DETAILED ACTION
for
URINARY EVENT DETECTION, TRACKING, AND ANALYSIS
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 the Claims
Regarding the status of the claims, please see the following:
Claims 21-22 and 37-36 are pending.
Claims 23-26 are cancelled.
Claims 28-36 New.
Response to Arguments
Applicants’ arguments, see page 6, filed 07/30/2026, with respect to the drawing objection have been fully considered and are persuasive. The drawing objection has been withdrawn per applicants’ amendments to the drawings.
Applicants’ arguments, see page 6, filed 07/30/2026, with respect to the specification objections have been fully considered and are persuasive. The specification objections have been withdrawn per applicants’ amendments to the specification.
Applicants’ arguments, see page 6-8, filed 07/30/2026, with respect to the 35 USC § 102 rejections, the remarks have been fully considered and are not persuasive. To benefit the Applicant, arguments will be discussed below.
On pages 6-8 of the remarks, Applicant alleges that Belotserkovsky fails to disclose at least a "voiding diary system" and "generating a graphical output of a urine flow rate, duration, volume, and timestamp data to develop a treatment plan". The Examiner respectfully disagrees with Applicants position.
In response to applicant’s argument that there is no teaching the examiner recognizes that ascertaining the differences between the prior art and the claim at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. See MPEP § 2111 - § 2116.01.
It is the understanding of the Examiner that a “void dairy system” (also called a bladder diary or frequency–volume chart) is a structured record of your urination habits over a set period.
The previous rejection explained why a person having ordinary skill in the art would have reasonably expected that Belotserkovsky clearly states in multiple location in the disclosure (see Belotserkovsky ([Page 3, ¶0037, lines 1-4], for example) that the primary purpose of the invention is a memory 52 for storing database patient's uroflowmetry data “voiding diary system” that includes the individual's voiding flow rate over time. The computerized system 50 is incorporated in a smartphone or tablet, a camera 56 can be employed to take images of urine flow patterns (see, ¶0037, lines 5-9).
For these reasons, there would have been a reasonable expectation of success. After have considered all of applicants’ arguments, the 35 USC § 102 rejections of claims 21-22 and 27 is maintained.
On pages 6-8 of the remarks, Applicant alleges that Belotserkovsky fails to disclose at least a "analyzing by the voiding diary system the flow event to determine a void event.". The Examiner respectfully disagrees with Applicants position.
In response to applicant’s argument that there is no teaching the examiner recognizes that ascertaining the differences between the prior art and the claim at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. See MPEP § 2111 - § 2116.01.
As explained in the attorney’s response, Belotserkovsky teaches the urine flow monitoring device generates a graph of the patient's urine flow pattern which is flow rate vs. time as depicted. Thus, Belotserkovsky discloses an electrical urine flow meters for providing urine flow data.
Belotserkovsky further discloses “Urine flow is detected by observing the change in volume as the patient voids into the container”. As previously stated by storing database patient's uroflowmetry data that includes the individual's voiding flow rate over time is equivalent to analyzing the flow event.
Thus, contrary to applicant assertion, Belotserkovsky displays analyzing the flow event. After having considered all of applicant arguments, the 35 USC § 102 rejections of claims 21-22 and 27 is maintained.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27, claim line 8: replace “the processing element post-treatment” with – a processing element post-treatment—to maintain antecedent basis.
Appropriate correction is required.
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)(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.
Claims 21-22 and 27-35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Belotserkovsky (US 2016/0113562).
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Regarding claim 21, Belotserkovsky discloses a method of processing data from a uroflowmeter (see abstract), the method providing a uroflowmeter in communication with a voiding diary system (Fig. 2); detecting flow event data by the uroflowmeter (2, Fig. 2); transmitting the flow event data to the voiding diary system (2, Fig. 2); analyzing by the voiding diary system the flow event to determine a void event (6, Fig. 2); analyzing urine fluid level (3, Fig. 2) and duration data to determine void characteristics (14, Fig. 4); and generating a graphical output of a urine flow rate, duration, volume, and timestamp data to develop a treatment plan (16-17, Fig. 4).
