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 .
Status of Claims
Claims 16 and 18-32 are pending and examined on the merits.
Claims 16, 18-22, 24, and 26 are currently amended.
Claims 1-15 and 17 are cancelled.
Response to Amendment
Applicant amendments filed 06/30/2026 have been fully considered.
Response to Arguments
Applicant provided amendments to the independent claims which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 06/30/2026 have been fully considered but they are moot. Mishima (U.S. Pre Grant Pub. No. 2015/0129498 A1) is introduced as a new secondary reference in the present rejection for disclosing and rendering obvious some of the limitations presented via the amendments. Maltais (U.S. Patent No. 5,589,070 A), Kenley (U.S. Patent No. 5,674,404 A), Roger (U.S. Pre Grant Pub. No. 2009/0088683 A1), Roeher (U.S. Pre Grant Pub. No. 2002/0107449 A1), and Weatherill (U.S. Pre Grant Pub. No. 2007/0102357 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious some of the limitations presented via the amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 16, 20-23, 26, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A) in view of Mishima (U.S. Pre Grant Pub. No. 2015/0129498 A1).
Regarding claim 16, Maltais teaches: A medical treatment apparatus (see at least Abstract; see also dialysis control unit 10 in Fig. 4) comprising:
a dialysis liquid inlet line (see one of the lines 42 or 58 in Fig. 4);
a dialysate outlet line (see one of the lines 42 or 58 in Fig. 4);
a pressure sensor (see at least col. 3, line 40);
a bypass line (see bypass block 74 at least in Fig. 4) for establishing fluid communication between the dialysis liquid inlet line and the dialysate outlet line (see Fig. 4), the bypass line comprising:
a first connector (76 in Fig. 4) for connecting the bypass line to achieve fluid communication with a connector of the dialysis liquid inlet line (see dialyzer inlet connector 44 in Fig. 4; see also col. 7, lines 26-30);
a second connector (78 in Fig. 4) for connecting the bypass line to achieve fluid communication with a connector of the dialysate outlet line (see connector 92 in Fig. 4; see also col. 7, lines 15-21); and
a non-return valve (see backflow prevention valve 140 at least in Fig. 4) which only allows flow through the bypass line from the first connector towards the second connector (see col. 7, lines 49-51); and
one or more processors configured to perform operations (see at least col. 7, lines 2-5).
However, Maltais fails to explicitly teach a housing, that the one or more processors are configured to perform operations comprising measuring a pressure within the dialysis liquid inlet line, and determining whether the bypass line is properly connected to the dialysis liquid inlet line and the dialysate outlet line based on the pressure within the dialysis liquid inlet line, as required by the claim.
Mishima teaches an analogous hemodialysis apparatus (see Abstract) comprising a housing (see for example Fig. 2), a pressure sensor 33 that measures pressure within a line 25 (see Fig. 2 and para. [0123]) and that allows for a user to detect and recognize when a pressure has reached a predetermined level so that a passage 6 can be connected to a port 31, thus enabling an operator to connect the passage 6 (see para. [0124]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais to incorporate the teachings of Mishima by including a housing at least in order to contain the various structural components of the device of Maltais (by including a housing, the dialysis liquid inlet line feeds dialysis fluid out of an interior of the housing to an exterior of the housing and the dialysate outlet line feeds dialysate from the exterior of the housing to the interior of the housing), and by configuring the one or more processors to measure a pressure within the dialysis liquid inlet line at least in order to allow for an operator to be notified of the pressure within the dialysis liquid inlet line, as taught by Mishima (see para. [0124]). Additionally, by including the pressure sensor within the dialysis liquid inlet line and measuring such pressure, the processor can determine whether the bypass line is properly connected at least because if the bypass line is not properly connected, the pressure sensor would read a pressure substantially similar to atmospheric pressure since the fluid circuit shown in Fig. 4 of Maltais would be open and not complete.
Regarding claim 20, Maltais teaches: A method (see Abstract), wherein the medical treatment apparatus comprises:
a dialysis liquid inlet line (see one of the lines 42 or 58 in Fig. 4) with a connector provided for connection to a blood filter (49 in Fig. 4);
a dialysate outlet line (see one of the lines 42 or 58 in Fig. 4) with a connector provided for connection to the blood filter (49); and
a conveying device (see pump 64 in Fig. 4) for conveying fluid within the dialysis liquid inlet line and/or within the dialysate outlet line (see for example col. 7, lines 30-43);
wherein the method comprises:
actuating the conveying device to deliver fluid within the dialysis liquid inlet line and/or within the dialysate outlet line to establish positive pressure or negative pressure therein (see for example col. 7, lines 30-43);
evaluating the at least one pressure value (see for example col. 7, lines 36-40).
