DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 9, 2026 has been entered.
Response to Arguments
Applicant's arguments filed February 9, 2026 have been fully considered but they are not persuasive. Applicant has amended the set of claims, changing the scope of the claimed invention, necessitating a modified grounds of rejection using the previous prior art references.
On page 10 of the Remarks section, Applicant discusses the 112(f) interpretations in the previous Office Action, acknowledging them.
On pages 10-12, Applicant discusses the previous 103 prior art rejections regarding independent Claim 1, involving primary reference Mitrovic et al., (US 2021/0128806), Brehm et al., (“Brehm”, US 2003/0168120), Olsson, (US 2004/0020852), and Polaschegg, (US 5,580,460). Applicant summarizes the amendments to the claimed invention here, in which the pressure test would be carried out if all three of the recited conditions are met. Applicant points to the instant Specification, demonstrating the advantages to evaluating these conditions. Applicant notes that the pressure holding test is not performed in the case that these conditions are not met. Applicant argues that primary reference Mitrovic discloses different conditions for closing the fluid system than those conditions that are claimed. Applicant also argues that other secondary references Brehm and Polaschegg do not disclose these limitations either, arguing that these references do not disclose that in order for a pressure test to be performed on a line portion, (a) a sensed fluid value of the fluid flow must meet a predetermined fluid value condition, (b) a sensed concentrate supply mode must meet a predetermined concentrate supply mode condition, and (c) a sensed position of the connecting means must meet a predetermined position state condition as in the presently claimed invention.
In response, the Examiner notes that paragraph [0059] of Mitrovic which was previously recited states that if “the total dissolved solids” measured by sensor 41 of the fluid flow path 54 falls outside a prescribed range, treatment can be stopped entirely, such that fluid is redirected from this flow path. The Examiner notes that this action would indicate that a sensed fluid value is meeting some sort of condition where fluid flow stops. Thus, the Examiner takes the position that Mitrovic discloses the limitation associated with (a) and the first sensed condition signal and the first predetermined condition as further shown in the prior art rejection section below. The Examiner notes that Mitrovic does not explicitly disclose the limitations associated with (b) a sensed concentrate supply mode must meet a predetermined concentrate supply mode condition, and (c) a sensed position of the connecting means must meet a predetermined position state condition. The Examiner turns to previously used secondary reference Brehm et al., (“Brehm”, US 2003/0168120) to disclose the limitation associated with (c) and the third sensed condition signal and the third predetermined condition as further shown in the prior art rejection section below. The Examiner also finds that newly found secondary reference Jonsson et al., (US 4,784,495) discloses the limitation associated with (b), (the concentrate supply mode), and the second sensed condition signal and the second predetermined condition as further shown in the prior art rejection section below. The Examiner finally notes that previously used reference, Polaschegg, (US 5,580,460), already discloses the limitation related to running a pressure holding test when the fluid system is closed and the dialyzer is disconnected to determine if there is a leak or not. The Examiner further states that primary reference Mitrovic already stops its fluid lines under a first condition to run a leak test, which correlates to the pressure holding test disclosed in Polaschegg. As a result, the Examiner takes the position that while Mitrovic does not disclose all of the limitations discussed and argued by Applicant, as shown here, the other references, Brehm, Jonsson, and Polaschegg disclose the other limitations in question as one combination. The Examiner finds these remarks by Applicant to be piecemeal analysis, and thus unpersuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 12-14, Applicant makes similar arguments with regard to independent claim 13, arguing that the previous combination of references does not disclose the limitations in question as discussed above. The Examiner makes the same rebuttal to these points as explained above in the Response to Arguments section.
On pages 8-14, Applicant argues against independent Claims 1 & 13 using some combination of primary reference Mitrovic et al., (US 2021/0128806), Brehm et al., (“Brehm”, US 2003/0168120), Olsson, (US 2004/0020852), and Polaschegg, (US 6,280,632). Applicant argues that previous secondary reference Polaschegg does not disclose a “closed fluid system”, and that it does not further disclose newly added limitations to the claims such as “a self-contained system”, “a stable pressure is achieved in the absence of a leakage” and more. First, the Examiner notes that primary reference Mitrovic et al., (US 2021/0128806) already disclosed the feature of a closed fluid system, so it was not necessary for Polaschegg to also do so. Next, the Examiner notes that the newly added claim features have changed the scope of the claimed invention and that newly found secondary reference Polaschegg, (US 5,580,460) discloses these features instead. The original Polaschegg, (US 6,280,632) is no longer relied upon. Since Applicant’s arguments are directed towards the original Polaschegg reference, they are considered moot since the newly found Polaschegg reference reads upon the added claim features instead.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 recites the limitation “a connecting means” coupled with “for transferring the first concentrate solution” on line 3. The instant Specification states this limitation can be “a flexible connection”, “hose arrangement’, “rigid connecting element”, or “suction wand”.
