DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 24, 2026 has been entered.
Response to Arguments
The amendment filed March 24, 2026 has overcome the prior rejection as previously set forth. However, the rejection has been amended below since Helle teaches a vial assembly which is substantially translatable. Therefore, in the cited combination, which has now been modified to reverse the assemblies of Hoffman and Helle, the modified device is considered to meet the claim limitations as currently set forth. However, regarding Applicant’s arguments directed to claim 36, the Examiner respectfully disagrees. Even if Carmel discloses the application of positive pressure for mixing, it is well-understood that pulling the plunger rearwardly through the barrel would generate negative pressure, thereby pulling fluid into the syringe from the fluid passageways. It is therefore fully capable of functioning in the claimed manner. The rejection is considered proper and is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 7-9, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helle et al. (US 2008/0260580) in view of Hoffman et al. (US 2016/0331998).
Regarding claim 1, Helle et al. (henceforth Helle) discloses a delivery assembly, comprising: a console (housing 90 and internal structural features seen in Figures 2-5) including a vial containment region and a base (accessed within cavity 91; ¶ [0043]; see annotated figure below), the base defining a containment region underlying the vial containment region (the vial containment region is the portion of the housing which receives the injector 18 and plunger 60; it may be considered a base as it is the bottom of the actuation assembly and is connected to the legs of the interior assembly; there is also a portion underneath the vial containment region accessed via door 94 which is capable of receiving a sled assembly for insertion in the cited combination); a vial engagement mechanism extending laterally along a lateral axis from the console within the vial containment region (see e.g., Figures 3-4, the brackets and assemblies for engaging injector 18 and plunger 60 which make up the vial assembly), wherein the vial engagement mechanism is configured to engage a translatable portion of a vial assembly (piston 56 and plunger adaptor 58 of actuator 20 engage plunger 60 to move it along the barrel length; ¶ [0042]) , and wherein a longitudinal axis of the vial assembly is parallel with a longitudinal axis of the console (Figure 4) and is perpendicular to the base (the base extends orthogonal to actuator 20; this can be seen in Figure 5 which depicts portions of the base of the assembly extending at right angles to the bracket 62 which carries frame 50 and actuator 20); and a safety shield (housing 90 and doors 92 and 94; ¶ [0045]) comprising a monolithic structure including top and side portions (the main body of the cabinet comprising the top and side portions is monolithic as claimed) insertable onto and removably couplable to the console over and to encompass the vial containment region (it covers the assembly and is therefore capable of being inserted over the assembly before being secured as it is just a hollow cabinet structure attached to the frame) and attach to the base such that the vial engagement mechanism and the vial assembly are encapsulated within and spaced from the top and side portions of the safety shield and inaccessible when the safety shield is coupled thereto (see Figures 2-3; the cabinet is secured around the entire assembly and the vial engagement assembly is located within the cabinet); wherein the vial assembly and the safety shield are configured to inhibit radioactive emissions from within the vial containment region (¶ [0045] discloses the syringe assembly 18 and needle 32 are formed from radiation shielding material; ¶ [0043] discloses that the housing 90 is a radiation shield). Helle fails to explicitly disclose a sled assembly separable from the console, configured to house the vial assembly, and removably couplable to the console at the sled assembly containment region via lateral insertion along the lateral axis of the console such that the vial assembly housed in the sled assembly projects upwardly along a longitudinal axis into the vial containment region when the sled assembly is coupled to the console.
Hoffman et al. (henceforth Hoffman) teaches (Figure 2A, 4B, and 4C) a shielded syringe delivery assembly comprising a sled assembly (28, 413, 414) which is designed to provide a shielded housing for a syringe (41; ¶ [0066]), and which is couplable to a console (21) for automatic actuation of the plunger of the syringe via a vial engagement means (¶ [0066] discloses coupling of the plunger of the syringe to the automated drive system).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Helle to replace the bound syringe assembly with the sled-type assembly of Hoffman so as to provide a means of releasably inserting a syringe into the housing of Helle while retaining the radiation shielding properties throughout use via the sled assembly of Hoffman. In such a modification, the sled of Hoffman would be placed into the cabinet of Helle, in the vertical orientation, and engage with the plunger manipulation means of Helle. Both Helle and Hoffman contemplate automated movement of the plunger via a vial engagement mechanism, and such a feature would be retained in the cited combination. Hoffman teaches the use of an enlarged portion of the housing assembly (411) for receiving the piston, motor, or pump, of the drive assembly for manipulation of the plunger. Therefore, in the combination, this feature would be maintained and provide for the sled to be introduced into the housing which would comprise the plunger engagement features of both devices.
