DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 13, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the new and amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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) 1, 5, 7-10, 35-36, 40-42, and 44-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cleary (US 2005/0228340) in view of Kwon (6,945,952), and further in view of Saulenas et al. (US 2013/0085449).
Regarding claims 1 and 35-36, Cleary discloses a microneedle patch (1) comprising: a base substrate (layers 10, 11, and 19) having a microneedle side and an opposing back side; an array of dissolvable microneedles extending from the microneedle side (comprising microneedles 19b) of the base substrate; and an indicator (34) connected to the opposing back side of the base substrate, wherein the indicator is configured to provide audible, tactile, and visual signals when a force applied to the patch by a user, in the course of manually applying the patch to a person’s skin to insert the microneedles into the skin, meets or exceeds a predetermined threshold (¶¶ [0072]-[0073]). Cleary fails to explicitly disclose the composition of the microneedles as comprising a substance of interest in a dry solid form and a water-soluble matrix, and the indicator configured to irreversibly change to the signaling configuration even after removal of force from the indicator.
Kwon teaches a microneedle drug delivery device (Figure 12A) comprising one of the claimed substances of interest (Col. 6, line 61-Col. 7, line 39 list drugs and/or other substances which might be considered active; Col. 8, lines 58-62 disclose the drugs formed in the microneedles or perforators), and a water-soluble matrix (Col. 5, lines 9-17) comprising polyvinyl alcohol and/or a sugar (Col. 5, lines 18-34; see also Col. 8, lines 23-34 which disclose forming the perforators from the matrix material with the active drug). Kwon further teaches wherein the substance of interest in a dry solid form (Col. 4, lines 38-49 disclose the step of drying thereby resulting in a dry solid form as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the microneedles of Cleary to comprise the substance of interest and water-soluble matrix as taught by Kwon so as to provide for a system which utilizes rate-controllable dissolving microneedles to deliver a drug to a target site over a desired time period as taught by Kwon. In addition, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the microneedles of Cleary to comprise a dry solid form, such as that taught by Kwon, to provide structure to the microneedles via the drying process so that they may be inserted into the skin as taught by Kwon.
Cleary/Kwon still fail to disclose the irreversible indicator as claimed.
Saulenas et al. (henceforth Saulenas) teaches (Figures 11A-12E) a mechanical force indicator (upper end of housing 11; it’s a housing and latch assembly which is considered “mechanical” as claimed in claim 35) which is configured to provide audible, tactile, and/or visual signals when a force is applied (¶¶ [0058]-[0059]; “The resistance force generated by the engagement of end 73 and detent lobe 71 is felt by the user and provides a key feedback to the user of the force required to activate the device…” and in ¶ [0059], “The user will detect the resistance generated by the interaction of detent peak 72 and front surface 81 which will serve as an indication to the user that full closure and locking of the device is imminent. Once clamp strike peak 79 moves sufficiently downwardly so that detent peak 72 is captured on strike peak 79, this serves to lock device 10 preventing upper housing 11 from being moved upwardly away from lower housing 12 on closing of the device.”; therefore the latch can be considered as the cooperation between 72 and 79 at the locking stage of depression), wherein the indicator is configured to irreversibly change from an initial configuration (e.g., Figure 12A) to a signaling configuration (e.g., when closed and latched as in Figure 12C) upon the force meeting or exceeding the predetermined threshold (¶ [0058]), the change to the signaling configuration remaining irreversible upon removal of the force applied to the device by the user (the inserter remains locked and latched as depicted in Figure 12E after the closing force is removed; see also ¶ [0059]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the indicator element of Cleary/Kwon to comprise the latching engagement configuration of Saulenas so as to provide a means for alerting a user that a force, sufficient to apply the patch, has been applied to the device before locking the device in a use configuration. In this manner, the mechanism of Saulenas allows for locking said device in the installed position during use to reduce the size of the device and provide additional visual indication to the user that the patch has been correctly applied via the engagement of the latch as taught by Saulenas.
