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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitations “a base housing having third and fourth longitudinal ends” in line 12 renders the claim indefinite. First and second longitudinal ends of the base housing have not been introduced in the claim. It is unclear if the base housing requires first and second longitudinal ends in addition to “third and fourth longitudinal ends”. For examination purposes, the limitation “a base housing having third and fourth longitudinal ends” has been interpreted as the base housing requires two longitudinal ends, such as a distal end and a proximal end. It is suggested to amend the limitation to “a base housing having first and second longitudinal ends”, “a base housing having distal and proximal ends” or similar. The amendments should be applied throughout the independent claim and its dependents.
Regarding claim 1, the limitations “a manifold having fifth and sixth longitudinal ends” in line 14 renders the claim indefinite. First, second, third, and fourth longitudinal ends of the manifold have not been introduced in the claim. It is unclear if the manifold requires first, second, third, and fourth longitudinal ends in addition to “fifth and sixth longitudinal ends”. For examination purposes, the limitation “a manifold having fifth and sixth longitudinal ends” has been interpreted as the manifold requires two longitudinal ends, such as a distal end and a proximal end. It is suggested to amend the limitation to “a manifold having first and second longitudinal ends”, “a manifold having distal and proximal ends” or similar. The amendments should be applied throughout the independent claim and its dependents.
Claims 2-26 are rejected for being dependent upon claim 1.
Regarding claim 27, the limitations “a sixth longitudinal end of the manifold” in line 12 and “a fifth longitudinal end thereof” in line 14 renders the claim indefinite. First, second, third, and fourth longitudinal ends of the manifold have not been introduced in the claim. It is unclear if the manifold requires first, second, third, and fourth longitudinal ends in addition to “a sixth longitudinal end” and “a fifth longitudinal end”. For examination purposes, the limitations “a sixth longitudinal end of the manifold” and “a fifth longitudinal end thereof” have been interpreted as the manifold requires two longitudinal ends, such as a distal end and a proximal end. It is suggested to amend the limitation to specify that the manifold has a first longitudinal end and a second longitudinal end, a distal end and a proximal end (corresponding to the fifth and sixth longitudinal ends currently recited), or similar. The amendments should be applied throughout the independent claim and its dependents.
Further regarding claim 27, the limitations “a third longitudinal end of a base housing, the base housing having the third longitudinal end and a fourth longitudinal end” in line 17-18 renders the claim indefinite. First and second longitudinal ends of the base housing have not been introduced in the claim. It is unclear if the base housing requires first and second longitudinal ends in addition to “a third longitudinal end” and “a fourth longitudinal end”. For examination purposes, the limitation “a third longitudinal end of a base housing, the base housing having the third longitudinal end and a fourth longitudinal end” has been interpreted as the base housing requires two longitudinal ends, such as a distal end and a proximal end. It is suggested to amend the limitation to “a first longitudinal end of a base housing, the base housing having the first longitudinal end and a second longitudinal end”, “a distal end of a base housing, the base housing having the distal end and a proximal end” or similar. The amendments should be applied throughout the independent claim and its dependents.
Claim 27 recites the limitation "the breached ports" in line 28-29. There is insufficient antecedent basis for this limitation in the claim. The limitation “the breached ports” has been interpreted to be the same structure as “the first and second sealed ports” that are breached in step (e). It is suggested to amend the limitation to “the first and second sealed ports that have been breached”, or similar.
Claims 28-40 are rejected for being dependent upon claim 27.
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 1-13, 14-21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Arocha (US 20150065993) in view of Basile et al. (US 20190022336).
