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
The amendments filed 13th May 2026 have been entered. Claims 1-20 are pending. Claim 20 has been withdrawn from consideration.
Response to Arguments
Applicant' s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first slot and second slot must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 6, 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 9987427 B1 to Polsky et al. (hereinafter, Polsky) in view of US 20190231263 A1 to Ribet et al. (hereinafter, Ribet).
Regarding Claim 1, Polsky discloses a wearable interstitial fluid (ISF) sensing device (Polsky: Abstract; Col. 1, lines 55-65) comprising:
a first patch layer (Polsky: Col. 13, lines 32-47); and
an electronics module component layer laminated to said first patch layer to form a patch component (Polsky: Col. 13, lines 32-47; Col. 5, lines 50-67) and
a plurality of microneedles extending from said patch component (Polsky: Col. 13, lines 32-47; Col. 5, lines 50-67),
said electronics module component layer comprising a substrate and at least one sensor positioned on said substrate (Polsky: Col. 13, lines 32-47),
each microneedle of said plurality of microneedles comprising: a microneedle base extending from said patch component (Polsky: Col. 9, lines 30-46; Note: the base of the microneedle.; Col. 5, lines 50-67);
a body extending from said microneedle base (Polsky: Col. 9, lines 30-46; Fig. 2),
said body defining a slot extending through said first patch layer of said body (Polsky: Col. 9, lines 30-46; Fig. 2; Note: Inner lumen),
the slot defining a first opening and a second opening (Polsky: Col. 9, lines 30-46; Fig. 2; Note: Inner lumen of a hollow microneedle contains an inlet and outlet.),
said at least one sensor positioned over the second opening, wherein the slot and said at least one sensor define a channel (Polsky: Fig. 2); and
the channel exposed to the environment (Polsky: Col. 3, lines 61-66);
a tip extending from said body (Polsky: Col. 9, lines 30-46; Fig. 2), wherein the channel is configured to channel ISF to said at least one sensor (Polsky: Col. 2, lines 8-13; Col. 2, line 64-Col. 3, line 6).
wherein the channel is configured to channel ISF to said at least one sensor (Polsky: Col. 2, lines 10-13)
Polsky does not explicitly teach wherein said electronics module component layer is positioned between said first patch layer and said second patch layer.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electronics module component layer of Polsky to be between the first patch layer and second patch layer by rearranging the electronics module component layer to optimize manufacturing parameters, the particular placement involving nothing more than what one skilled in the art is capable of and would choose, as taught by Polsky (Polsky: Col. 13, lines 44-47) and it has been held that rearranging parts of an invention involves only routine skill in the art (See MPEP 2144.04, VI. C.).
Polsky is silent on the at least one sensor being received in the slot.
However, Ribet teaches at least one sensor received in the slot (Ribet: Para. [0156-0160]; Fig. 10A-10C).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the slot and sensor of Polsky by rearranging the position of the sensor to be received in the slot, the particular placement involving nothing more than what one skilled in the art is capable of and would choose, as taught by Ribet (Ribet: Para. [0156-0160]; Fig. 10A-10C) and it has been held that rearranging parts of an invention involves only routine skill in the art (See MPEP 2144.04, VI. C.).
Regarding Claim 2, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 1. Polsky further discloses further comprising a second patch layer laminated to said first patch layer and said electronics module component layer (Polsky: Col. 13, lines 32-47),
wherein said first patch layer and said second patch layer structurally support said electronics module component layer (Polsky: Col. 13, lines 5-22; Fig. 2; Note: the first and second patch layers structurally support the electronics module component through providing a liquid-impermeable channel to direct fluidic communication).
Polsky does not explicitly teach wherein said electronics module component layer is positioned between said first patch layer and said second patch layer.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electronics module component layer of Polsky to be between the first patch layer and second patch layer by rearranging the electronics module component layer to optimize manufacturing parameters, the particular placement involving nothing more than what one skilled in the art is capable of and would choose, as taught by Polsky (Polsky: Col. 13, lines 44-47) and it has been held that rearranging parts of an invention involves only routine skill in the art (See MPEP 2144.04, VI. C.)
Regarding Claim 3, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 2. Polsky further discloses a first adhesive layer positioned between said first patch layer and said electronics module component layer (Polsky: Col. 13, lines 32-47),
wherein said first adhesive layer laminates said first patch layer to said electronics module component layer (Polsky: Col. 13, lines 32-47).
Regarding Claim 6, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 2. Polsky further discloses further comprising a second adhesive layer (Polsky: Col. 13, lines 32-47).
Polsky does not explicitly teach the second adhesive layer positioned between said second patch layer and said electronics module component layer; wherein said second adhesive layer laminates said second patch layer to said electronics module component layer
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electronics module component layer of Polsky by rearranging the electronics module component layer to be laminated by a second adhesive layer to the second patch layer to optimize manufacturing parameters, the particular placement involving nothing more than what one skilled in the art is capable of and would choose, as taught by Polsky (Polsky: Col. 13, lines 44-47) and it has been held that rearranging parts of an invention involves only routine skill in the art (See MPEP 2144.04, VI. C.)
