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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/04/2026 has been entered.
An amendment was filed on 09/04/2026. Claim 1 has been amended. Currently, claims 1-22 are pending, with claims 19-22 being previously withdrawn from consideration. Claims 1-18 are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, newly cited Fulkerson (US 20130292319) is utilized to teach the limitation of the device having less than 40 ml of extracorporeal blood present in the device at all times during operation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-7, 13-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle (US 20170173251) in view of Bellini (US 20130206655), and further in view of Fulkerson (US 20130292319).
Regarding claim 1, Doyle discloses an artificial diuresis device (paragraph 0002. It is noted that a “diuresis device”, as best understood by the instant specification, is a device used in conjunction with diuresis treatment, see paragraphs 0150-0165) that is wearable by a patient (paragraph 0156, “A portable module in accordance with the present invention can also be conveyed using a belt or harness on a patient”) and comprises a reusable machine (fig. 3A shows adapter 20 configured to be reusable, or alternatively the reusable machine can be the housing 32) and a disposable unit (paragraph 0083 describes the tubing set being disposable and replaceable)
wherein said disposable unit is completely filled, before use, with a treatment liquid (paragraph 0148 describes a priming sequence. Paragraph 0115 of the PGPUB of the instant specification recites that the disposable unit is completely filled with a saline solution as part of priming operations).
Doyle is silent to wherein the artificial diuresis device is configured to work with a volume of extracorporeal blood present in the device of less than 40 mL at all times during operation, and does not teach wherein the artificial diuresis device is portable and configured to be worn by the patient during operation, wherein the artificial diuresis device is powered by a battery so as to not require connection to a fixed electric power supply during use.
However, Bellini teaches a means of purifying organic fluids (abstract) that is portable and configured to be worn by the patient during operation (fig. 1 shows the assembly as a vest 1 with all of the components), wherein the device is powered by a battery so as to not require connection to a fixed electric power supply during use (paragraph 0069, “The latter pumps and the control unit 25 are power-supplied with a group of batteries 26, normally of rechargeable type”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that the artificial diuresis device is portable and configured to be worn by the patient during operation, wherein the artificial diuresis device is powered by a battery so as to not require connection to a fixed electric power supply during use, as taught and suggested by Bellini, for the purpose of providing a suitable structure that allows a patient to walk around during treatment and be independent of fixed machines and hospitals (see Bellini, paragraph 0001).
Doyle, as modified by Bellini, is silent to wherein the artificial diuresis device is configured to work with a volume of extracorporeal blood present in the device of less than 40 mL at all times during operation.
However, Fulkerson teaches an ultrafiltration device (abstract) wherein the blood set tubing has a suitable length and internal diameter wherein the prime volume of the blood set tubing, including the hemofilter, is less than 40 mL (paragraph 0366). As the purpose of priming a system involves filling the system entirely so as to remove potential air in the system, and the volume required to do so in Fulkerson is less than 40 mL, one of ordinary skill in the art would appreciate that the system of Fulkerson would be capable of having less than 40 mL of extracorporeal blood present at all times during operation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle in view of Bellini such that the artificial diuresis device is configured to work with a volume of extracorporeal blood present in the device of less than 40 mL at all times during operation, as taught by Fulkerson, for the purpose of allowing the system design to be more compact (see Fulkerson, paragraph 0211).
Regarding claim 2, Doyle discloses wherein the disposable unit comprises an operating box (fig. 3A, housing 322 which is capable of being disposed of and includes the tubing), which comprises, in turn, a plurality of measuring apparatuses (fig. 4 shows measuring apparatuses in the form of blood pressure sensor 424 and blood pressure sensor 426),
wherein said machine and said box are configured to be coupled to one another in a predefined configuration (fig. 3A, blood pump configured to releasably engage the tubing set, wherein the tubing set is replaceable), such that, where coupled, each of the plurality of measuring apparatuses interacts with a corresponding interaction area of the operating box (fig. 4 shows the blood pressure sensor 424 and blood pressure sensor 426 within respective areas of the box).