Regarding claim 1, Arocha discloses a pre-filled medical delivery assembly (syringe device 10) comprising:
(i) a module (carpule 70) having first and second longitudinal ends (Figure 7), the module comprising:
first and second chambers (two cylinders 71 and 72), the first chamber having a first liquid agent therein, the second chamber having a second liquid agent therein (“each chamber of the carpule or carpules contains an injectable fluid.” [0054]; “carpule 70 comprising two cylinders 71 and 72 for containing a medicament or diluent” [0083]);
first and second sealed ports (at puncturable carpule cap 75) proximal to the first longitudinal end of the module (Figure 7), the first sealed port being in fluid communication with the first chamber, the second sealed port being in fluid communication with the second chamber (“Each cylinder comprises a tubular structure having open ends which are closed by a puncturable carpule cap 75 at one end” [0084]); and
first and second actuation members (sliding plug 76) proximal to the second longitudinal end of the module (Figure 7), the first actuation member being in fluid communication with the first chamber, the second actuation member being in fluid communication with the second chamber (“Each cylinder comprises a tubular structure having open ends which are closed by…a sliding plug 76 at the other end (superior end).” [0084]); and
(ii) a mixing assembly (body 20 and mixing chamber 32) constructed to be coupled to the module (Figure 2; “a syringe housing forming the body or barrel of the syringe, said housing capable of receiving at least one multi-chambered carpule” [0018]), the mixing assembly comprising:
a base housing (body 20) having third and fourth longitudinal ends (Figure 2), the base housing defining a first internal volume extending from the third longitudinal end to the fourth longitudinal end (Figure 2);
a manifold (mixing chamber 32) having fifth and sixth longitudinal ends (Figure 2), the manifold defining a second internal volume extending from the fifth longitudinal end to the sixth longitudinal end (Figures 2 and 6), the fifth longitudinal end being disposed proximal to the third longitudinal end of the base housing (Figure 2), a portion of the second internal volume proximal to the fifth longitudinal end being sized and shaped to act as a mixing chamber (mixing chamber 32 having turbulence forming structure 40) for the first and second liquid agents (Figure 6; “the mixing chamber can comprise a turbulence-forming structure 40 to facilitate mixing of the two fluids entering the mixing chamber” [0082]), the sixth longitudinal end being sized and shaped to receive at least the first longitudinal end of the module therein (Figure 6), the manifold comprising first and second longitudinally- extending piercing elements (carpule-piercing means 30) disposed within the second internal volume to align with the first and second sealed ports (Figure 6; “the carpule 26, carpule-piercing means 30 having a tubular configuration, i.e., having an open lumen to provide for communication between the solution within the carpule and mixing chamber 32.” [0081]), respectively; and
a plunger (plunger ring 16, plunging actuator 17, dual stems 14, 16) comprising a laterally-extending first member (plunger actuator 17) and a longitudinally-extending second member (plunger ring 12 and dual stems 14, 16 having stem-adjusting means 18), the fourth longitudinal end of the base housing being sized and shaped to receive the plunger therein (Figures 2-5).
Arocha fails to explicitly disclose the module is a blow-fill-seal (BFS) module.
Basile discloses a pre-filled medical delivery assembly (drug delivery device 10) comprising: a blow-fill-seal (BFS) module (drug container 16; “the drug container is made using blow-fill-seal” [0032]), a base housing (outer body 24), a manifold (inner body 22), and a plunger (plunger 14).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the module of the pre-filled medical delivery assembly of Arocha to be a blow-fill-seal (BFS) module based on the teachings of Basile to reduce the packaging cost and prevent re-use of the pre-filled medical delivery assembly (Basile [0003-0004], [0027]).
Regarding claim 2, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein the first liquid agent, the second liquid agent, or both comprise a vaccine, a drug, a medicament, or a component of any of the foregoing (“carpule 70 comprising two cylinders 71 and 72 for containing a medicament or diluent” [0083]).
Regarding claim 3, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein a seal (puncturable carpule cap 75) of each of the first and second sealed ports comprises a foil, wax, paper, a section of the BFS module, or any combination of the foregoing (“Each cylinder comprises a tubular structure having open ends which are closed by a puncturable carpule cap 75 at one end” [0084]; Figure 7, wherein the cap 75 is part of the BFS module).
Regarding claim 4, modified Arocha discloses the pre-filled medical delivery assembly of claim 1.
Modified Arocha fails to explicitly disclose each of the first and second actuation members comprises a deformable or collapsible chamber.
