DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), 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) 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: "a plumbing unit for directing urine from the receptacle" in claims 1-4, 6-14 and 16-20; "a data acquisition unit for receiving and collecting urine flow data from the flow-through fluid sensors" in claims 1-20; "a data processing and storage unit for processing and storing urine flow data received from the data acquisition unit" in claims 1-20; "a data output unit which converts processed urine flow data from the data processing and storage unit to a readable format" in claims 2 and 12; "a toilet adapter unit for mounting the system to a rim of a toilet bowl" in claims 3, 10, 13 and 20; "a flow redirection unit…which redirects urinary streams aimed at a center portion of the receptable to side walls of the receptacle" in claims 4 and 14.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. With respect to the "plumbing unit," the corresponding disclosed structure is tubing (e.g., ¶ [0058] of the application as published, US 2024/0108266 A1). With respect to the "data acquisition unit," the corresponding disclosed structure is an electronic microcontroller connected via analog signal to the fluid sensors (e.g., ¶ [0061]), With respect to the "data processing and storage unit," the corresponding disclosed structure is a programmed computer (e.g., ¶ [0062]). With respect to the "data output unit," the corresponding disclosed structure is a printer (e.g., ¶ [0063]). With respect to the "toilet adapter unit," the corresponding disclosed structure is a universal mount including brackets (e.g., ¶¶ [0064]-[0067]) as illustrated in Applicant's Figs. 1-3, 10-11, etc. With respect to the "flow redirection unit," the corresponding disclosed structure is a dome-shaped structure placed in approximately the lower portion of the receptacle (e.g., ¶ [0070]) as illustrated in Applicant's Figs. 12-13.
If Applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed functions); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, 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) 1-20 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 11 and claims dependent thereon, the limitation "flow-through fluid sensors for measuring urine flow" is indefinite, as it is unclear how many sensors are required. Applicant discloses measuring urine flow using a thermal mass-flow principle is preferred (e.g., ¶ [0059]). One of ordinary skill in the art would readily appreciate using a thermal mass-flow principle typically utilizes two temperature sensors (see, e.g., US 2013/0041234 A1 to Grinstein, ¶ [0004]). Accordingly, it is not clear if the above-noted limitation is intended to require multiple independent sensors each producing a measure of urine flow, or is intended to indicate that multiple sensors are utilized in combination to produce a measure of urine flow.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5, 9, 11-12, 15 and 19 is/are rejected under 35 U.S.C. 103 as obvious over US 2022/0378348 A1 (Oh); or alternatively, over Oh in view of US 5,078,012 A (Ding) and/or US 2013/0041234 A1 (Grinstein).
Regarding claims 1, 9, 11 and 19, Oh discloses/suggests a method of conducting a uroflowmetry test on a subject, the method comprising:
obtaining a uroflowmetry system (portable uroflowmetry apparatus 100);
having the subject direct a urine flow into the uroflowmetry system (e.g., ¶¶ [0181]-[0182] introducing a fluid, i.e., urine, into apparatus 100); and
having the uroflowmetry system measure the urine flow (e.g., ¶ [0183] measuring the flow rate of the fluid introduced over time into the portable uroflowmetry apparatus 100),
wherein the uroflowmetry system comprises:
a receptacle for receiving urine (Figs. 3-4, etc., input part 111 where fluid (i.e., urine ¶ [0073]) is initially introduced);
a plumbing unit for directing urine from the receptacle (Figs. 3-4, etc., upper tube 112 having a path formed such that fluid introduced from input part 111 flows to an inlet of the examination module 120);
a flow-through fluid sensor for measuring urine flow (Figs. 3-10, etc., examination module 120 or rotation part 122 thereof, wherein rotation part 122 formed as an impeller having a shape where wing plates are radially installed between one pair of circular plates and is rotated around a rotation shaft by the load of the fluid);
an output port from which urine exits the system (Figs. 3-4, etc., lower tube 113 having a path formed such that the fluid measured in examination module 120 can be discharged outside);
a data acquisition unit for receiving and collecting urine flow data from the flow-through fluid sensors (¶¶ [0089]-[0092] controller 123, or measurement part 123a, for measuring the rotation motion of the rotation shaft and electrically signaling the same); and
a data processing and storage unit for processing and storing urine flow data received from the data acquisition unit, wherein the data processing and storage unit processes the urine flow data received from the data acquisition unit into clinically relevant metrics (¶¶ [0093]-[0095] controller 123, or analyzing part 123b thereof, for analyzing the flow rate of the introduced fluid over time to derive result values, such as maximum flow rate, mean flow rate, voided volume, etc.).