Regarding claim 22, Belotserkovsky discloses a method for generating a urinary diary for display on a user device, (Fig. 4); determining by a processing element that a urinary event occurred (Fig. 3); accessing void profile characteristics corresponding to the urinary event (Fig. 2), the void profile characteristics being detected by a voiding device in electronic communication with a server (22); receiving user input void data via the user device (Fig. 5); determining a diary time slot corresponding to the urinary event and the user void data (24); and associating the urinary event (3) and void profile characteristics to generate a correspondence between the user input void data (22) and the void profile characteristics (26).
Regarding claim 27, Belotserkovsky discloses a method of assessing urinary treatment effectiveness, receiving by a processing element pre-treatment void diary data corresponding to a patient urinary history during a first time interval (23; Fig.5), the pre-treatment void diary data including void characteristics detected by a voiding device during void events by the patient during the first time interval (22, Fig. 5); receiving by the processing element a treatment plan prescribed to the patient by a healthcare provider (¶0035, lines 1-6); receiving by the processing element post-treatment void diary data corresponding to the patient urinary history during a second time interval (22, Fig. 5), the post-treatment void diary data including void characteristics detected by the voiding device during void events by the patient during the second time interval (¶0037, lines 1-4); analyzing by the processing element the pre-treatment void diary data and the post-treatment void diary data to determine treatment effectiveness (25, Fig. 5); and outputting by the processing element to a display an effectiveness assessment (Fig. 4).
Regarding claim 28, Belotserkovsky further discloses applying a threshold to the detected flow event data and confirming a corresponding change in urine fluid level (void volume) over a duration sufficient to constitute a void event, and the graphical output includes a timeline with timestamps for the urine flow rate (time to max), duration (total time), and volume (void volume).
Regarding claim 29, Belotserkovsky further discloses the uroflowmeter communicates the flow event data to the voiding diary system via a networked connection (computerized system 50), and the voiding diary system stores (memory 52) the analyzed void event and void characteristics in association with a patient record (¶0037).
Regarding claim 30, Belotserkovsky further discloses generating the graphical output (Fig. 2) concurrently displaying a urine flow rate curve (Fig. 1) and numerical values for duration, volume (void volume), and timestamps to facilitate development of the treatment plan “the physician determines the proper course of treatment”.
Regarding claim 31, Belotserkovsky further discloses receiving the user input void data “patient's uroflowmetry data” and determining the diary time slot occur via the user device (Fig. 1), and the urinary diary displayed on the user device shows the user input void data and the corresponding void profile characteristics in a common entry for the diary time slot “the urine flow monitoring device generates a graph of the patient's urine flow pattern which is flow rate vs. time as depicted”.
Regarding claim 32, Belotserkovsky further discloses a server stores “memory 52 for storing”, for each diary time slot (Fig. 1), a combined record comprising the user input void data and the accessed void profile characteristics corresponding to the urinary event (¶0012; “ (4) total voided urine volume, (5) void time (or actual void time”).
Regarding claim 33, Belotserkovsky further discloses the user input void data “total voided urine” and the void profile characteristics are displayed together as a unified diary entry in a diary view of the user device for the determined time slot “void time”.
Regarding claim 34, Belotserkovsky further discloses analyzing the pre-treatment void diary data (Fig. 5) and the post-treatment void diary data comprises computing a difference between at least one void characteristic in the first time interval “Once evaluation is made, proper treatment can be administered by the physician” and a corresponding void characteristic in the second time interval to determine treatment effectiveness (Fig. 5), and the effectiveness assessment is based on the computed difference (50).
Regarding claim 35, Belotserkovsky further discloses outputting the effectiveness assessment displaying “incorporated in a smartphone or tablet” the effectiveness assessment together with representative void diary entries from the first time interval and the second time interval “analyzing the primary and secondary urine flow dynamic parameters”.
Allowable Subject Matter
Claim 36 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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 BRANDI N HOPKINS whose telephone number is (571)270-7042. The examiner can normally be reached M & F 9-5 and T-TH, 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kristina Deherrera can be reached at (303) 297-4237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDI N HOPKINS/Primary Examiner, Art Unit 2855
