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 .
Status of Claims
Claims 1-24 are currently pending. Claims 1, 13, 19, and 24 are currently amended. No new subject matter is added.
Response to Arguments
Applicant’s arguments, see pg. 1, filed 04/20/2026, with respect to claims 1, 13, 19, and 24 have been fully considered and are persuasive. The 112(b) rejection of Claims 1, 13, 19, and 24 has been withdrawn.
The applicant has not addressed the claim objection of Claim 20. Therefore, the claim objection of Claim 20 will remain.
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
Specifically Applicant argues in Claims 1, 13, 19, and 24 that the newly amended limitations would overcome the 112(a) written description requirement.
The examiner respectfully disagrees that the amended limitation would overcome the written description as previously discussed. It is still not clear how the system is configured to detect cannula blockage by monitoring the first sensor signal or the second signal, nor that the system is configured to automatically unblock a blocked cannula. The scope of the independent claims covers wherein the signal to control element to reduce the blood flow is issued in response to a high pressure signal or a high flow signal. There is no support in the description and drawings. Therefore, there is still no written description for the limitations.
Specifically Applicant argues in Claims 1, 13, 19, and 24 that the newly amended limitations of “a first sensor position along the venous blood pathway upstream of a first control element” and “a second sensor positioned along the venous blood pathway upstream of the first control element” would overcome the prior rejection.
The examiner respectfully disagrees that the newly amended limitations would be overcome the prior art. As discussed below, Claims 1, 13, 19, and 24 are newly rejected to rearrange the position of control element to be located downstream of the first sensor. The particular placement of the control element would be obvious matter of design choice to one skilled in the art and would not have modified the operation of the device (configured to reduce the blood flow within the venous blood pathway in response to receiving the second signal). Therefore, Claims 1, 13, 19, and 24 would still remain rejected in view of Du et al. (CN 116474192 A).
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites “a region of the venous blood pathway” in line 3 should be “the region of the venous blood pathway”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 13, 19, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 13, 19, and 24 recites the limitations “receive a sensor signal from the first sensor and automatically transmit a control signal to the first control element to reduce the blood flow within the venous blood pathway”. There is not sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time the application was filed. It is not defined in which situation the control unit is configured to transmit the control signal to the first control element. For example, it is not clear that the system is configured to detect cannula blockage by monitoring the first sensor signal, nor that the system is configured to automatically unblock a blocked cannula. The scope of the independent claims covers wherein the signal to control element to reduce the blood flow is issued in response to a high pressure signal or a high flow signal. There is no support in the description and drawings. Therefore, there is no written description for the limitations. Claims 2-12 are rejected for depending on claim 1. Claims 14-18 is rejected for depending on claim 13. Claims 20-23 is rejected for depending on claim 19.
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.
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.
Claims 1-5, 8-9, 12-15, 17, 19-20, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Du et al. (CN 116474192 A, as mapped by translated copy attached), hereinafter referred to as “Du”.
