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 .
Status of Claims
Claims 11 and 34-66 are canceled.
Claims 15-33 are withdrawn.
Claims 1-10 and 12-14 are examined.
Response to Arguments
Applicant’s arguments, see pg. 8, filed 06/18/2026, with respect to claim interpretation under 35 USC 112(f) have been fully considered and are persuasive in light of claim amendments. The claim interpretation under 35 USC 112(f) of claims 1, 7, 9, 11, and 12-13 has been withdrawn.
Applicant’s arguments, see pg. 8-10, with respect to claim rejections under 35 USC 103, have been fully considered. The amendments to independent claim 1 to include the added limitation of an optical sensor overcomes the rejection detailed in the non-final filed 03/24/2026. Since independent claim 1 was amended to include new limitations, new grounds of rejection are warranted for independent claim 1 and dependent claims 2-10, 12-14. See prior art rejections below.
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 1-2, 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US Pre-Grant Publication 2008/0300649), hereinafter ‘Gerber’, in view of Fu et al. (US Pre-Grant Publication 2019/0313913), hereinafter ‘Fu’, further in view of Ciquin et al. (US Pre-Grant Publication 2011/0124955), hereinafter ‘Ciquin’, further in view of Zdeblick (US Pre-Grant Publication 2016/0324442), hereinafter ‘Zdeblick’.
Regarding claim 1, Gerber teaches a system for sensing defecation events of a subject ([0005], automatic voiding diary that detects fecal voiding events based on signal from sensor, Fig. 8), the system comprising:
a wearable device configured to be carried on a torso of the subject ([0142], device 174 worn by patient and carried by belt 172, Fig. 8).
Gerber does not teach that the device has a wake-up sensor that senses a stimulus to switch the device from a sleep to active mode.
Fu teaches a system for monitoring a patient ([0006]), the system further comprising:
the wearable device being operable in a sleep mode and an active mode ([0044], transitions between inactive and active mode), the wearable device comprising:
a wake-up sensor configured to sense a first stimulus ([0044], transitions are based on sensor data that suggests if the garment is on patient); and
a processor configured to switch the wearable device from the sleep mode to the active mode based on the first stimulus sensed by the wake-up sensor ([0041-0042], processor 252 included in controller can operate in inactive/active mode).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber to incorporate the teachings of Fu to include sleep and active modes. Doing so would allow for the detection of sensor data that is more representative of the patient condition and for power conservation, as recognized by Fu ([0060]).
Gerber and Fu further teach the device comprising:
a muscle motion sensor configured to sense abdominal muscle movement signals of the subject (Gerber, sensing circuitry 40, [0091], sound produced by muscle that contracts/relaxes to control voiding);
a processor operably coupled to the wake-up sensor (Fu, [0044], transitions between inactive and active mode) and the muscle motion sensor; and
in the active mode the wearable device is configured to communicate with the processor to determine occurrence of defecation events of the subject based on abdominal muscle movement signals sensed by the muscle motion sensor (Gerber, [0162], device 212 can detect fecal voiding events using sensors for detecting bowel muscle contraction).
Gerber and Fu do not teach that the muscle motion sensor is a mechanomyogram sensor.
Ciquin teaches a device to prevent urinary leakage (Fig. 1), the device further comprising:
a mechanomyogram sensor configured to sense abdominal muscle movement signals of the subject ([0021], measure muscle activity using MMG sensor, [0023], measure rectus abdominis muscles).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber and Fu to incorporate the teachings of Ciquin to use a mechanoyogram (MMG) sensor to sense abdominal muscle movement signals. Doing so would allow for the patient’s activity to be measured, as recognized by Ciquin ([0069]).
Geber, Fu, and Ciquin do not specifically teach that the wake-up sensor is an optical sensor that senses increased light when the subject removes lower-body clothing.
Zdeblick teaches a system for detecting physiological information about a wearer (see abstract, [0002]), further comprising:
a wake-up sensor comprising an optical sensor configured to sense increased light when the subject removes lower-body clothing ([0113], electronics module comprises a light sensor, detects whether clothing has been removed) (Fig. 10, [0145], wearable system is configured as waistband 1002).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the wake-up sensor of Geber, Fu, and Ciquin to incorporate the teachings of Zdeblick to include an optical sensor that senses increased light. Doing so would allow for the detection of clothing removal, as recognized by Zdeblick [0113].
Regarding claim 2, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 1. Gerber teaches the device further comprising:
wherein the abdominal muscle movement signals of the subject is a second stimulus (sensing circuitry 40, [0091], sound produced by muscle that contracts/relaxes to control voiding), the system further comprising a third sensor operably coupled to the processor and configured to sense a third stimulus ([0013], automatic voiding diary processes signals generated by one or more sensors), and in the active mode the processor is configured to determine occurrence of defecation events of the subject based on abdominal muscle movement signals sensed by the muscle motion sensor and the third stimulus sensed by the third sensor ([0013], processes signals to detect voiding events).
