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 .
Status of Claims
Applicant’s amendments filed August 24, 2026 have been entered.
Independent claim 1 has been amended.
Claims 47-53 are new.
Claims 6 and 12 have been canceled.
Claims 1-5, 7-11, 13-20, and 47-53 are pending, of which claims 1, 47 and 49 are independent.
Previous 103 rejections of claims 1-5, 7-11, and 13-20 over Rosenberg in view of Baker are withdrawn.
Frederickson is no longer applied.
This action is FINAL.
Response to Arguments
Applicant argues on page 10, line 6 to page 11, line 3 in the remarks filed August 24, 2026, regarding claim 1, that Baker Figure 5 does not teach two or more inner resistance channels in fluidic connection with one inlet aperture.
Examiner agrees as to claim 1. That rejection is withdrawn. The same argument does not reach claims 47-49, which do not recite that limitation.
Applicant argues on page 11, line 4 to page 12, line 10 in the remarks filed August 24, 2026, regarding claim 1 (and on pages 14-15 as applied to claims 47-49), that Rosenberg does not disclose a manifold, that Rosenberg’s reservoir 30 is divided into chambers 34 by internal walls 32 for separate substances, that substituting Baker’s single common manifold would eliminate that divided reservoir and render Rosenberg unsatisfactory for its intended purpose (MPEP 2143.01(V) and (VI)), and that Rosenberg and Baker are directed to fundamentally different delivery architectures.
However, Examiner respectfully disagrees as to claims 47-49. Rosenberg is in the same field of endeavor as the claimed device: a microneedle apparatus that delivers fluid across a dermal barrier from a syringe-side coupling (device 10; coupling member 38; syringe 52; Figs. 1-3A; para [0031-0033]). Rosenberg is also reasonably pertinent to connecting a syringe fluid path to a microneedle array. Baker is relied on for the distribution block and manifold, not for a syringe. Combining Baker’s manifold with Rosenberg’s syringe-coupled hollow-microneedle housing does not require keeping Rosenberg’s optional multi-chamber wall 32. Rosenberg also discloses a single-substance fill through coupling 38 into chamber 34. Using one composition and one manifold does not change the principle of operation of delivering fluid through hollow microneedles from a proximal coupling. The “Col. 9, lines 6-25” citation in the prior action is withdrawn; the syringe connection mapping is Rosenberg, para [0035], [0042] and Figs. 1-3 (coupling member 38, syringe 52, barrel 56, Luer collar 54, tip 60), which is the hollow-needle embodiment.
Therefore, Rosenberg remains proper primary art for claims 47-49.
Applicant argues on page 14, lines 5-24 in the remarks filed August 24, 2026, regarding claims 47 and 48, that Frederickson’s (US 10,307,578) gasket is a packaging seal without a hole and outside the fluid path, and that Baker’s gasket 88 is not between a syringe connection assembly and the proximal face of the distribution block.
However, the Examiner respectfully disagrees as to the combination now applied. Frederickson is no longer applied. Ross (AU 2017/378022) teaches adhesive layer 200 (alternatively 192) with hole 224 (alternatively 204) in the stack between the plenum/connector assembly and manifold 238, in the fluid path. That meets the gasket-with-hole limitation of claim 47.
Applicant argues on pages 14, line 30 to page 15, line 5 in the remarks filed August 24, 2026, regarding claim 49, that Baker has no syringe interface and that Rosenberg’s coupling member 38 is a single Luer on top wall 20, so neither teaches a two-stage plenum and tubing connector.
However, the Examiner respectfully disagrees. Ross (AU 2017/378022) is relied on for that two-stage interface (plenum102; cannula 104 on mount 184 / surface 162; upper end of 104 to cartridge 18; distal face of the plenum stack to assembly 108 / inlet 254). Rosenberg supplies the syringe barrel. The combination is Rosenberg in view of Baker and Ross.
Claim Objections
Claim 1 is objected to.
Claim 1 recites that the resistance channels “comprise inner resistance channels located proximal to the lateral center of the fluidic distribution block, and outer resistance channels located distal to the lateral center of the fluidic distribution block,” and then recites “two or more inner resistance channels are in fluidic connection with one inlet aperture” and “each outer resistance channel is in fluidic connection with one inlet aperture.”