Regarding Claim 1, Du teaches An extracorporeal blood treatment system (an extracorporeal circulation device, see Abstract), comprising:
a cannula (drainage cannula, see pg. 4 ln 14) configured to be positioned within a venous blood pathway extending between the patient and a reservoir (the extracorporeal blood circuit is an "Extracorporeal Membrane Oxygenation (ECMO)" blood circuit wherein blood is directly drained with a pump 12 from the heart via a drainage cannula positioned in the atrium or the vena cava, see pg. 2 ln 6-12; it implying a presence of a venous reservoir), wherein the cannula includes a distal end region (side hole of drainage cannula, see pg. 4 paragraph 15-16) and a lumen extending therein (through which the blood enters the lumen of the cannula);
a first sensor (flow rate detection device 13) positioned along the venous blood pathway (position on the drainage cannula in the venous pathway); a first control element (reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph);
a second sensor positioned along the venous blood pathway upstream of the first control element (pressure detecting device 11 position upstream of the flow rate detection device 13);
a control unit (host computer 14) in communication with the first sensor (see Figure 1);
wherein the first sensor is configured to sense a first sensor parameter of blood passing through the venous blood pathway (blood flow rate via device 13);
wherein the first sensor is configured to automatically transmit a first signal corresponding to the first sensor parameter to the control unit (the flow rate detecting device 13 is used for monitoring the blood flow in the connecting pipe of the extracorporeal circulation device 10 in real time, and sending the blood flow to the main machine 14, see pg. 4 second to last paragraph);
wherein the control unit (14) is configured to receive the first signal and transmit a second signal to the first control element (the host 14 is used for automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph);
wherein the first control element is configured to receive the second signal from the control unit (host 14 will adjust the rotational speed of the power pump 12, see pg. 4 second to last paragraph);
wherein the first control element is configured to reduce the blood flow within the venous blood pathway in response to receiving the second signal (reducing an initial speed of the power pump 12, see pg. 3 ln 25-27), and wherein reducing the blood flow substantially equalizes a blood pressure within the lumen of the distal end region of the cannula and the blood pressure of a region of the venous blood pathway adjacent to the distal end region of the cannula (reduce the rotating speed to reduce the negative pressure so as to relieve the wall sticking condition, see pg. 4 paragraph 21-22).
However, Du does not explicitly disclose the a first sensor upstream of a first control element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the first control element to be located downstream of the first sensor, since the claims to an aperture which read on the prior art expect with regard to the position of the control element would not have modified the operation of the device (configured to reduce the blood flow within the venous blood pathway in response to receiving the second signal). The particular placement of the control element would be obvious matter of design choice to one skilled in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Regarding Claim 2, Du further teaches wherein the first sensor is a blood flow sensor (blood flow rate sensor 13).
Regarding Claim 3, Du teaches all of the limitations as described in claim 2 and Du further teaches wherein the first sensor parameter is a flowrate of blood passing through the venous blood pathway (the flow rate detecting device is used for monitoring the blood flow rate in the connecting pipe of the extracorporeal circulation device in real time see pg. 3 ln 22-24).
Regarding Claim 4, Du further teaches wherein the second sensor is a blood pressure sensor (pressure sensor 11).
Regarding Claim 5, Du teaches all of the limitations as discussed above in Claim 1 and Du further teaches the first sensor parameter is a blood flow rate passing through the venous blood pathway. However, Du does not explicitly disclose wherein the first sensor parameter is a pressure of blood passing through the venous blood pathway, the reservoir or both the venous blood pathway and the reservoir.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the first flow rate sensor of Du for a first pressure sensor since this would have been "a simple substitution of one known element (blood flow sensor) for another (blood pressure) to obtain predictable results (sensor measuring a parameter in the blood)".
Regarding Claim 8, Du further teaches wherein the first control element includes a pump (power pump 12), and wherein the pump is configured to adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit (the host 14 is used for automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph).
Regarding Claim 9, Du teaches all of the limitations as described in claim 8 and Du further teaches wherein the control unit is configured to automatically decrease a speed of the pump in response to receiving the first signal from the first sensor (the host 14 is used for automatically reducing the initial rotating speed of the power pump 12 based on the input end pressure measured by sensor 11, see pg. 4 second to last paragraph).
Regarding Claim 12, Du further teaches wherein equalizing the blood pressure within the lumen of the distal end region of the cannula and the blood pressure of a region of the venous blood pathway adjacent to the distal end region of the cannula restores blood flow within the lumen of the cannula (determining the occurrence of wall sticking condition. The host 14 will adjust the rotational speed of the power pump 12 in time and turn it down, so as to separate the cannula from the wall of the body cavity, reduce the negative pressure in the connecting tube and increase the blood flow, see pg. 5 paragraph 2).