The combination of Gerber, Fu, Ciquin, and Zdeblick above teaches that the muscle movement sensor is a mechanomyogram, as detailed above in the rejection of claim 1. Therefore Gerber, Fu, Ciquin, and Zdeblick meet the limitations of the claim.
Regarding claim 4, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 2. Gerber teaches the device further comprising:
wherein the third sensor is an audio sensor configured to sense toilet flushing sounds ([0133], sound associated with fecal voiding event can be toilet flushing).
Regarding claim 5, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 2. Gerber teaches the device further comprising:
wherein the third sensor is an electromyogram electrode configured to sense muscle electrical signals of the subject ([0162], device 212 can detect fecal voiding events using electromyography sensors for detecting bowel muscle contraction).
Regarding claim 6, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 2. Gerber teaches the device further comprising:
wherein the third sensor is an inertial measurement unit configured to sense a change in posture of the subject ([0083], voiding parameter can include activity and posture of patient).
Regarding claim 7, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 1. Gerber teaches the device further comprising:
wherein the wearable device further comprises a patch configured to be carried on the torso of the subject, the patch carrying the wake-up sensor and the muscle motion sensor ([0081], automatic voiding diary device is taped to skin of patient or otherwise wearable). The combination of Gerber, Fu, Ciquin, and Zdeblick above teaches that the muscle movement sensor is a mechanomyogram, as detailed above in the rejection of claim 1. Therefore Gerber, Fu, Ciquin, and Zdeblick meet the limitations of the claim.
Regarding claim 8, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 7. Gerber teaches the device further comprising:
wherein the patch further carries the processor ([0086], automatic voiding diary 14 includes processor 44).
Regarding claim 9, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 1. Gerber teaches the device further comprising:
a belt configured to extend around the torso of the subject, the belt carrying the wake-up sensor and the muscle movement sensor. ([0142], Fig. 8, device 174 carried by belt 172). The combination of Gerber, Fu, Ciquin, and Zdeblick above teaches that the muscle movement sensor is a mechanomyogram, as detailed above in the rejection of claim 1. Therefore Gerber, Fu, Ciquin, and Zdeblick meet the limitations of the claim.
Regarding claim 10, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 9. Gerber teaches the device further comprising:
wherein the belt further carries the processor ([0086], automatic voiding diary 14 includes processor 44).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US Pre-Grant Publication 2008/0300649) in view of Fu et al. (US Pre-Grant Publication 2019/0313913) further in view of Ciquin et al. (US Pre-Grant Publication 2011/0124955), further in view of Zdeblick (US Pre-Grant Publication 2016/0324442), further in view of Baek et al. (US Pre-Grant Publication 2021/0100694), hereinafter ‘Baek’.
Regarding claim 3, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 2, but do not teach a gas sensor for sensing flatus.
Baek teaches a defecation measurement system (Fig. 3), further comprising:
wherein the third sensor comprises a gas sensor disposed in the wearable device and configured to sense flatus ([0055], Fig. 3, defecation determination module 430 determines presence of defecation using gas sensor).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber, Fu, Ciquin, and Zdeblick to incorporate the teachings of Baek to include a gas sensor. Doing so would allow for the determination of presence/type of defecation, as recognized by Baek ([0055]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US Pre-Grant Publication 2008/0300649) in view of Fu et al. (US Pre-Grant Publication 2019/0313913) further in view of Ciquin et al. (US Pre-Grant Publication 2011/0124955), further in view of Zdeblick (US Pre-Grant Publication 2016/0324442), further in view of Baek et al. (US Pre-Grant Publication 2021/0100694).
Regarding claim 12, Gerber, Fu, Ciquin, and Zdeblick teach the device according to claim 1, but do not teach a solid-state vapor detection sensor.
Baek teaches a defecation measurement system (Fig. 3), further comprising:
wherein the wearable device further comprises a solid-state vapor detection sensor configured to sense a health stimulus associated with health of the subject ([0039], user wears device, [0041], VOC detection).
The examiner notes that the limitation “configured to sense a health stimulus associated with health of the subject” is intended use, and the solid-state vapor detection sensor of Baek is capable of performing the claimed function. See Ex parte Masham, 2 USPQ2d 1647 (1987).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber, Fu, Ciquin, and Zdeblick to incorporate the teachings of Baek to include a solid-state vapor detection sensor. Doing so would allow for the determination of the presence of defecation, as recognized by Baek [0013].
Regarding claim 13, Gerber, Fu, Ciquin, Baek, and Zdeblick teach the device according to claim 12. Baek teaches the device further comprising:
wherein the solid-state vapor detection sensor is configured to sense blood in stool of the subject ([0041], VOC detection).
The examiner notes that the limitation “configured to sense blood in stool of the subject” is intended use, and the solid-state vapor detection sensor of Baek is capable of performing the claimed function.
Regarding claim 14, Gerber, Fu, Ciquin, Baek, and Zdeblick teach the device according to claim 13. Baek teaches the device further comprising:
wherein the solid-state vapor detection sensor is configured to sense one or more volatile organic compounds ([0041], gas detection, VOC detection).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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