Regarding claim 5, Cleary/Kwon/Saulenas further teach (in the cited combination) wherein the indicator is a mechanical force indicator which comprises a button (the housing 11 may be considered a button, absent any substantially limiting structure as to what constitutes “a button”) that is deformed and/or displaced when the force applied to the patch which meets or exceeds the predetermined threshold (¶¶ [0058]-[0059] of Saulenas teaches “The force required to be applied to overcome this resistance results in deflection of latch arm 68 forwardly by peak 72. The user will detect the resistance generated by the interaction of detent peak 72 and front surface 81 which will serve as an indication to the user that full closure and locking of the device is imminent. Once clamp strike peak 79 moves sufficiently downwardly so that detent peak 72 is captured on strike peak 79, this serves to lock device 10 preventing upper housing 11 from being moved upwardly away from lower housing 12 on closing of the device.” ).
Regarding claims 7-8 and 40-42, Cleary/Kwon/Saulenas teach (as above for claims 5 and 35) a force indicator (upper end of housing 11) integrated with another component (e.g., 71, 73 form the latching system which anticipates the snap-in-place or latching mechanisms of claims 8 and 41-42 since the latch “snaps in place” when the latch engages) which is configured to provide audible, tactile, and/or visual signals when a force is applied (¶ [0058]; “The resistance force generated by the engagement of end 73 and detent lobe 71 is felt by the user and provides a key feedback to the user of the force required to activate the device…”), wherein the indicator is configured to irreversibly change from an initial configuration (e.g., Figure 12A) to a signaling configuration (e.g., when closed and latched as in Figure 12C) upon the force meeting or exceeding the predetermined threshold (¶ [0058]), the change to the signaling configuration remaining irreversible upon removal of the force applied to the device by the user (the inserter remains locked and latched as depicted in Figure 12E after the closing force is removed; see also ¶ [0059]).
Regarding claim 9, Cleary further discloses wherein the delivered substance is a vaccine (¶ [0052]; see also Kwon e.g., Col. 8, lines 18-19 for disclosure of using a vaccine as the active drug).
Regarding claims 10 and 46, Cleary further discloses wherein the solid microneedles have a height from about 100 um to 2000 um (¶ [0041] sets forth wherein the microneedles have a height from 20 — 500 microns which is within the claimed range).
Regarding claim 44, Kwon further teaches that the substance of interest is an active pharmaceutical ingredient (Col. 6, line 61-Col. 7, line 39 disclose a variety of substances which might be considered “active”; see also Col. 8, lines 23-34 for disclosure of including active drugs in the perforators).
Regarding claim 45, Cleary further discloses wherein the substance of interest is a vaccine (¶ [0052]; see also Kwon at Col. 8, lines 18-19 for disclosure of using a vaccine as the active drug).
Regarding claim 47, Saulenas discloses that the another component is a latch (upper end of housing 11; it’s a housing and latch assembly which is considered “mechanical” as claimed in claim 35) which is configured to provide audible, tactile, and/or visual signals when a force is applied (¶¶ [0058]-[0059]; “The resistance force generated by the engagement of end 73 and detent lobe 71 is felt by the user and provides a key feedback to the user of the force required to activate the device…” and in ¶ [0059], “The user will detect the resistance generated by the interaction of detent peak 72 and front surface 81 which will serve as an indication to the user that full closure and locking of the device is imminent. Once clamp strike peak 79 moves sufficiently downwardly so that detent peak 72 is captured on strike peak 79, this serves to lock device 10 preventing upper housing 11 from being moved upwardly away from lower housing 12 on closing of the device”; therefore the latch can be considered as the cooperation between 72 and 79 at the locking stage of depression).
Claim(s) 2-4 and 37-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cleary in view of Kwon in view of Saulenas, and further in view of Eckenhoff et al. (US 4,756,314).
Regarding claims 2-3 and 37-38, Cleary/Kwon/Saulenas teach the claimed invention substantially as set forth above for claim 1, and further discloses an adhesive layer (24, ¶ [0037]) for attaching the patch to the skin, but fail to explicitly disclose the handle layer affixed to the base substrate and comprising an elongated tab portion extending laterally away from a side of the microneedles.
