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 .
Election/Restrictions
Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/2025. Currently, claims 1-18 are pending and are being examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-5, 8-11, and 14-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4, 8, and 14 recite, respectively, a first measuring apparatus, a third measuring apparatus, and a fifth measuring apparatus. However, claim 2, of which claims 4, 8, and 14 depend on, already describe a plurality of measuring apparatuses. As such, it is not immediately clear on if this first and third measuring apparatus is intended to be a part of the plurality of measuring apparatuses in claim 2, or distinct from said plurality. For the purpose of examination, these apparatuses are interpreted to be a part of the plurality.
Similarly, claims 5 and 7 describing second and fourth measuring apparatuses are unclear as to if these are meant to be in the same plurality of claim 2. These will similarly be interpreted as being in the plurality of claim 2.
Claim 13 recites wherein the reusable machine has an inner cavity that holds one or more measuring apparatuses. However, it is not entirely clear as to if the claim discusses separate measuring apparatuses, or the measuring apparatuses of the disposable unit. For the purpose of examination, as it appears in fig. 6 of the instant specification, claim 13 will be interpreted as the reusable machine holding the measuring apparatuses of the box in its cavity.
Claims 15-16 recite wherein one or more measuring apparatuses exchange signals with the control unit and wherein operation of the pump depends on signals detected by one or more measuring apparatuses, respectively, and have a similar issue as to if these measuring apparatuses are meant to be the same ones in claim 2. For the purpose of examination, claims 15-16 will be interpreted as being the same measuring apparatuses recited in claim 2.
Claim 18 recites wherein said channels are obtained inside the body of said box. There is insufficient antecedent basis for “said channels”, as the channels are introduced in claim 3, which claim 18 does not depend on. For the purpose of examination, the limitation will be interpreted as -a plurality of channels-
Claims 5, 9-13 and 15-17 are rejected by being dependent on claims 4, 8, and 14
Claim Rejections - 35 USC § 102
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)(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.
(a)(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 1-6, 13-14, and 18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Doyle (US 20170173251).
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).
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).
However, if this is not clearly envisioned by the applicant, Bellini teaches wherein the plurality of measuring apparatuses involved share a common body (20) or box (fig. 3, common body 20 of the devices for executing hemofiltration therapy, paragraph 0088).
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 disposable unit comprises an operating 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 comprise 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 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 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 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 channels are obtained inside the body of said box (fig. 3A shows the tubing being held within the housing 322).
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Doyle.
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.
Claims 8 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle 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 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 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 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, which can be used one single time.
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 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 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 measuring apparatuses exchange signals with said control unit; wherein said control unit is configured to stop the operation of the device and/or emit sound and/or light alarm signals 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 emit sound 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).
Regarding claim 17, Doyle discloses the system comprising an interface (324) to exchange setting data and/or operating parameters and/or 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bellini (US 20130206655) discloses a wearable system that has a disposable system connected to a reusable controller.
Grupp (US 20210338966) discloses an optical sensor utilizing a reflecting element.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at (571) 270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781