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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 July 2026 has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021/113343 to Ross (Ross hereinafter, copy provided by applicant on 12/22/2025).
Regarding claim 1, Ross teaches a delivery device for delivery of medical agent to a biological barrier comprising:
a main body (12) including a central region defining a receptacle (24), a peripheral region defined by a number of petal members (48 or separated lower sections of collet 22), and a set of retention tabs (113) extending into the receptacle;
a reservoir (16, 18) including
at least one delivery sharp (14),
a main interior volume (272), and
at least one septum (322) in fluid communication with the main interior volume, the reservoir coupled to the main body via the retention tabs;
an adhesive (192) coupled to the main body; and
at least one bias member (370) positioned within the receptacle between the reservoir and a wall (400) of the receptacle.
Regarding claim 2, Ross teaches that the bias member is configured to distort upon transition of the main body from a first state (Fig. 2A) to a second state (Fig. 2B), the bias member configured to restore against the reservoir urging fluid out of the at least one delivery sharp once distorted by transition of the main body from the first to the second state (page 40, ln. 30 through page 41, ln. 13), the reservoir configured to displace toward the biological barrier (as shown in Fig. 2B) as the main body transitions from the first state to the second state.
Regarding claim 3, Ross teaches a wall (286) including a collapse facilitator (upper portion shown compressed in Fig. 2B).
Regarding claim 6, Ross teaches a guard (320, Fig. 22) comprising a septum (326) and a fluid pathway (274) from the main interior volume to the septum.
Regarding claim 7, Ross teaches a septum (326) including a plug portion (322) sealed with an aperture (274) through a rigid portion (278).
Regarding claim 8, Ross teaches a rigid portion (278) and a flexible portion (280), as well as a septum (322) with a first section (324) in a passage (272) through the rigid portion (278) and a second section (322) having a recessed channel (326) configured to block displacement of the flexible portion (280) into the channel at least by maintaining fluid pressure which holds the flexible portion away from the rigid portion.
Regarding claim 10, Ross teaches that the main body (12) is formable by or indistinguishable from a body formed by side action free injection molding. There is no evidence of record indicating that this method of making the apparatus produces a patentable distinction in the structure of the apparatus.
Claim(s) 11, 13, and 15-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 03/084598 to Wilkinson et al. (Wilkinson, copy provided by applicant on 12/22/2025).
Regarding claim 11, Wilkinson teaches a method of delivering an agent, comprising
affixing (with adhesive 66) to a surface (70) a delivery device (10) including at least one delivery sharp (36) coupled to a collapsible reservoir (22, 74) containing the agent;
applying pressure, or force, on the delivery device to transition first (23, 52, 64) and second (48) portions of a main body (23, 48, 52, 64) of the delivery device to respective distorted states, penetrate the surface with the at least one delivery sharp, and initiate collapse of the reservoir to force the agent out of the at least one delivery sharp (paragraph 58); and
relieving pressure (at least upon removal of the device, per “removably attached” in paragraph 44) on the delivery device to allow the first portion of the delivery device to at least partially restore from its distorted state and lift the surface, at least via friction with the delivery sharps (36).
Regarding claim 13, Wilkinson teaches contacting the surface (70) with a protrusion (30) from the reservoir after the delivery sharp has penetrated.
Regarding claim 15, Wilkinson teaches that collapse of the reservoir (at 74) occurs simultaneously with restoration of the first portion (23, 52 64) which will flex under the pressure exerted by the first portion.
Regarding claim 16, Wilkinson teaches an array of microneedles (36).
Regarding claim 17, Wilkinson teaches transitioning the second portion (48) from a protruding state (Fig. 6) to an indented state (Fig. 5, indented relative to inner surface 50).
Regarding claim 18, Wilkinson teaches a delivery device (10) for delivering fluid into a biological barrier (70) comprising:
a main body (12) including a peripheral region with a plurality of petal members (64); and
a reservoir (22) coupled to the main body including at least one delivery sharp (36); and
wherein the main body is configured to transition between a first state (Fig. 6) and a second state (Fig. 5), the petal members configured to stretchingly distort from an initial state, to an intermediate state, and at least partially restore from the intermediate state at any time, including as the main body transitions from the first state to the second state.
Regarding claim 19, Wilkinson teaches a protuberance (30) as the reservoir displaces along a vertical displacement path.
Regarding claim 20, Wilkinson teaches that reservoir is partly collapsible (at 48).
Regarding claim 21, Wilkinson teaches adhesive (66) and configuration for spreading displacement of the petal members by their formation from flexible polymeric film (paragraph 53).
Regarding claim 22, Wilkinson teaches that the petal members are substantially flat (see e.g. Fig. 6).
Regarding claim 23, Wilkinson teaches a constant, perpendicular angle to a vertical center axis of the device and a concave curvature leading to and attached to the central region of the main body.
