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 .
Response to Amendment
Applicant’s amendments filed on 03/03/2026 have been fully considered. Claims 1-2, 4-6, 8, 10-18, 20-22, 24, 26-33, and 35-40 are pending in this application. Claims 1, 17, and 33 are amended. Claims 3, 7, 9, 19, 23, 25, and 34 are cancelled. Claims 39-41 are newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1, 17, and 33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though overall the same prior art references are used herein, at least applicant’s amended independent claims 1, 17, and 33 required a change in the grounds of the rejection as detailed below in the prior art rejection.
More specifically, the claim limitation “wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device” further narrows the scope of the claimed invention.
The newly added claims 39-41 are addressed in the rejection below.
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) 1-2, 4-6, 8, 10-11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cork et al. (Publication No. US 2013/0138452 A1) in view of Kamen et al. (Publication No. US 2013/0317753 A1) and Wilt et al. (Publication No. US 2014/0299544 A1).
Regarding claim 1, Cork teaches a controller for a blood processing device (tablet controls apheresis machine; Paragraph 0021, 0024, and 0035; Figure 1) comprising: a body (a tablet has a body); a processor configured to remotely control the operation and components of the first blood processing device (processor 116 is configured to remotely control the operation and components of the apheresis device; Figure 1; Paragraph 0034-0036 and 0038-0039); and a user interface configured to display information regarding a first blood processing device and an ongoing apheresis procedure when the controller is remotely connected to the first blood processing device (device 900 has an interface that displays information regarding a medical device 901 and remote control of a blood collection procedure; Figure 9; Paragraph 0083-0084), the controller having a plurality mode in which the interface displays the information regarding the first blood processing device and information regarding at least a second blood processing device (tablet displays information regarding a first blood processing device 901 and a second blood processing device 904; Figure 9; Paragraph 0083-0084), the controller configured to allow the user to select which blood processing device the controller is controlling the operation and components of (tablet allows user to select which device to control; Figure 9; Paragraph 0083-0084), the controller configured to control the selected blood processing device when remotely connected to the first and second blood processing device (Paragraph 0083-0084; Figure 9), the processor configured to control the operation and components of the first blood processing device (Paragraph 0083-0084), the user interface configured to display information regarding the first blood processing device and an ongoing apheresis procedure (Paragraph 0083-0084), the controller configured to control the selected blood processing device during a collection procedure (Paragraph 0083-0084), the controller controlling the operation and components of the selected blood processing device according to a program loaded onto the selected blood processing device (Paragraph 0083-0084).
Cork does not teach the body configured to dock with a first blood processing device to connect the controller to the first blood processing device, the body also configured to undock with the first blood processing device to disconnect the controller from the first blood processing device; the processor configured to control the operation and components of the first blood processing device when the controller is docked with the first blood processing device and remotely control the operation and components of the first blood processing device when undocked; the user interface configured to display information regarding the first blood processing device and an ongoing apheresis procedure when the controller is docked to the first blood processing device and when the controller is undocked from the first blood processing device, the controller configured to control the selected blood processing device during a collection procedure when docked to the first and/or second blood processing device and when undocked from the first and second blood processing device.
However, Kamen teaches the body configured to dock with a first device to connect the controller to the first device (monitoring client 2102 configured to have a wired connection with a first device 2106; Figure 21; Paragraph 0589), the body also configured to undock with the first device to disconnect the controller from the first device (monitoring client 2102 can removed wired connection of device 2106 to have a wireless connection; Paragraph 0056 and 0591); the processor configured to control the operation and components of the first device when the controller is docked with the first device and remotely control the operation and components of the first device when undocked (Paragraph 0056, 0589, and 0591); the user interface configured to display information regarding the first device and an ongoing procedure when the controller is docked to the first device and when the controller is undocked from the first device (device 2102 is configured to display information of first device 2106, whether docked wired or wirelessly undocked; Paragraph 0056, 0589, and 0590), the controller configured to control the selected device during a collection procedure when docked to the first and/or second device and when undocked from the first and second device (monitoring client 2102 can be wired/wirelessly connected or docked/undocked to the device 2106 or device 2212, based on selection; Paragraph 0056 and 0589-0590).
Cork and Kamen are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork to incorporate the teachings of Kamen and have the controller/tablet of the Cork be capable of wirelessly and wired connecting by having a wired connector on the controller for a plurality of device, as taught by Kamen, from the first and second blood processing devices of Cork and operate during the wired and wireless connection, as taught by Kamen. This allows for the tablet to be wired or wirelessly connected to a plurality of medical devices, when desired (Kamen; Paragraph 0056). Furthermore, Cork teaches that a direct cable connection or wireless connection can be used for connecting the controller to devices (Paragraph 0038).