Regarding Claim 13, Du teaches an extracorporeal blood treatment system (an extracorporeal circulation device, see Abstract), comprising:
a cannula (drainage cannula, see pg. 4 ln 14) configured to be positioned within a venous blood pathway extending between the patient and a reservoir (the extracorporeal blood circuit is an "Extracorporeal Membrane Oxygenation (ECMO)" blood circuit wherein blood is directly drained with a pump 12 from the heart via a drainage cannula positioned in the atrium or the vena cava, see pg. 2 ln 6-12; it implying a presence of a venous reservoir), wherein the cannula includes a distal end region (side hole of drainage cannula, see pg. 4 paragraph 15-16) and a lumen extending therein (through which the blood enters the lumen of the cannula);
a first sensor positioned along the venous blood pathway (blood flow rate via device 13); a control unit (reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph);
a second sensor positioned along the venous blood pathway (blood pressure via sensor 11) upstream of the control unit (pressure detecting device 11 position upstream of the flow rate detection device 13, see Figure 1);
the control unit (host computer 14) in communication with the first sensor and the second sensor (see Figures 1-2);
wherein the first sensor is configured to sense a first sensor parameter of blood passing through the venous blood pathway (the flow rate detecting device 13 is used for monitoring the blood flow in the connecting pipe of the extracorporeal circulation device 10 in real time, see pg. 4 second to last paragraph);
wherein the second sensor is configured to sense a second sensor parameter of blood passing through the venous blood pathway (the pressure detecting device 11 is used for monitoring the input end pressure of the power pump 12 in real time, see pg. 4 second to last paragraph);
wherein the first sensor is configured to transmit a first signal corresponding to the first sensor parameter to the control unit (the flow rate detecting device 13 is used for sending the blood flow to the main machine 14, see pg. 4 second to last paragraph);
wherein the second sensor is configured to transmit a second signal corresponding to the second sensor parameter to the control unit (the pressure detecting device 11 is used for sending the input end pressure to the main machine 14, see pg. 4 second to last paragraph);
wherein the control unit is configured to receive the first signal and transmit a third signal to a first control element (the host 14 is used for determining the occurrence of the wall sticking condition when the input end pressure and blood flow meet the preset condition, and automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph; the third signal being when the blood flow meet a preset condition);
wherein the control unit is configured to receive the second signal and transmit a fourth signal to the first control element (the host 14 is used for determining the occurrence of the wall sticking condition when the input end pressure and blood flow meet the preset condition, and automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph; the fourth signal being when the input end pressure meets the preset condition);
wherein the first control element is configured to receive the third signal and the fourth signal from the control unit (automatically reducing the initial rotating speed of the power pump 12 based on the occurrence of the wall sticking condition, see pg. 4 second to last paragraph; );
wherein the first control element is configured to reduce the blood flow within the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the host 14 is used for determining the occurrence of the wall sticking condition when the input end pressure and blood flow meet the preset condition, and automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph), and wherein reducing the blood flow substantially equalizes a blood pressure within the lumen of the distal end region of the cannula and the blood pressure of a region of the venous blood pathway adjacent to the distal end region of the cannula (reduce the rotating speed to reduce the negative pressure so as to relieve the wall sticking condition, see pg. 4 paragraph 21-22).
However, Du does not explicitly disclose the a first sensor upstream of a first control element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the first control element to be located downstream of the first sensor, since the claims to an aperture which read on the prior art expect with regard to the position of the control element would not have modified the operation of the device (configured to reduce the blood flow within the venous blood pathway in response to receiving the second signal). The particular placement of the control element would be obvious matter of design choice to one skilled in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Regarding Claim 14, Du further teaches wherein the first sensor is a blood flow sensor (blood flow rate via device 13) and the second sensor is a blood pressure sensor (blood pressure sensor 11).
Regarding Claim 15, Du teaches all of the limitations as described in claim 14 and Du further teaches wherein the first sensor parameter is a flowrate of blood passing through the venous blood pathway (the flow rate detecting device is used for monitoring the blood flow rate in the connecting pipe of the extracorporeal circulation device in real time see pg. 3 ln 22-24) and the second sensor parameter is a pressure of blood passing through the venous blood pathway (the pressure between the cannula and the power pump 12 monitored by the pressure detecting device 11 can quickly determine the pressure at the current connecting pipe, see Col. 5 paragraph 2).
