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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
This office action is responsive to the amendment filed 18 November 2025. As directed by the amendment: claims 1-11 remain pending in this application. The amendments to claim 11 have overcome the previous claim objection. The amendments to claims 1-11 have overcome the previous 112(b) rejection.
Response to Arguments
Applicant's arguments filed 18 November 2025 have been fully considered but they are not persuasive.
Applicant argues that the vent hole of Wakamatsu cannot be combined with Roberts and further, the vent hold is used in a different process than the claimed invention, specifically, during a molding and drying stage. The language used in claim 1 regarding the vent hole does not specifically point to the vent hole being anything more than a hole that allows flow. The claim language is specifically functional in regards to the vent hole being used for renewing air in the device. Additionally, the vent hole of Wakamatsu is also functionally the same in the fact that is a hole that allows for the renewal of air to a device and when the vent hole is applied to the device does not matter, the hole is present on the device and is formed as a part of the device at one point in time. The vent hole of Wakamatsu does not prohibit combination with Roberts because, as stated above, it is a hole that allows for air flow, the context of being for manufacturing does not prevent the hole from allowing air flow.
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) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al. (US 2018/0362334) in view of Wakamatsu et al. (US 2017/0057124).
Regarding claim 1, Roberts discloses a sensor for a body monitoring system (Fig. 1-5, Fig. 12) comprising: at least one substrate (¶[0052]), 12) intended to come into contact with the skin (¶[0052]) and at least one microneedle (¶[0054], Fig. 5, 26), the microneedle mounted fixedly on the substrate (¶[0052], [0054], where the face 12 “gives rise to a row of microneedles” in para 52 and the microneedles in figures 4-5 are shown) and comprises a base, wherein the substrate comprises an open channel surrounding the base of the microneedle (¶[0054], Fig. 5, where there are multiple open channels at the base of the microneedles), the microneedle having a central axis of symmetry and the open channel having a minimum height (h) in a direction of the central axis of symmetry greater than 20 µm (¶[0029], [0054], [0056], [0059], [0062], where there is variable depths for the microneedles insertion and subsequently the channel minimum height as well) and having a minimum width greater than 200 µm in a radial direction to the central axis (¶[0029], where the ridge spacing for the microneedles includes the channel spacing and can be between 100 to 1000 microns meaning that 200 would be included), the channel forming a cavity in which the microneedle is housed (Fig. 12a-b, where the microneedles are housed in at least a cavity that is not flat to the face of the frame),
Roberts does not specifically disclose the substrate comprising at least one open passage formed in the substrate and ensuring a connection between the channel and the outside so as to renew the air surrounding the base of one or more microneedles.
Wakamatsu teaches an absorption sheet for transdermal use. Wakamatsu teaches the substrate comprising at least one open passage formed in the substrate and ensuring a connection between the channel and the outside so as to renew the air surrounding the base of one or more microneedles (¶[0147], where there is a vent hold in the mold 13 to allow vapor to pass through but not water, the vent hole is used to stabilize air flow in the device). The vent hold used in Wakamatsu ensures that the device is not an enclosed space and allows air flow for the device. By modifying the device of Roberts to include a vent hole, it would allow the device to transport air out of the device and would give ventilation to the device.
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Roberts to include a vent hold (¶[0147] from Wakamatsu) that allows for air passage in the device.
Regarding claim 2, Roberts in view of Wakamatsu teaches sensor according to claim 1, wherein the channel has a minimum height (h) in the direction of the central axis greater than 100 µm (¶[0056], [0059], where the depth is greater than 100 microns at each presented instance).
Roberts does not specifically disclose wherein the channel has a minimum width greater than 1000 µm in a radial direction to the central axis of symmetry, the channel forming a cavity in which the microneedle is housed.
Roberts discloses that the distance between the microneedles in the array can be optimized to have a greater distance on etching (¶[0029], [0062]). As disclosed in paragraphs 29 and 62, the spacing of the array of needles by the channels formed can be smaller or greater based on the necessary distance required meaning that this feature is disclosed to be a result effective variable in that changing the distance and depth of the microneedles allows for better skin penetration, reduced breakage of needles, and better targeted delivery depth. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Roberts device within the claimed range, as it involves only adjusting the dimension of a component disclosed to allow for adjustment. 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 device of Roberts to have a minimum width greater than 1000 µm as a matter of routine optimization since 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 3, Roberts in view of Wakamatsu teaches the sensor according to claim 1, Roberts further teaches wherein the substrate has a general shape of a ring having a central orifice and the passage connects the open channel of each microneedle to the central orifice (Fig. 12b, where the array has a cavity that has a lowered section that connects the channel portion of the device to the overall frame as shown in the Fence and Frame distinctions).