The combination of Cork in view of Kamen further teaches the user interface configured to display information regarding the first blood processing device and an ongoing apheresis procedure when the controller is docked to the first blood processing device and when the controller is undocked from the first blood processing device (tablet of Cork can display the status of an apheresis, when wired or unwired, as taught by Kamen; see combination above), the controller configured to control the selected blood processing device when docked to the first and/or second blood processing device and when undocked from the first and second blood processing device (controller of Cork in view of Kamen can select and operate the first and second apheresis devices, whether wired/unwired; see combination above). The combination of Cork in view of Kamen does not teach wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device.
However, Wilt teaches wherein when the controller’s body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device (when the body of the other tablet is physically paired/docked to the base, the other tablet automatically switches to control the device of the base without the user’s selection; Paragraph 0853; Figure 127).
Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen to incorporate the teachings of Wilt and have the controller/tablet of the Cork in view of Kamen automatically switch the control of the controller from a second to a first blood processing device when physically connected/docked to a first blood processing device, or vice versa, as taught by Wilt. This allows for the blood processing device to give priority to the docked controller/tablet over the wireless tablet (Wilt; Paragraph 0853). The combination of Cork in view of Kamen and Wilt further teaches wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device (controller of Cork that is configured to control the first and second blood processing device prioritizes the control of the first blood processing device when physically connected/docked with the base of the first blood processing device of Wilt; see combination above).
Regarding claim 2, Cork in view of Kamen and Wilt teaches the controller of claim 1. Cork further teaches wherein the controller is a portable computer (Paragraph 0024 and 0036).
Regarding claim 4, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller is configured to control the at least a second blood processing device when docked to the first blood processing device (Kamen; monitoring client 2102 is wired connected to device 2106 and can be wirelessly connected to device 2112 simultaneously for control; Paragraph 0589; see rejection of claim 1 above).
Regarding claim 5, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller is configured to control the at least a second blood processing device when undocked from the first blood processing device (Cork; Paragraph 0083-0084; Figure 9; Kamen; tablet can switch from wired to wireless connection with both the first and second devices; Paragraph 0056, 0589, and 0591; Figure 21; see rejection of claim 1 above).
Regarding claim 6, Cork in view of Kamen and Wilt teaches the controller of claim 1. Cork further teaches wherein the controller is configured to control the at least a second blood processing device remotely (Paragraph 0083-0084; Figure 9).
Regarding claim 8, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches wherein the body is configured to dock with the second blood processing device to connect the controller to the second blood processing device (Kamen; monitoring client 2102 can be wired connected to device 2112 for control; Paragraph 0589).
Regarding claim 10, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller is configured to perform at least one function selected from the group consisting of calibrating the blood processing device, calibrating additional components of a blood processing system, record procedure data, record and track procedure incidents, record donor activity, and record data related to sample collection (Cork; mobile device 114 can record procedure data; Paragraph 0041).
Regarding claim 11, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches further comprising: a controller connector located on the body (Kamen; monitoring client 2102 has a connector on its body to have a wired connection with devices 2106 and 2112; Paragraph 0581 and 0592; Figure 21), the controller connector configured to connect with a device connector on the first blood processing device when the controller is docked with the first blood processing device, thereby electrically connecting the controller to the first blood processing device (Kamen; Paragraph 0589).
Regarding claim 14, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches further comprising a data storage device configured to store data relating to an apheresis procedure (Cork; mobile device 114 has a memory 118 to store data relating to the procedure; Paragraph 0039 and 0041; Figure 1).
Regarding claim 15, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt further teaches wherein the first blood processing device is an apheresis device (Cork; Paragraph 0021, 0024, and 0035).
Regarding claim 16, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt does not teach wherein the connection between the controller and the first blood processing device when docked is a wireless connection.
However, another embodiment of Kamen further teaches where each patient device can have more than two communication modules so the user can select if the device should be wired/wirelessly connected with the controller (Paragraph 0380-0382).
Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of the embodiment of Kamen and have the controller/tablet of the Cork in view of Kamen and Wilt to be wirelessly connected during the wired/docked state of the first device, as taught by Kamen. This allows for the user to select how the medical device should be communicating with the controller by multiple communication forms (Kamen; Paragraph 0380-0382).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cork et al. (Publication No. US 2013/0138452 A1) in view of Kamen et al. (Publication No. US 2013/0317753 A1) and Wilt et al. (Publication No. US 2014/0299544 A1), as applied to claim 1 above, and further in view of Schabbach et al. (Publication No. US 2013/0197445 A1).