Regarding Claim 17, Du further teaches wherein the first control element includes a pump (power pump 12), and wherein the pump is configured to automatically change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the host 14 is used for automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph).
Regarding Claim 19, Du teaches an extracorporeal blood treatment system (an extracorporeal circulation device, see Abstract), comprising:
a first control element (power pump 12) coupled to a venous blood pathway extending between a patient and a reservoir (the extracorporeal blood circuit is an "Extracorporeal Membrane Oxygenation (ECMO)" blood circuit wherein blood is directly drained with a pump 12 from the heart via a drainage cannula positioned in the atrium or the vena cava, see pg. 2 ln 6-12; it implying a presence of a venous reservoir);
a blood flowrate sensor positioned along the venous blood pathway (flow rate detection device 13 position on the extracorporeal circuit, see Figure 1);
a blood pressure sensor positioned along the venous blood pathway (blood pressure sensor 11 position on the extracorporeal circuit, see Figure 1) upstream of the control element (upstream of power pump 12, see Figure 1); and
a control unit in communication with the blood flowrate sensor, the blood pressure sensor, and the first control element (host computer 14, see Figure 1);
wherein the blood flowrate sensor is configured to automatically transmit a first signal to the control unit, wherein the first signal corresponds to a flowrate of blood in the venous blood pathway (the flow rate detecting device 13 is used for sending the blood flow to the main machine 14, see pg. 4 second to last paragraph);
wherein the blood pressure sensor is configured to automatically transmit a second signal to the control unit, wherein the second signal corresponds to a pressure of blood in the venous blood pathway (the pressure detecting device 11 is used for sending the input end pressure to the main machine 14, see pg. 4 second to last paragraph);
wherein the control unit is configured to automatically receive the first signal and the second signal (the host 14 is used for determining the occurrence of the wall sticking condition when the input end pressure and blood flow meet the preset condition, see pg. 4 second to last paragraph);
wherein the control unit is configured to automatically send a third signal to the first control element in response to receiving the first signal, the second signal or both the first and the second signals (the host 14 is used for determining the occurrence of the wall sticking condition when the input end pressure and blood flow meet the preset condition, and automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph);
wherein the first control element is configured to automatically reduce the blood flow within the venous blood pathway in response to receiving the third signal (automatically reducing the initial rotating speed of the power pump 12 based on the occurrence of the wall sticking condition, see pg. 4 second to last paragraph), and wherein reducing the blood flow substantially equalizes a blood pressure within the lumen of the distal end region of a cannula configured to be positioned within the venous blood pathway and the blood pressure of a region of the venous blood pathway adjacent to the distal end region of the cannula (reduce the rotating speed to reduce the negative pressure so as to relieve the wall sticking condition, see pg. 4 paragraph 21-22).
However, Du does not explicitly disclose the blood flowrate sensor positioned along the venous blood pathway upstream of the control element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the control element to be located downstream of the blood flowrate sensor, since the claims to an aperture which read on the prior art expect with regard to the position of the control element would not have modified the operation of the device (configured to reduce the blood flow within the venous blood pathway). The particular placement of the control element would be obvious matter of design choice to one skilled in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Regarding Claim 20, Du further teaches wherein equalizing the blood pressure within the lumen of the distal end region of the cannula and the blood pressure of a region of the venous blood pathway adjacent to the distal end region of the cannula restores blood flow within the lumen of the cannula (reduce the rotating speed to reduce the negative pressure so as to relieve the wall sticking condition, see pg. 4 paragraph 21-22).
Regarding Claim 22, Du further teaches wherein the first control element includes a pump (power pump 12), and wherein the pump is configured to automatically change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the host 14 is used for automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph).
