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 .
Response to Amendment
The amendments filed on 07/06/2026 have been entered. Claims 1-6 have been amended. Accordingly, claims 1-6 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every 35. U.S.C. 112(b) rejection previously set forth in the Non-final Office action mailed on 04/07/2026. Therefore, all 35 U.S.C. 112(b) rejections are hereby withdrawn.
Response to Arguments
Applicant's arguments filed on 07/06/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “However, the drainage line 113 of Nakamagoe is an element of a blood circuit 110A (see Paragraphs [0023] to [0028]). The drainage line 113 of Nakamagoe is configured to drain a dialysate via a replenishing fluid line 140 during priming operation (see FIGS. 4A and 4B), and not to collect a dialysate that passes through a dialyzer 121. Therefore, Nakamagoe does not disclose "a dialysate collection passage that is connected to the dialyzer" along with the other features of the dialysate collection passage as claimed in Claim 1” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Said limitation recites a functional language of the dialysate collection passage, and said drainage line 113 is of Nakamagoe is fully capable of collecting a used dialysate that passes through the dialyzer during priming. Furthermore, Par. 54 of Nakamagoe in the provided translation also discusses that the priming liquid is sent from the hemodialyzer 120 side; thus, the used dialysate passing the hemodialyzer can be drained via drain line 113.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kanamagoe et al. JP 6900756 B2 (previously cited, hereinafter Kanamagoe), as cited in the IDS, in view of Glaser US 2016/0199559 A1 (previously cited, hereinafter Glaser) and Kopperschmidt US 2006/0254982 A1 (previously cited, hereinafter Kopperschmidt).
Regarding claim 1, Kanamagoe discloses a dialysis apparatus 100A (Fig. 4A – hemodialysis apparatus 100A) comprising
a dialyzer 120 (Fig. 4A – hemodialysis machine 120) that performs hemodialysis (Par. 2 in the provided translation – “Hemodiafiltration performed using a hemodialysis machine is known…”),
a dialysate supply passage 132a (Fig. 4A – dialysate introduction line 132a) that supplies a fresh dialysate to the dialyzer 120 (Fig. 4A, and Par. 35 in the provided translation – “The dialysate introduction line 132a connects… the dialysate inlet 123a of the hemodialysis machine 120, and introduces the dialysate… into the dialysate side flow path of the hemodialysis machine 120”),
a dialysate collection passage 113 (Fig. 4A – drain line 113) that is connected to the dialyzer 120 (Fig. 4A – drain line 113 is connected to the dialyzer via line 112) and collects a used dialysate that passes through the dialyzer 120 (Fig. 4B, and Par. 28 in the provided translation – “The drainage line 113 is a line for discharging the priming liquid in the priming process”),
a blood circuit 110A (Fig. 4A – blood circuit 110A) comprising an arterial side passage 111 (Fig. 4A – arterial line 111) that supplies blood to the dialyzer 120 (Fig. 4A, and Par. 24 in the provided translation – “the arterial line 111 is connected to the blood inlet 122a of the hemodialysis machine 120”) and a venous side passage 112 (Fig. 4A – venous line 112) that discharges blood from the dialyzer 120 (Fig. 4A, and Par. 26 in the provided translation – “the venous line 112 is connected to the blood outlet 122b of the hemodialysis machine 120”),
a replenisher passage 140 (Fig. 4A – replenishment fluid line 140) provided between the dialysate supply passage 132a (Fig. 4A) and the blood circuit 110A (Fig. 4A, and Par. 41 in the provided translation – “The replacement fluid line 140 is a line for directly supplying dialysate to the blood circuit 110A”), and
a liquid delivery device 140a (Fig. 4A – fluid replacement pump 140a) that delivers the fresh dialysate of the dialysate supply passage 132a (Fig. 4A) to the blood circuit 110A (Fig. 4A) via the replenisher passage 140 (Fig. 4A, and Par. 61 in the provided translation – “operate… the fluid replacement pump 140a to allow replacement fluid to flow from the replacement fluid line 140 into the blood circuit 110A”);
the replenisher passage 140 (Fig. 4A) being provided to be selectively connectable to the arterial side passage 111 (Fig. 4A, and Par. 50 in the provided translation – “Figure 4A shows the circuit connection state in the pre-dilution method, and Figure 4B shows the circuit connection state in the post-dilution method”) or the venous side passage 112 (Fig. 4B, Par. 41 in the provided translation – “Furthermore, as shown by the dashed line in Figure 1, if the downstream side of the replacement fluid line 140 is connected to the drip chamber 112a in the venous line 112”, and Par. 50 in the provided translation – “Figure 4B shows the circuit connection state in the post-dilution method”) of the blood circuit 110A (Fig. 4A-4B);