Regarding claim 12, Cork in view of Kamen and Wilt teaches the controller of claim 1. The combination of Cork in view of Kamen and Wilt does not teach wherein the body is configured to fit within a docking portion of the first blood processing device, the docking portion supporting the body when the controller is docked to the first blood processing device, thereby physically connecting the controller to the first blood processing device.
However, Schabbach teaches wherein the body is configured to fit within a docking portion of the first blood processing device (body of mating unit of apparatus is configured to fit within recess of medical device; Paragraph 0017-0019), the docking portion supporting the body when the controller is docked to the first blood processing device (docking portion supports the body through the connection between recess/protrusion; Paragraph 0019), thereby physically connecting the controller to the first blood processing device (mating unit of apparatus and medical device are releasably connectable to each other; Paragraph 0017-0019).
Schabbach and Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of medical devices with separate controllers for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of Schabbach and have the controller of Cork in view of Kamen and Wilt to have a body of the device/controller, with a protrusion, that fits into the recess of the docking portion of the apparatus, as taught by Schabbach. This allows for the user to removeably connect the medical device with the apparatus (Schabbach; Paragraph 0017-0019).
Regarding claim 13, Cork in view of Kamen, Wilt, and Schabbach teaches the controller of claim 12. The combination of Cork in view of Kamen, Wilt, and Schabbach teaches wherein the docking portion includes a recess (Schabbach; Paragraph 0018), the body configured to fit within the recess when docked (Schabbach; Paragraph 0018).
Claim(s) 17-18, 20-22, 24-27, 30-33, and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Cork et al. (Publication No. US 2013/0138452 A1) in view of Kamen et al. (Publication No. US 2013/0317753 A1), Wilt et al. (Publication No. US 2014/0299544 A1) and Auto-C Service Manual (https://elmedtech.com/schematics/medical/therapy/autopheresis-c_a-200/autopheresis-c.pdf).
Regarding claim 17, Cork teaches a blood processing device (Abstract; Paragraph 0021, 0024, and 0035) comprising: a blood component separation device for separating whole blood into one or more blood components (apheresis device, AUTOPHERESIS-C.TM, with separation chambers; see diagram of AUTOPHERESIS-C.TM in Figure 2.1 below; Paragraph 0064); at least one pump configured to control a flow of whole blood and/or blood components through the blood processing device (cell pump, anticoagulant pump, and blood pump; see Figure 2.1 below); and a controller having a body (tablet controls apheresis machine and having a body; Paragraph 0021, 0024, and 0035; Figure 1), the controller including: a processor configured to remotely control the operation and components of the blood processing device (processor 116 is configured to remotely control the operation and components of the apheresis device; Figure 1; Paragraph 0034-0036 and 0038-0039); and a user interface configured to display information regarding the blood processing device and an ongoing apheresis procedure when the controller is remotely connected to the first blood processing device (device 900 has an interface that displays information regarding a medical device 901 and remote control of a blood collection procedure; Figure 9; Paragraph 0083-0084), the controller having a plurality mode in which the interface displays the information regarding the first blood processing device and information regarding at least a second blood processing device (tablet displays information regarding a first blood processing device 901 and a second blood processing device 904; Figure 9; Paragraph 0083-0084), the controller configured to allow the user to select which blood processing device the controller is controlling the operation and components of (tablet allows user to select which device to control; Figure 9; Paragraph 0083-0084), the controller configured to control the selected blood processing device during a collection procedure (Paragraph 0083-0084; Figure 9), the controller controlling the operation and components of the selected blood processing device according to a program loaded onto the selected blood processing device (Paragraph 0083-0084).
Cork does not teach a cabinet defining the structure of the blood processing device and housing one or more components of the blood processing device, the cabinet including a docking portion; a controller having a body configured to dock with the docking portion to connect the controller to the blood processing device, the body also configured to undock with the blood processing device to disconnect the controller from the blood processing device, a processor configured to control the operation and components of the blood processing device when the controller is docked with the blood processing device and configured to remotely control the operation and components of the blood processing device when the controller is undocked; a user interface configured to display information regarding the blood processing device and an ongoing apheresis procedure when the controller is remotely connected to the first blood processing device, when the controller is docked to the blood processing device and when the controller is undocked from the blood processing device, the controller configured to allow the user to select which blood processing device the controller is controlling the operation and components of, the controller configured to control the selected blood processing device during a collection procedure when docked to the first and/or second blood processing device and when undocked from the first and second blood processing device.
