DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed 10/23/2025 have been entered.
Claims 1-12, 14 and 15 have thereby been amended.
Claim 13 has been cancelled.
Claims 1-12, 14 and 15 are being examined in this office action.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 20190117879) in view of Akouka (US 10434267) in further view of Kamen (US 20140343492).
Regarding claim 1, Imran discloses a delivery device for delivering a drug, comprising a housing (20) having an outlet (24), a cartridge (belt 106) filled with an active pharmaceutical formulation in solid form (drug 102 as medication pellets 100; page 4, para. [0036], sentences 1-2), a transporting mechanism (Fig. 1a: 90) configured to transport a predetermined amount of the active pharmaceutical formulation (page 5, para. [0040], sentence 1; 90 transports one pellet at a time, the predetermined amount of the pharmaceutical 102 contained in each pellet 100) to a flushing position (Fig. 2: flushing position at port 35), a pumping mechanism (pump between bladder 45 and mixing reservoir 30; page 7, para. [0050], last two sentences) connectable to a solvent reservoir (Fig. 4: bladder 45) and configured to deliver solvent (109) from the solvent reservoir towards the outlet (page 7, para. [0050], last sentence; Fig. 4, solvent is pulled from bladder 45 to 30 in the direction towards the outlet where 61 is), a jetting piston (91; page 2, para. [0013], second-to-last sentence describing the shaft of the jetting piston) configured to enter the flushing position (Fig. 2: flushing position at port 35; Fig. 1b and 2: jetting piston 91 enters flushing position 35 when advancing 100 as stated in page 5, para. [0039], sentence 6) and to flush the predetermined amount of the active pharmaceutical formulation from the flushing position (page 5, para. [0039], sentence 7; pellet is inserted into 30 after 30 is filled with solvent, drug pellet being flushed with the solvent upon jetting piston entering reservoir 30 via flushing position 35) with a predetermined amount of the solvent (page 5, para. [0043], sentences 2-4; solvent volume sensors and volume threshold, showing that the volume of solvent transported is predetermined) towards the outlet (Fig. 4: solvent and drug are moved/flushed through 30 towards the outlet at 61), and a controller (70) at least configured to control operation of at least one of the transporting mechanism, the pumping mechanism, the jetting piston (page 5, para. [0042], sentence 1; controller 70 controls transporting mechanism 90 and thereby the coupled jetting piston 91 and a pumping mechanism). Imran discloses the solid pharmaceutical formulation being contained in packaging containers (104) of a belt (106; seen in Fig. 2) but fails, however, to explicitly disclose the solid pharmaceutical formulation as a powder, as well as a cartridge filled with that solid pharmaceutical formulation and a cartridge compartment of the drug delivery device such that the cartridge could be replaced for device reuse. Imran also fails to explicitly disclose the jetting piston itself producing a jet of solvent to flush the pharmaceutical formulation.
Akouka teaches an analogous drug delivery device for sequentially delivering doses of a pharmaceutical, the device having a cartridge compartment (Fig. 4: 120) configured to receive a cartridge (Fig. 6B-C: 130) filled with an active pharmaceutical formulation in solid form (col. 8, line 39, the pharmaceutical formulation being in the individual doses 105), particularly in powder form (col. 14, claim 5). The cartridge taught by Akouka is the same belt shaped loop (Fig. 7A: 130) with individual blisters/package compartments (131), just as disclosed in Imran. The loop cartridge and cartridge compartment taught by Akouka is configured with an open center (150) configured to fit around compartment (151) of the device body, in an analogous geometry to the Imran cartridge which surrounds the circumference of the reservoir (Imran: Fig. 2; page 6, para. [0048], sentences 1-2). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Imran drug delivery device by incorporating the cartridge compartment taught by Akouka to hold the Imran cartridge belt and associated medication advancement mechanisms (Imran: Fig. 2), in order to be able to easily replace the pharmaceutical cartridge belt of Imran to allow for the drug delivery device to be refilled and reused (Akouka: col. 8, lines 12-14) for prolonged use and reduced treatment costs. It would also be obvious to one of ordinary skill to incorporate the teaching of the powder form of the pharmaceutical taught by Akouka into the Imran device in order to aid in its more effective and efficient dissolution in the solvent (Imran: page 2, para. [0014], last sentence).
However, although both Imran and Akouka teach the generation of jetting a stream to move and deliver the drug (Imran from 110 within 30, and Akouka from the synthetic jetting of the air: col. 7, lines 36-42), the Imran-Akouka delivery device combination fails still to explicitly disclose the jetting piston itself producing a jet of solvent to flush the pharmaceutical formulation.
