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 .
Response to Arguments
Applicant’s arguments, see Page 6, filed 21 July 2026, with respect to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments, see Page 7, filed 21 July 2026, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 1 & 7 have been withdrawn.
Applicant’s arguments, see Pages 7 & 8, filed 21 July 2026, with respect to the 35 U.S.C. § 112 rejections have been fully considered and are persuasive. The 35 U.S.C. § 112 rejection of claims 1, 4, 7, 9, 10, 12, & 15 has been withdrawn.
Applicant's arguments filed 21 July 2026, regarding the 35 U.S.C. § 102(a)(1)(2) rejection of claim 1, have been fully considered but they are not persuasive. Regarding the applicant’s argument that Gavish does not teach generating a second user perceptible stimulus that is indicative of the synchronization status, Examiner points out that Paragraphs 11 & 24 show that the device of Gavish can produce multiple stimuli. The cited paragraph 50 is being used to describe the process of each stimulus.
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) 1-5, 9-10, & 14-15 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by US 2015/0367097 hereinafter Gavish.
In regards to Claim 1: A method for controlling a sleep-aid apparatus, the sleep aid apparatus comprising one or more stimulus generators operable to generate user-perceptible stimuli with one or more sensory modalities, and the sleep aid apparatus further comprising a physiological sensor to generate sensor data (Gavish, Figure 1 Items 112 & 116); wherein the method comprises:
receiving the sensor data from the physiological sensor (Gavish, Paragraph 46);
determining a respiration phase of a user based on the sensor data (Gavish, Paragraph 51);
providing a first control signal to the one or more stimulus generators to generate a first user-perceptible stimulus to guide a user in matching a pacing of breathing of the user to a cycle frequency of the first user-perceptible stimulus (Gavish, Paragraph 50),
wherein the first control signal is provided to generate the first user-perceptible stimulus having the cycle frequency and a cycle phase (Gavish, Paragraph 50);
determining a synchronization status between the cycle phase of the first user-perceptible stimulus and the respiration phase of the user (Gavish, Paragraph 49); and
providing a second control signal to the one or more stimulus generators to generate a second user-perceptible stimulus indicative of the synchronization status (Gavish, Paragraph 50).
In regards to Claim 2: The method of claim 1, wherein the second user-perceptible stimulus comprises a vibration stimulus (Gavish, Paragraph 71).
In regards to Claim 3: The method of claim 2, wherein the second control signal is provided to modulate an amplitude of the vibration stimulus based on the synchronization status (Gavish, Paragraph 83).
In regards to Claim 4: The method of claim 2, wherein the first user-perceptible stimulus comprises a vibration stimulus, wherein the method comprises:
determining from the sensor data an inhalation cycle and an exhalation cycle of the respiration phase (Gavish, Paragraph 83), and providing the first control signal to increase the vibration stimulus during the inhalation cycle of the respiration phase, and to decrease the vibration stimulus during the exhalation cycle of the respiration phase (Gavish, Paragraph 83).
In regards to Claim 5: The method of claim 1, wherein the first control signal and the second control signal are provided to the one or more stimulus generators simultaneously (Gavish, Paragraph 24).
In regards to Claim 9: The method of claim 1, comprising providing the second control signal to continuously generate the second user-perceptible stimulus when the respiration phase is synchronized with the cycle phase of the first user-perceptible stimulus, and not to generate the second user-perceptible stimulus when the respiration phase is non-synchronized with the cycle phase of the first user-perceptible stimulus (Gavish, Paragraphs 19-21).
In regards to Claim 10: A sleep-aid apparatus comprising:
one or more stimulus generators operable to generate one or more user-perceptible stimuli with one or more sensory modalities (Gavish, Figure 1 Item 116);
a physiological sensor to generate sensor data (Gavish, Figure 1 Item 112); and
a processing device configured to perform the method of claim 1 using the one or more stimulus generators and the physiological sensor of the sleep-aid apparatus (Gavish, Figure 1 Item 114; Paragraphs 11, 24, & 50).
In regards to Claim 14: The sleep aid apparatus of claim 10, comprising an article for making physical contact with a user during sleep induction (Gavish, Paragraph 91); and
wherein the physiological sensor is integrated in the article (Gavish, Paragraph 91).
In regards to Claim 15: A non-transitory computer-readable storage medium storing instructions thereon which, when executed by a processing device, cause the processing device to perform the method according to claim 1 (Gavish, Paragraph 100).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0367097 hereinafter Gavish in view of US 2008/0269652 hereinafter Reiner.
In regards to Claim 6: Gavish teaches all of claim 1, but does not teach determining a heart rate variability (HRV) of the user based on the sensor data, and setting the cycle frequency of the first user-perceptible stimulus based on the heart rate variability.
