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 .
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 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.
Status of Claims
In the amendment filed on December 18th, 2025, claims 1 and 8 have been amended, claims 3, 9, 11 and 16 have been cancelled and new claims 17 and 18 have been added. Therefore, claims 1, 2, 4-8, 10, 12-15, 17 and 18 are pending for examination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-8, 12-15, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maffei (US 20150224029 A1) in view Udagawa et al. (EP 3284492 A1) and Nemoto (WO 2016039298 A1)
In regards to claim 1, Maffei teaches a drug transfer device comprising: a housing configured to be handheld by a user (Abstract; Paragraph 50)
The appliance for transferring biomedical fluids between hospital receptacles includes: a syringe device including a hollow body for containing the fluid and one sliding piston fitted sealed in the body, the latter having a first end, which has joining elements for joining with a hospital receptacle, and a second open end; a grippable operating device including a fastening seat which can be coupled in a removable way to the second end, which includes a thrust rod suitable for sliding through the second end; temporary fastening elements for coupling the rod and piston in a releasable way; motor elements for operating the rod; and control elements connected to the motor elements for controlling both the volumetric dosage of the quantity of fluid taken from a first hospital receptacle or dispensed in a second hospital receptacle. Storage elements are mounted on the syringe device, and the operating device includes reading/writing elements.[Abstr]
The proposed appliance 1 further comprises an operating device 12 that can be gripped (see FIG. 3), which in turn comprises a fastening seat 13 which can be coupled in a removable way to said second end 6 of the syringe device 2 (by means of releasable coupling means 16, 16', such as bayonet couplings or the like).[P-50]
Maffei then teaches a syringe interface on an exterior surface of the housing and configured to receive a plurality of syringe barrel sizes, as well as a drive member movable relative to the syringe interface, the drive member configured to move a stopper within a syringe barrel when the syringe barrel is engaged with the syringe interface (Paragraphs 46, 50, 52, 53; Figures 3, 4)
The dimensions of the syringe body 3 can vary according to the required containment capacity (e.g.: 10 ml, 20 ml, 30 ml, 50 ml or 60 ml).[P-46]
The proposed appliance 1 further comprises an operating device 12 that can be gripped (see FIG. 3), which in turn comprises a fastening seat 13 which can be coupled in a removable way to said second end 6 of the syringe device 2 (by means of releasable coupling means 16, 16', such as bayonet couplings or the like).[P-50]
As shown in the FIGS. 3 and 4, the operating device 12 first of all includes a thrust rod 15 suitable for sliding longitudinally through said second end 6, following the coupling between said syringe device 2 and said operating device 12. [P-52]
In practice, the syringe device 2 is meant to be fitted on the operating device 12 in its fastening seat 13, preferably placed at one front end, at which seat, the thrust rod 15 exits from the rest of the operating device 12 and is meant to cross the second end 6 of the syringe device 2 so as to be able to reach the piston 4. Temporary fastening means (such as a bayonet coupling or other coupling means suitable for the purpose) are therefore provided for the releasable coupling between the rod and the piston 4, suitable for enabling the operation of the rod to produce the sliding of the piston 4 within the syringe body 3 (and therefore the taking or dosing of the fluid).[P-53]
Maffei teaches a motor configured to move the drive member; a position sensor configured to measure a position of the drive member; a wireless communication device configured to send and receive information (Paragraph 57)
For the purpose of cooperating with such storage means 21, the operating device 12 advantageously comprises reading/writing means 22 for reading and writing the information from/on the storage means 21 of the syringe device 2, and furthermore, the above control means comprise a processing unit 18 able to control the reading/writing means 22 and also able to process said information according to a predefined program, the processing unit 18 can be connected to external electronic devices (by means of electronic Wi-Fi connection or by means of USB ports, etc . . . ).[P-57]
Furthermore, Maffei teaches an information reader configured to receive information from an information target, the information reader comprising at least one of a barcode reader, an RFID reader, and an NFC reader and the information target comprising at least one of a barcode, an RFID tag, and an NFC tag (Paragraphs 56, 57)
In an innovative and original way, the appliance 1 of the invention comprises storage means 21 (such as EEPROM memories or other electronic storage devices such as RFID tag, etc.), mounted on the syringe device 2 (and which can be seen in the FIGS. 2 and 3), and able to store information relating to the type of transferred fluid, the quantity of taken fluid, the quantity of dispensed fluid, when each dose has been taken and/or dispensed and how many doses have been dispensed/taken (and if necessary also other information, as will be explained later on).[P-56]
For the purpose of cooperating with such storage means 21, the operating device 12 advantageously comprises reading/writing means 22 for reading and writing the information from/on the storage means 21 of the syringe device 2, and furthermore, the above control means comprise a processing unit 18 able to control the reading/writing means 22 and also able to process said information according to a predefined program, the processing unit 18 can be connected to external electronic devices (by means of electronic Wi-Fi connection or by means of USB ports, etc . . . ).[P-57]
At least one processor in communication with the motor, the position sensor, the wireless communication device, and the information reader, and wherein movement of the stopper may either aspirate fluid into the syringe barrel or expel fluid from the syringe barrel(Paragraphs 57, 72, 74, 75)
For the purpose of cooperating with such storage means 21, the operating device 12 advantageously comprises reading/writing means 22 for reading and writing the information from/on the storage means 21 of the syringe device 2, and furthermore, the above control means comprise a processing unit 18 able to control the reading/writing means 22 and also able to process said information according to a predefined program, the processing unit 18 can be connected to external electronic devices (by means of electronic Wi-Fi connection or by means of USB ports, etc . . . ).[P-57]
Always preferably, the aforementioned control means 18 are programmable so as to automatically set the doses of fluid to take and dispense, both in the case relating to doses of different medicinal substances to use in the same therapy or, on the contrary, in the case of doses of the same medicinal substance to dispense in bags included in different infusion lines and then connected to different patients, etc . . .[P-72]
At practical level, once the syringe device 2 and the operating device 12 have been coupled together, the processing unit 18 automatically commands the forward movement of the thrust rod 15 until this has coupled with the piston 4. In this phase, the processing unit 18 proceeds to identify the cartridge 2 by means of the reading/writing means 22 which connect up to the storage means 21 and, in the event of its recognizing the cartridge 2 as being authentic, it permits the subsequent operation of the motor means 17.[P-74]
