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 Objections
Claims 35 and 41 are objected to because of the following informalities:
“issue an alarm.” in the last line of the second to last paragraph should be changed to read –issue an alarm;--
“values relate, .” in the last line Should be changed to read –values relate.--
Appropriate correction is required.
Claim 41, “setting parameter values.” in the paragraph starting with “setting the extracorporeal blood treatment” should be changed to read –" setting parameter values;--
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.
Claims 20-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kloeffel (US 2012/0212455) in view of Paolini (US 2011/0118647).
Regarding claim 20, Kloeffel discloses a system comprising an extracorporeal blood treatment apparatus (circuit including 101, 107, 105, 104, 103, figure 1, [0052]) and a remote device (100a is remote) the extracorporeal blood treatment apparatus comprising:
a filtration unit (103, figure 1) having a primary chamber and a secondary chamber separated by a semi- permeable membrane ([0052], filter of blood through the semipermeable membrane and there are sides on either side of the filter);
a blood circuit (101, 104) comprising:
a blood withdrawal line (101) extending between a first end connected to an inlet of the primary chamber and a second end for connection to a patient ([0052]); and
a blood return line (104) extending between a first end connected to an outlet of the primary chamber and a second end for connection to the patient ([0052]);
a blood pump (102, [0052]) to circulate blood in the blood circuit;
an effluent line (105, [0052]) connected to an outlet of the secondary chamber;
a reader (108, [0062]) configured to read optical patterns;
a control unit ([0012]) configured to control the blood pump and connected to the reader;
wherein the remote device comprises a user interface (100a is a display UI) and a controller (user can use 109 with fingers) configured to perform a remote procedure ([0057]) comprising:
allowing entry of values for setting parameter values via the user interface, wherein the setting parameter values define a setting of the extracorporeal blood treatment apparatus and are related to an identified patient, the setting parameter values comprising part of a patient prescription for the identified patient ([0057-0058], [0060-0061]),
Koeffel discloses an individual patient card that is scanned for dialysis treatment ([0025]), which is a step of generating an optical pattern encoding the setting parameter values, the optical pattern being variable as a function of the entered setting parameter values; and
wherein the control unit of the extracorporeal blood treatment apparatus is configured to perform an acquisition procedure comprising:
acquiring the setting parameter values by reading the optical pattern through the reader ([0025]); and
setting the extracorporeal blood treatment apparatus based on the values of the setting parameter values ([0025-0026]).
Koeffel discloses setting treatment parameters such as blood flow rate and dialysis flow rate, but Koeffel fails to disclose the setting parameter values comprising at least one of:
a patient fluid removal rate for the identified patient; and
two parameters for the identified patient selected from total weight loss, total treatment time, and ultrafiltration flow rate.
Paolini discloses extracorporeal treatment and teaches the user can set parameter values relating to total weight loss, total treatment time, and ultrafiltration flow rate ([0020-0021]).
Paolini provides ways to adjust the treatment to more effectively achieve an end result ([0021]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Koeffel with the further parameter adjustments of Paolini to obtain more precise/effective and goal-oriented treatment.
Regarding claim 21-22, Paolini further teaches the total weight loss parameter is a function of both the total treatment time and the ultrafiltration flow rate ([0020-0021]), wherein the total weight loss parameter is a function of both the total treatment time and the ultrafiltration flow rate according to the following relationship: WL=UFRxTT ([0021]-[0022], [0043])
Paolini provides ways to adjust the treatment to more effectively achieve an end result ([0021]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Koeffel with the further parameter adjustments of Paolini to obtain more precise/effective and goal-oriented treatment.
Regarding claim 23, Koeffel discloses wherein the optical pattern comprises an image encoding information comprising the setting parameter values ([0025, card has a barcode for example which is an image).
Regarding claim 24, Koeffel discloses wherein the remote device comprises a portable device defining one body (body encompassed by box in figure 1 or figure 2) and physically comprising both an input device (input can be through 108, 109, or 100a) configured to allow a user to enter the setting parameter values ([0053]-[0054]), and a display (display is used [0053]-[0054]) configured to visualize the optical pattern ([0025]), wherein the controller of the remote device is configured to visualize the optical pattern on the display ([0025, [0053]-[0054], [0057]).
Regarding claim 25, Koeffel discloses wherein the setting parameter values comprise a plurality of instructions for the extracorporeal blood treatment apparatus to subsequently perform the extracorporeal blood treatment on the patient ([0025]), and wherein the setting parameter values comprise patient information including a patient identification and at least one information selected from a patient age, a patient weight, a patient haematocrit value, a patient gender, and a patient related disease ([0023]).
