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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/06/25 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 02/17/26 has been entered. Claims 1, 4, 11, and 14-20 have been amended. Claims 2, 6-7, and 13 are in the original/ previously presented form. Claims 3, 5, 8-10, and 12 are cancelled. Claims 21-22 are newly presented. Thus, claims 1-2, 4, 6-7, 11, and 13-22 remain pending in the application. There were no objections or 112 rejections set forth in the Non-Final rejection mailed 10/17/25. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 recites multiple incidences of a “prior” cycle. Each incidence of “prior” should likely read “preceding” to ensure that there is proper antecedent basis for the limitation as claimed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4, 6-7, 11, and 13-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, lines 22-23 recite “determine a time delay factor for a subsequent cycle of the same peritoneal dialysis treatment”. Because “a” subsequent cycle of the peritoneal dialysis treatment has already been introduced in the claim, it is unclear to the examiner if Applicant intends for the “a subsequent cycle” as recited in lines 22-23 to be the same subsequent cycle as previously recited or a new subsequent cycle. According to Applicant disclosure, it seems that the time delay factor is determined for just the one subsequent cycle, based on a number of the preceding cycles (see [0014-0015] & [0021]). Therefore, for purposes of examination, the examiner interprets claim 1 lines 22-23 to read “determine a time delay factor for [[a]]the subsequent cycle of the same peritoneal dialysis treatment” to best align with applicant disclosure.
Due to claim dependency from claim 1, claims 2, 4, 6-7, 11, and 13-22 are subsequently rejected under 112b.
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.
The factual inquiries 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 1, 4, 6-7, 11, 13-14, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Griessmannn et al. (U.S. PGPUB No. 2017/0028118), hereinafter Griessmannn, in view of Hall et al. (U.S. PGPUB No. 2012/0095537), hereinafter Hall.
Regarding claim 1, Griessmann discloses a peritoneal dialysis machine configured to (configured to is functional language. Therefore, the system only needs to be capable of performing the following claim recitations) effect a plurality of peritoneal dialysis treatments, each peritoneal dialysis treatment of the plurality of peritoneal dialysis treatments having one or more preceding cycles and a subsequent cycle that is subsequent to the one or more preceding cycles (see [0012] & [0014-0017]: “last”/preceding cycle informs current/subsequent cycle and [0031]: machine runs for several cycles and is therefore configured to effect a plurality of treatments), each of the one or more preceding cycles and the subsequent cycle including an inflow phase, a dwell period, and a drainage phase for a dialysis fluid (see [0009]: machine performs peritoneal dialysis treatment including a “number of cycles”, each cycle having an inflow=inflow phase, a dwell time=dwell period, and outflow=drainage phase. In [0025], outflow is equated to drainage in this PGPUB), said peritoneal dialysis machine comprising a control unit (see [0037]: at least one logic or control unit with a memory for storing data/ preset values) and a measurement apparatus for determining an inflow of the dialysis fluid to a patient and a drainage of the dialysis fluid from the patient (see [0039]: machine has a means for determining inflow/ outflow==drainage thus must have a “measurement apparatus”), wherein
the control unit is configured to determine (i) a time progression of a flow rate sensed by the flow sensor (see [0037-0039]: memory saves data and the device has the ability to compare volume increases/decreases/slopes==a flow rate over time for inflow or outflow) or determined from weights measured by the scale at at least two different points in time during the inflow phase and/or during the drainage phase of at least one of the one or more preceding cycles of the same peritoneal dialysis treatment, (ii) a time progression of a hydrostatic pressure or a pressure drop sensed by the pressure sensor during the inflow phase and/or during the drainage phase of at least one of the one or more preceding cycles of the same peritoneal dialysis treatment, or (iii) both (i) and (ii),