However, Kamen teaches a controller having a body configured to dock to connect the controller to the device (monitoring client 2102 configured to have a wired connection with a first device 2106; Figure 21; Paragraph 0589), the body also configured to undock with the device to disconnect the controller from the device (monitoring client 2102 can removed wired connection of device 2106 to have a wireless connection; Paragraph 0056 and 0591), the processor configured to control the operation and components of the when the controller is docked with the device and configured to remotely control the operation and components of the device when the controller is undocked (Paragraph 0056, 0589, and 0591); the user interface configured to display information regarding the device and an ongoing apheresis procedure when the controller is remotely connected to the first device, when the controller is docked to the device and when the controller is undocked from the device (device 2102 is configured to display information of first device 2106, whether docked wired or wirelessly undocked; Paragraph 0056, 0589, and 0590), the controller configured to control the selected blood processing device during a collection procedure when docked to the first and/or second device and when undocked from the first and second device (monitoring client 2102 can be wired/wirelessly connected or docked/undocked to the device 2106 or device 2212, based on selection; Paragraph 0056 and 0589-0590).
Cork and Kamen are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork to incorporate the teachings of Kamen and have the controller/tablet of the Cork be capable of wirelessly and wired connecting by having a wired connector on the controller for a plurality of device, as taught by Kamen, from the first and second blood processing devices of Cork and operate during the wired and wireless connection, as taught by Kamen. This allows for the tablet to be wired or wirelessly connected to a plurality of medical devices, when desired (Kamen; Paragraph 0056). Furthermore, Cork teaches that a direct cable connection or wireless connection can be used for connecting the controller to devices (Paragraph 0038).
The combination of Cork in view of Kamen further teaches the user interface configured to display information regarding the blood processing device and an ongoing apheresis procedure when the controller is docked to the blood processing device and when the controller is undocked from the blood processing device (tablet of Cork can display the status of an apheresis, when wired or unwired, as taught by Kamen; see combination above), the controller configured to control the selected blood processing device when docked to the first and/or second blood processing device and when undocked from the first and second blood processing device (controller of Cork in view of Kamen can select and operate the first and second apheresis devices, whether wired/unwired; see combination above).
The combination of Cork in view of Kamen does not teach a cabinet defining the structure of the blood processing device and housing one or more components of the blood processing device, the cabinet including a docking portion; a controller having a body configured to dock with the docking portion to connect the controller to the blood processing device, wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device..
However, Wilt teaches a cabinet defining the structure of the blood processing device and housing one or more components of the blood processing device (hemodialysis unit 6001 has housing 6004 with components to process blood; Figure 60; Paragraph 0642 and 0839-0842), the cabinet including a docking portion (tablet/user interface has a body that is connectable to a dock onto a base for communications; Paragraph 0839-0842 and 0846; Figure 60); the controller having a body configured to dock with the docking portion to connect the controller to the blood processing device (tablet/user interface has a body that is connectable to a dock onto a base for communications; Paragraph 0839-0842 and 0846; Figure 60), wherein when the controller’s body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device (when the body of the other tablet is physically paired/docked to the base, the other tablet automatically switches to control the device of the base without the user’s selection; Paragraph 0853; Figure 127).
Wilt and Cork in view of Kamen are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilt to incorporate the teachings of Wilt and have the controller/tablet of the Cork in view of Kamen be shaped and capable to be able to dock and undock from the first and second blood processing devices of Cork in view of Kamen, with the cabinet structure including a docking portion, as taught by Wilt and have the controller/tablet of the Cork in view of Kamen automatically switch the control of the controller from a second to a first blood processing device when physically connected/docked to a first blood processing device, or vice versa, as taught by Wilt. This allows for the wired connection to establish a wireless connection through pairing (Wilt; Paragraph 0843) and allows for the blood processing device to give priority to the docked controller/tablet over the wireless tablet (Wilt; Paragraph 0853). The combination of Cork in view of Kamen and Wilt further teaches wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device (controller of Cork that is configured to control the first and second blood processing device prioritizes the control of the first blood processing device when physically connected/docked with the base of the first blood processing device of Wilt; see combination above).
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Figure 2.1 - https://elmedtech.com/schematics/medical/therapy/autopheresis-c_a-200/autopheresis-c.pdf Regarding claim 18, Cork in view of Kamen and Wilt teaches the controller of claim 17. Cork further teaches wherein the controller is a portable computer (Paragraph 0024 and 0036).
Regarding claim 20, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller is configured to control the at least one additional blood processing device when docked to the blood processing device (Kamen; monitoring client 2102 is wired connected to device 2106 and can be wirelessly connected to device 2112 simultaneously for control; Paragraph 0589; see rejection of claim 17 above).
