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 .
Claims 1-20 are the currently pending claims hereby under examination.
Claim Objections
Claims 1, 3, 12, and 19 are objected to because of the following informalities:
In claim 1, line 9, and claim 12, line 9: "a sensor body" in the hook limitation should be revised to "the sensor body” for consistency with the previously introduced sensor body; and
In claim 3, lines 3-4, and claim 19, lines 3-4: “while permitting the hook to pivot the first axis relative to the transverse axis” is grammatically incorrect and should be revised to “while permitting the first axis of the hook to pivot relative to the transverse axis”.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites “the channel extending along a transverse axis” in lines 2-3, and claim 12 recites the same language in lines 2-3. The specification defines the transverse axis as extending between the top and bottom sides of the device. Under the broadest reasonable interpretation, the recitation requires the channel to have an extent along that transverse direction, including the direction through which the hook can extend, but does not require the transverse direction to be the channel's sole or longest dimension (specification ¶[0043], ¶[0049], ¶[0078]; Figs. 1, 3C-3G).
Claim 1 recites “a sensor body” in line 9, and claim 12 recites the same language in line 9. Under the broadest reasonable interpretation consistent with the specification, “sensor body” is not limited to a spherical or semi-spherical shape and encompasses the disclosed securement-ball/body configurations. The recited relationships among the sensor body, sensor array, channel, and hook remain required (specification ¶[0052]-[0057]).
Claim 1 recites “an angle of pressure along the first axis relative to the transverse axis” in lines 12-13, and claim 12 recites the same language in lines 12-13. In context, this language is interpreted as referring to the direction of the applied load or force producing the detected pressure relative to the transverse axis, rather than an angle intrinsic to pressure as a scalar quantity (specification ¶[0060], ¶[0069]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The following is a list of prior art relied upon for the double patenting rejections.
U.S. Patent No. 12,246,146 B2 (hereafter reference, ref, or ‘146) and the instant application are related through the continuation relationship and name the same inventors. The ordinary one-way test is applied. Each comparison below uses the selected reference claim and its actual dependency chain. No non-inherited sibling claim is used to supply a limitation.
Triebold et al. (US 2014/0283337 A1), hereinafter Triebold, teaches a multi-axis ball/clip hinge in which spaced-apart clip arms substantially contain a spherical ball, while first and second bearing supports secure the ball against translational movement and allow rotation in three axes. Figures 4b-4c further depict second bearing support 30 with a concave curved bearing surface defining part of the ball-receiving region (Triebold ¶[0032], [0034]-[0036]; Figs. 3-4C; claims 1-2, 8-9). Although Triebold concerns a multi-axis hinge rather than fluid monitoring, it is reasonably pertinent to retaining a spherical member while permitting controlled articulation at a ball-receiving interface.
Spratte et al. (US 2009/0087253 A1), hereinafter Spratte, teaches ball-and-socket load measurement using a sensor array with pressure or force sensors and determination of force direction from the sensor outputs (Spratte ¶¶[0013], [0020]-[0023], [0030]-[0031], claim 15). Although Spratte exemplifies a motor-vehicle ball-and-socket joint, it is reasonably pertinent to the problem addressed by the claimed sensor interface because it concerns measuring the magnitude and direction of loads transmitted across a ball-and-socket interface.
Pahwa et al. (US 2017/0307423 A1), hereinafter Pahwa, teaches automated fluid-output monitoring, communication of measured data by USB or Bluetooth to an electronic medical record, a port for wiring between separately housed components, wired or unwired communication between separate housings, and urinary catheter drainage (Pahwa ¶¶[0007], [0018], [0026], [0029], [0033]).
Faries et al. (US 2004/0208780 A1), hereinafter Faries, teaches a medical stand having a controller housing secured to a support post of the stand, with sensing-device signals provided to the controller through a connector and receptacle. Faries is reasonably pertinent to locating control electronics on a medical stand and providing a defined signal connection between a sensor and stand-mounted controller (Faries ¶[0022], [0031], [0036]; Figs. 1-4).
Serany et al. (U.S. Patent No. 3,371,897), hereinafter Serany, teaches a drainage-bag support including a strap forming a closed loop around a hospital bed rail to suspend the assembly, wherein the loop may also serve as a handle, and further provides a separate handle for carrying and supporting the assembly (Serany, col. 2, ll. 24-48; Figs. 1-2; claims 4, 8).