Kamen teaches an analogous drug delivery device which mixes a powdered form of a pharmaceutical formulation with a solvent, in which the spikes (21a-c) analogous to the jetting piston of Imran-Akouka, produce a jet of the solvent so as to flush the predetermined amount of the active pharmaceutical formulation (para. [0045], sentence 1; par. [0043], sentences 1-3, it is ensured that the pressure in 11a-c is ambient in order to produce a sufficiently strong spray/jet of the solvent to reconstitute the powdered drug, and adequately flush it from 11a-c). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teaching of the jet of solvent produced by the spikes taught by Kamen into the Imran-Akouka device, such that the jetting piston (Imran: 91) additionally produces a jet of the solvent (for example, in place of the solvent jet produced by the needle of 110) in order to ensure that all of the pharmaceutical agent is sufficiently flushed out from the packaging containers (104), to ensure proper dosage is achieved and powdered agent is not left behind.
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Annotated Imran Figure, showing all components
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Annotated Imran and Akouka Combination Figure
Regarding claim 2, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, wherein the cartridge comprises a plurality of compartments (Imran: Fig. 2, 104) each of which is filled with the predetermined amount of the active pharmaceutical formulation (Imran: Imran: Fig. 2, 100), wherein the transporting mechanism is configured to transport the compartments to the flushing position in a subsequent order (Imran: page 6, para. [0048], last three sentences).
Regarding claim 3, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, wherein the cartridge compartment (Akouka: 120) is configured to receive a cartridge supply reel (Akouka: col. 8, line 39; blister strip being the cartridge supply reel, which may be 106 of Imran as described above) on which the cartridge is reeled (Akouka: Fig. 6B-C: cartridge 130 is reeled in single loop withing ring compartment of 120).
Regarding claim 4, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, wherein the transporting mechanism (Imran: 90) comprises a cartridge drive (Imran: 92, rotary motor; page 7, para. [0051], sentence 2) configured to rotate the cartridge supply reel (Imran: cartridge supply reel 106; 92 rotates 106 as seen in Fig. 2; page 6, para. [0048], last three sentences).
Regarding claim 5, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, further comprising a removal reel (Akouka: 141 + 145, which is part of the cartridge compartment 120) configured to be reeled with the cartridge after discharging of the active pharmaceutical formulation (Akouka: col. 8, lines 64-76) from at least one of the compartments at the flushing position (Imran: Fig. 2: discharging via 90/91 of the pharmaceutical formulation 100 occurs at the flushing position 35), wherein the cartridge drive (Imran: 92, rotary motor; page 7, para. [0051], sentence 2) comprises a cartridge drive gear configured to mesh with a removal reel gear of the removal reel (Akouka: 143 + 144).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the removal reel assembly taught by Akouka into the Imran-Akouka combination, as Akouka teaches the removal reel assembly (141, 145) as an integrated part of the cartridge compartment (120). Therefore, upon the incorporation of the cartridge compartment taught by Akouka into the Imran device, as described above, it would be obvious to one skilled in the art to include the incorporation of the removal reel in order to collect the used cartridge compartments for easy removal and replacement.
Akouka further teaches that the gear of the cartridge drive gear (140; col. 4, lines 42-43) is integrated with the removal reel (145; Fig. 7A: 140 nested in 145, where 143+144 shown in Fig. 7D interact and drive 145; col. 9, lines 9-10) and removal reel gear (143 + 144). It would have been obvious for a person of ordinary skill in the art upon combining the teachings of Akouka with the Imran device as described above, to have integrated the cartridge drive of the Imran device with the removal reel and removal reel gear of Akouka so that the cartridge supply reel is concertedly rotatable with the removal reel in order to prevent pulling of the cartridge or slacking of the spent cartridge foil.
Regarding claim 6, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, further comprising a removing device (Akouka: 141; col. 8, lines 64-66) configured to remove a foil sealing the compartments (Akouka: col. 8, lines 64-66; the foil of the Imran cartridge in page 6, para. [0047], second-to-last sentence) arranged at least partially between the cartridge compartment and the flushing position (Imran: Fig. 2: upon actuation of 90/91 the foil is removed between the flushing position 35 and 106 which, upon the combination, resides within the cartridge compartment) or the jetting piston is configured to pierce a foil sealing the compartments (Imran: page 6, para. [0048], sentence 6).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the removing device taught by Akouka into the Imran-Akouka combination, as Akouka teaches the removing device (141) as an integrated part of the cartridge compartment (120). Therefore, upon the incorporation of the cartridge compartment taught by Akouka into the Imran device, as described above, it would be obvious to one skilled in the art to include the incorporation of the removing device in order to collect the used cartridge compartments for easy removal and replacement.