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.
Claim(s) 13, 14 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mitrovic et al., (US 2021/0128806), in view of Jonsson et al., (US 4,784,495), in further view of Brehm et al., (“Brehm”, US 2003/0168120), in further view of Polaschegg, (US 5,580,460).
Claims 13, 14 & 22 are directed to a method, a method type invention group.
Regarding Claims 13, 14 & 22, Mitrovic discloses a method for controlling a fluid flow in a blood treatment device, (See Abstract, Mitrovic), wherein the blood treatment device comprises a fluid line system for guiding the fluid flow comprising a dialyzer, a dialysis fluid circuit that includes a line portion, that is configured to be formed as a closed fluid system, (See Abstract, Dialyzer 8, Dialysate Flow Path 54, See Figure 5, See paragraph [0050], [0092]), a pair of locking element valves, (Valves 29, 32 capable of bypass, See Figure 5, See paragraph [0059], [0093]) and a bypass valve, (Valve 34, See Figure 5, See paragraph [0062]), configured for disconnecting the dialyzer from the line portion under the bypass condition, (See paragraph [0059], [0062], [0092]), and at least a first concentrate supply line for supplying a first concentrate solution to the dialysis fluid circuit, and a connecting means for transferring the first concentrate solution into the first concentrate supply line, (Line with Reagent Source 61, See Figure 5, See paragraph [0064]); wherein the method comprises: detecting a first condition of the fluid line system by means of the sensor system, by sensing a fluid value of the fluid flow in the fluid line system, (Sensors 64/68, Sensor 41, See Figure 5, See paragraph [0064], [0059]); and comparing the first condition to a first predetermined condition by sending a corresponding fluid value signal that is based on the sensed fluid value, to a control unit, (See paragraph [0035], [0079], [0059]); and controlling with the control unit the pair of locking element valves and the bypass valve to disconnect the dialyzer from the line portion to form the closed fluid system when (a) the detected first condition of the fluid line system meets the first predetermined condition, (See paragraph [0059]; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed); and further comprising a pressure sensor for capturing a pressure value in the line portion, (See paragraph [0063] & [0081], Mitrovic), upon satisfying (a), (b), then performing a leak test and (iii) drawing a conclusion that there is no leakage in the line portion, (See paragraph [0080], [0084] Mitrovic; if the leak detector indicates an unsafe condition, the processor ceases further treatment (stops flow). The flow was operating previously when the conductivity sensors were measuring the concentrate levels).
Mitrovic does not disclose detecting a second condition of the fluid line system by means of the sensor system by sensing a concentrate supply mode of the fluid line system; comparing the second condition to a second predetermined condition, by sending a corresponding concentrate supply mode signal that is based on the sensed concentrate supply mode to the control unit to disconnect the dialyzer from the line portion to form the closed fluid system when (b) the detected second condition meets the second predetermined condition, sensing a position of a connecting means for transferring the first concentrate solution into the at least one first concentrate supply line; and detecting a third condition of the fluid line system by means of the sensor system by sensing a position of the connecting means, comparing the third condition to a third predetermined condition by sending a corresponding position signal that is based on the sensed position of the connecting means to the control unit and to form the closed fluid system when (c) the detected third condition meets the third predetermined condition or that the leak test is a pressure holding test and then performing a pressure holding test by (i) applying pressure to fluid in the line portion, while the dialyzer is disconnected from the line portion, to build up pressure in the closed fluid system, (ii) capturing pressure values in the line portion during a predetermined time period, and (iii) drawing a conclusion based on changes between the pressure values captured that there is no leakage in the line portion.