Regarding claim 21, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller is configured to control the at least one additional blood processing device when undocked from the blood processing device (Cork; Paragraph 0083-0084; Figure 9; Kamen; tablet can switch from wired to wireless connection with both the first and second devices; Paragraph 0056, 0589, and 0591; Figure 21; see rejection of claim 17 above).
Regarding claim 22, Cork in view of Kamen and Wilt teaches the controller of claim 17. Cork further teaches wherein the controller is configured to control the at least one additional blood processing device remotely (Paragraph 0083-0084; Figure 9).
Regarding claim 24, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches wherein the body is configured to dock with the at least one additional blood processing device to connect the controller to the at least one additional blood processing device (Kamen; monitoring client 2102 can be wired connected to device 2112 for control; Paragraph 0589).
Regarding claim 25, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt wherein the controller begins to automatically control the blood processing device to which it is docked (Kamen; monitoring client 2102 can automatically control devices 2106/2112 in a wired and wireless fashion; Paragraph 0589, 0591-0592).
Regarding claim 26, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller is configured to perform at least one function selected from the group consisting of calibrating the blood processing device, calibrating additional components of a blood processing system, record procedure data, record and track procedure incidents, record donor activity, and record data related to sample collection (Cork; mobile device 114 can record procedure data; Paragraph 0041).
Regarding claim 27, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches further comprising: a blood processing device connector located within the cabinet (Wilt; tablet connector on body to physically and electrically connect to base on dock; Paragraph 0846); and a controller connector located within the body of the controller (Kamen; monitoring client 2102 has a connector on its body to have a wired connection with devices 2106 and 2112; Paragraph 0581 and 0592; Figure 21), the controller connector configured to connect with the blood processing device connector when the controller is docked with the blood processing device, thereby electrically connecting the controller to the blood processing device (Kamen; Paragraph 0589).
Regarding claim 30, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches wherein the controller further includes a data storage device configured to store data relating to an apheresis procedure (Cork; mobile device 114 has a memory 118 to store data relating to the procedure; Paragraph 0039 and 0041; Figure 1). Regarding claim 31, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt further teaches wherein the blood processing device is an apheresis device (Cork; Paragraph 0021, 0024, and 0035).
Regarding claim 32, Cork in view of Kamen and Wilt teaches the controller of claim 17. The combination of Cork in view of Kamen and Wilt does not teach wherein the connection between the controller and the blood processing device when docked is a wireless connection.
However, another embodiment of Kamen further teaches where each patient device can have more than two communication modules so the user can select if the device should be wired/wirelessly connected with the controller (Paragraph 0380-0382).
Cork and Kamen are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen to incorporate the teachings of the embodiment of Kamen and have the controller/tablet of the Cork in view of Kamen to be wirelessly connected during the wired/docked state of the first device, as taught by Kamen. This allows for the user to select how the medical device should be communicating with the controller by multiple communication forms (Kamen; Paragraph 0380-0382).
Regarding claim 33, Cork teaches a method for controlling a blood processing device (Abstract; Paragraph 0021, 0024, and 0035) comprising: providing a blood processing device (Abstract; Paragraph 0021, 0024, and 0035) comprising: a blood component separation device for separating whole blood into one or more blood components (apheresis device, AUTOPHERESIS-C.TM, with separation chambers; see diagram of AUTOPHERESIS-C.TM in Figure 2.1 above; Paragraph 0064); connecting a controller with the blood processing device (device 900 has an interface that displays information regarding a medical device 901 and remote control of a blood collection procedure; Figure 9; Paragraph 0083-0084), the controller having a body (tablet controls apheresis machine and having a body; Paragraph 0021, 0024, and 0035; Figure 1), the controller also having a processor (processor 116 is configured to remotely control the operation and components of the apheresis device; Figure 1; Paragraph 0034-0036 and 0038-0039) and a user interface (device 900 has an interface that displays information regarding a medical device 901 and remote control of a blood collection procedure; Figure 9; Paragraph 0083-0084); controlling, using the controller and/or the processor, the operation and components of the blood processing device (device 900 has an interface that displays information regarding a medical device 901 and remote control of a blood collection procedure; Figure 9; Paragraph 0083-0084); remotely controlling the operation and components of the blood processing device (Figure 9; Paragraph 0083-0084); selecting, using the user interface, a second blood processing device (tablet displays information regarding a first blood processing device 901 and a second blood processing device 904 and control selected second blood processing device 904; Figure 9; Paragraph 0083-0084); and remotely controlling the operation and components of the second blood processing device using the controller (Paragraph 0083-0084; Figure 9), the controller configured to control the selected blood processing device during a collection procedure (Paragraph 0083-0084; Figure 9), the controller controlling the operation and components of the selected blood processing device according to a program loaded onto the selected blood processing device (Paragraph 0083-0084).
