DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 04/15/26 have 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 Claims 1-4, 7-9, 12-13 are pending for examination; claim 16 is withdrawn and claims 5-6, 10-11, 14-15 are cancelled.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 Pesnicak (US 5,810,773) in view of Middleton et al. (US 8,109,902), Hart (US 2002/0123737) and Cassidy et al. (US 6,175,688).
Regarding claim 1, Pesnicak discloses a system comprising:
a syringe 68 having a reservoir 70;
a vial 56 of fluid; and
a fill adapter device 80/86 comprising: a housing 86; wherein the fill adapter device 80 is configured to directly mate onto the vial 56 of fluid, and
wherein the system is configured such that, the syringe 68 draws the fluid from the vial 56 and when the fluid of the vial flows through the fluid pathway and through a nose of syringe (or the filling needle, as modified in below) for filling the reservoir 70, col. 6, lines 37-55.
Pesnicak does not disclose a filling needle in the syringe; a septum in the housing for piercing by the filling needle; a heat exchanger that comprises: a heating element; a fluid pathway; and comprising a processor configured to control the heating element in a plurality of preprogrammed profiles; the fluid flowing in the fluid pathway is heated by the heating element.
Middleton discloses a system comprising: a syringe 110 having a filling needle 111; a septum 103 in a housing 82 of a fill adapter device 80 for piercing by the filling needle 111.
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 system of Pesnicak with obtaining a filling needle being engaged to a syringe and obtaining a septum in the housing of the fill adapter, as taught by Middleton, in order to allow different size of the syringe being engaged to the fill adapter, and allowing the needle to pierce a septum for preventing leaking during fluid transferring and ready to inject into a patient right after mixing the drug via the fill adapter device.
Pesnicak in view of Middleton does not disclose a heat exchanger that comprises: a heating element; a fluid pathway; and comprising a processor configured to control the heating element in a plurality of preprogrammed profiles; the fluid flowing in the fluid pathway is heated by the heating element.
Hart discloses a system comprising: a syringe 24 having a reservoir 44; a vial 22; a fill adapter device (or a manifold 26) comprising: a housing 26; a heat exchanger 76 that comprises heating element (resistor coils or other heating devices are provided in the manifold 26, para [0025]); a fluid pathway (inside the manifold 26); wherein the fluid of vial 22 flows through the fluid pathway (inside the manifold 26) and through the syringe 36 for filling the reservoir 44, the fluid flowing in the fluid pathway is heated by the heating element.
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 Pesnicak in view of Middleton with including a heat exchanger device (e.g. heating element is provided in the fill adapter device, i.e. manifold), taught by Hart, 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.
Thus, Pesnicak in view of Middleton & Hart discloses that the system is configured such that, the syringe 68 draws a fluid from the vial 56 and when the fluid of the vial flows through the fluid pathway (inside the fill adapter device 86) is heated by the heating element (as modified by Hart).
Pesnicak in view of Middleton & Hart does not disclose that a processor configured to control the heating element in a plurality of preprogrammed profiles.
Cassidy discloses a fill adapter device 10 comprising: a housing, a heat exchanger comprising: a heat element, a fluid pathway 43, a processor 111 configured to control the heating element in a plurality of preprogrammed profiles (e.g., processor 111 determines whether the output fluid temperature is less than a predetermined target output fluid temperature, and if the output temperature is less than this target temperature, the processor 111 causes the system 111 to cease heating of the fluid in the flow path 43 by the heating elements 120, 122. Alternatively, if the processor 111 determines that the output fluid temperature is greater than the target temperature (but less than the predetermined maximum temperature), the processor 111 may command the system 114 to cease heating of the fluid in the flow path 43 by the heating elements 120, 122. (See, block 306). Thereafter, the processor 111 may wait a predetermined time period (e.g., several milliseconds), and then begin the control process again at block 300.... This relationship is preprogrammed into the processor and memory 111..., col. 10, lines 18-65, also see Figs. 11-14, col. 10, line 66-col. 14, line 33 that explain plurality of preprogramming profiles that relate to control the heating element).
Giving such a teaching by Cassidy, a person having ordinary skill in the art would have easily recognizes that modifying the device system of Pesnicak in view of Middleton & Hart with obtaining a processor including plurality of preprogrammed profiles to control the heating element, as taught by Cassidy, would provide the benefit of controlling temperatures of the heating element in the fluid pathway to bring the desired temperature of the fluid in the fluid pathway.
Regarding claim 2, Pesnicak in view of Middleton, Hart & Cassidy discloses all claimed subject matter as required. Pesnicak discloses that the syringe 68 including a plunger 76 and a plunger rod 74.
