DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed before March 16, 2013 is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 11/13/25 has been entered in the case. Claims 1-4,7-9, 12-13 are pending for examination; claim 16 is withdrawn and claims 5-6, 10-11, 14-15 are cancelled.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2009/0198215) in view of Laurent et al. (US 6,408,897) and Magliochetti et al. (US 5,729,653).
Regarding claim 1, Chong discloses a system, in Figs. 86A-C comprising:
a syringe 4260 having a filling needle (is to be modified by Laurent, as below) a reservoir 4260;
a vial of fluid 4250;
a fill adapter device 4240 comprising: a housing (includes elements 4241, 4242); a fluid pathway (inside the fill adapter device 4240); wherein the fill adapter device 4240 is configured to directly mate on the vial of fluid 4250, and wherein the system is configured such that, the syringe 4260 draws the fluid from the vial 4250, see Fig. 86B and para [0344], and when the fluid of the vial 4250 flows though the pathway (inside the fill adapter device 4240) and through a filling needle (as modified by Laurent, as below) for filling the reservoir 4260; a syringe 4210 (can be a syringe pump, as modified by Fig. 87A) to pump fluid into the fluid pathway (from the syringe 4260 into the fluid pathway, i.e., inside the fluid adapter device 4240) into at a predetermined rate.
Note: The Fig. 87A (different embodiment of Figs. 86A-C) comprising: a syringe pump 4310 is configured to pump fluid (from a vial 4350) into a fluid pathway 4343 at a predetermined rate. Therefore, a person skilled in the art would recognize that the syringe 4210 in Fig. 86C can be modified a syringe pump, as suggested in Fig. 87A in Chong, for the benefit of allowing a fluid flowing in the fluid pathway in the predetermined rate as desired.
Chong does not disclose the limitations that:
a filling needle; a septum of the housing in the fill adapter is being used for piercing by the filling needle;
a heat exchange that comprises: a heating element;
c) a processor configured to control the heating element in a plurality of preprogrammed profiles;
d) the fluid of the vial flows through the filling needle for filling the reservoir, the fluid flowing into the fluid pathway is heated by the heating element.
Laurent discloses a system comprising: a syringe 5 having a filling needle 12; a fill adapter device 2 comprising: a housing 13 that comprises a valve (i.e. septum 15b) for piercing by the filling needle 12/121, see Fig. 1. Note: the element 12 defines as a transfer means; and the element 121 defines as a nose. Since the nose 121 has a similar shape to a needle. Therefore, the nose 121 and the needle can be interchangeable as being used for transferring fluid. A person skilled in the art would recognize that the nose 121 can be replaced or equivalent as a needle as being used as a transfer means, i.e. for transferring a liquid.
Because both Chong and Laurent disclose a fluid transfer system, it would have been obvious to one skilled in the art to substitute one device (e.g., providing a valve, i.e. a septum, located in the housing of the fill adapter and a filling needle being a part of the syringe for the other to achieve sealing and to prevent of leaking when the syringe being connected to the fill adapter device.
Thus, Chong in view of Laurent device (see the marked-up Fig. 86A – Chong in view of Laurent below) comprising: a transfer guard 4240 includes a neck 17 & leak tight assembly means 50 (as modified by Laurent); wherein the filling needle 12 is part of the syringe 4260 (similar structure, e.g., the syringe 5 includes a filling needle 12, as modified by Laurent). In other words, Chong in view of Laurent discloses that the system is configured such that: the syringe 4260 draws the fluid from the vial 4250, and the fluid of the vial flows through the fluid pathway and through the filling needle 12 (as modified by Laurent) for filling the reservoir 4260.
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Chong in view of Laurent does not disclose the limitations that: a heat exchange that comprises: a heating element; a processor configured to control the heating element in a plurality of preprogrammed profiles; wherein the fluid flowing into the fluid pathway is heated by the heating element.
Magliochetti recognizes a typical problem for delivering (unheated) drug into a patient that the fluids are typically stored at room temperature which is much lower than a patient’s body temperature. Therefore, when introducing the cold fluids into a patient may well cause discomfort, shock, or another type of trauma, col. 1, lines 7-13. To solve the problem above, Magliochetti discloses a container device 10 (or equivalent to a fill adapter device) for heating a fluid to normothermic temperature prior to the delivery of the fluid to a patient for providing a comfort level to a patient, preventing shocking of cold fluid temperature to bring discomfort to the patient. Therefore, the fluid flowing in the fluid pathway (inside the chamber 12 or inside the housing 32) is heated by the heating element 26.
