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 .
Claim Objections
The claims contain minor informalities.
Claim 21 calls for “A fluid therapy system …” However, the remainder of the claim describes elements that only collect fluid, and do not administer or deliver fluid. The title “therapy system” appears less than accurate or appropriate. Examiner suggests to revise the preamble to describe a fluid “collection” or “measuring” system to more accurately describe the system’s role.
Claims 22-40 recite identical language and should be changed likewise.
In claim 31, the language “… a fluid line configured to direct fluid flow [[from]] to a collection device …” should be changed for clarity.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is 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 pre-AIA the applicant regards as the invention.
Claim 35 calls for “…and wherein the cartridge further comprises a detection sensor that engages when the cartridge is coupled to the console.” This language is ambiguous because it implies, but does not specify that the detection sensor engages the cartridge.
This language also contradicts the specification, which discloses that the detection sensor is part of the console and not part of the cartridge (¶ [0157] As shown in FIGS. 6E and 6F, the system 602 can further include one or more detection sensors 635. In some embodiments, the one of more sensors 635 are optical interrupter sensors including an emitter emitting an infrared beam and a receiver positioned to receive the beam. When the urine cartridge 620 is correctly coupled to the console 605, the beam is interrupted and not received by the receiver).
Examiner suggests to revise this as “… and wherein the [[cartridge]] console further comprises a detection sensor that engages the cartridge when the cartridge is coupled to the console.”
Or, “… and wherein the [[cartridge]] console further comprises a detection sensor that [[engages]] detects when the cartridge is coupled to the console.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-24, 26-29, 31-34, 36-38 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townsend; Seth et al. (US 20060100743 A1).
Regarding claim 21, Townsend discloses a fluid therapy system (¶ [0002], systems and methods that are used to detect acute renal failure; ¶ [0023], [0046], [0049], [0050] The system of the present invention at 110; ¶ [0053] FIG. 3, generally at 200; ¶ [0069] Referring to FIG. 6, generally at 400, a second embodiment of the system);
comprising: a fluid line configured to direct fluid flow to a collection device (¶ [0049], FIG. 2 … Drain line 104 connects to the Foley catheter; however, the drain line does not connect directly to urine collection bag 108 via drain line 106 but to the system of the present invention at 110; ¶ [0054] The first component of the flow rate sensor subsystem is cuvette 206 with in-flow line 204 connected to the top and out-flow line 208 connected to the bottom);
a cartridge coupled to the fluid line (¶ [0054], cuvette 206; ¶ [0062], FIG. 4, generally at 250, the disposable section of the flow rate sensor subsystem is shown … the disposable section that includes cuvette 206, magnetic stir element 230 in cuvette 206, in-flow line 204 with luer fitting 205, and out-flow line 208 with luer fitting 209; ¶ [0073] Referring to FIG. 7A, generally at 480, and FIG. 7B, generally at 490, along with FIG. 6, perspective views are shown of the relationship of overflow subsection 404 and cuvette 412 of disposable section 402);
a console configured to releasably receive the cartridge (¶ [0053] FIG. 3, generally at 200 … This Figure shows the two subsystems that form the present invention. They are both contained within housing 202; ¶ [0075] Lower part 416 of cuvette 412 will connect to out-flow line 464 (FIG. 10); ¶ [0076] The reusable section of the flow rate sensor subsystem, among other things, includes snap clamps 418 and 420 to releasably attach the disposable section of the flow rate sensor subsystem to the reusable section); and
a flow control device coupled to the console, wherein the flow control device is configured to operably engage the fluid line when the cartridge is received by the console (¶ [0057] The flow rate sensor subsystem also includes upper pinch valve 220 and lower pinch valve 222 … under the control of controller 218; ¶ [0076], The reusable section also includes pinch valves 434 and 436); and
wherein the flow control device is movable between (i) an open position and (ii) a closed position configured to inhibit fluid flow via the fluid line (¶ [0057], upper pinch valve 220 and lower pinch valve 222 … under the control of controller 218; ¶ [0064], The outputs of the photodiodes are processed by controller 218 to open and close pinch valves 220 and 222; ¶ [0076], The reusable section also includes pinch valves 434 and 436. The two pinch valves operate similar to the way their counterparts were described for the first embodiment shown in FIG. 3).
To clarify, Townsend discloses two embodiments which appear respectively in Figs. 2 and 10. Each of these embodiments are cited as individually teaching all features of claim 21.