the dialysis apparatus 100A (Fig. 4A) further comprising:
a connection passage 111a (Fig. 4A – blood pump 111a) in which one end communicates with the arterial side passage 111 (Fig. 4A) of the blood circuit 110A (Fig. 4A), and the other end communicates with the dialysate collection passage 113 (Fig. 4A-4B), and
a determination device 150+154 (Fig. 4A – control device 150 and determination unit 154, and Par. 22 in the provided translation – “a control device 150 as a determination device”) determining whether the replenisher passage 140 (Fig. 4A-4B) is connected to the arterial side passage 111 (Fig. 4A) or the venous side passage 112 (Fig. 4B, and Par. 45 in the provided translation – “In the determination method which will be described in detail later, the determination unit 154 determines whether the replacement fluid line 140 is connected to the arterial line 111 or the venous line 112”), in a state where the liquid delivery device 140a (Fig. 4A-4B) causes a liquid to flow into the blood circuit 110A (Fig. 4A) from the replenisher passage 140 (Fig. 4A-4B), and the liquid flows through the dialysate collection passage 113 (Fig. 4A-4B) via the connection passage 111a (Fig. 4A-4B) from the arterial side passage 111 (Fig. 4A – liquid flows into the arterial line 111 first) or the venous side passage 112 (Fig. 4B – liquid flows into the venous line 112 first).
However, Nakamagoe does not currently disclose a supply side pressure sensor that measures a pressure of a liquid flowing through the dialysate supply passage, a collection side pressure sensor that measures a pressure of a liquid flowing through the dialysate collection passage, and determining based on a differential pressure between a pressure measured by the supply side pressure sensor and a pressure measured by the collection side pressure sensor.
Glaser, in the same field of endeavor of dialysis treatment (Title), teaches a supply side pressure sensor 34 (Fig. 4 – pressure sensor 34) that measures a pressure of a liquid flowing through the dialysate supply passage (Par. 74 – “A pressure sensor and a temperature sensor (shown in combination as sensor 34) on the dialysate side at the inlet of the dialyzer”), a collection side pressure sensor 36 (Fig. 4 – pressure sensor 36) that measures a pressure of a liquid flowing through the dialysate collection passage (Par. 76 – “A pressure sensor and a temperature sensor (shown in combination as sensor 36) on the dialysate side at the outlet of the dialyzer”), and a differential pressure between a pressure measured by the supply side pressure sensor and a pressure measured by the collection side pressure sensor (Par. 25 – “at least two pressure sensors are arranged in the extracorporeal blood circuit so that the transmembrane pressure can be measured at the dialyzer. A conceivable arrangement in this connection comprises the presence of pressure sensors on the dialysate side and on the blood side of the dialysis machine, optionally at one side or respectively at the inlet side and the outlet side”).
Kopperschmidt, in the same field of endeavor of detection of predilution or postdilution (Abstract), teaches determining based on a differential pressure (Abstract – “for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyser or filter, predilution or postdilution being recognized on the basis of the change in pressure”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nakamagoe to further include supply side and collection side pressure sensor as taught by Glaser, in order to measure a transmembrane pressure at the dialyzer (Par. 25 of Glaser). This measurement can also monitor the flowing fluid, such as blood, the lack of disturbing cables, etc. (Par. 23 of Glaser).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further incorporate the operation of determining connection, i.e. pre-dilution or post-dilution, based on a differential pressure as taught by Kopperschmidt, as it is well-established in the field that detection facility using detected pressure are known (Par. 23 of Kopperschmidt). Therefore, one of ordinary skill in the art would have had the technological capability and motivation to implement detected pressures and differential pressures to evaluate the state of connection of a pre-dilution/post-dilution configuration as taught by Kopperschimdt to improve the determination procedure of Nakamagoe in view of Glaser with reasonable expectation of success. MPEP 2143.I.C.
