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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18-31 and 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,702,606 to Peter, Jr. et al. (hereinafter “Peter”).
Regarding claim 18, Peter teaches a blood treatment apparatus (see Figures 6, 13) comprising:
a blood pump (458) for pumping blood through an extracorporeal blood circuit during a blood treatment session, during which the blood treatment apparatus is connected to the extracorporeal blood circuit (400) and to a blood filter e.g. dialyzer (404) comprising a semi-permeable membrane (see col. 25, line 61 – col. 26, line 31);
an air bubble detector (486, 446) for detecting air bubbles inside the extracorporeal blood circuit (see col. 26, lines 53-57; col. 26, lines 21-24);
a pump (242 in Figure 6) for conveying dialysis liquid and/or dialysate (see col. 18, lines 30-36);
a vibration device for causing the extracorporeal blood circuit, a section thereof, or contents thereof to vibrate (see col. 42, lines 19-29: “To shear any remaining bubbles from the fibers of the dialyzer 404, pressure surges (or spikes) are induced in the arterial line 432. This is accomplished by opening and closing in rapid sucession the clamps 490 (venous clamp) and 444 (arterial clamp) and varying the flow direction of the blood pump 458”); and
a control device or closed-loop control device (612) for controlling the blood pump, the pump for conveying dialysis liquid and/or dialysate, and the vibration device (see Figure 16; col. 35, lines 5-11).
Regarding claim 19, Peter teaches that the vibration device (see Figure 13; col. 42, lines 19-29: the clamps 490 (venous clamp) and 444 (arterial clamp) and the blood pump 458 in arterial line 432).
Regarding claim 20, Peter teaches that the vibration device is a venous tubing clamp (490) (see Figure 13; col. 42, lines 19-29); and the control device or closed-loop control device (612) is programmed to control the venous tubing clamp to automatically open and close several times within a minute or within a second (see Figure 16; col. 35, lines 5-11).
Regarding claim 21, Peter teaches that the vibration device is a venous tubing clamp (490) (see Figure 13; col. 42, lines 19-29) which is a holding device for releasably holding at least a section of the extracorporeal blood circuit.
Regarding claim 22, Peter teaches that the control device or closed-loop control device is configured to modulate, or to prompt the modulation of, frequency of the vibrations generated by the vibration device (see Figure 16; col. 35, lines 5-11; col. 42, lines 19-29).
Regarding claim 23, Peter teaches that the blood treatment apparatus is connected to the extracorporeal blood circuit (400) and a blood filter e.g. dialyzer (404) having the semi-permeable membrane (see Figure 13).
Regarding claim 24, Peter teaches that the extracorporeal blood circuit (404) comprises a blood tubing set and/or a blood cassette (see Figure 13).
Regarding claim 25, Peter teaches that the blood treatment apparatus is a hemodialysis apparatus, hemofiltration apparatus, hemodiafiltration apparatus, or as an apparatus for carrying out a separation procedure (see Figure 13).
Regarding claim 26, Peter teaches a method configured to be carried out on a blood treatment apparatus, the method comprising:
detecting air bubbles (via 446, 486) in an extracorporeal blood circuit (404) connected to the blood treatment apparatus (during priming mode); and
in response:
stopping a blood pump of the blood treatment apparatus or reducing a conveying rate of the blood pump (see col. 26, lines 47-50);
generating a negative transmembrane pressure across a semi-permeable membrane of the blood treatment apparatus by appropriately controlling a pump (242 in Figure 6) for conveying dialysis liquid and/or dialysate (see col. 18, lines 30-36), while a blood pump of the blood treatment apparatus is stopped or the conveying rate of the blood pump is reduced (see col. 26, lines 47-50); or reversing a conveying direction of the blood pump (see col. 26, lines 50-53),
wherein:
the blood pump (458) of the blood treatment apparatus is configured for pumping blood through the extracorporeal blood circuit (400) during a blood treatment session, during which the blood treatment apparatus is connected to the extracorporeal blood circuit and to a blood filter e.g. dialyzer (404) comprising a semi-permeable membrane (see col. 25, line 61 – col. 26, line 31);
an air bubble detector (486, 446) for detecting air bubbles inside the extracorporeal blood circuit (see col. 26, lines 53-57; col. 26, lines 21-24);
the pump (242 in Figure 6) for conveying dialysis liquid and/or dialysate (see col. 18, lines 30-36);
a vibration device for causing the extracorporeal blood circuit, a section thereof, or contents thereof to vibrate (see col. 42, lines 19-29: “To shear any remaining bubbles from the fibers of the dialyzer 404, pressure surges (or spikes) are induced in the arterial line 432. This is accomplished by opening and closing in rapid sucession the clamps 490 (venous clamp) and 444 (arterial clamp) and varying the flow direction of the blood pump 458”); and
a control device or closed-loop control device (612) for controlling the blood pump, the pump for conveying dialysis liquid and/or dialysate, and the vibration device (see Figure 16; col. 35, lines 5-11).
