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
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 16-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Lavi et al. (WO 0172354 A2) in view of Daily et al. (US 20150182699 A1), in further view of Foshee et al. (US 20120089088 A1).
Regarding claim 16, Lavi discloses an adapter (drug delivery system 720, Fig 32A-32E; with similar injection assembly as shown in Fig 17A-C; Page 38, lines 25-28:“the injection assembly is similar to the embodiments shown in Figures 11, 13-17.”) for a drug mixing and injection system (drug delivery system 720 is a reconstitution and injection system) comprising a first subunit (FS: 1000+ 1003, Annotated Fig 1) comprising a first opening (1000, Annotated Fig 1) adapted to hold a vial (vial 102, Fig 17A), said vial (102) comprising a pierceable lid (1001, Annotated Fig 1), and exhibiting a first longitudinal central axis (1002, Annotated Fig 1), and a second opening (1003, Annotated Fig 1) adapted to hold a reservoir (syringe 390, Fig 17A) comprising an injectable liquid (diluent 166, Fig 17A), and exhibiting a second longitudinal central axis (1004, Annotated Fig 1), wherein the first (1000, Annotated Fig 1) and the second openings (1003, Annotated Fig 1) are arranged to hold the vial (102) and the reservoir (390) in a position with the first (1002, Annotated Fig 1) and the second (1004, Annotated Fig 1) longitudinal central axes positioned at an angle below 75° (First 1002 and second 1004 longitudinal axes are parallel at an angle of 0°) a second subunit (SS: 730 + outlet + 398) comprising a valve (knob 730, Fig 32A) and an outlet port (outlet port where needle 731 is coupled in fluid connection); at least one internal adapter channel (channel 398, Fig 17A) enabling fluid connection between the first opening (1000, Annotated Fig 1), the second opening (1003, Annotated Fig 1), and the outlet port (outlet port where needle 731 is coupled in fluid connection with channel 398); wherein the valve (730) is adapted to switch at least between a first position (Non-use position indicated by alignment of A-B; Page 38, lines 25-28) enabling a first fluid flow between the first opening and the second opening (fluid flow between first and second openings for reconstitution process), and blocking the fluid connection to the outlet port (Page 38, lines 25-28), and a second position (Use position indicated by alignment of B-C; Page 38, lines 25-28) enabling a second fluid flow (fluid of reconstituted drug through outlet port); a first cannula (needle 396, Fig 17A-B) positioned between the valve (730) and the first opening (1000, Annotated Fig 1) (from bottom to top; see Fig 32A and 17A for similar internals), said first cannula (396) being adapted to pierce the lid (1001, Annotated Fig 1) of the vial (102) and to enable fluid connection between the vial (102) and the at least one internal adapter channel (398), and wherein the first (FS) and the second (SS) subunits are engageable with each other, in such a way that the adapter (720) has a resting position (Pre-assembled position (PAP)) in which the first (FS) and the second subunits (SS) are releasably or unreleasably connected (the first subunit (FS) and second subunit (SS) are unreleasably connected) and the first cannula (396) does not pierce through the lid of the vial (In the pre-assembled position (PAP), the vial 102 and syringe 390 have yet to be inserted); and an activated position (Assembled position (AP)) in which the first (FS) and the second subunits (SS) are in a position ( position shown in Fig 17A) in which the first cannula (396) pierces through the lid (1001, Annotated Fig 1) of the vial (102), thereby enabling fluid connection between the vial (102) and the at least one internal adapter channel (398), wherein the reservoir (390) is provided in the form of a syringe (Syringe 390,Fig 17A); and wherein the outlet port (outlet) is adapted such that it can be used to perform an injection after attaching an injection needle to the outlet port (Page 38, lines 25-28): needle is attached to a port in fluid connection with the reconstituted drug and is used to perform an injection)
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Lavi is silent regarding and a valve comprising a second position enabling a second fluid flow between the second opening and the outlet port, and blocking the fluid connection to the first opening; the adapter activated position comprising the first and the second subunits are shifted towards each other.
