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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 34-59, in the reply filed on 07 October 2025 is acknowledged. The traversal is on the ground(s) that there is no undue searching. This is not found persuasive because the current application lacks unity of invention. This is standard for Applications that enter the national stage as a 371 which is different from US convention standards. Under unity of invention, the standard does not rely on arguing undue search burden which is required for US convention. In this case, groups I-III lack unity of invention a posteriori due to the feature blood circuit and pump listed in all the groups not making a contribution over Ware.
The requirement is still deemed proper and is therefore made FINAL.
Claims 34-59 are examined on the merits.
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.
Claim(s) 34-36, 38-43, 45, 49-58 are rejected under 35 U.S.C. 103 as being unpatentable over Paolini (US 2011/0118647) in view of Pouchoulin (US 2015/0060362).
Regarding claim 34, Paolini discloses an apparatus for extracorporeal blood treatment for chronic therapy, the apparatus comprising:
a filtration unit (2, figure 1) having a primary chamber (3) and a secondary chamber (4) separated by a semi- permeable membrane (5, [0015]);
a blood circuit (8 and 9, figure 1) coupled to the filtration unit and comprising a blood withdrawal line (8) connected to an inlet of the primary chamber, a blood return line (9) connected to an outlet of the primary chamber (figure 1), said blood withdrawal line and blood return line being configured for connection to a patient cardiovascular system ([0015]);
a blood pump ([0015], blood transport pump) configured to be coupled to a pump section of the blood circuit ([0015], sections of 8 and 9 can comprise the pump);
a dialysis circuit (11 and 15, [0017]) comprising a dialysis supply line (15, [0017]) for a fresh dialysis fluid (16) connected to an inlet of the secondary chamber and a dialysis effluent line ([0016]) for a spent dialysis fluid connected to an outlet of the secondary chamber;
a preparation device ([0017]) for preparing the fresh dialysis fluid, wherein the preparation device is connected to the dialysis supply line and comprises a regulating device (sensors and system used to prepare fluid [0017]) for regulating the composition of the fresh dialysis fluid;
a nutritional bag ([0017]) containing a nutritional solution ([0017], infusion fluid patch source);
a nutritional line (18) having a first end in fluid communication with the nutritional bag and a second end for infusing the nutritional solution into either the blood return line or directly into the patient vascular system ([0019]);
an ultrafiltration device (13) configured to achieve a fluid removal from the patient through the semi-permeable membrane;
at least one sensor (14, [0016])configured to provide a second signal related to an ultrafiltration rate; and
a control unit (20) connected to the ultrafiltration device, and to the at least one sensor, the control unit programmed for:
receiving a patient prescription including at least one of
a total patient weight loss to be achieved at the end of the blood treatment and a total treatment time ([0021]-[0022]), and
a desired net ultrafiltration rate ([0021-0022]),
collecting from the at least one sensor the second signal and determining a second parameter related to the ultrafiltration rate ([0021-0022]), and
controlling the ultrafiltration device to achieve the patient prescription based on the first parameter and on the second parameter ([0021-0022]).
Paolini does not disclose at least one sensing element configured to provide a first signal related to an actual flow rate in the nutritional line.
Pouchoulin teaches at least one sensing element (34, 37, 35, 36, [0080], figure 2) configured to provide a first signal related to an actual flow rate in the nutritional line ([0080], weight related to flow); the device when combined would naturally have the control unit (10, [0065]) that connects to all elements of the device.
Pouchoulin provides a sensor in order to monitor further elements of the treatment ([0080]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini by further incorporating a sensor in order to monitor further elements of the extracorporeal circuit.
Regarding claim 35, Paolini does not disclose wherein the at least one sensing element is a weighing device configured to provide a weight of the nutritional bag, wherein the control unit is configured to receive a weight signal from the weighing device and to determine the first parameter based on the weight variation over time of the nutritional bag, the first parameter being the actual flow rate in the nutritional line.
Pouchoulin further teaches wherein the at least one sensing element is a weighing device configured to provide a weight of the nutritional bag, wherein the control unit is configured to receive a weight signal from the weighing device and to determine the first parameter based on the weight variation over time of the nutritional bag, the first parameter being the actual flow rate in the nutritional line ([0080]).
Pouchoulin provides a sensor in order to monitor further elements of the treatment ([0080]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini by further incorporating a sensor in order to monitor further elements of the extracorporeal circuit.
Regarding claim 36, Paolini does not disclose wherein the control unit is programmed for calculating and/or storing data related to the nutritional solution administered during the extracorporeal blood treatment, said data comprising at least one of: the weight of the nutritional bag, a feeding rate of the nutritional solution through the nutritional line, an amount of nutritional solution administered at an instant of time, a total amount of the nutritional solution to be administered, or a composition of the nutritional solution.