To keep the claim language consistent with the inner and outer groups already recited in the claim (see figs. 3H-3J; specification para [0207]), the last two clauses should refer to those groups as already defined, rather than repeating “inner resistance channels” and “outer resistance channels” without tying them back to that earlier recitation.
Appropriate correction is as follows:
Wherein two or more of the inner resistance channels are in fluidic connection with one inlet aperture; and
each of the outer resistance channels is in fluidic connection with one inlet aperture.
Claims 2-5, 7-11, 13-20, and 50-53 are objected to as depending from objected claim 1.
Allowable Subject Matter
Claims 1-5, 7-11, 13-20, and 50-53 are objected to, but would be allowable if rewritten to correct the informalities set forth in paragraphs 14-18.
The following is a statement of reasons for the indication of allowable subject matter:
Independent claim 1 is directed to a device for delivering a fluidic composition across a dermal barrier, comprising a microneedle fluidic block assembly (microneedle array on a base plate and a fluidic distribution block with a manifold) and a syringe connection assembly. The manifold includes a proximal entrance, supply channels, resistance channels, and outlet apertures. Claim 1 further requires that each resistance channel include one or more inlet apertures adapted to be in fluidic connection with the supply channels; that the resistance channels comprise inner resistance channels located proximal to a lateral center of the fluidic distribution block and outer resistance channels located distal to the lateral center; that two or more inner resistance channels are in fluidic connection with one inlet aperture; and that each outer resistance channel is in fluidic connection with one inlet aperture.
The prior art of record, including Rosenberg (EP 1 086 718), Baker (CA 3 022 378), Ross (AU 2017378022), and the other cited references, does not disclose or render obvious this inner-shared / outer-dedicated inlet-aperture geometry in combination with the claimed microneedle distribution block and syringe connection assembly.
Baker Figure 5 shows a manifold (inlet channel 190, supply channels 192, resistance channels 194, outlet channels 196). Each resistance channel 194 meets a supply channel 192 at its own junction. Baker can be read on a one-to-one inlet for outer-type channels. Baker does not teach two or more inner resistance channels in fluidic connection with one inlet aperture (specification element 301; Figs. 3H-3J).
Accordingly, claim 1 would be allowable over the prior art of record upon correction of the objection.
Claims 2-5, 7-11, 13-20, and 50-53 depend from claim 1 and would be allowable for at least the same reasons.
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 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (EP 1 086 718) in view of Baker (CA 3 022 378), and further in view of Ross (AU 2017378022).
Regarding claim 47, Rosenberg discloses a device for delivering a fluidic composition across a dermal barrier of a patient (Rosenberg: 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 (Rosenberg: opening 36 in top wall 20 to chamber / reservoir 34 to microneedles in figs. 1, 3; para [0035] and [0042]), 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 fluidic path of the syringe connection assembly fluidically connected to the fluid distribution manifold (Rosenberg: opening 36 in top wall 20 to chamber / reservoir 34 to microneedles in figs. 1, 3; para [0035] and [0042]; connected to Baker’s distribution manifold 172 in figs. 3-5); and
a proximal end (Rosenberg: coupling member 38, Luer lock on top wall 20 in fig. 3; para [0035] and [0042]) configured to be coupled to a syringe barrel having a bore defined therein (Rosenberg: syringe 52 with syringe barrel 56, tip 60 and locked together with Luer lock collar 54 in fig. 3; para [0035] and [0042]), the fluidic path of the syringe connection assembly configured to be fluidically connected to the bore of the syringe barrel (Rosenberg: Luer lock collar 54 threads onto coupling member 38, fluid injects from the barrel through 38 and opening 36 into chamber 34; para [0035] and [0042]);
Rosenberg fails, however, to disclose that the device for delivering a fluidic composition across a dermal barrier of a patient comprises:
a microneedle fluidic block assembly comprising:
a microneedle array comprising a plurality of microneedles disposed on a distal face of a base plate, wherein the microneedles have a fluidic exit channel defined therein, the microneedles 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; and
a fluidic distribution block having a distal face coupled to a proximal face of the base plate of the microneedle array, the fluidic distribution block comprising a fluid distribution manifold defined therein and configured to be fluidically connected with the fluidic exit channels of the microneedles and to controllably distribute the fluidic composition to the plurality of microneedles through the fluidic exit channels.