Regarding claim 2, Nakamagoe in view of Glaser in view of Kopperschmidt suggests the invention of claim 1. The combination further discloses wherein:
the determination device 150+154 (Fig. 4A-4B of Nakamagoe) calculates a differential pressure (Par. 25 of Glaser – “at least two pressure sensors are arranged in the extracorporeal blood circuit so that the transmembrane pressure can be measured at the dialyzer”) between a pressure measured by the supply side pressure sensor 34 (Fig. 4 of Glaser) and a pressure measured by the collection side pressure sensor 36 (Fig. 4 of Glaser) in a state where the liquid which the liquid delivery device delivers 140a (Fig. 4A of Nakamagoe) to the blood circuit 110A (Fig. 4A of Nakamagoe) from the replenisher passage 140 (Fig. 4A of Nakamagoe) is caused to flow out to the dialysate collection passage 113 (Fig. 4A of Nakamagoe) via the connection passage 111 (Fig. 4A of Nakamagoe) from an end portion of the arterial side passage 111 (Fig. 4A of Nakamagoe – liquid flows into the arterial line 111 first).
However, the combination does not disclose and when the differential pressure is smaller than a first threshold, the determination device determines that the replenisher passage is connected to the arterial side passage, and when the differential pressure is larger than the first threshold, the determination device determines that the replenisher passage is connected to the venous side passage.
According to the discussion of Kopperschmidt in Abstract reciting “One embodiment provides, for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyser or filter, predilution or postdilution being recognized on the basis of the change in pressure” and Par. 23 reciting “Most of the components necessary for the detection facility are generally already present in the known blood treatment devices. For example, it is possible to make use of the venous pressure sensor for measuring the pressure in the blood stream downstream of the dialyser or filter”, the measured pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said measured pressures directly affects detecting outcomes of replenishment/substitution connection. Therefore, appropriate predetermined pressure thresholds/limits are desired in order to compare the output pressures for connection evaluation (Par. 21 of Kopperschmidt discusses necessity of predetermined upper and lower limit value). As such, without showing unexpected results, the claimed first threshold for determining whether the replenisher passage is connected to the arterial side passage or to the venous side passage cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the predetermined first threshold against which the measured differential pressure is compared in the apparatus of the combination to obtain the desired connection detection of an extracorporeal device, as taught by Kopperschmidt (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 3, Nakamagoe in view of Glaser in view of Kopperschmidt suggests the invention of claim 1. The combination further discloses wherein:
the determination device 150+154 (Fig. 4A-4B of Nakamagoe) calculates a differential pressure (Par. 25 of Glaser – “at least two pressure sensors are arranged in the extracorporeal blood circuit so that the transmembrane pressure can be measured at the dialyzer”) between a pressure measured by the supply side pressure sensor 34 (Fig. 4 of Glaser) and a pressure measured by the collection side pressure sensor 36 (Fig. 4 of Glaser), in a state where the liquid which the liquid delivery device 140a (Fig. 4B of Nakamagoe) delivers to the blood circuit 110A (Fig. 4B of Nakamagoe) from the replenisher passage 140 (Fig. 4B of Nakamagoe) is caused to flow out to the dialysate collection passage 113 (Fig. 4B of Nakamagoe) via the connection passage 111 (Fig. 4B of Nakamagoe) from an end portion of the venous side passage 112 (Fig. 4B of Nakamagoe – liquid flows into the venous line 112 first).
However, the combination does not disclose when the differential pressure is smaller than a second threshold, the determination device determines that the replenisher passage is connected to the venous side passage, and when the differential pressure is larger than the second threshold, the determination device determines that the replenisher passage is connected to the arterial side passage.