Regarding claim 26, Koeffel discloses wherein the setting parameter values comprise a therapy configuration including one or more information selected from:
a dialysis treatment type, comprising one of an ultrafiltration treatment, a haemodialysis treatment, a haemofiltration treatment, and a haemodiafiltration treatment ([0023]);
a disposable fluid line set type representative of the dialysis treatment type;
a dialysis filter or filter-set type representing a dialyzer type or a disposable set including the dialyzer type;
an anticoagulation setting for the extracorporeal blood treatment apparatus, the anticoagulation setting being selected from heparin anticoagulation and regional anticoagulation; and
presence or absence of a blood warmer.
Regarding claim 27, Koeffel discloses wherein the patient prescription comprises one or more flow rate values to be set to the extracorporeal blood treatment apparatus ([0026]), the one or more flow rate values being selected between a blood flow rate ([0026]), a Pre Blood Pump flow rate, a syringe flow rate, a fresh dialysis flow rate, and a replacement fluid flow rate.
Regarding claim 28, Koeffel discloses further comprising:
a disposable component ([0025]) configured for coupling to the extracorporeal blood treatment apparatus for a treatment to be carried out ([0025], can be paired i.e., coupled to the machine), the disposable component comprising an identification code to identify the disposable component ([0025]);
wherein the control unit of the extracorporeal blood treatment apparatus is configured to perform a consistency procedure comprising:
receive the identification code of the disposable component to identify the disposable component ([0025]), the control unit configured to receive the identification code from:
the reader of the extracorporeal blood treatment apparatus (scanner, [0025]), wherein the identification code of the disposable component comprises a respective optical pattern (optical pattern generated upon reading the information); or
a frequency scanner ([0045], RFID reader), distinct from the reader of the apparatus, wherein the identification code of the disposable component comprises a frequency related signal ([0045]);
verifying consistency between the identified disposable component and the setting parameter values acquired through reading the optical image from the display ([0029]);
when one or more of the setting parameter values are not consistent with the identified disposable component for the extracorporeal blood treatment apparatus, prevent the extracorporeal blood treatment apparatus to be set based on the setting parameter values ([0029]).
Regarding claim 29, Kloeffel further comprising a plurality of disposable components (there are a plurality of the cards, each unique to user ([0029]) configured for coupling to the extracorporeal blood treatment apparatus for a treatment to be carried out, wherein each disposable component comprises a respective component identifier encoding a respective identification code ([0029]),
wherein the setting parameter values comprise a treatment identifier representative of the dialysis treatment to be set in the extracorporeal blood treatment apparatus, the dialysis treatment selected from an ultrafiltration treatment, a haemodialysis treatment, a haemofiltration treatment, and a haemodiafiltration treatment ([0025-0027]);
wherein the consistency procedure comprises verifying whether the respective component identifier of the disposable component matches the treatment identifier of the extracorporeal blood treatment apparatus according to a predefined compatibility list ([0025-0027]),
wherein the predefined compatibility list comprises, for each dialysis treatment selected from an ultrafiltration treatment, a haemodialysis treatment, a haemofiltration treatment, and a haemodiafiltration treatment, a series of identification codes representative of disposable components compatible with the respective dialysis treatment ([0025-0027]).
Regarding claim 30, Kloeffel discloses wherein the setting parameter values comprise patient information including an identification of the patient identifying the patient to which the setting parameter values relate ([0025]),
wherein the control unit of the extracorporeal blood treatment apparatus is configured to perform a cross check procedure including:
associating the extracorporeal blood treatment apparatus with a patient intended to undergo the extracorporeal blood treatment ([0025-0027]);
providing the extracorporeal blood treatment apparatus with an identification of the patient from an information source different from the optical pattern ([0025-0027]);
checking for a match between the patient identification of the setting parameter values read through the optical pattern and the identification of the patient provided through the information source different from the optical pattern ([0025], [0027]);
when no match is found between the patient identification of the setting parameter values and the identification of the patient from the information source, preventing the extracorporeal blood treatment apparatus to be set based on the setting parameter values and issuing an alarm ([0061]).
Regarding claim 31, Kloeffel discloses wherein the acquisition procedure comprises a safety procedure comprising verifying a validity of the setting parameter values acquired by the optical pattern, the safety procedure comprising verifying whether all the setting parameter values are within a predefined validity range ([0060]-[0061]),
when one or more of the setting parameter values exceeds the predefined validity range, preventing the extracorporeal blood treatment apparatus to be set based on the setting parameter values ([0061]), and
wherein when one or more of the setting parameter values exceeds the predefined validity range, the safety procedure comprises commanding the extracorporeal blood treatment apparatus to emit an alarm signal ([0061]).
Regarding claim 32, Kloeffel discloses wherein the control unit of the apparatus and the controller of the remote device are configured to pair the remote device with the extracorporeal blood treatment apparatus based on an authentication code to allow an authorized user to perform the pairing ([0025]) so that:
when the pairing is successful, the acquisition procedure is performed ([0025]);
when the pairing is not successful, the acquisition procedure is prevented from being carried on, or the setting parameter values are prevented from setting the extracorporeal blood treatment apparatus ([0027]).
