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 1, 5-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (EP Publication No. 1086718), hereinafter, Rosenberg, in view of Baker (CA Patent No. 3022378), hereinafter, Baker.
Regarding claim 1, Rosenberg discloses a device for delivering a fluidic composition across a dermal barrier of a patient (device 10 in figs. 1-3A; para [0031-0032]), the device comprising:
a syringe connection assembly (Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3) having a fluidic path defined therein (Col. 9, Lines 6-25), the syringe connection assembly comprising:
a distal end coupled to a proximal face (Rosenberg, coupling member 38 attached to top wall 20 in fig. 3) of the fluidic distribution block (the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5), the fluidic path of the syringe connection assembly fluidically connected to the fluid distribution manifold (distribution manifold 172 in figs. 3-5; Col. 9, Lines 6-25); and
a proximal end configured to be coupled to a syringe barrel having a bore defined therein (Rosenberg, tip 60 of the syringe barrel 56 and locked together with Luer lock collar 54 in fig. 3), the fluidic path of the syringe connection assembly configured to be fluidically connected to the bore of the syringe barrel (distribution manifold 172 in figs. 3-5; Col. 9, Lines 6-25).
but Rosenberg fails to disclose a microneedle fluidic block assembly comprised therein.
Baker teaches a microneedle fluidic block assembly (microneedle array assembly 80 in fig. 3) comprising:
a microneedle array comprising a plurality of microneedles (microneedles 178 in figs. 3-4) disposed on a distal face (base surface 180 in fig. 4) of a base plate (microneedle array 170 in figs. 3), wherein the microneedles (microneedles 178 in figs. 3-4) have a fluidic exit channel (passageways 208 in fig. 4) defined therein, the microneedles (microneedles 178 in figs. 3-4) capable of penetrating the stratum corneum of the skin of a patient and delivering a fluidic composition to a depth below the surface of the skin of the patient (para [0042]);
a fluidic distribution block (the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5) having a distal face (distal face of distribution manifold 172 in figs. 3-5) coupled to a proximal face of the base plate (back surface 182 in fig. 4) of the microneedle array (microneedles 178 in figs. 3-4), the fluidic distribution block (the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5) comprising a fluid distribution manifold (distribution manifold 172 in figs. 3-5) defined therein and configured to be fluidically connected (fluid distribution network 184 in fig. 3) with the fluidic exit channels (passageways 208 in fig. 4) of the microneedles (microneedles 178 in figs. 3-4) and to controllably distribute the fluidic composition (para [0051, 0058]) to the plurality of microneedles (microneedles 178 in figs. 3-4) through the fluidic exit channels (passageways 208 in fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal interface of Rosenberg’s device so that its coupling member is fluidically connected to, and mechanically coupled with, the fluid distribution block of the microneedle array assembly taught by Baker in order to allow Rosenberg’s syringe-driven device to deliver fluid through a microneedle manifold having controlled and substantially equalized flow to each microneedle.
Regarding claim 5, modified Rosenberg discloses the device of claim 1, wherein the fluid distribution manifold (Baker, distribution manifold 172 in figs. 3-5) is configured to provide a substantially equal flow rate of the fluidic composition (Baker, para [0051, 0058]) to the exit channels (Baker, passageways 208 in fig. 4) in each microneedle (Baker, microneedles 178 in figs. 3-4).
Regarding claim 6, modified Rosenberg discloses the device of claim 1, wherein the fluid distribution manifold (Baker, distribution manifold 172 in figs. 3-5) comprises:
a proximal entrance (Baker, inlet channel 190 in figs. 4-5) disposed within the proximal face (Baker, top surface 186 in fig. 4) of the fluidic distribution block (Baker, the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5) and in fluidic connection (Baker, Col. 9, Lines 6-25) with the distal end of the syringe connection assembly (Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3); and
supply channels (Baker, supply channels 192 in figs. 4-5) fluidically connected (Baker, fluid distribution network 184 in fig. 3) to the proximal entrance (Baker, inlet channel 190 in figs. 4-5) and configured to distribute a fluidic composition (Baker, fluid distribution network 184 in fig. 3) to a plurality of resistance channels (Baker, resistance channels 194 in fig. 4-5);
wherein the plurality of resistance channels (Baker, resistance channels 194 in fig. 4-5) fluidically connected (Baker, fluid distribution network 184 in fig. 3) to the supply channels (Baker, supply channels 192 in figs. 4-5) and configured to provide a resistance to flow of the fluidic composition (Baker, para [0050]);
and a plurality of outlet apertures (Baker, outlet channels 196), each outlet aperture fluidically connected (Baker, fluid distribution network 184 in fig. 3, para [0050]) to a resistance channel (Baker, resistance channels 194 in fig. 4-5) and a fluidic exit channel (Baker, passageways 208 in fig. 4).
Regarding claim 7, modified Rosenberg discloses the device of claim 6, wherein the fluidic distribution block (Baker, the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5) comprises a proximal portion (Baker, proximal portion of fluidic distribution block including distribution manifold 172 with fluid distribution network 184 in fig. 3) having a distal face coupled to a proximal face of a distal portion (Baker, distal portion of fluidic distribution block including base plate of microneedle array 170 with plurality of microneedles 178 in fig. 3), wherein the supply channels (Baker, supply channels 192 in figs. 4-5) and the resistance channels (Baker, resistance channels 194 in fig. 4-5) are disposed on the distal face of the proximal portion and/or the proximal face of the distal portion (Baker, supply and resistance channels disposed on distal face of proximal portion in fig. 3).
Regarding claim 8, modified Rosenberg discloses the device of claim 7, wherein the fluidic distribution block (Baker, the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5) comprises a polymer material, a glass material and/or a silicon material (Baker, para [0044, 0054, 0064]), and the fluid distribution manifold (Baker, distribution manifold 172 in figs. 3-5) is formed therein by a drilling method, a cutting method, a powder blasting method, and/or an etching method (Baker, para [0052]).
Regarding claim 9, modified Rosenberg discloses the device of claim 7, wherein the proximal portion and the distal portion are bonded together (Baker, adhesive layer in fig. 3; para [0042]).
Regarding claim 10, modified Rosenberg discloses the device of claim 6, comprising resistance channels (Baker, resistance channels 194 in fig. 4-5, 7). Modified Rosenberg does not disclose specific dimensions of those channels: a length of from 400μm to 1,000μm; an axial depth of from 10μm to about 20μm; and a lateral width of from 15μm to 70μm. Modified Rosenberg does, however, disclose the structure of resistance channels (Baker, resistance channels 194 in fig. 4-5, 7) and the function of those resistance channels (para [0050, 0057]) which is to increase flow resistance in the channels by 5 to about 100 times the resistance of the flow through the supply channels (Baker, supply channels 192 in figs. 4-5). Additionally, the resistance channels are increasing in resistance as fluid proceeds through the fluidic resistors by reducing cross-sectional area in the channels (fig. 7, para (0057).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the resistance channels of the Rosenberg-Baker device so that their length, depth, and width are selected within micrometer-scale ranges, including the claimed ranges of 400μm to 1000μm length, 10μm to 20μm depth, and 15μm to 70μm lateral width, as a matter of routine optimization of a result-effective variable (hydraulic resistance) in view of Baker’s teaching that channel geometry is adjusted to achieve the desired resistance and flow balancing. Selecting particular channel dimensions within these known microfluidic ranges to obtain a target resistance and substantially equal flow to each microneedle would have been a predictable design choice and does not patentably distinguish the claimed device over Rosenberg in view of Baker.
Regarding claim 11, modified Rosenberg discloses the device of claim 1, wherein the plurality of microneedles is from 2 to 100 microneedles (Baker, microneedles 178 in figs. 3-4; 10x10 microneedle grids are disclosed in figs. 3-5).
Regarding claim 12, modified Rosenberg discloses the device of claim 6, wherein: each of the resistance channels (Baker, resistance channels 194 in fig. 4-5) includes one or more inlet apertures adapted to be in fluidic connection with the supply channel (Baker, supply channels 192 in figs. 4-5);
the resistance channels (Baker, resistance channels 194 in fig. 4-5) comprise inner resistance channels (Baker, resistance channels 194 located closer to the lateral center of distribution manifold 172 in fig. 4-5) located proximal to a lateral center of the fluidic distribution block (Baker, the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5), and outer resistance channels (Baker, resistance channels 194 located further from the lateral center of distribution manifold 172 in fig. 4-5) located distal to the lateral center of the fluidic distribution block (Baker, the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5);
wherein two or more inner resistance channels (Baker, resistance channels 194 located closer to the lateral center of distribution manifold 172 in fig. 5, 7) are in fluidic connection with one inlet aperture (Baker, the junction where a single supply channel 192 branches to feed multiple inner resistance channels 194 in figs. 5, 7); and
each outer resistance channel (Baker, resistance channels 194 located further from the lateral center of distribution manifold 172 in fig. 4-5) is in fluidic connection with one inlet aperture (Baker, the junction where a supply channel 192 feeds an outer resistance channels 194 in figs. 5, 7).
Regarding claim 15, modified Rosenberg discloses the device of claim 1, further comprising a syringe (Rosenberg, syringe 52 in fig. 3) including a barrel (Rosenberg, syringe barrel 56 in fig. 3), wherein the proximal end of the syringe connection assembly (Rosenberg, tip 60 of the syringe barrel 56 and locked together with Luer lock collar 54 in fig. 3) is coupled to the syringe barrel (Rosenberg, syringe barrel 56 in fig. 3) and fluidically connected to the bore of the syringe barrel (Rosenberg, distribution manifold 172 in figs. 3-5; Col. 9, Lines 6-25).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Baker, as applied to claim 1 above, in view of Ross (AU Patent Application No. 2017378022), hereinafter, Ross(8022).
Regarding claim 2, modified Rosenberg discloses the device of claim 1, comprising a syringe connection assembly (Modified Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3).
Modified Rosenberg does not disclose a plenum coupled to and fluidically connected with a tubing connector; wherein the tubing connector has:
a distal portion coupled to a proximal face of the plenum; and
a proximal portion configured to be fluidically connected to the bore of the syringe barrel; and the plenum has:
a distal face coupled to the proximal face of the fluidic distribution block and fluidically connected to the fluid distribution manifold.
Ross teaches a plenum (Ross, plenum assembly 16 in figs. 2-6) coupled to and fluidically connected with a tubing connector (para [0079], tubing corresponds to the interface of Ross’s cannula 104 and cartridge assembly 18 in figs. 2,5); wherein the tubing connector has:
a distal portion (Ross, distal portion of cartridge assembly 18 in fig. 2) coupled to a proximal face of the plenum (Ross, upper surface 162 of plenum component 102 in figs. 5-6, para [0079]); and
a proximal portion configured to be fluidically connected (Ross, fluid passage 186 in fig. 5 to the bore of the syringe barrel (cannula 104 in fig. 5, para [0079]); and the plenum (Ross, plenum assembly 16 in figs. 2-6) has:
a distal face (Ross, lower surface 164 of plenum frame 170 in fig. 12) coupled to the proximal face of the fluidic distribution block (Ross, microneedle array assembly 108 in fig. 6) and fluidically connected to the fluid distribution manifold (Ross, fluid distribution network in fig. 18, para [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe connection assembly of Rosenberg so that, instead of directly coupling the syringe barrel tip to Baker’s fluidic distribution block, the assembly further includes an intermediate plenum coupled to and fluidically connected with a tubing connector, as taught by Ross, in order to improve fluid volume and flow into the manifold and maintain control of volumes delivered to microneedle array.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Baker, as applied to claim 1 above, and in further view of Frederickson (US Patent No. 10307578), hereinafter, Frederickson.
Regarding claim 3, modified Rosenberg discloses the device of claim 1, but fails to disclose a gasket comprised therein.
Frederickson teaches a first gasket (Frederickson, gasket 82 in fig. 9) disposed between and coupled to the distal end of the syringe connection assembly (Modified Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3) and the proximal face of the fluidic distribution block (the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5); wherein the first gasket has a hole in fluidic connection with the fluidic path (Col. 9, Lines 32-34) of the syringe connection assembly and the fluid distribution manifold (distribution manifold 172 in figs. 3-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interface between the distal end of the syringe connection assembly of modified Rosenberg and the proximal face of the fluidic distribution block to include a gasket disposed between and couple to those components, the gasket having a hole aligned with and in fluidic connection with the fluid path of the syringe connection assembly and the fluid distribution manifold, as taught by Frederickson, in order to provide a sealed and mechanically stable junction between the syringe connector and the manifold.
Regarding claim 4, modified Rosenberg discloses the device of claim 3, wherein the first gasket (Frederickson, gasket 82 in fig. 9-10) has a proximal face and a distal face, wherein the proximal face and the distal face has an adhesive layer (Frederickson, adhesive 34 in fig. 9-10) disposed thereon and adapted to adhere the distal end of the syringe connection assembly (Modified Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3) to the proximal face of the fluidic distribution block (proximal face of the block that contains the distribution manifold 172 and base plate of microneedle array 170 with plurality of microneedles 178 in figs. 3-5).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Baker, as applied to claim 1 above, and in further view of Poon (WO Publication No. 2014/153447), hereinafter, Poon.
Regarding claim 13, modified Rosenberg discloses the device of claim 1, but fails to disclose a protective cap coupled to the distal end of the syringe connection assembly (Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3) and configured to protect the physical integrity and/or sterility of the microneedle (Baker, microneedles 178 in figs. 3-4) fluidic block assembly.
Poon teaches a protective cap (cover 122 in figs. 1-3, Col. 21, Line 17 – Col. 22, Line 12) coupled to the distal end of the syringe connection assembly and configured to protect the physical integrity and/or sterility of the microneedle fluidic block assembly.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Rosenberg-Baker device to include a protective cap that is slidably coupled to the distal end of the syringe connection assembly and covering the microneedle fluidic assembly block, as taught by Poon, in order to protect the microneedle array and maintain sterility.
Regarding claim 14, modified Rosenberg discloses the device of claim 13, wherein the protective cap (cover 122 in figs. 1-3, Col. 21, Line 17 – Col. 22, Line 12) is configured to be slidably coupled (Col. 21, Line 17 – Col. 22, Line 12) to the syringe connection assembly (Rosenberg, coupling member 38 attached to top wall 20 connects to tip 60 of the syringe barrel and lock together with Luer lock collar 54 in fig. 3).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Baker, as applied to claim 1 and 15 above, and in further view of Ross (US Publication No. 20210228853), hereinafter, Ross(8853).
Regarding claim 16, modified Rosenberg discloses the device of claim 15, wherein the bore has a longitudinal axis, the syringe (syringe 52 in fig. 3) further comprising a plunger (plunger rod assembly 58 in fig. 3) slidably disposed within the longitudinal axis of the bore (Col. 9, Lines 10-14; standard syringe), but modified Rosenberg fails to disclose the syringe (syringe 52 in fig. 3) that is adapted to eject a volume of from 1μL - 500μL of a fluidic composition disposed within the bore in response to an axial force applied to the plunger.
Ross teaches a syringe that is adapted to eject a volume of from 1μL to 500μL of a fluidic composition disposed within the bore in response to an axial force applied to the plunger (para [0222] teaches delivery rates by driving means including syringes; para [0247] teaches flow rates including 1μL per hour per microneedle, which falls in range of ejection volume rates as disclosed in claims 16 and 17, (500μL / 300 sec).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to operate the syringe of the Rosenberg-Baker device so that, in response to axial force on the plunger, it ejects a volume of fluid in the 1μL - 500μL range as taught by Ross, as a matter of routine optimization of result-effective variables such as dose volume and flow rate in view of the known microliter-scale operation of microneedle delivery systems. Selecting a particular dose volume within this microliter range to achieve a desired therapeutic effect with predictable changes in delivered amount would have been a routine design choice that does not patentably distinguish claim 16 over modified Rosenberg in further view of Ross.
Regarding claim 17, modified Rosenberg discloses the device of claim 16, wherein the syringe is adapted to eject the volume of the fluidic composition over a period of time from 0.1 second to 300 seconds (para [0247] teaches flow rates including 1μL per hour per microneedle, which falls in range of ejection volume rates as disclosed in claims 16 and 17, (500μL / 300 sec).
Regarding claim 18, modified Rosenberg discloses the device of claim 16, wherein the syringe (Rosenberg, syringe 52 in fig. 3) further comprises a fluidic composition disposed within the bore (Rosenberg, Col. 10, Lines 26-28).
Regarding claim 19, modified Rosenberg discloses the device of claim 18, wherein in response to an axial force applied to the plunger (Rosenberg, plunger rod assembly 58 in fig. 3), the device (modified Rosenberg) is adapted to deliver the fluidic composition to a patient through the exit channels (Baker, passageways 208 in fig. 4) of the plurality of microneedles (Baker, microneedles 178 in figs. 3-4; (Col. 10, Lines 26-32).
Regarding claim 20, the functional language has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the device (modified Rosenberg) of claim 19. Since the device (modified Rosenberg) of claim 20 is the same structure as the device (modified Rosenberg) in claim 19, they are able to be used in the same manner as set forth in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571)272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783