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 .
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.
Election/Restrictions
Applicant's election with traverse of Invention I, drawn to a urination monitoring system of claims 1-10 in the reply filed on 1/29/26 is acknowledged. The traversal is on the ground(s) that Invention I and II are not a materially different process since both generate an output corresponding to a urinary episode characteristic and that Invention III is just an example if Inventions I and II. This is not found persuasive. With respect to Invention I and II, Invention I recites a “display” that is part of the claimed “analyzer.” This display is what allows the Invention I to practice another and materially different method of assessing renal or kidney function, assessing bladder function, and/or assessing liver function. Without being able to visualize the data, a healthcare provider would have difficulty monitoring and assessing the vitality of any of these bodily organs. Another way to put it is that the method can be practiced on another and materially different apparatus such as an analyzer without a display. With respect to Invention III, claim 21 is not merely an example of claim 1 (which is also not the standard for determining whether claims are restrictable), they recite divergent subject matter such that they can have a materially different design, mode of operation, function, or effect (i.e., the standard that is recited in the MPEP). Specifically, claim 1 has the claimed “controller” perform the function of “determining a urinary episode characteristic therefrom” and claim 21 has the claimed “analyzer” perform the function of “determining a urinary episode characteristic therefrom.” Additionally, claim 1 has the claimed “display” as part of the “analyzer,” whereas in claim 21 the claimed “display” is coupled to the “analyzer.” This allows for different system designs where, for example, claim 1 is a local device and claim 21 is a remote system.
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 10-21 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/29/26.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 9 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 9, the claim language “the analyzer generates a flap leak signal based on the denoised and demodulated signal” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of generating a flap leak signal based on the denoised and demodulated signal, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. All the specification says is that a classifier performs this function. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
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.
Claim(s) 1-10 is/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.
For claim 1, the claim language “a vibration sensor … generating a vibration signal corresponding to vibration of the exterior of the commode” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “a urination monitoring system,” but instead to a method. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as meaning that the vibration sensor is configured to generate a vibration signal.
For claim 1, the claim language “a signal shaping circuit … generating a processed vibration signal” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “a urination monitoring system,” but instead to a method. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as meaning that the vibration sensor is configured to generate a processed vibration signal.
For claim 1, the claim language “a controller … receiving the processed vibration signal and determining a urinary episode characteristic therefrom” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “a urination monitoring system,” but instead to a method. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as meaning that the controller is configured to receive the processed vibration signal and determine a urinary episode characteristic therefrom.
For claim 1, the claim language “a controller comprising a trained classifier coupled to the sensor” is ambiguous. What is coupled to the sensor? Is it the controller or the trained classifier? The claim is examined under the former interpretation.
For claim 1, the claim language “an analyzer … generating an output corresponding to the urinary episode characteristic” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “a urination monitoring system,” but instead to a method. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as meaning that the analyzer is configured to generate an output corresponding to the urinary episode characteristic.
For claim 2, the claim term “low strength” is ambiguous. How weak does the strength have to be to be considered “low” strength? The claim is examined as meaning a strength underneath a threshold.
Dependent claim(s) 2-10 fail cure the ambiguity of independent claim 1, thus claim(s) 1-10 is/are rejected under 35 U.S.C. 112(b).
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.
Claim(s) 1, 3-4, and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0025218 to Bagger et al. (hereinafter “Bagger”) in view of U.S. Patent Application Publication No. 2024/0008750 to Bachner-Hinenzon et al. (hereinafter “Bachner”) and U.S. Patent Application Publication No. 2015/0168322 to Alocilja et al. (hereinafter “Alocilja”).
For claim 1, Bagger discloses a urination monitoring system for a commode (Abstract) (Fig. 1) comprising:
a vibration sensor (9) (Fig. 1) (para [0118] and [0121]) coupled to an exterior of the commode (as can be seen in Fig. 1);
the vibration sensor (9) (Fig. 1) (para [0118] and [0121]) generating a vibration signal corresponding to vibration of the exterior of the commode (para [0119] and [0121]);
a circuit (24) (Fig. 2) (para [0135]) coupled to the vibration sensor (i.e., via 28) (Fig. 2) (para [0135]);
a controller (25) (Fig. 2) (para [0136]) comprising a trained classifier (para [0144]) coupled to the sensor (i.e., via 28) receiving the vibration signal and determining a urinary episode characteristic therefrom (para [0144]); and
an analyzer comprising a display (27) (Fig. 2) (para [0136]), said analyzer coupled to the controller (see Fig. 2) and generating an output corresponding to the urinary episode characteristic (para [0139]).
Bagger does not expressly disclose that the vibration sensor is disposed within the housing such that the housing is coupled to the exterior of the commode instead of the vibration sensor.
However, Bachner teaches a vibration sensor disposed within a housing (para [0004]).
It would have been obvious to a skilled artisan to modify Bagger such that the vibration sensor is disposed within the housing such that the housing is coupled to the exterior of the commode instead of the vibration sensor, in view of the teachings Bachner, for the obvious advantage of protecting the sensor and keeping it sanitary.