Pouchoulin teaches wherein the control unit is programmed for calculating and/or storing data related to the nutritional solution administered during the extracorporeal blood treatment, said data comprising at least one of: the weight of the nutritional bag, a feeding rate of the nutritional solution through the nutritional line, an amount of nutritional solution administered at an instant of time, a total amount of the nutritional solution to be administered, or a composition of the nutritional solution ([0080]).
Pouchoulin provides a sensor in order to monitor further elements of the treatment ([0080]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini by further incorporating a sensor in order to monitor further elements of the extracorporeal circuit.
Regarding claim 38, Paolini does not specifically disclose wherein a feeding rate of the nutritional solution during blood treatment is between 50 ml/h and 500 ml/h.
Paolini discloses [0004] that infusion velocity is important to the calculations of desired patient treatment. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Paolini device to have desired velocity of the infusion, as it involves only adjusting rate in which the fluid moves. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Paolini by making the flow rate between 50 ml/h and 500 ml/h as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 39, Paolini discloses an infusion pump (19, [0019) coupled to the nutritional line to deliver a feeding rate of the nutritional solution through the nutritional line, wherein the control unit is connected to the infusion pump and is programmed for controlling the infusion pump and for changing the feeding rate of the nutritional solution ([0019-0020]).
Regarding claim 40, Paolini discloses wherein the second parameter includes the ultrafiltration rate ([0021-0022]) but does not disclose wherein the first parameter includes the weight of the nutritional bag at an instant of time.
Pouchoulin further teaches the first parameter includes the weight of the nutritional bag at an instant of time ([0080]).
Pouchoulin provides a sensor in order to monitor further elements of the treatment ([0080]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini by further incorporating a sensor in order to monitor further elements of the extracorporeal circuit.
Regarding claim 41, Paolini does not disclose wherein a net ultrafiltration rate is calculated by calculating a feeding rate of the nutritional solution from the weight of the nutritional bag and by subtracting the feeding rate from the ultrafiltration rate, and wherein the ultrafiltration device is controlled so that the net ultrafiltration rate matches the desired net ultrafiltration rate ([0080], [0019], [0094]).
Pouchoulin provides a sensor in order to monitor further elements of the treatment ([0080]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini by further incorporating a sensor in order to monitor further elements of the extracorporeal circuit.
Regarding claim 42, while Paolini and Pouchoulin does not disclose exactly a formula wherein a patient weight loss at an instant of time is calculated by integrating the ultrafiltration rate at that instant of time and by subtracting the weight of the nutritional bag at that instant of time from the integrated flow rate, and wherein the ultrafiltration device is controlled so that the patient weight loss at the end of the blood treatment matches the total patient weight loss, the limitation above is a functional limitation in which the device of Paolini and Pouchoulin is capable of performing as the steps in an apparatus claim as both include a controller in which the weight loss is being calculated.
Regarding claim 43, Paolini discloses wherein the at least one sensor comprises a flowmeter placed on at least one of the dialysis supply line and the dialysis effluent line, and wherein the second signal is a signal from said flowmeter ([0016]).
Regarding claim 45, Paolini comprising a display screen connected to the control unit, wherein the control unit is programmed for displaying on said display screen the data related to the nutritional solution ([0023], user interface).
Regarding claim 49, Paolini discloses wherein the patient prescription includes at least one of: (i) a total patient weight loss to be achieved at the end of the blood treatment and a total treatment time, (ii) an ultrafiltration rate and a total treatment time, (iii) a total patient weight loss to be achieved at the end of the blood treatment and an ultrafiltration rate, and (iv) a desired net ultrafiltration rate and a nutritional flow rate, or a nutritional total weight to be infused during the treatment, together with a total treatment time or together with a total patient weight loss ([0021-0022]).
Regarding claim 50, Paolini discloses wherein the sensor for providing the second signal related to an ultrafiltration rate senses one or more of: a difference between an amount or a flow rate of fresh dialysis fluid prepared by the preparation device and entering into the filtration unit and a spent dialysis fluid exiting the filtration unit; a difference between an amount or a flow rate of fresh dialysis fluid prepared by the preparation device and infused into the blood circuit and a spent dialysis fluid exiting the filtration unit; and a difference between an amount or a flow rate of fresh dialysis fluid prepared by the preparation device and entering both into the filtration unit and into the blood circuit and a spent dialysis fluid exiting the filtration unit ([0016], [0019]).