Then, from time to time, the processing unit 18 automatically drives the thrust rod 15, according to the predefined program, so this slides along stroke lengths corresponding to the quantity of biomedical fluid to be taken and/or dispensed. The operator can nevertheless exploit the possibility of a transparent syringe body 3 with graduated scale (like that shown on the attached tables) in order to make a visual check of the taking or dispensing of the liquid, for the purpose of a definitive safety control.[P-75]
Maffei fails to teach the drive member is configured to automatically move the stopper based upon the information received from the information target, Udagawa on the other hand teaches the drive member is configured to automatically move the stopper based upon the information received from the information target (Abstract; Paragraph 65)
A chemical-liquid injector includes a piston-driving mechanism (130) that moves a piston member of a syringe containing a contrast medium, which includes an actuator and a ram member which is moved back and forth by the actuator, a control circuit (150) which is electrically connected to the actuator, and an operating knob unit (170) which includes an operating knob that is to be operated by an operator, and a rotation sensor that outputs an electric signal corresponding to a rotation of the operating knob. The control circuit is configured to generate a predetermined control signal accordingly, on the basis of a signal from the rotation sensor, and the piston-driving mechanism is operated according to the control signal.[Abstr]
As a specific example, it is possible to carry out detection by using the plurality of magnets, where, in a case of both N (north) poles, it will be detected as a first type, in a case of both S (south) poles, it will be detected as a second type, in a case of one N-pole and the other S-pole, it will be detected as a third type, and in a case of one S-pole and the other N-pole, it will be detected as a fourth type. In an embodiment, it is preferable that the chemical-liquid injector is configured to set automatically the movable range of the ram member on the basis of the information read in such manner. Moreover, the chemical-liquid injector may have been configured to identify a type of the chemical liquid or a product name, or whether or not it is a pre-filled syringe.[P-65]
Therefore, it would have been obvious to one of ordinary skill in the art during the filing date of the invention to combine Odagawa’s teaching with Maffei’s teaching in order to enable a more cost effective concise way of measuring and administering medical solutions
Maffei modified fails to teach automatically moving the stopper based upon the information received from the information target, the at least one processor controls the motor to move the drive member to aspirate or expel a required amount of the fluid into or from the syringe barrel, as determined from the information received from the information target.
Nemoto on the other hand teaches automatically moving the stopper based upon the information received from the information target, the at least one processor controls the motor to move the drive member to aspirate or expel a required amount of the fluid into or from the syringe barrel, as determined from the information received from the information target (Page 5, Paragraphs 2, 8, 9; Page 6, Paragraphs 6, 7)
For example, a stopper provided with a limit switch that detects the position of the piston holder 33 by contacting the piston holder 33 as the piston holder 33 moves is provided in a direction parallel to the moving direction of the piston holder 32 below the piston holder 33. It is possible to adopt a mechanical configuration that is supported in a freely movable manner. As long as the position of the piston holder 33 can be detected, the limit switch may have any configuration such as an optical sensor such as a photocoupler or a magnet limit switch. According to this configuration, if the operation of the piston drive mechanism 53 is stopped when the limit switch comes into contact with the piston holder 33 and is turned on, the chemical solution is filled in a desired amount corresponding to the position of the stopper. The Therefore, this method can be called a movement amount limiting method.[Pg 5, P-2]
The suction control unit 58 can be configured as a so-called microcomputer, and can have an interface with a CPU, ROM, RAM, and other devices. A computer program for controlling the chemical suction device 30 is mounted in the ROM. The computer program can be configured to cause a system including the chemical liquid suction device 30 to execute processing related to the operation of the chemical liquid suction device 30, for example, processing performed by the suction control unit 58. The CPU controls the operation of each part of the chemical liquid suction device 30 by executing each function corresponding to this computer program. The RAM temporarily stores data acquired by the barcode reader 151, data acquired by the RFID module 52, suction amount (set value, calculated actual suction amount, or both), and the like.[ Pg 5, P-8]
Also, the suction control unit 58 has a clock function using a clock possessed by the CPU, and can include the current date and time (current time) in the data. It is recommended that the drug solution, particularly the contrast agent, be used within a predetermined time after the drug solution container 20 is transferred from the drug solution container 20 to the syringe 10, and preferably after the drug solution container 20 is opened. Also referred to as “recommended expiration date after aspiration”). Therefore, if one of the data to be written in the RFID tag 503 includes the date and time when the chemical solution is sucked, when the chemical solution is injected using a chemical solution injection device capable of reading the data recorded in the RFID tag 503, the suction is performed. The chemical injection device can determine how much time has passed since the end date and time.[Pg 5, P-9]
On the other hand, when the cylinder member 501 is held by the cylinder holder 32, the attachment / detachment detection sensor 54 detects the holding of the cylinder member 501, in other words, the attachment of the syringe 10 to the chemical liquid suction device 30. When the attachment of the syringe 10 is detected, the suction control unit 58 sets the barcode reader 51 in a state where data can be read. Therefore, when the user holds the scanner head over the barcode 23 of the chemical solution container 20, the barcode reader 51 reads the barcode 23 and the chemical solution data is acquired from the barcode 23.[Pg 6, P-6]
In addition, after detecting that the syringe 10 is mounted on the chemical liquid suction device 30, the suction control unit 58 controls the operation of the piston drive mechanism 53, whereby the piston member 502 is pushed most into the cylinder member 501. The piston member 502 may be reciprocated a plurality of times within a predetermined range including the most advanced position, which is the position at which it is located. Thereby, the air bleeding which sends the air in the connection tube 12 and the syringe 10 into the chemical | medical solution container 20 can be performed. By venting the syringe 10 with the chemical liquid suction device 30, it is possible to eliminate the need for air venting when the chemical liquid is injected with the chemical liquid injector described below.[Pg 6, P-7]
Therefore, it is obvious to one of ordinary skill in the art to combine Nemoto’s teaching with Maffei modified’s teaching in order to enable a more cost effective concise way of measuring and administering medical solutions to patients accordingly.