Liu et al. (CN 202920689 U), hereinafter Liu, describes a drainage-bag hook coupled to a supporting splint through a mating insertion opening and hanging block, and the translation states that “the hook and the sheet material are detachable” and storage is convenient (Liu, Abstract; claim 1; ¶¶[0014], [0024]; claim 1). An English machine translation is relied upon below.
For purposes of the following comparisons, the claimed channel is construed in light of the instant claim requirement that the sensor body be received and movable therein. The instant specification describes the opposed arms and channel as cooperating to define socket 118, which receives securement ball 134, and describes socket 118 including channel 116 as securing the ball while allowing movement. Accordingly, the claimed channel encompasses the ball-receiving portion of the arm/channel/socket structure and is not limited to only the narrower hook-clearance opening. The same construction applies to the engagement and concave-geometry limitations of claims 3, 4, 19, and 20. (Instant application, ¶[0043], [0048]-[0049], Figs. 1, 5A-5B.)
Claims 1, 3-4, 6, and 8-11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,246,146 B2 (hereafter reference, ref, or ’146), through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), hereafter Triebold, Spratte et al. (US 2009/0087253 A1), hereafter Spratte, and Pahwa et al. (US 2017/0307423 A1), hereafter Pahwa.
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 9 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 1: An automated fluid monitoring system, comprising:
Ref claim 1, inherited by reference claim 9 through claim 5: "An automated fluid monitoring system, comprising:"
The preamble is substantively the same.
Claim 1: a stand including a channel between a first arm and a second arm, the channel extending along a transverse axis;
Ref claim 1, inherited by reference claim 9 through claim 5: "a stand including a socket extending along a transverse axis;"
Reference claim 1, inherited by reference claim 9 through claim 5, recites a stand including a socket extending along a transverse axis, but does not recite first and second arms with a channel therebetween. Triebold teaches a ball-retaining clip having spaced-apart arms that substantially contain a spherical ball, with the space between the arms providing the ball-receiving opening shown in Fig. 3. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed socket in view of Triebold to use the spaced-arm ball-retaining configuration, thereby providing a ball-receiving channel between first and second arms while retaining the transverse orientation and rotatable ball support required by reference claim 1 and providing reliable retention during multi-axis articulation. (Triebold ¶[0029]-[0032]; Fig. 3; claim 1.)
Claim 1: a hanger, comprising:
Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 9 through claim 5, expressly recites the hanger having the securement ball and hook.
Claim 1: a sensor body configured to be received in the channel of the stand, wherein the sensor body is moveable in the channel;
Ref claim 1, inherited by reference claim 9 through claim 5: "a stand including a socket extending along a transverse axis;" Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 9 through claim 5, recites a semi-spherical securement ball configured to rotatably engage the socket and a sensor array disposed on the securement-ball surface. Under the claim interpretation above, the reference-claimed securement ball corresponds to the claimed sensor body, but reference claim 1 does not expressly require that body to be received and movable in a channel. Triebold teaches spherical ball 22a substantially contained by spaced-apart clip arms 26b, with the ball retained in the ball-receiving interface while remaining rotatable about three axes. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed ball/socket arrangement in view of Triebold so that the reference-claimed securement ball is received and movable within the ball-receiving space between the spaced arms in order to retain and center the ball while permitting the rotational engagement already required by reference claim 1. (Triebold ¶[0029]-[0035]; Figs. 2-4C; claims 1-2, 8-9.)
Claim 1: a sensor array disposed on a surface of the sensor body, the sensor array including one or more pressure sensors; and
Ref claim 1, inherited by reference claim 9 through claim 5: "a sensor array disposed on a surface of the securement ball and configured to detect a change in pressure between the hanger and the stand, and to detect an angle of pressure along the first axis, relative to the transverse axis."
Reference claim 1, inherited by reference claim 9 through claim 5, recites a sensor array on the securement-ball surface that detects a pressure change and pressure angle, but does not expressly specify that the array includes pressure sensors. Spratte teaches a ball-and-socket sensor arrangement using pressure or force sensors and determines the direction of the resulting force from the sensor signals. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed sensor array in view of Spratte to include one or more pressure sensors in order to obtain the pressure measurements used to determine the magnitude and direction of the applied load while retaining the array location and detection functions of reference claim 1. (Spratte ¶[0013], [0020]-[0023], [0030]-[0031], claim 15.)
