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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/19/2026.
Applicant’s arguments filed on 02/19/2026, with respect to the Restriction requirement have been fully considered and are persuasive. The restriction requirement between group I, claims 1-3, and group II, claims 4-6 has been withdrawn. Accordingly, claims 1-6 are pending and under examination.
Claim Rejections - 35 USC § 112
Claims 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the connection passage" in line 9-10. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets “the connection passage” as “a connection passage”.
Claim 6 recites the limitation "the connection passage" in line 9-10. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets “the connection passage” as “a connection passage”.
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 (hereinafter Kanamagoe), as cited in the IDS, in view of Glaser US 2016/0199559 A1 (hereinafter Glaser) and Kopperschmidt US 2006/0254982 A1 (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 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 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 wherein
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”) is further provided, the determination device 150+154 (Fig. 4A) 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 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 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 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 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 including
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) causes a liquid to flow into the blood circuit 110A (Fig. 4A) from the replenisher passage 140 (Fig. 4A-4B), and the liquid is caused 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 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 (fig. 4a of Nakamagoe – connection passage 111; see 112(b) rejection above) 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 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 differentia 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.
A 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.
Kanatsu JP 2020151034 A teaches a determination method of circuit set
Gronau et al. US 2013/0028788 A1 teaches using pressure for testing.
Wolff et al. US 2013/0303961 A1 teaches two pressure sensors on the dialysate side.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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