Regarding claim 33, Kloeffel discloses wherein the pairing is based on a physical proximity wireless protocol and the authentication code comprises at least one of a password, a serial number, a fingerprint, and a facial recognition algorithm ([0025]).
Regarding claim 34, Kloeffel discloses wherein the remote procedure is performed at a remote distance from the patient and from the extracorporeal blood treatment apparatus (inputting data is using the screen which is remote from patient), and the acquisition procedure is performed at an acquisition distance from the patient and from the medical apparatus (data acquired after scanning card, [0025]), wherein the remote distance is longer than the acquisition distance (distance of remote procedure is further away from the acquisition since the card need be scanned using the scanner on machine),
wherein the remote procedure is performed: remotely at a safety distance with respect to the patient and with respect to the medical apparatus (inputting data on the machine is away from patient) , wherein the safety distance is higher than 20 meters; and/or
separately from the patient by a barrier,
wherein the barrier and/or the safety distance being configured to isolate a user, in charge of entering the setting parameter values into the remote device, from the patient to avoid bacteria and/or virus transmission between the patient and the user (data input away from the user and avoids touching the patient), and
wherein the acquisition procedure is performed close to the extracorporeal blood treatment apparatus ([0025]), and close to the patient, wherein during the acquisition procedure the user, in charge of performing the acquisition procedure, is at a distance from the patient shorter than 3 meters (acquisition procedure performed using scan which is up against the scanner, [0025]).
Regarding claim 35, Koeffel discloses wherein the control unit of the extracorporeal blood treatment apparatus is configured to perform a cross check procedure including:
associating the extracorporeal blood treatment apparatus with a patient intended to undergo the extracorporeal blood treatment ([0027]);
providing the extracorporeal blood treatment apparatus with an identification of the patient from an information source different from the optical pattern ([0027]);
checking for a match between the patient identification of the setting parameter values read through the optical pattern and the identification of the patient provided through the information source different from the optical pattern ([0027]);
when no match is found between the patient identification of the setting parameter values and the identification of the patient from the information source, preventing the extracorporeal blood treatment apparatus to be set based on the setting parameter values and issuing an alarm ([0027]);
wherein the cross check procedure is performed at a cross check distance substantially equal to the acquisition distance, wherein the setting parameter values comprise patient information including an identification of the patient identifying the patient to which the setting parameter values relate ([0027], [0061]).
Regarding claim 36, Kloeffel discloses, wherein the user interface of the remote device comprises both the display and a input device (100a, display also inputs data) for entering the setting parameter values, wherein the controller of the remote device is configured to perform a local procedure temporally interposed between the remote procedure and the acquisition procedure ([0024]), the local procedure comprising:
entering or allowing a user to enter one or more further setting parameter values into the remote device through the user interface of the remote device, the further setting parameter values comprising one or more of a patient prescription, a therapy configuration, and a patient information ([0024-0026]); and/or
modifying, updating, or allowing a user to modify or update, through the user interface of the remote device, one or more of the setting parameter values entered during the remote procedure ([0024, manual input constitutes allowing user to update information),
wherein the local procedure is performed by a user at a local distance from the patient (input through the display) and from the extracorporeal blood treatment apparatus, while the remote procedure is performed by a user at a remote distance from the patient and from the extracorporeal blood treatment apparatus, wherein the local distance is shorter than the remote distance (distance of input should be smaller than the input of the remote procedure), and
wherein the local procedure and the acquisition procedure are performed substantially at the same place and at the same distance with respect to the patient and to the extracorporeal blood treatment apparatus (inputs are both through the display).
Regarding claim 37, wherein the acquisition procedure comprises a confirmation procedure ([0060]) temporally subsequent to acquiring the setting parameter values by reading the optical pattern through the reader,
wherein the confirmation procedure comprises:
displaying on a display of the apparatus one or more of the setting parameter values (100a displays data);
requiring, from a user, an approval signal of the one or more of the setting parameter values received by the apparatus ([0060]);
checking whether the approval signal is received ([0061]);
when the approval signal is received by the apparatus, allowing setting of the extracorporeal blood treatment apparatus based on the values of the setting parameter values received by the apparatus ([0061]);
when the approval signal is not received by the apparatus, preventing setting of the extracorporeal blood treatment apparatus based on the values of the setting parameter values received by the apparatus ([0061]).
Regarding claim 38, Kloeffel discloses wherein requiring an approval signal from a user during the confirmation procedure comprises:
requiring one and only one approval signal representative of approval of all the setting parameter values received by the apparatus ([0061]); or
partitioning the setting parameter values into two or more groups, each group comprising respective setting parameter values received by the apparatus, and requiring an approval signal for each group of setting parameter values.