While Oh does not expressly disclose the data processing and storage unit stores urine flow data received from the data acquisition unit, Oh discloses the data processing and storage unit processes the urine flow data received from the data acquisition unit into clinically relevant metrics, including maximum flow rate, mean flow rate, voided volume, etc., which one of ordinary skill in the art would at once envisage would require storing the urine flow data received from the data acquisition unit, at least temporarily, in order to derive said metric(s). For example, all flow rates measured during an event would need to be stored and accessible by the controller (or analyzing part thereof) of Oh in order to enable the data processing and storage unit to determine the maximum flow rate for said event.
Alternatively/Additionally, Ding discloses a uroflowmetry system comprising a sensor for measuring urine flow (transducer assembly 3); a data acquisition unit (signal processing system) for receiving and collecting urine flow data from the sensor (col. 2, lines 61 - col., 3, line 14, signal processing system begins timing and sampling of the transducer output at regular intervals to produce at each time of sampling a value of instantaneous flow rate (Ri)); and a data processing and storage unit for processing and storing urine flow data received from the data acquisition unit, wherein the data processing and storage unit processes the urine flow data received from the data acquisition unit into clinically relevant metrics (col. 2, lines 61 - col., 3, line 14, signal processing system stores all sampled Ri values obtained during voiding in memory for further processing, e.g., determining maximum flow rate, voiding volume, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with a data acquisition unit for receiving and collecting urine flow data from the flow-through fluid sensor; and a data processing and storage unit for processing and storing urine flow data received from the data acquisition unit as taught/suggested by Ding in order to facilitate processing the urine flow data received from the data acquisition unit into the disclosed clinically relevant metrics (Ding, col. 2, lines 61 - col., 3, line 14).
Oh/Oh as modified does not expressly disclose sensors (plural) for measuring urine flow. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Oh with a plurality of flow-through sensors because Applicant has not disclosed that more than one sensor or measuring urine flow provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the sensor (e.g., paddlewheel) disclosed by Oh for measuring urine flow because either arrangement permits urine to flow through the plumbing unit as flow is detected and measured.
Alternatively/Additionally, Grinstein discloses flow-through fluid sensors for measuring urine flow (Fig. 1, temperature sensors 110, 112; Figs. 2, 4, etc., temperature sensors 210, 212). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh flow-through fluid sensors for measuring urine flow as taught/suggested by Grinstein in order to provide simple, cost-effective, and accurate flow rate meters, which enable measuring the flow rate of a liquid (Grinstein, ¶ [0015]) and/or as a simple substitution of one means for measuring urine flow for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 2 and 12, Oh as modified discloses/suggests the system further comprises a data output unit which converts processed urine flow data from the data processing and storage unit to a readable format (e.g., ¶ [0100] display 124 is for displaying at least one or more of the examination date, examination time, result value derived in the analyzing part 12b and the result determined in the determining part 123c; Fig. 5; etc. and/or display of terminal 200).
Alternatively/Additionally, Ding discloses a data output unit which converts processed urine flow data from the data processing and storage unit to a readable format (e.g., col. 2, lines 48-60, conventional printer for printing out determined clinically-relevant metrics). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with the data output unit which converts processed urine flow data from the data processing and storage unit to a readable format as taught/suggested by Ding as a simple substitution of suitable data output means for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 5 and 15, Oh as modified discloses/suggests the plumbing unit comprises tubing which receives urine from the receptacle, and directs urine to the flow-through fluid sensors and the output port (Figs. 3-4, etc., upper tube 112 having a path formed such that fluid introduced from input part 111 flows to an inlet of the examination module 120).