Daily teaches an adapter for a drug mixing and injection system (Fig 9A-B) a valve (fluid valve 210, Fig 9A) comprising a first (Fig 9A) and second position (Fig 9B); the second position (Fig 9B) enabling a second fluid flow between the second opening (opening defined by luer adapter 238) and the outlet port (outlet coupled to needle 34, Fig 9A-B) ([0087]), and blocking the fluid connection to the first opening ([0097]; once rotated from vertical to horizontal position the communication between the vial and the syringe barrel 242 is blocked)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi with similar valve allowing selective communication as taught by Daily for the purpose of stablishing an isolated fluid communication between the syringe and the vial for in a first position and between the syringe and the and the outlet in a second position to dispense the drug ([0098]).
Lavi/Daily are silent wherein the adapter activated position comprising the first and the second subunits are shifted towards each other.
Foshee teaches an adapter for a drug mixing and injection system (Fig 1; abstract) comprising a first subunit (upper housing 101, Fig 6b, [0082]) comprising a first opening (opening where container 111 is located, Fig 6D) adapted to hold a vial (container 111 held in the opening, Fig 3b), said vial (111) comprising a pierceable lid (penetrable septum 111a, Fig 3b), and exhibiting a first longitudinal central axis (116, Fig 3), and a second opening (opening where intermediate container 112 is located, Fig 6D) adapted to hold a reservoir (intermediate container 112 held in the second opening, Fig 4B) comprising an injectable liquid (media 113, Fig 4B), and exhibiting a second longitudinal central axis (longitudinal axis of intermediate container 112), wherein the first and the second openings are arranged to hold the vial (111) and the reservoir (112) in a position with the first and the second longitudinal central axes positioned at an angle below 75 (first and second longitudinal axis of opening for vial 111 and reservoir 112 are parallel);a second subunit (lower housing 104, Fig 3B) comprising a valve (vent 117a, including a check valve; [0089]) and an outlet port (conduit opening 124a, Fig 9B) ; at least one internal adapter channel (accessing member 123, Fig 9B) enabling fluid connection between the first opening (opening where container 111 is located, Fig 6D), the second opening (opening where intermediate container 112 is located, Fig 6D), and the outlet port (conduit opening 124a, Fig 9B) (each of the openings houses a container of fluid that is connected to outlet port via accessing members (i.e., 116, 120) and accessing member 123; [0105]); a first cannula (spike 120, Fig 3B) positioned between the valve (117a) and the first opening (opening where container 111 is located, Fig 6D) ([0100]), said first cannula (120) being adapted to pierce the lid (111a) of the vial (111) and to enable fluid connection between the vial (111) and the at least one internal adapter channel (123) ([0100]), and wherein the first (101) and the second subunits (104) are engageable with each other (Fig 7B shows subunits in engagement position), in such a way that the adapter (123) has a resting position in which the first (101) and the second (104) subunits are releasably (Fig 5B) or unreleasably (Fig 7B) connected and the first cannula (120) does not pierce through the lid (111a) of the vial (111) (Fig 5B show position where spike 120 do not pierce the lid of vial 111);
Foshee further teaches an activated position (Fig 7B) in which the first (101) and the second (104) subunits are shifted towards each other and are in a position in which the first cannula (120) pierces through the lid (111a) of the vial (111), thereby enabling fluid connection between the vial (111) and the at least one internal adapter channel (123) ([0100])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi with similar lower housing coupled to the conduit system having an engagement mechanism with the first subunit; the subunits having a relative movable position as taught by Foshee to improve the efficiency of the activation step and safety of the user by reducing chance of inadvertent puncture ([0100]).
Regarding claim 17, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi is silent wherein the adapter comprises guiding means for guiding the first subunit and the second subunit when shifting them towards each other from the resting position into the activated position and/or wherein the first or the second subunit comprise at least one subunit locking means for the engagement of the first subunit with the second subunit
Foshee teaches wherein the adapter (100) comprises guiding means (inner surface of upper housing 101, Fig 7B) for guiding the first subunit (101) and the second subunit (104) when shifting them towards each other from the resting position (initial position, Fig 5A-5C) into the activated position (activated position, 6A-6D ) and/or wherein the first or the second subunit comprise at least one subunit locking means for the engagement of the first subunit with the second subunit.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi/Daily/Foshee with similar guiding surface as taught by Foshee for the purpose of provide alignment for the relative sliding fit of the subunits ([0100]; Fig 7B)
Regarding claim 18, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi discloses wherein in the resting position (PAP) the first and the second subunits are unreleasably connected (the first subunit (FS) and second subunit (SS) are unreleasably connected, See Fig 17A), or wherein in the resting position and in the activated position the first and the second subunits are unreleasably connected.
