8DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 06/29/2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claim(s) 13 and 16-30 is/are pending in the application.
Claim(s) 13 and 16-30 is/are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 06/29/2026 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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 and 16-23 is/are rejected under 35 U.S.C 103 as being unpatentable over Gunther (US PGPUB 20120251998) in view of Breuch (EP 3721918 – English translation attached).
Regarding claim 13, Gunther discloses a control device configured for controlling a blood treatment apparatus (a central control and computing unit 27 configured for controlling a blood treatment apparatus: Abstract, ¶0042, and Fig. 1), wherein:
the blood treatment apparatus (Fig. 1) comprises:
a compressed air line (from line 19 to line 19B to air storage unit 18: ¶0036 and Fig. 1);
a compressed air device in fluid communication with the compressed air line (a compressor 20: ¶0036-0037 and Fig. 1), the compressed air device configured for generating pressure and/or an air flow within the compressed air line (¶0036);
a blood pump (a blood pump 6: ¶0029, 0042, and Fig. 1) for conveying blood through or within a blood tubing set (a blood supply line 8 and a blood return line 9: ¶0030 and Fig. 1);
a venous patient tube clamp (a venous hose clamp 12: ¶0042 and Fig. 1),
wherein the control device is configured to control or regulate both the blood pump and the compressed air device (the control device 27 is configured to control or regulate both the blood pump and the compressed air device: ¶0042);
wherein the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump (the blood pump 6 is operated throughout the whole arterial phase, the compressed air device 20 stands still: ¶0056), and
wherein the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device (the blood pump 6 stands still while the compressed air device 20 operates during venous phase: ¶0046, 0052, and 0060).
Gunther does not disclose a venous bubble trap and an arterial patient tube clamp.
In the same field of endeavor, blood treatment apparatus, Breuch discloses a hemodialysis arrangement comprising a control device 50 and a dialyzer 62. Breuch further discloses having an arterial patient tube clamp (an arterial controllable hose clamp 66: pg. 3, ¶9, and Fig. 1) positioned between arterial patient access and a blood pump 68 (Fig. 1) for the purpose of providing a way to selectively close or open an arterial line 72 to allow blood pass through extracorporeal circuit (pg. 3, ¶9). Breuch only discloses having a venous bubble trap (a venous bubble trap 63: pg. 3, ¶9, and Fig. 1) positioned in a venous blood-carrying line 72 (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Gunther in view of Breuch by incorporating an arterial patient tube clamp positioned in the blood supply line and a venous bubble trap positioned in the blood return line, in order to provide a way to selectively close or open an arterial line to allow blood pass through extracorporeal circuit, as suggested in pg. 3, ¶9 of Breuch. In addition, one would have been motivated to incorporate a venous bubble trap positioned in the blood return line in order to provide a location at which air bubbles present in the returning blood can be captured/separated from the blood before the blood is returned to the patient.
Regarding claim 16, Gunther further discloses during conveyance by the compressed air device with at least 15% of a maximum conveying capacity of the compressed air device, the arterial patient tube clamp and/or the venous patient tube clamp closes or remains closed (the venous hose clamp 12 remains closed throughout the whole arterial phase while the compressed air device 20 stands still: ¶0056).
Regarding claim 17, Hogard further discloses during conveyance by the compressed air device with at least 20% of a maximum conveying capacity of the compressed air device, the arterial patient tube clamp and/or the venous patient tube clamp closes or remains closed (the venous hose clamp 12 remains closed throughout the whole arterial phase while the compressed air device 20 stands still: ¶0056).
Regarding claim 18, Gunther discloses a blood treatment apparatus (Abstract and Fig. 1) comprising:
a compressed air line (from line 19 to line 19B to air storage unit 18: ¶0036 and Fig. 1);
a compressed air device in fluid communication with the compressed air line (a compressor 20: ¶0036-0037 and Fig. 1), the compressed air device configured for generating pressure and/or an air flow within the compressed air line (¶0036);
a blood pump (a blood pump 6: ¶0029, 0042, and Fig. 1) for conveying blood through or within a blood tubing set (a blood supply line 8 and a blood return line 9: ¶0030 and Fig. 1);
a venous patient tube clamp (a venous hose clamp 12: ¶0042 and Fig. 1),
a control device is configured to control or regulate both the blood pump and the compressed air device (a central control and computing unit 27 is configured to control or regulate both the blood pump and the compressed air device: ¶0042);
wherein the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump (the blood pump 6 is operated throughout the whole arterial phase, the compressed air device 20 stands still: ¶0056), and
wherein the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device (the blood pump 6 stands still while the compressed air device 20 operates during venous phase: ¶0046, 0052, and 0060).
Gunther does not disclose a venous bubble trap and an arterial patient tube clamp.
In the same field of endeavor, blood treatment apparatus, Breuch discloses a hemodialysis arrangement comprising a control device 50 and a dialyzer 62. Breuch further discloses having an arterial patient tube clamp (an arterial controllable hose clamp 66: pg. 3, ¶9, and Fig. 1) positioned between arterial patient access and a blood pump 68 (Fig. 1) for the purpose of providing a way to selectively close or open an arterial line 72 to allow blood pass through extracorporeal circuit (pg. 3, ¶9). Breuch only discloses having a venous bubble trap (a venous bubble trap 63: pg. 3, ¶9, and Fig. 1) positioned in a venous blood-carrying line 72 (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the apparatus of Gunther in view of Breuch by incorporating an arterial patient tube clamp positioned in the blood supply line and a venous bubble trap positioned in the blood return line, in order to provide a way to selectively close or open an arterial line to allow blood pass through extracorporeal circuit, as suggested in pg. 3, ¶9 of Breuch. In addition, one would have been motivated to incorporate a venous bubble trap positioned in the blood return line in order to provide a location at which air bubbles present in the returning blood can be captured/separated from the blood before the blood is returned to the patient.
Regarding claim 19, Gunther in view of Breuch further discloses the blood treatment apparatus is connected to the blood tubing set that comprises the venous bubble trap (see rejection of claim 18 above).
Regarding claim 20, Gunther further discloses the blood treatment apparatus is connected to a blood filter or dialyzer (a dialyzer 2: ¶0028 and Fig. 1) for pediatric blood treatment (the blood treatment apparatus can be used for any patients: ¶0002).
Regarding claim 21, Gunther further discloses the blood treatment apparatus is connected to a blood filter or dialyzer (a dialyzer 2: ¶0028 and Fig. 1) for adult blood treatment (the blood treatment apparatus can be used for any patients: ¶0002).
Regarding claim 22, Gunther further discloses the blood treatment apparatus is configured for apheresis or dialysis (¶0027-0028).
Regarding claim 23, Gunther does not disclose the blood treatment apparatus is configured for hemodialysis, hemofiltration, or hemodiafiltration.
Breuch further disclose the blood treatment apparatus is configured for hemodialysis (Abstract).
Thus, Gunther in view of Breuch further discloses the blood treatment apparatus that is configured for hemodialysis.
Claim(s) 24 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Gunther (US PGPUB 20120251998) in view of Breuch (EP 3721918 – English translation attached) and as evidenced by O’mahony (US PGPUB 20190201604).
Regarding claim 24, Gunther does not disclose the blood treatment apparatus is configured for acute renal replacement therapy, chronic renal replacement therapy, or continuous renal replacement therapy.
Breuch further disclose the blood treatment apparatus is configured for hemodialysis (Abstract).
Thus, Gunther in view of Breuch further discloses the blood treatment apparatus is configured for acute renal replacement therapy, chronic renal replacement therapy, or continuous renal replacement therapy (hemodialysis is acute and chronic renal replacement therapies).
O’mahony teaches that acute and chronic renal replacement therapies comprise ultrafiltration, hemodialysis, hemofiltration, hemodiafiltration, hemoconcentration (¶0007), thereby meeting the limitations of the claim.
Claim(s) 13, 18 and 25-30 is/are rejected under 35 U.S.C 103 as being unpatentable over Crnkovich (US PGPUB 20180318486) in view of Gunther (US PGPUB 20120251998).
Regarding claim 13, Crnkovich discloses a control device configured for controlling a blood treatment apparatus (a control unit 29 for controlling a blood treatment apparatus 4: ¶0203 and Fig. 1), wherein:
the blood treatment apparatus comprises:
a compressed air line (a fresh dialysis liquid inlet line 31a comprising a compressed air device 26: ¶0208 and Fig. 3);
a compressed air device in fluid communication with the compressed air line (a compressed air device 26: ¶0208 and Fig. 3), the compressed air device configured for generating pressure and/or an air flow within the compressed air line (¶0138);
a blood pump for conveying blood (a blood pump 11: ¶0205 and Figs. 1-3) through or within a blood tubing set (tubing set 9 and 23: ¶0204 and Figs. 1-3) that comprises a venous bubble trap (a venous air separation chamber 21: ¶0212 and Figs. 1-3);
an arterial patient tube clamp (an arterial patient tube clamp 6: ¶0204 and Figs. 1-3); and
a venous patient tube clamp (a venous patient tube clamp 7: ¶0204 and Figs. 1-3);
the control device is configured to control or regulate the blood pump (¶0013, 0132, and 0138).
Since Crnkovich discloses the control unit is programmed and/or configured for executing the method in interaction with the treatment apparatus (¶0013) and a method of introducing air into the extracorporeal blood circuit by means of the compressed air source (¶0138), Crnkovich implicitly discloses the control device is capable of controlling/regulating the compressed air device.
Crnkovich does not disclose the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump, and the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device.
