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 filed on08/14/26 has been entered in the case. Claims 1-4, 7-9, 12-13, 17-24 are pending for examination; claim 16 is withdrawn and claims 5-6, 10-11, 14-15 are cancelled.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation, i.e., the fill adapter further comprises “a vial-side needle” of claim 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Note: the Fig. 13 (drawings 08/14/26) shows that a needle 734 is a part of a vial 702. Meanwhile, the claim 17 requires that the vial-side needle is being a part of the fill adapter device.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17, 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The Fig. 13 (drawings 08/14/26) shows that a needle 734 is a part of a vial 702. Meanwhile, claim 17 requires that the fill adapter further comprises a vial-side needle (e.g., the vial-side needle is being a part of the fill adapter device). Therefore, it is unclear to Examiner that the via-side needle is being a part of the vial 702 or being a part of the fill adapter device 700.
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;
Note: A vial is a small glass or plastic container used to hold liquids, powders, or small samples; it is commonly used to hold injectable drugs. Similarly, a syringe is a small glass or plastic container used to hold injectable drugs. Because the claimed invention does not define any specific feature of the vial other than the general term 'vial’, a person skilled in the art would recognize that the terms 'vial' and 'syringe' are interchangeable.
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, 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;
Note: A vial is a small glass or plastic container used to hold liquids, powders, or small samples; it is commonly used to hold injectable drugs. Similarly, a syringe is a small glass or plastic container used to hold injectable drugs. Because the claimed invention does not define any specific feature of the vial other than the general term 'vial', a person skilled in the art would recognize that the terms 'vial' and 'syringe' are interchangeable.
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.
NEW SET OF THE REJECTION OF CLAIMS 17-24
Claims 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2009/0198215) in view of Middleton et al. (US 8,109,902), Hart (US 2002/0123737) and Cassidy et al. (US 6,175,688).
Regarding claim 17, Chong discloses a system 4200 in Fig. 86A-C comprising:
a syringe 4260 having a reservoir 4260;
a vial 4850/4950 of fluid;
a fill adapter device 4240 comprising: a housing that comprises a valve 4246 (possibly a septum, the valve 4246 is to be modified by Middleton below).
a fluid pathway (an interior space of the housing of the fill adapter device 4240);
wherein the fill adapter device 4240 is configured to directly mate onto the vial 4250 of fluid;
wherein the system is configured such that the syringe 4260 draws the fluid from the vial 4250 and when the fluid of the vial 4250 flows through the fluid pathway and through the filling needle (as modified by Middleton below) for filling the reservoir 4260;
wherein the fill adapter device further comprises a via-side needle 4249, separate from the filling needle (as modified by Middleton below), configured to establish fluid communication between an interior of the vial 4250 and the fluid pathway when the fill adapter device is directly mated onto the vial 4250.
Chong does not disclose that a filling needle being included in the syringe; a septum of the housing for piercing by the filling needle; a heat exchanger that comprises a heating element; a processor configured to control the heating element in a plurality of preprogrammed profiles.
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.
At the time of the invention, it would have been obvious to a person having ordinary skill in the art to modify the system of Chong by using a valve as a septum valve and incorporating a filling needle within the syringe, as taught by Middleton. One of ordinary skill would have been motivated to make this modification to accommodate syringes of various sizes. Furthermore, piercing the septum with the needle prevents leakage during fluid transfer and ensures the syringe is immediately ready for patient injection following drug mixing.
Chong in view Middleton does not disclose a heat exchanger that comprises a heating element; a processor configured to control the heating element in a plurality of preprogrammed profiles.
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 Chong in view of Middleton to include a heat exchanger device - such as a heating element provided in the fill adapter device (i.e., manifold) as taught by Hart - to control the temperature of a heating fluid before delivery to a patient, thereby preventing discomfort, shock, or other trauma.
Thus, the combination of Chong, Middleton, and Hart renders obvious a system configured such that the syringe draws a fluid from the vial, which is then heated by the heating element (as modified by Hart) as it flows through the fluid pathway inside the fill adapter device.
Chong 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, 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).
Given the teachings of Cassidy, a person having ordinary skill in the art would have found it obvious to modify the system of Chong in view of Middleton to incorporate a processor with a plurality of preprogrammed profiles. As taught by Cassidy, using these profiles to control the heating element provides the benefit of regulating the heating element's temperature, thereby achieving the desired fluid temperature within the fluid pathway.