Baker teaches a microneedle fluidic block assembly (Baker: microneedle array assembly 80 in fig. 3) comprising:
a microneedle array comprising a plurality of microneedles (Baker: microneedles 178 in figs. 3-4) disposed on a distal face (Baker: base surface 180 in fig. 4) of a base plate (Baker: microneedle array 170 in figs. 3), wherein the microneedles (Baker: microneedles 178 in figs. 3-4) have a fluidic exit channel (Baker: passageways 208 in fig. 4) defined therein, the microneedles (Baker: 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 (Baker: para [0042]);
a 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) having a distal face (Baker: distal face of distribution manifold 172 in figs. 3-5) coupled to a proximal face of the base plate (Baker: back surface 182 in fig. 4) of the microneedle array (Baker: microneedles 178 in figs. 3-4), the fluidic distribution block comprising a fluid distribution manifold (Baker: distribution manifold 172 in figs. 3-5) defined therein and configured to be fluidically connected (Baker: fluid distribution network 184 in fig. 3) with the fluidic exit channels (Baker: passageways 208 in fig. 4) of the microneedles (Baker: microneedles 178 in figs. 3-4) and to controllably distribute the fluidic composition (Baker: para [0051, 0058]) to the plurality of microneedles (Baker: microneedles 178 in figs. 3-4) through the fluidic exit channels (Baker: 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 housing and reservoir of Rosenberg to include the fluidic distribution block and supply-channel / resistance-channel / outlet-aperture manifold, as taught by Baker, in order to controllably and evenly distribute fluid from the syringe coupling to each microneedle.
Modified Rosenberg fails to disclose a first gasket disposed between and coupled to the distal end of the syringe connection assembly and the proximal face of the fluidic distribution block; wherein the first gasket has a hole in fluidic connection with the fluidic path of the syringe connection assembly and the fluid distribution manifold.
Ross, however, teaches a gasket (Ross ‘8022: third adhesive layer 200, alternatively first adhesive layer 192, of plenum cap assembly 106 in figs. 14, 17; para [0081], [0084-0086]) disposed between and coupled to the distal end of the syringe connection assembly and the proximal face of the fluidic distribution block; wherein the first gasket has a hole (Ross ‘8022: slot 224, alternatively aperture 204 in fig. 14, 17) in fluidic connection with the fluidic path of the syringe connection assembly and the fluid distribution manifold (Ross ‘8022: pressure sensitive layer 200 or 192 is sandwiched in the stack between the plenum cap assembly 106 and distribution manifold 238 in fluid communication with both the upstream path and manifold; para [0081], [0084-0086]).
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 joint of the syringe connection assembly of modified Rosenberg to include the through-hole adhesive layer, as taught by Ross, in order to seal that stacked interface while leaving a lumen from the connector path into the manifold.
Regarding claim 48, modified Rosenberg discloses the device of claim 47, wherein the first gasket (Ross ‘8022: third adhesive layer 200, alternatively first adhesive layer 192, of plenum cap assembly 106 in figs. 14, 17; para [0081], [0084-0086]) has a proximal face and a distal face(Ross ‘8022: proximal and distal face of third adhesive layer 200, alternatively first adhesive layer 192, of plenum cap assembly 106 in figs. 14, 17; para [0081], [0084-0086]), wherein each of the proximal face and the distal face has an adhesive layer disposed thereon and adapted to adhere (Ross ‘8022: plenum cap assembly 106 is bonded to the mounting surface 174 of the plenum component 102 via a first adhesive layer 192, which is fabricated from pressure-sensitive adhesive film; para [0081]) the distal end of the syringe connection assembly to the proximal face 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).