Regarding claim 39, Kloeffel discloses the alternative of the requiring the signatures of requiring one and only one approval signal representative of approval of all the setting parameter values received by the apparatus ([0061]); which is alternative from the language of claim 38, this claim additionally adds in the alternative wherein the setting parameter values are partitioned in the groups based on a category of each setting parameter value, wherein at least a flow rate group is provided comprising only setting parameter values related to flow rates to set the extracorporeal blood treatment apparatus.
Regarding claim 40, Kloeffel discloses wherein a variation of the setting parameter values entered corresponds to a variation in the optical pattern displayed on the user interface of the remote device ([0055]), the optical pattern being displayed on the display of the remote device ([0055]), and wherein displaying the optical pattern on the display is performed during the acquisition procedure and temporarily after the remote procedure ([0027-0029]), and is subordinated to a successful pairing between the remote device and the extracorporeal blood treatment apparatus ([0060]), wherein the optical pattern in not displayed when the paring is not successful ([0057-0059]).
Regarding claim 41, Kloeffel discloses a system comprising an extracorporeal blood treatment apparatus (circuit including 101, 107, 105, 104, 103, figure 1, [0052]) and a remote device (100a is remote) the extracorporeal blood treatment apparatus, a disposal component (0025]) comprising:
a filtration unit (103, figure 1) having a primary chamber and a secondary chamber separated by a semi- permeable membrane ([0052], filter of blood through the semipermeable membrane and there are sides on either side of the filter);
a blood circuit (101, 104) comprising:
a blood withdrawal line (101) extending between a first end connected to an inlet of the primary chamber and a second end for connection to a patient ([0052]); and
a blood return line (104) extending between a first end connected to an outlet of the primary chamber and a second end for connection to the patient ([0052]);
a blood pump (102, [0052]) to circulate blood in the blood circuit;
an effluent line (105, [0052]) connected to an outlet of the secondary chamber;
a reader (108, [0062]) configured to read optical patterns;
a control unit ([0012]) configured to control the blood pump and connected to the reader;
wherein the remote device comprises a user interface (100a is a display UI) and a controller (user can use 109 with fingers) configured to perform a remote procedure ([0057]) comprising:
allowing entry of values for setting parameter values via the user interface, wherein the setting parameter values define a setting of the extracorporeal blood treatment apparatus and are related to an identified patient, the setting parameter values comprising part of a patient prescription for the identified patient ([0057-0058], [0060-0061]),
Koeffel discloses an individual patient card that is scanned for dialysis treatment ([0025]), which is a step of generating an optical pattern encoding the setting parameter values, the optical pattern being variable as a function of the entered setting parameter values; and
wherein the control unit of the extracorporeal blood treatment apparatus is configured to perform an acquisition procedure comprising:
acquiring the setting parameter values by reading the optical pattern through the reader ([0025]); and
setting the extracorporeal blood treatment apparatus based on the values of the setting parameter values ([0025-0026]).
Koeffel discloses setting treatment parameters such as blood flow rate and dialysis flow rate, but Koeffel fails to disclose the setting parameter values comprising at least one of:
a patient fluid removal rate for the identified patient; and
two parameters for the identified patient selected from total weight loss, total treatment time, and ultrafiltration flow rate.
Paolini discloses extracorporeal treatment and teaches the user can set parameter values relating to total weight loss, total treatment time, and ultrafiltration flow rate ([0020-0021]).
Paolini provides ways to adjust the treatment to more effectively achieve an end result ([0021]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Koeffel with the further parameter adjustments of Paolini to obtain more precise/effective and goal-oriented treatment;
the disposable component ([0025]) configured for coupling to the extracorporeal blood treatment apparatus for a treatment to be carried out ([0025], can be paired i.e., coupled to the machine), the disposable component comprising an identification code to identify the disposable component ([0025]);
wherein the control unit of the extracorporeal blood treatment apparatus is configured to perform a consistency procedure comprising:
receive the identification code of the disposable component to identify the disposable component ([0025]), the control unit configured to receive the identification code from:
the reader of the extracorporeal blood treatment apparatus (scanner, [0025]), wherein the identification code of the disposable component comprises a respective optical pattern (optical pattern generated upon reading the information); or
a frequency scanner ([0045], RFID reader), distinct from the reader of the apparatus, wherein the identification code of the disposable component comprises a frequency related signal ([0045]);
verifying consistency between the identified disposable component and the setting parameter values acquired through reading the optical image from the display ([0029]);
when one or more of the setting parameter values are not consistent with the identified disposable component for the extracorporeal blood treatment apparatus, prevent the extracorporeal blood treatment apparatus to be set based on the setting parameter values ([0029]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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