the control unit (see [0037]) is configured to (configured to is functional language. Therefore, the system only needs to be capable of performing the following claim recitations) determine a time delay factor (see [0007-0008]: time delays can be percentage increase of introduction period==inflow or outflow period==drainage. See [0018]: example time delay values such as a delay in inflow may be 10%, while 50% at outflow) for [[a]]the subsequent cycle of the same peritoneal dialysis treatment (control unit determines a time delay factor and is therefore “configured to” determine a time delay factor for the subsequent cycle of the same peritoneal dialysis treatment), the determination being made based on measured values collected over a plurality of the inflow phases and/or the drainage phases (see [0014-0019]: values collected to determine and adjust a “time-dependent operational state of the catheter” == time delay factor, over several cycles, i.e.: [0016] gives time of 4minutes where several cycles will have taken place as in Figure 1) of the one or more preceding cycles of the same peritoneal dialysis treatment (control unit determines a time delay factor based on measured values collected over a number of phases and is therefore configured to determine the time delay factor based on the preceding cycles of the same peritoneal dialysis treatment), the time delay factor representing a numerical relationship (see [0018]: for example delay of 10% for inflow and 50% for outflow. 10% and 50% represent a ‘numerical relationship’) between a theoretical duration of the inflow of the dialysis fluid to the patient and/or the drainage of the dialysis fluid from the patient (INFLOW--see [0019]: inflow delay compared to an ideal==theoretical inflow & [0063], DRAINAGE-- see [0022]: outflow determined from estimated==theoretical initial outflow and then the delay value is modified by time delay value. See also [0021-0025] for details on applying time delay factor and [0065]. Lastly see [0031]: other estimates==theoretical values that are used), during the subsequent cycle of the same peritoneal dialysis treatment (see [0078]: A is an estimated/ theoretical value calculated for the treatment and therefore the control unit is configured to perform such a calculation for any cycle/subsequent cycle of the same peritoneal dialysis treatment), and an actual duration of the inflow of the dialysis fluid to the patient and/or the drainage of the dialysis fluid from the patient (see [0010]: there is a magnitude of time variation between actual treatment and prescribed==theoretical, [0042]: FIG. 1 shows estimated treatment compared to actual and therefore has a ‘numerical relationship’, [0078]: A is estimated and A’ is actual and [0083]: most effective==actual inflow and outflow rates shown by A’ used in the analysis/ calculation), during the subsequent cycle of the same peritoneal dialysis treatment (A’ is actual== “subsequent” treatment),
the control unit is configured such that a peritoneal dialysis treatment parameter is automatically (see [0020]: delay values can all be set with apparatus and [0037] & [0039]: control unit stores values and threshold values and therefore is configured to “automatically” modify parameters) modified for the subsequent peritoneal dialysis treatment, by the control unit, to form a modified treatment parameter (see [0030-0034]: estimated treatment duration compared to threshold and edited==modified and [0039]: “a change of values may be performed by the apparatus” and therefore the control until is configured to automatically modify a modified treatment parameter), when the time delay factor exceeds a specific threshold value (see [0034]: estimated treatment duration compared to threshold lower threshold and thus determined if value “exceeds” a threshold.), and
the time delay factor is a mean value (see [0009], [0080], and [0083]: calculations performed over a number of cycles) that is individual to the patient (see [0007]: delay times specific to patient), with an algorithm being stored in the control unit with reference to which a determination of a real total duration period (Δttotal,real) is calculated (see [0033]: realistic evaluated values are displayed) according to the following equation:
Δttotal,real = Δtin,ideal x Fin+ Δtdwell,real + Δtdrn,ideal x Fdrn x n + Δtinit,ideal x Fdrn + Δtfin,ideal x Fin wherein n denotes a number of cycles, Δtin,ideal denotes an ideal inflow duration, Δtdwell,real denotes a real dwell duration, Δtdrn,ideal denotes an ideal drainage duration, Δtinit,ideal denotes an ideal initial drainage phase, Δtfin,ideal denotes an ideal duration of the final inflow phase, Fdrn denotes a time delay factor for drainage, and Fin denotes a time delay factor for inflow (see below):
[0012] discloses ideal treatment duration includes initial drainage duration, ideal cycle duration multiplied by number of cycles, and ideal duration of the last inflow; this can be re-written as a first equation: Δttotal,ideal = (Δtcycle,ideal) x n + Δtinit,ideal + Δtfin,ideal
[0013] discloses the ideal cycle duration comprises ideal inflow duration, ideal dwell time, and ideal outflow, or a second equation: Δtcycle,ideal = Δtin,ideal + Δtdwell,ideal + Δtdrn,ideal ; Thus, Δtcycle,ideal of the first equation is substituted with Δtin,ideal + Δtdwell,ideal + Δtdrn,ideal since the values are equivalent according to the second equation, yielding: Δttotal,ideal = (Δtin,ideal + Δtdwell,ideal + Δtdrn,ideal) x n + Δtinit,ideal + Δtfin,ideal