Regarding claim 49, Rosenberg in view of Baker discloses a device for delivering a fluidic composition across a dermal barrier of a patient (Rosenberg: device 10 in figs. 1-3A; para [0031-0032]), the device comprising:
a microneedle fluidic block assembly (Baker: microneedle array assembly 80 in fig. 3) comprising: a microneedle array comprising a plurality of microneedles (Baker: microneedles 178 in figs. 3-4) disposed on a distal face (Baker: base surface 180 in fig. 4) of a base plate (Baker: microneedle array 170 in figs. 3), wherein the microneedles (Baker: microneedles 178 in figs. 3-4) have a fluidic exit channel (Baker: passageways 208 in fig. 4) defined therein, the microneedles (Baker: 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 (Baker: para [0042]);
a 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) having a distal face (Baker: distal face of distribution manifold 172 in figs. 3-5) coupled to a proximal face of the base plate (Baker: back surface 182 in fig. 4) of the microneedle array (Baker: microneedles 178 in figs. 3-4), the fluidic distribution block comprising a fluid distribution manifold (Baker: distribution manifold 172 in figs. 3-5) defined therein and configured to be fluidically connected (Baker: fluid distribution network 184 in fig. 3) with the fluidic exit channels (Baker: passageways 208 in fig. 4) of the microneedles (Baker: microneedles 178 in figs. 3-4) and to controllably distribute the fluidic composition (Baker: para [0051, 0058]) to the plurality of microneedles (Baker: microneedles 178 in figs. 3-4) through the fluidic exit channels (Baker: passageways 208 in fig. 4); and
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 (Rosenberg: opening 36 in top wall 20 to chamber / reservoir 34 to microneedles in figs. 1, 3; para [0035] and [0042]), 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 fluidic path of the syringe connection assembly fluidically connected to the fluid distribution manifold (Rosenberg: opening 36 in top wall 20 to chamber / reservoir 34 to microneedles in figs. 1, 3; para [0035] and [0042]; connected to Baker’s distribution manifold 172 in figs. 3-5); and
a proximal end (Rosenberg: coupling member 38, Luer lock on top wall 20 in fig. 3; para [0035] and [0042]) configured to be coupled to a syringe barrel having a bore defined therein (Rosenberg: syringe 52 with syringe barrel 56, tip 60 and locked together with Luer lock collar 54 in fig. 3; para [0035] and [0042]), the fluidic path of the syringe connection assembly configured to be fluidically connected to the bore of the syringe barrel (Rosenberg: Luer lock collar 54 threads onto coupling member 38, fluid injects from the barrel through 38 and opening 36 into chamber 34; para [0035] and [0042]).
Rosenberg in view of Baker fails, however, to disclose that the syringe connection assembly comprises 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 ‘8022 teaches that the syringe connection assembly comprises a plenum (Ross ‘8022: plenum component 102 / assembly 16 in figs. 2-6) coupled to and fluidically connected with a tubing connector (Ross ‘8022: cannula 104 in figs. 2, 5; para [0079]); wherein the tubing connector has:
a distal portion coupled to a proximal face of the plenum (Ross ‘8022: lower end of cannula 104 in mount 184 on upper surface 162 of plenum component 102 in figs. 5-6, para [0079]); and
a proximal portion configured to be fluidically connected to the bore of the syringe barrel (Ross ‘8022: upper end of cannula 104 coupling into cartridge assembly 18 in fig. 5, para [0079]; Rosenberg provides the syringe); and the plenum (Ross ‘8022: plenum component 102 / assembly 16 in figs. 2-6) has:
a distal face (Ross ‘8022: lower surface 164 of plenum frame 170 in fig. 12) coupled to the proximal face of the fluidic distribution block (Ross ‘8022: lower surface of plenum stack on assembly 108 / manifold inlet 254 in figs. 6, 19A) and fluidically connected to the fluid distribution manifold (Ross ‘8022: 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 modified Rosenberg in view of Baker to include the plenum and cannula tubing connector, as taught by Ross, in order to provide an intermediate chamber and a tubular coupling from the syringe bore into the distribution manifold.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
/WESLEY G HARRIS/Examiner, Art Unit 3783
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