Magliochetti also discloses that the fill adapter device 10 comprising: a housing 32; a heat exchanger that comprises a heating element 26 inserted into a center wall 42 of the chamber 12, col. 4, lines 22-44; a processor 90 configured to control the heating element 26 in a plurality of preprogrammed profiles, col. 5, lines27-col 6, line 47, also see Figs. 9B & 10.
For example: a) the controller 72 can be equipped with a LED two-digital display 84 of the outlet fluid temperature for easy visual temperature monitoring. In addition, the front of the controller 72 can be equipped with one or more lights 86 for indicating a fault condition and/or whether the desired pre-determined outlet fluid temperature has been reached, a power ON/OFF switch 88 and a RESET switch 89 for easy operator access, col. 5,lines 27-34. In order to perform the functions, i.e., displaying the outlet (heated) fluid temperature, or the lights to indicating the fault condition or the desired heated fluid temperature, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
b) The internal circuit loop 90 for controlling temperature and power is shown in FIG. 10. The controller 72 supplies power from the power module 92 via electrical line 94 through electrical connection pads 80B and 78B to the heating element 26. The resistance of heating element 26 can be monitored via line 96 through electrical connection pads 80A and 78A by a resistance sensor 38 which can be disposed on the controller 72 (of the processor 90). … the electrical resistance of the heating element 26 itself can be used to measure the temperature of the heating element and correlated to fluid temperature. … Alternatively, the temperature monitoring element 34A (shown in dotted lines in FIG. 10) can be disposed on the controller …. This information can be transmitted back to the power module 92 via line 98A. … Additional temperature monitoring and control can be accomplished with an infrared temperature sensor 108 disposed on the controller 72 which senses outlet fluid temperature through a window 110 on the chamber outlet port 30 or elsewhere in the fluid line. This information can be relayed to the power module 92 via line 112 and also used for the temperature monitoring, col. 5, lines 39-col. 6, line 7. In order to perform the functions as described above, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
c) If the resistance or temperature exceeds a pre-determined level, the power module 92 can automatically shut off power to the heating element 26. In addition, the power module can sound an alarm 118 via line 120 and/or illuminate a warning light 86B via line 122 to warn the user of a fault condition. In order to perform these functions, i.e., auto shut off power or providing a warning alarm or warning light in fault condition, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Chong in view of Laurent with including a heat exchanger device (e.g. heating element inserted into a chamber); processor configured to control the heating element in a plurality of preprogrammed profiles and a fluid pathway inside the housing of the fill adapter device being heated, as taught by Magliochetti, for the benefits of controlling a heating fluid before delivery to a patient to prevent discomfort, shock or another type of trauma to the patient.
Regarding claim 2, Chong discloses in Fig. 86A that the syringe 4260 further comprising a reservoir 4260 including a plunger 4262 and a plunger rod 4263.
Regarding claim 3, Chong discloses in Fig. 86A (or Chong in view of Laurent and Magliochetti) that wherein the fluid pathway is fluidly connected to a filling needle input 4249 configured to guide fluid into the heat exchanger inside the fill adapter device 4240 (e.g. the heat exchanger includes the heating element, as modified by Magliochetti).
Regarding claim 4, wherein the filling needle 12 (as modified by Laurent) is configured to be removably attached to the reservoir/syringe 4260.
Regarding claim 7, Chong in view of Laurent and Magliochetti discloses all claimed subject matter as required in the claim 1. Laurent (or Chong in view of Laurent and Magliochetti) also discloses that the filling needle input is the septum, see the marked-up in claim 1 above.
Regarding claim 8, Chong in view of Laurent and Magliochetti discloses all claimed subject matter as required in the claim 1. Chong discloses that the fill adapter device 4240 is removably attached to the vial 4250.
Claims 9 & 12-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2009/0198215) in view of Magliochetti et al. (US 5,729,653).
Regarding claim 9, Chong discloses a fill adapter device 4240 in Fig. 86A comprising:
a fluid pathway (inside the fill adapter device 4240) connected to a filling needle input (a nose of the syringe 4260) and a vial 4250;
whereby fluid from the vial 4250 is pumped into the fluid pathway (inside the fill adapter device 4240) at a predetermined rate and wherein fluid (from the vial 4250) enters the heat exchanger (is to be modified by Magliochetti, as below) flows through the fluid pathway (a fluid passageway located inside the fill adapter device 4240) and whereby the fluid is heated by the heating element (is to be modified by Magliochetti, as below).