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Regarding claim 2, Helle further discloses wherein the vial assembly comprises: a vial body (body of syringe 18) formed of a material that inhibits radioactive emissions from within the vial body (¶ [0045]); and a plunger (60) as the translatable portion of the vial assembly slidably translatable relative to the body of the device (Figure 4, the plunger extends through the barrel and retention features of the frame assembly), and through the vial body in response to the vial engagement mechanism engaging the vial assembly (e.g., ¶ [0042]). Helle fails to explicitly disclose a locking feature for securing the vial assembly to a sled assembly.
Hoffman further teaches (e.g., Figures 4A-4F) wherein the vial assembly (e.g., syringe 41) comprises: a vial body (syringe barrel; Figure 4C) formed of a material (412) that inhibits radioactive emissions from within the body (¶ [0066]); a locking feature (e.g., groove 419 which engages flange 420 of the syringe) coupled to the vial body and configured to securely engage the vial assembly to the sled assembly when the vial assembly is received therein; and a plunger (422) as the translatable portion of the vial assembly, slidably translatable relative to the locking feature and through the vial assembly (to deliver the medicament).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the locking feature of the sled of Hoffman in the combined device so as to provide a means of securing the vial within the sled during use as taught by Hoffman.
Regarding claim 7, Helle/Hoffman further teach wherein the vial engagement mechanism (e.g., portion of actuator 20 of Helle which engages plunger of vial assembly in the combined device) is disposed within the vial containment region (Figure 4, it would be located on the actuator to engage the plunger) and proximate to the sled assembly when the sled assembly is coupled to the console (the engagement mechanism is located within the vial containment region to lock the vial assembly to the console via the sled assembly in the combined device; it would be adjacent the plunger to couple to the plunger rod of the syringe).
Regarding claims 8 and 9, Hoffman further discloses a delivery handle (29) coupled to the vial engagement mechanism and configured to move the vial engagement mechanism within the via containment region, wherein the delivery handle (29) is configured to move the vial assembly relative to the sled assembly in response to actuating the delivery handle (the handle 29 moves the syringe case relative to 203 which is part of the sled assembly.
Regarding claim 20, Hoffman further discloses (Figure 4F) wherein the plunger includes an upper engagement head (e.g., thumb flange engaged with 434) and a lower engagement head (flange engaged with 419) positioned relatively beneath the upper engagement head (the orientation is relative; Figures 4C and 4F) along a longitudinal length of the plunger.
Claim(s) 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helle in view of Schwartz et al. (US 2003/0009132), and further in view of Shaw et al. (US 5,309,959).
Regarding claim 34, Helle discloses a treatment delivery device, comprising: a housing (panels 90) having a protective shielding material (¶ [0043]), wherein the housing is sized and shaped to couple to an instrument (Figure 4, the housing couples around the frame of the syringe assembly); a vial compartment (for retaining syringe 18) having a central axis perpendicular to the base plate (Figure 4, it’s a vertical syringe assembly) and disposed within the housing (the compartment is part of the inner portion of the cabinet assembly), wherein the vial compartment is configured to house a solid therapeutic media therein (the vial compartment can hold any vial regardless of contents), and wherein the protective shielding material inhibits exposure of the solid therapeutic media external from the housing (frame 90 is a radiation shield and is therefore designed to perform this function; also vial 18 is formed from a radiation shielding material as per ¶ [0045]); a fluid reservoir (inside of syringe 18) having a central axis perpendicular to the base plate and disposed within the housing and translatable with respect to and within the vial compartment (Figure 4, ¶ [0038] sets forth that the syringe is movable to pierce a vial to withdraw fluid therefrom), wherein the fluid reservoir along a monolithic and unimpeded interior central wall area comprises a central lumen of a needle (Figure 4, there is a retention plate through which the distal end of the syringe assembly passes to maintain orientation which meets the limitation) and is configured to receive the fluid medium from the encasement device therein via the needle, and wherein the fluid reservoir is in fluidic communication with the vial compartment such that the fluid medium is transferred into the vial compartment via the plurality of side holes as the needle translates downward; and an actuator movably coupled to the housing such that moving the actuator delivers the fluid medium to the vial compartment (¶ [0040]); wherein the actuator is configured to deliver a liquid-solid mixture of the fluid medium and the solid therapeutic to the instrument (the syringe is configured to ensure that the proper amount of radioisotope is dispensed as per ¶ [0040]). Helle fails to explicitly disclose wherein the distal end of the housing is disposed on, within, and fully surrounded by a periphery of, a base plate, the base plate comprising an elongated member disposed in parallel to the housing on the base plate, or the syringe needle comprises a plurality of side holes.
