system of Yamaki to arrive at the claimed rate of beat frequency reduction, because time increments of treatments are varied and are optimized depending on the state of the patient as taught by Ashby.
Claim(s) 10 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0110461 (Yamaki et al., hereinafter Yamaki) as applied to claims 1 and 25 above, and further in view of US 2013/0303837 (Berka et al., hereinafter Berka).
In regards to claims 10 and 33, Yamaki discloses the limitations of claims 1 and 25. However, Yamaki does not state that the altering step includes generating a stimulation pattern configured for sleep maintenance. In a related area, Berka discloses systems and methods for optimization of sleep and post-sleep performance (title and abstract, paragraphs 41-114). Berka shows in paragraphs 40-43 the generation of stimuli (which would have a pattern) to maintain a current sleep state. Berka suggests maintaining sleep maintenance in order to obtain efficient sleep in a manner that lowers the amount of patient’s sleep debt (paragraph 88). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method and system of Yamaki to generate a stimulation pattern for sleep maintenance as taught by Berka in order to obtain efficient sleep in a manner that lowers the amount of patient’s sleep debt.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0110461 (Yamaki et al., hereinafter Yamaki) as applied to claim 25 above, and further in view of US 2016/0015314 (Dusanter et al., hereinafter Dusanter).
In regards to claim 47, Yamaki discloses the limitations of claim 25. Yamaki further shows the determining of effectiveness of the stimulation (paragraphs 51-67; figure 8; system checks sleep state and determines next process) but does not state the process of generating visual feedback to the subject of the sleep or state or effectiveness. In a related area, Dusanter discloses a system and method to monitor and assist an individual’s sleep (title; abstract; paragraphs 59-163). Paragraphs 74-88 and 133-135 discloses the presence of a display unit as part of the system and displays data about the user’s sleep such as graphs of sleep quality, sleep stages, or hypnograms to provide the user with information relating to his/her health. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the system of Yamaki to generate visual feedback to the subject of at least one of the sleep state or the effectiveness in order to provide the user with information relating to his/her health.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791