Cork does not teach a cabinet defining the structure of the blood processing device and housing one or more components of the blood processing device, the cabinet including a docking portion; and docking a controller with the blood processing device, the body configured to dock with the docking portion to connect the controller to the blood processing device, undocking the controller from the blood processing device, undocking the controller disconnecting the controller from the blood processing device; remotely controlling the operation and components of the blood processing device using the undocked controller; the controller configured to control the selected blood processing device during a collection procedure when docked to the first and/or second blood processing device and when undocked from the first and second blood processing device.
However, Kamen teaches docking a controller with the blood processing device (monitoring client 2102 configured to have a wired connection with a first device 2106; Figure 21; Paragraph 0589), the body configured to dock to connect the controller to the blood processing device (monitoring client 2102 configured to have a wired connection with a first device 2106; Figure 21; Paragraph 0589), undocking the controller from the blood processing device (monitoring client 2102 can removed wired connection of device 2106 to have a wireless connection; Paragraph 0056 and 0591), undocking the controller disconnecting the controller from the blood processing device (monitoring client 2102 can removed wired connection of device 2106 to have a wireless connection; Paragraph 0056 and 0591); remotely controlling the operation and components of the blood processing device using the undocked controller (Paragraph 0056, 0589, and 0591); the controller configured to control the selected blood processing device during a collection procedure when docked to the first and/or second blood processing device and when undocked from the first and second blood processing device (monitoring client 2102 can be wired/wirelessly connected or docked/undocked to the device 2106 or device 2212, based on selection; Paragraph 0056 and 0589-0590).
Cork and Kamen are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork to incorporate the teachings of Kamen and have the controller/tablet of the Cork be capable of wirelessly and wired connecting by having a wired connector on the controller for a plurality of device, as taught by Kamen, from the first and second blood processing devices of Cork and operate during the wired and wireless connection, as taught by Kamen. This allows for the tablet to be wired or wirelessly connected to a plurality of medical devices, when desired (Kamen; Paragraph 0056). Furthermore, Cork teaches that a direct cable connection or wireless connection can be used for connecting the controller to devices (Paragraph 0038).
The combination of Cork in view of Kamen does not teach a cabinet defining the structure of the blood processing device and housing one or more components of the blood processing device, the cabinet including a docking portion; and docking a controller with the blood processing device, the body configured to dock with the docking portion to connect the controller to the blood processing device, wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device.
However, Wilt teaches a cabinet defining the structure of the blood processing device and housing one or more components of the blood processing device (hemodialysis unit 6001 has housing 6004 with components to process blood; Figure 60; Paragraph 0642 and 0839-0842), the cabinet including a docking portion (tablet/user interface has a body that is connectable to a dock onto a base for communications; Paragraph 0839-0842 and 0846; Figure 60); and docking a controller with the blood processing device (Paragraph 0839-0842), the body configured to dock with the docking portion to connect the controller to the blood processing device (tablet/user interface has a body that is connectable to a dock onto a base for communications; Paragraph 0839-0842 and 0846; Figure 60), wherein when the controller’s body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device (when the body of the other tablet is physically paired/docked to the base, the other tablet automatically switches to control the device of the base without the user’s selection; Paragraph 0853; Figure 127).
Wilt and Cork in view of Kamen are considered to be analogous to the claimed invention because they are in the same field of blood treatment systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilt to incorporate the teachings of Wilt and have the controller/tablet of the Cork in view of Kamen be shaped and capable to be able to dock and undock from the first and second blood processing devices of Cork in view of Kamen, with the cabinet structure including a docking portion, as taught by Wilt and have the controller/tablet of the Cork in view of Kamen automatically switch the control of the controller from a second to a first blood processing device when physically connected/docked to a first blood processing device, or vice versa, as taught by Wilt. This allows for the wired connection to establish a wireless connection through pairing (Wilt; Paragraph 0843) and allows for the blood processing device to give priority to the docked controller/tablet over the wireless tablet (Wilt; Paragraph 0853). The combination of Cork in view of Kamen and Wilt further teaches wherein when the controller is remotely controlling the operation of the second blood processing device and the body docks with the first blood processing device, the controller is configured to automatically switch to controlling the first blood processing device based on the docking without a user selection of the first blood processing device (controller of Cork that is configured to control the first and second blood processing device prioritizes the control of the first blood processing device when physically connected/docked with the base of the first blood processing device of Wilt; see combination above).