According to the discussion of Kopperschmidt in Abstract reciting “One embodiment provides, for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyser or filter, predilution or postdilution being recognized on the basis of the change in pressure” and Par. 23 reciting “Most of the components necessary for the detection facility are generally already present in the known blood treatment devices. For example, it is possible to make use of the venous pressure sensor for measuring the pressure in the blood stream downstream of the dialyser or filter”, the measured pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said measured pressures directly affects detecting outcomes of replenishment/substitution connection. Therefore, appropriate predetermined pressure thresholds/limits are desired in order to compare the output pressures for connection evaluation (Par. 21 of Kopperschmidt discusses necessity of predetermined upper and lower limit value). As such, without showing unexpected results, the claimed second threshold for determining whether the replenisher passage is connected to the arterial side passage or to the venous side passage cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the predetermined second threshold against which the measured differential pressure is compared in the apparatus of the combination to obtain the desired connection detection of an extracorporeal device, as taught by Kopperschmidt (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 4, Nakamagoe discloses a method for checking connection of a replenisher passage 140 (Fig. 4A, Par. 45 in the provided translation – “In the determination method which will be described in detail later, the determination unit 154 determines whether the replacement fluid line 140 is connected to the arterial line 111 or the venous line 112”), including
a dialyzer 120 (Fig. 4A – hemodialysis machine 120) that performs hemodialysis (Par. 2 in the provided translation – “Hemodiafiltration performed using a hemodialysis machine is known…”),
a dialysate supply passage 132a (Fig. 4A – dialysate introduction line 132a) that supplies a fresh dialysate to the dialyzer 120 (Fig. 4A, and Par. 35 in the provided translation – “The dialysate introduction line 132a connects… the dialysate inlet 123a of the hemodialysis machine 120, and introduces the dialysate… into the dialysate side flow path of the hemodialysis machine 120”),
a dialysate collection passage 113 (Fig. 4A – drain line 113) that is connected to the dialyzer 120 (Fig. 4A – drain line 113 is connected to the dialyzer via line 112) collects a used dialysate that passes through the dialyzer 120 (Fig. 4B, and Par. 28 in the provided translation – “The drainage line 113 is a line for discharging the priming liquid in the priming process”),
a blood circuit 110A (Fig. 4A – blood circuit 110A) comprising an arterial side passage 111 (Fig. 4A – arterial line 111) that supplies blood to the dialyzer 120 (Fig. 4A, and Par. 24 in the provided translation – “the arterial line 111 is connected to the blood inlet 122a of the hemodialysis machine 120”) and a venous side passage 112 (Fig. 4A – venous line 112) that discharges blood from the dialyzer 120 (Fig. 4A, and Par. 26 in the provided translation – “the venous line 112 is connected to the blood outlet 122b of the hemodialysis machine 120”),
a replenisher passage 140 (Fig. 4A – replenishment fluid line 140) provided between the dialysate supply passage 132a (Fig. 4A) and the blood circuit 110A (Fig. 4A, and Par. 41 in the provided translation – “The replacement fluid line 140 is a line for directly supplying dialysate to the blood circuit 110A”), and
a liquid delivery device 140a (Fig. 4A – fluid replacement pump 140a) that delivers the fresh dialysate in the dialysate supply passage 132a (Fig. 4A) the blood circuit 110A (Fig. 4A) via the replenisher passage 140 (Fig. 4A, and Par. 61 in the provided translation – “operate… the fluid replacement pump 140a to allow replacement fluid to flow from the replacement fluid line 140 into the blood circuit 110A”), and
determining whether the replenisher passage 140 (Fig. 4A-4B) is connected to the arterial side passage 111 (Fig. 4A), or the venous side passage 112 (Fig. 4B, and Par. 45 in the provided translation – “In the determination method which will be described in detail later, the determination unit 154 determines whether the replacement fluid line 140 is connected to the arterial line 111 or the venous line 112”) in the blood circuit 110A (Fig. 4A), the method comprising:
in a state where either one of the arterial side passage 111 (Fig. 4A – liquid flows into the arterial line 111) or the venous side passage 112 (Fig. 4B – liquid flows into the venous line 112) of the blood circuit 110A (Fig. 4A) is caused to communicate with the dialysate collection passage 113 (Fig. 4A-4B, and Par. 51 in the provided translation – “In this case, the priming fluid is discharged from the drain line 113”, indicating priming fluid has to communicate with line 111 and 112 in both cases of Fig. 4A and Fig. 4B), the liquid delivery device 140a (Fig. 4A-4B) causing a liquid to flow into the blood circuit 110A (Fig. 4A) from the replenisher passage 140 (Fig. 4A-4B), and the liquid is causing to flow to the dialysate collection passage 113 (Fig. 4A-4B) from the arterial side passage 111 (Fig. 4A – liquid flows into the arterial line 111 first) or the venous side passage 112 (Fig. 4B – liquid flows into the venous line 112 first); and
determining whether a connection destination of the replenisher passage 140 (Fig. 4A-4B) is the arterial side passage 111 (Fig. 4A) or the venous side passage 112 (Fig. 4B, and Par. 45 in the provided translation – “In the determination method which will be described in detail later, the determination unit 154 determines whether the replacement fluid line 140 is connected to the arterial line 111 or the venous line 112”).