Chong does not disclose a heat exchanger including a heating element provided in the fill adapter device; a processor configured to control the heating element in a plurality of preprogrammed profiles; whereby the fluid is heated by the heating element.
Magliochetti recognizes a typical problem for delivering (unheated) drug into a patient that the fluids are typically stored at room temperature which is much lower than a patient’s body temperature. Therefore, when introducing the cold fluids into a patient may well cause discomfort, shock, or another type of trauma, col. 1, lines 7-13. To solve the problem above, Magliochetti discloses a container device 10 (or equivalent to a fill adapter device) for heating a fluid to normothermic temperature prior to the delivery of the fluid to a patient for providing a comfort level to a patient, preventing shocking of cold fluid temperature to bring discomfort to the patient. Therefore, the fluid flowing in the fluid pathway (inside the chamber 12 or inside the housing 32) is heated by the heating element 26.
Magliochetti also discloses that the fill adapter device 10 comprising: a housing 32; a heat exchanger that comprises a heating element 26 inserted into a center wall 42 of the chamber 12, col. 4, lines 22-44; a processor 90 configured to control the heating element 26 in a plurality of preprogrammed profiles, col. 5, lines27-col 6, line 47, also see Figs. 9B & 10.
For example: a) the controller 72 can be equipped with a LED two-digital display 84 of the outlet fluid temperature for easy visual temperature monitoring. In addition, the front of the controller 72 can be equipped with one or more lights 86 for indicating a fault condition and/or whether the desired pre-determined outlet fluid temperature has been reached, a power ON/OFF switch 88 and a RESET switch 89 for easy operator access, col. 5,lines 27-34. In order to perform the functions, i.e., displaying the outlet (heated) fluid temperature, or the lights to indicating the fault condition or the desired heated fluid temperature, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
b) The internal circuit loop 90 for controlling temperature and power is shown in FIG. 10. The controller 72 supplies power from the power module 92 via electrical line 94 through electrical connection pads 80B and 78B to the heating element 26. The resistance of heating element 26 can be monitored via line 96 through electrical connection pads 80A and 78A by a resistance sensor 38 which can be disposed on the controller 72 (of the processor 90). … the electrical resistance of the heating element 26 itself can be used to measure the temperature of the heating element and correlated to fluid temperature. … Alternatively, the temperature monitoring element 34A (shown in dotted lines in FIG. 10) can be disposed on the controller …. This information can be transmitted back to the power module 92 via line 98A. … Additional temperature monitoring and control can be accomplished with an infrared temperature sensor 108 disposed on the controller 72 which senses outlet fluid temperature through a window 110 on the chamber outlet port 30 or elsewhere in the fluid line. This information can be relayed to the power module 92 via line 112 and also used for the temperature monitoring, col. 5, lines 39-col. 6, line 7. In order to perform the functions as described above, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
c) If the resistance or temperature exceeds a pre-determined level, the power module 92 can automatically shut off power to the heating element 26. In addition, the power module can sound an alarm 118 via line 120 and/or illuminate a warning light 86B via line 122 to warn the user of a fault condition. In order to perform these functions, i.e., auto shut off power or providing a warning alarm or warning light in fault condition, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the fill adapter device of Chong with including a heat exchanger device (e.g. heating element inserted into a chamber); processor configured to control the heating element in a plurality of preprogrammed profiles and a fluid pathway inside the housing of the fill adapter device being heated, as taught by Magliochetti, for the benefits of controlling a heating fluid before delivery to a patient to prevent discomfort, shock or another type of trauma to the patient.
Alternatively, claim 9 is being rejected with respect to different embodiment in Fig. 92
Regarding claim 9, Chong discloses a fill adapter 4870, in Fig. 92 comprising:
a housing 4870 (can be interpreted as a heat exchanger, as modified by Magliochetti below)
a fluid pathway (inside a filter 4877, para [0358]); wherein the fluid pathway connected to a filling needle input 4871/4872 and a vial 4850, whereby fluid from the vial 4850 is pumped into the fluid pathway at a predetermined rate and wherein fluid enters the housing (or the heat exchanger, as modified by Magliochetti below) of the fill adapter fluidly connected to a filing needle input 4852 and a vial 4850; wherein fluid enters (via needle 4872) the housing 4870 and flows through the fluid pathway and whereby the fluid is heated by the heating element (as modified by Magliochetti below)
Chong does not disclose a heat exchanger including a heating element provided in the fill adapter device; a processor configured to control the heating element in a plurality of preprogrammed profiles; whereby the fluid is heated by the heating element.