Regarding claim 3, Doyle discloses wherein the operating box has:
a first inlet for an organic liquid to be treated drawn from the patient (fig. 3A, arterial line 52)
a first liquid outlet to send the organic liquid to be treated to a filtering unit (fig. 4, blood filter entry line 342 has an end as a liquid outlet)
an inlet channel, which connects the first inlet to the first outlet (fig. 4, blood filter entry line 342 as a whole as a channel connecting the arterial line 52 with the end of the filter entry line 342)
a second inlet for a treated organic liquid coming from said filtering unit (fig. 4, blood filter exit line 344 has an inlet at the end of blood filter 330)
a second outlet to send the treated organic liquid to the patient (fig. 4, venous line 54)
an outlet channel, which connects the second inlet to the second outlet (fig. 4, blood filter exit line 344).
Regarding claim 4, Doyle discloses wherein said box has a first interaction area along said inlet channel (fig. 4, interaction area denoted as area with blood pressure sensor 424)
wherein said device comprises, as one of the plurality of measuring apparatuses, a first measuring apparatus, which detects, in use, the pressure of the organic liquid to be treated in the first interaction area (fig. 4, blood pressure sensor 424 within the first interaction area along the inlet channel/ blood filter entry line 342).
Regarding claim 5, Doyle discloses wherein said box has a second interaction area, wherein said box has a second interaction area (fig. 4, second interaction area denoted as area with blood pressure sensor 426), wherein the device comprises, as another one of the plurality of measuring apparatuses, a second measuring apparatus (426), which detects, in use, the pressure of the treated organic liquid in the second interaction area (fig. 4, blood pressure sensor 426 measures pressure of liquid in the interaction area).
Regarding claim 6, Doyle discloses wherein the box has
a third inlet for an ultra-filtered liquid (fig. 4, fill/drain valve 468 as an inlet within fill/drain line for draining dialysate, paragraph 0155).
a third outlet (466) to send the ultra-filtered liquid to a collecting bag (fig. 4, fill/drain port 466 to drain out dialysate fluid. The collecting bag is interpreted to not be positively recited)
an ultra-filtered channel (464), which connects the third inlet to the third outlet (fig. 4, fill/drain line 464).
Regarding claim 7, Doyle discloses wherein the third inlet (466) is configured for injection of liquid into the ultra-filtered channel (paragraph 0155 discloses wherein the port 466 is for both draining and filling), but does not teach wherein the box has a fourth inlet to inject liquid into the ultra-filtered channel.
However, Doyle in another embodiment discloses a separate inlet for dialysate from the outlet (fig. 9A shows a dialysate entry line 346 and a dialysate exit line 348). It is also noted that this entered dialysate via line 346 indirectly leads into exit line 348.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that the box has a fourth inlet to inject liquid into the ultra-filtered channel, as taught by fig. 9A of Doyle, for the purpose of providing a suitable structure that grants a closed loop and keeps the port for clean dialysate separate from the port of used dialysate.
Regarding claim 13, Doyle discloses wherein said reusable machine comprises a body having an inner cavity (fig. 1C, positioning recesses either 126 or 128),
wherein one or more of the plurality of measuring apparatuses interact, in use, with a respective portion of the disposable unit in the respective interaction areas (fig. 4 shows the pressure sensors 424 and 426 interacting with blood filter entry line 342 and exit line 344 respectively).
Doyle does not teach wherein the measuring apparatuses are housed inside the inner cavity.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that the one or more measuring apparatuses are housed inside the inner cavity, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In this instance, an occlusion detector (422) or air bubble sensor (428) being relatively close to the adapter (20) could feasibly be within the cavity while maintaining the same functionality.
Regarding claim 14, Doyle discloses the system comprising a fifth measuring apparatus (428) which is configured to detect the presence of bubbles inside the treated organic liquid (fig. 4, air bubble sensor 428, paragraph 0155); wherein said fifth measuring apparatus is arranged in the area of said second outlet (fig. 4, air bubble sensor 428 in the filter exit line 344 that leads to venous line 50/ patient end 54).
Regarding claim 18, Doyle discloses wherein said box is one single indivisible body (fig. 3A shows housing 322 as a single piece), wherein said inlet and outlet channels are obtained inside the body of said box (fig. 3A shows the tubing being held within the housing 322).
Claims 8 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle in view of Bellini and Fulkerson, and further in view of Boag (US 3990973).
