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
This office action is responsive to the amendment filed on 3/2/26. As directed by the amendment: claims 1, 39, 40, and 45-47 have been amended, claims 3-5, 12, 13, 15-33, 35, 38, 42, and 48-68 have been cancelled, and no new claims have been added. Thus, claims 1, 2, 6-11, 14, 34, 36, 37, 39-41, and 43-47 are presently pending in this application.
Drawings
The drawings were received on 3/2/26. These drawings are accepted. The objections to the drawings from the prior action are withdrawn.
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, 2, 6-11, 14, 34, 36, 37, 39-41, and 43-47 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 independent claim 1, the phrase “flow rate variability of less than 50%” is unclear. It is not clear from what reference parameter the 50% calculation should be measured, or how variability should be applied relative to the other recited limitations.
The remaining dependent claims inherit this deficiency.
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.
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.
Claim(s) 1, 2, 6-11, 14, 34, 39, 41, and 43-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (WO 2018/111620).
Regarding claim 1, as best understood, Ross et al. discloses a device for delivering a fluidic composition across a dermal barrier of a subject (overall device illustrated in fig. 1A; par. 00109), the device comprising: a fluid distribution assembly 108 (fig. 19A) comprising: a base 260; a plurality of protrusions 234 defined on the base, wherein each of the protrusions has a tip 248 and a height (see fig. 19A, described in par. 00109) at a microscale (par. 00109) with a fluidic path 246 defined therein along the height from the base (see fig. 19A); a nanopatterned layer 232 comprising a plurality of nanostructures (nano-imprints, par. 00106) and covering a surface of the plurality of protrusions (see fig. 19A, par, 00105-00106); a gasket comprising a pressure-sensitive adhesive (PSA) layer (additional adhesive layer 242, par. 00106; adhesive layers are pressure-sensitive, see par. 00100, 00102, 00104); a fluidic distribution manifold 238 configured to be fluidically connected with the fluidic path of each of the plurality of protrusions and to controllably distribute the fluidic composition among the plurality of protrusions through the fluidic path of each of the plurality of protrusions (par. 00105; connected to each of the fluidic paths 246); a plenum assembly 16 (fig. 1A-2) slidably coupled to the fluid distribution assembly (illustrated coupled together in fig. 5, and slidability of coupled assembly relative to other components as illustrated at least in fig. 1A-B) and configured to hold the fluidic distribution assembly (fluid distribution assembly illustrated but not labeled in fig. 2 as held by 16); a collet assembly 12 constituting the housing of the device (see fig. 1A-2) and configured to contact a surface of the subject's skin sufficient for penetration of the plurality of protrusions into the surface of the subject's skin and across the dermal barrier (fully capable of performing this function when arranged as shown in fig. 1B); and a controller assembly 20 slidably coupled to the fluid distribution assembly (again see at least fig. 1A-B) and configured to control the flow of the fluidic composition during delivery of the fluidic composition through the plurality of protrusions (via biasing plunger component, par. 00123); wherein the device is capable of controllably delivering the fluidic composition to a location below the dermal barrier at a flow rate of greater than about 0.1 µL/hour per protrusion, or at a flow rate ranging from about 0.1 µL/hour to about 10 µL/hour per protrusion (par. 00186 describes rate ranges of greater than 0.1 µL/hour and describes the device’s capability to vary flow rate based on applied pressure; the device is fully capable of delivering greater than 0.1 µL/hour per protrusion under sufficient pressure); and wherein the device is capable of delivering the fluidic composition with a protrusion to protrusion flow rate variability of less than 50% over at least 75% of the protrusions (par. 0186 describes utilizing a constant flow rate, which anticipates this limitation; additionally, the functionality of the device as described at least in par. 0182-0186 with its adjustability of flow rate parameters results in structures as cited above that are fully capable of performing this claimed function).
Ross et al. also discloses the number of protrusions in the plurality of protrusions in a range from about 10 per square cm to about 1500 per square cm, but does not disclose the size covered or the overall range of protrusions present, and therefore does not disclose a number of protrusions between about 4 to about 3000. There is no evidence of record that establishes that changing the number of protrusions would result in a difference of function of the Ross et al. device. Further, a person having ordinary skill in the art, being faced with modifying the number of protrusions of Ross et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given a number of protrusions within the claimed range. Lastly, applicant has not disclosed that the claimed range of number of protrusions solves any stated problem, indicating that the number of protrusions is from “about” 4 to “about” 3000 (pg. 3) while offering no further instruction or purpose for selection within or outside of the quite large range, and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the density of protrusions disclosed by Ross et al., or choose a density of protrusions within the ranges disclosed by Ross et al., so that the total number of protrusions falls with the claimed range of about 4 to about 3000 as an obvious matter of design choice within the skill of the art.
Regarding claim 2, Ross et al. further discloses the fluid distribution manifold comprising: an inlet channel 264; a plurality of supply channels 256 and resistance channels (par. 00112), wherein each supply channel is connected to a respective resistance channel that facilitates an increase in the resistance to the flow of the fluid (par. 00112); a plurality of outlet channels 258 aligned with and fluidically connected toa corresponding fluidic path of each of the plurality of protrusions (par. 00112).