Regarding claim 31, Townsend discloses a fluid therapy system (¶ [0002], systems and methods that are used to detect acute renal failure; ¶ [0023], [0046], [0049], [0050] The system of the present invention at 110; ¶ [0053] FIG. 3, generally at 200; ¶ [0069] Referring to FIG. 6, generally at 400, a second embodiment of the system);
comprising: a fluid line configured to direct fluid flow from to a collection device, the fluid line including a first portion and a second portion (¶ [0049], FIG. 2 … Drain line 104 connects to the Foley catheter; however, the drain line does not connect directly to urine collection bag 108 via drain line 106 but to the system of the present invention at 110; ¶ [0054] The first component of the flow rate sensor subsystem is cuvette 206 with in-flow line 204 connected to the top and out-flow line 208 connected to the bottom);
a flow control device configured to (i) operably engage the first portion of the fluid line to regulate the fluid flow therethrough and (ii) move from a first position to a second position, wherein the flow control device in the second position inhibits the fluid flow via the fluid line (¶ [0057] The flow rate sensor subsystem also includes upper pinch valve 220 and lower pinch valve 222 … under the control of controller 218; ¶ [0076], The reusable section also includes pinch valves 434 and 436); and
a cartridge configured to be coupled to the second portion of the fluid line (¶ [0054], cuvette 206; ¶ [0062], FIG. 4, generally at 250, the disposable section of the flow rate sensor subsystem is shown … the disposable section that includes cuvette 206, magnetic stir element 230 in cuvette 206, in-flow line 204 with luer fitting 205, and out-flow line 208 with luer fitting 209; ¶ [0073] Referring to FIG. 7A, generally at 480, and FIG. 7B, generally at 490, along with FIG. 6, perspective views are shown of the relationship of overflow subsection 404 and cuvette 412 of disposable section 402).
To clarify, Townsend’s two embodiments in Figs. 2 and 10 each individually describe all features of claim 31.
Regarding claims 22-24, 26-29, 30-34, 36-38 and 40, Townsend discloses a fluid therapy system wherein the console further comprises a flow sensor positioned to measure the fluid flow to the collection device via the fluid line; wherein the flow sensor is positioned downstream from the flow control device, relative to the fluid line (¶ [0055] The next components of the flow rate sensor subsystem are laser diodes ("LDs") 210 and 212 and their companion photodiodes 214 and 216, respectively. The LDs and photodiodes are controlled by controller 218. Each LD emits an energy beam at a predetermined frequency that impinges on its companion photodiode. The photodiode will sense this energy and produce an output signal);
wherein the flow sensor and the cartridge together define opposing sides of a channel that receives a portion of the fluid line between the opposing sides; wherein the flow control device defines a slot configured to receive a portion of the fluid line when the cartridge is received by the console (¶ [0063] Referring to FIG. 5, generally at 300, the reusable section of the flow rate detection subsystem that is shown in FIG. 3 is shown without the disposable section connected to it. This Figure also shows the
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analyte detection subsystem and its components);
wherein the flow control device includes a pinch valve; wherein the fluid line includes an external surface, and wherein flow control device is configured to operably engage the external surface; wherein the flow control device is configured to regulate the urine flow through the fluid line without touching the urine within the fluid line (¶ [0064], The outputs of the photodiodes are processed by controller 218 to open and close pinch valves 220 and 222; ¶ [0076] The reusable section of the flow rate sensor subsystem, among other things, includes snap clamps 418 and 420 to releasably attach the disposable section of the flow rate sensor subsystem to the reusable section. The reusable section also includes pinch valves 434 and 436);
wherein the first portion of the fluid line is upstream from the second portion of the fluid line (¶ [0054] The first component of the flow rate sensor subsystem is cuvette 206 with in-flow line 204 connected to the top and out-flow line 208 connected to the bottom);
wherein the cartridge includes an engagement feature configured to operably engage the second portion of the fluid line with the flow sensor (¶ [0076] The reusable section of the flow rate sensor subsystem, among other things, includes snap clamps 418 and 420 to releasably attach the disposable section of the flow rate sensor subsystem to the reusable section).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Townsend; Seth et al. (US 20060100743 A1) in view of Hogard; Michael Edward et al. (US 20200061273 A1).