[0016] discloses that catheter performance is taken into account in the form of a relative increase in ideal inflow and/or ideal drainage-- this is a time delay factor for both the inflow process and drainage process;
[0018] discloses that different values are assumed for different phases, like the inflow vs drainage phase. Therefore, the time delay factor for ideal inflow can be written Fin and ideal drainage can be written Fdrn. The time delay factors are relative changes in view of an ideal value and thus, are multiplied by the ideal values, yielding a third equation for the time delay factor of inflow Δtin,ideal x Fin and a fourth equation for the time delay factor of drainage Δtdrn,ideal x Fdrn
[0019-0020] discloses that no factor needs to be applied to the dwell time, therefore Δtdwell,ideal = Δtdwell,real
[0016] discloses that a corresponding procedure is conceived for the duration of the last inflow, yielding Δtfin,ideal x Fin
[0017] discloses that the delay may also be applied to the initial drainage, yielding Δtinit,ideal x Fdrn
Substituting all of the above equations together for an estimated Δttotal, with the subsequent adjustments for time delay factors, yields the equation:
Δttotal,estimated = Δtin,ideal x Fin + Δtdwell,real + Δtdrn,ideal x Fdrn x n + Δtinit,ideal x Fdrn + Δtfin,ideal x Fin, which is identical to the claimed equation.
Griessmann further discloses the modified treatment parameter is a criterion for fixing an end of the drainage phase of the subsequent cycle of the same peritoneal dialysis treatment (see [0030-0034] & [0039]: control unit configured to modify outflow rate based on falling below threshold values, aligning with Applicant disclosure in [0018]: the criterion “for fixing the end of the drainage phase” is a minimal outflow rate. see [0015]: estimation of an outflow duration via general process described in [0016-0019]. In [0016], an example is given for determining inflow duration, but same process could be applied for outflow—see [0017]. See [0052] where initial ideal outflow duration is set. Then, the process in [0065-0068] determines a time delay factor such that outflow duration is shown in the table of [0071] based on the time delay factor. Examples of arriving at the outflow duration/ modified treatment parameter are in [0075-0076]),
the one or more preceding cycles includes a prior cycle (see [0012] & [0014-0017]: “last”/preceding/ prior cycle informs current/subsequent cycle)
the control unit is configured to determine whether the drainage phase of the prior cycle has ended, and, if so, to enable the inflow phase of the subsequent cycle to begin, the determination being based on a preset minimal drainage volume of the drainage phase of the prior cycle (see [0012]: “the patient is emptied as long as any volume may be discharged from the abdominal cavity.” And thus the preset minimal drainage volume is a volume capable of being discharged by the device and [0022-0023]: initial outflow volume may be increased, such as when not meeting the estimated/minimum outflow volume as described further in [0025]. Control unit does not impede next phase and is therefore “configured to enable” the start of the subsequent cycle), and/or based on whether a drainage flow rate of the drainage phase of the prior cycle falls below a threshold drainage flow rate (see [0030-0034] & [0039]), and
the control unit is configured to correct the threshold drainage flow rate in at least one subsequent cycle, including in the subsequent cycle, downward when the time delay factor for drainage exceeds a specific threshold value (see [0034] & [0039] control unit configured to modify outflow rate based on falling below threshold values and is therefore is configured to modify the outflow rate threshold. see [0083-0085]. see [0015]: estimation of an outflow duration via general process described in [0016-0019]. In [0016], an example is given for determining inflow duration, but same process could be applied for outflow—see [0017]. See [0052] where initial ideal outflow duration is set. Then, the process in [0065-0068] determines a time delay factor such that outflow duration is shown in the table of [0071] based on the time delay factor. Examples of arriving at the outflow duration/ modified treatment parameter are in [0075-0076]), and
the measurement apparatus determines a patient pressure (see [0067]: a patient pressure is recorded, therefore there must be a pressure sensor OR a calculation performed from the flow sensor as in [0039] to determine such a patient pressure).
Griessman is silent to “the measurement apparatus comprises a flow sensor, a pressure sensor, a scale, or a combination thereof.”