Magliochetti recognizes a typical problem for delivering (unheated) drug into a patient that the fluids are typically stored at room temperature which is much lower than a patient’s body temperature. Therefore, when introducing the cold fluids into a patient may well cause discomfort, shock, or another type of trauma, col. 1, lines 7-13. To solve the problem above, Magliochetti discloses a container device 10 (or equivalent to a fill adapter device) for heating a fluid to normothermic temperature prior to the delivery of the fluid to a patient for providing a comfort level to a patient, preventing shocking of cold fluid temperature to bring discomfort to the patient. Therefore, the fluid flowing in the fluid pathway (inside the chamber 12 or inside the housing 32) is heated by the heating element 26.
Magliochetti also discloses that the fill adapter device 10 comprising: a housing 32; a heat exchanger that comprises a heating element 26 inserted into a center wall 42 of the chamber 12, col. 4, lines 22-44; a processor 90 configured to control the heating element 26 in a plurality of preprogrammed profiles, col. 5, lines27-col 6, line 47, also see Figs. 9B & 10.
For example: a) the controller 72 can be equipped with a LED two-digital display 84 of the outlet fluid temperature for easy visual temperature monitoring. In addition, the front of the controller 72 can be equipped with one or more lights 86 for indicating a fault condition and/or whether the desired pre-determined outlet fluid temperature has been reached, a power ON/OFF switch 88 and a RESET switch 89 for easy operator access, col. 5,lines 27-34. In order to perform the functions, i.e., displaying the outlet (heated) fluid temperature, or the lights to indicating the fault condition or the desired heated fluid temperature, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
b) The internal circuit loop 90 for controlling temperature and power is shown in FIG. 10. The controller 72 supplies power from the power module 92 via electrical line 94 through electrical connection pads 80B and 78B to the heating element 26. The resistance of heating element 26 can be monitored via line 96 through electrical connection pads 80A and 78A by a resistance sensor 38 which can be disposed on the controller 72 (of the processor 90). … the electrical resistance of the heating element 26 itself can be used to measure the temperature of the heating element and correlated to fluid temperature. … Alternatively, the temperature monitoring element 34A (shown in dotted lines in FIG. 10) can be disposed on the controller …. This information can be transmitted back to the power module 92 via line 98A. … Additional temperature monitoring and control can be accomplished with an infrared temperature sensor 108 disposed on the controller 72 which senses outlet fluid temperature through a window 110 on the chamber outlet port 30 or elsewhere in the fluid line. This information can be relayed to the power module 92 via line 112 and also used for the temperature monitoring, col. 5, lines 39-col. 6, line 7. In order to perform the functions as described above, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
c) If the resistance or temperature exceeds a pre-determined level, the power module 92 can automatically shut off power to the heating element 26. In addition, the power module can sound an alarm 118 via line 120 and/or illuminate a warning light 86B via line 122 to warn the user of a fault condition. In order to perform these functions, i.e., auto shut off power or providing a warning alarm or warning light in fault condition, the processor 90 is inherently to obtain the pre-programmed profiles so that the processor is able to control the heating element for heating desired fluid temperature.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the fill adapter device of Chong with including a heat exchanger device (e.g. heating element inserted into a chamber); processor configured to control the heating element in a plurality of preprogrammed profiles and a fluid pathway inside the housing of the fill adapter device being heated, as taught by Magliochetti, for the benefits of controlling a heating fluid before delivery to a patient to prevent discomfort, shock or another type of trauma to the patient.
Note: the heat exchanger or heat element 26 inserted into a wall of the chamber (or the fill transfer device 4870, as modified by Magliochetti). Therefore, when the fluid enters the housing 4870 (or heat exchanger, as modified by Magliochetti) and flows through the fluid pathway and whereby the fluid is heated by the heating element 26 (as suggested in Magliochetti)
Regarding claim 12, Chong in view of Magliochetti discloses all claimed subject matter as required in the claim 9. Chong discloses that the fill adapter device 4240 is removably attached to the vial 4250.