In the same field of endeavor, blood treatment apparatus, Gunther discloses a control device configured for controlling a blood treatment apparatus (a central control and computing unit 27 configured for controlling a blood treatment apparatus: Abstract, ¶0042, and Fig. 1) and the blood treatment apparatus comprising a compressed air device 20 and a blood pump 6 (¶0029, 0036-0037, 0042, and Fig. 1). Gunther further discloses the control device is configured to control or regulate both the blood pump and the compressed air device (a central control and computing unit 27 is configured to control or regulate both a blood pump 6 and the compressed air device 20: ¶0042). In addition, Gunther discloses the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump (the blood pump 6 is operated throughout the whole arterial phase, the compressed air device 20 stands still: ¶0056), and the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device (the blood pump 6 stands still while the compressed air device 20 operates during venous phase: ¶0046, 0052, and 0060) for the benefit of providing a blood treatment system that the level of the means for collecting blood can be ascertained as accurately as possible without level sensors (¶0021).
Since Crnkovich discloses the control device is programmed and/or configured for executing the method in interaction with the treatment apparatus (¶0013), it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the control device of Crnkovich in view of Gunther by configuring/programing the control device for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump, and for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device, in order to provide a blood treatment system that the level of the means for collecting blood can be ascertained as accurately as possible without level sensors, as suggested in ¶0021 of Gunther.
Regarding claim 18, Crnkovich discloses a blood treatment apparatus (a blood treatment apparatus 4: ¶0203 and Fig. 1), wherein:
the blood treatment apparatus comprises:
a compressed air line (a fresh dialysis liquid inlet line 31a comprising a compressed air device 26: ¶0208 and Fig. 3);
a compressed air device in fluid communication with the compressed air line (a compressed air device 26: ¶0208 and Fig. 3), the compressed air device configured for generating pressure and/or an air flow within the compressed air line (¶0138);
a blood pump for conveying blood (a blood pump 11: ¶0205 and Figs. 1-3) through or within a blood tubing set (tubing set 9 and 23: ¶0204 and Figs. 1-3) that comprises a venous bubble trap (a venous air separation chamber 21: ¶0212 and Figs. 1-3);
an arterial patient tube clamp (an arterial patient tube clamp 6: ¶0204 and Figs. 1-3); and
a venous patient tube clamp (a venous patient tube clamp 7: ¶0204 and Figs. 1-3);
a control device is configured to control or regulate the blood pump (¶0013, 0132, and 0138).
Since Crnkovich discloses the control unit is programmed and/or configured for executing the method in interaction with the treatment apparatus (¶0013) and a method of introducing air into the extracorporeal blood circuit by means of the compressed air source (¶0138), Crnkovich implicitly discloses the control device is capable of controlling/regulating the compressed air device.
Crnkovich does not disclose the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump, and the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device.
Gunther discloses the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump (the blood pump 6 is operated throughout the whole arterial phase, the compressed air device 20 stands still: ¶0056), and the control device is configured for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device (the blood pump 6 stands still while the compressed air device 20 operates during venous phase: ¶0046, 0052, and 0060) for the benefit of providing a blood treatment system that the level of the means for collecting blood can be ascertained as accurately as possible without level sensors (¶0021).
Since Crnkovich discloses the control device is programmed and/or configured for executing the method in interaction with the treatment apparatus (¶0013), it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the control device of Crnkovich in view of Gunther by configuring/programing the control device for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the compressed air device during conveyance by the blood pump, and for disallowing, preventing, limiting to a predetermined value, or terminating a conveyance by the blood pump during conveyance by the compressed air device, in order to provide a blood treatment system that the level of the means for collecting blood can be ascertained as accurately as possible without level sensors, as suggested in ¶0021 of Gunther.
Regarding claim 25, Crnkovich further discloses a non-transitory digital storage medium with electronically readable control signals configured to interact with a programmable computer system to program or reprogram the control device according to claim 13 (¶0001, 0013, 0015, 0018, and 0022).
Regarding claim 26, Crnkovich further discloses a non-transitory digital storage medium with electronically readable control signals configured to interact with a programmable computer system to program or reprogram the control device according to claim 18 (¶0001, 0013, 0015, 0018, and 0022).
Regarding claim 27, Crnkovich further discloses a computer program product configured to interact with a programmable computer system to program or reprogram the control device according to claim 13 (¶0001, 0013, 0015, 0018, and 0022).
Regarding claim 28, Crnkovich further discloses a computer program product configured to interact with a programmable computer system to program or reprogram the control device according to claim 18 (¶0001, 0013, 0015, 0018, and 0022).
Regarding claim 29, Crnkovich further discloses a computer program having a program code for programming or reprogramming the control device according to claim 13 (¶0001, 0013, 0015, 0018, and 0022).
Regarding claim 30, Crnkovich further discloses a computer program having a program code for programming or reprogramming the control device according to claim 18 (¶0001, 0013, 0015, 0018, and 0022).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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