DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 10/22/2025 has been entered. Claims 1-3, 5-9, 11-17, 19-24, and 27-34 are pending in the application. Claims 4, 10, 18, and 25-26 are cancelled. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 7/22/2025.
The Examiner notes that claim 4 has been cancelled in the amendment of 10/22/2025, however the text of the claim is still presented and entirely stricken-through. For future amendments, any cancelled claim should not present the claim text (see 37 CFR 1.121(c)).
Claim Objections
Claims 1, 3, 11, 13, 17, and 23-24 are objected to because of the following informalities:
-Claim 1, line 13: please correct “the respective drug container” to “the respective one drug container”
-Claim 1, line 15: please correct “the respective drug container” to “the respective one drug container”
-Claim 3, line 5: please correct “the respective drug container” to “the respective one drug container”
-Claim 11, line 29: please correct “the cartridge” to “the removable cartridge”
-Claim 11, line 30: please correct “the cartridge” to “the removable cartridge”
-Claim 13, line 2: please correct “electrical” to “electronic”
-Claim 17, line 3: please correct “the cartridge” to “the removable cartridge”
-Claim 23, lines 3-4: please correct “the medical device” to “the external medical device”
-Claim 24, lines 2-3: please correct “the medical device” to “the external medical device”
-Claim 24, line 11: please correct “the medical device” to “the external medical device”
Appropriate correction is required.
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 1-3, 5-9, 11-17, 19-24, and 27-34 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.
Claim 1 recites the limitations “a cartridge comprising a fluid guide system…wherein the cartridge comprises a rigid case” and “the fluid guide system comprising…a carrier”. It is unclear whether the “cartridge” and the “carrier” are intended to be the same structure or different structures. In the previous claim set filed 1/17/2025, claim 3 recited the limitations “wherein the carrier comprises a rigid cartridge, and wherein the rigid cartridge comprises a rigid case”. Thus, the previous interpretation of the claims linked the carrier/cartridge/case to all forming part of the same rigid structure. However, with how claim 1 has been amended on 10/22/2025, it appears that the cartridge/case may be an entirely different structure than the carrier. This is further made clear in claim 3 of the 10/22/2025 filing, which states “wherein the carrier comprises the rigid case” such that in claim 1 the carrier is a different structure from the cartridge/case but in claim 3 the carrier/case/cartridge may now be referring to the same structure. Thus, the scope of the claim limitations regarding the cartridge, carrier, and case are unclear. For examination purposes, the Examiner interprets that the cartridge/carrier/case in claim 1 and each of its dependent claims are all referring to the same structure.
Claims 2-3, 5-9, 21-24, 27, 29, and 31 are rejected by virtue of their dependency on rejected claim 1.
Claim 2 recites the limitation “at least one hole or of at least two holes” in line 15 and again in line 17. It is unclear whether this hole(s) is referring to the same hole(s) which has been added to line 29 of claim 1 or whether this is a different hole(s). For examination purposes, the Examiner interprets that the hole(s) recited in lines 15 and 17 of claim 2 are referring to the hole(s) recited in line 29 of claim 1.
Claims 3 and 21 are rejected by virtue of their dependency on rejected claim 2.
Claim 3 recites the limitation “wherein the carrier comprises the rigid case” in line 2. As discussed in the 112b rejection of claim 1 above, this limitation is additionally unclear as to the scope of the carrier, case, and cartridge. For examination purposes, the Examiner interprets that the cartridge/carrier/case in claim 3 is referring to the same structure.
Claim 11 recites the limitations “A medical device…comprising: a case, a support portion arranged within the case or on the case and configured to support a removable cartridge” and “wherein the cartridge comprises a rigid case”. It is unclear whether the case of line 2 and the rigid case of line 29 are referring to the same structure or different structures. Further, it is unclear from previous versions of the claim whether the “carrier” in line 25 should also be referring to the same structure(s) (see also 112b rejection of claim 1 above). For examination purposes, the Examiner interprets that the case of lines 2-4 is a case of the medical device which receives the cartridge/carrier/rigid case of lines 25 and 29, such that the case of lines 2-4 is referring to a different structure than the cartridge/carrier/rigid case of line 29.
Claims 12-17, 19-20, 28, 30, and 32-34 are rejected by virtue of their dependency on rejected claim 11.
Claim 14 recites the limitation "the at least one pump" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the at least one pump” as “the at least one pump interface” per line 26 of claim 11.
Claim 20 recites the limitations "the at least one pump" three times throughout lines 3-5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the at least one pump” in line 3 of claim 20 as “at least one pump of the medical device”, which would provide proper antecedent basis for the remaining recitations in the claim.
Claim 22 is dependent on claim 4, which has been cancelled. It is unclear from which claim that claim 22 should depend. For examination purposes, the Examiner interprets claim 22 as dependent on claim 1.
Claim 22 recites the limitation "the flexible carrier portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “the flexible carrier portion” as “a flexible carrier portion of the carrier”.
Claim 23 recites the limitations “wherein the carrier comprises a rigid cartridge; wherein the rigid cartridge comprises a rigid case” in lines 9-10. As discussed in the 112b rejection of claim 1 above, these limitations are additionally unclear as to the scope of the carrier, case, and cartridge. Further, based on the antecedent basis in claim 23, it is unclear whether an additional rigid cartridge and an additional rigid case are being introduced. For examination purposes, the Examiner interprets that the cartridge/carrier/case in claim 23 are referring to the same rigid structure which has already been previously introduced and that no additional rigid cartridges/cases are being introduced.
Claim 28 recites the limitations “wherein the carrier comprises a rigid cartridge; wherein the rigid cartridge comprises a rigid case” in lines 8-9. As discussed in the 112b rejection of claim 11 above, these limitations are additionally unclear as to the scope of the carrier, case(s), and cartridge. Further, based on the antecedent basis in claim 28, it is unclear whether an additional rigid cartridge and an additional rigid case are being introduced. For examination purposes, the Examiner interprets that the carrier/rigid cartridge/rigid case in lines 8-9 of claim 28 are all referring to the same cartridge/case/carrier which was already previously introduced in lines 25 and 29 of claim 11, with no additional rigid cartridge or case being introduced in claim 28.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-6, 8-9, 21-22, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et al. (US 2002/0045856 A1) in view of McLoughlin et al. (US 2022/0370289 A1).