Jonsson discloses detecting a second condition of the fluid line system by means of the sensor system by sensing a concentrate supply mode of the fluid line system; comparing the second condition to a second predetermined condition, by sending a corresponding concentrate supply mode signal that is based on the sensed concentrate supply mode to the control unit to disconnect the dialyzer from the line portion to form the closed fluid system when (b) the detected second condition meets the second predetermined condition, (See column 15, lines 6-37; The system senses via detectors whether the cartridges full of concentrate powder have water or not, considered a supply mode, to determine if they are usable or unusable (its condition). A measurement is made from the detectors and is sent via signal to generate an alarm and valves to this line portion to the dialyzer are closed as part of the fluid system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood treatment of modified Mitrovic by incorporating detecting a second condition of the fluid line system by means of the sensor system by sensing a concentrate supply mode of the fluid line system; comparing the second condition to a second predetermined condition, by sending a corresponding concentrate supply mode signal that is based on the sensed concentrate supply mode to the control unit to disconnect the dialyzer from the line portion to form the closed fluid system when (b) the detected second condition meets the second predetermined condition as in Jonsson because “if a column or cartridge…is filled with water and left therein for any period of time, either because the concentrate fluid produced is unused or only partly used, there is risk that the dry powder…may be altered or that bacteria growth may occur”, (See column 15, lines 12-17, Jonsson), so in this case when detecting “the presence of water…in the cartridges or columns, suitable alarms can be actuated for insuring that the prepared solution is not delivered to the dialyzer”, (See column 15, lines 32-37, Jonsson).
Brehm discloses a blood treatment device, (See Abstract, [0049], Brehm), sensing a position of a connecting means for transferring the first concentrate solution into the at least one first concentrate supply line; and detecting a third condition of the fluid line system by means of the sensor system by sensing a position of the connecting means, (Chamber 30 and Connector 1, See Figure 4, 8, See paragraphs [0029]-[0033], Brehm), comparing the third condition to a third predetermined condition by sending a corresponding position signal that is based on the sensed position of the connecting means to the control unit and to form the closed fluid system when (c) the detected third condition meets the third predetermined condition, (Detector Means 58, Proximity Detectors 63 & 64, See Figures 4 & 5, See paragraphs [0034] & [0036], Brehm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood treatment device of Mitrovic by incorporating comparing the third condition to a third predetermined condition by sending a corresponding position signal that is based on the sensed position of the connecting means to the control unit and to form the closed fluid system when (c) the detected third condition meets the third predetermined condition as in Brehm in order to “confirm the correct mount” of the connecting means and chamber, (See paragraph [0034], Brehm), to “block the flow of any…fluid until such confirmation has taken place”, (See paragraph [0034], Brehm), which “considerably simplifies the handling during the connection procedure”, (See paragraph [0006], Brehm).
Polaschegg discloses a blood treatment device, (See Abstract, Polaschegg), hat the leak test is a pressure holding test and then performing a pressure holding test by (i) applying pressure to fluid in the line portion, while the dialyzer is disconnected from the line portion, to build up pressure in the closed fluid system, (ii) capturing pressure values in the line portion during a predetermined time period, and (iii) drawing a conclusion based on changes between the pressure values captured that there is no leakage in the line portion, (See column 6, lines 9-24, lines 30-59, and column 6, lines 64-67, column 7, lines 1-7, lines 18-29, Polaschegg; the system is a closed system, the system bypasses the dialyzer, and air is added into the system. If the pressure measured remains stable after additional air is added, there are no leaks).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood treatment device of modified Mitrovic by incorporating hat the leak test is a pressure holding test and then performing a pressure holding test by (i) applying pressure to fluid in the line portion, while the dialyzer is disconnected from the line portion, to build up pressure in the closed fluid system, (ii) capturing pressure values in the line portion during a predetermined time period, and (iii) drawing a conclusion based on changes between the pressure values captured that there is no leakage in the line portion as in Polaschegg to “ensure that the treatment begins with an intact or tight…system”, (See column 6, lines 9-10, Polaschegg), and “detect a defect during treatment before it causes dangerous effects”, (See column 6, lines 30-31, Polaschegg).
Additional Disclosures Included:
Claim 14: The method according to claim 13, wherein for sensing the fluid value of the fluid flow in the fluid line system, the sensor system comprises a first concentrate sensor configured to determine a first concentrate value prevailing in the first concentrate supply line, and wherein the first predetermined condition is met only when the first concentrate value meets a predetermined concentrate value, (See paragraph [0064], [0059] Mitrovic; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed).
Claim 22: The method according to claim 13, wherein detecting a first condition by sensing a fluid value comprises sensing a mixed fluid value by means of a mixed fluid sensor configured for determining the mixed fluid value in the fluid line system downstream from the concentrate supply line, and the first predetermined condition is a predetermined mixed fluid value condition, (Conductivity Sensor 68, See Figure 5, See paragraph [0064], [0059] Mitrovic; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed).
