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 .
Election/Restrictions
Applicant’s election of Group 1 (claims 1-14) in the reply filed on 02/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Wake-up sensor in claims 1, 7, 9, 11: interpreted as an optical sensor or resistive force sensor ([0074])
Health sensor in claims 12-13: interpreted as solid-state vapor detection sensor ([0076])
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-2, 4-11 is/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’.
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]).
Regarding claim 2, Gerber, Fu, and Ciquin 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, and Ciquin above teaches that the muscle movement sensor is a mechanomyogram, as detailed above in the rejection of claim 1. Therefore Gerber, Fu, and Ciquin meet the limitations of the claim.
Regarding claim 4, Gerber, Fu, and Ciquin 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, and Ciquin 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, and Ciquin 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, and Ciquin 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, and Ciquin above teaches that the muscle movement sensor is a mechanomyogram, as detailed above in the rejection of claim 1. Therefore Gerber, Fu, and Ciquin meet the limitations of the claim.
Regarding claim 8, Gerber, Fu, and Ciquin 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, and Ciquin 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, and Ciquin above teaches that the muscle movement sensor is a mechanomyogram, as detailed above in the rejection of claim 1. Therefore Gerber, Fu, and Ciquin meet the limitations of the claim.
Regarding claim 10, Gerber, Fu, and Ciquin 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).
Regarding claim 11, Gerber, Fu, and Ciquin teach the device according to claim 9. Fu teaches the device further comprising:
wherein the wake-up sensor comprises one of an optical sensor and a resistive force sensor configured to sense when the subject removes lower-body clothing ([0080], Fig. 6, steps 630 and 660, [0095], forces applied to garment).
Claim(s) 3 is/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 Baek et al. (US Pre-Grant Publication 2021/0100694), hereinafter ‘Baek’.
Regarding claim 3, Gerber, Fu, and Ciquin 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, and Ciquin 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]).
Claim(s) 12-14 is/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 Baek et al. (US Pre-Grant Publication 2021/0100694), further in view of Liu (US Pre-Grant Publication 2017/0248541), hereinafter ‘Liu’.
Regarding claim 12, Gerber, Fu, and Ciquin teach the device according to claim 1, but do not teach a health sensor.
Baek teaches a defecation measurement system (Fig. 3), further comprising:
wherein the wearable device further comprises a health sensor configured to sense a health stimulus associated with health of the subject ([0039], user wears device, [0041], VOC detection).
Liu teaches a sensor for VOC detection (Fig. 1).
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, and Ciquin to incorporate the teachings of Baek to include a health sensor. Doing so would allow for the determination of a patient’s health, as recognized by Liu ([0011], VOCs present in biological sample can be indicative of health or progression of a disease).
Regarding claim 13, Gerber, Fu, Ciquin, Baek, and Liu teach the device according to claim 12. Liu teaches the device further comprising:
wherein the health sensor comprises a blood sensor configured to sense blood in stool of the subject ([0002], gaseous VOC emissions emanating from patient’s blood).
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, and Ciquin to incorporate the teachings of Baek to include a blood sensor. Doing so would allow for the determination of a patient’s health, as recognized by Liu ([0011], VOCs present in biological sample can be indicative of health or progression of a disease).
Regarding claim 14, Gerber, Fu, Ciquin, Baek, and Liu teach the device according to claim 13. Baek teaches the device further comprising:
wherein the blood sensor comprises a solid-state vapor detection sensor configured to sense one or more volatile organic compounds ([0041], gas detection, VOC detection).
Liu teaches a sensor for VOC detection (Fig. 1).
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, and Ciquin to incorporate the teachings of Baek to include a solid-state vapor detection sensor. Doing so would allow for the determination of a patient’s health, as recognized by Liu ([0011], VOCs present in biological sample can be indicative of health or progression of a disease).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Roe et al. (US Patent No. 6,407,308) teaches a disposable article for detecting body waste elimination.
Shelton, IV et al. (US Pre-Grant Publication 2022/0233119) teaches a method of adjusting parameters based on biomarkers.
Nakanishi et al. (US Pre-Grant Publication 2017/0202503) teaches a bowel movement prediction device.
Jin (Korean Patent No. 2019/0057771) teaches a wearable device for detecting defecation.
Won (Korean Patent No. 102116665) teaches an apparatus for detecting bowel movements.
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
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792