In regards to claim 4, Maffei modified via Udagawa teaches the wireless communication device is configured to communicate via at least one of Bluetooth, Wi-Fi, and NFC (such as RFID communication) (Udagawa, Paragraph 109).
Although one embodiment of the injection head has been described above, other than the arrangements disclosed above, various modifications are possible as the injection head. For example, the injection head may include one or plurality of the following components: an inclination sensor, a motor-current detector, an RFID (radio frequency identification) communication device, a data receiver, a data transmitter and so on. The inclination sensor detects an inclination of the injection head. Generally, in the injection head of this type, the suction of chemical liquid into the syringe is executed in a posture in which a distal-end side (in other words, a syringe-side) of the injection head becomes upward. Whereas, the injecting of chemical liquid is executed in a posture in which the distal-end side of the injection head becomes relatively downward (posture in which the tip-end side is directed somewhat downward). By using a detection result of the inclination sensor, it is possible to prevent the suction of chemical liquid or injecting of chemical liquid in a posture which is not desirable. Motor-current detector monitors a motor current while the motor is in operation, and the control circuit calculates an estimated value of a pressure of the chemical liquid on the basis of the motor current. The RFID communication device is a device which, by a non-contact method, reads information of IC tags attached to the syringe, the protective case, or other members. A writing function may have been provided according to the requirement. The data receiver is for receiving predetermined information transmitted from external equipment. The data transmitter is for transmitting predetermined information from the injection head to external equipment.[P-109]
In regards to claim 5, Maffei modified teaches when the motor moves the drive member, it moves the stopper within the syringe barrel to either aspirate fluid from a container into the syringe or expel fluid from the syringe barrel into a container, for preparation purposes (Paragraphs 74, 75, Maffei)
At practical level, once the syringe device 2 and the operating device 12 have been coupled together, the processing unit 18 automatically commands the forward movement of the thrust rod 15 until this has coupled with the piston 4. In this phase, the processing unit 18 proceeds to identify the cartridge 2 by means of the reading/writing means 22 which connect up to the storage means 21 and, in the event of its recognizing the cartridge 2 as being authentic, it permits the subsequent operation of the motor means 17.[P-74]
Then, from time to time, the processing unit 18 automatically drives the thrust rod 15, according to the predefined program, so this slides along stroke lengths corresponding to the quantity of biomedical fluid to be taken and/or dispensed. The operator can nevertheless exploit the possibility of a transparent syringe body 3 with graduated scale (like that shown on the attached tables) in order to make a visual check of the taking or dispensing of the liquid, for the purpose of a definitive safety control.[P-75]
In regards to claim 6, Maffei modified via Udagawa teaches the position sensor measures the position of the plunger interface of the drive member such that the position of the syringe barrel is determined (Udagawa, Paragraphs 96, 109).
In the present embodiment, the following control may be carried out by using the features of the operating knob 171. As shown in a flowchart in Fig. 9, the control circuit 150, to start with, monitors a detection result of the position sensor 162 (refer to Fig. 4) (step S11). Moreover, the control circuit 150 makes a judgment of whether or not the ram member 131 has moved up to an end portion (most advanced position or most retreated position) of the movable range thereof (step S12). It is possible to carry out this judgment on the basis of a detection result of the first position sensor and the second position sensor.[P-96]
Although one embodiment of the injection head has been described above, other than the arrangements disclosed above, various modifications are possible as the injection head. For example, the injection head may include one or plurality of the following components: an inclination sensor, a motor-current detector, an RFID (radio frequency identification) communication device, a data receiver, a data transmitter and so on. The inclination sensor detects an inclination of the injection head. Generally, in the injection head of this type, the suction of chemical liquid into the syringe is executed in a posture in which a distal-end side (in other words, a syringe-side) of the injection head becomes upward. Whereas, the injecting of chemical liquid is executed in a posture in which the distal-end side of the injection head becomes relatively downward (posture in which the tip-end side is directed somewhat downward). By using a detection result of the inclination sensor, it is possible to prevent the suction of chemical liquid or injecting of chemical liquid in a posture which is not desirable. Motor-current detector monitors a motor current while the motor is in operation, and the control circuit calculates an estimated value of a pressure of the chemical liquid on the basis of the motor current. The RFID communication device is a device which, by a non-contact method, reads information of IC tags attached to the syringe, the protective case, or other members. A writing function may have been provided according to the requirement. The data receiver is for receiving predetermined information transmitted from external equipment. The data transmitter is for transmitting predetermined information from the injection head to external equipment.[P-109]
In regards to claim 7, Maffei modified via Udagawa teaches the processor is adapted to communicate with the motor to move the drive member to a position that corresponds to a position based on the position sensor which corresponds to information from the wireless communication device (Udagawa, Paragraph 109).