Claim(s) 1, 2, 5-9, 12, 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mitrovic et al., (US 2021/0128806), in view of Jonsson et al., (US 4,784,495), in further view of Brehm et al., (“Brehm”, US 2003/0168120), in further view of Polaschegg, (US 5,580,460).
Claims 1, 2, 5-9, 12 & 16-21 are directed to a blood treatment device, an apparatus or device type invention group.
Regarding Claims 1, 2, 5-9, 12 & 16-21, Mitrovic discloses a blood treatment device, (See Abstract, Mitrovic), having a fluid line system for guiding a fluid flow comprising a dialyzer and a dialysis fluid circuit that includes a line portion configured to be formed into a closed fluid system under a bypass condition, (See Abstract, Dialyzer 8, Dialysate Flow Path 54, See Figure 5, See paragraph [0050], [0059], [0092]), a pair of locking element valves, (Valves 29, 32 capable of bypass, See Figure 5, See paragraph [0059], [0093]) and a bypass valve, (Valve 34, See Figure 5, See paragraph [0062]), configured for disconnecting the dialyzer from the line portion under the bypass condition, (See paragraph [0059], [0062], [0092]), and comprising at least one first concentrate supply line for supplying a first concentrate solution, (Line with Reagent Source 61, See Figure 5, See paragraph [0064]); a fluid pump for conveying a fluid in the fluid line system, (Pump 33, See Figure 5, See paragraph [0054]); a sensor system configured for (i) sensing a first condition of the fluid line system by means of the sensor system, by sensing a fluid value of a fluid flow in the fluid line system, and (iv) sending a first sensed condition signal that corresponds to the first sensed condition, (Sensors 64/68, Sensor 41, See Figure 5, See paragraph [0064], [0059]); a control unit configured to receive the first sensed condition signal configured to control the pair of locking element valves, the bypass valve, and the fluid flow, and configured to form the closed fluid system, (See paragraph [0035], [0079]); wherein the control unit is configured to evaluate the sensed condition signal to determine based on the sensed condition signal whether the condition of the state of the fluid line system is a certain condition and to form the line portion into the closed fluid system when the sensed condition of the state of the fluid line system is in the certain condition, (See paragraph [0059]; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed), further comprising a pressure sensor for capturing pressure values in the line portion under the bypass condition, (See paragraph [0063] & [0081], Mitrovic), wherein the sensor system comprises a fluid value sensor for sensing the fluid value of the fluid flow in the fluid line system and sending the first sensed condition signal to the control unit, (Sensors 64/68, Sensor 41, See Figure 5, See paragraph [0064], [0059]), the sensor system comprises a concentrate supply mode sensor for sensing the concentrate supply mode of the fluid line system, (Sensors 64/68, Sensor 41, See Figure 5, See paragraph [0064], [0059]), and sending the second sensed condition signal to the control unit, the control unit is configured to evaluate the first sensed condition signal, to determine based on the first sensed condition signal, whether the fluid value meets a first predetermined condition, the control unit is configured to form the line portion into the closed fluid system when the fluid value meets the first predetermined condition, the control unit is configured to perform a leak test in the line portion when the line portion is formed into the closed fluid system, (See paragraph [0080], [0084] Mitrovic; if the leak detector indicates an unsafe condition, the processor ceases further treatment (stops flow). The flow was operating previously when the conductivity sensors were measuring the concentrate levels).
Mitrovic does not disclose (ii) sensing a second condition of the fluid line system by means of the sensor system, by sensing a concentrate supply mode of the fluid line system and (iv) sending a second sensed condition signal, that correspond to the second sensed condition, the control unit configured to receive the second sensed condition signal; further having the sensor system configured for sensing a condition of a position state of the fluid line system to determine a third sensed condition, a connecting means for transferring the first concentrate solution into the at least one first concentrate supply line; a chamber into which the connecting means is introduced when transferring the first concentrate solution into the at least one first concentrate supply line, the control unit is configured to evaluate the second sensed condition signal, to determine based on the second sensed condition signal, whether the concentrate supply mode meets a second predetermined condition, the control unit is configured to form the line portion into the closed fluid system when the concentrate supply mode meets the second predetermined condition, the sensor system comprises a position sensor for sensing the position state of the connecting means; and sending the third sensed condition signal to the control unit, the sensed condition signal is the position signal, the control unit is configured to evaluate the third sensed condition signal to determine based on the third sensed condition signal whether the position state of the connecting means meets a third predetermined condition, the control unit is configured to form the line portion when the sensed position state of the connecting means meets the third predetermined condition, or that the leak test is a pressure holding test, and the pressure holding test involves applying a pressure to fluid in the line portion, capturing the pressure values in the line portion during a predetermined time period, and drawing a conclusion based on changes between the pressure values captured that there is a leakage in the line portion.