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as obvious over Oh (or Oh in view of Ding and/or Grinstein) as applied to claim(s) 1 and 11 above, and further in view of US 6,811,754 B2 (House).
Regarding claims 3 and 13, Oh as modified teaches/suggests the limitations of claims 1 and 11, as discussed above, but does not expressly disclose the system comprises a toilet adapter unit for mounting the system to a rim of a toilet bowl. However, Oh does disclose the system is portable, and discloses/suggests said system can be utilized at home or in a public toilet (e.g., ¶ [0006]),
House discloses a system comprising a receptacle for receiving urine (receptacle or catch bowl 14) and a toilet adapter unit for mounting the system to a rim of a toilet bowl (bracket 16 for supporting and holding the catch receptacle in position, e.g., Figs. 1-2, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with the system further comprising a toilet adapter unit for mounting the system to a rim of a toilet bowl as taught/suggested by House in order to facilitate using the system under conditions that would not affect a subject's psychological state and where the usual voiding pattern can be well revealed, e.g., at home or in a public toilet (Oh, ¶ [0006]; House, col. 2, lines 38-45; etc.).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as obvious over Oh (or Oh in view of Ding and/or Grinstein) as applied to claim(s) 1 and 11 above, and further in view of US 5,046,510 A (Ams) and US 2005/0066435 A1 (Barnes).
Regarding claims 4 and 14, Oh as modified teaches/suggests the limitations of claims 1 and 11, as discussed above, and further discloses/suggests the receptacle comprises a funnel (e.g., ¶ [0075] input part 111 has a shape of a funnel), but does not disclose the system further comprises a flow redirection unit placed inside the receptacle, wherein the flow redirection unit is a structure which redirects urinary streams aimed at a center portion of the receptable to side walls of the receptacle.
Ams discloses a flow-through uroflowmetry system (Abstract), disclosing turbulence in a urinary stream can cause measuring errors to occur in the subsequent measurement of the through-flow (col. 1, lines 49-58). Barnes discloses a receptacle including a funnel (funnel-shaped drain body 64); and a flow redirection unit (fluid-deflecting plug 72) placed inside the receptacle (e.g., Figs. 3, 7, etc.), wherein the flow redirection unit is a structure which redirects fluid aimed at a center portion of the receptable to side walls of the receptacle (e.g., ¶ [0039] secure fluid-deflecting plug 72 within the interior of the funnel-shaped drain body 64 maintains a fixed spacing between the sidewall 70 of funnel-shaped drain body 64 and the sidewall 74 of fluid-deflecting plug 72 that defines a fluid-flow channel which extends from funnel mouth 66 to the funnel outlet or neck 68). Barnes further discloses the above-noted arrangement enables providing laminar flow between the mouth and neck of the receptacle/funnel-shaped body (e.g., ¶ [0044]). Barnes is at least reasonably pertinent to the problem addressed by the flow redirection unit (e.g., ¶ [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with the system further comprising a flow redirection unit placed inside the receptacle, wherein the flow redirection unit is a structure which redirects urinary streams aimed at a center portion of the receptable to side walls of the receptacle, as taught/suggested by Barnes in order to facilitate providing a laminar urine flow to the plumbing unit (Barnes, ¶ [0044]), thereby increasing accuracy/reliability of the urine flow measurements and/or clinical parameters derived based thereon (Ams, col. 1, lines 49-58).
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as obvious over Oh in view of Grinstein (or Oh in view of Ding and Grinstein) as applied to claim(s) 1 and 11 above, and further in view of US 2007/0017285 A1 (Wang).
Regarding claims 6 and 16, Oh as modified discloses/suggests the limitations of claims 1 and 11, and further discloses/suggests the flow-through fluid sensors comprise liquid flow sensors, as discussed above, but does not expressly disclose said sensors comprise MEMS liquid flow sensors.