However, Nakamagoe does not currently disclose providing a supply side pressure sensor that measures a pressure in the dialysate supply passage, and a collection side pressure sensor that measures a pressure in the dialysate collection passage; and determining based on a differential pressure between a pressure measured by the supply side pressure sensor and a pressure measured by the collection side pressure sensor.
Glaser, in the same field of endeavor of dialysis treatment (Title), teaches providing a supply side pressure sensor 34 (Fig. 4 – pressure sensor 34) that measures a pressure in the dialysate supply passage (Par. 74 – “A pressure sensor and a temperature sensor (shown in combination as sensor 34) on the dialysate side at the inlet of the dialyzer”), and a collection side pressure sensor 36 (Fig. 4 – pressure sensor 36) that measures a pressure in the dialysate collection passage (Par. 76 – “A pressure sensor and a temperature sensor (shown in combination as sensor 36) on the dialysate side at the outlet of the dialyzer”), and a differential pressure between a pressure measured by the supply side pressure sensor and a pressure measured by the collection side pressure sensor (Par. 25 – “at least two pressure sensors are arranged in the extracorporeal blood circuit so that the transmembrane pressure can be measured at the dialyzer. A conceivable arrangement in this connection comprises the presence of pressure sensors on the dialysate side and on the blood side of the dialysis machine, optionally at one side or respectively at the inlet side and the outlet side”).
Kopperschmidt, in the same field of endeavor of detection of predilution or postdilution (Abstract), teaches determining based on a differential pressure (Abstract – “for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyser or filter, predilution or postdilution being recognized on the basis of the change in pressure”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nakamagoe to further include supply side and collection side pressure sensor as taught by Glaser, in order to measure a transmembrane pressure at the dialyzer (Par. 25 of Glaser). This measurement can also monitor the flowing fluid, such as blood, the lack of disturbing cables, etc. (Par. 23 of Glaser).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further incorporate the operation of determining connection, i.e. pre-dilution or post-dilution, based on a differential pressure as taught by Kopperschmidt, as it is well-established in the field that detection facility using detected pressure are known (Par. 23 of Kopperschmidt). Therefore, one of ordinary skill in the art would have had the technological capability and motivation to implement detected pressures and differential pressures to evaluate the state of connection of a pre-dilution/post-dilution configuration as taught by Kopperschimdt to improve the determination procedure of Nakamagoe in view of Glaser with reasonable expectation of success. MPEP 2143.I.C.
Regarding claim 5, Nakamagoe in view of Glaser in view of Kopperschmidt suggests the invention of claim 4. The combination further discloses wherein a connection passage 111a (Fig. 4A of Nakamagoe – blood pump 111a) is provided in which one end communicates with the arterial side passage 111 (Fig. 4A of Nakamagoe) of the blood circuit 110A (Fig. 4A of Nakamagoe), and the other end communicates with the dialysate collection passage 113 (Fig. 4A-4B of Nakamagoe), further comprising:
calculating a differential pressure (Par. 25 of Glaser – “at least two pressure sensors are arranged in the extracorporeal blood circuit so that the transmembrane pressure can be measured at the dialyzer”) between a pressure measured by the supply side pressure sensor 34 (Fig. 4 of Glaser) and a pressure measured by the collection side pressure sensor 36 (Fig. 4 of Glaser), in a state where the liquid delivered to the blood circuit 110A (Fig. 4A of Nakamagoe) from the replenisher passage 140 (Fig. 4A of Nakamagoe) by the liquid delivery device 140a (Fig. 4A of Nakamagoe) is caused to flow out to the dialysate collection passage 113 (Fig. 4A of Nakamagoe) via the connection passage 111a (Fig. 4a of Nakamagoe – connection passage 111) from an end portion of the arterial side passage 111 (Fig. 4A of Nakamagoe – liquid flows into the arterial line 111 first).