Regarding claim 7, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, wherein the cartridge is a blister tape (Imran: page 6, para. [0047], second-to-last sentence, describes a blister tape; Akouka: explicitly discloses blister strip in col. 4, lines 34-38), wherein the compartments are formed as closed pockets sealed by a foil (Imran: page 6, para. [0047], second-to-last sentence).
Regarding claim 9, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, further comprising a mixing device (Imran: Fig. 2: 39) being in fluid communication with the outlet (Imran: Fig. 2: 39 is within 30, in fluid communication with outlet at 61, via fluid paths 11 and 60) and configured to mix the predetermined amount of the solvent and predetermined amount of the active pharmaceutical formulation flushed from the flushing position (Imran: page 5, para. [0039], sentence 7; mixing occurs in 30 after pellet is inserted into 30 after 30 is filled with solvent, drug pellet being flushed with the solvent upon jetting piston entering reservoir 30 via flushing position 35) so as to provide the drug, wherein the mixing device comprises a mixing chamber (Imran: chamber 30) configured to receive the predetermined amount of the solvent and the predetermined amount of the active pharmaceutical formulation flushed from the flushing position (Imran: page 5, para. [0039], sentence 7; pellet is inserted into 30 after 30 is filled with solvent, drug pellet being flushed with the solvent upon jetting piston entering reservoir 30 via flushing position 35).
Regarding claim 10, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, further comprising a power source (Imran: 80), particularly a rechargeable power source (Imran: page 7, para. [0052], sentence 2), configured to supply electrical power to at least one of the transporting mechanism, the pumping mechanism, the jetting piston, the controller and the mixing device (Imran: page 7, para. [0052], sentence 1; 80 powers controller 70, transporting mechanism 90 and thereby the coupled jetting piston 91 and a pumping mechanism).
Regarding claim 11, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, further comprising an input device (Imran: portable phone or other portable device; page 5, para. [0042], sentence 4) configured to allow a user to input instructions to the controller (Imran: page 5, para. [0042], sentences 4-7; user can send wirelessly via portable device, instructions for controller to change delivery intervals).
Regarding claim 14, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, wherein the delivery device is configured to communicate with an in-situ blood sensor (Imran: 87 located in the patient tissue, communication with controller 70 shown as 87i in Fig. 1c; page 6, para. [0045], first and last sentences).
Regarding claim 15, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, wherein the delivery device is a single use device or wherein the delivery device is reusable (Akouka: col. 9, lines 54-56), wherein the cartridge compartment is configured to allow a replacement of the cartridge (Akouka: col. 8, lines 12-14).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 20190117879) in view of Akouka (US 10434267) in further view of Kamen (US 20140343492) in further view of Planas (US 20160378298).
Regarding claim 12, Imran in view of Akouka in further view of Kamen teaches the delivery device according to claim 1, as described above, further comprising a gas sensor configured to detect gas bubbles, particularly air bubbles (Imran: 50 comprises sensor for air bubbles; page 3, para. [0018], second-to-last sentence), within the predetermined amount of the solvent and the predetermined amount of the active pharmaceutical formulation flushed from the flushing position (Imran: 50 detects air bubbles withing the solvent delivered from 30 where the “predetermined amount of the solvent and the predetermined amount of the active pharmaceutical formulation flushed from the flushing position” are delivered from, seen in Fig. 4), and a sensor to detect a concentration of the predetermined amount of the active pharmaceutical formulation solved within the predetermined amount of the solvent (Imran: optical sensor; page 7, para. [0050], sentences 6-7). Imran in view of Akouka, however, fails to teach that the optical sensor for detecting the concentration of the pharmaceutical formula in the solution is also the same sensor as the gas sensor for detecting gas bubbles in the same solution.
Planas teaches an analogous optical sensor for a fluid delivery device, which is able to both determine the concentration a desired component in solution, and detect air bubbles in that solution (page 3, para. [0032], sentence 2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the single optical sensor taught by Planas into the Imran-Akouka device in order to achieve the air bubble detection and solution concentration detection taught by Imran-Akouka using a single sensor rather than two sensors, in order to reduce the space, processing power, and cost of the device.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 20190117879) in view of Kamen (US 20140343492) in further view of Faden (US 9770551) in further view of Akouka (US 10434267).
Regarding claim 1, Imran discloses a delivery device for delivering a drug, comprising a housing (20) having an outlet (24), a cartridge (belt 106) filled with an active pharmaceutical formulation in solid form (drug 102 as medication pellets 100; page 4, para. [0036], sentences 1-2), a transporting mechanism (Fig. 1a: 90) configured to transport a predetermined amount of the active pharmaceutical formulation (page 5, para. [0040], sentence 1; 90 transports one pellet at a time, the predetermined amount of the pharmaceutical 102 contained in each pellet 100) to a flushing position (flushing position interpreted to be the top portion of micropump 50 where the fluid is flushed by the pump 50, and flows from the inlet of 50 to the outlet of 50, as seen in annotated Imran micropump figure below), a pumping mechanism (pump between bladder 45 and mixing reservoir 30; page 7, para. [0050], last two sentences) connectable to a solvent reservoir (Fig. 4: bladder 45) and configured to deliver solvent (109) from the solvent reservoir towards the outlet (page 7, para. [0050], last sentence; Fig. 4, solvent is pulled from bladder 45 to 30 in the direction towards the outlet where 61 is), and flush the predetermined amount of the active pharmaceutical formulation from the flushing position (page 5, para. [0040], sentences 2-3; solution must be flushed out of flushing position as micropump 50 pumps the solution towards the outlet) with a predetermined amount of the solvent (page 5, para. [0040], sentence 3; micropump 50 flushes predetermined doses, therefore comprising predetermined amounts of the pharmaceutical formulation and solvent) towards the outlet (annotated Imran micropump figure below: solvent and drug are moved/flushed through 50 towards the outlet), and a controller (70) at least configured to control operation of at least one of the transporting mechanism, the pumping mechanism (page 5, para. [0042], sentence 1; controller 70 controls transporting mechanism 90 and micropump 50). However, although Imran teaches the generation of jetting a stream to move and deliver the drug (from 110 within 30), the Imran delivery device combination fails still to explicitly disclose the jetting piston itself producing a jet of solvent to flush the pharmaceutical formulation, as well as to explicitly disclose a jetting piston that enters the flushing position to flush the solution.
Kamen teaches an analogous drug delivery device which mixes a powdered form of a pharmaceutical formulation with a solvent, in which the spikes (21a-c) analogous to the jetting piston of Imran, produce a jet of the solvent so as to flush the predetermined amount of the active pharmaceutical formulation (para. [0045], sentence 1; par. [0043], sentences 1-3, it is ensured that the pressure in 11a-c is ambient in order to produce a sufficiently strong spray/jet of the solvent to reconstitute the powdered drug, and adequately flush it from 11a-c). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teaching of the jet of solvent produced by the spikes taught by Kamen into the Imran device, such that the jetting piston (Imran: 91) additionally produces a jet of the solvent (for example, in place of the solvent jet produced by the needle of 110) in order to ensure that all of the pharmaceutical agent is sufficiently flushed out from the packaging containers (104), to ensure proper dosage is achieved and powdered agent is not left behind. However, the Imran-Kamen device still fails to explicitly disclose a jetting piston that enters the flushing position to flush the solution
Faden teaches an analogous fluid delivery system with a pump (360) having a flushing position (see annotated Faden pump figure below), including a jetting piston (Figs. 3A-B: piston 362) configured to enter the flushing position (Fig. 3B: piston 362 in the top portion/flushing position) and to flush the predetermined amount of the active pharmaceutical formulation from the flushing position (Fig. 3B: arrows showing flow of solution from the flushing position to outlet 356). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Imran-Kamen micropump of the drug device by incorporating the specific piston and associated one-way valves the pump taught by Faden, in order to ensure the solution is fully flushed and expelled from the pump so that accurate doses are delivered (col. 8, lines 3-5). The Imran-Kamen-Faden device teaches the solid pharmaceutical formulation being contained in packaging containers (Imran: 104) of a belt (Imran: 106; seen in Fig. 2) but fails, however, to explicitly disclose the solid pharmaceutical formulation as a powder, as well as a cartridge filled with that solid pharmaceutical formulation and a cartridge compartment of the drug delivery device such that the cartridge could be replaced for device reuse.
Akouka teaches an analogous drug delivery device for sequentially delivering doses of a pharmaceutical, the device having a cartridge compartment (Fig. 4: 120) configured to receive a cartridge (Fig. 6B-C: 130) filled with an active pharmaceutical formulation in solid form (col. 8, line 39, the pharmaceutical formulation being in the individual doses 105), particularly in powder form (col. 14, claim 5). The cartridge taught by Akouka is the same belt shaped loop (Fig. 7A: 130) with individual blisters/package compartments (131), just as disclosed in Imran. The loop cartridge and cartridge compartment taught by Akouka is configured with an open center (150) configured to fit around compartment (151) of the device body, in an analogous geometry to the Imran cartridge which surrounds the circumference of the reservoir (Imran: Fig. 2; page 6, para. [0048], sentences 1-2).
Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Imran drug delivery device by incorporating into the Imran-Kamen-Faden device, the cartridge compartment taught by Akouka to hold the Imran cartridge belt and associated medication advancement mechanisms (Imran: Fig. 2), in order to be able to easily replace the pharmaceutical cartridge belt of Imran to allow for the drug delivery device to be refilled and reused (Akouka: col. 8, lines 12-14) for prolonged use and reduced treatment costs. It would also be obvious to one of ordinary skill to incorporate the teaching of the powder form of the pharmaceutical taught by Akouka into the Imran-Kamen-Faden device in order to aid in its more effective and efficient dissolution in the solvent (Imran: page 2, para. [0014], last sentence).
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Annotated Imran Micropump Figure
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Annotated Faden Pump Figure
Regarding claim 8, Imran in view of Kamen in further view of Faden in further view of Akouka teaches the delivery device according to claim 1, as described above, further comprising a fluid channel in fluid communication with the solvent reservoir and the outlet (Imran: Fig. 4: channels 47, 11, 60, connecting 45 to outlet at 61), wherein the jetting piston is moveable between a retracted position where the fluid channel is blocked (Faden: Fig. 3B: piston 362 is blocking connection of flow from 354 to 356), and an extended position, where the jetting piston provides a fluid communication with the fluid channel and the flushing position (Faden: Fig. 3A: fluid flows from 354 to 356), wherein the pumping mechanism comprises a pump, particularly a syringe pump configured to suck the predetermined amount of the solvent from the solvent reservoir (Imran: pump between bladder 45 and mixing reservoir 30; page 7, para. [0050], last two sentences) and a non-return valve configured to block a flow of the sucked predetermined amount of the solvent back to the solvent reservoir (Imran: Fig. 4: 57). Imran fails to explicitly teach its pumping mechanism as a syringe pump. However, it would have been obvious for a person of ordinary skill in the art to have also modified the pumping mechanism of Imran by incorporating the specific piston of the syringe pump taught by Faden (360), in order to ensure accurate predetermined amounts of fluid drawn through it (col. 8, lines 3-5).
Response to Arguments
Applicant's arguments filed 10/23/2025 regarding the prior art rejections of claims 1-12, 14 and 15 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Imran does not disclose a jetting piston, Examiner maintains that 91 of Imran does read on the limitation of a “jetting piston” given its broadest reasonable interpretation, as 91 of Imran is in fact a piston, and does jet/punch out to push out the medication from the packages. Therefore, according to the limitation of a jetting piston as the claims are currently written, Examiner maintains that this is disclosed by Imran. Further, the amended limitations including the jet of solvent produced by the jetting piston has now been rejected by Imran in view of Kamen, as described in the new rejection of independent claim 1 above.
Applicant further argues that Imran teaches a drug delivery device which is implantable and does not allow a replacement of a cartridge. However, the structures of the Imran device do not require implantation to operate, and rather, merely allow for implantation for in vivo delivery of the drugs. Additionally, Imran alone is not relied upon to teach replacement of the cartridge, as Imran in view of Akouka is relied upon to teach this limitation, as described in the rejections above. Examiner maintains that it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Akouka with the device of Imran despite the references teaching aerosol and liquid delivery of the drugs, respectively, as Applicant argues, because it is the structures and overall functions of the devices which make them analogous despite the gaseous vs liquid final drug products.
Applicant also argues that Imran teaches that advancement mechanism (90) transports the medicaments into a reservoir (30) and not into a flushing position. However, Examiner maintains the interpretation of the flushing position as described in the rejections and annotated figures above, as a specific lower portion within the reservoir in which the medicament is delivered and flushed at. The claims, as currently written, do not provide any more specific structure or positioning of the flushing position that would teach away from this interpretation.
For these reasons, given the broadest reasonable interpretation for the claimed limitations as they are currently written, the prior art rejections of claims 1-12, 14 and 15 stand rejected as recited above.
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.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783