Wang discloses flow-through fluid sensors comprising MEMS fluid flow sensors (e.g., ¶ [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with flow-through fluid/liquid flow sensors comprising MEMS liquid flow sensors as taught/suggested by Wang in order to utilize sensors with small size, low power, and high reliability at low cost (Wang, ¶ [0006]).
Claim(s) 7-8 and 17-18 is/are rejected under 35 U.S.C. 103 as obvious over Oh in view of Ding (or Oh in view of Ding and Grinstein) as applied to claim(s) 1 and 11 above, and further in view of US 2014/0296746 A1 (Whitaker).
Regarding claims 7-8 and 17-18, Oh as modified discloses/suggests the limitations of claims 1 and 11, as discussed above. Oh does not expressly disclose the data acquisition unit, upon receiving urine flow data from the flow-through fluid sensors that the urine flow has gone above a predetermined threshold, begins sending the urine flow data to the data processing and storage unit, and, upon receiving urine flow data from the flow-through fluid sensors that the urine flow has gone below a predetermined threshold, stops sending the urine flow data to the data processing and storage unit.
However, Ding (or Oh as modified thereby above) discloses the data acquisition unit, upon receiving urine flow data from a sensor indicating a urine flow (e.g., voiding event) has started, begins sending the urine flow data to the data processing and storage unit, and upon receiving urine flow data from the sensor indicating the urine flow has stopped, stops sending the urine flow data to the data processing and storage unit (col. 2, lines 61 - col., 3, line 14, once the elastic cantilever deflects indicating urinary flow impact, the signal processing system begins sampling and storing Ri at regular intervals and continues said sampling/storing until voiding is concluded). Whitaker discloses a comparable system comprising a data acquisition unit that, upon receiving sensor data indicating that the urine flow has gone above a predetermined threshold, begins recording/storing said sensor data, and, upon receiving sensor data indicating that the urine flow has gone below a predetermined threshold, stops recording/storing said sensor data (e.g., ¶ [0022]). Accordingly, Ding discloses the data acquisition unit begins sending the urine flow data to the data processing and storage unit for recording/storage thereof when the beginning of a voiding event (i.e., reception of urine flow within the uroflowmetry system) is identified and stops sending the urine flow data to the data processing and storage unit for recording/storage thereof when the voiding event has concluded. Whitaker discloses the beginning and ending of a voiding event can be identified based on a comparison of urine flow data to predetermined thresholds.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with the data acquisition unit, upon receiving urine flow data from the flow-through fluid sensors that the urine flow has gone above a predetermined threshold, begins sending the urine flow data to the data processing and storage unit, and, upon receiving urine flow data from the flow-through fluid sensors that the urine flow has gone below a predetermined threshold, stops sending the urine flow data to the data processing and storage unit as taught/suggested by Ding and Whitaker in order to facilitate automatically collecting urine flow data for each voiding event received by the system for analysis (Whitaker, ¶ [0001]).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as obvious over Oh in view of House (or Oh in view of Ding and/or Grinstein and House) as applied to claim(s) 3 and 13 above, and further in view of US 2022/0386917 A1 (Mann).
Regarding claims 10 and 20, Oh as modified discloses/suggests the limitations of claims 3 and 13, as discussed above, but does not expressly disclose the toilet adapter unit is adjustable to allow mounting to toilets of different sizes.
Mann discloses a toilet adapter unit (platform 130) for mounting a uroflowmetry system (urinary output measuring system 100), or receptacle (urine hat 110) thereof, wherein the toilet adapter unit is adjustable to allow mounting to toilets of different sizes (e.g., ¶ [0041] length of connecting members 133 of platform 130 may be adjustable to accommodate different sizes and shapes of the toilet bowl).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Oh with the toilet adapter unit being adjustable to allow mounting to toilets of different sizes as taught/suggested by Mann in order to facilitate using the system with toilets of various sizes and/or shapes (Mann, ¶ [0041]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791