However, the combination does not disclose determining that the replenisher passage is connected to the arterial side passage when the differential pressure is smaller than a first threshold, and determining that the replenisher passage is connected to the venous side passage when the differential pressure is larger than the first threshold.
According to the discussion of Kopperschmidt in Abstract reciting “One embodiment provides, for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyser or filter, predilution or postdilution being recognized on the basis of the change in pressure” and Par. 23 reciting “Most of the components necessary for the detection facility are generally already present in the known blood treatment devices. For example, it is possible to make use of the venous pressure sensor for measuring the pressure in the blood stream downstream of the dialyser or filter”, the measured pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said measured pressures directly affects detecting outcomes of replenishment/substitution connection. Therefore, appropriate predetermined pressure thresholds/limits are desired in order to compare the output pressures for connection evaluation (Par. 21 of Kopperschmidt discusses necessity of predetermined upper and lower limit value). As such, without showing unexpected results, the claimed first threshold for determining whether the replenisher passage is connected to the arterial side passage or to the venous side passage cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the predetermined first threshold against which the measured differential pressure is compared in the apparatus of the combination to obtain the desired connection detection of an extracorporeal device, as taught by Kopperschmidt (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 6, Nakamagoe in view of Glaser in view of Kopperschmidt suggests the invention of claim 4. The combination further discloses wherein a connection passage 111a (Fig. 4A of Nakamagoe – blood pump 111a) is provided in which one end communicates with the arterial side passage 111 (Fig. 4A of Nakamagoe) of the blood circuit 110A (Fig. 4A of Nakamagoe), and the other end communicates with the dialysate collection passage 113 (Fig. 4A-4B of Nakamagoe), further comprising:
calculating a differential pressure (Par. 25 of Glaser – “at least two pressure sensors are arranged in the extracorporeal blood circuit so that the transmembrane pressure can be measured at the dialyzer”) between a pressure measured by the supply side pressure sensor 34 (Fig. 4 of Glaser) and a pressure measured by the collection side pressure sensor 36 (Fig. 4 of Glaser) in a state where the liquid delivered to the blood circuit 110A (Fig. 4B of Nakamagoe) from the replenisher passage 140 (Fig. 4B of Nakamagoe) by the liquid delivery device 140a (Fig. 4B of Nakamagoe) is caused to flow out to the dialysate collection passage 113 (Fig. 4B of Nakamagoe) via the connection passage (fig. 4a of Nakamagoe – connection passage 111; see 112(b) rejection above) from an end portion of the venous side passage 112 (Fig. 4B of Nakamagoe – liquid flows into the venous line 112 first).
However, the combination does not disclose determining that the replenisher passage is connected to the venous side passage when the differential pressure is smaller than a second threshold, and determining that the replenisher passage is connected to the arterial side passage when the differential pressure is larger than the second threshold.
According to the discussion of Kopperschmidt in Abstract reciting “One embodiment provides, for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyser or filter, predilution or postdilution being recognized on the basis of the change in pressure” and Par. 23 reciting “Most of the components necessary for the detection facility are generally already present in the known blood treatment devices. For example, it is possible to make use of the venous pressure sensor for measuring the pressure in the blood stream downstream of the dialyser or filter”, the measured pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said measured pressures directly affects detecting outcomes of replenishment/substitution connection. Therefore, appropriate predetermined pressure thresholds/limits are desired in order to compare the output pressures for connection evaluation (Par. 21 of Kopperschmidt discusses necessity of predetermined upper and lower limit value). As such, without showing unexpected results, the claimed second threshold for determining whether the replenisher passage is connected to the arterial side passage or to the venous side passage cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the predetermined second threshold against which the measured differential pressure is compared in the apparatus of the combination to obtain the desired connection detection of an extracorporeal device, as taught by Kopperschmidt (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Beden et al. US 2011/0237997 A1 teaches method and device for monitoring the introduction of substitution fluids.
THIS ACTION IS MADE FINAL. 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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Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
