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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Claims Accounting
Applicant's arguments, filed 03/25/2026, have been fully considered.
Applicant elected claims 1-16 without traverse in the reply filed on 07/25/2025. Claims 17-20 remain withdrawn.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, entered 04/28/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 8, and 12 have been amended.
Claims 1-6, 8-10, 12-14, 16, and 21 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/28/2026 and 04/29/2026 have been considered by the examiner.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites “a rotatable claim or bracket” in line 3. This should read “a rotatable clamp or bracket”.
Appropriate correction is required.
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 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.
Claims 8 and 16 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.
Regarding claim 8, the claim recites “The device according to claim 1, wherein the attachment system further includes: a first attachment mechanism including a rotatable clamp or bracket…; and a second attachment mechanism including one or more of: a suction member”. The device according to claim 1 includes a mounting member configured to removably engage with a securing surface to affix the urinary output monitoring device to the securing surface. The mounting members are identified in the specification as various attachments 112A-B in Figs. 4A-4E, as these attachments are coupled to contact points which are coupled to rails. It is noted that the attachments 122A-B are configured to be removably attached to a securing surface (150), as recited in par. [0056] of the published application. In this configuration, it is unclear how a further inclusion of the first attachment mechanism and second attachment mechanism would be integrated with the device of claim 1. The one or more mounting members of the device of claim 1 (identified as the attachments 122) appear to be the same elements as what is described by the first attachment mechanism and the second attachment mechanism. Therefore, it is unclear how the recited first and second attachment mechanisms are integrated into the device of claim 1 in addition to the one or more mounting members. Clarification is requested.
For the purposes of examination, the claim is interpreted as “The device according to claim 1, wherein the one more mounting members includes: a first attachment mechanism… and a second attachment mechanism”.
Regarding claim 16, the claim recites “The device according to claim 12, wherein the attachment system includes: a first attachment mechanism including a rotatable claim or bracket… and a second attachment mechanism including one or more of: a suction member”. The device according to claim 12 includes a mounting member configured to removably engage with a securing surface to affix the urinary output monitoring device to the securing surface. Claim 16 is rendered indefinite for the same reasons as claim 8. Clarification is requested.
For the purposes of examination, the claim is interpreted as “The device according to claim 12, wherein the one more mounting members includes: a first attachment mechanism… and a second attachment mechanism”.
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.
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Annotated Fig. 7 of Holt
Claims 1-2, 5-6, 9, 12-14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2019/0069830 by Holt et al. – previously cited, hereinafter “Holt” in view of US Patent Publication 2020/0296406 by Keelen, hereinafter “Keelen”.
Regarding claim 1, Figs. 1-7 of Holt teaches a urinary output monitoring device (gravimetric apparatus 2), comprising: a load cell (S-type load cell 16) coupled between a bag attachment member (hook 4) and a first side of a body of the urinary output monitoring device (See annotated Fig. 7.), the load cell configured to define an electrical signal based on a weight of urine output suspended from the bag attachment member ([0010]; “Gravimetric devices measure the volume of voided urine using a weight transducer to measure the weight of urine
collected in a urine collection vessel. Using this information, which can be obtained using a known gravimetric device, and the specific gravity of urine, the skilled person is able to accurately calculate the volume of urine produced.”); an attachment system comprising one or more mounting members (See annotated Fig. 7), the mounting members coupled with a second side of the body of the urinary output monitoring device (See annotated Fig. 7),
a console coupled with the load cell (Fig. 4, Signal Processing Module 26 and display on device 52), the console including a number of processors ([0041]; microcontroller 22) and a non-transitory computer readable storage medium having logic stored thereon (Figs. 2-4, [0041]; Memory 28 interacts with the processor inn the signal processing module 26 to carry out the calculations and perform the function of the device, such as the functions of software/algorithm 54) that, when executed by the processors, performs operations ([0043, 0047]; Data is processed by software 54), including:
receiving electrical signals from the load cell ([0041]; Load cell converts the force into an analogue electrical signal and is passed to the signal processing module via amp 18 and analog to digital converter (ADC) 20);
converting the electrical signals into weight data pertaining to the weight of urine output ([0007]; the apparatus is configured to measure the weight of the vessel);
converting the weight data into volume data ([0007]; “thereby calculate, in real-time, the volume of urine therein”);
storing the volume data in a data store ([0041]; “the data can be monitored in real time and/or stored in the patient's electronic record”); and
transmitting the volume data to a display for depiction of the volume data thereon ([0041]; “The wifi module 24a enables wireless telemetry of urine output data to a separate computer located at, for example, a nursing station 14, such that the data can be monitored in real time”).
Holt does not teach the attachment system comprising one or more rails coupled with a second side of the body of the urinary output monitoring device, two or more contract points coupled to the one or more rails, and one or more mounting members coupled to the two or more contact points, wherein the contact points are configured to slide along the one or more rails, and the one or more mounting members are configured to removably engage with a securing surface to affix the urinary output monitoring device to the securing surface.