However, Maltais fails to explicitly teach measuring a pressure prevailing in the dialysis inlet line and/or in the dialysate outlet line at a first time point, determining at least one pressure value based on the measured pressure, or emitting or outputting a signal indicating the condition of the bypass line as a result of the evaluation, as required by the claim.
Mishima teaches a pressure sensor 33 that measures pressure within a line 25 (see Fig. 2 and para. [0123]) and that allows for a user to detect and recognize when a pressure has reached a predetermined level by use of a monitor 5 so that a passage 6 can be connected to a port 31, thus enabling an operator to connect the passage 6 (see para. [0124]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Maltais to incorporate the teachings of Mishima by measuring a pressure prevailing in the dialysis inlet line and/or in the dialysate outlet line at a first time point (such as by including a pressure sensor within the dialysis liquid inlet line to measure a pressure within the dialysis liquid inlet line at least in order to allow for an operator to be notified of the pressure within the dialysis liquid inlet line, as taught by Mishima, see para. [0124]), determining at least one pressure value based on the measured pressure (such as by notifying a monitor, as taught by Mishima, see para. [0124]), and/or emitting or outputting a signal indicating the condition of the bypass line as a result of the evaluation (such as by notifying a monitor, as taught by Mishima, see para. [0124]). In addition, the method of Maltais in view of Mishima is for checking a condition of a bypass line connected to a medical treatment apparatus, as required by the claim.
Regarding claim 21, Maltais in view of Mishima teaches the invention as discussed above in claim 20. Additionally, Maltais teaches whereby the result is an indication of a faulty connection of the bypass line with the dialysis liquid inlet line and the dialysate outlet line, and/or wherein evaluating of the at least one pressure value comprises a comparison of the at least one pressure value with a first reference value or reference range (col. 7, lines 36-40 teach that the dialysate pressure is checked to see if it is less than atmospheric).
Regarding claim 22, Maltais in view of Mishima teaches the invention as discussed above in claim 20. Additionally, Mishima teaches that when pressure is measured with the pressure sensor 33, a detection result indicating the pressure in the circuit has reached a predetermined pressure (see para. [0124]). Therefore, if there is a faulty function in a valve, the pressure sensor would not indicate that the pressure has reached a predetermined pressure.
Regarding claim 23, Maltais in view of Mishima teaches the invention as discussed above in claim 20. Additionally, Maltais teaches wherein, to determine the pressure value, both the pressure prevailing in the dialysis liquid inlet line at the first time point, and the pressure prevailing in the dialysate outlet line are or have been measured (col. 7, lines 36-40 teaches that a pressure sensor is used to check dialysate pressure), wherein, a pressure difference is determined between the pressure measured in the dialysis liquid inlet line and the pressure measured in the dialysate outlet line or vice versa (col. 7, lines 36-40 teaches that pressure is measured and checked that is less than atmospheric pressure);
wherein evaluating the at least one pressure value comprises a comparison of this pressure difference with a second reference value or reference range therefor (col. 7, lines 36-40 teaches that pressure is measured and checked against atmospheric pressure).
Regarding claim 26, Maltais in view of Mishima teaches the invention as discussed above in claim 20. Additionally, Maltais teaches wherein actuating the at least one conveying device takes place when a first valve is open which is upstream of the connector of the dialysis liquid inlet line but downstream of the first pressure sensor (see backflow prevention valve 140 in Fig. 4; col. 7, lines 51-52 teaches that valve 140 is a check valve; therefore, the check valve is open in one direction which causes the conveying device to be actuated; see also Fig. 4) and/or when a second valve is open, which is arranged downstream of the second connector of the dialysate outlet line but upstream of the second pressure sensor.