Regarding claim 19, Lavi/Daily/Foshee discloses the adapter according to claim 16, wherein the first and the second subunits are adapted such that they can be shifted towards each other single-handedly.
Foshee further teaches wherein the first and the second subunits (101,104) are adapted such that they can be shifted towards each other single-handedly ([0100]: “(…) an external force, typically by the hand of a user, is employed to urge the upper housing into the lower housing of the device and subsequently allow the media container accessing spikes to pierce their respective media containers(…)”; Device of Foshee is structurally capable of being actuated to an active position with one hand).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi/Daily/Foshee with similar lower housing coupled to the conduit system having an engagement mechanism with the first subunit; the subunits having a relative movable position by a force applied by the hand of the user as taught by Foshee to improve the efficiency of the activation step and safety of the user by reducing chance of inadvertent puncture ([0100])
Regarding claim 20, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi discloses wherein the first (1002, Annotated Fig 1) and the second (1004, Annotated Fig 1) longitudinal central axes are positioned at an angle between 50° and 0°, preferably between 20° and 0° (First 1002 and second 1004 longitudinal axes are parallel at an angle of 0°).
Regarding claim 21, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi embodiment of Fig 32/17 is silent wherein the first opening is equipped with a vial locking means for unreleasably connecting the vial to the first opening.
Lavi embodiment of Fig 20A teaches an adapter (drug delivery system 498, Fig 20A) wherein the first opening (2000, Annotated Fig 2) is equipped with a vial locking means (arms 505 having ridges 507, Fig 20A) for unreleasably connecting the vial to the first opening (Fig 20A) ((Page 31, lines 22-24):“Once inserted, the lip 505 A of a standard vial 500 is locked into position by means of a pair of arms 505 having ridges 507 projecting inwardly therefrom”).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi/Daily/Foshee with similar locking means as taught by Lavi embodiment of Fig 20 for the purpose of securing the vial from unintended disconnection (Page 31, lines 22-24).
Regarding claim 22, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi is silent wherein the adapter, preferably the second subunit, further comprises at least one dedicated site for resting a finger when bringing the adapter from the resting position into the activated position.
Foshee teaches the adapter (100), preferably the second subunit (104), further comprises at least one dedicated site for resting a finger when bringing the adapter from the resting position into the activated position ([0100]: second subunit of adapter of Foshee is structurally capable of performing the claimed function. Adapter can be held with one hand; the thumb can be placed on the lower surface of second subunit 104 while the rest of the fingers are placed on top of the first subunit 101 to exert the hand force).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi/Daily/Foshee with similar lower housing coupled to the conduit system having an engagement mechanism with the first subunit; the subunits having a relative movable position by a force applied by the hand of the user as taught by Foshee to improve the efficiency of the activation step and safety of the user by reducing chance of inadvertent puncture ([0100]).
Regarding claim 23, Lavi/Daily/Foshee discloses the adapter according to claim 16, Lavi discloses wherein the adapter is sterilizable (adapter of Lavi is structurally capable of being sterilized).
Regarding claim 24, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi discloses wherein the adapter (760) comprises a second cannula (needle 394, Fig 17A)positioned between the valve and the second opening (See Fig 17A and 32A), said second cannula (394) being adapted to pierce the lid of the reservoir (390) (Fig 17A) and to enable a fluid connection between the reservoir (390) and the at least one internal adapter channel (398).
Regarding claim 26, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi discloses wherein the outlet port comprises an injection means, or is adapted for attaching an injection means (outlet port comprises injection needle 731, Fig 32E).
Regarding claim 27, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi discloses wherein the adapter (720) is preassembled prior to use (Fig 32B shows adapter 720 assembled prior to use).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Lavi et al. (WO 0172354 A2) in view of Daily et al. (US 20150182699 A1), in further view of Foshee et al. (US 20120089088 A1) in further view of Kraus et al. (US 20070079894 A1).