Regarding claim 51, Paolini discloses wherein the sensor for providing the second signal related to an ultrafiltration rate takes into account a net amount/flow rate of the fresh dialysis fluid prepared by the preparation device, irrespective of the fresh dialysis fluid being fed to the filtration unit, removed from the filtration unit and infused into the blood circuit ([0016], [0019]).
Regarding claim 52, Paolini discloses wherein the apparatus comprises an infusion line (18) branching from the dialysis supply line to infuse fresh dialysis fluid into the blood circuit (figure 1), the sensor configured to provide a second signal related to an ultrafiltration rate being operative at least upstream (14 is upstream) a branch of the infusion line to take into account for the fresh dialysis fluid fed either or both to the filtration unit through the dialysis supply line or/and the blood circuit through the infusion line.
Regarding claim 53, Paolini discloses wherein the at least one sensor comprises either: a flowmeter placed on the dialysis supply line and another flowmeter placed on the dialysis effluent line, the control unit configured to receive the signals from the two flowmeters to determine a differential flow between dialysis fluid supplied to the supply line and removed with the dialysis effluent line; or a differential flowmeter placed on the dialysis supply line and the dialysis effluent line to sense a differential flow between the dialysis supply line and the dialysis effluent line ([0016]).
Regarding claim 54, Paolini discloses balance chambers ([0016]) operatively coupled to the dialysis circuit to precisely balance fresh dialysis fluid prepared by the preparation device with spent dialysis fluid exiting the filtration unit; and an ultrafiltration line (line in combination with 11) and pump to remove spent dialysis fluid from upstream of the balance chamber in the dialysis effluent line, the at least one sensor sensing the amount of spent dialysis fluid removed by the ultrafiltration pump (14, [0016]), wherein the second parameter is a flow rate in the ultrafiltration line or a liquid volume removed through the ultrafiltration line ([0016]).
Regarding claim 55, Paolini discloses wherein the ultrafiltration device comprises a first dialysis pump (17) coupled to the dialysis supply line and a second dialysis pump (13) coupled to the dialysis effluent line.
Regarding claim 56, Paolini discloses wherein a first balance chamber (12) operates on the dialysis supply line and a second balance chamber (16) operates on the dialysis effluent line.
Regarding claim 57, Paolini discloses receiving, as prescription input:
a desired nutritional feeding rate target or a total amount of the nutritional solution administered at the end of the treatment time ([0021-0022]), and
the total patient weight loss and the total treatment time or the desired net ultrafiltration rate ([0022-0023]),
commanding the infusion pump to deliver the nutritional solution according to the nutritional feeding rate target ([0029]), and
commanding the ultrafiltration device to achieve the total patient weight loss or the desired net ultrafiltration rate ([0029-0030], [0043]).
Paolini does not disclose receiving a desired blood flow rate,
commanding the blood pump to pump blood according to the desired blood flow rate or to reach the total amount of the nutritional solution administered at the end of the total treatment time.
Pouchoulin teaches receiving a desired blood flow rate ([00168]),
commanding the blood pump to pump blood according to the desired blood flow rate or to reach the total amount of the nutritional solution administered at the end of the total treatment time ([0168]).
Pouchoulin senses the blood rate and sets it in order to further control the stages of therapy ([0168]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini with the controls of Pouchoulin in order to provide more control over therapy.
Regarding claim 58, Paolini discloses wherein the control unit is programmed to receive, as a prescription input, a total amount of the nutritional solution to be administered within the end of the total treatment time, to determine a nutritional feeding rate target to deliver the total amount of the nutritional solution at the latest at an end of the total treatment time and to command the infusion pump to deliver the nutritional solution according to the nutritional feeding rate target ([0021-0023]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Paolini (US 2011/0118647) in view of Pouchoulin (US 2015/0060362) further in view of Bartholomew (US 7836920).
Regarding claim 37, Paolini and Pouchoulin do not disclose the nutritional solution contained in said nutritional bag, said nutritional solution comprising a mixture of protein, carbohydrate, and fat.
Bartholomew discloses useful solutions to infuse into the body realtively pertinent to Paolini’s infusion fluid. Bartholomew teaches a nutritional solution contained in said nutritional bag, said nutritional solution comprising a mixture of protein, carbohydrate, and fat (col 3, lines 53-67).
Bartholomew provides this common basic mixture into the body of the patient to help with nutritional needs (col 3, lines 53-57). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini with the mixture of Bartholomew in order to help the patient recover since Paolini only provides infusion liquid but does not state the contents.