Although one embodiment of the injection head has been described above, other than the arrangements disclosed above, various modifications are possible as the injection head. For example, the injection head may include one or plurality of the following components: an inclination sensor, a motor-current detector, an RFID (radio frequency identification) communication device, a data receiver, a data transmitter and so on. The inclination sensor detects an inclination of the injection head. Generally, in the injection head of this type, the suction of chemical liquid into the syringe is executed in a posture in which a distal-end side (in other words, a syringe-side) of the injection head becomes upward. Whereas, the injecting of chemical liquid is executed in a posture in which the distal-end side of the injection head becomes relatively downward (posture in which the tip-end side is directed somewhat downward). By using a detection result of the inclination sensor, it is possible to prevent the suction of chemical liquid or injecting of chemical liquid in a posture which is not desirable. Motor-current detector monitors a motor current while the motor is in operation, and the control circuit calculates an estimated value of a pressure of the chemical liquid on the basis of the motor current. The RFID communication device is a device which, by a non-contact method, reads information of IC tags attached to the syringe, the protective case, or other members. A writing function may have been provided according to the requirement. The data receiver is for receiving predetermined information transmitted from external equipment. The data transmitter is for transmitting predetermined information from the injection head to external equipment.[P-109]
In regards to claim 8, Maffei teaches a system for drug preparation comprising: a drug transfer device comprising: a housing configured to be handheld by a user (Abstract; Paragraph 50)
The appliance for transferring biomedical fluids between hospital receptacles includes: a syringe device including a hollow body for containing the fluid and one sliding piston fitted sealed in the body, the latter having a first end, which has joining elements for joining with a hospital receptacle, and a second open end; a grippable operating device including a fastening seat which can be coupled in a removable way to the second end, which includes a thrust rod suitable for sliding through the second end; temporary fastening elements for coupling the rod and piston in a releasable way; motor elements for operating the rod; and control elements connected to the motor elements for controlling both the volumetric dosage of the quantity of fluid taken from a first hospital receptacle or dispensed in a second hospital receptacle. Storage elements are mounted on the syringe device, and the operating device includes reading/writing elements.[Abstr]
The proposed appliance 1 further comprises an operating device 12 that can be gripped (see FIG. 3), which in turn comprises a fastening seat 13 which can be coupled in a removable way to said second end 6 of the syringe device 2 (by means of releasable coupling means 16, 16', such as bayonet couplings or the like).[P-50]
Maffei then teaches a syringe interface on an exterior surface of the housing and configured to receive a plurality of syringe barrel sizes, a drive member movable relative to the syringe interface, the drive member configured to move a stopper within a syringe barrel when the syringe barrel is engaged with the syringe interface (Paragraphs 46, 50, 52, 53; Figures 3, 4)
The dimensions of the syringe body 3 can vary according to the required containment capacity (e.g.: 10 ml, 20 ml, 30 ml, 50 ml or 60 ml).[P-46]
The proposed appliance 1 further comprises an operating device 12 that can be gripped (see FIG. 3), which in turn comprises a fastening seat 13 which can be coupled in a removable way to said second end 6 of the syringe device 2 (by means of releasable coupling means 16, 16', such as bayonet couplings or the like).[P-50]
As shown in the FIGS. 3 and 4, the operating device 12 first of all includes a thrust rod 15 suitable for sliding longitudinally through said second end 6, following the coupling between said syringe device 2 and said operating device 12. [P-52]
In practice, the syringe device 2 is meant to be fitted on the operating device 12 in its fastening seat 13, preferably placed at one front end, at which seat, the thrust rod 15 exits from the rest of the operating device 12 and is meant to cross the second end 6 of the syringe device 2 so as to be able to reach the piston 4. Temporary fastening means (such as a bayonet coupling or other coupling means suitable for the purpose) are therefore provided for the releasable coupling between the rod and the piston 4, suitable for enabling the operation of the rod to produce the sliding of the piston 4 within the syringe body 3 (and therefore the taking or dosing of the fluid).[P-53]
Maffei teaches a motor configured to move the drive member; a position sensor configured to measure a position of the drive member; a wireless communication device configured to send and receive information (Paragraph 57)
For the purpose of cooperating with such storage means 21, the operating device 12 advantageously comprises reading/writing means 22 for reading and writing the information from/on the storage means 21 of the syringe device 2, and furthermore, the above control means comprise a processing unit 18 able to control the reading/writing means 22 and also able to process said information according to a predefined program, the processing unit 18 can be connected to external electronic devices (by means of electronic Wi-Fi connection or by means of USB ports, etc . . . ).[P-57]
Furthermore, Maffei teaches an information reader (comprising at least one of a barcode reader, an RFID reader, and an NFC reader) configured to receive information from an information target, the information reader comprising at least one of a barcode reader, an RFID reader, and an NFC reader and the information target comprising at least one of a barcode, an RFID tag, and an NFC tag (Paragraphs 56, 57)
In an innovative and original way, the appliance 1 of the invention comprises storage means 21 (such as EEPROM memories or other electronic storage devices such as RFID tag, etc.), mounted on the syringe device 2 (and which can be seen in the FIGS. 2 and 3), and able to store information relating to the type of transferred fluid, the quantity of taken fluid, the quantity of dispensed fluid, when each dose has been taken and/or dispensed and how many doses have been dispensed/taken (and if necessary also other information, as will be explained later on).[P-56]
