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 .
Election/Restriction
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a microneedle actuator for monitoring interstitial fluid of a user, classified in A61B5/14514.
II. Claim 20, drawn to a method of detecting a biomarker within the interstitial fluid, classified in A61B2010/008.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, invention I can be practiced with another materially different method that does not require the adherence to a user’s skin as required of Invention II or could be used in a method of monitoring other types of biological fluids.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention I requires searching in A61B5/14514 for device level searching of microneedle actuators, requiring search queries related to ‘microneedle; layer; laminat$; patch; channel’, etc.
Invention II requires searching in A61B2010/008 for method searching of biomarker detection/identification, requiring search queries related to ‘adher$ with skin or patch and skin; biomarker’, etc.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
The prior art applicable to one invention would not likely be applicable to another invention; and
The inventions are likely to raise different non-prior art issues under 35 U.S.C. § 101 and/or 35 U.S.C. § 112.
Complete examination of each invention would require nonoverlapping searches and would create a serious burden.
During a telephone conversation with Megan Tappan on 2nd February 2026 a provisional election was made without traverse to prosecute Invention I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, recites ‘wherein the first opening, the slot, and said at least one sensor define a channel exposed to the environment’, this limitation is rendered indefinite for the following reasons: ‘the slot’ is structured as ‘… a slot extending through said first patch layer of said body, the slot defining a first opening and a second opening’ (emphasis added), thus it is unclear whether ‘the first opening’ and ‘the slot’ can structurally define a channel given the slot includes the first opening as recited previously or if the recitation of both ‘the first opening’ and ‘the slot’ was a typographical error or if the intent is for the limitation of ‘the first opening’ to instead introduce a supplementary opening to the first and second openings. Examiner interprets the indefinite limitation to be a typographical error, as the slot already includes the first opening in its recited structure, as best understood by the disclosure.
Claim 9 is rejected for similar reasons as Claim 1, ‘wherein the third opening, the second slot, and said at least one second sensor define a second channel exposed to the environment’, this limitation is rendered indefinite. The second slot is recited as: ‘wherein the second slot defines a third opening and a fourth opening’, it is unclear whether ‘the third opening’ and ‘the second slot’ is meant to structurally define a channel given that the second slot includes the third opening in its structure as recited previously or if the recitation of both ‘the third opening’ and ‘the second slot’ was a typographical error or if the intent is for the limitation of ‘the third opening’ to instead introduce a supplementary opening to the third and fourth openings. Examiner interprets the indefinite limitation to be a typographical error, as the second slot already includes the third opening in its recited structure, as best understood by the disclosure.
Claim 19 recites 'at least one sensor comprises a plurality of biosensors', it is unclear whether each sensor of the at least one sensor comprises a plurality of biosensors, or if the at least one sensor is a plurality of biosensors, rendering Claim 19 indefinite. Examiner interprets the limitation to mean that the at least one sensor is a plurality of biosensors.
Claims 2-19 are rejected for their dependence on a rejected base claim.
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 20230012662 A1 to Tehrani et al. (hereinafter, Tehrani) in view of US 9987427 B1 to Polsky et al. (hereinafter, Polsky).