Regarding claims 6-11, Ross et al. discloses wherein the device is capable of delivering the fluidic composition to a location below the dermal barrier and proximate to the lymphatic system, wherein the dermal barrier comprises the stratum corneum, wherein the dermal barrier comprises a portion of the epidermis, wherein the dermal barrier comprises the entire thickness of the epidermis, and/or wherein the dermal barrier comprises at least a portion of the dermis (par. 00109 and 00182-00185). Furthermore, Ross et al. teaches varying the length of the microneedles to target a specific depth of fluid delivery needed for treatment (par. 00109). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a length of microneedle that would accomplish the desired depth/location of fluid delivery, such as depths/locations as recited in claims 6-11, since Ross et al. teaches doing so (par. 00109). Additionally, it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, the device of Ross et al. is fully capable of delivering the fluidic composition having a bioactive agent in a concentration from about 5 mg/mL to about 100 mg/mL.
Regarding claim 34, Ross et al. discloses the fluidic path of each of the plurality of protrusions has a length and a cross-sectional dimension perpendicular to the length, wherein an aspect ratio of the length to the cross-sectional dimension ranges from about 1 to about 50 (2, 3, or 4, for example; par. 00109).
Regarding claim 39, Ross et al. discloses a cartridge assembly 18 including a reservoir component 270 comprising an upper cavity 272 and an opposing lower cavity 274 coupled together in flow communication with the fluid distribution assembly (par. 00117).
Regarding claim 41, Ross et al. discloses the collet assembly comprising a colllet lock 50 coupled to a collet 22.
Regarding claims 43-44, Ross et al. discloses an attachment band assembly 430 (fig. 36) configured to couple to the collet assembly to facilitate contact with a surface of the subject's skin sufficient for penetration of the plurality of protrusions into the surface of the subject's skin and across the dermal barrier (par. 00142-00148), the attachment band assembly comprising an annular body 432 comprising a wall 434 defining a hollow interior space 435 and a coupling member (attachment apertures 440) configured to engage with a corresponding coupling member of the collet (coupling members 68 of the collet lock 50, par. 00143), and a strap assembly 446,448 removably engaged with the annular body and comprising a hook-and-loop type fastening strap such that in use, the strap is threaded through a portion of the annular body 496 and folded back to tighten the strap around the skin of the subject (par. 00142-00148).
Regarding claims 45 and 46, Ross et al. discloses the controller assembly includes a plunger member 362 (fig. 31) positionable in a range from a first position proximal to the plenum, to a second position distant from the plenum; and a bias assembly 364 positioned between the plenum and the plunger member, the bias assembly being configured to apply a pressure to the plunger member, wherein the pressure applied to the plunger member by the biasing assembly is transmitted to the plenum and facilitates displacing the fluidic composition into the fluidic block (par. 00167-00170).
Claim(s) 36 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. in view of Ross (US 20110270221).
Regarding claims 36 and 37, Ross et al. teaches the device as claimed, including nanostructures comprising a height and cross-sectional dimension, except for specifically disclosing a portion of the nanostructures having one of the characteristics listed in claim 36, and a plurality of additional nanostructures having a cross-sectional dimension less than the cross-sectional dimension of the (earlier recited) nanostructures as required by claim 37. However, Ross, similarly to Ross et al., teaches applying a nanopatterned layer onto a microneedle array (par. 0323). Ross further teaches, regarding claim 37 specifically, an embodiment of nanopatterned layer which includes nanostructures of two different heights, one greater than the other (par. 0243), and regarding claim 36 specifically, a height of 30 micrometers (par. 0243) which falls with the claimed range of 10 nanometers to 30 micrometers. Ross teaches varying a number of parameters of the nanostructures within the scope of ordinary skill in the art (such as par. 0074, 0077), and teaches optimizing these parameters to improve interaction between microneedle and biological surfaces (such as par. 0104-0152, which describe a number of possible relationships that may be influenced by nanostructure design). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Ross et al. nanostructures to have the parameters claimed in claims 36 and 37, as taught by Ross, for the purpose of achieving a desired interaction between microneedle surface and treatment surface to improve interaction therebetween (par. 0104).
Claim(s) 40 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. in view of Garstein et al. (US 6379324).
Regarding claims 40 and 47, Ross et al. teaches the device as claimed, except for the fluid distribution assembly configured to connect fluidically to a reservoir for holding the fluidic composition located exterior of the device, and the controller assembly is configured to couple with an external infusion pump and a tubing system to provide a pressured flow of the fluidic composition from a reservoir for holding the fluidic composition located exterior of the device into the device and through the plenum to the fluidic block. However, Garstein et al. teaches a microneedle array apparatus (fig. 30-31), and teaches that it is known to utilize an external reservoir and pump system to provide fluid dispensing through microneedles (col. 21, ln. 33-39; fig. 31). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Ross et al. microneedle apparatus to utilize an external reservoir and pumping mechanism, as taught by Garstein et al., since this would allow further quantities of fluid to be dispensed through the microneedles as opposed to what is possible with an on-board reservoir (col. 21, ln. 33-39).
Response to Arguments
Applicant’s arguments filed 3/2/26, on pg. 9-10 of the Remarks, with respect to rejection of claim 40 under 35 U.S.C. 112(a) from the previous action, have been fully considered and are persuasive. That rejection is withdrawn.
Applicant's remaining arguments filed 3/2/26 have been fully considered but they are not persuasive. Applicant argues on pg. 10 of the Remarks that Ross et al. does not disclose the newly amended limitation in claim 1. This limitation has been addressed by updated rejection of claim 1, as presented above. Examiner further notes that this amended limitation, as best understood, is not tied to any particular claimed or disclosed structure or structural arrangement, and appears to be disclosed and recited only as a possible method or result of utilizing the device which can be achieved by manipulation during use. Thus, the structure disclosed and taught by Ross et al. is fully capable of being operated to achieve this result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783