Regarding claim 1, Jaafar discloses a cartridge (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21) comprising a fluid guide system (fluid structures of the device, see annotated Fig. 1 below) configured to interact with an external medical device (pumping and electronic control structures of the device, see annotated Fig. 1 below) for performing a reconstitution of at least one lyophilized drug contained within a plurality of drug containers (vials within drug library 17) by transferring a diluent into the plurality of drug containers (vials within drug library 17) in order to reconstitute the at least one lyophilized drug to at least one reconstituted drug and transferring a fluid comprising the diluent and the at least one reconstituted drug out of the plurality of drug containers (vials within drug library 17) (see Fig. 1, par. [0022], [0026], [0028], [0036], [0038]), the fluid guide system (fluid structures of the device, see annotated Fig. 1 below) comprising:
at least one fluid port (needle carrier 1, IV needle 2, and filter 5) configured to dispense the fluid comprising the diluent and the at least one reconstituted drug from the fluid guide system (see Fig. 1, par. [0022], [0026], [0028], [0034], [0038]),
at least two drug ports (needle sets 16), wherein each of the at least two drug ports (needle sets 16) is coupleable or coupled to a respective one drug container (one of vials within drug library 17) of the plurality of drug containers (vials within drug library 17) such that the respective one drug container (one of vials within drug library 17) can be or is directly mechanically coupled to a respective drug port (needle sets 16) of the at least two drug ports (needle sets 16) (see Fig. 1, par. [0036]), and wherein each of the at least two drug ports (needle sets 16) comprises a fluid transmitting portion (channels through needle sets 16) configured to transmit the fluid from the respective one drug container (one of vials within drug library 17) (see Fig. 1, par. [0036]-[0038]),
a fluid channel system (channels through all of fluid conduits) comprising at least two different fluid paths including a first fluid path (path from saline diluent reservoir 14 to vials within drug library 17) configured to transfer the diluent to the respective one drug container (one of vials within drug library 17) and a second fluid path (path from vials within drug library 17 to needle carrier 1) configured to transfer the fluid comprising the diluent and the at least one reconstituted drug out of the respective one drug container (one of vials within drug library 17) (see Fig. 1, par. [0034]-[0038]),
at least one flow control portion (valves 6, 10, 13, 15) comprising at least one valve portion (valves 6, 10, 13, 15) that controls which of the at least two different fluid paths is active, wherein the at least one valve portion (valves 6, 10, 13, 15) is configured to be actuated by at least one valve actuator of the external medical device (pumping and electronic control structures of the device, see annotated Fig. 1 below) (see Fig. 1, par. [0034]-[0038]),
a carrier (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21, see 112b rejection of claim 1 above) configured to carry the fluid channel system (channels through all of fluid conduits) (see Fig. 1, par. [0036]-[0037], at least portions of conduit 11 are carried by a carrier); and
at least one pump interface (interface between fluid guide system and IV pump 22) (see annotated Fig. 1 below, par. [0037]);
wherein each drug container of the plurality of drug containers (vials within drug library 17) is a vial (see Fig. 1, par. [0036]);
wherein the first fluid path (path from saline diluent reservoir 14 to vials within drug library 17) ends on the at least two drug ports (needle sets 16) and the second fluid path (path from vials within drug library 17 to needle carrier 1) starts on the at least two drug ports (needle sets 16) (see Fig. 1, par. [0034]-[0038]);
wherein the cartridge (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21) comprises a rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21) (see Fig. 1, see 112b rejection/interpretation of claim 1 above;
wherein the fluid channel system (channels through all of fluid conduits) is formed integrally within the cartridge (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21) (see Fig. 1, portions of the fluid conduits of the system of Fig. 1 are integrally within the housing for needle sets 16, engaging mechanism 19, and rail 21).
However, Jaafar fails to expressly state wherein the cartridge comprises at least one hole or recess forming the at least one pump interface by providing a receiving portion for an actuator of a pump arranged in the external medical device.
McLoughlin teaches a cartridge (module 10) comprising a fluid guide system (fluid structures internal to module 10) configured to interact with an external medical device (pump module 56, flexible tubing 72, and IV bag 74) (see Figs. 1-3), wherein the cartridge (module 10) comprises at least one hole or recess (ports 38 and 44) forming the at least one pump interface (interface between module 10 and pump module 56) by providing a receiving portion for an actuator (ports 58 and 60) of a pump (pump 64) arranged in the external medical device (pump module 56, flexible tubing 72, and IV bag 74) (see Figs. 1-3, par. [0031]-[0036]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of Jaafar to include wherein the cartridge comprises at least one hole or recess forming the at least one pump interface by providing a receiving portion for an actuator of a pump arranged in the external medical device, as taught by McLoughlin, in order to form fluidly sealed structures for holding the fluid guide system and the external medical device together (see McLoughlin par. [0036]). In order to perform such a modification, the cartridge (Jaafar, cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21) of Jaafar can be expanded to house the fluid channel system (Jaafar, channels through all of fluid conduits) as is shown by the fluid channel system (McLoughlin, fluid lines 26, 32, 46, and 42) of McLoughlin additionally being housed within the cartridge (McLoughlin, module 10) (see McLoughlin Figs. 1-3, par. [0031] and [0036]).