Claim 1: a hook extending from a sensor body along a first axis, wherein the sensor array is configured to:(i) detect a change in pressure between the hanger and the stand, and(ii) detect an angle of pressure along the first axis relative to the transverse axis;
Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;" Ref claim 1, inherited by reference claim 9 through claim 5: "a sensor array disposed on a surface of the securement ball and configured to detect a change in pressure between the hanger and the stand, and to detect an angle of pressure along the first axis, relative to the transverse axis."
Reference claim 1, inherited by reference claim 9 through claim 5, expressly recites the hook extending from the semi-spherical securement ball along the first axis and the sensor array configured to perform both recited pressure-detection functions. Under the claim interpretation above, the reference-claimed securement ball corresponds to the claimed sensor body.
Claim 1: a fluid collection bag configured to be suspended from the hook; and
Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 9 through claim 5, recites the hook coupled with the fluid collection bag, but does not expressly require the bag to be suspended from the hook. Pahwa teaches a fluid collection bag hanging from a measuring device by a hook-shaped lower attachment member received through an aperture of the bag. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed hook and fluid collection bag in view of Pahwa such that the bag is suspended from the hook in order to support the bag and transmit the weight of collected fluid through the hook to the measuring assembly. (Pahwa ¶[0007], [0017]-[0018]; Fig. 1.)
Claim 1: a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic, wherein the fluid output logic is configured to receive a signal from the sensor array and determine a fluid volume within the fluid collection bag, or a change in fluid volume within the fluid collection bag over time.
Ref claim 5, inherited by reference claim 9: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 9: "wherein the fluid output logic is configured to receive a signal from the sensor array and determine a fluid volume within the fluid collection bag, or a change in fluid volume within the fluid collection bag over time."
Reference claim 5, inherited by reference claim 9, expressly recites the same console components, and reference claim 9 expressly recites the same fluid-output function.
Claim 3: The automated fluid monitoring system according to claim 1, wherein the channel is configured to engage the sensor body to prevent linear movement along a longitudinal axis and a lateral axis while permitting the hook to pivot the first axis relative to the transverse axis.
Ref claim 1, inherited by reference claim 9 through claim 5: "a stand including a socket extending along a transverse axis;" Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 1 are addressed above by reference claim 9 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 9 through claim 5, additionally requires the securement ball to rotatably engage the socket, but does not expressly require restraint against linear movement along the longitudinal and lateral axes while permitting the recited pivoting. Triebold teaches first and second bearing supports that secure spherical ball 22a within housing 24 while allowing rotation in three axes and preventing translational movement along the ball/rod axis and left-to-right movement. It would have been obvious to one of ordinary skill in the art to apply Triebold’s translational restraint to the reference-claimed ball-receiving channel in order to maintain the securement ball centered and retained during pivoting while preserving rotational movement. (Triebold ¶[0034]-[0036]; Figs. 3-4C; claims 1-2, 8-9.)
Claim 4: The automated fluid monitoring system according to claim 1, wherein the channel includes a semi-spherical concave shape, wherein the sensor body is in the form of a semi-spherical securement ball, and wherein the securement ball is rotatable in the channel.
Ref claim 1, inherited by reference claim 9 through claim 5: "a stand including a socket extending along a transverse axis;" Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 1 are addressed above by reference claim 9 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 9 through claim 5, expressly recites a semi-spherical securement ball configured to rotatably engage the socket, but does not expressly require the receiving channel to include a semi-spherical concave shape. Triebold teaches spherical ball 22a received within housing 24 with first and second bearing supports 28 and 30 that secure the ball while permitting rotation, and Figs. 4b-4c depict second bearing support 30 with a concave curved surface defining part of the ball-receiving region. It would have been obvious to one of ordinary skill in the art to provide the reference-claimed ball-receiving channel with the concave bearing geometry taught by Triebold in order to conformingly support and retain the semi-spherical securement ball while permitting its rotational movement. (Triebold ¶[0034]-[0036]; Figs. 4a-4c.)
Claim 6: The automated fluid monitoring system according to claim 1, wherein the console is disposed in the hanger and is communicatively coupled with one of the stand, a network, an external computing device, or an electronic health record system.
Ref claim 5, inherited by reference claim 9: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 9 through claim 5, recites the hanger and stand. No corresponding limitation is recited in the selected reference-claim chain requiring the console to be disposed in the hanger or communicatively coupled with the recited external systems.