Jonsson discloses ii) sensing a second condition of the fluid line system by means of the sensor system, by sensing a concentrate supply mode of the fluid line system and (iv) sending a second sensed condition signal, that correspond to the second sensed condition, the control unit configured to receive the second sensed condition signal the control unit is configured to evaluate the second sensed condition signal, to determine based on the second sensed condition signal, whether the concentrate supply mode meets a second predetermined condition, the control unit is configured to form the line portion into the closed fluid system when the concentrate supply mode meets the second predetermined condition, (See column 15, lines 6-37; The system senses via detectors whether the cartridges full of concentrate powder have water or not, considered a supply mode, to determine if they are usable or unusable. A measurement is made from the detectors and is sent via signal to generate an alarm and valves to this line portion are closed as part of the fluid system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood treatment of modified Mitrovic by incorporating ii) sensing a second condition of the fluid line system by means of the sensor system, by sensing a concentrate supply mode of the fluid line system and (iv) sending a second sensed condition signal, that correspond to the second sensed condition, the control unit configured to receive the second sensed condition signal the control unit is configured to evaluate the second sensed condition signal, to determine based on the second sensed condition signal, whether the concentrate supply mode meets a second predetermined condition, the control unit is configured to form the line portion into the closed fluid system when the concentrate supply mode meets the second predetermined condition as in Jonsson because “if a column or cartridge…is filled with water and left therein for any period of time, either because the concentrate fluid produced is unused or only partly used, there is risk that the dry powder…may be altered or that bacteria growth may occur”, (See column 15, lines 12-17, Jonsson), so in this case when detecting “the presence of water…in the cartridges or columns, suitable alarms can be actuated for insuring that the prepared solution is not delivered to the dialyzer”, (See column 15, lines 32-37, Jonsson).
Brehm discloses a blood treatment device, (See Abstract, [0049], Brehm), further having a connecting means for transferring the first concentrate solution into the at least one first concentrate supply line; a chamber into which the connecting means is introduced when transferring the first concentrate solution into the at least one first concentrate supply line, (Chamber 30 and Connector 1, See Figure 4, 8, See paragraphs [0029]-[0033], Brehm), the sensor system configured for sensing a condition of a position state of the fluid line system to determine a third sensed condition, the sensor system comprises a position sensor for sensing the position state of the connecting means; and sending the third sensed condition signal to the control unit, the sensed condition signal is the position signal, the control unit is configured to evaluate the third sensed condition signal to determine based on the third sensed condition signal whether the position state of the connecting means meets a third predetermined condition, the control unit is configured to form the line portion when the sensed position state of the connecting means meets the third predetermined condition, (Detector Means 58, Proximity Detectors 63 & 64, See Figures 4 & 5, See paragraphs [0034] & [0036], Brehm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood treatment device of Mitrovic by incorporating further having a connecting means for transferring the first concentrate solution into the at least one first concentrate supply line; a chamber into which the connecting means is introduced when transferring the first concentrate solution into the at least one first concentrate supply line the sensor system configured for sensing a condition of a position state of the fluid line system to determine a third sensed condition, the sensor system comprises a position sensor for sensing the position state of the connecting means; and sending the third sensed condition signal to the control unit, the sensed condition signal is the position signal, the control unit is configured to evaluate the third sensed condition signal to determine based on the third sensed condition signal whether the position state of the connecting means meets a third predetermined condition, the control unit is configured to form the line portion when the sensed position state of the connecting means meets the third predetermined condition as in Brehm in order to “confirm the correct mount” of the connecting means and chamber, (See paragraph [0034], Brehm), to “block the flow of any…fluid until such confirmation has taken place”, (See paragraph [0034], Brehm), which “considerably simplifies the handling during the connection procedure”, (See paragraph [0006], Brehm).