Regarding claims 3 & 7, Pesnicak in view of Middleton, Hart & Cassidy discloses all claimed subject matter as required. Pesnicak in view of Middleton, Hart & Cassidy further discloses that wherein the fluid pathway is fluidly connected to a filling needle input 103 (as shown in Middleton) configured to guide fluid into the heat exchanger (as modified by Hart & Cassidy); wherein the filling needle input 103 is the septum.
Regarding claim 4, wherein the filling needle 111 (as modified by Middleton) is configured to be removably attached to the reservoir/syringe 68 in Pesnicak.
Regarding claim 8, Pesnicak in view of Middleton, Hart & Cassidy discloses all claimed subject matter as required. Pesnicak discloses that wherein the fill adapter device 86 is removably attached to the vial 56.
Claims 1-4 & 7-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pesnicak (US 5,810,773) in view of Middleton et al. (US 8,109,902), Hart (US 2002/0123737) and Neer (US 2010/0004534).
Regarding claim 1, Pesnicak discloses a system comprising:
a syringe 68 having a reservoir 70;
a vial 56 of fluid; and
a fill adapter device 80/86 comprising: a housing 86; wherein the fill adapter device 80 is configured to directly mate onto the vial 56 of fluid, and
wherein the system is configured such that, the syringe 68 draws the fluid from the vial 56 and when the fluid of the vial flows through the fluid pathway and through a nose of syringe (or the filling needle, as modified in below) for filling the reservoir 70, col. 6, lines 37-55.
Pesnicak does not disclose a filling needle in the syringe; a septum in the housing for piercing by the filling needle; a heat exchanger that comprises: a heating element; a fluid pathway; and comprising a processor configured to control the heating element in a plurality of preprogrammed profiles; the fluid flowing in the fluid pathway is heated by the heating element.
Middleton discloses a system comprising: a syringe 110 having a filling needle 111; a septum 103 in a housing 82 of a fill adapter device 80 for piercing by the filling needle 111.
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 system of Pesnicak with obtaining a filling needle being engaged to a syringe and obtaining a septum in the housing of the fill adapter, as taught by Middleton, in order to allow different size of the syringe being engaged to the fill adapter, and allowing the needle to pierce a septum for preventing leaking during fluid transferring and ready to inject into a patient right after mixing the drug via the fill adapter device.
Pesnicak in view of Middleton does not disclose a heat exchanger that comprises: a heating element; a fluid pathway; and comprising a processor configured to control the heating element in a plurality of preprogrammed profiles; the fluid flowing in the fluid pathway is heated by the heating element.
Hart discloses a system comprising: a syringe 24 having a reservoir 44; a vial 22; a fill adapter device (or a manifold 26) comprising: a housing 26; a heat exchanger 76 that comprises heating element (resistor coils or other heating devices are provided in the manifold 26, para [0025]); a fluid pathway (inside the manifold 26); wherein the fluid of vial 22 flows through the fluid pathway (inside the manifold 26) and through the syringe 36 for filling the reservoir 44, the fluid flowing in the fluid pathway is heated by the heating element.
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 Pesnicak in view of Middleton with including a heat exchanger device (e.g. heating element is provided in the fill adapter device, i.e. manifold), taught by Hart, 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.
Thus, Pesnicak in view of Middleton & Hart discloses that the system is configured such that, the syringe 68 draws a fluid from the vial 56 and when the fluid of the vial flows through the fluid pathway (inside the fill adapter device 86) is heated by the heating element (as modified by Hart).
Pesnicak in view of Middleton & 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 Pesnicak in view of Middleton & 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 fluid pathway to bring the desired temperature of the fluid in the fluid pathway.
Regarding claim 2, Pesnicak in view of Middleton, Hart & Neer discloses all claimed subject matter as required. Pesnicak discloses that the syringe 68 including a plunger 76 and a plunger rod 74.
Regarding claims 3 & 7, Pesnicak in view of Middleton, Hart & Neer discloses all claimed subject matter as required. Pesnicak in view of Middleton, Hart & Neer further discloses that wherein the fluid pathway is fluidly connected to a filling needle input 103 (as shown in Middleton) configured to guide fluid into the heat exchanger (as modified by Hart & Neer); wherein the filling needle input 103 is the septum.
Regarding claim 4, wherein the filling needle 111 (as modified by Middleton) is configured to be removably attached to the reservoir/syringe 68 in Pesnicak.
Regarding claim 8, Pesnicak in view of Middleton, Hart & Neer discloses all claimed subject matter as required. Pesnicak discloses that wherein the fill adapter device 86 is removably attached to the vial 56.
Claims 9, 12-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Middleton et al. (US 8,109,902) in view of Hart et al. (US 2002/0123737) and Cassidy et al. (US 6,175,688).