Reference claim 5, inherited by reference claim 9, expressly recites the console, while reference claim 1, inherited through claim 5, recites the hanger and stand, but the selected chain does not locate the console in the hanger or require the claimed communication alternatives. Pahwa teaches an integrated fluid-output measuring device in which the measuring hardware, including the microprocessor, power source, and transmission electronics, is housed together with the load cell in a single housing positioned between the upper and lower attachment structures, and teaches transmitting fluid-output data by USB or Bluetooth to a computer or electronic medical record. It would have been obvious to one of ordinary skill in the art to dispose the reference-claimed console in the hanger assembly and communicatively couple it with at least an external computing device or electronic health record system, as taught by Pahwa, in order to consolidate sensing and processing electronics in the hanging measurement assembly and provide real-time transmission of fluid-output data. (Pahwa ¶[0010]-[0011], [0017], [0024]-[0025], [0029]-[0031]; Figs. 1-4.)
Claim 8: The automated fluid monitoring system according to claim 1, wherein the console is disposed remotely from both the hanger and the stand as a stand-alone device and is wirelessly communicatively coupled with the sensor array.
Ref claim 5, inherited by reference claim 9: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 9 through claim 5, recites the hanger and stand. No corresponding limitation is recited in the selected reference-claim chain requiring the console to be disposed remotely from the hanger and stand as a stand-alone device or wirelessly coupled with the sensor array.
Reference claim 5, inherited by reference claim 9, expressly recites the console, but the selected chain does not require remote stand-alone placement or wireless coupling with the sensor array. Pahwa teaches a two-housing fluid-output monitor in which the load cell and associated attachment structures are contained in a first housing while the amplifier, microprocessor, power source, and transmitter are contained in a separate second housing, with communication between the housings being either wired or unwired; Pahwa further teaches Bluetooth transmission. It would have been obvious to one of ordinary skill in the art to place the reference-claimed console in the separate processing housing remote from the hanger and stand and wirelessly couple it with the sensor array in order to separate the processing electronics from the sensing assembly and avoid a physical tether while preserving signal communication. (Pahwa ¶[0010]-[0011], [0024]-[0026], [0032]-[0033]; Fig. 5.)
Claim 9: The automated fluid monitoring system according to claim 1, wherein the pressure mapping logic is configured to receive a signal from the sensor array and determine an angle of the first axis relative to the transverse axis.
Ref claim 5, inherited by reference claim 9: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 9 through claim 5: "a sensor array disposed on a surface of the securement ball and configured to detect a change in pressure between the hanger and the stand, and to detect an angle of pressure along the first axis, relative to the transverse axis."
Reference claim 5, inherited by reference claim 9, expressly recites pressure mapping logic, and reference claim 1, inherited through claim 5, requires the sensor array to detect an angle of pressure along the first axis relative to the transverse axis, but the selected chain does not expressly assign receipt of the sensor-array signal and angular determination to the pressure mapping logic. Spratte teaches registering pressure-sensor signals and determining the resulting force vector in value and direction. It would have been obvious to one of ordinary skill in the art to configure the reference-claimed pressure mapping logic in view of Spratte to receive the sensor-array signal and determine the corresponding angle in order to perform directional load mapping from the pressure measurements already required by reference claim 1. (Spratte ¶[0013], [0030]-[0031].)
Claim 10: The automated fluid monitoring system according to claim 1, wherein the calibration logic is configured to receive a signal from the sensor array and calibrate one or more of the sensor array, the fluid output logic and the pressure mapping logic.
Ref claim 5, inherited by reference claim 9: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic."
Reference claim 5, inherited by reference claim 9, expressly recites calibration logic together with the sensor array, fluid output logic, and pressure mapping logic, but does not expressly recite the claimed signal-based calibration operation. Pahwa teaches applying a calibration factor to a digitized sensor-derived signal and performing that calibration in the microprocessor before converting the measured signal to fluid volume and flow rate. It would have been obvious to one of ordinary skill in the art to configure the reference-claimed calibration logic in view of Pahwa to receive the sensor-array signal and calibrate at least the sensor array, one of the recited alternatives, in order to convert the sensed load signal into an accurate measurement used by the fluid-monitoring system. (Pahwa ¶[0028]; Fig. 3.)
Claim 11: The automated fluid monitoring system according to claim 1, wherein the fluid collection bag is in fluid communication with a urinary catheter, and wherein the urinary catheter is configured to drain a fluid from a bladder of a patient.
Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 9 through claim 5, recites the fluid collection bag but does not require the bag to be in fluid communication with a urinary catheter configured to drain the bladder. Pahwa teaches a urine collection bag having tubing in fluid communication with a catheter placed in a patient’s bladder. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed fluid collection bag in view of Pahwa to receive fluid from a urinary catheter draining the patient’s bladder in order to use the automated fluid-monitoring system to measure urinary output. (Pahwa ¶[0007], [0018].)