Regarding claim 8, Doyle does not teach wherein said box has a third interaction area for the interaction with said machine along said ultra- filtered channel, wherein the device comprises, as one of the plurality of measuring apparatuses a third measuring apparatus to detect the flow of the ultra-filtered liquid in the third interaction area.
However, Boag teaches the use of an ultrafiltration rate meter (10) with a flow rate meter (12) in the return pathway for dialysate (fig. 1, flow rate meter 12 in communication with effluent conduit, col. 3, lines 38-44).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that the box has a third interaction area for the interaction with said machine along said ultra-filtered channel, wherein the device comprises a third measuring apparatus to detect the flow of the ultra-filtered liquid in the third interaction area, as taught by Boag, for the purpose of providing a suitable structure that can be utilized to measure the ultrafiltration rate in the dialysis system (see Boag, abstract).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle in view of Bellini, Fulkerson, and Boag, and further in view of Hutchisson (US 4083777).
Regarding claim 9, Doyle appears to disclose wherein said box has a fourth interaction area along said ultra-filtered channel (fig. 4, fourth interaction area denoted by location of blood leak sensor 440); wherein said device comprises, as another one of the plurality of measuring apparatuses a fourth measuring apparatus to detect blood traces in the ultra- filtered liquid (fig. 4, blood leak sensor 440 to detect traces of blood).
However, if this is not clearly envisioned by the applicant, Hutchisson teaches a hemodialysis system (abstract) that comprises a measuring apparatus (20) that detects blood leakage into the dialysate solution (fig. 1, sensing assembly comprises means for detecting blood leakage into the dialysate solution (col. 7, lines 13-16). Such a detection happens in an interaction area.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that said box has a fourth interaction area along said ultra-filtered channel; wherein said device comprises a fourth measuring apparatus to detect blood traces in the ultra- filtered liquid, as taught by Hutchisson, for the purpose of providing a suitable structure that detects blood leakage into the dialysate solution (see Hutchisson, col. 7, lines 13-16).
Regarding claim 10, Doyle, as modified by Boag and Hutchisson, does not teach wherein the third interaction area and the fourth interaction area coincide.
However, Hutchisson teaches wherein a dialysate solution sensing assembly (20) can have multiple sensors for different parameters of the dialysate (col. 6, lines 29-33 suggest temperature sensing in the assembly 20, lines 45-47 suggest sensing electrolytic conductivity, and col. 7, lines 13-17 suggest sensing detecting blood leakage. As such, it grants motivation for the sensing area of Hutchisson to coincide with the sensing area of Boag since they both measure parameters of the dialysate. While the measurement of blood traces is done in the influent line of the dialysate, one of ordinary skill in the art would appreciate such a feature would also be useful when measured in the effluent line.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle in view of Boag and Hutchisson such that the third interaction area and the fourth interaction area coincide, as suggested by Hutchisson, for the purpose of providing a suitable structure that compacts sensing means for parameters of the dialysate.
Regarding claim 11, Doyle, as modified by Boag and Hutchisson, is silent to wherein the third measuring apparatus and the fourth measuring apparatus are incorporated in a disposable unit, the disposable unit being configured for single use.
However, Hutchisson teaches wherein multiple measuring apparatuses can be within a dialysate solution sensing assembly (20). Moreover, the unit being disposable and usable for one single time is a matter of intended use, as most things that can be disposed of are disposable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle in view of Boag and Hutchisson such that the third measuring apparatus and the fourth measuring apparatus are incorporated in a disposable unit, which can be used one single time, for the purpose of providing a suitable structure that compacts sensing means for parameters of the dialysate.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Doyle in view of Bellini, Fulkerson, Boag, and Hutchisson, and further in view of Chevallet (US 5644402).
Regarding claim 12, Doyle, as modified by Hutchisson, discloses wherein the means of detecting blood traces involves a photocell detection means with a light source (col. 15, lines 20-32), but does not teach wherein said reusable machine comprises a reflecting element, which laterally delimits a respective portion of the fourth interaction area and interacts with said fourth measuring apparatus so as to delimit a passage section for the ultra-filtered liquid and increase the contrast of possible blood traces in the ultra-filtered liquid.