Regarding Claim 24, Du teaches an extracorporeal blood treatment system (an extracorporeal circulation device, see Abstract), comprising:
a cannula (drainage cannula, see pg. 4 ln 14) configured to be positioned within a venous blood pathway extending between the patient and a reservoir (the extracorporeal blood circuit is an "Extracorporeal Membrane Oxygenation (ECMO)" blood circuit wherein blood is directly drained with a pump 12 from the heart via a drainage cannula positioned in the atrium or the vena cava, see pg. 2 ln 6-12; it implying a presence of a venous reservoir), wherein the cannula includes a distal end region (side hole of drainage cannula, see pg. 4 paragraph 15-16) and a lumen extending therein (through which the blood enters the lumen of the cannula);
a first sensor positioned along the venous blood pathway (flow rate detection device 13);
a second sensor positioned along the venous blood pathway (pressure sensor 11); and
a control unit (host computer 14) in communication with the first sensor (see Figure 1);
wherein the first sensor is configured to sense a first sensor parameter of blood passing through the venous blood pathway (blood flow rate via device 13);
wherein the first sensor is configured to automatically transmit a first signal corresponding to the first sensor parameter to the control unit (the flow rate detecting device 13 is used for monitoring the blood flow in the connecting pipe of the extracorporeal circulation device 10 in real time, and sending the blood flow to the main machine 14, see pg. 4 second to last paragraph);
wherein the control unit is configured to receive the first signal and transmit a second signal to one or more of a clamp, a pump and a vacuum unit (the host 14 is used for automatically reducing the initial rotating speed of the power pump 12, see pg. 4 second to last paragraph);
wherein one or more of the clamp, the pump and the vacuum unit are configured to receive the second signal from the control unit (host 14 will adjust the rotational speed of the power pump 12, see pg. 4 second to last paragraph);
wherein one or more of the clamp, the pump and the vacuum unit are configured to reduce the blood flow within the venous blood pathway in response to receiving the second signal (reducing an initial speed of the power pump 12, see pg. 3 ln 25-27), and wherein reducing the blood flow substantially equalizes a blood pressure within the lumen of the distal end region of the cannula and the blood pressure of a region of the venous blood pathway adjacent to the distal end region of the cannula (reduce the rotating speed to reduce the negative pressure so as to relieve the wall sticking condition, see pg. 4 paragraph 21-22).
the second sensor are positioned upstream of the one or more of the clamp, the pump and the vacuum unit (pressure sensor 11 is positioned upstream of the pump 12, see Figure 1).
However, Du does not explicitly disclose the wherein the first sensor are positioned upstream of the one or more of the clamp, the pump and the vacuum unit.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the pump to be located downstream of the first sensor, since the claims to an aperture which read on the prior art expect with regard to the position of the pump would not have modified the operation of the device (configured to reduce the blood flow within the venous blood pathway in response to receiving the second signal). The particular placement of the control element would be obvious matter of design choice to one skilled in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Claims 6-7, 10-11, 16, 18, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Du (CN 116474192 A) in view of Penka (US 20220080094 A1).
Regarding Claim 6, Du teaches all of the limitations as discussed above in claim 1. However, Du does not explicitly disclose wherein the first control element includes a clamp, and wherein the clamp is configured to decrease the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit.
Penka teaches a blood treatment system (extracorporeal blood circulation system, see Abstract) comprising a first control element includes a clamp (restricting unit 4), and wherein the clamp is configured to decrease the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit (the control means 6 according to the invention converts the setting carried out by the user by means of the single operating element 7 into a corresponding actuation of the restricting unit 4 so as to thereby cause a reduction of the venous inflow below the gravitational amount by closing (clamping) the venous inflow tube line 2, see Paragraph [0022]).
Du and Penka are analogous art because both teach extracorporeal blood circulation system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first control element of Du and further include wherein the first control element includes a clamp, and wherein the clamp is configured to decrease the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit, as taught by Penka. Penka teaches the clamp is beneficial when supplying blood from the reservoir to the patient, care must be taken to ensure that no more blood is removed from the reservoir than is present therein or is supplied thereto. The user must therefore make sure that there is a sufficient minimum amount in the reservoir and additionally coordinate the inflow and outflow such that sufficient amounts are built up in the reservoir but are also supplied to the patient since a physiologically sufficient supply of the patient must always be ensured in an extracorporeal blood circulation system (see Paragraph [0006]).