Bagger and Bachner do not expressly disclose that the circuit is a signal shaping circuit generating a processed vibration signal.
However, Alocilja teaches a signal shaping circuit generating a processed signal (para [0059]).
It would have been obvious to a skilled artisan to modify Bagger such that the circuit is a signal shaping circuit generating a processed vibration signal, in view of the teachings of Alocilja, for the obvious advantage of cleaning up the signal.
For claim 3, Bagger further discloses a commode wall and wherein the vibration sensor is coupled within the commode wall (as can be seen in Fig. 13).
For claim 4, Bagger further discloses wherein the vibration sensor comprises a piezoelectric sensor (para [0121] and [0161]).
For claim 6, Bagger, as modified, further discloses wherein the signal shaping circuit comprises an amplifier and a signal de-noising circuit (see para [0059] of Alocilja).
For claim 7, Bagger, as modified, further discloses wherein the de-noising circuit comprises a band pass filter (see para [0059] of Alocilja).
For claim 8, Bagger, as modified, further discloses a demodulation circuit in communication with the signal shaping circuit and forming a denoised and demodulated signal (see para [0059] of Alocilja), wherein the analyzer identifies a urinating individual based on the denoised and demodulated signal (para [0070]) (also see para [0071]-[0072]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagger in view of Bachner and Alocilja, and further in view of U.S. Patent Application Publication No. 2022/0151510 to Kashyap et al. (hereinafter “Kashyap”).
For claim 2, Bagger, Bachner, and Alocilja do not expressly disclose wherein the urinary episode comprises at least one of a urinary frequency, urinary flow strength and duration, a number of episodes within a urination episode, a low strength and duration of sub-episodes within the episode.
However, Kashyap teaches wherein the urinary episode comprises at least one of a urinary frequency, urinary flow strength and duration, a number of episodes within a urination episode, a low strength and duration of sub-episodes within the episode (para [0100]).
It would have been obvious to a skilled artisan to modify Bagger wherein the urinary episode comprises at least one of a urinary frequency, urinary flow strength and duration, a number of episodes within a urination episode, a low strength and duration of sub-episodes within the episode, in view of the teachings of Kashyap, for the obvious advantage of providing more data that can be helpful in diagnosing an individual, which is what Bagger wants to do (see para [0021] of Bagger).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagger in view of Bachner and Alocilja, and further in view of U.S. Patent Application Publication No. 2007/0284969 to Xu.
For claim 5, Bagger, Bachner, and Alocilja do not expressly disclose wherein the piezoelectric sensor comprises a cantilever comprising a first end fixed within the housing at a base, said cantilever comprising a second end comprising a ballast, said sensor comprising a piezoelectric layer disposed between the ballast and the base.
However, Xu teaches a piezoelectric sensor comprises a cantilever (200) comprising a first end fixed at a base (220 and/or 280), said cantilever comprising a second end comprising a ballast (260), said sensor comprising a piezoelectric layer (240) disposed between the ballast and the base (as can be seen in Fig. 2).
It would have been obvious to a skilled artisan to modify Bagger wherein the piezoelectric sensor comprises a cantilever comprising a first end fixed within the housing at a base, said cantilever comprising a second end comprising a ballast, said sensor comprising a piezoelectric layer disposed between the ballast and the base, in view of the teachings of Xu, for the obvious advantage of being able to harvest power from the vibrational energy in addition to the function of sensing the vibrational energy (see para [0016] of Xu).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagger in view of Bachner and Alocilja, and further in view of U.S. Patent No. 11,542,178 to Chandler Jr. et al. (hereinafter “Chandler”).
For claim 9, Bagger, Bachner, and Alocilja do not expressly disclose wherein the analyzer generates a flap leak signal based on the denoised and demodulated signal.
However, Chandler teaches generating a flap leak signal based on a sensor signal (col. 35, lines 27-44).
It would have been obvious to a skilled artisan to modify Bagger wherein the analyzer generates a flap leak signal based on the denoised and demodulated signal, in view of the teachings of Chandler, for the obvious advantage of diagnosing an issue with the commode so that it may be repaired by a user.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagger in view of Bachner and Alocilja, and further in view of U.S. Patent Application Publication No. 2012/0053540 to Belotserkovsky.
For claim 10, Bagger, Bachner, and Alocilja do not expressly disclose wherein the analyzer analyzes urinary episodes and sub-episodes based on energy therein.
However, Belotserkovsky teaches analyzing urinary episodes and sub-episodes based on energy therein (see Fig. 10 and para [0065]).
It would have been obvious to a skilled artisan to modify Bagger wherein the analyzer analyzes urinary episodes and sub-episodes based on energy therein, in view of the teachings of Belotserkovsky, for the obvious advantage of distinguishing strong versus weak voids to help diagnose the individual, which is what Bagger wants to do (see para [0021] of Bagger).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791