Regarding claim 13, Chong in view of Magliochetti discloses all claimed subject matter as required in the claim 9. Chong further discloses that the filling needle input 4852 is a septum.
Claims 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2009/0198215) in view of Magliochetti et al. (US 5,729,653) and further in view of Laurent et al. (US 6,408,897).
Regarding claim 13, Chong (as shown in Fig. 86A) in view of Magliochetti discloses all claimed subject matter as required in the claim 9 except for the limitation that a septum is provided in the filling needle input.
Laurent discloses a system comprising: a syringe 5 having a filling needle 12; a fill adapter device 2 comprising: a housing 13 that comprises a valve (i.e. septum 15b) for piercing by the filling needle 12/121, see Fig. 1. Note: the element 12 defines as a transfer means; and the element 121 defines as a nose. Since the nose 121 has a similar shape to a needle. Therefore, the nose 121 and the needle can be interchangeable as being used for transferring fluid. A person skilled in the art would recognize that the nose 121 can be replaced or equivalent as a needle as being used as a transfer means, i.e. for transferring a liquid.
Because both Chong and Laurent disclose a fluid transfer system, it would have been obvious to one skilled in the art to substitute one device (e.g., providing a valve, i.e. a septum, located in the housing of the fill adapter and a filling needle being a part of the syringe for the other to achieve sealing and to prevent of leaking when the syringe being connected to the fill adapter device.
Thus, Chong in view of Magliochetti and further in view of Laurent device (see the marked-up Fig. 86A – Chong in view of Laurent in the rejection in claim 1 above) comprising: a transfer guard 4240 includes a neck 17 & leak tight assembly means 50 (as modified by Laurent); wherein the filling needle 12 is part of the syringe 4260 (similar structure, e.g., the syringe 5 includes a filling needle 12, as modified by Laurent). In other words, Chong in view of Magliochetti & Laurent discloses that the system is configured such that: the syringe 4260 draws the fluid from the vial 4250, and the fluid of the vial flows through the fluid pathway and through the filling needle 12 (as modified by Laurent) for filling the reservoir 4260.
Claims 1-4, 8-9 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2009/0198215) in view of Laurent et al. (US 6,408,897) and Hart et al. (US 2002/0123737).
Regarding claim 1, Chong discloses a system, in Figs. 86A-C comprising:
a syringe 4260 having a filling needle (is to be modified by Laurent, as below) a reservoir 4260;
a vial of fluid 4250;
a fill adapter device 4240 comprising: a housing (includes elements 4241, 4242); a fluid pathway (inside the fill adapter device 4240); wherein the fill adapter device 4240 is configured to directly mate on the vial of fluid 4250, and wherein the system is configured such that, the syringe 4260 draws the fluid from the vial 4250, see Fig. 86B and para [0344], and when the fluid of the vial 4250 flows though the pathway (inside the fill adapter device 4240) and through a filling needle (as modified by Laurent, as below) for filling the reservoir 4260; a syringe 4210 (can be a syringe pump, as modified by Fig. 87A) to pump fluid into the fluid pathway (from the syringe 4260 into the fluid pathway, i.e., inside the fluid adapter device 4240) into at a predetermined rate.
Note: The Fig. 87A (different embodiment of Figs. 86A-C) comprising: a syringe pump 4310 is configured to pump fluid (from a vial 4350) into a fluid pathway 4343 at a predetermined rate. Therefore, a person skilled in the art would recognize that the syringe 4210 in Fig. 86C can be modified a syringe pump, as suggested in Fig. 87A in Chong, for the benefit of allowing a fluid flowing in the fluid pathway in the predetermined rate as desired.
Chong does not disclose the limitations that:
a filling needle; a septum of the housing in the fill adapter is being used for piercing by the filling needle;
a heat exchange that comprises: a heating element;
c) a processor configured to control the heating element in a plurality of preprogrammed profiles;
d) the fluid of the vial flows through the filling needle for filling the reservoir, the fluid flowing into the fluid pathway is heated by the heating element.
Laurent discloses a system comprising: a syringe 5 having a filling needle 12; a fill adapter device 2 comprising: a housing 13 that comprises a valve (i.e. septum 15b) for piercing by the filling needle 12/121, see Fig. 1. Note: the element 12 defines as a transfer means; and the element 121 defines as a nose. Since the nose 121 has a similar shape to a needle. Therefore, the nose 121 and the needle can be interchangeable as being used for transferring fluid. A person skilled in the art would recognize that the nose 121 can be replaced or equivalent as a needle as being used as a transfer means, i.e. for transferring a liquid.