Basile discloses a pre-filled medical delivery assembly (drug delivery device 10) comprising: a BFS module (drug container 16) comprising a chamber (within drug container 16), a port (outlet port 42), and an actuation member that is a deformable or collapsible chamber (at top 40; “the top 40 of drug container 16 is a priming bellow which requires less force to compress than the remaining bellows of drug container 16” [0068]; “As pressure was applied to the plunger 14 at the proximal end 32, the plunger 14 moved axially toward the drug container 16, causing the drug container 16 to compress.” [0072]; Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first and second actuation members of the pre-filled medical delivery assembly of Arocha to each be a deformable or collapsible chamber based on the teachings of Basile to allow for priming to evacuate any trapped air before delivering the liquid agents, prevent refilling of the chambers, and prevent wasting residual liquid agents (Basile [0068], [0027]).
Regarding claim 5, modified Arocha discloses the pre-filled medical delivery assembly of claim 4.
Modified Arocha fails to explicitly disclose one or both of the first and second actuation members are shaped as bellows.
Basile discloses a pre-filled medical delivery assembly (drug delivery device 10) comprising: a BFS module (drug container 16) comprising a chamber (within drug container 16), a port (outlet port 42), and an actuation member that is shaped as bellows (“a drug container 16 comprising bellows” [0067]; “the top 40 of drug container 16 is a priming bellow which requires less force to compress than the remaining bellows of drug container 16” [0068]; “As pressure was applied to the plunger 14 at the proximal end 32, the plunger 14 moved axially toward the drug container 16, causing the drug container 16 to compress.” [0072]; Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first and second actuation members of the pre-filled medical delivery assembly of Arocha to each be shaped as bellows based on the teachings of Basile to allow for priming to evacuate any trapped air before delivering the liquid agents, prevent refilling of the chambers, and prevent wasting residual liquid agents (Basile [0068], [0027]).
Regarding claim 6, modified Arocha discloses the pre-filled medical delivery assembly of claim 4, wherein the first and second actuation members (sliding plug 76) are constructed to be independently actuatable (Figure 7, showing that each carpule’s sliding plug 76 is independent of the other and “The other stem 16 (shown in partial cut-away view) comprises a stem-adjusting means 18 which provides for adjusting the length of the stem within stem housing 16…The adjustable-length stem can provide for delivery of different or varying desired volumes or amounts of solution from actuation of the adjustable stem.” [0066]).
Regarding claim 7, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein at least a portion of the fifth longitudinal end of the manifold is disposed in or extends through the third longitudinal end of the base housing (Figures 2 and 6).
Regarding claim 8, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein, with the plunger received in the fourth longitudinal end of the base housing (Figure 1), a bottom surface of the first member of the plunger faces or is in contact with the first and second actuation members (Figure 2, showing a bottom surface of plunging actuator 17 faces the plugs 29/76), and a portion of the second member (plunger ring 12) of the plunger extends longitudinally between the first and second actuation members (Figure 2).
Regarding claim 9, modified Arocha discloses the pre-filled medical delivery assembly of claim 8, wherein the BFS module further comprises a bridge member (connecting means 43) that connects the first and second chambers along facing lateral surface portions (“Cylinders 71 and 72 are connected to one another by connecting means 73, which can be a connecting flange or can be an adhesive or other affixing material which holds the cylinders together in tandem” [0083]), and the portion of the second member, which extends between the first and second actuation members, contacts the bridge member (Figures 2-5, via the contact between the plunger and the body 20).
Regarding claim 10, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, further comprising: (iii) an administration assembly comprising: a hub (needle-securing nut 36) disposed proximal to the fifth longitudinal end of the manifold (Figure 6); and at least one administration conduit (hypodermic needle 34) having an outlet at an end thereof longitudinally spaced from the hub and being in fluid communication with the mixing chamber so as to receive a combination of the first and second liquid agents therefrom (Figure 6; “the mixed solution is administered to the targeted tissue from the end of the mixing chamber via a needle affixed at the other end of the mixing chamber.” [0025]).
Regarding claim 11, modified Arocha discloses the pre-filled medical delivery assembly of claim 10, wherein at least part of the administration assembly is formed separate from and constructed to be coupled to the manifold, or at least part of the administration assembly is integrally formed with the manifold (Figure 6; “The nozzle 38 formed at one end of the mixing chamber comprises a needle-securing nut 36 for securing a disposable hypodermic needle 34 thereto.” [0081]).