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Regarding claim 2, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed. Modified Jaafar further teaches wherein at least one of a), b), or c) is implemented: a) a width and a length and/or a height of the fluid guide system are adapted to a width and a length and or a height of a retaining space of the external medical device for retaining the fluid guide system (see Fig. 1, the structures recited in claim 1 are proportioned to interact with the remaining structures of Fig. 1), b) the pump (IV pump 22) is part of the external medical device that comprises a retaining space for retaining the cartridge (see previous modifications in rejection of claim 1 above) comprising the fluid guide system (see Fig. 1, par. [0037]), or c) (i) an inlet port (port of saline diluent reservoir 14) of the fluid guide system is configured to be connected to a flexible inlet tube (conduit 12) (see Fig. 1), and (ii) an outlet port (syringe outlet 7) of the fluid guide system is configured to be connected or is connected to a flexible outlet tube (conduit 4) (see Fig. 1), and (iii) wherein a geometrical arrangement of the inlet port (port of saline diluent reservoir 14) relative to the outlet port (syringe outlet 7) corresponds to a geometrical arrangement of at least one hole or of at least two holes (McLoughlin, ports 38 and 44) providing access to a retaining space of the external medical device (see Fig. 1, the port of saline diluent reservoir 14 and the syringe outlet 7 are arranged in holes/spaces of the system of Fig. 1, see previous modifications in rejection of claim 1 above), and (iv) wherein the at least one hole or the at least two holes (McLoughlin, ports 38 and 44) are configured to allow passage of a portion of the flexible inlet tube (conduit 12) and a portion of the flexible outlet tube (conduit 4) (see Fig. 1, conduits 4 and 12 are arranged in holes/spaces of the system of Fig. 1, see previous modifications in rejection of claim 1 above).
Regarding claim 3, modified Jaafar teaches the cartridge according to claim 2 substantially as claimed. Modified Jaafar further teaches wherein the carrier (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) comprises the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above), wherein the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) comprises at least two openings (openings in wall 20 for each of needles 16 to connect with vials within drug library 17) configured to allow access to the at least two drug ports (needle sets 16) in order to couple the respective drug container (vials in drug library 17) to the respective drug port (needle sets 16) of the at least two drug ports (needle sets 16) (see Fig. 1, par. [0036]).
Regarding claim 5, modified Jaafar teaches the fluid guide system according to claim 1 substantially as claimed. Jaafar further teaches wherein the at least two drug ports (needle sets 16) are fluidically connected or connectable to the at least one fluid port (needle carrier 1, IV needle 2, and filter 5) via the at least one flow control portion (valves 6, 10, 13, 15) (see Fig. 1, par. [0034]- [0038]), and wherein the at least one flow control portion (valves 6, 10, 13, 15) is configured to allow a fluid flow through the at least one flow control portion (valves 6, 10, 13, 15) in a flow-through operation mode of the at least one flow control portion (valves 6, 10, 13, 15) and to prevent the fluid flow through the at least one flow control portion (valves 6, 10, 13, 15) in a blocking operation mode of the at least one flow control portion (valves 6, 10, 13, 15) (see Fig. 1, par. [0034]-[0038], each of valves 6, 10, 13, and 15 are controllable to be open or closed).
Regarding claim 6, modified Jaafar teaches the fluid guide system according to claim 1 substantially as claimed. Modified Jaafar further teaches wherein each of the at least two drug ports (needle sets 16) comprises at least one respective needle (needle sets 16) (see Fig. 1, par. [0036]), and wherein the at least one respective needle (needle sets 16) is arranged movably relative to the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) (see Fig. 1, par. [0036]-[0037]).
Regarding claim 8, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed. Jaafar further teaches wherein the fluid guide system comprises at least one channel (channel of valve 15) extending along a plurality of the at least two drug ports (needle sets 16) (see Fig. 1), and at least two auxiliary channels (channels connecting valve 15 to needle sets 16) connecting a respective drug port (needle sets 16) of the at least two drug ports (needle sets 16) fluidically with the at least one channel (channel of valve 15) (see Fig. 1, par. [0036]).
However, Jaafar fails to expressly state wherein the at least two auxiliary channels and the at least one channel form an angle within a range of 30 degrees to 60 degrees.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of modified Jaafar to include wherein the at least two auxiliary channels and the at least one channel form an angle within a range of 30 degrees to 60 degrees, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the instant case, the cartridge of modified Jaafar would not operate differently with the claimed range and since the at least one channel (channel of valve 15) and the at least two auxiliary channels (channels connecting valve 15 to needle sets 16) must connect to each other at some angle to allow fluidic communication between them (see Jaafar Fig. 1, par. [0036]), the fluid guide system would function appropriately having the claimed angle ranges. Further, it appears the Applicant places no criticality on the ranges claimed, indicating simply that the angle "may" and "alternatively" be within the claimed range (see Specification page 12 lines 4-10, page 38 lines 1-7, page 74 lines 26-37, page 76 line 34 - page 77 line 2).
Regarding claim 9, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed. Jaafar further teaches wherein the fluid guide system comprises: at least one output port (port of saline diluent reservoir 14) configured to be connected or connectable to a further drug container (saline diluent reservoir 14), wherein the further drug container (saline diluent reservoir 14) is an infusion bag (see Fig. 1, par. [0035]-[0036]), and at least one input port (third needle set 16) configured to be connected or connectable to an auxiliary drug container (third vial of drug library 17) (see Fig. 1), wherein the at least one output port (port of saline diluent reservoir 14) and the at least one input port (third needle set 16) are both fluidically connectable or connected to at least one intermediate fluid channel (conduit star 8) of the fluid guide system (see Fig. 1, par. [0034]-[0036]), and wherein the pump interface (interface between fluid guide system and IV pump 22) is selectively coupleable to the at least one input port (third needle set 16) and to the at least one output port (port of saline diluent reservoir 14) (see Fig. 1, par. [0034]-[0038]).
Regarding claim 21, modified Jaafar teaches the cartridge according to claim 2 substantially as claimed. Modified Jaafar further teaches wherein c) is implemented and wherein the at least one hole or the at least two holes (McLoughlin, ports 38 and 44) are arranged within a moveable cover (McLoughlin, front face 40) of the retaining space (see McLoughlin Figs. 1-3, McLoughlin par. [0032] and [0036], see previous modifications in rejection of claim 1 above).