Regarding claim 9, Middleton discloses a fill adapter device 80 comprising: a fluid pathway 83 fluidly connected to a filling needle input 103 and a vial 10a or 110; wherein fluid enters the fill adapter device (or the heat exchanger, as modified in below) and flows through the fluid pathway 83.
Middleton does not disclose a heat exchanger comprising: a heating element, a processor configured to control the heating element in a plurality of preprogrammed profiles; whereby the fluid is heated by the heating element.
Hart discloses a system comprising: a syringe 24 having a reservoir 44; a vial 22; a fill adapter device (or a manifold 26) comprising: a housing 26; a heat exchanger 76 that comprises heating element (resistor coils or other heating devices are provided in the manifold 26, para [0025]); a fluid pathway (inside the manifold 26); wherein the fluid of vial 22 flows through the fluid pathway (inside the manifold 26) and through the syringe 36 for filling the reservoir 44, the fluid flowing in the fluid pathway is heated by the heating element.
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 Middleton with including a heat exchanger device (e.g. heating element is provided in the fill adapter device, i.e. manifold), taught by Hart, 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.
Thus, Middleton & Hart discloses that when fluid enters the heat exchanger (as modified by Hart) and flows through the fluid pathway and whereby the fluid is heated by the heating element.
Middleton & Hart does not disclose that a processor configured to control the heating element in a plurality of preprogrammed profiles.
Cassidy discloses a fill adapter device 10 comprising: a housing, a heat exchanger comprising: a heat element, a fluid pathway 43, a processor 111 configured to control the heating element in a plurality of preprogrammed profiles (e.g., processor 111 determines whether the output fluid temperature is less than a predetermined target output fluid temperature, and if the output temperature is less than this target temperature, the processor 111 causes the system 111 to cease heating of the fluid in the flow path 43 by the heating elements 120, 122. Alternatively, if the processor 111 determines that the output fluid temperature is greater than the target temperature (but less than the predetermined maximum temperature), the processor 111 may command the system 114 to cease heating of the fluid in the flow path 43 by the heating elements 120, 122. (See, block 306). Thereafter, the processor 111 may wait a predetermined time period (e.g., several milliseconds), and then begin the control process again at block 300.... This relationship is preprogrammed into the processor and memory 111..., col. 10, lines 18-65, also see Figs. 11-14, col. 10, line 66-col. 14, line 33 that explain plurality of preprogramming profiles that relate to control the heating element).
Giving such a teaching by Cassidy, a person having ordinary skill in the art would have easily recognizes that modifying the device system of Pesnicak in view of Middleton & Hart with obtaining a processor including plurality of preprogrammed profiles to control the heating element, as taught by Cassidy, would provide the benefit of controlling temperatures of the heating element in the fluid pathway to bring the desired temperature of the fluid in the fluid pathway.
Regarding claim 12, Middleton discloses that wherein the fill adapter 82 is configured to be attached to a vial of fluid 10a or 110.
Regarding claim 13, Middleton discloses that wherein the filling needle input 103 is a septum.
Claims 9, 12-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Middleton et al. (US 8,109,902) in view of Hart et al. (US 2002/0123737) and Neer (US 2010/0004534).
Regarding claim 9, Middleton discloses a fill adapter device 80 comprising: a fluid pathway 83 fluidly connected to a filling needle input 103 and a vial 10a or 110; wherein fluid enters the fill adapter device (or the heat exchanger, as modified in below) and flows through the fluid pathway 83.
Middleton does not disclose a heat exchanger comprising: a heating element, a processor configured to control the heating element in a plurality of preprogrammed profiles; whereby the fluid is heated by the heating element.
Hart discloses a system comprising: a syringe 24 having a reservoir 44; a vial 22; a fill adapter device (or a manifold 26) comprising: a housing 26; a heat exchanger 76 that comprises heating element (resistor coils or other heating devices are provided in the manifold 26, para [0025]); a fluid pathway (inside the manifold 26); wherein the fluid of vial 22 flows through the fluid pathway (inside the manifold 26) and through the syringe 36 for filling the reservoir 44, the fluid flowing in the fluid pathway is heated by the heating element.
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 Middleton with including a heat exchanger device (e.g. heating element is provided in the fill adapter device, i.e. manifold), taught by Hart, 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.
Thus, Middleton & Hart discloses that when fluid enters the heat exchanger (as modified by Hart) and flows through the fluid pathway and whereby the fluid is heated by the heating element.
Middleton & 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 Middleton & 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, Middleton discloses that wherein the fill adapter 82 is configured to be attached to a vial of fluid 10a or 110.
Regarding claim 13, Middleton discloses that wherein the filling needle input 103 is a septum.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-9, 12 *& 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights