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 .
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) 1-12 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stenton (EP 2269517) in view of Koska et al. (US 2023/0045719).
Regarding claim 1, Stenton discloses an accessory system for a medical dispensing device, comprising:
an assistive dispensing collar (Fig. 1, 21) comprising an attachment member (Fig. 1, 22) including at least one opening sized to mate with a portion of a blow-fill-seal (BFS) vial defining a fluid reservoir (Fig. 1, where reservoir 4 is mated with the device body 3 between 24), a first arm and a second arm pivotally connected on opposing sides of the attachment member (see annotated figure below), each of the first and second arms including a gripping end (Fig. 1, 23) and a pivoting end (Fig. 1, portion near 24 on the left side of the arms), and at least one protrusion (Fig. 1, 25);
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wherein upon a mating of the at least one opening of the assistive dispensing collar with the portion of the BFS vial, the at least one protrusion of each of the first and second arms are disposed in a first position adjacent the fluid reservoir (¶[0031], where 25 is in position to contact the walls 8 of the reservoir 4), and
wherein in response to receiving a first compression force exerted at the gripping end of the assistive dispensing collar, the first and second arms transition to a second position where the at least one protrusion of each of the first and second arms apply a corresponding second compression force to the fluid reservoir so as to cause contents of the fluid reservoir to be dispensed (¶[0038]-[0039], where the applied pressure of the first and second arms goes through 25 into the walls 8 of the reservoir 4 to allow fluid to be dispensed).
Stenton does not specifically teach the fluid reservoir being a blow-fill-seal vial.
Koska teaches a blow-fill-seal vial that can be removably attached to another device. This type of vial is common in the art and would be reasonably combined with Stenton by making the reservoir 4 in Stenton into a removable blow-fill-seal vial such as the vial 110 that can be removed in Koska (¶[0016] from Koska). This modification would allow for the vial to be easily sealed and also replaced in the device of Stenton (¶[0016] from Koska).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Stenton to include a blow-fill-seal vial that can be attached to a delivery device (Fig. 1, 110, ¶[0016] from Koska).
Regarding claim 2, Stenton and Koska teach the accessory system of claim 1, wherein the attachment member mates with a connection portion of the BFS vial disposed adjacent a proximal end of the vial and acts a lever for generating the second compression force (see annotated figure below, where the attachment area of 22 acts as a lever for generating a second compressive force).
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Regarding claim 3, Stenton and Koska teach the accessory system of claim 2, Stenton further teaches wherein the at least one protrusion (25) comprises at least one inward curvature formed by the body of the first and second arms (Fig. 1, where 25 has inward curvature formed by the arms 21).
Regarding claim 4, Stenton and Koska teach the accessory system of claim 3, Stenton further teaches wherein the first and second arms comprise a generally S shape curvature (Fig. 1, where both arms are generally S-shaped) and wherein each of the first arm and second arm include a support structure supported on an outer curved surface of each of the first arm and second arm to increase the stiffness of each arm to facilitate application of the second compressive force (Fig. 1, where 21 has two surfaces and the outer surface with a portion between each with the outer surface having a protruding side that increases the support function).
Regarding claim 5, Stenton and Koska teach the accessory system of claim 3, Stenton further teaches wherein the attachment member further comprises a pair of flanges (Fig. 1, 24 & Fig. 4, 24) extending inwardly from a portion of the attachment member, the pair of flanges constructed and arranged to support the assistive dispensing collar on the BFS vial (¶[0038]).
Regarding claim 6, Stenton and Koska teach the accessory system of claim 5, Stenton further teaches further comprising a pair of spreading projections extending from the attachment member and including a gripping surface, wherein in response to receiving a third compression force exerted on the gripping surface the spreading projections move the flanges apart a sufficient width to receive a portion of the vial (Fig. 1, where applied pressure at the jutting portion near 22 would allow for the spread of the arms 21 to allow for a vial to be inserted or removed from the dispensing portion of the device).
Regarding claim 7, Stenton and Koska teach the accessory system of claim 1, Stenton further teaches wherein the attachment member mates with a connection portion of the BFS vial disposed below the fluid reservoir and acts a lever for generating the second compression force (Fig. 1, where the mating near part 22 forms a connection between the vial and the dispensing portion and compresses the vial).
Regarding claim 8, Stenton and Koska teach the accessory system of claim 1, Stenton further teaches wherein the at least one protrusion includes at least one arcuate portion. (Fig. 1, where 25 is arcuate)
Regarding claim 9, Stenton and Koska teach the accessory system of claim 8, Stenton further teaches wherein the at least one arcuate portion includes at least one extension portion (Fig. 1, where 25 extends distally and proximally to connect with the arms).
