DETAILED ACTION
Response to Amendment
The amendment filed June 1, 2026 has been entered. Claims 1, 34, and 36 have been amended. Claims 1-4, 7-9, 17-26, 34, and 36-37 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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 Yanke et al. (US 8,069,886), and further 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.
Yanke et al. (henceforth Yanke) teaches (Figures 1A and 10) a vial holder (16; Col. 3, lines 17-26) which is formed as a sled assembly (outer housing 184 may be considered a “sled” as it is moved into engagement with the rest of the system within a track in base plate 32), which is configured to house the vial assembly prior to coupling with the console (the vial is placed within the holder before it is placed in the system), and a safety shield (e.g., front panel 38 as in Figure 1E) which is monolithic (it’s a single piece) and which is a hingeless structure (the shield itself is hingeless as it’s only a panel (even if attached to a hinge, the panel itself is hingeless) to encapsulate the system and prevent access via top and side portions of the shield (Figure 1E).
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 comprise the vial sled of Yanke to provide a means of safely handling the vial of radioactive material prior to inserting into the transfer system as taught by Yanke. In addition, it would have been obvious to cover the assembly with the front panel of Yanke to provide a means for accessing the interior of the system while protecting the user and system components via the cover as taught by Yanke (Col. 3, lines 46-60).
As above, Helle fails to disclose the vial engagement mechanism extending laterally from the console and configured to engage a translatable portion of a vial assembly during use.
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/Yanke 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/Yanke 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) in view of Shaw et al. (US 5,309,959), and further in view of Christie (US 1,906,369).
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, the non-rotatable U-shaped hook, 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 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]).
As above, Helle fails to teach the use of a non-rotatable U-shaped hook for holding an encasement.
Christie teaches (Figure 1) a holding device (hook 53) which is useable for holding an encasement (page 2, lines 6-16 disclose the hook 53 as being used to hold a liquid container).
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 provide for a non-rotatable U-shape hook to be attached to the base plate to provide a means of securely holding a liquid container on the base plate as taught by Christie.
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 Bhatt (US 4,795,441).
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.
Bhatt teaches a liquid transfer device (Figures 1-2) comprising first and second devices support syringes 14) 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 (Col. 4, lines 29-56 disclose any valved fluid coupling wherein, with use of a three-way stopcock, fluid flow can be controlled between any of the syringes and valves to apply negative or positive pressure to move fluid between each fluidly coupled syringe through the valve bodies as desired) 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). Bhatt further teaches (Figure 2) an external plunger (48) handle for actuating the device (the thumb press may be considered a handle as it can be held). In addition, Bhatt teaches that linear, non-rotational motion of the plunger is used to perform the fluid transfer (the plungers are standard push/pull plunger assemblies).
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. Furthermore, in the cited combination, the manifold of the combined Pawelka/Bhatt device would provide for fluid connection between two vials attached within the housing. An application of negative pressure to one vial containing a liquid, and another vial being pressurized, would cause the fluid to flow into the syringe which is being pressurized as claimed. The structure of the combined device is fully capable of functioning in the claimed manner via filling an empty syringe via application of negative pressure to the other syringe, or to fill an empty syringe via positive pressure application to a syringe containing liquid, which is fluidly coupled to a syringe without liquid. For this reason, the combined device is considered to meet the limitations as currently set forth. In addition, it would have been obvious to one of ordinary skill to replace the rotatable, dose-setting plunger rod of Pawelka with the linear plunger of Bhatt since such an actuation is well-known in the art of syringes. The rotational feature of the plunger of Pawelka is used for precise dose setting, however, if the syringe volume is the dose, or some standard unit-dose, which does not require precise dosing, then it would be obvious to use a standard plunger rod to perform the features of mixing and delivering as taught by Bhatt. This combination retains the housing and delivery features of Pawelka, with the simplified use of a standard plunger with a mixing assembly.
Regarding claim 37, Pawelka/Bhatt 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 Pawelka to comprise the plunger handle of Bhatt to allow for selective application of pressure to the device to mix and deliver the drug components during a procedure as taught by Bhatt (Col. 5, lines 58-61).
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 Yanke in view of Hoffman, and further in view of Eguchi (US 2006/0091329).
Regarding claims 3 and 17, Helle/Yanke/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/Yanke/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 Yanke in view of Hoffman, and further in view of Page et al. (US 4,923,446).
Regarding claim 23, Helle/Yanke/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/Yanke/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 Yanke in view of Hoffman, and further in view of Eggert (US 2014/0236093).
Regarding claim 4, Helle/Yanke/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 Yanke in view of Hoffman, and further in view of James (US 2002/0083564).
Regarding claim 18, Helle/Yanke/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/Yanke/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
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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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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