Regarding claim 22, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed (see 112b rejection/interpretation of claim 22 above). Jaafar further teaches wherein heat sealing has been performed to produce channels (channels of fluid structures of the device) of the fluid guide system (fluid structures of the device, see annotated Fig. 1 above) (see Fig. 1, see 112b rejection/interpretation of claim 22 above, note: this is a product-by-process limitation and as such the claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Since Jaafar teaches channels of the fluid guide system, the claim is rejected - see MРЕР 2113).
Regarding claim 27, modified Jaafar teaches the cartridge according to claim 9 substantially as claimed. Jaafar further teaches wherein the further drug container (saline diluent reservoir 14) is configured to receive the fluid and to store the fluid intermediately for later use after decoupling of the further drug container from the at least one output port (port of saline diluent reservoir 14) (see Fig. 1, par. [0035], note: this is a functional limitation which is possible when saline diluent reservoir 14 is detached from valve 13).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et al. (US 2002/0045856 A1) in view of McLoughlin et al. (US 2022/0370289 A1), as applied to claim 1 above, further in view of Jones et al. (US 2021/0369958 A1).
Regarding claim 7, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed. However, Jaafar fails to expressly state wherein the at least two drug ports comprise at least four drug ports, wherein the at least four drug ports are arranged in a matrix comprising at least two columns and at least two lines.
Jones teaches a cartridge (see Fig. 2) wherein the at least two drug ports (port at each spike assembly 200) comprise at least four drug ports (see Fig. 2 - eight total drug ports are shown with one at each spike assembly 200), wherein the at least four drug ports (port at each spike assembly 200) are arranged in a matrix comprising at least two columns and at least two lines (see Fig. 2, each of the eight drug ports are able to be considered 4 lines/2 columns or 4 columns/2 lines).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of modified Jaafar to include wherein the at least two drug ports comprise at least four drug ports, wherein the at least four drug ports are arranged in a matrix comprising at least two columns and at least two lines, as taught by Jones, in order to provide a symmetrical and concise arrangement to accommodate a larger number of drug ports (see Jones Fig. 2, par. [0080]-[0081]).
Claims 11-17, 19-20, 30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et al. (US 2002/0045856 A1) in view of Patrick et al. (US 2015/0297831 A1).
Regarding claim 11, Jaafar discloses a medical device for drug handling (see Fig. 1, par. [0022], [0026], [0028], [0036], [0038]), comprising:
at least one electronic control unit (control unit 3) (see Fig. 1, par. [0036]-[0038]),
at least one valve actuator (see par. [0036]-[0037], actuation mechanisms of valves 6, 10, 13, 15 controlled by control unit 3);
wherein a fluid guide system comprises:
at least one fluid port (needle carrier 1, IV needle 2, and filter 5) configured to dispense a fluid comprising a diluent and at least one reconstituted drug based on at least one lyophilized drug from the fluid guide system (see Fig. 1, par. [0022], [0026], [0028], [0034], [0038]),
at least two drug ports (needle sets 16) configured to be directly mechanically connected to a respective one drug container of a plurality of drug containers (vials within drug library 17) comprising the at least one lyophilized drug (see par. [0022], [0026], [0028], [0034]-[0038]), and wherein each of the at least two drug ports (needle sets 16) comprises a fluid transmitting portion configured to transmit the fluid from the respective one drug container (vials within drug library 17) (see Fig. 1, par. [0036]-[0038]),
a fluid channel system (channels through conduits 4, 11, and 12) comprising at least two different fluid paths including a first fluid path (path from saline diluent reservoir 14 to vials within drug library 17) for transferring the diluent to the respective one drug container (vials within drug library 17) and a second fluid path (path from vials within drug library 17 to needle carrier 1) for transferring the fluid comprising the diluent and the at least one reconstituted drug out of the respective one drug container (vials within drug library 17) (see Fig. 1, par. [0034]-[0038]), wherein the first fluid path (path from saline diluent reservoir 14 to vials within drug library 17) ends on the at least two drug ports (needle sets 16) and the second fluid path (path from vials within drug library 17 to needle carrier 1) starts on the at least two drug ports (needle sets 16) (see Fig. 1, par. [0034]-[0038]);
at least one flow control portion (valves 6, 10, 13, 15) comprising at least one valve portion (valves 6, 10, 13, 15) that controls which of the at least two different fluid paths is active, wherein the at least one valve portion (valves 6, 10, 13, 15) is configured to be actuated by the at least one valve actuator of the medical device (see Fig. 1, par. [0034]-[0038]),
a carrier (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21) configured to carry the fluid channel system (conduits 4, 11, and 12) (see Fig. 1, par. [0036]-[0037], at least portions of conduit 11 are carried by a carrier); and
at least one pump interface (interface between fluid lines and IV pump 22) (see Fig. 1, par. [0037]);
wherein each drug container of the plurality of drug containers (vials within drug library 17) is a vial comprising the at least one Iyophilized drug (see Fig. 1, par. [0022], [0026], [0028], [0036]);
wherein the at least one electronic control unit (control unit 3) is configured to control an operation of the medical device during the drug handling using the at least one lyophilized drug (see Fig. 1, par. [0022], [0026], [0028], [0036]-[0038]),
wherein the at least one electronic control unit (control unit 3) is configured to select an appropriate program for reconstitution steps of the at least one lyophilized drug within the respective drug container (vials within drug library 17) by transferring the diluent to the respective one drug container (vials within drug library 17) (see Fig. 1, par. [0022], [0026], [0028], [0034]-[0038]).
However, Jaafar fails to expressly state a case, and a support portion arranged within the case or on the case and configured to support a removable cartridge comprising the fluid guide system, wherein the cartridge comprises a rigid case, wherein the fluid channel system is formed integrally within the cartridge.