For the purpose of cooperating with such storage means 21, the operating device 12 advantageously comprises reading/writing means 22 for reading and writing the information from/on the storage means 21 of the syringe device 2, and furthermore, the above control means comprise a processing unit 18 able to control the reading/writing means 22 and also able to process said information according to a predefined program, the processing unit 18 can be connected to external electronic devices (by means of electronic Wi-Fi connection or by means of USB ports, etc . . . ).[P-57]
At least one processor in communication with the motor, the position sensor, the wireless communication device, and the information reader, and wherein movement of the stopper may either aspirate fluid into the syringe barrel or expel fluid from the syringe barrel(Paragraphs 57, 72, 74, 75)
For the purpose of cooperating with such storage means 21, the operating device 12 advantageously comprises reading/writing means 22 for reading and writing the information from/on the storage means 21 of the syringe device 2, and furthermore, the above control means comprise a processing unit 18 able to control the reading/writing means 22 and also able to process said information according to a predefined program, the processing unit 18 can be connected to external electronic devices (by means of electronic Wi-Fi connection or by means of USB ports, etc . . . ).[P-57]
Always preferably, the aforementioned control means 18 are programmable so as to automatically set the doses of fluid to take and dispense, both in the case relating to doses of different medicinal substances to use in the same therapy or, on the contrary, in the case of doses of the same medicinal substance to dispense in bags included in different infusion lines and then connected to different patients, etc . . .[P-72]
At practical level, once the syringe device 2 and the operating device 12 have been coupled together, the processing unit 18 automatically commands the forward movement of the thrust rod 15 until this has coupled with the piston 4. In this phase, the processing unit 18 proceeds to identify the cartridge 2 by means of the reading/writing means 22 which connect up to the storage means 21 and, in the event of its recognizing the cartridge 2 as being authentic, it permits the subsequent operation of the motor means 17.[P-74]
Then, from time to time, the processing unit 18 automatically drives the thrust rod 15, according to the predefined program, so this slides along stroke lengths corresponding to the quantity of biomedical fluid to be taken and/or dispensed. The operator can nevertheless exploit the possibility of a transparent syringe body 3 with graduated scale (like that shown on the attached tables) in order to make a visual check of the taking or dispensing of the liquid, for the purpose of a definitive safety control.[P-75]
Maffei fails to teach the drive member is configured to automatically move the stopper based upon the information received from the information target, Udagawa on the other hand teaches the drive member is configured to automatically move the stopper based upon the information received from the information target (Abstract; Paragraph 65)
A chemical-liquid injector includes a piston-driving mechanism (130) that moves a piston member of a syringe containing a contrast medium, which includes an actuator and a ram member which is moved back and forth by the actuator, a control circuit (150) which is electrically connected to the actuator, and an operating knob unit (170) which includes an operating knob that is to be operated by an operator, and a rotation sensor that outputs an electric signal corresponding to a rotation of the operating knob. The control circuit is configured to generate a predetermined control signal accordingly, on the basis of a signal from the rotation sensor, and the piston-driving mechanism is operated according to the control signal.[Abstr]
As a specific example, it is possible to carry out detection by using the plurality of magnets, where, in a case of both N (north) poles, it will be detected as a first type, in a case of both S (south) poles, it will be detected as a second type, in a case of one N-pole and the other S-pole, it will be detected as a third type, and in a case of one S-pole and the other N-pole, it will be detected as a fourth type. In an embodiment, it is preferable that the chemical-liquid injector is configured to set automatically the movable range of the ram member on the basis of the information read in such manner. Moreover, the chemical-liquid injector may have been configured to identify a type of the chemical liquid or a product name, or whether or not it is a pre-filled syringe.[P-65]
Therefore, it would have been obvious to one of ordinary skill in the art during the filing date of the invention to combine Odagawa’s teaching with Maffei’s teaching in order to enable a more cost effective concise way of measuring and administering medical solutions
Maffei modified fails to teach automatically moving the stopper based upon the information received from the information target, the at least one processor controls the motor to move the drive member to aspirate or expel a required amount of the fluid into or from the syringe barrel, as determined from the information received from the information target.
Nemoto on the other hand teaches automatically moving the stopper based upon the information received from the information target, the at least one processor controls the motor to move the drive member to aspirate or expel a required amount of the fluid into or from the syringe barrel, as determined from the information received from the information target (Page 5, Paragraphs 2, 8, 9; Page 6, Paragraphs 6, 7)
For example, a stopper provided with a limit switch that detects the position of the piston holder 33 by contacting the piston holder 33 as the piston holder 33 moves is provided in a direction parallel to the moving direction of the piston holder 32 below the piston holder 33. It is possible to adopt a mechanical configuration that is supported in a freely movable manner. As long as the position of the piston holder 33 can be detected, the limit switch may have any configuration such as an optical sensor such as a photocoupler or a magnet limit switch. According to this configuration, if the operation of the piston drive mechanism 53 is stopped when the limit switch comes into contact with the piston holder 33 and is turned on, the chemical solution is filled in a desired amount corresponding to the position of the stopper. The Therefore, this method can be called a movement amount limiting method.[Pg 5, P-2]