Regarding claim 12, modified Arocha discloses the pre-filled medical delivery assembly of claim 10, wherein the at least one administration conduit comprises a needle (hypodermic needle 34) or cannula.
Regarding claim 14, modified Arocha discloses the pre-filled medical delivery assembly of claim 10, wherein the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the combination of the first and second liquid agents into a spray, or the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the combination of the first and second liquid agents into one or more droplets (“the exit port or nozzle can be configured, as in a conventional syringe, to receive a disposable hypodermic needle for injection of the mixed drug/buffer composition into the tissue of a patient in need of the drug composition.” [0023], noted that the limitations “configured to facilitate dispersion of the combination of the first and second liquid agents into a spray” and “configured to facilitate dispersion of the combination of the first and second liquid agents into one or more droplets” are recitations of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Regarding claim 15, modified Arocha discloses the pre-filled medical delivery assembly of claim 10.
Modified Arocha fails to explicitly disclose wherein the manifold, the BFS module, and the administration assembly are constructed to be removed as a unit from the base housing after combination of the first and second liquid agents in the mixing chamber.
Basile discloses a pre-filled medical delivery assembly (drug delivery device 10) comprising: a BFS module (drug container 16; “the drug container is made using blow-fill-seal” [0032]), a base housing (outer body 24), a manifold (inner body 22), a plunger (plunger 14), and an administration assembly (needle 20); wherein the manifold, the BFS module, and the administration assembly are constructed to be removed as a unit from the base housing after use of the pre-filled medical delivery assembly (“As pressure is applied to the plunger 14 at the proximal end 32, the plunger 14 moves axially toward the drug container 16, causing the drug container 16 to compress. As the release cams 36 on the plunger 14 arrive at the first set of locking windows 26, the release cams 36 displace the release and lock beams 30 causing them to disengage from the first set of locking windows 26. Once the release and lock beams 30 disengage from the first set of locking windows 26, the spring 18 urges the outer body 24 to extend axially to shield the needle 20. This extended position is shown in FIG. 2.” [0065-0066]; “FIG. 2 shows an embodiment of the drug delivery device described herein, in its post-injection position or second position wherein the safety shield is in an extended state. FIG. 2 shows a drug delivery device 10 that comprises a main body 12, a plunger 14, a drug container 16, a spring 18 and a needle 20. The main body 12 includes an inner body 22 and an outer body 24.” [0068], wherein the manifold, the BFS module, and the administration assembly are removed as a unit from at least the distal end of the base housing/outer body 24).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the module of the pre-filled medical delivery assembly of Arocha such that the manifold, the BFS module, and the administration assembly are constructed to be removed as a unit from the base housing after combination of the first and second liquid agents in the mixing chamber based on the teachings of Basile to shield the administration assembly in order to prevent needle stick injuries (Basile [0004]).
Regarding claim 16, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein: a first portion of the second internal volume has a frustoconical or tapered shape that narrows along a direction from the sixth longitudinal end toward to the fifth longitudinal end of the manifold in a cross-sectional view (Figure 6, showing that the mixing chamber 32 narrows and tapers to form the pathways into carpule piercing means 30); a second portion of the second internal volume proximal to the fifth longitudinal end has a cylindrical shape having a first diameter (at nozzle 38); a third portion of the second internal volume proximal to the sixth longitudinal end has a shape with a maximum cross-sectional dimension greater than the first diameter (Figure 6); or any combination of the above.
Regarding claim 17, modified Arocha discloses the pre-filled medical delivery assembly of claim 16, wherein the first and second piercing elements (carpule piercing means 30) extend longitudinally from an inclined sidewall of the manifold defining the frustoconical or tapered shape of the first portion (sidewalls of mixing chamber 32 are inclined to form the fluid pathways into carpule piercing means 30).
Regarding claim 18, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein a volume of the mixing chamber is greater than or equal to a combined volume of the first and second liquid agents (“depressing or actuating the plunger causes the carpule cap to be depressed against the carpule-piercing means, whereby the carpule cap is pierced or punctured to allow delivery of the predetermined amount or volume of drug and second injectable fluid to the mixing chamber. The two solutions are thoroughly mixed in the mixing chamber before being administered through the exit port or nozzle used for injection of the mixed drug/buffer composition into the tissue of a patient in need of the mixed drug/buffer composition.” [0063]).
Regarding claims 19-20, modified Arocha discloses the pre-filled medical delivery assembly of claim 1.
Modified Arocha fails to explicitly disclose the base housing, the plunger, or both are formed of a material having a hardness greater than that of the manifold, as required by claim 19; and wherein: the base housing, the plunger, or both are formed of polypropylene; and the manifold is formed of polycarbonate, as required by claim 20.
Basile discloses a pre-filled medical delivery assembly (drug delivery device 10) comprising: a BFS module (drug container 16; “the drug container is made using blow-fill-seal” [0032]), a base housing (outer body 24), a manifold (inner body 22), and a plunger (plunger 14), wherein the base housing, the plunger, or both are formed of a material having a hardness greater than that of the manifold and wherein: the base housing, the plunger, or both are formed of polypropylene and the manifold is formed of polycarbonate (“The drug container and housing of the delivery devices described herein are preferably made of a biocompatible, non-biodegradable polymer. Suitable biocompatible, non-biodegradable polymers include but are not limited to…a polypropylene…a polycarbonate…Each component of the drug delivery device described herein can be made of the same or different biocompatible, non-biodegradable polymer.” [0106]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pre-filled medical delivery assembly of Arocha to include that the base housing, the plunger, or both are formed of a polypropylene having a hardness greater than that of the manifold formed of polycarbonate based on the teachings of Basile to ensure that the pre-filled medical delivery assembly is both biocompatible and non-biodegradable (Basile [0106]).
Regarding claim 21, modified Arocha discloses the pre-filled medical delivery assembly of claim 1, wherein the second member of the plunger (plunger ring 12 and dual stems 14, 16 having stem-adjusting means 18) is movable along a longitudinal direction with respect to the first member of the plunger (“stem 16 (shown in partial cut-away view) comprises a stem-adjusting means 18 which provides for adjusting the length of the stem within stem housing 16. For example a stem-length adjusting means can be a rod threaded on its outer surface such that it threadingly and matingly engages with an inner threaded surface of housing 16.” [0074]).
Regarding claim 26, modified Arocha discloses the pre-filled medical delivery assembly of claim 1.
Modified Arocha fails to explicitly disclose at least the manifold and the BFS module are constructed to be removed as a unit from the base housing via the third longitudinal end after combination of the first and second liquid agents in the mixing chamber.
Basile discloses a pre-filled medical delivery assembly (drug delivery device 10) comprising: a BFS module (drug container 16; “the drug container is made using blow-fill-seal” [0032]), a base housing (outer body 24), a manifold (inner body 22), a plunger (plunger 14), and an administration assembly (needle 20); wherein at least the manifold and the BFS module are constructed to be removed as a unit from the base housing via the third longitudinal end after use of the pre-filled medical delivery assembly (“As pressure is applied to the plunger 14 at the proximal end 32, the plunger 14 moves axially toward the drug container 16, causing the drug container 16 to compress. As the release cams 36 on the plunger 14 arrive at the first set of locking windows 26, the release cams 36 displace the release and lock beams 30 causing them to disengage from the first set of locking windows 26. Once the release and lock beams 30 disengage from the first set of locking windows 26, the spring 18 urges the outer body 24 to extend axially to shield the needle 20. This extended position is shown in FIG. 2.” [0065-0066]; “FIG. 2 shows an embodiment of the drug delivery device described herein, in its post-injection position or second position wherein the safety shield is in an extended state. FIG. 2 shows a drug delivery device 10 that comprises a main body 12, a plunger 14, a drug container 16, a spring 18 and a needle 20. The main body 12 includes an inner body 22 and an outer body 24.” [0068], wherein the manifold and the BFS module are removed proximally as a unit from at least the distal end of the base housing/outer body 24).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the module of the pre-filled medical delivery assembly of Arocha such that at least the manifold and the BFS module are constructed to be removed as a unit from the base housing via the third longitudinal end after combination of the first and second liquid agents in the mixing chamber based on the teachings of Basile to shield the administration assembly in order to prevent needle stick injuries (Basile [0004]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Arocha (US 20150065993) in view of Basile et al. (US 20190022336) as applied in claim 12 above, and further in view of Koska (US 20190060168).
Regarding claim 13, modified Arocha discloses the pre-filled medical delivery assembly of claim 12.
Modified Arocha fails to explicitly disclose the needle has a length in a range of 0.5 mm to 4 mm, inclusive, or in a range of 4 mm to 15 mm, inclusive, or in a range of 15 mm to 30 mm, inclusive.
Koska discloses a pre-filled medical delivery assembly (Figure 10) comprising a BFS module (BFS vial 210), a manifold (hub assembly 1026), and a needle (needle element 1080) having a length in a range of 0.5 mm to 4 mm, inclusive, or in a range of 4 mm to 15 mm, inclusive, or in a range of 15 mm to 30 mm, inclusive (“lengths of the needle elements 1080a-d may be in the range of one half millimeter (0.5 mm) to fifty millimeters (50 mm).” [0087]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the needle of the pre-filled medical delivery assembly of Arocha to have a length in a range of 0.5 mm to 4 mm, inclusive, or in a range of 4 mm to 15 mm, inclusive, or in a range of 15 mm to 30 mm, inclusive based on the teachings of Koska to ensure that the needle has the length necessary for a specific type of injection, such as intramuscular, subcutaneous, intravenous or intradermal (Koska [0087]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Arocha (US 20150065993) in view of Basile et al. (US 20190022336) as applied in claim 1 above, and further in view of Smedly et al. (USPN 5240146).
Regarding claim 22, modified Arocha discloses the pre-filled medical delivery assembly of claim 1.
Modified Arocha fails to explicitly disclose the first member of the plunger comprises a threaded cylindrical portion; and the fourth longitudinal end of the base housing has a threaded internal surface portion constructed to engage with threads of the cylindrical portion of the first member.
Smedly discloses a pre-filled medical delivery assembly (dispenser 2) comprising a module having first and second chambers (cartridges 6, 7); and a mixing assembly comprising a base housing (sliding body 66) and a plunger (dosage adjusters 60, 61 and drive stems 36, 37) comprising a laterally-extending first member (dosage adjusters 60, 61, wherein at least the proximal end of the dosage adjusters 60, 61 extends laterally) and a longitudinally- extending second member (drive stems 36, 37), wherein the first member of the plunger comprises a threaded cylindrical portion (external threads 72); and the fourth longitudinal end of the base housing has a threaded internal surface portion (threaded holes 68) constructed to engage with threads of the cylindrical portion of the first member (“Dosage adjusters 60, 61 each include external threads 72 which engage threaded holes 68 to permit the user to adjust the axial positions of dosage adjusters 60, 61 relative to sliding body 66 as suggested in FIG. 3 by arrow 74.” [Col 5, lines 1-5]; Figure 3A).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pre-filled medical delivery assembly of Arocha to include the first member of the plunger comprises a threaded cylindrical portion; and the fourth longitudinal end of the base housing has a threaded internal surface portion constructed to engage with threads of the cylindrical portion of the first member based on the teachings of Smedly to allow the user to individually adjust the dosages of each of the first and second liquid agents (Smedly [Col 6, lines 3-13]).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Arocha (US 20150065993) in view of Basile et al. (US 20190022336) as applied in claim 1 above, and further in view of Modi (US 20070191780).
Regarding claim 23, modified Arocha discloses the pre-filled medical delivery assembly of claim 1.
Modified Arocha fails to explicitly disclose the second member of the plunger is disposed such that longitudinal displacement of the second member toward the third longitudinal end of the base housing pushes the BFS module toward the manifold, so as to breach the first and second sealed ports using the piercing elements without pressing the first and second actuation members.
