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 16-32 are pending and examined on the merits.
Claims 16-32 are new.
Claims 1-15 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/09/2023 was filed before the mailing date of the First Office Action on the Merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claims 16, 20-21, 23, 26, and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maltais (U.S. Patent No. 5,589,070 A).
Regarding claim 16, Maltais teaches: A bypass line (see bypass block 74 at least in Fig. 4) for establishing fluid communication between: (i) a dialysis liquid inlet line of a medical treatment apparatus (see internal dialysate supply line 37 and external dialysate line 42 at least in Fig. 4) by which dialysis fluid is fed out of an interior of the treatment apparatus into an exterior of the treatment apparatus (see at least col. 5, lines 14-18), and (ii) a dialysate outlet line (see external spent dialysate line 58 and internal spent dialysate line 62 at least in Fig. 4) by which dialysate is fed back from the exterior into the interior of the treatment apparatus (see at least col. 5, lines 61 thru col. 6, line 1), 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 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).
Regarding claim 20, Maltais teaches: A method of checking a condition of the bypass line according to claim 16 connected to a medical treatment apparatus provided with the dialysis liquid inlet line and the dialysate outlet line (), wherein the treatment apparatus comprises:
the dialysis liquid inlet line (37, 42 in Fig. 4) with a connector provided for connection to a blood filter (49 in Fig. 4);
the dialysate outlet line (58, 62 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 encompasses:
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);
measuring a pressure prevailing in the dialysis inlet line and/or in the dialysate outlet line at a first time point (see for example col. 7, lines 36-40);
determining at least one pressure value based on the measured pressure (see for example col. 7, lines 36-40);
evaluating the at least one pressure value (see for example col. 7, lines 36-40); and
emitting or outputting a signal indicating the condition of the bypass line as a result of the evaluation (see for example col. 7, lines 30-43 explaining that a user is made aware that the negative pressure in the bypass line is sufficient and that cleaning can be initiated).
Regarding claim 21, Maltais 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 23, Maltais 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 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 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 teaches A medical treatment apparatus comprising the control device according to claim 31 (see above).
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 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A) in view of Kenley (U.S. Patent No. 5,674,404 A).
Regarding claim 17, Maltais teaches the invention as discussed above in claim 16. Additionally, Maltais teaches the bypass line of claim 16. However, Maltais fails to explicitly teach a housing, as required by the claim.
Kenley teaches an analogous medical treatment apparatus (see Abstract) comprising a housing (see col. 11, lines 54-56).
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 Kenley by including a housing 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 18, Maltais in view of Kenley teaches the invention as discussed above in claim 17. 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). Additionally, Kenley teaches wherein the bypass line is completely or at least partially accommodated in the housing of the treatment apparatus (col. 11, lines 54-58 teach that the housing is installed in the water treatment module 24; therefore, the bypass line 85 is at least partially accommodated in the housing).
Regarding claim 19, Maltais in view of Kenley teaches the invention as discussed above in claim 17. 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 having a connector provided for connection to a blood filter, and the conveying device for conveying fluid within the dialysis liquid inlet line and/or within the dialysate outlet line.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Maltais (U.S. Patent No. 5,589,070 A), in view of Roger (U.S. Pre Grant Pub. No. 2009/0088683 A1).
Regarding claim 22, Maltais teaches the invention as discussed above in claim 20. However, Maltais fails to explicitly teach wherein the result is a faulty function of the non-return valve of the bypass line or an indication of the faulty function of the non-return valve of the bypass line; and/or the result that the faulty connection exists, is or presupposes a connection of the connector of the dialysis liquid inlet line to the second connector of the bypass line and a connection of the connector of the dialysate outlet line to the first connector of the bypass line, as required by the claim.
Roger teaches an analogous extracorporeal therapy device (see Abstract) that detects when an access disconnection has occurred and provides an alert for access disconnection (see para. [0008 and 0029]).
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 Roger by indicating when a faulty connection exists at least in order to minimize blood loss from a patient, as taught by Roger (see para. [0049]).
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 Roeher (U.S. Pre Grant Pub. No. 2002/0107449 A1).
Regarding claim 24, Maltais teaches the invention as discussed above in claim 20. However, Maltais fails 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 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 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 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 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 Weatherill (U.S. Pre Grant Pub. No. 2007/0102357 A1).
Regarding claim 27, Maltais 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 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 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 teaches the invention as discussed above in claim 27. However, Maltais 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 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 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 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 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sanna (U.S. Pre Grant Pub. No. 2010/0243543 A1) - MEDICAL CONNECTOR ABLE TO CONNECT SPECIFIC MEDICAL TUBE AND INPUT PORT
Hacker (U.S. Pre Grant Pub. No. 2019/0321533 A1) - Extracorporeal Blood Treatment Device And Method For Monitoring The Integrity Of A Dialyzer Of An Extracorporeal Blood Treatment Device
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
/CATHARINE L ANDERSON/ Primary Examiner, Art Unit 3781