Claim(s) 44 is rejected under 35 U.S.C. 103 as being unpatentable over Paolini (US 2011/0118647) in view of Pouchoulin (US 2015/0060362) further in view of Lo (US 2011/0303598).
Regarding claim 44, Paolini discloses wherein the nutritional line (18) comprises a pump segment (19), a feeding tube segment (segment that would connect to pump 19) connected to an inlet of the pump segment (inlet of pump), a delivery tube segment (segment leading out of the pump) connected to an outlet of the pump segment (outlet of the pump) but does not disclose one rigid portion comprising two pump connectors for receiving opposite ends of the pump segment, a delivery tube segment connector for receiving one end of the delivery tube segment, and a feeding tube segment connector for receiving one end of the feeding tube segment, wherein the feeding tube segment and/or the delivery tube segment includes a respective removable connector, the removable connector of the delivery tube segment configured to be connected to a corresponding counter connector on the blood return line.
Lo discloses a hemodialysis system with a pump (100b) with one rigid portion (pump ridged due to material used for outer shell) comprising two pump connectors for receiving opposite ends of the pump segment (connectors 106, figure 9A), a delivery tube segment connector for receiving one end of the delivery tube segment (the opposed connector that would connect to the end 104), and a feeding tube segment connector (the opposed connector that would connect to the end 104) for receiving one end of the feeding tube segment, wherein the feeding tube segment and/or the delivery tube segment includes a respective removable connector (connector would be removable as shown in figure 9A where the connector is off), when device would be connected to the system of Paolini as combined, the removable connector of the delivery tube segment configured to be connected to a corresponding counter connector on the blood return line.
Lo provides connectors on the ports to allow the device to connect to other elements ([0115]). Paolini and Pouchoulin both include a pump but does not provide a pump structure, the Lo device would naturally be able to perform the intended operation of the prior art device. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Paolini with the connectors of Lo in order to allow the device to apply vacuum through the pump.
Claim(s) 46-48, 59 are rejected under 35 U.S.C. 103 as being unpatentable over Paolini (US 2011/0118647) in view of Pouchoulin (US 2015/0060362) further in view of Ware (US 2005/0085760).
Regarding claim 46,Paolini and Pouchoulin do not disclose wherein the control unit is contained in or supported by the main body, wherein the infusion pump and the blood pump are supported by the main body, wherein the blood circuit and the filtration unit are disposable and are coupled in removable manner to the main body and to the blood pump, wherein the nutritional line is disposable and is coupled in removable manner to the main body and to the infusion pump, and wherein the dialysis circuit is non-disposable and is integrated in the main body.
Ware discloses a MFT machine and teaches wherein the extracorporeal blood treatment apparatus includes a main body (20), and wherein the infusion pump and the blood pump are supported by the main body (figure 1), wherein the blood circuit and the filtration unit are disposable and are coupled in removable manner to the main body and to the blood pump (blood lines are generally disposed to prevent contamination), wherein the nutritional line is disposable (lines are disposed to prevent contamination) and is coupled in removable manner to the main body and to the infusion pump, and wherein the dialysis circuit is non-disposable and is integrated in the main body. Ware provides a singular unit for integral movement and easy transport ([0038-0040]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with the singular housing of Ware in order to provide easy transport of the device. Further, it has been held that making a one piece construction would be merely a matter of obvious engineering choice.
Regarding claim 47, Paolini does not disclose wherein the infusion pump and the blood pump are peristaltic pumps.
Pouchoulin discloses the pumps can be peristaltic pump ([0168]).
Pouchoulin provides the peristaltic pump to move fluid ([0168]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the device of Paolini by using a peristaltic pump of Pouchoulin since a peristaltic pump is suitable blood pump that can perform the function as stated in Paolini.
Regarding claim 48, Paolini discloses wherein the ultrafiltration device comprises at least one dialysis pump (13) coupled to the dialysis supply line and/or to the dialysis effluent line, and wherein said at least one dialysis pump is mounted on the main body. Further, it has been held that making a one piece construction would be merely a matter of obvious engineering choice. In this case, it would have been obvious to mount the pump on the main body.
Regarding claim 59, Paolini does not disclose wherein the extracorporeal blood treatment apparatus includes a main body, and wherein the infusion pump is attached to the main body and is placed on a front panel of the main body.
Ware discloses a MFT machine and teaches wherein the extracorporeal blood treatment apparatus includes a main body (20), and wherein the infusion pump is attached to the main body and is placed on a front panel of the main body (pumps in front of the body).
Ware provides a singular unit for integral movement and easy transport ([0038-0040]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with the singular housing of Ware in order to provide easy transport of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/Primary Examiner, Art Unit 3781