The suction control unit 58 can be configured as a so-called microcomputer, and can have an interface with a CPU, ROM, RAM, and other devices. A computer program for controlling the chemical suction device 30 is mounted in the ROM. The computer program can be configured to cause a system including the chemical liquid suction device 30 to execute processing related to the operation of the chemical liquid suction device 30, for example, processing performed by the suction control unit 58. The CPU controls the operation of each part of the chemical liquid suction device 30 by executing each function corresponding to this computer program. The RAM temporarily stores data acquired by the barcode reader 151, data acquired by the RFID module 52, suction amount (set value, calculated actual suction amount, or both), and the like.[ Pg 5, P-8]
Also, the suction control unit 58 has a clock function using a clock possessed by the CPU, and can include the current date and time (current time) in the data. It is recommended that the drug solution, particularly the contrast agent, be used within a predetermined time after the drug solution container 20 is transferred from the drug solution container 20 to the syringe 10, and preferably after the drug solution container 20 is opened. Also referred to as “recommended expiration date after aspiration”). Therefore, if one of the data to be written in the RFID tag 503 includes the date and time when the chemical solution is sucked, when the chemical solution is injected using a chemical solution injection device capable of reading the data recorded in the RFID tag 503, the suction is performed. The chemical injection device can determine how much time has passed since the end date and time.[Pg 5, P-9]
On the other hand, when the cylinder member 501 is held by the cylinder holder 32, the attachment / detachment detection sensor 54 detects the holding of the cylinder member 501, in other words, the attachment of the syringe 10 to the chemical liquid suction device 30. When the attachment of the syringe 10 is detected, the suction control unit 58 sets the barcode reader 51 in a state where data can be read. Therefore, when the user holds the scanner head over the barcode 23 of the chemical solution container 20, the barcode reader 51 reads the barcode 23 and the chemical solution data is acquired from the barcode 23.[Pg 6, P-6]
In addition, after detecting that the syringe 10 is mounted on the chemical liquid suction device 30, the suction control unit 58 controls the operation of the piston drive mechanism 53, whereby the piston member 502 is pushed most into the cylinder member 501. The piston member 502 may be reciprocated a plurality of times within a predetermined range including the most advanced position, which is the position at which it is located. Thereby, the air bleeding which sends the air in the connection tube 12 and the syringe 10 into the chemical | medical solution container 20 can be performed. By venting the syringe 10 with the chemical liquid suction device 30, it is possible to eliminate the need for air venting when the chemical liquid is injected with the chemical liquid injector described below.[Pg 6, P-7]
Therefore, it is obvious to one of ordinary skill in the art to combine Nemoto’s teaching with Maffei modified’s teaching in order to enable a more cost effective concise way of measuring and administering medical solutions to patients accordingly.
In regards to claim 12, Maffei modified via Udagawa teaches the wireless communication device is configured to communicate via at least one of Bluetooth, Wi-Fi, and NFC (such as RFID communication) (Udagawa, Paragraph 109).
Although one embodiment of the injection head has been described above, other than the arrangements disclosed above, various modifications are possible as the injection head. For example, the injection head may include one or plurality of the following components: an inclination sensor, a motor-current detector, an RFID (radio frequency identification) communication device, a data receiver, a data transmitter and so on. The inclination sensor detects an inclination of the injection head. Generally, in the injection head of this type, the suction of chemical liquid into the syringe is executed in a posture in which a distal-end side (in other words, a syringe-side) of the injection head becomes upward. Whereas, the injecting of chemical liquid is executed in a posture in which the distal-end side of the injection head becomes relatively downward (posture in which the tip-end side is directed somewhat downward). By using a detection result of the inclination sensor, it is possible to prevent the suction of chemical liquid or injecting of chemical liquid in a posture which is not desirable. Motor-current detector monitors a motor current while the motor is in operation, and the control circuit calculates an estimated value of a pressure of the chemical liquid on the basis of the motor current. The RFID communication device is a device which, by a non-contact method, reads information of IC tags attached to the syringe, the protective case, or other members. A writing function may have been provided according to the requirement. The data receiver is for receiving predetermined information transmitted from external equipment. The data transmitter is for transmitting predetermined information from the injection head to external equipment.[P-109]
In regards to claim 13, Maffei modified teaches when the motor moves the drive member, it moves the stopper within the syringe barrel to either aspirate fluid from a container into the syringe or expel fluid from the syringe barrel into a container, for preparation purposes (Paragraphs 74, 75, Maffei)
At practical level, once the syringe device 2 and the operating device 12 have been coupled together, the processing unit 18 automatically commands the forward movement of the thrust rod 15 until this has coupled with the piston 4. In this phase, the processing unit 18 proceeds to identify the cartridge 2 by means of the reading/writing means 22 which connect up to the storage means 21 and, in the event of its recognizing the cartridge 2 as being authentic, it permits the subsequent operation of the motor means 17.[P-74]
Then, from time to time, the processing unit 18 automatically drives the thrust rod 15, according to the predefined program, so this slides along stroke lengths corresponding to the quantity of biomedical fluid to be taken and/or dispensed. The operator can nevertheless exploit the possibility of a transparent syringe body 3 with graduated scale (like that shown on the attached tables) in order to make a visual check of the taking or dispensing of the liquid, for the purpose of a definitive safety control.[P-75]
In regards to claim 14, Maffei modified via Udagawa teaches the position sensor measures the position of a plunger interface of the drive member such that the position of the syringe barrel is determined (Udagawa, Paragraphs 96, 109).