Claim 2 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,246,146 B2, through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), Spratte et al. (US 2009/0087253 A1), Pahwa et al. (US 2017/0307423 A1), and Serany et al. (U.S. Patent No. 3,371,897).
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 9 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 2: The automated fluid monitoring system according to claim 1, wherein the hanger further includes a stabilizing handle configured to engage one of a medical bed, a door, or an intravenous pole.
Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 1 are addressed above by reference claim 9 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 9 through claim 5, recites the hanger but does not require a stabilizing handle configured to engage a medical support. Serany teaches a drainage-bag support in which strap 22 forms a closed loop around a hospital bed rail and may serve as a handle, and further provides handle 34 for carrying and supporting the assembly. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed hanger in view of Serany to include a support-engaging stabilizing handle in order to permit the hanger and attached collection bag to be supported from an available medical support during handling or repositioning. (Serany, col. 2, ll. 24-48; Figs. 1-2; claims 4, 8.)
Claim 5 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,246,146 B2, through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), Spratte et al. (US 2009/0087253 A1), Pahwa et al. (US 2017/0307423 A1), and Liu et al. (CN 202920689 U).
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 9 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 5: The automated fluid monitoring system according to claim 1, wherein the hook is detachable from the hanger.
Ref claim 1, inherited by reference claim 9 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 1 are addressed above by reference claim 9 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 9 through claim 5, recites the hook as part of the hanger but does not require the hook to be detachable. Liu teaches a drainage-bag hook fitted to a supporting splint through a matching insertion opening and hanging block, and the English machine translation expressly states that the hook and sheet material are detachable. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed hanger in view of Liu to provide a detachable hook in order to permit removal for handling or storage while retaining the same bag-support function when installed. (Liu, Abstract; claim 1; English machine translation, Description.)
Claim 7 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,246,146 B2, through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), Spratte et al. (US 2009/0087253 A1), Pahwa et al. (US 2017/0307423 A1), and Faries et al. (US 2004/0208780 A1).
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 9 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 7: The automated fluid monitoring system according to claim 1, wherein the console is disposed in the stand and is communicatively coupled with the sensor array via a connector wire or a port disposed on the hanger.
Ref claim 5, inherited by reference claim 9: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 9 through claim 5, recites the stand and sensor array. No corresponding limitation is recited in the selected reference-claim chain requiring the console to be disposed in the stand or communicatively coupled with the sensor array via a connector wire.
Reference claim 5, inherited by reference claim 9, expressly recites the console, and reference claim 1, inherited through claim 5, recites the stand and sensor array, but the selected chain does not locate the console in the stand or require the claimed wired signal path. Faries teaches a medical stand having controller housing 45 secured to support post 16 of the stand, with sensing-device signals supplied to the controller through connector 91 and receptacle 49. It would have been obvious to one of ordinary skill in the art to dispose the reference-claimed console in the stand and communicatively couple the sensor array to the console through a connector wire, as taught by Faries, in order to locate the control electronics on the supporting structure and provide a defined signal path from the sensor to the stand-mounted controller. (Faries ¶[0022], [0031], [0036]; Figs. 1-4.)
Claims 12, 14, and 16-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,246,146 B2, through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), hereafter Triebold, Spratte et al. (US 2009/0087253 A1), hereafter Spratte, and Pahwa et al. (US 2017/0307423 A1), hereafter Pahwa.
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 10 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 12: An automated fluid monitoring system, comprising:
Ref claim 1, inherited by reference claim 10 through claim 5: "An automated fluid monitoring system, comprising:"
The preamble is substantively the same.
Claim 12: a stand including a channel between a first arm and a second arm, the channel extending along a transverse axis;
Ref claim 1, inherited by reference claim 10 through claim 5: "a stand including a socket extending along a transverse axis;"
Reference claim 1, inherited by reference claim 10 through claim 5, recites a stand including a socket extending along a transverse axis, but does not recite first and second arms with a channel therebetween. Triebold teaches a ball-retaining clip having spaced-apart arms that substantially contain a spherical ball, with the space between the arms providing the ball-receiving opening shown in Fig. 3. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed socket in view of Triebold to use the spaced-arm ball-retaining configuration, thereby providing a ball-receiving channel between first and second arms while retaining the transverse orientation and rotatable ball support required by reference claim 1 and providing reliable retention during multi-axis articulation. (Triebold ¶[0029]-[0032]; Fig. 3; claim 1.)