Polaschegg discloses a blood treatment device, (See Abstract, Polaschegg), that the leak test is a pressure holding test, and the pressure holding test involves applying a pressure to fluid in the line portion, capturing the pressure values in the line portion during a predetermined time period, and drawing a conclusion based on changes between the pressure values captured that there is a leakage in the line portion, (See column 6, lines 9-24, lines 30-59, and column 6, lines 64-67, column 7, lines 1-7, lines 18-29, Polaschegg; the system is a closed system, the system bypasses the dialyzer, and air is added into the system. If the pressure measured remains stable after additional air is added, there are no leaks).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood treatment device of modified Mitrovic by incorporating that the leak test is a pressure holding test, and the pressure holding test involves applying a pressure to fluid in the line portion, capturing the pressure values in the line portion during a predetermined time period, and drawing a conclusion based on changes between the pressure values captured that there is a leakage in the line portion as in Polaschegg to “ensure that the treatment begins with an intact or tight…system”, (See column 6, lines 9-10, Polaschegg), and “detect a defect during treatment before it causes dangerous effects”, (See column 6, lines 30-31, Polaschegg).
Additional Disclosures Included:
Claim 2: The blood treatment device according to claim 1, wherein the fluid value sensor comprises comprises a first concentrate sensor configured to sense a first concentrate value prevailing in the at least one first concentrate supply line, (Conductivity Sensor 64, See Figure 5, See paragraph [0064], [0059], Mitrovic; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed).
Claim 5: The blood treatment device according to claim 1 further comprising a second concentrate supply line for supplying a second concentrate solution into the line portion, wherein the fluid value sensor further comprises a second concentrate sensor for sensing a second concentrate value in the second concentrate supply line, the control unit is configured to form the line portion into the closed fluid system only when the second concentrate value meets a second predetermined concentrate value condition, (Conductivity Sensor 68, See Figure 5, See paragraph [0064], [0059] Mitrovic; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed).
Claim 6: The blood treatment device according to claim 1, wherein the position sensor comprises a magnetic sensor or a contact sensor, (See paragraph [0034] or [0036], Brehm).
Claim 7: The blood treatment device according to claim 1, wherein the position sensor is arranged on the chamber, (Detector 58 placed on Fluid Preparation Device 50 or Proximity Detectors 63/64 on Device 50, See Figure 4 & 5, See paragraph [0034] & [0036], Brehm).
Claim 8: The blood treatment device according to claim 2, wherein the first concentrate sensor is a conductance sensor, a conductivity sensor or an ultrasonic sensor, (See paragraph [0064], [0059] Mitrovic; all are conductivity sensors).
Claim 9: The blood treatment device according to claim 1 wherein the line portion has at least one partial portion and the blood treatment device further comprises a line branch, that is formed parallel to the at least one partial portion of the line portion, the line branch being configured such that a fluid flow can be connected via the line branch to the at least one partial portion; wherein the dialyzer is in the line branch, (Dialyzer 8 in Line 53 and in Line 54, See Figure 5, See paragraph [0050], [0052] Mitrovic).
Claim 12: The blood treatment device according to claim 1, comprising at least one first concentrate pump configured to convey the first concentrate solution, (Pumps 62/66, See Figure 5, See paragraph [0064] Mitrovic).
Claim 16: The blood treatment device according to claim 1, wherein the position sensor is a Hall sensor or a mechanical switch, (See paragraph [0034] or [0036], Brehm).
Claim 17: The blood treatment device according to claim 1, wherein the pressure applied to the fluid in the line portion is from 600 to 800 mmHg, (See column 8, lines 50-59, Polaschegg; Approximately 1 bar converts to 750 mm Hg, anticipating the claimed range at this value).
Claim 18: The blood treatment device according to claim 1, wherein the pressure applied to the fluid in the line portion is from 700 to 750 mmHg, (See column 8, lines 50-59, Polaschegg; Approximately 1 bar converts to 750 mm Hg, anticipating the claimed range at this value).
Claim 19: The blood treatment device according to claim 1, wherein the fluid value sensor comprises a mixed fluid sensor for sensing a mixed fluid value prevailing in the fluid line system downstream from the first concentrate supply line, and the first predetermined condition is a predetermined mixed fluid value, (Conductivity Sensor 68, See Figure 5, See paragraph [0064], [0059] Mitrovic; if the measured state is not in the range prescribed, treatment can be stopped entirely which means the line is closed).
Claim 20: The blood treatment device according to claim 19, wherein the mixed fluid sensor is a conductance sensor, a conductivity sensor, or an ultrasonic sensor, (Conductivity Sensor 68, See Figure 5, See paragraph [0064], [0059] Mitrovic; all are conductivity sensors).
Claim 21: The blood treatment device according to claim 1, wherein the position sensor is attached to a concentrate container that is configured to be fastened to the blood treatment device, (Detector 58 placed on Fluid Preparation Device 50 or Proximity Detectors 63/64 on Device 50, See Figure 4 & 5, See paragraph [0034] & [0036], Brehm).
Conclusion
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779