Fig. 6 of Keelen teaches a catheter system 100 featuring a display and catheter tube 106, the catheter system configured to transmit data regarding the volume of fluid in the reservoir (Abstract). The system also has a clamp and/or bracket 112 (i.e., mounting member) that can be removably engaged to a surface and can be rotated such that it can be mounted to a standard hospital bed frame, transport poles, or any other suitable location (i.e., horizontal or vertical bars). The clamp is attached to back of the smart catheter system, as shown in Fig. 6B, and can be adjusted (i.e., slide) up or down along a track (i.e., rail) on the back of the smart catheter (See annotated Fig. 6B of Keelen). The center portion of the track between the two slots can be considered a rail (See annotated Fig. 6B of Keelen) and the area of the track that contacts the clamp can be considered an area of contact points coupled to both the clamp and the track. This area contains any number of points, and can therefore be considered two or more contact points. As the clamp is adjusted up or down the track, the contact points move with the clamp and are always in contact with both the clamp and the track. This clamp allows for the device to be attached to an increased number of surfaces ([0063]).
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Annotated Fig. 6B of Keelen
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Holt such the attachment system comprised one or more rails coupled with a second side of the body of the urinary output monitoring device, two or more contract points coupled to the one or more rails, and one or more mounting members coupled to the two or more contact points, wherein the contact points are configured to slide along the one or more rails, and the one or more mounting members are configured to removably engage with a securing surface to affix the urinary output monitoring device to the securing surface, in order to increase the number of surfaces the device can be attached to, as taught by Keelen ([0063]).
Regarding claim 2, the combination of Holt and Keelen teaches the device according to claim 1, wherein the bag attachment member (Holt, hook 4) is configured to couple with and suspend a urine collection bag (Holt, See Annotated Fig. 7, [0040]; “hook 4 that is used to bear the weight of a urine collection bag 8”), the urine collection bag including a drainage tube coupled with a urinary catheter so that urine output from patient is collected within the urine collection bag (Holt; The catheter 10 is attached to the patient, and comprises a drainage tube that is fed directly into a urine collection bag 8).
Regarding claim 5, the combination of Holt and Keelen teaches the device according to claim 1, wherein the volume data includes a time of day correlated therewith (Holt, Fig. 6, [0045]; Raw data includes multiple digitised load cell values with a date-time stamp. The second graph shows the load output with volume and date-time stamps).
Regarding claim 6, the combination of Holt and Keelen teaches the device according to claim 1, wherein the operations further include receiving input from the display (Holt, [0017]; The display is touch-sensitive and button areas on the display may be used by a clinical operator. Therefore, the operations include receiving inputs (via the buttons) from the clinical operator via the display).
Regarding claim 9, the combination of Holt and Keelen teaches the device according to claim 1, wherein the one or more mounting members include a clamp rotatably coupled with the body so that the clamp is rotatable between a horizontal orientation and a vertical orientation (Keelen, Fig. 6B, [0063]; clamp and/or bracket 112 can be rotated between a horizontal and vertical orientation).
Regarding claim 12, the combination of Holt and Keelen (see the rejection of claim 1) teaches all of the limitations of claim 12, including a display (Holt, Fig. 7, [0017]; Display on device. [0044]; Alternatively, the transportable display 14 that receives wireless data).
Regarding claim 13, the combination of Holt and Keelen teaches the device according to claim 12, further comprising a urine collection bag (Holt, See Annotated Fig. 7, [0040]; urine collection bag 8) having a drainage tube configured for coupling with a urinary catheter (Holt; The catheter 10 is attached to the patient, and comprises a drainage tube that is fed directly into a urine collection bag 8), the urine collection bag configured for suspension from the bag attachment member (Holt, See Annotated Fig. 7, [0040]; “hook 4 that is used to bear the weight of a urine collection bag 8”).
Regarding claim 14, the combination of Holt and Keelen teaches the device according to claim 12, wherein the display defines a user interface of the urinary output monitoring system (Holt, [0017], “The display may be a resistive touch display or ideally, a capacitive touch display type (which does not require actuator force), such that button areas on the display may be used by the clinical operator.”).
Regarding claim 21, Holt in view of Keelen teaches the system according to claim 12, wherein the display is a transportable computing device, including at least one of a tablet, a cell phone, or a computer coupled with a medical cart (Holt, [0044]; “display 14 of a computer, mobile phone, smart phone, tablet or similar monitoring device, an example of which is shown in FIG. 5, which may be located at a nursing station”.).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Keelen, as applied to claim 1, in view of US Patent 5,769,087 by Westphal et al. – previously cited, hereinafter “Westphal”.