Patrick teaches a medical device for drug handling (see Figs. 1-12) comprising: a case (housing 110), and a support portion (recess or groove 114) arranged within the case (housing 110) or on the case (housing 110) and configured to support a removable cartridge (cassette 300) comprising the fluid guide system (see Figs. 1-12, par. [0146]-[0147], [0155]-[0157], [0165]), wherein the cartridge (cassette 300) comprises a rigid case (see par. [0165]), wherein the fluid channel system (fluid lines within cassette 300) is formed integrally within the cartridge (cassette 300) (see Fig. 8).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of Jaafar to include a case, and a support portion arranged within the case or on the case and configured to support a removable cartridge comprising the fluid guide system, wherein the cartridge comprises a rigid case, wherein the fluid channel system is formed integrally within the cartridge, as taught by Patrick, in order to receive and house the disposable fluid delivery components of the fluid guide system and removably couple them to the reusable electronic control components housed by the medical device (see Patrick par. [0155]-[0157]).
Regarding claim 12, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Jaafar further teaches wherein the at least one flow control portion (valves 6, 10, 13, 15) is configured to control flow in the fluid channel system of the fluid guide system in a flow-through operation mode and in a blocking operation mode (see Fig. 1, par. [0034]-[0038], each of valves 6, 10, 13, and 15 are controllable to be open or closed), and wherein the at least one valve actuator (see par. [0036]-[0037], actuation mechanisms of valves 6, 10, 13, 15 controlled by control unit 3) is configured to interact with the at least one flow control portion (valves 6, 10, 13, 15) of the fluid guide system (see Fig. 1, par. [0036]-[0037]), and wherein the at least one electronic control unit (control unit 3) is further configured to control an operation of the at least one valve actuator (see par. [0036]-[0037], actuation mechanisms of valves 6, 10, 13, 15 controlled by control unit 3) during the drug handling using the at least one lyophilized drug (see Fig. 1, par. [0022], [0026], [0028], [0036]-[0038]).
Regarding claim 13, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Jaafar further teaches wherein the at least one electrical control unit (control unit 3) is configured to control the operation of the medical device such that at least two lyophilized drugs of the at least one lyophilized drug contained in the plurality of drug containers (vials within drug library 17) coupled to the at least two drug ports (needle sets 16) are used for the drug handling (see Fig. 1, par. [0022], [0026], [0028], [0034]-[0038]), and wherein the drug handling includes reconstitution of at least one of the at least two lyophilized drugs (see par. [0022], [0026], [0028], [0038]).
Regarding claim 14, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Jaafar further teaches wherein the at least one pump comprises a positive displacement pump (IV pump 22 is a positive displacement pump, see Fig. 1, par. [0034]-[0038]).
Regarding claim 15, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Modified Jaafar further teaches a movable cover member (Patrick, housing 302 is a two-part outer structure which can removably enclose/expose the internal structures of cassette 300, see Fig. 4, par. [0161]) configured to cover the fluid guide system when the fluid guide system is supported by the medical device (see Patrick Figs. 1 and 4-5B, par. [0161], see previous modifications in rejection of claim 11 above), wherein the movable cover member (Patrick, housing 302) comprises a plurality of openings (Patrick, openings in housing 302 for syringes 360 at baffles, see Fig. 8, par. [0186]) and wherein each opening of the plurality of openings (Patrick, openings in housing 302 for syringes 360 at baffles, see Fig. 8, par. [0186]) is configured to receive the respective one drug container (Jaafar vials within drug library 17, as further taught by Patrick par. [0186], see previous modifications in rejection of claim 11 above),
wherein the movable cover member (Patrick, housing 302) comprises at least one hole or at least two holes (Patrick, holes in housing 302 at receiving sites 310 and luer connector 306) configured to allow an arrangement of a portion of an inlet tube (Patrick, see par. [0164], receiving sites 310 include a standard or luer lock connector, which is capable of connection to a tube) and an arrangement of a portion of an outlet tube (Patrick, fluid delivery line 250) within the at least one hole or at least two holes (Patrick, holes in housing 302 at receiving sites 310 and luer connector 306) (see Patrick Figs. 1-2 and 7-8, par. [0164] and [0198], see previous modifications in rejection of claim 11 above),
wherein the inlet tube (see Patrick par. [0164], receiving sites 310 include a standard or luer lock connector, which is capable of connection to a tube) is configured to be fluidically connected or is fluidically connected to an inlet port (Patrick, receiving sites 310) of the fluid guide system (see Patrick Fig. 7, par. [0164], see previous modifications in rejection of claim 11 above), and
wherein the outlet tube (Patrick, fluid delivery line 250) is configured to be fluidically connected or is fluidically connected to an outlet port (Patrick, luer fitting 306) of the fluid guide system (see Patrick, Figs. 1-2 and 7-8, par. [0198], see previous modifications in rejection of claim 11 above).
Regarding claim 16, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Jaafar further teaches at least one automatically movable actuator element (engaging mechanism 19, rail 21, and automated electric motor, see par. [0037]) configured to move at least one needle (needle sets 16) arranged within or on the fluid guide system through a closing element (rubber caps of vials within drug library 17, see par. [0037]) of the respective one drug container (vials within drug library 17) (see Fig. 1, par. [0036]-[0037]).
Regarding claim 17, modified Jaafar teaches a method for drug handling (see Fig. 1), comprising:
performing at least one drug handling step automatically using the medical device according to claim 11 (see claim 11 rejection above) when the cartridge (Patrick, cassette 300) is applied to the support portion (Patrick, recess or groove 114) of the medical device (see claim 11 rejection above).
Regarding claim 19, modified Jaafar teaches a computer-implemented method performed by the at least one electronic control unit (control unit 3) of the medical device according to claim 11 (see claim 11 rejection above) (see Fig. 1), comprising:
sensing or prompting a user to confirm a coupling of the plurality of drug containers (vials within drug library 17) to a respective one of the at least two drug ports (needle sets 16) of the fluid guide system (see Fig. 1, par. [0028] and [0038], the machine is highly automated and the patient activates the machine),
wherein the at least two drug ports (needles 16) are configured to receive the at least one reconstituted drug from the respective one drug container (vials within drug library 17) (see Fig. 1, par. [0034]-[0038]).