Regarding claim 35, Cork in view of Kamen and Wilt teaches the method of claim 33. The combination of Cork in view of Kamen and Wilt further comprising: docking the controller with a second blood processing device (Kamen; monitoring client 2102 can be wired connected to device 2112 for control; Paragraph 0589); and controlling the second blood processing device with the controller (Kamen; monitoring client 2102 can automatically control device2112 in a wired fashion; Paragraph 0589, 0591-0592).
Regarding claim 36, Cork in view of Kamen and Wilt teaches the method of claim 33. The combination of Cork in view of Kamen and Wilt further comprising: docking a second controller to the blood processing device; and controlling the blood processing device with the second controller.
Since the applicant has not disclosed that having a second controller does anything more than produce predictable results (i.e. allows another user to control the blood processing device), the mere duplication of the controller is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Cork in view of Kamen and Wilt to include a second controller that is connectable to the blood processing device, in order to predictably allow a second user to control the blood processing device. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
The modified Cork in view of Kamen and Wilt further teaches further comprising: docking a second controller to the blood processing device (second controller of Cork in view of Kamen and Wilt can dock onto blood processing device; see combination above); and controlling the blood processing device with the second controller (see combination above).
Regarding claim 37, Cork in view of Kamen and Wilt teaches the method of claim 33. The combination of Cork in view of Kamen and Wilt does not teach further comprising: selecting, using a second user interface on a second controller, the blood processing device; and remotely controlling the blood processing device using the second controller.
Since the applicant has not disclosed that having a second controller does anything more than produce predictable results (i.e. allows another user to control the blood processing device), the mere duplication of the controller is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Cork in view of Kamen and Wilt to include a second controller that is remotely connectable to the blood processing device, in order to predictably allow a second user to control the blood processing device. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
The modified Cork in view of Kamen and Wilt further teaches further comprising: selecting, using a second user interface on a second controller, the blood processing device; and remotely controlling the blood processing device using the second controller (second controller of Cork in view of Kamen and Wilt is able to remotely connect to a blood processing device; see combination above).
Regarding claim 38, Cork in view of Kamen and Wilt teaches the method of claim 33. The combination of Cork in view of Kamen and Wilt wherein the connection between the controller and the blood processing device when docked is at least one selected from the group consisting of a physical connection, an electrical connection and/or a wireless connection (Cork; wireless and wired connection; Paragraph 0038 and 0046; Kamen; electrical wired and wireless; Paragraph 0589).
Claim(s) 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Cork et al. (Publication No. US 2013/0138452 A1) in view of Kamen et al. (Publication No. US 2013/0317753 A1) and Wilt et al. (Publication No. US 2014/0299544 A1), as applied to claim 17 above, and further in view of Schabbach et al. (Publication No. US 2013/0197445 A1).
Regarding claim 28, Cork in view of Kamen and Wilt teaches the device of claim 27. The combination of Cork in view of Kamen and Wilt does not teach wherein the blood processing device connector is located within the docking portion.
However, Schabbach teaches wherein the blood processing device connector is located within the docking portion (body of mating unit of apparatus fits within recess of medical device; Paragraph 0017-0019).
Schabbach and Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of medical devices with separate controllers for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of Schabbach and have the controller of Cork in view of Kamen and Wilt to have a body of the device/controller, with a protrusion, that fits into the recess of the docking portion of the apparatus, as taught by Schabbach. This allows for the user to removeably connect the medical device with the apparatus (Schabbach; Paragraph 0017-0019).
Regarding claim 29, Cork in view of Kamen and Wilt teaches the device of claim 17. The combination of Cork in view of Kamen and Wilt does not teach wherein the docking portion includes a recess, the body configured to fit within the recess when docked, thereby physically connecting the controller to the blood processing device.
However, Schabbach teaches wherein the docking portion includes a recess (Paragraph 0018), the body configured to fit within the recess when docked (Paragraph 0018), thereby physically connecting the controller to the blood processing device (mating unit of apparatus and medical device are releasably connectable to each other; Paragraph 0017-0019).
Schabbach and Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of medical devices with separate controllers for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of Schabbach and have the controller of Cork in view of Kamen and Wilt to have a body of the device/controller, with a protrusion, that fits into the recess of the docking portion of the apparatus, as taught by Schabbach. This allows for the user to removeably connect the medical device with the apparatus (Schabbach; Paragraph 0017-0019).