Claim 12: a hanger, comprising:
Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 10 through claim 5, expressly recites the hanger having the securement ball and hook.
Claim 12: a sensor body configured to be received in the channel of the stand, wherein the sensor body is moveable in the channel;
Ref claim 1, inherited by reference claim 10 through claim 5: "a stand including a socket extending along a transverse axis;" Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 10 through claim 5, recites a semi-spherical securement ball configured to rotatably engage the socket and a sensor array disposed on the securement-ball surface. Under the claim interpretation above, the reference-claimed securement ball corresponds to the claimed sensor body, but reference claim 1 does not expressly require that body to be received and movable in a channel. Triebold teaches spherical ball 22a substantially contained by spaced-apart clip arms 26b, with the ball retained in the ball-receiving interface while remaining rotatable about three axes. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed ball/socket arrangement in view of Triebold so that the reference-claimed securement ball is received and movable within the ball-receiving space between the spaced arms in order to retain and center the ball while permitting the rotational engagement already required by reference claim 1. (Triebold ¶[0029]-[0035]; Figs. 2-4C; claims 1-2, 8-9.)
Claim 12: a sensor array disposed on a surface of the sensor body, the sensor array including one or more pressure sensors; and
Ref claim 1, inherited by reference claim 10 through claim 5: "a sensor array disposed on a surface of the securement ball and configured to detect a change in pressure between the hanger and the stand, and to detect an angle of pressure along the first axis, relative to the transverse axis."
Reference claim 1, inherited by reference claim 10 through claim 5, recites a sensor array on the securement-ball surface that detects a pressure change and pressure angle, but does not expressly specify that the array includes pressure sensors. Spratte teaches a ball-and-socket sensor arrangement using pressure or force sensors and determines the direction of the resulting force from the sensor signals. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed sensor array in view of Spratte to include one or more pressure sensors in order to obtain the pressure measurements used to determine the magnitude and direction of the applied load while retaining the array location and detection functions of reference claim 1. (Spratte ¶[0013], [0020]-[0023], [0030]-[0031], claim 15.)
Claim 12: a hook extending from a sensor body along a first axis, wherein the sensor array is configured to:(i) detect a change in pressure between the hanger and the stand, and(ii) detect an angle of pressure along the first axis relative to the transverse axis;
Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;" Ref claim 1, inherited by reference claim 10 through claim 5: "a sensor array disposed on a surface of the securement ball and configured to detect a change in pressure between the hanger and the stand, and to detect an angle of pressure along the first axis, relative to the transverse axis."
Reference claim 1, inherited by reference claim 10 through claim 5, expressly recites the hook extending from the semi-spherical securement ball along the first axis and the sensor array configured to perform both recited pressure-detection functions. Under the claim interpretation above, the reference-claimed securement ball corresponds to the claimed sensor body.
Claim 12: a fluid collection bag configured to be suspended from the hook; and
Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 10 through claim 5, recites the hook coupled with the fluid collection bag, but does not expressly require the bag to be suspended from the hook. Pahwa teaches a fluid collection bag hanging from a measuring device by a hook-shaped lower attachment member received through an aperture of the bag. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed hook and fluid collection bag in view of Pahwa such that the bag is suspended from the hook in order to support the bag and transmit the weight of collected fluid through the hook to the measuring assembly. (Pahwa ¶[0007], [0017]-[0018]; Fig. 1.)
Claim 12: a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic, wherein the pressure mapping logic is configured to receive a signal from the sensor array and determine an angle of the first axis relative to the transverse axis.
Ref claim 5, inherited by reference claim 10: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 10: "wherein the pressure mapping logic is configured to receive a signal from the sensor array and determine an angle of the first axis relative to the transverse axis."
Reference claim 5, inherited by reference claim 10, expressly recites the same console components, and reference claim 10 expressly recites the same pressure-mapping function.
Claim 14: The automated fluid monitoring system according to claim 12, wherein the console is disposed in the hanger and is communicatively coupled with one of the stand, a network, an external computing device, or an electronic health record system.
Ref claim 5, inherited by reference claim 10: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 10 through claim 5, recites the hanger and stand. No corresponding limitation is recited in the selected reference-claim chain requiring the console to be disposed in the hanger or communicatively coupled with the recited external systems.