Regarding Claim 1, Tehrani discloses a wearable interstitial fluid (ISF) sensing device (Tehrani: Para. [0004]) comprising:
a first patch layer (Tehrani: Para. [0064] ‘a substrate providing an array of spiked microneedles (e.g., “spiked microneedle array substrate” 171),’; Fig. 1C item 171); and
an electronics module component layer attached to said first patch layer to form a patch component and a plurality of microneedles extending from said patch component (Tehrani: Para. [0063] ‘the electronics unit 120 coupled to the microneedle sensor unit 110, which includes an array of spiked microneedles 111 that protrude outward of the device 100’),
said electronics module component layer comprising a substrate and at least one sensor positioned on said substrate (Tehrani: Para. [0064] ‘an electronics interface board 169 (e.g., printed circuit board (PCB))’; Para. [0093, [0097]; [0075]; Fig. 1F),
each microneedle of said plurality of microneedles comprising: a microneedle base extending from said patch component (Tehrani: Para. [0093]; Fig. 4C item 413);
a body extending from said microneedle base (Tehrani: Para. [0093]; Fig. 4C item 411),
said body defining a slot extending through said first patch layer of said body (Tehrani: Fig. 4A, item 417A),
the slot defining a first opening and a second opening (Tehrani: Fig. 4A, item 417A; Para. [0094]-[0095]; the channel having openings to convey fluids),
said at least one sensor positioned over the second opening, wherein the first opening, the slot, and said at least one sensor define a channel (Tehrani: Para. [0094]-[0095]; Fig. 4A, item 417B or 417C); and
a tip extending from said body (Tehrani: Para. [0093] ‘spiked microneedle structures 411 and substructure of substrate 413 with an example electrical conduit 412 that is configured to electrically couple the electrode 411E of the spiked microneedle structure 411 to a terminus or contact region of the electrical conduit 412 on the substrate 413’), wherein the channel is configured to channel ISF to said at least one sensor (Para. [0090]).
Tehrani is silent on the attachment between the electronics module component layer and the first patch layer being laminated; and the channel being exposed to the environment; and should Tehrani be found to not be explicit on wherein the channel is configured to channel ISF to said at least one sensor.
However, Polsky teaches wherein the electronics module component layer is laminated to the first patch layer (Polsky: Col. 13, lines 32-47); and a channel exposed to the environment (Polsky: Col. 3, lines 61-66); wherein the channel is configured to channel ISF to said at least one sensor (Polsky: Col. 2, lines 10-13).
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 Tehrani to specify a multi-layered laminated structure, with channels exposed to the environment channeling ISF to sensors. 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 Polsky (Polsky: Col. 12, lines 19-29; Col. 7, lines 64-67).
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 Tehrani in view 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 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 2, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 1. Tehrani is silent on further comprising a second patch layer laminated to said first patch layer and said electronics module component layer.
However, Polsky teaches 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).
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 Tehrani to specify a multi-layered laminated structure as taught by Polsky, motivated by the desire to control flow of the sample (Polsky: Col. 7, lines 64-67).
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 Tehrani in view 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 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 3, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 2. Tehrani is silent on the specifics regarding multiple patch layers.
However, Polsky teaches 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).
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 Tehrani in view of Polsky by rearranging the electronics module component layer to be laminated by an adhesive layer to the first 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 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 6, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 2. Tehrani is silent on the specifics of layers.
However, Polsky teaches 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 Tehrani in view 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 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 9, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 2, Tehrani discloses wherein said slot comprises a first slot (Tehrani: Para. [0093]; Fig. 4A, item 417, 417A),
wherein said body defines a second slot (Tehrani: Para. [0093]; Fig. 4C; Note: the figure is a cross-section of a single microneedle in an array, various microfluidic channels are possible and include a plurality of slots, see Fig. 4A, item 417, 417A)
wherein the second slot defines a third opening and a fourth opening (Tehrani: Para. [0092]; Fig. 4A, item 417, 417A),
wherein said at least one sensor comprises at least one first sensor (Tehrani: Para. [0093]; Fig. 4C, 411E)
wherein said electronics module component layer further comprises at least one second sensor positioned on said substrate (Tehrani: Para. [0093]; Fig. 4C item 412; Note: the figure is a cross-section of a single microneedle in an array)
wherein said at least one sensor is positioned over the fourth opening (Tehrani: Para. [0094]-[0095]; Fig. 4C; Note: the figure is a cross-section of a single microneedle in an array; See Fig. 4A, item 417A).
wherein the third opening, the second slot, and said at least one second sensor define a second channel (Tehrani: Para. [0094]-[0095]; Fig. 4C; Note: the figure is a cross-section of a single microneedle in an array; See Fig. 4A, item 417, 417A)
Tehrani is silent on the channel being exposed to the environment; and the second slot extending through said second patch layer of said body.
However, Polsky teaches a channel exposed to the environment (Polsky: Col. 3, lines 61-66).