Regarding claim 20, modified Jaafar teaches a computer-implemented method according to claim 19 substantially as claimed. Jaafar further teaches: controlling a pump drive unit that is configured to drive the at least one pump (IV pump 22) (see Fig. 1, par. [0037]-[0038], wherein at least a part of the at least one pump (IV pump 22) is implemented on the fluid guide system or wherein the at least one pump (IV pump 22) is configured to generate a pumping force for a fluid flow within the fluid guide system (see Fig. 1, par. [0037]-[0038]),
prompting the user to begin a drug handling process (see par. [0028], the patient activates the machine);
performing a calculation to calculate a dose of the at least one lyophilized or reconstituted drug (see par. [0022], [0026], [0028], [0037]-[0038], the control unit 3 calculates the rate/dose),
providing alerts and/or guidance to the user, or
sensing a presence of at least one further container (third vial within drug library 17) (see Fig. 1, par. [0028] and [0038], the machine is highly automated and the patient activates the machine).
Regarding claim 30, modified Jaafar teaches the method according to claim 17 substantially as claimed. Jaafar further teaches coupling the plurality of drug containers (vials within drug library 17) to the fluid guide system (see Fig. 1);
transferring the diluent to at least one drug container of the plurality of drug containers (vials within drug library 17) via the first fluid path (path from saline diluent reservoir 14 to vials within drug library 17) (see Fig. 1, par. [0034]-[0038]);
actuating the at least one valve portion (valves 6, 10, 13, 15) by the at least one valve actuator (see par. [0036]-[0037], actuation mechanisms of valves 6, 10, 13, 15 controlled by control unit 3) in order to activate the second fluid path (path from vials within drug library 17 to needle carrier 1) in order to reconstitute the at least one lyophilized drug to the at least one reconstituted drug (see Fig. 1, par. [0022], [0026], [0028], [0034]-[0038]);
dispensing the fluid comprising the diluent and the at least one reconstituted drug from the fluid guide system via the second fluid path (path from vials within drug library 17 to needle carrier 1) (see Fig. 1, par. [0034]-[0038]).
Regarding claim 32, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Jaafar further teaches wherein the at least one valve actuator (see par. [0036]-[0037], actuation mechanisms of valves 6, 10, 13, 15 controlled by control unit 3) is connected to an electronic interface of the at least one electronic control unit (control unit 3) (see Fig. 1, par. [0036]-[0038]).
Regarding claim 33, modified Jaafar teaches the medical device according to claim 11 substantially as claimed. Jaafar further teaches wherein the medical device is configured such that multiple of the plurality of drug containers (vials within drug library 17) can be simultaneously or sequentially connected to a single diluent source (saline diluent reservoir 14) via the first fluid path (path from saline diluent reservoir 14 to vials within drug library 17) (see Fig. 1, par. [0034]-[0038]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et al. (US 2002/0045856 A1) in view of McLoughlin et al. (US 2022/0370289 A1), as applied to claim 5 above, further in view of Khan (US 2018/0344927 A1).
Regarding claim 23, modified Jaafar discloses the cartridge according to claim 5 substantially as claimed. Modified Jaafar further teaches wherein the carrier (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) comprises a rigid cartridge (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above); wherein the rigid cartridge (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) comprises a rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above); and wherein the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) comprises the fluid channel system (channels through all of fluid conduits) and the at least one flow control portion (valves 6, 10, 13, 15) (see 112b rejection/interpretation of claim 23 above).
However, modified Jaafar fails to state wherein the at least one flow control portion comprises a flexible tubing portion which is configured to perform a pinch valve function when interacting with an actuator pin of the medical device, wherein the actuator pin is external to the fluid guide system, wherein the flexible tubing portion is arranged at a valve actuator opening of the rigid case of the cartridge, the valve actuator opening being configured to allow the actuator pin to pinch the flexible tubing portion, wherein the rigid case comprises the valve actuator opening.
Khan teaches a cartridge (see Fig. 7) wherein the at least one flow control portion (pinch valve shown in Fig. 7) comprises a flexible tubing portion (tubing 702) which is configured to perform a pinch valve function when interacting with an actuator pin (plunger 706c) of the medical device (see Fig. 7, par. [0107]-[0108]), wherein the actuator pin (plunger 706c) is external to the fluid guide system (see Fig. 7), and wherein the flexible tubing portion (tubing 702) is arranged at a valve actuator opening (opening through which tubing 702 extends, see Fig. 7) of the rigid case (case surrounding tubing 702 and plunger 706c, see Fig. 7) of the cartridge (case surrounding tubing 702 and plunger 706c, see Fig. 7), the valve actuator opening (opening through which tubing 702 extends, see Fig. 7) being configured to allow the actuator pin (plunger 706c) to pinch the flexible tubing portion (tubing 702) (see Fig. 7, par. [0107]-[0108]), wherein the rigid case (case surrounding tubing 702 and plunger 706c, see Fig. 7) comprises the valve actuator opening (opening through which tubing 702 extends, see Fig. 7).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of modified Jaafar to include wherein the at least one flow control portion comprises a flexible tubing portion which is configured to perform a pinch valve function when interacting with an actuator pin of the medical device, wherein the actuator pin is external to the fluid guide system, and wherein the flexible tubing portion is arranged at a valve actuator opening of the rigid case of the cartridge, the valve actuator opening being configured to allow the actuator pin to pinch the flexible tubing portion, wherein the rigid case comprises the valve actuator opening, as taught by Khan, in order to allow electrical control of the opening/closing of the at least one flow control portion (see Khan par. [0107]-[0108]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et (US 2002/0045856 A1) in view of McLoughlin et al. (US 2022/0370289 A1), as applied to claim 6 above, further in view of Beiriger (US 2011/0004187 A1).