Regarding claim 25, Townsend discloses a cartridge (¶ [0054], cuvette 206; ¶ [0062], FIG. 4, generally at 250, the disposable section of the flow rate sensor subsystem is shown; ¶ [0073] Referring to FIG. 7A, generally at 480, and FIG. 7B, generally at 490); and
wherein the flow control device is configured to operably engage a first portion of the fluid line (Fig. 3, pinch valves 220, 222 engage first portions of lines 204, 208); and
the flow sensor is configured to measure the urine flow through a second portion of the fluid line (Fig. 3, sensors 224, 226 optically measure flow through the cuvette 206).
Townsend does not explicitly disclose first, second and third coupling features. Hogard discloses a cartridge including a first coupling feature, a second coupling feature, and a third coupling feature (¶ [0081], Referring to FIG. 5, a user can ensure proper placement of the cartridge relative to the front panel with organizer 124 by aligning holes 125 of the organizer with the locator pegs 260 of the front panel. FIG. 5 shows a plurality of aligning holes 125 near the top of the organizer, but it should be understood that any number and location of aligning holes and locator pegs can be used to align and mount the cartridge 120 … Also shown in FIG. 5, the cartridge can include a number of access holes 2165 for gaining access to features on the dialysis delivery system);
the second coupling feature is positioned between the first and third coupling features; a first portion of the fluid line is positioned between the first and second coupling features and a second portion of the fluid line is positioned between the second and third coupling features (¶ [0081], it should be understood that any number and location of aligning holes and locator pegs can be used to align and mount the cartridge 120).
Hogard reliably mounts a cartridge to a console by embedding or constraining a fluid line on a perforated rigid plate and then engaging the plate’s holes with locator pegs. A skilled artisan would have been able to modify Townsend with Hogard’s coupling features by mounting Townsend’s fluid line on a perforated plate. One would be motivated to modify Townsend with Hogard’s coupling features and fluid line arrangement since Townsend otherwise relies on only a pair of clips to mount the tube and its cuvette. Therefore, it would have been obvious to modify Townsend with Hogard’s coupling features in order to more securely mount the cartridge.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Townsend; Seth et al. (US 20060100743 A1) in view of Kushnir; Alexander et al. (US 20190046102 A1).
Regarding claim 30, Townsend discloses a console further including a flow sensor positioned to measure the urine flow from the patient (¶ [0055] The next components of the flow rate sensor subsystem are laser diodes ("LDs") 210 and 212 and their companion photodiodes 214 and 216, respectively).
Townsend lacks a mounting component configured to measure a weight of the urine collection device. Kushnir discloses fluid/urine monitoring devices and systems (¶ [0007], [0096], [0097], [0134] As shown in FIG. 1, the fluid measuring device desirably includes a video display such as an LCD screen 2);
comprising a mounting component configured to measure a weight of a urine collection device (¶ [0125] The fluid measuring device desirably includes a load cell 6, such as a bending beam load cell; ¶ [0139] FIG. 3 … The load cell 6 is at the bottom of the enclosure body 5 and in operational connectivity to a hook 7. A fluid collection container 10 is suspended from the hook 7; ¶ [0152] In FIG. 5B, the device has been raised so that the fluid collection bag is no longer on the floor. The entire weight (force) of the bag is supported by the load cell and can be measured accurately by the device).
Kushnir generates data for a machine learning system, in order to detect or diagnose diseases (¶ [0017], the device may be used for assessing response to diuretic therapy in patients with heart failure, early diagnosis of acute kidney injury in patients; ¶ [0176], machine learning … The software/firmware may also be programmed to track the volume level over time to calculate flow rate. The software/firmware may also signal that the volume level, flow rate, and any other measured/calculated parameters be displayed on or transferred to a monitor, computer, smart phone, and/or other device). One would be motivated to modify Townsend with Kushnir’s weight sensor to generate more data for a machine learning algorithm to analyze, in order to improve its accuracy or sensitivity. Therefore, it would have been obvious to modify Townsend with Kushnir’s weight sensor in order to more accurately evaluate a patient.
Regarding claim 35, Townsend discloses a console including a flow control device (¶ [0057], upper pinch valve 220 and lower pinch valve 222 … under the control of controller 218; ¶ [0076], pinch valves 434 and 436); and a cartridge (¶ [0054], cuvette 206; ¶ [0062], FIG. 4, generally at 250, the disposable section of the flow rate sensor subsystem is shown; ¶ [0073] Referring to FIG. 7A, generally at 480, and FIG. 7B, generally at 490).