Reference claim 5, inherited by reference claim 10, expressly recites the console, while reference claim 1, inherited through claim 5, recites the hanger and stand, but the selected chain does not locate the console in the hanger or require the claimed communication alternatives. Pahwa teaches an integrated fluid-output measuring device in which the measuring hardware, including the microprocessor, power source, and transmission electronics, is housed together with the load cell in a single housing positioned between the upper and lower attachment structures, and teaches transmitting fluid-output data by USB or Bluetooth to a computer or electronic medical record. It would have been obvious to one of ordinary skill in the art to dispose the reference-claimed console in the hanger assembly and communicatively couple it with at least an external computing device or electronic health record system, as taught by Pahwa, in order to consolidate sensing and processing electronics in the hanging measurement assembly and provide real-time transmission of fluid-output data. (Pahwa ¶[0010]-[0011], [0017], [0024]-[0025], [0029]-[0031]; Figs. 1-4.)
Claim 16: The automated fluid monitoring system according to claim 12, wherein the console is disposed remotely from both the hanger and the stand as a stand-alone device and is wirelessly communicatively coupled with the sensor array.
Ref claim 5, inherited by reference claim 10: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 10 through claim 5, recites the hanger and stand. No corresponding limitation is recited in the selected reference-claim chain requiring the console to be disposed remotely from the hanger and stand as a stand-alone device or wirelessly coupled with the sensor array.
Reference claim 5, inherited by reference claim 10, expressly recites the console, but the selected chain does not require remote stand-alone placement or wireless coupling with the sensor array. Pahwa teaches a two-housing fluid-output monitor in which the load cell and associated attachment structures are contained in a first housing while the amplifier, microprocessor, power source, and transmitter are contained in a separate second housing, with communication between the housings being either wired or unwired; Pahwa further teaches Bluetooth transmission. It would have been obvious to one of ordinary skill in the art to place the reference-claimed console in the separate processing housing remote from the hanger and stand and wirelessly couple it with the sensor array in order to separate the processing electronics from the sensing assembly and avoid a physical tether while preserving signal communication. (Pahwa ¶[0010]-[0011], [0024]-[0026], [0032]-[0033]; Fig. 5.)
Claim 17: The automated fluid monitoring system according to claim 12, wherein the calibration logic is configured to receive a signal from the sensor array and calibrate one or more of the sensor array, the fluid output logic and the pressure mapping logic.
Ref claim 5, inherited by reference claim 10: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic."
Reference claim 5, inherited by reference claim 10, expressly recites calibration logic together with the sensor array, fluid output logic, and pressure mapping logic, but does not expressly recite the claimed signal-based calibration operation. Pahwa teaches applying a calibration factor to a digitized sensor-derived signal and performing that calibration in a microprocessor before calculating fluid volume and flow rate. It would have been obvious to one of ordinary skill in the art to configure the reference-claimed calibration logic in view of Pahwa to receive the sensor-array signal and calibrate at least the sensor array, one of the recited alternatives, in order to convert the sensed load signal into an accurate measurement used by the fluid-monitoring system. (Pahwa ¶[0028]; Fig. 3.)
Claim 18: The automated fluid monitoring system according to claim 12, wherein the fluid collection bag is in fluid communication with a urinary catheter, and wherein the urinary catheter is configured to drain a fluid from a bladder of a patient.
Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
Reference claim 1, inherited by reference claim 10 through claim 5, recites the fluid collection bag but does not require the bag to be in fluid communication with a urinary catheter configured to drain the bladder. Pahwa teaches a urine collection bag having tubing in fluid communication with a catheter placed in a patient’s bladder. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed fluid collection bag in view of Pahwa to receive fluid from a urinary catheter draining the patient’s bladder in order to use the automated fluid-monitoring system to measure urinary output. (Pahwa ¶[0007], [0018].)
Claim 19: The automated fluid monitoring system according to claim 12, wherein the channel is configured to engage the sensor body to prevent linear movement along a longitudinal axis and a lateral axis while permitting the hook to pivot the first axis relative to the transverse axis.
Ref claim 1, inherited by reference claim 10 through claim 5: "a stand including a socket extending along a transverse axis;" Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 12 are addressed above by reference claim 10 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 10 through claim 5, additionally requires the securement ball to rotatably engage the socket, but does not expressly require restraint against linear movement along the longitudinal and lateral axes while permitting the recited pivoting. Triebold teaches first and second bearing supports that secure spherical ball 22a within housing 24 while allowing rotation in three axes and preventing translational movement along the ball/rod axis and left-to-right movement. It would have been obvious to one of ordinary skill in the art to apply Triebold’s translational restraint to the reference-claimed ball-receiving channel in order to maintain the securement ball centered and retained during pivoting while preserving rotational movement. (Triebold ¶[0034]-[0036]; Figs. 3-4C; claims 1-2, 8-9.)