Modi teaches a pre-filled medical delivery assembly (device 50) comprising a module () having a chamber (filed reservoir body 70), a sealed port (distal surface of reservoir body 70), and an actuation member (proximal end of reservoir body 70); a base housing (housing 52), a manifold (reservoir chamber 62) having a piercing element (upper end 74 of needle 72), and a plunger (actuator 80 and upper housing 96) having a first member (upper housing 96) and a longitudinally extending second member (actuator 80), wherein the second member of the plunger is disposed such that longitudinal displacement of the second member toward a third longitudinal end of the base housing pushes the module toward the manifold, so as to breach the sealed port using the piercing element without pressing the actuation members (“Referring now to FIGS. 2E and 2F, as continued pressure is applied to the actuator 80, the tab 102 is released from the notch 100 and the plunger 82 descends within the reservoir chamber forcing the filled reservoir 70 downwards until it contacts the base 64 of the reservoir chamber 62. As the actuator 80 exerts pressure on the reservoir 70, the reservoir 70 contacts the upper end 74 of the needle 72 and is punctured. The cannula of the needle 72 is now in fluid communication with the contents of the reservoir. Referring now to FIGS. 2G and 2H, continued pressure on the actuator 80 compresses the reservoir 70 and forces all the contents to flow through the needle 72 and into the patient.” [0039-0040], wherein the proximal end of the reservoir body is not compressed until after the reservoir is punctured).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pre-filled medical delivery assembly of Arocha to include the second member of the plunger is disposed such that longitudinal displacement of the second member toward the third longitudinal end of the base housing pushes the BFS module toward the manifold, so as to breach the first and second sealed ports using the piercing elements without pressing the first and second actuation members based on the teachings of Modi to ensure that the first and second chambers remain sealed until the liquid agents are about to be injected in order to maintain sterility of the liquid agents (Modi [0012, 0038-0041]).
Regarding claim 24, modified Arocha discloses the pre-filled medical delivery assembly of claim 23, wherein the first member of the plunger is disposed such that longitudinal displacement of the first member toward the third longitudinal end of the base housing presses the first and second actuation members of the BFS module, so as to cause the first and second liquid agents to be dispensed from the first and second chambers into the mixing chamber via the breached ports (“In order to mix the separate solutions, a carpule-piercing or puncturing means is provided for engaging with and piercing or puncturing the cap end of the carpule. The plunger can then apply pressure to the sliding plug end of the carpule, forcing the solutions out of the carpule. Preferably, the carpule-piercing means is a hollow needle which is in communication with the contents of the carpule and a mixing chamber provided between the carpule and exit port.” [0060]).
Regarding claim 25, modified Arocha discloses the pre-filled medical delivery assembly of claim 24, wherein each of the first and second longitudinally- extending piercing elements (carpule piercing means 30) is substantially solid, such that the liquid agents from the first and second chambers flow around the respective piercing element extending through the respective breached port (Figure 6; “carpule-piercing means 30 having a tubular configuration, i.e., having an open lumen to provide for communication between the solution within the carpule and mixing chamber 32.” [0081], wherein the carpule-piercing means 30 are considered to be ‘substantially solid’ because they are formed of a solid material, and the liquid agents flow around at least a portion of the carpule-piercing means 30).
Allowable Subject Matter
Claims 27-40 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to anticipate or render obvious a method for delivery of liquid agents to a patient comprising the steps of “(g) after (f), removing the plunger from the base housing, such that the first and second actuation members of the BFS module revert to respective uncompressed states; (h) after (g), removing the manifold and the BFS module as a unit from the base housing; and (i) after (h), re-compressing the first and second actuation members to pressurize the first chamber, the second chamber, and the mixing chamber to cause dispensing of contents thereof” in combination with the other limitations of independent claim 27. The closest prior art of record is Arocha (US 20150065993) in view of Basile et al. (US 20190022336) and further in view of Modi (US 20070191780), which disclose a pre-filled medical delivery assembly as detailed in the rejection of claims 1 and 23 above, that performs the steps (a)-(f) of the method for claim 27. However, none of hte prior art of record disclose that after the first and second liquid agents are dispensed into the mixing chamber, the plunger is removed from the base housing so the actuation members revert to an uncompressed state, followed by removing the manifold and the BFS module as a unit form the base housing and re-compressing the actuation members to cause dispensing of the contents therefrom as required by steps (g)-(i) of claim 27.
Conclusion
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/LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783