However, Hall teaches a peritoneal dialysis machine configured to effect a plurality of peritoneal dialysis treatments (see [0113]: machine can deliver peritoneal dialysis fluid to see [0004]: peritoneal cavity), the peritoneal dialysis machine having a measurement apparatus, the measurement apparatus comprises a flow sensor, a pressure sensor, a scale, or a combination thereof (see [0121]: sensors can be pressure sensors or flow sensors).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the measurement apparatus for determining flow rates disclosed in Griessmann to specifically be a flow sensor as taught by Hall for the purpose of using the sensed values in a feedback loop to control and regulate the device flow rate (see [0148]), thus achieving “the measurement apparatus comprises a flow sensor, a pressure sensor, a scale, or a combination thereof”.
Regarding claim 4, the modified system of Griessmann teaches the peritoneal dialysis machine in accordance with claim 1, but Griessmann is silent to “wherein the measurement apparatus comprises a flow sensor.”
However, Hall teaches a peritoneal dialysis machine configured to effect a plurality of peritoneal dialysis treatments (see [0113]: machine can deliver peritoneal dialysis fluid to see [0004]: peritoneal cavity), the peritoneal dialysis machine having a measurement apparatus, wherein the measurement apparatus comprises a flow sensor (see [0121]: sensors can be flow sensor).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the measurement apparatus for determining flow rates disclosed in Griessmann to specifically be a flow sensor as taught by Hall for the purpose of using the sensed values in a feedback loop to control and regulate the device flow rate (see [0148]), thus achieving “wherein the measurement apparatus comprises a flow sensor.”
Regarding claim 6, the modified system of Griessmann teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmann further discloses wherein the control unit is configured to output an estimate of the total treatment duration for a specific prescription for the subsequent peritoneal dialysis treatment (configured to is functional language. The control unit is configured to output an estimate of total treatment duration and therefore can achieve the same “for a specific prescription for the subsequent peritoneal dialysis treatment”), with a theoretical and/or calculated inflow duration and/or drainage duration being multiplied by the time delay factor in a preparation of the estimate (see [0018] discloses that different values are assumed for different phases, like the inflow vs drainage phase. Therefore, the time delay factor for ideal inflow can be written Fin and ideal drainage can be written Fdrn. The time delay factors are relative changes in view of an ideal value and thus, are multiplied by the ideal values, yielding a third equation for the time delay factor of inflow Δtin,ideal x Fin and a fourth equation for the time delay factor of drainage Δtdrn,ideal x Fdrn then the estimate for the total treatment duration is output utilizing the formula as described in the rejection of claim 1 above).
Regarding claim 7, the modified system of Griessmann teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmann further discloses wherein the control unit is configured such that a signal is output when the time delay factor exceeds the specific threshold value (See [0037]: values are stored and compared to stored threshold values and in [0038]: the device has some means for visibly displaying information, like time, to a user. Thus, the device would be capable of outputting a signal to the visual display—i.e.: ‘ALERT’ text—to indicate a threshold value being exceeded).
Regarding claim 11, the modified system of Griessmann teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmann further discloses wherein the time delay factor is stored in a treatment protocol in a memory, to enable a further processing (see explanation above for time delay factor derivation and see [0037]: memory stores any value for system functioning and thus stores the time delay factor).
Regarding claim 13, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 11, and Griessmannn discloses wherein the further processing is a graphical processing of the time delay factor over a plurality of treatments (See [0037]: values are stored and compared to stored threshold values by control unit and in [0038]: the device has some means for visibly displaying information to a user. Thus, the device provides graphical processing--see Figure 1, [0042] and [0078]--over a plurality of treatments where A is an estimated and A’ is an actual in accordance with the treatment which includes the time delay factor. Therefore graphs in Figure 1 is a ‘graphical processing’ of the time delay factor because the data displayed is based on the time delay factor.).
Regarding claim 14, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmannn further discloses the control unit is configured to determine and record in a memory a time progression of a flow rate sensed during the inflow phase and/or during the drainage phase of the preceding peritoneal dialysis treatment (see [0037-0039]: memory saves data and the device has the ability to compare volume increases/decreases/slopes==a flow rate over time for inflow or outflow. Therefore, the control unit is configured to determine and record in the memory a time progression of a flow rate).