In the present embodiment, the following control may be carried out by using the features of the operating knob 171. As shown in a flowchart in Fig. 9, the control circuit 150, to start with, monitors a detection result of the position sensor 162 (refer to Fig. 4) (step S11). Moreover, the control circuit 150 makes a judgment of whether or not the ram member 131 has moved up to an end portion (most advanced position or most retreated position) of the movable range thereof (step S12). It is possible to carry out this judgment on the basis of a detection result of the first position sensor and the second position sensor.[P-96]
Although one embodiment of the injection head has been described above, other than the arrangements disclosed above, various modifications are possible as the injection head. For example, the injection head may include one or plurality of the following components: an inclination sensor, a motor-current detector, an RFID (radio frequency identification) communication device, a data receiver, a data transmitter and so on. The inclination sensor detects an inclination of the injection head. Generally, in the injection head of this type, the suction of chemical liquid into the syringe is executed in a posture in which a distal-end side (in other words, a syringe-side) of the injection head becomes upward. Whereas, the injecting of chemical liquid is executed in a posture in which the distal-end side of the injection head becomes relatively downward (posture in which the tip-end side is directed somewhat downward). By using a detection result of the inclination sensor, it is possible to prevent the suction of chemical liquid or injecting of chemical liquid in a posture which is not desirable. Motor-current detector monitors a motor current while the motor is in operation, and the control circuit calculates an estimated value of a pressure of the chemical liquid on the basis of the motor current. The RFID communication device is a device which, by a non-contact method, reads information of IC tags attached to the syringe, the protective case, or other members. A writing function may have been provided according to the requirement. The data receiver is for receiving predetermined information transmitted from external equipment. The data transmitter is for transmitting predetermined information from the injection head to external equipment.[P-109]
In regards to claim 15, Udagawa modified teaches the processor is adapted to communicate with the motor to move the drive member to a position that corresponds to a position based on the position sensor which corresponds to information from the wireless communication device (Udagawa, Paragraph 109).
Although one embodiment of the injection head has been described above, other than the arrangements disclosed above, various modifications are possible as the injection head. For example, the injection head may include one or plurality of the following components: an inclination sensor, a motor-current detector, an RFID (radio frequency identification) communication device, a data receiver, a data transmitter and so on. The inclination sensor detects an inclination of the injection head. Generally, in the injection head of this type, the suction of chemical liquid into the syringe is executed in a posture in which a distal-end side (in other words, a syringe-side) of the injection head becomes upward. Whereas, the injecting of chemical liquid is executed in a posture in which the distal-end side of the injection head becomes relatively downward (posture in which the tip-end side is directed somewhat downward). By using a detection result of the inclination sensor, it is possible to prevent the suction of chemical liquid or injecting of chemical liquid in a posture which is not desirable. Motor-current detector monitors a motor current while the motor is in operation, and the control circuit calculates an estimated value of a pressure of the chemical liquid on the basis of the motor current. The RFID communication device is a device which, by a non-contact method, reads information of IC tags attached to the syringe, the protective case, or other members. A writing function may have been provided according to the requirement. The data receiver is for receiving predetermined information transmitted from external equipment. The data transmitter is for transmitting predetermined information from the injection head to external equipment.[P-109]
In regards to claim 17, Maffei modified via Nemoto teaches when the drive member operates to aspirate the required amount of fluid into the syringe barrel stopper as determined from the information received from the information target, the required dose of fluid is determined based on information stored on the processor or accessed from a server or other remote device via the wireless communication device(Page 5, Paragraphs 2, 8, 9; Page 6, Paragraphs 6, 7)
For example, a stopper provided with a limit switch that detects the position of the piston holder 33 by contacting the piston holder 33 as the piston holder 33 moves is provided in a direction parallel to the moving direction of the piston holder 32 below the piston holder 33. It is possible to adopt a mechanical configuration that is supported in a freely movable manner. As long as the position of the piston holder 33 can be detected, the limit switch may have any configuration such as an optical sensor such as a photocoupler or a magnet limit switch. According to this configuration, if the operation of the piston drive mechanism 53 is stopped when the limit switch comes into contact with the piston holder 33 and is turned on, the chemical solution is filled in a desired amount corresponding to the position of the stopper. The Therefore, this method can be called a movement amount limiting method.[Pg 5, P-2]
The suction control unit 58 can be configured as a so-called microcomputer, and can have an interface with a CPU, ROM, RAM, and other devices. A computer program for controlling the chemical suction device 30 is mounted in the ROM. The computer program can be configured to cause a system including the chemical liquid suction device 30 to execute processing related to the operation of the chemical liquid suction device 30, for example, processing performed by the suction control unit 58. The CPU controls the operation of each part of the chemical liquid suction device 30 by executing each function corresponding to this computer program. The RAM temporarily stores data acquired by the barcode reader 151, data acquired by the RFID module 52, suction amount (set value, calculated actual suction amount, or both), and the like.[ Pg 5, P-8]
Also, the suction control unit 58 has a clock function using a clock possessed by the CPU, and can include the current date and time (current time) in the data. It is recommended that the drug solution, particularly the contrast agent, be used within a predetermined time after the drug solution container 20 is transferred from the drug solution container 20 to the syringe 10, and preferably after the drug solution container 20 is opened. Also referred to as “recommended expiration date after aspiration”). Therefore, if one of the data to be written in the RFID tag 503 includes the date and time when the chemical solution is sucked, when the chemical solution is injected using a chemical solution injection device capable of reading the data recorded in the RFID tag 503, the suction is performed. The chemical injection device can determine how much time has passed since the end date and time.[Pg 5, P-9]
On the other hand, when the cylinder member 501 is held by the cylinder holder 32, the attachment / detachment detection sensor 54 detects the holding of the cylinder member 501, in other words, the attachment of the syringe 10 to the chemical liquid suction device 30. When the attachment of the syringe 10 is detected, the suction control unit 58 sets the barcode reader 51 in a state where data can be read. Therefore, when the user holds the scanner head over the barcode 23 of the chemical solution container 20, the barcode reader 51 reads the barcode 23 and the chemical solution data is acquired from the barcode 23.[Pg 6, P-6]