Regarding claim 10, Stenton and Koska teach the accessory system of claim 1, Stenton further teaches wherein the first arm includes a pivoting end adjacent the attachment member and a gripping end opposite the pivoting end (Fig. 1, where the arms 21 have a pivoting end towards 3 and the gripping end is opposite near the end of the arms where 23 is located).
Regarding claim 11, Stenton and Koska teach the accessory system of claim 10, Stenton further teaches wherein the gripping end of the first arm and the second arm is adjacent a proximal end of the BFS dispensing system (Fig. 1, where 23 is adjacent the proximal end of the device).
Regarding claim 12, Stenton and Koska teach the accessory system of claim 9, Stenton further teaches wherein the gripping end of the first arm and the second arm is adjacent a distal end of the BFS dispensing system (Fig. 1, where the gripping end of the arm is adjacent to the distal end of the device as it is located between the two ends).
Regarding claim 15, Stenton and Koska teach the accessory system of claim 1, Stenton further teaches further comprising at least one gripping portion disposed on an outer surface of the assistive dispensing collar (Fig. 2, where the gripping structure 23 includes multiple ridges).
Regarding claim 16, Stenton and Koska teach the accessory system of claim 1, Stenton further teaches further comprising an injection assembly designed to be secured to a distal end of the BFS vial (Fig. 1, 3).
Regarding claim 17, Stenton and Koska teach the accessory system of claim 1, Stenton further teaches wherein the assistive dispensing collar is removably attached to the vial through the opening in the attachment member (Fig. 3, where the dispensing collar is not attached to the vial end the rest of the applicator).
Regarding claim 18, Stenton and Koska teach an accessory system, Stenton further teaches comprising:
an assistive dispensing collar (Fig. 1, 21) comprising an attachment member (Fig. 1, 22) including at least one opening sized to mate with a portion of a blow-fill-seal (BFS) vial defining a fluid reservoir (Fig. 1, where reservoir 4 is mated with the device body 3 between 24), a first arm and a second arm pivotally connected on opposing sides of the attachment member (see annotated figure below), each of the first and second arms including a gripping end (Fig. 1, 23) and a pivoting end (Fig. 1, portion near 24 on the left side of the arms), and at least one protrusion (Fig. 1, 25)designed to apply pressure to the fluid reservoir upon engagement with the fluid reservoir (¶[0039]);
wherein the assistive dispensing collar is configured to, in response to receiving a first compression force, move the one or more protrusions from a first attached position to a second compressed position where the one or more protrusions apply a force sufficient to begin compressing the fluid reservoir to dispense the fluid out of the fluid reservoir (Fig. 14a-e, ¶[0039]).
Regarding claim 19, Stenton and Koska teach the accessory system of claim 18, Stenton further teaches wherein the first arm and the second arm are movable between different stages of engagement as compression is increased, with the final stage of engagement dispensing the liquid (Fig. 14a-e, where the stages of compression of the arms is shown).
Regarding claim 20, Stenton and Koska teach the accessory system of claim 18, Stenton further teaches wherein the second compression force is along a direction substantially perpendicular to a longitudinal axis of the fluid reservoir (Fig. 14a, where the compressive force is shown to be at angle a relative to the axis).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Stenton (EP 2269517) in view of Koska et al. (US 2023/0045719) as applied to claim 1 above, and further in view of Gold (US 2011/0313397).
Regarding claim 13, Stenton and Koska teach the accessory system of claim 1, however, Stenton and Koska do not teach wherein the first arm includes a first dosage setting member, the second arm includes a second dosage setting member, and the first and second dosage setting members engage with each other during the application of the first compression force to limit further movement of the one or more protrusions.
Gold teaches a dose stopping mechanism that prevents further dosing when a dosage stop (Fig. 24, 1049) is triggered (¶[0064]). This also indicates a dosage setting as the stop occurs when desired dosing occurs and an audible click is used to indicate the dosage stop. Adding a dosage stop mechanism that allows for the dosing to have a predetermined limit and feedback for said dosage stop is known in the art and having extra protrusions on the exterior of the arms on Stenton would not destroy the device, but would improve the device by allowing only a desired dosing to occur (¶[0064 from Gold).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the combined device of Stenton and Koska to include a dose setting and stop mechanism (¶[0064] from Gold).
Regarding claim 14, Stenton, Koska and Gold teach the accessory system of claim 13, Gold further teaches wherein the assistive dispensing collar is constructed to produce audible or tactile feedback when the limit of movement of the one or more protrusions is reached (¶[0064], where adding a protruding element to Stenton would allow for an audible clicking sound to be produced when the stop occurs).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783