Regarding claim 4, Roberts in view of Wakamatsu teaches the sensor according to claim 3,
Wakamatsu does not specifically disclose wherein the passage can have a minimum height in the direction of the central axis greater than 100 µm and has a minimum width greater than 100 µm in a transverse direction to the central axis.
There is no evidence of record that establishes that changing size of the vent hole in Wakamatsu would result in a difference in function of the device. Further, a person having ordinary skill in the art, being faced with modifying the vent hole of Wakamatsu, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the width and height. Lastly, applicant has not disclosed that the claimed range solves any stated problem 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 vent hole of Wakamatsu to have a minimum height in the direction of the central axis greater than 100 µm and has a minimum width greater than 100 µm in a transverse direction to the central axis.
Regarding claim 5, Roberts in view of Wakamatsu teaches the sensor according to claim 1, Roberts further teaches wherein the support substrate comprises one opening connecting at least two channels, each channel surrounding the base of at least one microneedle (Fig. 12b, where the cavity that is shown has two sides that form channels and are connected by the surrounding area in said cavity).
Regarding claim 6, Roberts in view of Wakamatsu teaches the sensor according to claim 1, Wakamatsu further teaches wherein the substrate comprises at least one open passage common to at most two hundred microneedles , advantageously at most sixteen microneedles and preferentially at most eight microneedles (Fig. 19, where there are at least 8 microneedle recesses shown and a single vent hole for 13 is being used for the air ventilation process is being used).
Regarding claim 7, Roberts in view of Wakamatsu teaches the sensor according to claim 1, Wakamatsu further teaches comprising at least one passage connecting the channel to the outside and comprising a barrier of semipermeable material, i.e., impermeable to water and permeable to air (¶[0147], where the barrier used in the vent hole for 13 is water vapor permeable and not specified as water permeable).
Regarding claim 8, Roberts in view of Wakamatsu teaches the sensor according to claim 1, Wakamatsu further teaches comprising at least one passage connecting the channel to the outside, said passage having a section designed to prevent the entrance of water by capillary repulsion (¶[0147], where the vent hole for 13 is designed to allow vapor to pass through but not designed to allow a liquid to flow in either direction).
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al. (US 2018/0362334) in view of Wakamatsu et al. (US 2017/0057124) as applied to claim 1 above, and further in view of Heikenfeld (US 2021/0364464).
Regarding claim 9, Roberts in view of Wakamatsu teaches a body monitoring system comprising a sensor according to claim 1, however, Roberts in view of Wakamatsu does not specifically teach the body monitoring system comprising a module configured to exploit an electrical signal issued by the sensor and provide information representative of an analyte.
Heikenfeld teaches a sensing device for detecting analyte in a solution. Heikenfeld teaches comprising a module configured to exploit an electrical signal issued by the sensor and provide information representative of an analyte (¶[0028]-[0029], where the sensing device senses analyte and uses and electrode for the sensing process). By modifying the combined device of Roberts in view of Wakamatsu to include an analyte sensor, it would improve the functionality of the device by providing relevant information on the body when certain solution are present (¶[0003]-[0004] from Heikenfeld).
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the combined device of Roberts and Wakamatsu to include an electrically operated analyte sensor (¶[0028]-[0029] from Heikenfeld).
Regarding claim 10, Roberts in view of Wakamatsu and further in view of Heikenfeld teaches the body monitoring system according to claim 9, Roberts further teaches comprising at least one opening connecting the at least one channel to the outside of the system (Fig. 12b, where the fencing portion is open and allows for external communication of the cavity system to the external portion of the system through the ridges formed).
Regarding claim 11, Roberts in view of Wakamatsu does not specifically teach a method for body monitoring comprising a step in which a sensor for the body monitoring system according to claim 1 used.
Heikenfeld teaches a sensing device for detecting analyte in a solution. Heikenfeld teaches comprising a module configured to exploit an electrical signal issued by the sensor and provide information representative of an analyte (¶[0028]-[0029], where the sensing device senses analyte and uses and electrode for the sensing process). By modifying the combined device of Roberts in view of Wakamatsu to include an analyte sensor, it would improve the functionality of the device by providing relevant information on the body when certain solution are present (¶[0003]-[0004] from Heikenfeld).
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the combined device of Roberts and Wakamatsu to include an electrically operated analyte sensor (¶[0028]-[0029] from Heikenfeld).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783