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 11/20/2025. As directed by the amendment: Claims 1 and 28 have been amended, claims 6, 11, 13, 15, and 18-26 have been cancelled, and no claims have been added. Thus, claims 1-5, 7-10, 12, 14, 16-17, and 27-34 are presently pending in the application.
Response to Arguments
Applicant’s arguments, see pages 7-11, filed 11/20/2025, with respect to the rejection of the claims have been fully considered and are persuasive. The amendments to the independent claims overcame the previous rejection; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Gilbert (US 10076649).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the limitation "the skin" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites “the rigid movable portion” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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.
Claims 1-5, 7-10, 12, 14, 16-17, and 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert (US 10076649); in view of Windmiller (US 2022/0031244).
Regarding Claim 1, Gilbert discloses apparatus (Fig.7) for contacting one or more projections to the skin of a subject for an extended period, the apparatus comprising: one or more electrodes (112; Fig.4), each configured to penetrate the skin (lines 22-24 in column 5); a skin contacting portion defining a skin contacting surface (216) (lines 26-29 in column 12) and one or more spaces (space within sidewalls 211-213 Fig.9A) allowing the one or more electrodes to extend therethrough (Fig.9A); a rigid movable portion (110) configured to move the one or more electrodes from a first position (Fig.9A) behind the skin contacting surface (lines 4-12 in column 15) to a second position (Fig.9B) proud of the skin contacting surface (lines 30-44 in column 15); a housing (201) surrounding the one or more electrodes (112) when the rigid movable portion is in the first position (Fig.9A); and a deformable portion (217) which is connected to and extends inwardly from the housing (Figs.7-8) and is configured to engage with the movable portion (110) so as to prevent movement the movable portion (110) from the first position (Fig.9A) toward the second position (Fig.9B) (lines 4-12 in column 15), but upon application of a sufficient force to the movable portion or the deformable portion the deformable portion (217) deforms to allow movement of the movable portion (110) toward the second position (Fig.9B), and in moving toward the second position the movable portion disengages from the deformable portion (lines 30-44 in column 15).
Gilbert does not explicitly disclose that the electrodes are sensor electrodes.
Windmiller teaches it was known in the art to have a microneedle array 140 with electrode that include one or more electrochemical sensors (electrodes) (lines 11-15 in parag. [0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gilbert to incorporate the teachings of Windmiller to have a sensor electrode in order to measure analytes within the skin (lines 11-15 in parag. [0060]).
Regarding Claim 2, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the movable portion (110) is movable along a generally arcuate path from the first position to the second position (the movable portion 110 is movable along an arcuate/curved path as seen in Figs.9A-B).
Regarding Claim 3, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the movable portion (110) has a connected end (130) and a free end (120), and the free end travels a greater distance than the connected end (Figs.9A-B).
Regarding Claim 4, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the movable portion (110) is associated with a mounting portion (206 c and 207; Fig.7), and wherein, in use, the mounting portion is stationary, and the movable portion is movable relative to the mounting portion (Figs.9A-9B).
Regarding Claim 5, Gilbert as modified discloses the apparatus of claim 4, and further discloses wherein the mounting portion comprises a portion allowing the movable portion to pivot (lines 3-19 in column 13), hinge, flex or attach.
Regarding Claim 7, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the sufficient force is directed generally toward the skin contacting portion (lines 30-44 in column 15).
Regarding Claim 8, Gilbert as modified discloses the apparatus of claim 1, and further discloses comprising a locking portion (211a and 212 a) configured to lock the movable portion when in the second position (lines 59-64 in column 13).
Regarding Claim 9, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the one or more sensor electrodes (112) is/are mechanically connected directly or indirectly to the moving portion (110) (Fig.4).
Regarding Claim 10, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the one or more sensor electrodes (112) is/are wire(s), needle(s), and/or microneedle(s) of sufficient length so as to be contactable with the epidermis, the dermis (lines 52-56 in column 10), or the hypodermis of the subject.
Regarding Claim 12, Gilbert as modified discloses all the limitations of claim 1 above.
Gilbert does not appear to disclose one or more sensor electrodes is/are each electrically conductive and the apparatus further comprises a circuit having an audio, visual or tactile indicator, the circuit configured to actuate the indicator when the one or more sensor electrodes are in contact with an electrically conductive fluid naturally present in the skin.
Windmiller teaches it was known in the art to have an apparatus comprising one or more electrically conductive sensor electrodes (microneedle array 140 includes an electrode 520 on each microneedle 510, wherein the electrode is connected to an electrically conductive pathway; fig. 5B, [0087], [0092)), wherein the apparatus further comprises a circuit (circuit required for controlling indicator lights of a user interface; fig. 831A, [0056], [0075], [0084]) having a visual indicator (3124a-c; fig. 31A, [0084]), the circuit configured to actuate the indicator when the one or more sensor electrodes are in contact with an electrically conductive fluid naturally present in the skin (indicator lights may be actuated to indicate information representative of analyte measurement, which occurs when electrodes 520 of microneedle array 140 is in contact electrically conductive fluid present in the skin; [0084], [0056], [0064]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson to incorporate the teachings of Windmiller to have a circuit having an audio, visual or tactile indicator, the circuit configured to actuate the indicator when the one or more sensor electrodes are in contact with an electrically conductive fluid naturally present in the skin in order to allow a user to receive information regarding measurements from said sensor electrodes (Windmiller [0084] - an indicator light can be actuated to indicate information representative of analyte measurement).