Regarding claim 24, as shown in Fig. 3, the curved segment is intermediate first and second flat regions (upper and lower edges) of the petal members (64).
Regarding claim 25, Wilkinson teaches that the peripheral edge of the delivery device is defined by the outermost edges of the petal members, the outermost edges being able to curve along a skin path other than that defined by a constant radius extending from a point along the center axis of the delivery device.
Regarding claim 26, Wilkinson teaches that the main body includes a central region (16) formed integrally with the peripheral region, the central region including a portion (48) configured to flip from a protruding state (Fig. 6) to a depressed state (Fig. 5, depressed from inner surface 50) as the delivery device transitions from the first state to the second state, and wherein the delivery device further comprises a bias member between the reservoir and the portion, the bias member configured to distort when the portion is flipped to the depressed state.
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.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross in view of Wilkinson.
Regarding claim 4, Ross teaches the limitations of claim 1 as discussed above, and further teaches that diverse bias elements may be used, including “resilient elements” broadly (page 39, ln. 11), as well as hollow bias members (e.g. 370). Ross does not explicitly teach elastomeric materials. Wilkinson, as noted above, teaches another delivery device generally, and particularly teaches that resilient bias may be provided by elastomeric materials (paragraph 51). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the hollow bias member of Ross formed from an elastomeric material as taught by Wilkinson in order to provide the desired resilience.
Regarding claim 5, Ross teaches two bias tiers (366, 370) which are concentric and therefore have differing footprint areas.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross in view of US Pre-Grant Publication 2015/0320990 to Burton et al. (Burton).
Regarding claim 9, Ross teaches the limitations of claim 1 as discussed above, but does not teach the use of vaccines in the delivery device. Burton teaches another delivery device generally, and particularly teaches that such devices may be used to provide vaccines (paragraph 59) which have known prophylactic properties. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to fill the reservoir of Ross with a vaccine as taught by Burton in order to take advantage of the prophylaxis offered thereby.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson in view of US Pre-Grant Publication 2005/0261631 to Clarke et al. (Clarke).
Regarding claims 14 and 19, the previously applied references teach the limitations of claims 11 and 18 from which claim 14 and 19 respectively depend, but do not teach a marking protrusion. Clarke teaches a marking protrusion (270) which allows marking of locations where microneedles have pierced the skin (paragraph 87). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a marking protrusion as taught by Clarke to the device of Wilkinson in order to mark where the stratum corneum has been pierced.
Response to Arguments
Applicant’s arguments, see page 6, filed 6 July 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and 103 have been fully considered but are not persuasive.
With respect to the argument that Ross does not teach the elements of claim 1, the examiner is not persuaded. First, the recitations of “a main body” including “a receptacle” and “a set of petal members” is broad in scope. The examiner reads a receptacle as synonymous with any opening capable of receiving another element, which Ross clearly teaches (24). Petal members are read as synonymous with any set of members extending in a longitudinal or transverse direction, which scope includes the mapped elements as discussed above. Finally, Ross teaches that the retention tabs (113 in Fig. 8, also shown at their ends 122 in Fig. 5) extend into the noted receptacle. Accordingly, the examiner cannot agree that the broadest reasonable interpretation of the independent claims patentably distinguishes the claimed invention from Ross. Furthermore, regarding the bias member, applicant argues that the bias member (370, see Fig. 23) is absent from a listing of elements defining the receptacle. First, the bias member is not functionally limited: only the position of the bias element is specified. As shown in Fig. 23, the bias member is part of the assembly (20) which is inserted into the receptacle as shown in Fig. 2B, where it is located between any given radial section of the reservoir and a diametrically opposed section of the wall.
With respect to Wilkinson, the applicant argues that no single force transitions portions to distorted states while also penetrating the surface and initiating collapse of the reservoir. However, the examiner notes that the application of force is not limited and the claim is open ended. Accordingly, at the least, the claimed force may include an application force and an inflation force (i.e. from 72, see Fig. 5). In other words, the broadest reasonable interpretation of claim 11 includes applying a first force to distort, a second force to penetrate, and a third force to initiate collapse, and these forces need not be applied in that order or simultaneously. Regarding the distortion, Wilkinson clearly shows the distortion of the bulb (48, see Figs. 5 and 6), and sufficient force to produce a visible level of deformation will at least minimally distort the housing as well. Alternatively, the limitations of “portions” may be read to include multiple sections of the bulb (48) itself.
With respect to the petals of Wilkinson, applicant argues that the petals (64) are not “part of… item 12”. However, as is clearly illustrated, Wilkinson teaches a single assembled device, and therefore the entire apparatus may be considered to constitute the main body, including the petals (64). Regarding configuration of the petals, they are capable of being deformed by the user at any desired point. This configuration therefore does not require structure in addition to that taught by Wilkinson.
In view of the above, the examiner maintains that the claimed invention is unpatentable as currently drafted.
Conclusion
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 5 September 2026
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