Regarding claim 18, similar to the rejection of claim 17 above, Chong in view of Middleton, Hart, and Cassidy discloses all claimed subject matter as discussed in claim 17 above. The vial in Chong contains insulin. It is well-known in the art that insulin must be stored in a refrigerator (or below room temperature) to prevent degradation of the insulin solution. As mentioned in claim 17 above, Chong in view of Middleton, Hart and Cassidy discloses a plurality of preprogrammed profiles to control the fluid in the system, including a profile designed for insulin. Therein, the processor is configured to control the heating element according to the profile designed for insulin to heat the insulin to room temperature during the filling of the reservoir.
Regarding claims 19-20, similar to the rejection of claim 17 above, Chong in view of Middleton, Hart, and Cassidy discloses all claimed subject matter as discussed in claim 17 above.
The claimed invention does not require exact values for the length and diameter of the fluid pathway. Under the broadest reasonable interpretation, any fluid pathway having a length and diameter capable of inducing out-gassing of the insulin as it is heated from below room temperature to room temperature (the desired temperature, as modified by Hart & Cassidy) during filling of the reservoir satisfies this limitation.
Chong discloses an air trap 4247 configured to allow gas released by out-gassing to escape. While Chong discloses that the air trap 4247 is located adjacent to a syringe 4210, a person skilled in the art would recognize that the air trap can instead be provided adjacent to the syringe 4260, which represents a routine rearrangement of parts. Positioning the air trap adjacent to the syringe 4260 allows gas to escape from the fill adapter device (or from the heat exchanger, as modified by Hart and Cassidy) before the heated insulin passes through the filling needle into the reservoir, wherein the air trap comprises a hydrophobic filter (paragraph [0310]). In addition, it is well-known in the art to construct an air trap using a hydrophobic filter.
Claims 21-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2009/0198215) in view of Hart (US 2002/0123737) and Cassidy et al. (US 6,175,688).
Regarding claim 21, Chong discloses a fill adapter 4240/4870/4940 in Figs. 92-93 comprising:
a fluid pathway (an interior of the fill adapter 4870/4940) fluidly connected to a filling needle input 4871/4872 and a vial 4850; wherein the fill adapter device is configured to directly mate onto the vial comprises a vial-side needle 4872 configured to establish fluid communication between an interior of the vial 4856 and the fluid pathway when the fill adapter device is directly mated onto the vial.
Chong does not disclose a heat exchanger comprising heating element, a processor configured to control the heating element in a plurality of preprogrammed profiles.
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 Chong to include a heat exchanger device - such as a heating element provided in the fill adapter device (i.e., manifold) as taught by Hart - to control the temperature of a heating fluid before delivery to a patient, thereby preventing discomfort, shock, or other trauma.
Thus, the combination of Chong and Hart renders obvious a system configured such that the syringe draws a fluid from the vial, which is then heated by the heating element (as modified by Hart) as it flows through the fluid pathway inside the fill adapter device.
Chong in view of 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, 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).
Given the teachings of Cassidy, a person having ordinary skill in the art would have found it obvious to modify the system of Chong in view of Middleton to incorporate a processor with a plurality of preprogrammed profiles. As taught by Cassidy, using these profiles to control the heating element provides the benefit of regulating the heating element's temperature, thereby achieving the desired fluid temperature within the fluid pathway.
Regarding claim 22, similar to the rejection of claim 21 above, Chong in view of Hart, and Cassidy discloses all claimed subject matter as discussed in claim 21 above. The vial in Chong contains insulin. It is well-known in the art that insulin must be stored in a refrigerator (or below room temperature) to prevent degradation of the insulin solution. As mentioned in claim 21 above, Chong in view of Hart and Cassidy discloses a plurality of preprogrammed profiles to control the fluid in the system, including a profile designed for insulin. Therein, the processor is configured to control the heating element according to the profile designed for insulin to heat the insulin to room temperature during the filling of the reservoir.
Regarding claims 23-24, similar to the rejection of claim 21 above, Chong in view of Middleton, Hart, and Cassidy discloses all claimed subject matter as discussed in claim 21 above.
The claimed invention does not require exact values for the length and diameter of the fluid pathway. Under the broadest reasonable interpretation, any fluid pathway having a length and diameter capable of inducing out-gassing of the insulin as it is heated from below room temperature to room temperature (the desired temperature, as modified by Hart & Cassidy) during filling of the reservoir satisfies this limitation.
Chong discloses an air trap 4877/4947 configured to allow gas released by out-gassing to escape from the heat exchanger (as modified by Hart and Cassidy) before the heated insulin passes through a filling needle 4871 received at the filling needle input 4814 for filling a reservoir, wherein the air trap comprises a hydrophobic filter (paragraph [0310]). In addition, it is well-known in the art to construct an air trap using a hydrophobic filter.