Townsend lacks a detection sensor. Hogard discloses Dialysis systems and methods (¶ [0003], [0014], [0062] FIG. 1 … dialysis system 100);
comprising a console, wherein a cartridge is configured to be releasably coupled to the console (¶ [0063] Dialysis system 100 can also include a cartridge 120 which can be removably coupled to the housing 106 of the system); and
wherein the cartridge further comprises a detection sensor that engages when the cartridge is coupled to the console (¶ [0080] Still referring to FIG. 4 … attaching the cartridge onto the front panel 210 properly will engage cartridge presence detector 214, which can be a switch or a sensor configured to communicate to the dialysis system (e.g., to a controller of the system) that a cartridge is installed on the front panel).
Hogard improves the system’s safety by operating valves only when a cartridge has been properly seated in the console (¶ [0080] As a safety precaution, the system will not allow pinch valves 180a-d to be closed until the cartridge presence detector 214 indicates that the cartridge is installed properly). One would be motivated to modify Townsend with Hogard’s detection sensor to more safely operate the system’s clamp valves. Therefore, it would have been obvious to modify Townsend with Hogard’s detection sensor in order to operate the system more safely.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Townsend; Seth et al. (US 20060100743 A1) in view of Rahe-Meyer, Niels (US 20050119626 A1).
Regarding claim 39, Townsend discloses a flow control device that moves from the first position to the second position (¶ [0057] The flow rate sensor subsystem also includes upper pinch valve 220 and lower pinch valve 222; ¶ [0076], The reusable section also includes pinch valves 434 and 436). Townsend’s flow control device does not explicitly rotate and instead appears to move linearly.
Rahe-Meyer discloses a fluid line that extends through a cartridge along a first axis (¶ [0001], a method for the measuring of, and for the management and control of, the dosage of medications; ¶ [0020], tube (4); ¶ [0022] Shown in FIG. 5 and 6 is another version … tube (4)); and
a flow control device, when moving from a first position to a second position, rotates about a second axis normal to the first axis (¶ [0022], The rotation axis of the motor (16), via its rotation, changes the position of the clamp lever (19) and therefore, the clamp puts pressure onto the tube (4), which therefore changes its cross-section flow up to completely cutting it off. The regulation of the motor (16) and the position of the clamp lever (19), is dictated by the electronics unit (1), which works together with a angled coding device (18) which is set on the rotation axis (17), with which the position of the motor axis (17) or the clamp (20) is being measured).
Rahe-Meyer describes how to construct and operate an electronically controlled valve. One would be motivated to modify Townsend with Rahe-Meyer’s rotating flow control device since Townsend calls for controlling pinch valves with an electronic controller (¶ [0053], The two subsystems are controlled by controller 218 that preferably is a microcontroller (".mu.P"); ¶ [0057] The flow rate sensor subsystem also includes upper pinch valve 220 and lower pinch valve 222 … under the control of controller 218). Therefore, it would have been obvious to modify Townsend with Rahe-Meyer’s rotating clamp in order to construct a known type of electronic clamp.
Double Patenting
The following patents are relevant to the claimed invention:
17/805897 Conley; Eric et al. US 11633137 B2
18/193508 Conley; Eric et al. US 11986302 B2
17/659393 Conley; Eric et al. US 12303271 B2
16/153380 Halpert; Andrew V. et al. US 11213621 B2
Each patent reference claims a urine collection system, fluid therapy system or method including a fluid line or flow control assembly. However, none of the cited patents claims a fluid line, cartridge and a flow control device. Therefore none of these references are cited in a double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Silver; Brian H. US 4745929 A
Hessberg; Sigfried Dipl Ing et al. DE 4023336 A1
Hesberg; Sigfried Dipl Ing DE 4137075 C2
Hickle, Randall S. US 20040073177 A1
Rahe-Meyer, Niels US 20050119626 A1
Drake; Scott et al. US 20070258838 A1
Eubanks; Shannon et al. US 20110106004 A1
Woolford; Brady US 20130267892 A1
Haddad; Ihsan A. et al. US 20130304027 A1
Tout; Aidan et al. US 20140163487 A1
Grandolfo; Nicola US 20150025468 A1
Kushnir; Alexander et al. US 20190046102 A1
Hogard; Michael Edward et al. US 20200061273 A1
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Fax 571-273-2590
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781