Reiner teaches determining a heart rate variability (HRV) of the user based on the sensor data (Reiner, Paragraphs 4 & 18), and setting the cycle frequency of the first user-perceptible stimulus based on the heart rate variability (Reiner, Paragraph 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the sensor able to sense the patient’s heart rate variability taught in Reiner to the method taught in Gavish, the motivation being to provide a sensor that can accurately ascertain the state of the user before and during treatment.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0367097 hereinafter Gavish in view of US 2008/0269652 hereinafter Reiner in view of US 2012/0238800 hereinafter Naujokat.
In regards to Claim 7: A modified Gavish teaches all of Claims 6 & 1, but does not teach implementing a calibration procedure for setting the cycle frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs, and wherein: the cycle frequency of the first user-perceptible stimulus is set at a different respective value in each respective epoch; during each epoch, sensor data is processed to determine an HRV of the user; and the cycle frequency of the first user-perceptible stimulus is set equal to the one of the different respective values set during the calibration procedure which coincided with a highest measured HRV.
Naujokat teaches implementing a calibration procedure for setting the cycle frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs (Naujokat, Paragraphs 66 & 70), and wherein: the cycle frequency of the first user-perceptible stimulus is set at a different respective value in each respective epoch (Naujokat, Paragraphs 66 & 70); during each epoch, sensor data is processed to determine an HRV of the user (Naujokat, Paragraph 66 & 70); and the cycle frequency of the first user-perceptible stimulus is set equal to the one of the different respective values set during the calibration procedure which coincided with a highest measured HRV (Naujokat, Paragraphs 66 &70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the calibration system taught in Naujokat to the method taught in a modified Gavish, the motivation being to provide a system that can reliably provide an accurate measurement to ensure a proportional response.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0367097 hereinafter Gavish in view of 2014/0057232 hereinafter Wetmore.
In regards to Claim 8: Gavish teaches all of Claim 1, but does not teach performing one or more adjustments of the cycle phase of the first user-perceptible stimulus so as to align with a current respiration phase of the user.
Wetmore teaches performing one or more adjustments of the cycle phase of the first user-perceptible stimulus so as to align with a current respiration phase of the user (Wetmore, Paragraph 304; “By comparing the recorded brain activity (i.e. slow oscillations or another type of brain rhythm) to a target value or other target parameter (e.g. frequency, phase, coherence across brain regions), a subsequent Modulatory Sleep Stimulus can be adjusted if necessary to achieve the desired target value by changing one or more parameter of a Modulatory Sleep Stimulus.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the ability to adjust the stimulation taught in Wetmore to the method for inducing sleep taught in Gavish, the motivation being to allow for a more personalized therapy to be administered.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0367097 hereinafter Gavish in view of US 9,566,411 hereinafter Sherpa.
In regards to Claim 11: Gavish teaches all of claim 10, but does not teach wherein the physiological sensor is a PPG sensor.
Sherpa teaches wherein the physiological sensor is a PPG sensor (Sherpa, Column 7 Lines 52-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the PPG sensor taught in Sherpa to the system for inducing sleep taught in Gavish, the motivation being to provide a sensor that can accurately ensure the user is still receiving enough oxygen.
In regards to Claim 12: Gavish teaches all of claim 10, but does not teach wherein the first user-perceptible stimulus generated by the one or more stimulus generators is a tactile or haptic stimulus and comprises a cyclical motion induced by an actuation mechanism.
Sherpa teaches wherein the first user-perceptible stimulus generated by the one or more stimulus generators is a tactile or haptic stimulus and comprises a cyclical motion induced by an actuation mechanism (Sherpa, Column 9 Lines 46-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the tactile stimulus actuator taught in Sherpa to the system for inducing sleep taught in Gavish, the motivation being to provide feedback to the user in a universal way.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0367097 hereinafter Gavish in view of US 9,566,411 hereinafter Sherpa in further view of 2013/0123570 hereinafter Ly.
In regards to Claim 13: A modified Gavish teaches all of claims 10 & 12, but does not teach wherein the cyclical motion comprises cyclical expansion and contraction of at least a part of an article adapted for being in contact with a user during use.
Ly teaches wherein the cyclical motion comprises cyclical expansion and contraction of at least a part of an article adapted for being in contact with a user during use (Ly, Paragraph 29; “Many other devices could be used to create the breathing and/or heartbeat like effects, including vibration devices as are commonly found in cell phone or video game controllers, piezoelectric devices, materials which contract when electricity is applied to them and the like.”; “the invention may resemble a functional backpack, a side-curried "messenger-style" bag, bedding, furniture, a small garment worn on the torso of the individual, a jacket or other article of clothing with a pouch or pocket that contains the breathing apparatus, or any other form or structure wearable by a person and/or in contact with that person.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the expanding and contracting device as part of an article in contact with a user taught in Ly to the system for inducing sleep taught in Gavish, the motivation being to ensure the tactile stimulus is in constant contact with the user.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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