Regarding Claim 7, Du and Penka teach all of the limitations as discussed above in claim 6 and Penka further teaches wherein the control unit (control means 6) is configured to automatically actuate the clamp in response to receiving the first signal from the first sensor (the restricting unit 4 (e.g., a clamp) is configured to be electronically controlled, modified, manipulated, and/or adjusted, such as to be automatically adjusted (e.g., by the control means 6) in response to the venous flow rate measured by the sensor 16, see Paragraph [0026]).
Regarding Claim 10, Du teaches all of the limitations as discussed above in claim 1. However, Du does not explicitly disclose wherein the first control element includes a vacuum unit, and wherein the vacuum unit is configured to adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit.
Penka teaches a blood treatment system (extracorporeal blood circulation system, see Abstract) comprising a first control element includes a vacuum unit (vacuum unit 5 can be used dynamically with restricting unit 4, see Paragraph [0029]), and wherein the vacuum unit is configured to adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit (the vacuum unit 5 is configured to be electronically controlled, modified, manipulated, and/or adjusted, such as to be automatically adjusted (e.g., by the control means 6) in response to the venous flow rate measured by the sensor 16, see Paragraph [0028]).
Du and Penka are analogous art because both teach extracorporeal blood circulation system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first control element of Du and further include wherein the first control element includes a vacuum unit, and wherein the vacuum unit is configured to adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the second signal from the control unit, as taught by Penka. Penka teaches the vacuum unit is beneficial when supplying blood from the reservoir to the patient, care must be taken to ensure that no more blood is removed from the reservoir than is present therein or is supplied thereto. The user must therefore make sure that there is a sufficient minimum amount in the reservoir and additionally coordinate the inflow and outflow such that sufficient amounts are built up in the reservoir but are also supplied to the patient since a physiologically sufficient supply of the patient must always be ensured in an extracorporeal blood circulation system (see Paragraph [0006]).
Regarding Claim 11, Du and Penka teach all of the limitations as discussed above in claim 10 and Penka further teaches wherein the control unit is configured to automatically reduce the suction of the vacuum unit in response to receiving the first signal from the first sensor (the vacuum unit 5 is configured to be electronically controlled, modified, manipulated, and/or adjusted, such as to be automatically adjusted (e.g., by the control means 6) in response to the venous flow rate measured by the sensor 16, see Paragraph [0028]).
Regarding Claim 16, Du teaches all of the limitations as discussed above in claim 13. However, Du does not explicitly disclose wherein the first control element includes a clamp, and wherein the clamp is configured to automatically adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals.
Penka teaches a blood treatment system (extracorporeal blood circulation system, see Abstract) comprising a first control element includes a clamp (restricting unit 4), and wherein the clamp is configured to automatically adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the control means 6 according to the invention converts the setting carried out by the user by means of the single operating element 7 into a corresponding actuation of the restricting unit 4 so as to thereby cause a reduction of the venous inflow below the gravitational amount by closing (clamping) the venous inflow tube line 2, see Paragraph [0022]).
Du and Penka are analogous art because both teach extracorporeal blood circulation system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first control element of Du and further include wherein the first control element includes a clamp, and wherein the clamp is configured to automatically adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals, as taught by Penka. Penka teaches the clamp is beneficial when supplying blood from the reservoir to the patient, care must be taken to ensure that no more blood is removed from the reservoir than is present therein or is supplied thereto. The user must therefore make sure that there is a sufficient minimum amount in the reservoir and additionally coordinate the inflow and outflow such that sufficient amounts are built up in the reservoir but are also supplied to the patient since a physiologically sufficient supply of the patient must always be ensured in an extracorporeal blood circulation system (see Paragraph [0006]).
Regarding Claim 18, Du teaches all of the limitations as discussed above in claim 13. However, Du does not explicitly disclose wherein the first control element includes a vacuum unit, and wherein the vacuum unit is configured to change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals.