However, Chevallet teaches a means for detecting blood concentrations in a spent liquid (col. 2, lines 30-36) that comprises a reflecting element (8 and 9), which laterally delimits a respective portion of the interaction area and interacts with the respective measuring apparatus (fig. 1, mirrors 8 and 9 serves as reflecting elements that also delimit the interaction area and interacts with diode 6 and transistor 7) so as to delimit a passage section for the ultra-filtered liquid (fig. 1, mirrors 8 and 9 delimit passage section for line 2). Such a structure would increase the contrast by increasing the amount of light that can possibly detect blood traces
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle in view of Hutchisson such that the system comprises a reflecting element, which laterally delimits a respective portion of the fourth interaction area and interacts with said fourth measuring apparatus so as to delimit a passage section for the ultra-filtered liquid and increase the contrast of possible blood traces in the ultra-filtered liquid, as taught by Chevallet, for the purpose of providing a suitable structure that has an increased ability to discriminate between fluids of different natures of different quality (see Chevallet, col. 1, lines 64-67 and col. 2, lines 1-2).
Doyle, as modified by Chevallet, does not teach wherein the reusable machine comprises the reflecting element.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle in view of Chevallet such that the reusable machine comprises the reflecting element, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In this instance, assuming coordinated placement of the reflecting element on the reusable module and the sensor within the box, one of ordinary skill in the art would appreciate identical functionality.
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle in view of Bellini and Fulkerson, and further in view of Cosentino (US 4021341)
Regarding claim 15, Doyle appears to disclose the device comprising a control unit (paragraph 0135 describes the user interface 86 with various functionalities which controls a blood processing mode of operation, thus implying a control unit);
but is silent to wherein one or more of the plurality of measuring apparatuses exchange signals with said control unit; and wherein said control unit is configured to stop the operation of the device and emit at least one of a sound alarm signal and a light alarm signal in case values not complying with predetermined parameters are detected.
However, Cosentino teaches wherein a processor utilizes signals from a pressure sensor on the dialysate side to sound an alarm or shut the system down if there is an unsafe pressure while using control units (col. 5, lines 39-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that one or more measuring apparatuses exchange signals with said control unit, and wherein said control unit is configured to stop the operation of the device or emit at least one of a sound alarm signal and a light alarm signal in case values not complying with predetermined parameters are detected, as taught by Cosentino, for the purpose of providing a suitable means to prevent dialysate side pressure from rupturing the membrane (see Cosentino, col. 5, lines 39-50).
Doyle, as modified by Cosentino, is silent to wherein the control unit is configured to stop operation of the device and emit a sound alarm signal.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle in view of Cosentino such that the control unit stops operation of the device and emits a sound alarm signal, for the purpose of simultaneously alerting a user of an issue while stopping the system to prevent bursting the membrane.
Regarding claim 17, Doyle discloses the system comprising an interface (324) to exchange at least one of setting data, operating parameters, and alarm signals with the outside (paragraph 0199, “The user interface serves to convey the treatment status visually and can provide the ability to adjust treatment settings. In an emergency situation, display of a potentially hazardous alarm state can be maintained”), wherein said interface is integrated in the reusable machine and/or in an external device (paragraph 0132 describes controller interfaces including smartphones, tablets, or smartwatches alternatively or in addition to user interface 86 integrated into reusable machine).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Doyle in view of Bellini, Fulkerson, and Cosentino, and further in view of O’Mahony (US 20060009727).
Regarding claim 16, Doyle, as modified by Cosentino, discloses wherein said machine comprises a peristaltic pump (see Doyle, paragraph 0127 describes engagement loop 62 to engage with a peristaltic pump), and appears to discloses wherein said control unit adjusts the operation of the pump depending on the signals detected by one or more measuring apparatuses (see Cosentino, col. 5, lines 39-50 wherein the system shuts down (i.e., adjusts the operation of a pump) depending on a signal detected by a pressure sensor for dialysate side pressure).
If this is not clearly envisioned by the applicant, O’Mahony teaches a means for extracorporeal control of blood glucose (abstract) wherein if blood pressure falls or rises beyond a pressure limit, the blood pump speed is adjusted (paragraph 0022)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Doyle such that the control unit adjusts the operation of the pump depending on the signals detected by one or more measuring apparatuses, as taught by O’Mahony, for the purpose of providing a suitable structure that can adjust the pump to maintain a blood pressure for a current flow rate (see O’Mahony, paragraph 0022).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
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