Claim 20: The automated fluid monitoring system according to claim 12, wherein the channel includes a semi-spherical concave shape, wherein the sensor body is in the form of a semi-spherical securement ball, and wherein the securement ball is rotatable in the channel.
Ref claim 1, inherited by reference claim 10 through claim 5: "a stand including a socket extending along a transverse axis;" Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 12 are addressed above by reference claim 10 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 10 through claim 5, expressly recites a semi-spherical securement ball configured to rotatably engage the socket, but does not expressly require the receiving channel to include a semi-spherical concave shape. Triebold teaches spherical ball 22a received within housing 24 with first and second bearing supports 28 and 30 that secure the ball while permitting rotation, and Figs. 4b-4c depict second bearing support 30 with a concave curved surface defining part of the ball-receiving region. It would have been obvious to one of ordinary skill in the art to provide the reference-claimed ball-receiving channel with the concave bearing geometry taught by Triebold in order to conformingly support and retain the semi-spherical securement ball while permitting its rotational movement. (Triebold ¶[0034]-[0036]; Figs. 4a-4c.)
Claim 13 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,246,146 B2, through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), Spratte et al. (US 2009/0087253 A1), Pahwa et al. (US 2017/0307423 A1), and Serany et al. (U.S. Patent No. 3,371,897).
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 10 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 13: The automated fluid monitoring system according to claim 12, wherein the hanger further includes a stabilizing handle configured to engage one of a medical bed, a door, or an intravenous pole.
Ref claim 1, inherited by reference claim 10 through claim 5: "a hanger having a securement ball defining a semi-spherical shape and including a hook extending therefrom along a first axis, the hook coupled with a fluid collection bag, the securement ball configured to rotatably engage the socket;"
The incorporated limitations of instant claim 12 are addressed above by reference claim 10 in view of Triebold, Spratte, and Pahwa. Reference claim 1, inherited by reference claim 10 through claim 5, recites the hanger but does not require a stabilizing handle configured to engage a medical support. Serany teaches a drainage-bag support in which strap 22 forms a closed loop around a hospital bed rail and may serve as a handle, and further provides handle 34 for carrying and supporting the assembly. It would have been obvious to one of ordinary skill in the art to modify the reference-claimed hanger in view of Serany to include a support-engaging stabilizing handle in order to permit the hanger and attached collection bag to be supported from an available medical support during handling or repositioning. (Serany, col. 2, ll. 24-48; Figs. 1-2; claims 4, 8.)
Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,246,146 B2, through its dependence from claims 5 and 1, in view of Triebold et al. (US 2014/0283337 A1), Spratte et al. (US 2009/0087253 A1), Pahwa et al. (US 2017/0307423 A1), and Faries et al. (US 2004/0208780 A1).
The analysis follows. The bolded and underlined portions in the Instant Application Claim Language column identify language absent from or materially different from reference claim 10 and the limitations inherited through claims 5 and 1.
Instant Application Claim Language
Corresponding Reference-Claim Language
Concise Double-Patenting / Obviousness Analysis
Claim 15: The automated fluid monitoring system according to claim 12, wherein the console is disposed in the stand and is communicatively coupled with the sensor array via a connector wire or a port disposed on the hanger.
Ref claim 5, inherited by reference claim 10: "further including a console including one or more processors, an energy source, a data store, a calibration logic, a pressure mapping logic, and a fluid output logic." Ref claim 1, inherited by reference claim 10 through claim 5, recites the stand and sensor array. No corresponding limitation is recited in the selected reference-claim chain requiring the console to be disposed in the stand or communicatively coupled with the sensor array via a connector wire.
Reference claim 5, inherited by reference claim 10, expressly recites the console, and reference claim 1, inherited through claim 5, recites the stand and sensor array, but the selected chain does not locate the console in the stand or require the claimed wired signal path. Faries teaches a medical stand having controller housing 45 secured to support post 16 of the stand, with sensing-device signals supplied to the controller through connector 91 and receptacle 49. It would have been obvious to one of ordinary skill in the art to dispose the reference-claimed console in the stand and communicatively couple the sensor array to the console through a connector wire, as taught by Faries, in order to locate the control electronics on the supporting structure and provide a defined signal path from the sensor to the stand-mounted controller. (Faries ¶[0022], [0031], [0036]; Figs. 1-4.)
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