Griessman is silent to “wherein the sensor comprises a flow sensor” and the flow rate is sensed “by the flow sensor”
However, Hall teaches a peritoneal dialysis machine configured to effect a plurality of peritoneal dialysis treatments (see [0113]: machine can deliver peritoneal dialysis fluid to see [0004]: peritoneal cavity), the peritoneal dialysis machine having a measurement apparatus, the measurement apparatus comprises a sensor, wherein the sensor comprises a flow sensor (see [0121]: sensors can be pressure sensors or flow sensors).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the measurement apparatus for determining flow rates disclosed in Griessmann to specifically be a flow sensor as taught by Hall for the purpose of using the sensed values in a feedback loop to control and regulate the device flow rate (see [0148]), thus achieving “wherein the sensor comprises a flow sensor” and the flow rate is sensed “by the flow sensor”.
Regarding claim 19, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmannn further discloses wherein the time delay factor is determined by the control unit (see claim 1 rejection above) using a plurality of measured progressions of drainage rates and inflow rates (see [0037-0039]: memory saves data and the device has the ability to measure and compare volume increases/decreases/slopes==a flow rate over time for inflow or outflow) that were measured in a specific number of the one or more preceding cycles (see [0009] & [0070]: at least two cycles) of the same peritoneal dialysis treatment.
Regarding claim 21, the modified system of Griessman teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmannn further discloses wherein the determination of whether the drainage phase of the prior cycle has ended, is based on both the preset minimal drainage volume of the drainage phase of the prior cycle (see [0012]: “the patient is emptied as long as any volume may be discharged from the abdominal cavity.” And thus the preset minimal drainage volume is a volume capable of being discharged by the device.) and based on whether the drainage flow rate of the drainage phase of the prior cycle falls below a threshold drainage flow rate (see [0030-0034] & [0039]: control unit configured to modify outflow rate based on falling below threshold values).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Griessmannn in view of Hall as applied to claim 1 above, and further in view of Popovich et al. (U.S. Patent No. 4,239,041), hereinafter Popovich.
Regarding claim 2, the modified system of Griessmann teaches the peritoneal dialysis machine in accordance with claim 1, but Modified Griessmann is silent to “wherein the machine is a gravimetrically working machine”.
However, Popovich teaches a peritoneal dialysis treatment machine (see Fig. 2) wherein the machine is a gravimetrically working machine (see col. 3 lines 64-68).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the drainage pump disclosed in Griessmannn with a gravimetric working machine as taught in Popovich for the purpose of maintaining a fluid flow such that there is constant presence of dialysis fluid in the patient (depending on the inlet flow rate, a drainage flow by gravity may be better suited for maintaining fluid) (see col. 3 line 56- col. 4 line 3), thus achieving “wherein the machine is a gravimetrically working machine”.
Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a dialysis pump controlling the drainage rate) for another known element (gravity controlling the drainage rate) in the art to obtain the predictable result of controlling the drainage rate of a peritoneal dialysis machine treatment device (see MPEP § 2143.I.B).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Griessmann in view of Hall as applied to claim 1 above, and further in view of Crawford et al. (U.S. PGPUB No. 2018/0001009), hereinafter Crawford.
Regarding claim 15, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 1, but Griessmann is silent to “wherein the sensor comprises a pressure sensor and the control unit is configured to determine and record in a memory a time progression of a hydrostatic pressure or a pressure drop sensed by the pressure sensor during the inflow phase and/or during the drainage phase of the preceding peritoneal dialysis treatment.”
However, Crawford teaches a peritoneal dialysis machine (102, see FIG. 20 unless otherwise noted) with a sensor (pressure sensor 151A, see FIG. 2) and a control unit (2010, see [0265: processor 2010) with a memory (2020, see [0265]), wherein the sensor comprises a pressure sensor (see [0233]: 151A is a pressure sensor) and the control unit is configured to determine and record in the memory (see [0265-0266]: memory processes instructions and stores information such as from input devices 2040) a time progression of a hydrostatic pressure or a pressure drop sensed by the pressure sensor during the inflow phase and/or during the drainage phase of the preceding peritoneal dialysis treatment (see [0233]: hydrostatic pressure drop sensed by pressure sensor 151A over time as shown in FIG. 17B. see also [0082]. And [0139]: patient line delivers fluid to patient and therefore the pressure is indicative of inflow, compared to the drain line 132 in [0143]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor taught by Modified Griessmann to be a pressure sensor as taught by Crawford for the purpose of quickly detecting occlusions in the fluid lines (see [0202]), thus achieving “wherein the sensor comprises a pressure sensor”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the control unit disclosed in Griessmannn to monitor a hydrostatic pressure or pressure drop over time as taught in Crawford for the purpose of calculating accurate pressure measurements within the patient fluid line, even when a patient is at an elevation different than the pressure sensor (see [0233]), thus achieving the control unit is configured to determine and record in a memory a time progression of a hydrostatic pressure or a pressure drop sensed by the pressure sensor during the inflow phase and/or during the drainage phase of the preceding peritoneal dialysis treatment.”