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 Tehrani to specify a multi-layered laminated structure with channels exposed to the environment channeling ISF to sensors. 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 Polsky (Polsky: Col. 12, lines 19-29; Col. 7, lines 64-67).
Polsky 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 Tehrani in view of Polsky 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, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 1, Tehrani further discloses wherein said microneedle base comprises a pliable material (Tehrani: Para. [0068] ‘the substrate 113 includes an electrically insulative material, which can be rigid or flexible… the substrate 113 can include polymethyl methacrylate (PMMA) or other electrically insulative polymer, e.g., including UV curable polymers; whereas in other embodiments, the substrate 113 can include an electrically insulative ceramic and/or metallic material, including a composite material, which may include a polymeric material.’; [0092] 413 is equivalent to 113).
Regarding Claim 11, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 1, Tehrani further discloses wherein said electronics module component comprises an on-patch control module configured to enable wireless communication with a mobile computing device (Tehrani: Para. [0061]; Fig. 1A).
Regarding Claim 12, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 1, Tehrani further discloses wherein said electronics module component further comprises an on-patch control module and an off-patch control module (Tehrani: Para. [0062]; Fig. 1A).
Regarding Claim 13, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 12. Tehrani further discloses comprising a cable communicatively coupling said at least one sensor and said on-patch control module to said off-patch control module. (Tehrani: Para. [0072] ‘the electrical interface 126 can be configured as an array of electronic interface components, such as pins, that electrically couples to a corresponding array of electrical conduit terminus sites in connection with the array of electrodes (e.g., of the spiked microneedles 111) of the sensor unit 110, which electrically couples the array of electrodes to the signal conditioning unit 125 and/or other circuitry of the electronics unit 120.’; [0074], [0075] ‘the data processing unit 124 can interface with other devices using a wired connection via the I/O unit 123.’; Fig. 1F).
Regarding Claim 14, Tehrani in view of Polsky discloses The wearable ISF sensing device of Claim 12, Tehrani further discloses wherein said on-patch control module comprises an analog-to-digital conversion signal module component coupled to said base (Tehrani: Para. [0136-0138]).
Regarding Claim 15, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 12, Tehrani further discloses wherein said on-patch control module is in wireless communication with said off-patch control module (Tehrani: Para. [0062]; Fig. 1A).
Regarding Claim 16, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 12, Tehrani further teaches wherein said off-patch control module is configured to wirelessly communicate with a mobile computing device. (Tehrani: Para. [0062]; Fig. 1A).
Regarding Claim 17, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 12, Tehrani further discloses wherein said patch component is disposable and wherein said electronics module component is reusable (Tehrani: Para. [0064]; Fig. 1d)
Regarding Claim 18, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 1, Tehrani further discloses wherein said at least one sensor comprises a biosensor configured to detect at least one biomarker within the ISF (Tehrani: Para. [0063] ‘The right diagram of FIG. 1B illustrates a bottom view of the example microneedle sensor patch device 100, showing an example of the device 100 having (i) two sensors (sensor 1 and sensor 2) configured to sense two distinct analytes via two arrays of spiked microneedle sensors 111A and 111B providing working (detecting) electrodes, and (ii) one or more reference electrodes (“RE”) and (iii) one or more counter electrodes (“CE”). In this example, sensor 1 is configured to detect glucose, and sensor 2 is configured to detect lactate.’).
Regarding Claim 19, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 1, Tehrani further comprises wherein said at least one sensor comprises a plurality of biosensors configured to detect at least one biomarker within the ISF. (Tehrani: Para. [0057], [0058] ‘the disclosed spiked microneedle sensor technology provides physically isolated and independently operating multiplexed microneedle arrays on a single platform, overcoming the limiting single-analyte sensing capability of the current CGM devices.’).
Claim(s) 4-5, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani in view of Polsky in further view of JP 7141625 B1 to Koma et al. (hereinafter, Koma).
Regarding Claim 4, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 3, Tehrani 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 Tehrani 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, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 3, Tehrani 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 Tehrani 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, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 6, Tehrani 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 Tehrani 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, Tehrani in view of Polsky discloses the wearable ISF sensing device of Claim 6, Tehrani 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 Tehrani 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
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