Regarding claim 25, Lavi/Daily/Foshee discloses the adapter according to claim 16. Lavi/Daily/Foshee are silent wherein the first subunit has a gas-permeable and liquid-impermeable filter, said filter being configured to compensate and/or equilibrate pressure.
Kraus teaches an adapter comprising a first subunit (covering element 360 + main body element 302, Fig 5) has a gas-permeable and liquid-impermeable filter (membrane 336 and carbon filter 340, Fig 4), said filter being configured to compensate and/or equilibrate pressure ([0177]: sterile air is allowed to pass, which contributes to pressure equilibrium in the system).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lavi/Daily/Foshee with similar filter system as taught by Kraus for the purpose of allow free passage of air into the drug mixing system while preventing passage thereinto of liquid and air-borne particles, microorganisms ([0177]).
Response to Arguments
Applicant's arguments filed 02/25/2026 have been fully considered but they are not persuasive. Applicant submits that claims are non-obvious over the combination of Lavi, Daily, and Foshee because the combination does not teach, suggest, or hint at every element of the claims. Furthermore, the skilled person has no motivation to combine the references because the proposed modification would render the references being modified inoperable for their intended purposes. If a proposed modification would render the reference being modified unsatisfactory for its intended purpose, there is no suggestion or motivation to make the proposed modification.
Examiner respectfully disagrees, Lavi discloses all limitations of claim 16. Lavi discloses a first position where communication between the syringe and vial is permitted. The diluent from the syringe is delivered into the vial. However, the device is structurally capable of reconstitution. The forwards and backwards movement of the plunger of the syringe any number of desired cycles permits further reconstitution if desired because the first position of the valve allow communication between the syringe and the vial. Lavi discloses a second position of the valve where there is communication with the outlet. However, as applicant stated, the connection is between the vial and the outlet.
Daily teaches an adapter for a drug mixing and injection system (Fig 9A-B) a valve (fluid valve 210, Fig 9A) comprising a first (Fig 9A) and second position (Fig 9B); the second position (Fig 9B) enabling a second fluid flow between the second opening (opening defined by luer adapter 238) and the outlet port (outlet coupled to needle 34, Fig 9A-B) ([0087]), and blocking the fluid connection to the first opening ([0097]; once rotated from vertical to horizontal position the communication between the vial and the syringe barrel 242 is blocked)
Daily, as seen above, teaches a valve allowing communication between the vial and the syringe in a first position, also structurally capable of reconstitution by forward and backwards movement of the piston. Daily further teaches a communication between the outlet and the syringe to dispense the medicament.
Modification proposed do not indicate a direct replacement of one valve with another, but is intended to maintain the scope of the mechanism of Daily by having a similar valve that allows communication between the syringe and the vial in a first position and allow dispensing of medication in a second position. The modification will allow a communication between the outlet and the syringe in the second position, as taught by Daily. This will permit the user to dispense the medication through the syringe plunger as seen in Daily, [0098] or by the center button of the vial. Alternatively, the button function could be replaced by the syringe plunger to simplify the design and reduce the number of parts. The modification does not alter the intended function of the device, allowing dispensation of the medication.
Applicant submits that Foshee does not teach the device to achieve a resting position in which the subunits are engaged but the system is not yet in an activated fluid-transfer state.
Examiner respectfully disagrees please see relevant portion below:
Foshee teaches that the adapter (123) has a resting position in which the first (101) and the second (104) subunits are releasably (Fig 5B) or unreleasably (Fig 7B) connected and the first cannula (120) does not pierce through the lid (111a) of the vial (111) (Fig 5B show position where spike 120 do not pierce the lid of vial 111); an activated position (Fig 7B) in which the first (101) and the second (104) subunits are shifted towards each other and are in a position in which the first cannula (120) pierces through the lid (111a) of the vial (111), thereby enabling fluid connection between the vial (111) and the at least one internal adapter channel (123) ([0100])
Modification will enhance safety of the user by reducing chance of inadvertent puncture ([0100]). Also, it will allow the user to maintain the vial sealed and sterile when assembled until the user proceed to inject the medication.
Conclusion
THIS ACTION IS MADE FINAL. 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 GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783.
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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