Regarding Claim 14, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the movable portion (110) is supported in the first position by the deformable portion (217) (Fig.9A).
Regarding Claim 16, Gilbert as modified discloses the apparatus of claim 1, and further discloses wherein the movable portion (110) is in hinged association with the skin contacting portion (216/201) (lines 59-60 in column 3).
Regarding Claim 17, Gilbert as modified discloses the apparatus of claim 16, and further discloses wherein the hinge (110 a) is disposed at or toward a peripheral region of the movable portion (110) and the skin contacting portion (216/201) (Fig.9A) (lines 59-60 in column 3 and lines 13-19 in column 13).
Regarding Claim 27, Gilbert as modified discloses the apparatus of claim 1, and further discloses configured such that the movable portion (110) is prevented from:(i) moving upwardly from the first position (Fig.9A) and away from the skin contacting surface (via engagement between ledge 217 b and the carrier head 120) (lines 7-12 in column 15), (ii) travelling outside a shortest or a most direct path between the first position (Fig.9A) and the second position (Fig.9B) (path between upper 202 and lower 201 housing portions), and (iii) once in the second position (Fig.9B) moving in a direction toward the first position (Fig.9A) (via ridge portions 211a and 212 a) (lines 59-64 in column 13).
Regarding Claim 28, Gilbert discloses apparatus (Fig.7) for contacting one or more projections to the skin of a subject for an extended period, the apparatus comprising: one or more electrodes (112; Fig.4), each configured to penetrate the skin (lines 22-24 in column 5); a skin contacting portion defining a skin contacting surface (216) (lines 26-29 in column 12) and one or more spaces (space within sidewalls 211-213 Fig.9A) allowing the one or more electrodes to extend therethrough (Fig.9A); a movable portion (110 and 230) having first (130) and second ends (120) with a deformable region (230) therebetween (Figs.9A-B) (since the bight portion 238 is engaged with carrier head 120) (lines 39-41 in column 13), the movable portion (110) being configured to move the one or more electrodes (112) from a first position (Fig.9A) behind the skin contacting surface (lines 4-12 in column 15) to a second position (Fig.9B) proud of the skin contacting surface (lines 30-44 in column 15); a housing (201) surrounding the one or more electrodes (112) when the rigid movable portion is in the first position (Fig.9A); and a support member (217) connected to and extending inwardly from an inner surface of the housing (Figs.7-8); wherein the support member (217) is configured to engage with the movable portion (110) so as to prevent movement of the movable portion (110) from the first position (Fig.9A) toward the second position (Fig.9B) (lines 4-12 in column 15), but upon application of a sufficient force to the deformable region (230) the movable portion deforms (displacing/releasing/actuating deformable region/spring 230) allowing the movable portion (110) to move toward the second position (Fig.9B), and in moving toward the second position the movable portion (110) disengages from the support element (217) (lines 20-44 in column 15).
Gilbert does not explicitly disclose that the electrodes are sensor electrodes.
Windmiller teaches it was known in the art to have a microneedle array 140 with electrode that include one or more electrochemical sensors (electrodes) (lines 11-15 in parag. [0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gilbert to incorporate the teachings of Windmiller to have a sensor electrode in order to measure analytes within the skin (lines 11-15 in parag. [0060]).
Regarding Claim 29, Gilbert as modified discloses the apparatus of claim 28, and further discloses wherein the movable portion (110) is movable along a generally arcuate path from the first position to the second position (the movable portion 110 is movable along an arcuate/curved path as seen in Figs.9A-B).
Regarding Claim 30, Gilbert as modified discloses the apparatus of claim 28, and further discloses wherein the movable portion (110) comprises a connected end (130) and a free end (120), and the free end travels a greater distance than the connected end (Figs.9A-B).
Regarding Claim 31, Gilbert as modified discloses the apparatus of claim 28, and further discloses wherein the movable portion (110) is associated with a mounting portion (206 c and 207; Fig.7, and wherein, in use, the mounting portion is stationary, and the movable portion is movable relative to the mounting portion (Figs.9A-9B).
Regarding Claim 32, Gilbert as modified discloses the apparatus of claim 28, and further discloses wherein the sufficient force is directed generally toward the skin contacting portion (lines 30-44 in column 15).
Regarding Claim 33, Gilbert as modified discloses the apparatus according to claim 1, and further discloses wherein the housing (201) is stationary relative to the skin contacting portion (the skin contacting portion/surface 216 is part of housing 201 wherein housing 201 is stationary as seen in Figs.9A-B).
Regarding Claim 34, Gilbert as modified discloses the apparatus according to claim 28, and further discloses wherein the housing (201) is stationary relative to the skin contacting portion (the skin contacting portion/surface 216 is part of housing 201 wherein housing 201 is stationary as seen in Figs.9A-B).
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 TANIA M ISMAIL whose telephone number is (313)446-6625. The examiner can normally be reached Monday-Thursday 8:00-3:30 pm.
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/T.I./ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783