Penka teaches a blood treatment system (extracorporeal blood circulation system, see Abstract) comprising a first control element includes a vacuum unit (vacuum unit 5 can be used dynamically with restricting unit 4, see Paragraph [0029]), and wherein the vacuum unit is configured to change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the vacuum unit 5 is configured to be electronically controlled, modified, manipulated, and/or adjusted, such as to be automatically adjusted (e.g., by the control means 6) in response to the venous flow rate measured by the sensor 16, see Paragraph [0028]).
Du and Penka are analogous art because both teach extracorporeal blood circulation system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first control element of Du and further include wherein the first control element includes a vacuum unit, and wherein the vacuum unit is configured to change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals, as taught by Penka. Penka teaches the clamp is beneficial when supplying blood from the reservoir to the patient, care must be taken to ensure that no more blood is removed from the reservoir than is present therein or is supplied thereto. The user must therefore make sure that there is a sufficient minimum amount in the reservoir and additionally coordinate the inflow and outflow such that sufficient amounts are built up in the reservoir but are also supplied to the patient since a physiologically sufficient supply of the patient must always be ensured in an extracorporeal blood circulation system (see Paragraph [0006]).
Regarding Claim 21, Du teaches all of the limitations as discussed above in claim 19. However, Du does not explicitly disclose wherein the first control element includes a clamp, and wherein the clamp is configured to automatically adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals.
Penka teaches a blood treatment system (extracorporeal blood circulation system, see Abstract) comprising a first control element includes a clamp (restricting unit 4), and wherein the clamp is configured to automatically adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the control means 6 according to the invention converts the setting carried out by the user by means of the single operating element 7 into a corresponding actuation of the restricting unit 4 so as to thereby cause a reduction of the venous inflow below the gravitational amount by closing (clamping) the venous inflow tube line 2, see Paragraph [0022]).
Du and Penka are analogous art because both teach extracorporeal blood circulation system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first control element of Du and further include wherein the first control element includes a clamp, and wherein the clamp is configured to automatically adjust the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals, as taught by Penka. Penka teaches the clamp is beneficial when supplying blood from the reservoir to the patient, care must be taken to ensure that no more blood is removed from the reservoir than is present therein or is supplied thereto. The user must therefore make sure that there is a sufficient minimum amount in the reservoir and additionally coordinate the inflow and outflow such that sufficient amounts are built up in the reservoir but are also supplied to the patient since a physiologically sufficient supply of the patient must always be ensured in an extracorporeal blood circulation system (see Paragraph [0006]).
Regarding Claim 23, Du teaches all of the limitations as discussed above in claim 19. However, Du does not explicitly disclose wherein the first control element includes a vacuum unit, and wherein the vacuum unit is configured to change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals.
Penka teaches a blood treatment system (extracorporeal blood circulation system, see Abstract) comprising a first control element includes a vacuum unit (vacuum unit 5 can be used dynamically with restricting unit 4, see Paragraph [0029]), and wherein the vacuum unit is configured to change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals (the vacuum unit 5 is configured to be electronically controlled, modified, manipulated, and/or adjusted, such as to be automatically adjusted (e.g., by the control means 6) in response to the venous flow rate measured by the sensor 16, see Paragraph [0028]).
Du and Penka are analogous art because both teach extracorporeal blood circulation system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first control element of Du and further include wherein the first control element includes a vacuum unit, and wherein the vacuum unit is configured to change the flowrate of blood flowing through the venous blood pathway in response to receiving the third signal, the fourth signal or both the third and the fourth signals, as taught by Penka. Penka teaches the clamp is beneficial when supplying blood from the reservoir to the patient, care must be taken to ensure that no more blood is removed from the reservoir than is present therein or is supplied thereto. The user must therefore make sure that there is a sufficient minimum amount in the reservoir and additionally coordinate the inflow and outflow such that sufficient amounts are built up in the reservoir but are also supplied to the patient since a physiologically sufficient supply of the patient must always be ensured in an extracorporeal blood circulation system (see Paragraph [0006]).
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.
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/ERIC RASSAVONG/ (7/29/26)Examiner, Art Unit 3781 /ANDREW J MENSH/Primary Examiner, Art Unit 3781
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