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Cork et al. (Publication No. US 2013/0138452 A1) in view of Kamen et al. (Publication No. US 2013/0317753 A1) and Wilt et al. (Publication No. US 2014/0299544 A1), as applied to claim 1 above, and further in view of Blumker et al. (Publication No. US 2018/0001010 A1).
Regarding 39, Cork in view of Kamen and Wilt teaches the device of claim 1. The combination of Cork in view of Kamen and Wilt does not teach wherein when a second controller attempts to control a blood processing device already under the control of the controller, the second controller or blood processing device sends a message to the controller requesting permission for the second controller to control the blood processing device and the user interface is configured to display the request and a selectable option for a user to allow or not allow the request from the second controller.
However, Blumker teaches wherein when a second controller attempts to control a blood processing device already under the control of the controller, the second controller or blood processing device sends a message to the controller requesting permission for the second controller to control the blood processing device and the user interface is configured to display the request and a selectable option for a user to allow or not allow the request from the second controller (second remote controller attempts to control a device currently being controlled by a first remote control, where the attempt to connect to the device requires the user input to allow for the connection of the second remote control only if the multiple remote control criterion is selected by the user; Paragraph 0039-0040 and 0055-0057).
Blumker and Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of medical devices with separate controllers for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of Blumker and have a second controller of Cork in view of Kamen and Wilt, as taught by Blumker, to attempt to connect to the device by the user selection of the selectable option of the multiple remote control criterion, as taught by Blumker. This allows for a device to be controlled by multiple users for training purposes (Blumker; Paragraph 0039).
Claim(s) 40 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Cork et al. (Publication No. US 2013/0138452 A1) in view of Kamen et al. (Publication No. US 2013/0317753 A1), Wilt et al. (Publication No. US 2014/0299544 A1) and Auto-C Service Manual (https://elmedtech.com/schematics/medical/therapy/autopheresis-c_a-200/autopheresis-c.pdf), as applied to claims 17 and 33 above, and further in view of Blumker et al. (Publication No. US 2018/0001010 A1).
Regarding claim 40, Cork in view of Kamen and Wilt teaches the device of claim 17. The combination of Cork in view of Kamen and Wilt does not teach wherein when a second controller attempts to control a blood processing device already under the control of the controller, the second controller or blood processing device sends a message to the controller requesting permission for the second controller to control the blood processing device and the user interface is configured to display the request and a selectable option for a user to allow or not allow the request from the second controller.
However, Blumker teaches wherein when a second controller attempts to control a blood processing device already under the control of the controller, the second controller or blood processing device sends a message to the controller requesting permission for the second controller to control the blood processing device and the user interface is configured to display the request and a selectable option for a user to allow or not allow the request from the second controller (second remote controller attempts to control a device currently being controlled by a first remote control, where the attempt to connect to the device requires the user input to allow for the connection of the second remote control only if the multiple remote control criterion is selected by the user; Paragraph 0039-0040 and 0055-0057).
Blumker and Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of medical devices with separate controllers for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of Blumker and have a second controller of Cork in view of Kamen and Wilt, as taught by Blumker, to attempt to connect to the device by the user selection of the selectable option of the multiple remote control criterion, as taught by Blumker. This allows for a device to be controlled by multiple users for training purposes (Blumker; Paragraph 0039).
Regarding claim 41, Cork in view of Kamen and Wilt teaches the method of claim 33. The combination of Cork in view of Kamen and Wilt does not teach further comprising: sending, when a second controller attempts to control a blood processing device already under the control of the controller, a message from the second controller or blood processing device to the controller requesting permission for the second controller to control the blood processing device; and displaying on the user interface the request and a selectable option for a user to allow or not allow the request from the second controller..
However, Blumker teaches further comprising: sending, when a second controller attempts to control a blood processing device already under the control of the controller, a message from the second controller or blood processing device to the controller requesting permission for the second controller to control the blood processing device; and displaying on the user interface the request and a selectable option for a user to allow or not allow the request from the second controller. (second remote controller attempts to control a device currently being controlled by a first remote control, where the attempt to connect to the device requires the user input to allow for the connection of the second remote control only if the multiple remote control criterion is selected by the user; Paragraph 0039-0040 and 0055-0057).
Blumker and Cork in view of Kamen and Wilt are considered to be analogous to the claimed invention because they are in the same field of medical devices with separate controllers for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cork in view of Kamen and Wilt to incorporate the teachings of Blumker and have a second controller of Cork in view of Kamen and Wilt, as taught by Blumker, to attempt to connect to the device by the user selection of the selectable option of the multiple remote control criterion, as taught by Blumker. This allows for a device to be controlled by multiple users for training purposes (Blumker; Paragraph 0039).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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