Regarding claim 24, modified Jaafar teaches the cartridge according to claim 6 substantially as claimed. Modified Jaafar further teaches wherein at least one of the at least two drug ports (needle sets 16) comprises within the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) a drug container opening (openings through wall 20) for the respective drug container (vials within drug library 17) (see Fig. 1, par. [0036]), wherein the at least one respective needle (needle sets 16) is arranged within the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) and at the drug container opening (openings through wall 20) of the rigid case (cooler 18 and housing for needle sets 16, engaging mechanism 19, and rail 21; see previous modifications in rejection of claim 1 above) (see Fig. 1, par. [0036]-[0037]).
However, modified Jaafar fails to state wherein the at least one respective needle is configured to be actuated by a cam actuator of the medical device, wherein a cam actuator opening is arranged on the rigid case opposite to the drug container opening; and wherein the cam actuator opening is configured to allow an arrangement of the cam actuator of the medical device within the cam actuator opening and to allow the cam actuator to move the at least one respective needle.
Beiriger teaches a cartridge (see Fig. 23) wherein the at least one respective needle (spike assembly 1122) is configured to be actuated by a cam actuator (cam 1114) of the medical device (see Fig. 23, par. [0369]), wherein a cam actuator opening (opening/space for cam 1114) is arranged on the rigid case (case/body of Fig. 23) opposite to the drug container opening (opening through lower member 1120) (see Fig. 23, par. [0369]); and wherein the cam actuator opening (opening/space for cam 1114) is configured to allow an arrangement of the cam actuator (cam 1114) of the medical device within the cam actuator opening (opening/space for cam 1114) and to allow the cam actuator (cam 1114) to move the at least one respective needle (spike assembly 1122) (see Fig. 23, par. [0369]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of modified Jaafar to include wherein the at least one respective needle is configured to be actuated by a cam actuator of the medical device, wherein a cam actuator opening is arranged on the rigid case opposite to the drug container opening; and wherein the cam actuator opening is configured to allow an arrangement of the cam actuator of the medical device within the cam actuator opening and to allow the cam actuator to move the at least one respective needle, as taught by Beiriger, in order to automatically control the coupling of the respective needle with containers of the system (see Beiriger par. [0369]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et al. (US 2002/0045856 A1) in view of Patrick et al. (US 2015/0297831 A1), as applied to claim 12 above, further in view of Khan (US 2018/0344927 A1).
Regarding claim 28, modified Jaafar teaches the medical device according to claim 12. Modified Jaafar further teaches wherein the carrier comprises a rigid cartridge (see 112b rejection/interpretation of claim 28 above, Patrick cassette 300); wherein the rigid cartridge comprises a rigid case (see 112b rejection/interpretation of claim 28 above, Patrick par. [0165]); and wherein the rigid case comprises the fluid channel system and the at least one flow control portion (see 112b rejection/interpretation of claim 28 above, see previous modifications in rejection of claim 11 above, see Patrick Fig. 8).
However, modified Jaafar fails to state wherein the at least one flow control portion comprises a flexible tubing portion which is configured to perform a pinch valve function when interacting with an actuator pin of the medical device, wherein the actuator pin is external to the fluid guide system; wherein the flexible tubing portion is arranged at a valve actuator opening of the rigid case, the valve actuator opening being configured to allow the actuator pin to pinch the flexible tubing portion; wherein the rigid case comprises the valve actuator opening.
Khan teaches a medical device (see Fig. 7) wherein the flow control portion (pinch valve shown in Fig. 7) comprises a flexible tubing portion (tubing 702) which is configured to perform a pinch valve function when interacting with an actuator pin (plunger 706c) of the medical device (see Fig. 7, par. [0107]-[0108]), wherein the actuator pin (plunger 706c) is external to the fluid guide system (see Fig. 7), and wherein the flexible tubing portion (tubing 702) is arranged at a valve actuator opening (opening through which tubing 702 extends, see Fig. 7) of the rigid case (case surrounding tubing 702 and plunger 706c, see Fig. 7), the valve actuator opening (opening through which tubing 702 extends, see Fig. 7) being configured to allow the actuator pin (plunger 706c) to pinch the flexible tubing portion (tubing 702) (see Fig. 7, par. [0107]-[0108]), wherein the rigid case (case surrounding tubing 702 and plunger 706c) comprises the valve actuator opening (opening through which tubing 702 extends, see Fig. 7).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of modified Jaafar to include wherein the flow control portion comprises a flexible tubing portion which is configured to perform a pinch valve function when interacting with an actuator pin of the medical device, wherein the actuator pin is external to the fluid guide system, and wherein the flexible tubing portion is arranged at a valve actuator opening of the rigid case, the valve actuator opening being configured to allow the actuator pin to pinch the flexible tubing portion, wherein the rigid case comprises the valve actuator opening, as taught by Khan, in order to allow electrical control of the opening/closing of the at least one flow control portion (see Khan par. [0107]-[0108]).
Claims 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et al. (US 2002/0045856 A1) in view of McLoughlin et al. (US 2022/0370289 A1), as applied to claim 1 above, further in view of Patrick et al. (US 2015/0297831 A1).
Regarding claim 29, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed. However, modified Jaafar fails to expressly state at least one vent which is part of a connection between the fluid guide system and the plurality of drug containers and which allows air only to freely escape and/or enter.
Patrick teaches a cartridge (see Figs. 1-12) comprising at least one vent (ventilation member 390) which is part of a connection between the fluid guide system and the plurality of drug containers (syringes 360) (see Fig. 6A) and which allows air only to freely escape and/or enter (see Figs. 6A, 7, and 10, par. [0171]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of modified Jaafar to include at least one vent which is part of a connection between the fluid guide system and the plurality of drug containers and which allows air only to freely escape and/or enter, as taught by Patrick, in order to a filtered and ventilated transfer of fluids within the system (see Patrick par. [0171]).
Regarding claim 31, modified Jaafar teaches the cartridge according to claim 1 substantially as claimed. However, modified Jaafar fails to expressly state wherein the at least one pump interface comprises at least one peristaltic pump interface or at least one diaphragm pump interface.