Because both Chong and Laurent disclose a fluid transfer system, it would have been obvious to one skilled in the art to substitute one device (e.g., providing a valve, i.e. a septum, located in the housing of the fill adapter and a filling needle being a part of the syringe for the other to achieve sealing and to prevent of leaking when the syringe being connected to the fill adapter device.
Thus, Chong in view of Laurent device (see the marked-up Fig. 86A – Chong in view of Laurent below) comprising: a transfer guard 4240 includes a neck 17 & leak tight assembly means 50 (as modified by Laurent); wherein the filling needle 12 is part of the syringe 4260 (similar structure, e.g., the syringe 5 includes a filling needle 12, as modified by Laurent). In other words, Chong in view of Laurent discloses that the system is configured such that: the syringe 4260 draws the fluid from the vial 4250, and the fluid of the vial flows through the fluid pathway and through the filling needle 12 (as modified by Laurent) for filling the reservoir 4260.
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Chong in view of Laurent does not disclose a heat exchanger includes a heating element, the fluid flowing into the fluid pathway is heated by the heating element, as required in the claimed invention.
Hart discloses a system for transfer fluid, i.e. contrast solution or other fluids as well, para [0019], comprising: a fill adapter device 26 comprising: a housing 26; a heat exchanger 76 that comprise: a heating element 76 (e.g. heating coils, resistor coils or other heating devices; wherein the heater element 76 is provided in the manifold 26, para [0025]); and a fluid pathway (a passage located inside the manifold 26); wherein the fluid flowing in the fluid pathway is heated by the heating element 76. Hart recognizes that elevating the temperature of the fluid, which in turn decreases its density and decreases its viscosity and increase the speed flowing of the fluid, para [0026].
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the fill adapter device of Chong in view of Laurent with including a heat exchanger device (e.g. heating element is embedded in or attached to the manifold/fill adapter device) and a fluid pathway inside the housing of the fill adapter device being heated, as taught by Hart, for the benefits reducing the density and viscosity of the fluid to increase the speed flowing of the fluid.
Chong in view Laurent and Hart does not disclose that a processor configured to control the heating element in a plurality of preprogrammed profiles.
Neer discloses a system comprising: a reservoir or a housing 16; a heat exchanger 13 comprising: a heating element 18 (including heating coils disposed within the reservoir 16, para [0040]; a process 28 configured to control the heating element in a plurality of preprogrammed profiled (e.g., para [0031], … the controller 28 may have circuitry and/or code (Note: equivalent to the claimed preprogrammed profiled) adapted to control the temperature of the fluid 32, the rate of change of the temperature of the fluid 32. Para [0036], … the controller 28 may exercise feedback or feed forward control over a variety of parameters. For example, the controller 28 may receive feedback signals from the sensor 26 indicative of the fluid 32 temperature, ... In some embodiments, the controller 28 may output a signal to the heat source 18 in response to one or more of these feedback signals. Para [0037], … the controller 28 may signal the heat source 18 to stop adding heat 50 to the fluid 32, reduce the amount of heat added to the fluid 32, or apply heat 50 to the fluid 32 at a rate that maintains the temperature of the fluid 32.
Giving such a teaching by Neer, a person having ordinary skill in the art would have easily recognizes that modifying the device of Chong in view Laurent and Hart with a processor including plurality of preprogrammed profiles to control the heating element, as taught by Neer, would provide the benefit of controlling temperatures of the heating element in the reservoir to bring the desired temperature of the fluid in the reservoir.
Regarding claim 2, Chong discloses in Fig. 86A that the syringe 4260 further comprising a reservoir 4260 including a plunger 4262 and a plunger rod 4263.
Regarding claim 3, Chong discloses in Fig. 86A (or Chong in view of Laurent and Hart) that wherein the fluid pathway is fluidly connected to a filling needle input 4249 configured to guide fluid into the heat exchanger inside the fill adapter device 4240 (e.g. the heat exchanger includes the heating element, as modified by Hart).
Regarding claim 4, wherein the filling needle 12 (as modified by Laurent) is configured to be removably attached to the reservoir/syringe 4260.
Regarding claim 7, Chong in view of Laurent, Hart & Neer discloses all claimed subject matter as required in the claim 1. Laurent (or Chong in view of Laurent, Hart & Neer) also discloses that the filling needle input is the septum, see the marked-up in claim 1 above.