In addition, after detecting that the syringe 10 is mounted on the chemical liquid suction device 30, the suction control unit 58 controls the operation of the piston drive mechanism 53, whereby the piston member 502 is pushed most into the cylinder member 501. The piston member 502 may be reciprocated a plurality of times within a predetermined range including the most advanced position, which is the position at which it is located. Thereby, the air bleeding which sends the air in the connection tube 12 and the syringe 10 into the chemical | medical solution container 20 can be performed. By venting the syringe 10 with the chemical liquid suction device 30, it is possible to eliminate the need for air venting when the chemical liquid is injected with the chemical liquid injector described below.[Pg 6, P-7]
In regards to claim 18, Maffei modified via Nemoto teaches when the drive member operates to aspirate the required amount of fluid into the syringe barrel stopper as determined from the information received from the information target, the required dose of fluid is determined based on information stored on the processor or accessed from a server or other remote device via the wireless communication device(Page 5, Paragraphs 2, 8, 9; Page 6, Paragraphs 6, 7)
For example, a stopper provided with a limit switch that detects the position of the piston holder 33 by contacting the piston holder 33 as the piston holder 33 moves is provided in a direction parallel to the moving direction of the piston holder 32 below the piston holder 33. It is possible to adopt a mechanical configuration that is supported in a freely movable manner. As long as the position of the piston holder 33 can be detected, the limit switch may have any configuration such as an optical sensor such as a photocoupler or a magnet limit switch. According to this configuration, if the operation of the piston drive mechanism 53 is stopped when the limit switch comes into contact with the piston holder 33 and is turned on, the chemical solution is filled in a desired amount corresponding to the position of the stopper. The Therefore, this method can be called a movement amount limiting method.[Pg 5, P-2]
The suction control unit 58 can be configured as a so-called microcomputer, and can have an interface with a CPU, ROM, RAM, and other devices. A computer program for controlling the chemical suction device 30 is mounted in the ROM. The computer program can be configured to cause a system including the chemical liquid suction device 30 to execute processing related to the operation of the chemical liquid suction device 30, for example, processing performed by the suction control unit 58. The CPU controls the operation of each part of the chemical liquid suction device 30 by executing each function corresponding to this computer program. The RAM temporarily stores data acquired by the barcode reader 151, data acquired by the RFID module 52, suction amount (set value, calculated actual suction amount, or both), and the like.[ Pg 5, P-8]
Also, the suction control unit 58 has a clock function using a clock possessed by the CPU, and can include the current date and time (current time) in the data. It is recommended that the drug solution, particularly the contrast agent, be used within a predetermined time after the drug solution container 20 is transferred from the drug solution container 20 to the syringe 10, and preferably after the drug solution container 20 is opened. Also referred to as “recommended expiration date after aspiration”). Therefore, if one of the data to be written in the RFID tag 503 includes the date and time when the chemical solution is sucked, when the chemical solution is injected using a chemical solution injection device capable of reading the data recorded in the RFID tag 503, the suction is performed. The chemical injection device can determine how much time has passed since the end date and time.[Pg 5, P-9]
On the other hand, when the cylinder member 501 is held by the cylinder holder 32, the attachment / detachment detection sensor 54 detects the holding of the cylinder member 501, in other words, the attachment of the syringe 10 to the chemical liquid suction device 30. When the attachment of the syringe 10 is detected, the suction control unit 58 sets the barcode reader 51 in a state where data can be read. Therefore, when the user holds the scanner head over the barcode 23 of the chemical solution container 20, the barcode reader 51 reads the barcode 23 and the chemical solution data is acquired from the barcode 23.[Pg 6, P-6]
In addition, after detecting that the syringe 10 is mounted on the chemical liquid suction device 30, the suction control unit 58 controls the operation of the piston drive mechanism 53, whereby the piston member 502 is pushed most into the cylinder member 501. The piston member 502 may be reciprocated a plurality of times within a predetermined range including the most advanced position, which is the position at which it is located. Thereby, the air bleeding which sends the air in the connection tube 12 and the syringe 10 into the chemical | medical solution container 20 can be performed. By venting the syringe 10 with the chemical liquid suction device 30, it is possible to eliminate the need for air venting when the chemical liquid is injected with the chemical liquid injector described below.[Pg 6, P-7]
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maffei (US 20150224029 A1) in view Udagawa et al. (EP 3284492 A1) and Nemoto (WO 2016039298 A1) as applied to claims 1 and 8 above, and further in view of Gillespie Jr. et al. (US 20030233069 A1).
In regards to claim 2, Maffei modified via Ugadawa modified teaches a battery (Paragraph 21), however is not specific to a rechargeable battery. Gillespie on the other hand teaches a rechargeable battery (Paragraphs 18).
According to one aspect of the invention, the infusion pump is configured to be powered by either a disposable battery or a rechargeable battery. The infusion pump has a housing having a recess. A motor is positioned within the housing and is operably connected to an electrical contact disposed in the recess. The motor powers the pump. The recess is adapted to receive one of a disposable battery unit and a rechargeable battery unit.[P-18]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Gillespie’s teaching with Maffei modified’s teaching in order to enable the recharging of the battery in situations where the battery is low.
In regards to claim 10, Maffei modified fails to teach a printer in communication with the drug transfer device and/or the medication workflow system. Gillespie teaches a printer in communication with the drug transfer device and/or the medication workflow system (Paragraph 102).
The pump 10 may also communicate directly to a printer. In one embodiment, a handheld printer having an appropriate data port, can be held up to the data port 76 of the pump 10. Via infrared communication, data can be transferred from the pump 10 and printed by the handheld computer.[P-102]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Gillespie’s teaching with Maffei modified’s teaching in order to enable the retrieval of information related to a component of the medical device(s) for the purpose of logging the medicament preparation and administering history and print the said information accordingly.
Response to Arguments
Examiner acknowledges applicants amended claims and has addressed them under new grounds of rejection.
Conclusion
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/ANTHONY D AFRIFA-KYEI/ Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/ Supervisory Patent Examiner, Art Unit 2686