Regarding claim 27, Peter teaches that the negative transmembrane pressure is generated across the semi-permeable membrane when a venous tubing clamp of the blood treatment apparatus is completely or partially closed (see col. 26, lines 51-53). Peter teaches in col. 26, lines 43-50 that “Because the fluid in the chamber 474 is normally under positive pressure during dialysis, the level may be raised (when identified as being too low by the level sensor 478) by opening valve 777 until the level is raised to the level sensor 476. The level may be lowered by stopping the occlusive blood pump 458, opening valve 777, and operating UF (ultrafiltration/dialysis) pump 242 (Figure 6) until the level is lowered and sensed by sensor 478” – negative transmembrane pressure is created by UF pump to lower the blood level).
Regarding claim 28, Peter teaches implicitly that opening a venous tubing clamp of the blood treatment apparatus when the negative transmembrane pressure has already been generated while maintaining a negative transmembrane pressure to return to dialysis mode (see col. 26, lines 47-50).
Regarding claim 29, Peter teaches implicitly that the venous tubing clamp is opened if a pressure sensor of the blood treatment apparatus has determined that a minimum value of a negative transmembrane pressure has been reached to return to dialysis mode (see col. 26, lines 47-50).
Regarding claim 30, Peter teaches that the negative transmembrane pressure is reached by using the pump (242) for conveying dialysis liquid and/or dialysate while a substitute fluid pump of the blood treatment apparatus is stopped or is not conveying (see col. 26, lines 47-50).
Regarding claim 31, Peter teaches that generating the negative transmembrane pressure is terminated as soon as a predetermined negative transmembrane pressure is reached or a volume of at least 30 to 60 ml or more blood has been conveyed in a direction of an arterial connection needle or a venous air separation chamber by or due to the transmembrane pressure to return to dialysis mode (see col. 26, lines 47-50).
Regarding claim 33, Peter teaches implicitly that generating a negative transmembrane pressure is terminated after the air bubble detector no longer detects air bubbles or air pockets, and/or no air bubble alarm is present to return to dialysis mode (see col. 26, lines 47-50).
Regarding claim 34, Peter teaches implicitly that at least one of detecting the air bubbles, stopping the blood pump, generating the negative transmembrane pressure, and reversing the conveying direction is overlapping in time (see col. 26, lines 46-57).
Regarding claim 35, Peter teaches that the pump for conveying dialysis liquid and/or dialysate is an ultrafiltration pump (242)(see col. 18, lines 30-36);
.
Claim Rejections - 35 USC § 103
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.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Peter.
Peter teaches the method of claim 25 configured to be carried out on a blood treatment apparatus as described above.
Claim 32 differs from Peter in reciting the predetermined negative transmembrane pressure is between −300 mmHg and −500 mmHg.
Peter teaches creating negative transmembrane pressure by ultrafiltration pump (see col. 26, lines 51-53).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize negative transmembrane pressure between −300 mmHg and −500 mmHg to remove air bubbles, since it has been held that where the general conditions of a 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 233.
Conclusion
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/John Kim/Primary Examiner, Art Unit 1772
JK
7/23/26
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