Regarding claim 8, Chong in view of Laurent, Hart & Neer discloses all claimed subject matter as required in the claim 1. Chong discloses that the fill adapter device 4240 is removably attached to the vial 4250.
Claims 9 & 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hart et al. (US 2002/0123737) in view of Neer (US 2010/0004534).
Regarding claim 9, Hart discloses a fill adapter device 26 comprising: a manifold 26; wherein a heat element 76 can be located in the manifold 26, para [0025]. Therefore, the manifold 26 is equivalent to the claimed heat exchanger comprises a heating element 76 (e.g. heating coils, resistor coils or other heating devices); and a fluid pathway (a passage located inside the manifold 26) connected to a filling needle input 54 and a vial 22 (via conduit 66 & conduit 28)
Note: the port 54 is being connected to a nose 50 of the sysringe. A person skilled in the art would recognize that the port 54 is adapted to accept a filling needle therein. Therefore, the port 54 is equivalent to the claimed “filling needle input”. B)
; wherein the fluid flowing in the fluid pathway is heated by the heating element 76. Hart recognizes that elevating the temperature of the fluid, which in turn decreases its density and decreases its viscosity and increase the speed flowing of the fluid, para [0026].
Hart does not disclose that a processor configured to control the heating element in a plurality of preprogrammed profiles.
Neer discloses a system comprising: a reservoir or a housing 16; a heat exchanger 13 comprising: a heating element 18 (including heating coils disposed within the reservoir 16, para [0040]; a process 28 configured to control the heating element in a plurality of preprogrammed profiled (e.g., para [0031], … the controller 28 may have circuitry and/or code (Note: equivalent to the claimed preprogrammed profiled) adapted to control the temperature of the fluid 32, the rate of change of the temperature of the fluid 32. Para [0036], … the controller 28 may exercise feedback or feed forward control over a variety of parameters. For example, the controller 28 may receive feedback signals from the sensor 26 indicative of the fluid 32 temperature, ... In some embodiments, the controller 28 may output a signal to the heat source 18 in response to one or more of these feedback signals. Para [0037], … the controller 28 may signal the heat source 18 to stop adding heat 50 to the fluid 32, reduce the amount of heat added to the fluid 32, or apply heat 50 to the fluid 32 at a rate that maintains the temperature of the fluid 32.
Giving such a teaching by Neer, a person having ordinary skill in the art would have easily recognizes that modifying the device of Chong in view Laurent and Hart with a processor including plurality of preprogrammed profiles to control the heating element, as taught by Neer, would provide the benefit of controlling temperatures of the heating element in the reservoir to bring the desired temperature of the fluid in the reservoir.
Regarding claim 12, Hart discloses that the fill adapter 26 is configured to be attached to a vial of fluid (via conduit 28 and valve 68, see Fig. 1)
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hart et al. (US 2002/0123737) in view of Neer (US 2010/0004534) and further in view of Laurent (US 6,408,897).
Regarding claim 13, Hart in view of Neer discloses all claimed subject matter as required in the claim 9 except for the limitation that the filling needle input is a septum.
Laurent discloses a system comprising: a syringe 5 having a filling needle 12; a fill adapter device 2 comprising: a housing 13 that comprises a valve (i.e. septum 15b) for piercing by the filling needle 12/121, see Fig. 1. Note: the element 12 defines as a transfer means; and the element 121 defines as a nose. Since the nose 121 has a similar shape to a needle. Therefore, the nose 121 and the needle can be interchangeable as being used for transferring fluid. A person skilled in the art would recognize that the nose 121 can be replaced or equivalent as a needle as being used as a transfer means, i.e. for transferring a liquid.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the fill adapter device of Hart (or Hart in view of Neer) with providing a septum located inside the filling needle input, as taught by Laurent, in order to achieve sealing and to prevent of leaking when the syringe being connected to the fill adapter device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-9 & 12 have been considered but are moot because the new ground of rejection is being applied in this current office action.
Applicant argues that the prior art of records does not disclose the limitation of a processor configured to control the heating element in a plurality of preprogrammed profiles.
In response, Examiner clearly provides evidence in the prior arts Magliochetti et al. (US 5,729,653) & Neer (US 2010/0004534) that teaching the claimed feature, i.e., a processor configured to control the heating element in a plurality of preprogrammed profiles. Please see the rejection above for more details.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783