Regarding claim 16, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 15, and Griessmannn further discloses wherein the memory is a component of the peritoneal dialysis machine (see [0037]: the device has one or more memories and thus is a ‘component’ of the machine) or can also be designed as an external memory.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Griessmann in view of Hall and Crawford as applied to claim 15 above, and further in view of Groeber et al. (U.S. PGPUB No. 2016/0216150), hereinafter Groeber.
Regarding claim 17, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 15, but Griessmann is silent to “wherein the memory is an external memory.”
However, Groeber teaches a peritoneal dialysis machine (see [0001]) with a control unit (see [0022]) and a memory, wherein the memory is an external memory (see [0041-0042]: memory can be external memory media).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit having a memory disclosed in Griessmann to include an external memory as taught by Groeber for the purpose of easing subsequent transfer of data between devices (see [0042-0043]), thus achieving “wherein the memory is an external memory.”
Claims 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Griessmann in view of Hall as applied to claim 1 above, and further in view of Jansson et al. (U.S. PGPUB No. 2010/0137782), hereinafter Jansson.
Regarding claim 18, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 1, but Griessmann is silent to “wherein the measurement apparatus comprises a scale and the control unit is configured to measure flow rate by weighing the dialysis solution with the scale at at least two different points in time.”
However, Jansson teaches a peritoneal dialysis machine (see [0002-0003]) with a measurement apparatus (37, see FIG. 2 and [0056]: sensor 37 is a scale) and a control unit (30), wherein the measurement apparatus comprises a scale (see [0056]) and the control unit (30) is configured to measure flow rate (see [0056]: 30 receives values from scale 37 to sense volume over time) by weighing the dialysis solution with the scale at at least two different points in time (see [0066] & [0068]: scale continuously senses and therefore measures at at least two different points in time. Scale values reflect flow rate).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the measurement apparatus disclosed in Griessmann to include a scale as taught by Jansson for the purpose of using the weight change measured by the scale to reflect the flow rate draining from the patient (see [0066]), thus achieving “wherein the measurement apparatus comprises a scale”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit disclosed in Griessmann to be configured to use the sensed values from the scale to calculate the flow rate as taught by Jansson for the purpose of monitoring a critical change in the flow rate (see [0066]) to determine if changes in treatment should occur (see [0068-0070]), thus achieving “and the control unit is configured to measure flow rate by weighing the dialysis solution with the scale at at least two different points in time.”
Regarding claim 22, the modified system of Griessmann teaches the peritoneal dialysis machine in accordance with claim 1, but Griessmann is silent to “wherein the measurement apparatus comprises a flow sensor and a scale.”
However, Hall teaches a peritoneal dialysis machine configured to effect a plurality of peritoneal dialysis treatments (see [0113]: machine can deliver peritoneal dialysis fluid to see [0004]: peritoneal cavity), the peritoneal dialysis machine having a measurement apparatus, the measurement apparatus comprises a flow sensor (see [0121]: sensors can be pressure sensors or flow sensors).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the measurement apparatus for determining flow rates disclosed in Griessmann to specifically be a flow sensor as taught by Hall for the purpose of using the sensed values in a feedback loop to control and regulate the device flow rate (see [0148]), thus achieving “wherein the measurement apparatus comprises a flow sensor”.
Griessman in view of Hall remain silent to the measurement apparatus comprises “and a scale”.