Eckenhoff et al. (henceforth Eckenhoff) teaches (Figure 4) a device (20) comprising a handle (skin attachment portion of layer 26) layer affixed to the base substrate (Figure 4; it’s attached on one edge to the base and the other to the skin of the patient) and including an elongated tab portion (portion of layer extending radially outwardly from the base) extending laterally away from a base substrate (skin adjacent flanged portion of 20) configured for manual manipulation of the patch (it can be held and secured to the skin); and an adhesive layer which comprises a first adhesive composition disposed between and securing together the base substrate and the handle layer (adhesive securing layer 26 to the base; Figure 4), and a second adhesive composition disposed on the handle layer beyond the base substrate and configured to releasably secure the patch to the skin (portion of layer 26 attached to skin; Col. 7, lines 28-45; Figure 4).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the microneedle device of Cleary/Kwon/Saulenas to comprise a handle layer feature such as that taught by Eckenhoff so as to allow a user to manipulate the patch at the skin site while providing the utility of facilitating assembly of the device and increasing the potential use cases of the device in a commercial environment as taught by Eckenhoff (Col. 7, lines 28-45).
Regarding claims 4 and 39, Cleary/Kwon/Saulenas/Eckenhoff disclose the use of adhesives for layers of the patch device, but fail to disclose different coefficients of adhesion between the handle layer and base as compared to the handle layer and skin. Cleary discloses that the adhesive is used to connect the different layers of the patch body together prior to use and Eckenhoff teaches attaching the handle to the base as well as the skin. There is no evidence of record that establishes that modifying the coefficients of adhesion between the body and handle or between the handle and skin would result in a difference in function of the device of Cleary/Kwon/Saulenas/Eckenhoff. Furthermore, one of ordinary skill in the art, being faced with modifying the device of Cleary/Kwon/Saulenas/Eckenhoff would have a reasonable expectation of success in making such a modification as it appears the device would function as intended given the claimed adhesive coefficients. Lastly, applicant has not disclosed that the claimed coefficients solve any stated problem (other than removal of the patch from the skin without removing the handle from the base), indicating that the coefficient of adhesion “may” be different between the claimed portions (see e.g., page 8, lines 3-18 of the filed disclosure or ¶¶ [0036]-[0037] of the published application) and therefore there appears to be no criticality placed on the claimed coefficients of adhesion such that they produce an unexpected result. On the contrary, one of ordinary skill would be motivated to use a stronger adhesive between the handle and base as opposed to that between the handle and skin so as to prevent delaminating of the handle layer from the base during placement or removal of the device from the skin). Therefore, it would have been obvious to one of ordinary skill in the art to adhere the handle to the base more firmly than the handle to the skin so as to allow the handle and base to be removed together after the patch is placed at the target location.
Claim(s) 6 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cleary in view of Kwon in view of Saulenas, and further in view of Glenn et al. (US 2007/0088248).
Regarding claims 6 and 43, Cleary/Kwon/Saulenas teach the claimed invention substantially as set forth above for claims 5 and 35, and Cleary further discloses that the force gauge (34) may be a separate attachment to the layer 10 (see ¶ [0071]), but Cleary/Kwon fail to explicitly disclose a snap dome disposed inside a housing.
Glenn et al. (henceforth Glenn) teaches (Figures 1A-1B) a snap dome (Figure 1A; ¶ [0021]) disposed in a housing (it is retained between the upper and lower handle portions thereby creating a housing for the snap dome itself).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the snap dome force indicating means of Glenn as the mechanical force indicator of Cleary/Kwon/Saulenas so as to alert a user that a minimum amount of pressure required to insert the microneedles has been applied to the device as taught by Glenn (¶ [0021]) and as contemplated by Cleary/Kwon as set forth above. In such a combination, the force indicator of Cleary would be modified to the snap dome of Glenn before being applied into the latching housing assembly of Saulenas. This way, the housing can be compressed, which would force the snap dome to deform, and cause the audible click verifying that the desired amount of force has been applied to the device. After such a step, the latching element of Saulenas would engage, to provide the means of retaining the housing in the final configuration, with the snap dome remaining in the deformed state as the housing portions are locked together to prevent it from returning to its initial state.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783