Response to Arguments
Applicants’ arguments filed 08/14/26 have been fully considered but they are not persuasive.
1) Applicant argues that in use, both of syringes 56 & 67 are filled before connection, and their respective plungers are alternatively depressed to pump the fluids back and forth until mixed. Applicant further states that the syringe 56 as an active, plunger-operated member of a reciprocal two syringe mixing system, not as the vial from the claimed syringe draws fluid through a directly mated fill adapter to fill its reservoir,
In response, the claimed invention does not require that syringe 708 be emptied prior to use. Further, the claimed invention does not preclude the mixing of drugs between the vial and the syringe. Instead, the claim requires only that the syringe draw fluid from the vial. In the criticized embodiment, the second syringe 68 draws fluid from the vial (first syringe 56) into said second syringe (col. 6, lines 48-51).
Therefore, Pesnicak clearly discloses the limitation that: the syringe 68 draws the fluid from the vial/first syringe 56 and when the fluid of the vial 56 flows through the fluid pathway.
2) Applicant argues that the claim 1 itself uses “syringe” and “vial” as separate terms.
In response, a vial is a small glass or plastic container used to hold liquids, powders, or small samples; it is commonly used to hold injectable drugs. Similarly, a syringe is a small glass or plastic container used to hold injectable drugs. Because the claimed invention does not define any specific feature of the vial other than the general term 'vial,' a person skilled in the art would recognize that the terms 'vial' and 'syringe' are interchangeable. Therefore, the syringe 56 is fair enough to call as a vial.
3) Applicant argues that Middleton is relied upon for filling needle and septum but Middleton also expressly describes elements 10, 10a and 110 as syringes. Hart describes contrast supply or source 22 as connected to manifold 26 through first fluid line 28 rather than directly mated to the manifold. Cassidy is relied upon for processor control heating. None of these teaching provides a vial directly mated to Pesnicak’s stopcock body 86 in the claimed arrangement.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Middleton relies on a teaching syringe 110 having a filling needle 111 that pierces a septum of an adapter 80 for fluid transfer between the syringe and the adapter. The filling needle is inserted into the septum to prevent leaking during fluid transfer.
Hart teaches a fill adapter 26 comprising a heat exchanger 76, which includes a heating element (resistor coils or other heating devices are provided in the manifold 26, para [0025]) and a fluid pathway, wherein the fluid pathway is heated by the heating element as fluid enters the fill adapter [para 0025]. Based on these teachings of Hart, a person skilled in the art would recognize that providing a heat exchanger within the fill adapter would provide the benefit of heating the fluid before it enters a patient.
Meanwhile, Cassidy discloses a processor configured to control a heating element according to a plurality of preprogrammed profiles. Therefore, a person skilled in the art would find it obvious to combine the teachings of Hart with the preprogrammed profiled in the processor of Cassidy to control the heating element, thereby maintaining the fluid at a desired temperature prior to patient delivery.
Note: This approach uses the teachings of Hart and Cassidy, such as heat exchange and pre-programmed profiles, and incorporates them into Pesnicak’s stopcock body (or the claimed filled adapter device). This provides the benefit of controlling the desired fluid temperature before it enters a patient. Hart and Cassidy do not rely on modifying the claimed arrangement, where the vial is directly mated to the stopcock body.
4) Applicant argues on page 12 of the Remarks that Neer also does not expressly disclose the claimed plurality of preprogrammed profiles. Neer distinguishes thermo-mechanical drive fluid 32 from medical fluid 48: heating drive fluid 32 expands that fluid to move actuator 24 and syringe interface 40, which depresses plunger 44 to expel medical fluid 48 from a separate syringe. Neer [3[ [0024]-[0037]. The cited feedback and feed-forward control of drive-fluid temperature, including commands to stop, reduce, or maintain heating, is not an express disclosure of two or more preprogrammed heating profiles.
In response, the claimed invention does not include specifically plurality of preprogrammed profiles. The term “profiles” is very broad and interpreted as data or equivalent meaning. In this case, Neer discloses Neer discloses in para [0036] that: ... For instance, the controller 28 may control ... the temperature of fluid 32... The controller 28 may target a set point for one or more of these parameters (Note: “a set point for one or more of these parameters” is equivalent to the claimed “plurality of preprogrammed profiles). In para [0037] states that: ... 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. In order to add or reduce the heat to the fluid, the controller 28 must be included the pre-programmed profiles to control the fluid temperature.
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
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