Shaw et al. (henceforth Shaw) teaches (Figure 1) a syringe-based dispensing apparatus comprising a base plate (12) from which a syringe filling assembly (e.g., 30) extends. In addition, Shaw teaches an elongated member (10) extending from the base plate (12) which comprises hooks (e.g., jaws 20a and 20b) for holding an encasement (the jaws can functionally hold anything).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the assembly of Helle to place it on the working table of Shaw to provide a means of creating a workspace for vial manipulation including holding means as taught by Shaw. Such a modification allows the features of the device of Helle to be used in larger workflow scenarios or with robotic manipulation means as taught by Shaw (e.g., Col. 2, lines 1-18).
Schwartz teaches a syringe assembly comprising a needle (2) comprising a plurality of side holes (¶ [0068] discloses a solid needle comprising a plurality of side holes formed therein; the holes are depicted in Figures 1-3).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the needle of Helle to comprise a plurality of side holes formed therein as Schwartz teaches that such features allow for controlled flow out of an into the needle to control the transfer of fluid through the needle (see e.g., ¶¶ [0068] and [0070]).
Claim(s) 36 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pawelka et al. (US 5,584,815) in view of Carmel et al. (US 2002/0004643).
Regarding claim 36, Pawelka et al. (henceforth Pawelka) discloses a handheld delivery device, comprising: a first chamber (e.g., inside of cartridge 184 in retainer 188; Figure 3) longitudinal axis continuously parallel with a longitudinal axis of the handheld delivery device (Figure 3) during insertion and after reception of a first device (cartridge 184; see Figure 3 for the assembled configuration; it is parallel along the device during axial insertion of the cartridge and during use) comprising a first chamber longitudinal axis (along the vial receiving portion) parallel with a longitudinal axis of the handheld delivery device (Figure 3), the first chamber sized and shaped to receive, along the first chamber longitudinal axis (Figure 2) the first device, a first device including a plunger and including therapeutic particles stored therein (primary medicament in 184, drug molecules are considered particles), wherein the plunger, configured for longitudinal translation, externally extends from the first chamber after reception of the device in the first chamber (the plunger extends beyond the proximal end of cartridge retainer 188 and is therefore considered to extend external to it; Figure 3); a second chamber (within 186) comprising a second chamber longitudinal axis (along the cartridge axis) sized and shaped to house a second device including fluid medium (cartridge 186 and drug therein; Col. 5, lines 50-54) stored therein (Figure 5) and a distal port (exit port connected to needle), the second chamber longitudinal axis being continuously parallel to the first chamber longitudinal axis (see the two cartridges parallel to each other in Figure 3) during insertion and after reception of the second device (it’s parallel during axial insertion and throughout use); a distal end including a manifold (192) and a needle (208) and a pair of delivery lines (lumens of passage from both cartridge piercing needles 208, 210 through needle 41 within the manifold) disposed therein, the distal end is coupled to the first chamber and the second chamber such that the manifold is in fluid communication with the first device and the second device (Figure 3) via respectively a first (e.g., fluid passage through manifold from needle 208 through needle 41) delivery line and a second delivery line (e.g., fluid passage through manifold from needle 210 through needle 41) of the pair of delivery lines, wherein the needle extends into the first chamber and coupled to the first device received within the first chamber (Figure 3). Pawelka fails to explicitly disclose the passing of the fluid via application of positive or negative pressure to the first device and the plunger rod already installed into the device and extending from the chamber.
Carmel et al. (henceforth Carmel) teaches a liquid transfer device comprising first and second devices (Figures 3 and 4) wherein liquid is configured to pass from a second device to a first device upon application of positive pressure so as to form mixture to be injected from the first device through the outlet (¶ [0043]) and is capable of allowing for flow at the delivery line via application of negative pressure (e.g., one can apply negative pressure to the outlet to withdraw the fluid mixture and therefore the device is fully capable of performing the claimed function). Carmel further teaches (Figure 4) an external plunger (12) for actuating the device.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Pawelka to allow for transfer from the second reservoir to the first reservoir if it was desired to form a mixed solution from two initial components for injection during a procedure as taught by Carmel.
Regarding claim 37, Pawelka/Carmel further teach wherein the first device is punctured by the needle when received within the first chamber (e.g., Figure 3, the needle 208 punctures the septum of the cartridge 184), wherein the first device comprises a handle (e.g., 132) externally coupled to the plunger (Figure 3 of Pawelka) and comprising a handle width larger than a plunger width of the plunger (Figure3), wherein translation of the handle in a first direction (downward in an arc as per Figures 3-5 of Pawelka; Col. 8, lines 1-20) causes the application of the positive pressure, and translation of the handle in a second direction (upward) causes the application of a negative pressure.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Eggert to comprise the plunger handle of Carmel to allow for selective application of pressure to the device to mix and deliver the drug components during a procedure as taught by Carmel (¶¶ [0040]-[0042]).
Claim(s) 3, 17, 19, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helle, in view of Hoffman, and further in view of Eguchi (US 2006/0091329).