Regarding Claim 9, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 2, Polsky further discloses wherein said slot comprises a first slot (Polsky: Col. 9, lines 30-46; Fig. 2; Note: Inner lumen),
wherein said electronics module component layer further comprises at least one second sensor positioned on said substrate (Polsky: Col. 23, lines 40-49; Fig. 2)
Polsky is silent on wherein the body defines a second slot
However, Ribet teaches wherein said body defines a second slot (Ribet: Para. [0149-0154]; Fig. 9A-9B)
wherein the second slot defines a third opening and a fourth opening (Ribet: Para. [0149-0154]; Fig. 9A-9B),
wherein said at least one sensor comprises at least one first sensor (Ribet: Para. [0149-0154]; Fig. 9A-9B)
wherein said at least one sensor is positioned over the fourth opening and received in the second slot (Ribet: Para. [0149-0154]; Fig. 9A-9B).
wherein the second slot and said at least one second sensor define a second channel exposed to the environment (Ribet: Para. [0149-0154]; Fig. 9A-9B).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the microneedle of Polsky to specify a second slot. A skilled artisan would understand how to optimize channel geometry to fluidically connected one or more needles to one or more electrodes, and be motivated by the desire to control flow of the sample as taught by Ribet (Ribet: Para. [0149-0154]).
Polsky in view of Ribet does not explicitly teach wherein the second slot extends through said second patch layer of said body.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the second slot of Polsky in view of Ribet to extend through the second patch layer and second patch layer by rearranging the electronics module component layer to optimize manufacturing parameters, the particular placement involving nothing more than what one skilled in the art is capable of and would choose, as taught by Polsky (Polsky: Col. 13, lines 44-47) and since it has been held that rearranging parts of an invention involves only routine skill in the art (See MPEP 2144.04, VI. C.)
Regarding Claim 10, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 1, Polsky further discloses wherein said microneedle base comprises a pliable material (Polsky: Col. 8, lines 32-49; Col. 13, lines 5-14).
Regarding Claim 11, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 1, Polsky further discloses wherein said electronics module component comprises an on-patch control module configured to enable wireless communication with a mobile computing device (Polsky: Col. 4 lines 58-63).
Regarding Claim 12, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 1, Polsky further discloses wherein said electronics module component further comprises an on-patch control module and an off-patch control module (Polsky: Col. 4 lines 58-63).
Regarding Claim 13, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 12. Polsky further discloses comprising a cable communicatively coupling said at least one sensor and said on-patch control module to said off-patch control module. (Polsky: Col. 4, lines 58-63).
Regarding Claim 14, Polsky in view of Ribet discloses The wearable ISF sensing device of Claim 12, Polsky further discloses wherein said on-patch control module comprises an analog-to-digital conversion signal module component coupled to said base (Polsky: Col. 6, lines 14-20).
Regarding Claim 15, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 12, Polsky further discloses wherein said on-patch control module is in wireless communication with said off-patch control module (Polsky: Col. 4 lines 58-63).
Regarding Claim 16, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 12, Polsky further teaches wherein said off-patch control module is configured to wirelessly communicate with a mobile computing device. (Polsky: Col. 4 lines 58-63;Col. 16, lines 20-33; Col. 21, lines 41-45).
Regarding Claim 17, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 12, Polsky further discloses wherein said patch component is disposable and wherein said electronics module component is reusable (Polsky: Col. 20, line 56-Col. 21, line22)
Regarding Claim 18, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 1, Polsky further discloses wherein said at least one sensor comprises a biosensor configured to detect at least one biomarker within the ISF (Polsky: Col. 21, lines 46-56; Col. 23, lines 7-17 & 40-49).
Regarding Claim 19, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 1, Polsky further comprises wherein each sensor of said at least one sensor comprises a multi-electrode biosensor configured to detect at least one biomarker within the ISF. (Polsky: Col. 21, lines 46-56; Col. 23, lines 7-17 & 40-49).
Claim(s) 4-5, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Polsky in view of Ribet in further view of JP 7141625 B1 to Koma et al. (hereinafter, Koma).
Regarding Claim 4, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 3, Polsky is silent on specifics regarding adhesive layers.
However, Koma teaches wherein said first adhesive layer comprises a sheet of a curable adhesive (Koma: Para. [0038]; Para. [0041]; Para. [0043] ‘a second primer layer may be provided between the second adhesive layer 115 and the substrate 11… may be the same as the first primer layer’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the patch & substrate components of Polsky to specify a multi-layered laminated structure as taught by Koma, motivated by the advantage of improved adhesiveness and suppressed peeling (Koma: Para. [0043]).
Regarding Claim 5, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 3, Polsky is silent on specifics regarding adhesive layers.
However, Koma teaches wherein said first adhesive layer comprises a pressure sensitive adhesive (Koma: Para. [0042]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the patch & substrate components of Polsky to specify a multi-layered laminated structure as taught by Koma, motivated by the advantage of improved adhesiveness and suppressed peeling (Koma: Para. [0043]).
Regarding Claim 7, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 6, Polsky is silent on specifics regarding adhesive layers.
However, Koma teaches wherein said second adhesive layer comprises a sheet of a curable adhesive (Koma: Para. [0038]; Para. [0041]; Para. [0043]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the patch & substrate components of Polsky to specify a multi-layered laminated structure as taught by Koma, motivated by the advantage of improved adhesiveness and suppressed peeling (Koma: Para. [0043]).
Regarding Claim 8, Polsky in view of Ribet discloses the wearable ISF sensing device of Claim 6, Polsky is silent on specifics regarding adhesive layers.
However, Koma teaches wherein said second adhesive layer comprises a pressure sensitive adhesive (Koma: Para. [0038]; Para. [0043]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the patch & substrate components of Polsky to specify a multi-layered laminated structure as taught by Koma, motivated by the advantage of improved adhesiveness and suppressed peeling (Koma: Para. [0043]).
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 SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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