Patrick teaches a cartridge (see Figs. 1-12), wherein the at least one pump interface comprises at least one peristaltic pump interface or at least one diaphragm pump interface (see par. [0138]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge of Jaafar to substitute the at least one pump interface of Jaafar with at least one peristaltic pump interface or at least one diaphragm pump interface, as taught by Patrick, because Patrick teaches that these are alternative types of pumps for transferring fluids through and out of drug systems (see Patrick par. [0138]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Jaafar et (US 2002/0045856 A1) in view of Patrick et al. (US 2015/0297831 A1), as applied to claim 16 above, further in view of Beiriger (US 2011/0004187 A1).
Regarding claim 34, modified Jaafar teaches the fluid guide system according to claim 16 substantially as claimed. Modified Jaafar further teaches wherein at least one of the at least two drug ports (needle sets 16) comprises within the rigid case (Patrick, cassette 300) a drug container opening (openings through wall 20) for the respective one drug container (vials within drug library 17) (see Fig. 1, par. [0036]),
wherein the at least one needle (needle sets 16) is arranged within the rigid case (Patrick, cassette 300) and at a drug container opening (openings through wall 20) of the rigid case (Patrick, cassette 300) of the removable fluid guide system (see Fig. 1, par. [0036]-[0037]).
However, Jaafar fails to state wherein the at least one needle is configured to be actuated by a cam actuator of the medical device, wherein a cam actuator opening is arranged on the rigid case opposite to the drug container opening; wherein the cam actuator opening is configured to allow an arrangement of the cam actuator of the medical device within the cam actuator opening and to allow the cam actuator to move the at least one needle; and wherein the cam actuator is the automatically movable actuator element.
Beiriger teaches a fluid guide system (see Fig. 23) wherein the at least one needle (spike assembly 1122) is configured to be actuated by a cam actuator (cam 1114) of the medical device (see Fig. 23, par. [0369]), wherein a cam actuator opening (opening/space for cam 1114) is arranged on the rigid case (case/body of Fig. 23) opposite to the drug container opening (opening through lower member 1120) (see Fig. 23, par. [0369]); wherein the cam actuator opening (opening/space for cam 1114) is configured to allow an arrangement of the cam actuator (cam 1114) of the medical device within the cam actuator opening (opening/space for cam 1114) and to allow the cam actuator (cam 1114) to move the at least one needle (spike assembly 1122) (see Fig. 23, par. [0369]); and wherein the cam actuator (cam 1114) is the automatically movable actuator element (see Fig. 23, par. [0369]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid guide system of Jaafar to include wherein the at least one needle is configured to be actuated by a cam actuator of the medical device, wherein a cam actuator opening is arranged on the rigid case opposite to the drug container opening; wherein the cam actuator opening is configured to allow an arrangement of the cam actuator of the medical device within the cam actuator opening and to allow the cam actuator to move the at least one needle; and wherein the cam actuator is the automatically movable actuator element, as taught by Beiriger, in order to automatically control the coupling of the respective needle with containers of the system (see Beiriger par. [0369]).
Response to Arguments
Applicant’s arguments with respect to claim 1 and its dependent claims (see Remarks, pages 14-15) have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument. The amendments to the claim to modify the fluid guide system to be a cartridge comprising a fluid guide system as well as the combination of added limitations in lines 27-31 changes the scope of the claim, necessitating the new grounds of rejection.
Applicant's arguments with respect to claim 11 and its dependent claims (see Remarks, pages 15-16) have been fully considered but they are not persuasive.
First, Applicant argues that it would not have been obvious to use a cartridge as taught by Patrick in the system of Jaafar because the system of Jaafar is only intended for rare use and a cartridge would only increase the costs of the system. This argument is not found to be persuasive. It is not clear how providing parts of Jaafar’s system within a cartridge would require the system to be used more frequently or would significantly increase costs associated with the system. Cassettes are well known in the art of fluid delivery systems and allow for just the cassette to be disposable and replaced with new cassettes while the remainder of the system can be reusable (see Patrick par. [0157], [0183]). This would appear to reduce costs by only needing to replace a portion of the system rather than the whole system, and can further maintain sterility of the cassette by housing the fluid delivery portions of the system within the cassette and housing non-sterile portions of the system in the reusable portion (see Patrick par. [0187], [0381]). Regardless, neither Patrick nor Jaafar teach that cassettes would be an undesirable modification because they increase costs, thus neither Patrick nor Jaafar would be teaching away from such a modification.
Second, Applicant argues that none of Jaafar, Patrick, or Beiriger teaches a medical device comprising a valve actuator acting on a flow control portion of a cartridge as recited in claim 11. This argument is not found to be persuasive. Jaafar teaches a valve actuator (see par. [0036], control unit 3 controls the system to actuate the valves 6, 10, 13, and 15 thus the actuation mechanisms controlled by the control unit 3 would be the “valve actuator”) and a flow control portion (valves 6, 10, 13, and 15). Patrick additionally teaches housing these components within a cartridge (cartridge 300) see Figs. 1-12, par. [0146]-[0147], [0155]-[0157], [0165]). The Examiner maintains that the modified combination of Jaafar and Patrick teaches the valve actuator, flow control portion, and cartridge limitations as recited in the claim and as described in the rejection of claim 11 above.
Third, Applicant argues that Jaafar’s system is intended to be used for reconstitution of lyophilized drugs and Patrick’s system is used for mixing entirely different drugs and thus the structures of the Jaafar system and the Patrick system are not compatible. This argument is not found to be persuasive. The modification in the rejection of claim 11 is to house portions of medical device of Jaafar within a case, support portion, and cartridge as is shown throughout Figs. 1-12 of Patrick and described in the rejection of claim 11 above. Beyond these housing-type structures, the pumping or fluid delivery structures of Patrick have not been imported into the device of Jaafar. Thus, modification of Jaafar in view of Patrick in the rejection of claim 11 above would not alter the ability of Jaafar’s system to reconstitute lyophilized drugs. Additionally, the two references are analogous in that they are in the related art of mixing systems for liquid drug delivery.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783