Regarding claims 3 and 17, Helle/Hoffman teach the claimed invention substantially as set forth above for claims 1, 2, and 20, but does not explicitly disclose the resilient arms and lever arms as claimed.
Eguchi teaches (Figure 9) a mechanism for retaining a syringe (24) in a holder which comprises a plunger (plunger and flange 32) having a pair of resilient arms (e.g., the flange portions may be considered arms) which are sized and shaped to interlock with a pair of lever arms (102a and 102b) of the housing mechanism (Figure 9; ¶ [0046]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the retention means of Helle/Hoffman to include the lever arms interlocked with the resilient arms as taught by Eguchi as Eguchi teaches that such a securement means is sufficient for retaining a syringe device within a housing to prevent movement of the syringe during use (¶ [0046]).
Regarding claim 19, Eguchi further teaches wherein the pair of flexible wings (of flange 32) are configured to form an engagement surface that is sized and shaped to interlock with the pair of lever arms in response to deformation of the pair of flexible wings as the plunger translates outwardly from the vial body (the flange is designed to lock between 102a, 102b, and 100; the flange is fully capable of being deformed, to some extent, by insertion into this area, even during plunger movement; one could pull rearwardly on the plunger while engaging the flange into this space for retention).
Regarding claim 21, Eguchi further teaches upper and lower engagement surfaces for engaging with corresponding upper and lower engagement surfaces of the vial engagement mechanism (Figure 9, the upper and lower surfaces of plunger flange 32 are engaged with top surfaces of 102a and 102b, as well as bottom surfaces of 100).
Regarding claim 22, the device of Helle/Hoffman/Eguchi would be fully capable of interlocking with the lever arms via at least some downward translation (e.g., the flange could move down to slide into the space between the arms 102a and 102a and the base 100).
Claims 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helle in view of Hoffman, and further in view of Page et al. (US 4,923,446).
Regarding claim 23, Helle/Hoffman teach the claimed invention substantially as set forth above for claim 22, but fail to explicitly disclose the plunger track.
Page et al. (henceforth Page) teaches (Figure 1) a syringe assembly comprising a first element having a curved track and a linear track (34; a portion of the track is curved and another portion, such as at the terminal ends of the track, may be considered substantially linear) wherein the track is configured to receive a fixed pin (36) of another member therein.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the plunger of Hoffman/Helle to comprise the pin and track engagement means of Page so as to allow the plunger to rotate relative to an external member during translation as taught by Page (e.g., Col. 2, lines 15-23).
Regarding claim 24, Page further teaches wherein the curved track (34) extends around the exterior surface of the plunger and the linear track extends along the exterior surface and parallel to a longitudinal length of the plunger (Figure 1).
Regarding claim 25, Page further teaches wherein the plunger is configured to rotate within and translate outwardly from the vial body in response to the pair of lever arms interlocking with the bottom surface of the upper engagement head when the vial engagement mechanism translates upward due to the fixed pin being received within the curved track (the modified plunger is able to rotate relative to an outer body which would be engaged by the lever arms in the cited combination as claimed).
Regarding claim 26, Page further teaches, wherein the plunger is configured to translate into the vial body at a fixed orientation relative thereto in response to the pair of lever arms interlocking with the top surface of the lower engagement head when the vial engagement mechanism translates downward due to the fixed pin being received within the linear track (the plunger is fully capable of performing this function in the cited combination as claimed).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helle in view of Hoffman, and further in view of Eggert (US 2014/0236093).
Regarding claim 4, Helle/Hoffman teach the claimed invention substantially as set forth above for claim 1, but does not explicitly disclose a septum within the vial body.
Eggert teaches (Figure 11) a vial body (90) comprising a septum (depicted in Figure 11) for sealing the vial prior to use (¶ [0110]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vial of Helle/Hoffman to comprise a pierceable septum so as to maintain sterility of the drug within the vial until use as taught by Eggert.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helle in view of Hoffman, and further in view of James (US 2002/0083564).
Regarding claim 18, Helle/Hoffman teach the claimed invention substantially as set forth above for claim 17, but does not explicitly disclose a pair of flexible wings rotatable coupled to the plunger so that they deform in response to translation of the plunger outwardly from the vial body.
James teaches (Figure 1) a clip for securing a drug vial to a syringe with comprises a plurality of wings (each pair of curved arms) which are rotatably coupled to the syringe (when the syringe is passed into the clip the friction fit will force the arms to rotate outward around the body being inserted therein) such that the pair of flexible wings are configured to flexibly deform in response to translation of the element to be inserted into the arms (they will bend outward so as to receive the element therein before returning to size and retaining the desired elements relative to each other; ¶ [0004]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the plunger retention means of Helle/Hoffman to comprise a clip-style retention means as taught by James as James teaches that such a means is suitable for retaining elements of a syringe relative to another element. It is therefore a known securement means for syringe devices in the art.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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