Regarding claim 30, Maltais in view of Mishima teaches the invention as discussed above in claim 27. Additionally, Maltais teaches wherein a signal associated with a faulty condition of the bypass line is emitted or output when:
evaluating the pressure value results in the pressure value exceeding a reference value or leaving a reference range (col. 9, lines 34-56 teach that a signal is generated if hoses 42, 58 are properly connected to the bypass block connectors 76, 78; conversely, when an improper connection is made, a signal will not be generated; therefore, a lack of a signal is in itself a signal to a user that a faulty connection exists), and/or
determining the pressure value based on pressures within the dialysis liquid inlet line measured after the pressure was released results in a pressure increase.
Regarding claim 31, Maltais teaches: A control device (see controller in col. 6, line 10 thru col. 10 line 29) programmed to carry out a test to check a condition of a bypass line connected to the dialysis liquid inlet line and the dialysate outlet line of a medical blood treatment apparatus (see col. 7, lines 22-30; see also col. 9, lines 32-67), the test comprising the method according to claim 20 (see above).
Regarding claim 32, Maltais in view of Mishima teaches A medical treatment apparatus comprising the control device according to claim 31 (see above).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A) in view of Mishima (U.S. Pre Grant Pub. No. 2015/0129498 A1), as applied to claim 16 above, and further in view of Kenley (U.S. Patent No. 5,674,404 A).
Regarding claim 18, Maltais in view of Mishima teaches the invention as discussed above in claim 16. Additionally, Maltais teaches wherein the first connector and the second connector of the bypass line are accessible from the exterior of the treatment apparatus (as shown in Fig. 4, the connectors 76, 78 are located on an exterior of the treatment apparatus). However, neither Maltais nor Mishima explicitly teach wherein the bypass line is completely or at least partially accommodated in the housing of the treatment apparatus, as required by the claim.
Kenley teaches an analogous medical treatment apparatus (see Abstract) comprising a housing (see col. 11, lines 54-56) that is installed in the water treatment module 24 (see col. 11, lines 54-58). Therefore, the bypass line 85 is at least partially accommodated in the housing.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais in view of Mishima to incorporate the teachings of Kenley by including completely or at least partially accommodating the bypass line in the housing of the treatment apparatus at least in order to contain all or part of the medical treatment apparatus as taught by Kenley, (see col. 11, lines 54-56).
Regarding claim 19, Maltais in view of Mishima teaches the invention as discussed above in claim 16. Additionally, Maltais teaches further comprising the dialysis liquid inlet line having a connector provided for connection to a blood filter (see col. 5, lines 11-18; dialyzer 49 is considered a blood filter), the dialysate outlet line comprises a connector provided for connection to a blood filter (see col. 5, lines 11-18), and the medical treatment apparatus comprises a conveying device for conveying fluid within the dialysis liquid inlet line and/or within the dialysate outlet line (see pump 64 in Fig. 4 and col. 7, lines 30-43).
Claims 24, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A), in view of Mishima (U.S. Pre Grant Pub. No. 2015/0129498 A1), as applied to claim 20 above, and further in view of Roeher (U.S. Pre Grant Pub. No. 2002/0107449 A1).
Regarding claim 24, Maltais in view of Mishima teaches the invention as discussed above in claim 20. However, Maltais and Mishima fail to explicitly teach measuring pressure at a second time point, as required by the claim.
Roeher teaches an analogous blood treatment apparatus (see Abstract) comprising taking into account a first pressure measurement and a second pressure measurement at time intervals (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais in view of Mishima by incorporating the teachings of Roeher by measuring the pressure prevailing in the dialysis liquid inlet line and/or in the dialysate outlet line at a second time point and determining at least a second pressure value based thereon, wherein evaluating the pressure value comprises a comparison of the pressure difference between the pressure values determined in the dialysis liquid inlet line at the first and second time points and/or a comparison of the pressure difference between the pressure values determined in the dialysate outlet line at the first and second time points with a third or fourth reference value or range therefor, respectively at least because Roeher teaches that pressure measurements are carried out at intervals which reduces the number of pressure measurements and the resultant discomfort of a patient (see at least Abstract).
Regarding claim 25, Maltais in view of Mishima teaches the invention as discussed above in claim 20. Additionally, Maltais teaches wherein actuating the conveying device comprises building a negative pressure in the dialysis liquid inlet line as well as in the dialysate outlet line (see at least col. 9, lines 48-51); and wherein the method comprises releasing the negative pressure in the dialysate outlet line (col. 9, lines 48-51 teaches that negative pressure is created in the bypass block 74; since this is a closed loop system, negative pressure created in the bypass block 74 will act on the dialysate outlet line). However, Maltais in view of Mishima fails to explicitly teach wherein measuring a pressure prevailing in the dialysis liquid inlet line and/or in the dialysate outlet line comprises a measurement at one or more times after the pressure release, as required by the claim.