However, Jansson teaches a peritoneal dialysis machine (see [0002-0003]) with a measurement apparatus (37, see FIG. 2 and [0056]: sensor 37 is a scale) and a control unit (30), wherein the measurement apparatus comprises a scale (see [0056]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the measurement apparatus disclosed in Griessmann to include a scale as taught by Jansson for the purpose of using the weight change measured by the scale to reflect the flow rate draining from the patient (see [0066]), thus achieving “wherein the measurement apparatus comprises a scale”.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Griessmann in view of Hall as applied to claim 1 above, and further in view of Olde et al. (U.S. PGPUB No. 2014/0231319), hereinafter Olde.
Regarding claim 20, the modified system of Griessmannn teaches the peritoneal dialysis machine in accordance with claim 1, and Griessmannn further discloses wherein the one or more preceding cycles of the same peritoneal dialysis treatment comprises at least two preceding cycles of the same peritoneal dialysis treatment (see [0009] & [0070]: at least two cycles), and the time delay factor is determined by the control unit (see claim 1 rejection above) using a plurality of measured progressions of drainage rates and inflow rates (see [0037-0039]: memory saves data and the device has the ability to measure and compare volume increases/decreases/slopes==a flow rate over time for inflow or outflow) that were measured in a specific number of the one or more preceding cycles (see [0009] & [0070]: at least two cycles).
Griessman is silent to the number of cycles being at least “20” of the one or more preceding cycles.
However, Olde teaches a peritoneal dialysis machine (see [0005]) with a mean value data calculation (similar to the time delay factor as claimed in the current Application and disclosed in Griessmann) based on a number of preceding cycles to form a cycle synchronized data sample (see [0067-0068]). Olde further teaches that modifying the number of preceding cycles used in the mean value calculation will change the accuracy of the calculation (see [0068]). Therefore, a person of ordinary skill in the art would consider the calculation accuracy to be a result effect variable that is optimized through routine experimentation of changing/modifying the number of preceding cycles used in the mean value calculation to obtain a desired level of accuracy for the calculation.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the mean value calculation for calculating the time delay factor from at least two preceding cycles disclosed in Griessmann by increasing the number of preceding cycles to 20 in order to obtain a higher accuracy of the calculation as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), thus achieving the number of cycles being at least “20” of the one or more preceding cycles.
Response to Arguments
Applicant's arguments filed 02/17/26 have been fully considered but they are not persuasive.
On pages 8- 9 of Applicant remarks, Applicant argues that Griessman fails to disclose “a dynamic downward correction of a minimal outflow discharge rate threshold for the subsequent cycle is provided at the end of the drainage phase” as in the presently claimed invention. First, this argument does not align with the breadth of the claim language that merely recites “the control unit is configured to correct the threshold drainage flow rate in at least one subsequent cycle, including in the subsequent cycle, downward when the time delay factor for drainage exceeds a specific threshold value.” Further, in Applicant disclosure, this “downward” correction is only mentioned in [0033]: “The control unit is furthermore configured such that the value for a drainage rate used as a criterion for determining the end of a drainage phase is corrected downward by a specific amount at the end of the drainage phase”. Therefore, the examiner argues that Griessman discloses a similarly functioning control unit configured to employ a downward threshold correction as cited above (see explanations in the rejection of claim 1 above:
[0016] discloses that catheter performance is taken into account in the form of a relative increase in ideal inflow and/or ideal drainage-- this is a time delay factor for both the inflow process and drainage process;
[0018] discloses that different values are assumed for different phases, like the inflow vs drainage phase. Therefore, the time delay factor for ideal inflow can be written Fin and ideal drainage can be written Fdrn. The time delay factors are relative changes in view of an ideal value and thus, are multiplied by the ideal values, yielding a third equation for the time delay factor of inflow Δtin,ideal x Fin and a fourth equation for the time delay factor of drainage Δtdrn,ideal x Fdrn
“see [0034] & [0039] control unit configured to modify outflow rate based on falling below threshold values and is therefore is configured to modify the outflow rate threshold. see [0083-0085]. see [0015]: estimation of an outflow duration via general process described in [0016-0019]. In [0016], an example is given for determining inflow duration, but same process could be applied for outflow—see [0017]. See [0052] where initial ideal outflow duration is set. Then, the process in [0065-0068] determines a time delay factor such that outflow duration is shown in the table of [0071] based on the time delay factor. Examples of arriving at the outflow duration/ modified treatment parameter are in [0075-0076]”).
Therefore, the examiner was not persuaded by this argument and has maintained the rejection.
Because no further arguments were presented, the depending claim rejections were subsequently maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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