The combination of Holt and Keelen teaches the device according to claim 1, but does not teach the device comprising one or more sensors coupled with the console, the one or more sensors configured to determine the orientation of the load cell, wherein the operations further include applying a correction factor to the weight data based on the orientation of the load cell.
Fig. 6 of Westphal teaches a body fluid measurement apparatus that measures the weight of the body fluid mass collected in a container by using a force transducer. The apparatus further comprises two angle sensors 42 that generate a signal for the inclined position of the holder. An erroneous placing of the entire housing 12 and the force transducer 38 can be compensated for by correcting the signal delivered by the force transducer 38 by multiplying by the cosine of the pertinent erroneous angle (Col. 7, lines 38-64; Col 10, lines 4-26). Correcting for the angle from the vertical axis generates a more accurate weight measurement.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Holt and Keelen to include one or more sensors coupled with the console, the one or more sensors configured to determine the orientation of the load cell, wherein the operations further include applying a correction factor to the weight data based on the orientation of the load cell, in order to generate a more accurate weight measurement, as taught by Westphal (Col. 7, lines 38-64; Col 10, lines 4-26).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Keelen, as applied to claim 1, in view of US Patent Publication 2016/0374874 by Trepanier et al. – previously cited, hereinafter “Trepanier”.
The combination of Holt and Keelen teaches the device according to claim 1, but does not teach wherein: the load cell includes a first load cell and a second load cell oriented at an angle with respect the first load cell, and the operations include: receiving a first electrical signal from the first load cell; receiving a second electrical signal from the second load cell; and converting a combination of the first electrical signal with the second electrical signal into the weight data.
Fig. 12 of Trepanier teaches a system with a load cell that may experience loads from multiple directions (D1 and D2). Load cells are oriented perpendicular from each other (i.e., at an angle) such that when a force is applied, vector addition can be used and the components of the resulting vector sum can be determined ([0088]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Holt and Keelen such that the load cell includes a first load cell and a second load cell oriented at an angle with respect the first load cell, and the operations include: receiving a first electrical signal from the first load cell; receiving a second electrical signal from the second load cell; and converting a combination of the first electrical signal with the second electrical signal into the weight data, as taught by Trepanier ([0088]). This combination merely comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Holt in view of Keelen, as applied to claims 1 and 12, in view of US Patent Publication 2010/0262047 by Genis – previously cited, hereinafter “Genis”.
Regarding claim 8, the combination of Holt and Keelen teaches the device according to claim 1, wherein the attachment system includes: a first attachment mechanism including a rotatable clamp or backet configured to attach the urinary output monitoring device to at least one of a horizontal bar or a vertical bar (Keelen; clamp and/or bracket 112), but does not teach a second attachment mechanism including one or more of: a suction member, a clip, or a fastener configured to attach the urinary output monitoring device to vertical flat surface.
Fig 5 of Genis teaches a system with an object 204 with a sensor configured to be removably attached to a surface. The object may include mounting structures such as a hook, aperture, catch, adhesive, suction cup, stand or combinations thereof, allowing the object to be mounted on a number of surfaces ([0066]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Holt and Keelen to include a suction member such that it comprises a second attachment mechanism configured to attach the urinary output monitoring device to vertical flat surface, in order to enable the device to be able to be attached to more securing surfaces, as taught by Genis ([0066]).
Regarding claim 10, the combination of Holt, Keelen, and Genis teaches the device according to claim 1, comprising a second attachment system, wherein the second attachment system includes a suction cup. See the rejection of claim 8 above. The second attachment mechanism comprises a suction cup (Genis; Fig. 5, [0066]). The combination of Holt, Keelen, and Genis does not teach the suction cup being a plurality of suction cups.
The courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (See MPEP 2144.04-VI-B).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the suction cup taught by the combination of Holt, Keelen, and Genis to be a plurality of suction cups, as a plurality of suction cups would provide stronger adhesion to a surface.
Regarding claim 16, the combination of Holt, Keelen, and Genis teaches the system of claim 12, wherein the attachment system includes: a first attachment mechanism including a rotatable clamp or backet configured to attach the urinary output monitoring device to at least one of a horizontal bar or a vertical bar; and a second attachment mechanism including one or more of: a suction member, a clip, or a fastener configured to attach the urinary output monitoring device to vertical flat surface. See rejection of claim 8 above.
Response to Arguments
Applicant’s arguments, filed 03/27/2026 have been fully considered.
Applicant’s assertion regarding the rejection of the independent claims under 35 U.S.C. 103 is acknowledged. These assertions are moot as they are based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
It is noted that the amendments overcome the rejections of record of the previous Office action, mailed 01/30/2026. The rejections of the independent claims in this Office action rely on the same references as the Office action mailed 01/30/2026. However, given further consideration, the track integrated into the device body of Keelen can be considered a rail and corresponding contact points can be identified in Keelen. Therefore, the independent claims are rejected with the same references as the previous Office action, but on new grounds.
Conclusion
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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