Roeher teaches taking pressure measurements at intervals (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais in view of Mishima by incorporating the teachings of Roeher by measuring a pressure prevailing in the dialysis liquid inlet line and/or in the dialysate outlet line comprises a measurement at one or more times after the pressure release at least because Roeher teaches that pressure measurements are carried out at intervals which reduces the number of pressure measurements and the resultant discomfort of a patient (see at least Abstract).
Claims 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A), in view of Mishima (U.S. Pre Grant Pub. No. 2015/0129498 A1), as applied to claim 20 above, and further in view of Weatherill (U.S. Pre Grant Pub. No. 2007/0102357 A1).
Regarding claim 27, Maltais in view of Mishima teaches the invention as discussed above in claim 20. Additionally, Maltais teaches wherein releasing the negative pressure in the dialysate outlet line is achieved by connecting the dialysate outlet line to a fluid source (col. 9, lines 48-52 teach that negative pressure is created in the bypass block 74 so as to facilitate the injection of fluid; therefore, negative pressure is released when the device is connected to container 124). However, Maltais in view of Mishima fails to explicitly teach a fresh water source or a drain, as required by the claim.
Weatherill teaches an analogous dialysis device (see para. [0006]) comprising a fresh water source (see at least para. [0006]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais in view of Mishima to incorporate the teachings of Weatherill by connecting the dialysate outlet line to a fresh water source or to a drain at least in order to sanitize the system, as taught by Weatherill (see at least para. [0005]).
Regarding claim 29, Maltais in view of Mishima teaches the invention as discussed above in claim 27. However, Maltais in view of Mishima fails to teach opening a valve to a fresh water line or a valve to a drain line, as required by the claim.
Weatherill teaches an analogous dialysis device (see para. [0006]) comprising valves and components that open and close to pass water through selected flow paths (see para. [0007]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais in view of Mishima to incorporate the teachings of Weatherill by opening a valve to a fresh water line to release negative pressure at least in order to automatically operate cleaning and sanitizing cycles, as taught by Weatherill (see para. [0007]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A), in view of Mishima (U.S. Pre Grant Pub. No. 2015/0129498 A1), further in view of Weatherill (U.S. Pre Grant Pub. No. 2007/0102357 A1), as applied above to claim 27, and further in view of Roeher (U.S. Pre Grant Pub. No. 2002/0107449 A1).
Regarding claim 28, Maltais, in view of Mishima, and further in view of Weatherill teaches the invention as discussed above in claim 27. Additionally, Maltais teaches further comprising:
fluidically shutting off the dialysate outlet line after the negative pressure in the dialysate outlet line has been released in such a way that there is no longer any connection between the dialysate outlet line and the fresh water source or the drain (col. 9, lines 48-52 teach that negative pressure is created in the bypass block 74 which facilitates injection of fluid; conversely, when negative pressure is not detected, injection of the fluid is prevented),
wherein a signal is emitted or output which is associated with a faulty condition of the bypass line when as a result of evaluating the at least one pressure value pressure change within the dialysate outlet line is detected (col. 9, lines 34-56 teach that a signal is generated if hoses 42, 58 are properly connected to the bypass block connectors 76, 78; conversely, when an improper connection is made, a signal will not be generated; therefore, a lack of a signal is in itself a signal to a user that a faulty connection exists).
However, Maltais, in view of Mishima, and further in view of Weatherill fails to explicitly teach wherein, to determine the at least one pressure value, at least two pressures are measured in the dialysate outlet line at two different times points after the dialysate outlet line has been blocked, as required by the claim.
Roeher teaches taking pressure measurements at intervals (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Maltais, in view of Mishima, and further in view of Weatherill by incorporating the teachings of Roeher by measuring at least two pressures in the dialysate outlet line at two different times points after the dialysate outlet line has been blocked at least because Roeher teaches that pressure measurements are carried out at intervals which reduces the number of pressure measurements and the resultant discomfort of a patient (see at least Abstract).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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