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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/06/2024 and 10/07/2024 have been considered by the examiner.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities:
Claim 1, line 3 recites the term “oxidise”. This should read “oxidize”.
Claim 10, line 3 recites the term “millimetres”. This should read “millimeters”.
Appropriate correction is required.
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 4 and 6 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.
Regarding claim 4, the claim recites “wherein the hydrogel material consists of between about 0.1 percent weight per volume (% w/v) and about 4% w/v agarose hydrogel.” It is unclear how a hydrogel can consist of a percentage weight by volume of agarose hydrogel. An agarose hydrogel would be a hydrogel that contains agarose. Therefore, the entire hydrogel is an agarose hydrogel, wherein a certain amount of the hydrogel comprises agarose. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein the hydrogel material consists of between about 0.1 percent weight per volume (% w/v) and about 4% w/v agarose.”
Regarding claim 6, the claim recites “wherein the hydrogel material consists of between about 0.1% w/v and about 10% w/v gelatin hydrogel.” It is unclear how a hydrogel can consist of a percentage weight by volume of gelatin hydrogel for the same reasons as stated above in the rejection of claim 4. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein the hydrogel material consists of between about 0.1 percent weight per volume (% w/v) and about 4% w/v gelatin.”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 10-13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Non-patent literature Wearable hydrogel patch with noninvasive… by Lin et al., (2022) – cited by Applicant, hereinafter “Lin”.
Regarding claims 1, 3, and 11, Lin teaches an epidermal biosensor (Abstract, noninvasive sweat glucose sensor with wearable hydrogel patch), comprising: a diffusion layer operable to dissolve a solid-phase epidermal analyte, wherein the diffusion layer comprises a hydrogel material (Abstract, “The wearable hydrogel patch rapidly takes up natural sweat from the hand and serves as a medium for electrochemical sensing”. Therefore the hydrogel patch portion is capable of dissolving the solid constituents of sweat into the sensor); an enzymatic bioreceptor operable to oxidise the dissolved epidermal analyte from the diffusion layer (Fig. 1D, 1.5. Fabrication and characterize of the glucose sensor; the glucose oxidase layer (GOx) used for using glucose sensing); a transducer having an interface with the diffusion layer, wherein the transducer comprises a screen-printed electrode (Fig. 1D, 1.3. Fabrication of the PB-PEDOT NC electrode; The screen-printed carbon electrode (SPCE) has a counter electrode in contact with the hydrogel patch); a processor configured to process electrochemical data from the transducer (Figs. 4-6, 2. Results and discussion; the results obtained from the sensor are analyzed. Therefore, there must be a processor in communication with the transducer to collect the signals for analysis.); and a substrate to which the enzymatic bioreceptor and the transducer are attached (Fig. 2A, the bioreceptor (GOx) and the SPCE are attached to the Nafion).
Regarding claim 2, Lin teaches the epidermal biosensor of claim 1, wherein the diffusion layer comprises a matrix of hydrophilic polymers (1.2. Hydrogel fabrication; The hydrogel comprises agarose, which is a hydrophilic polymer).
Regarding claim 4, Lin teaches the epidermal biosensor of claim 3, wherein the hydrogel material consists of between about 0.1 percent weight per volume (% w/v) and about 4% w/v agarose hydrogel (1.2. Hydrogel fabrication; “Hydrogels (containing 2% agarose) were prepared by dissolving agarose powder in pure water”).
Regarding claim 10, Lin teaches the epidermal biosensor of claim 1, wherein the diffusion layer has a thickness of between about 300 microns (μm) and about 1.5 millimetres (mm) (1.2. Hydrogel fabrication; The hydrogel patch was weight controlled for thicknesses including 300 and 550 μm).
Regarding claim 12, Lin teaches the epidermal biosensor of claim 11, wherein the electrode comprises graphite (1.5. Fabrication and characterize of the glucose sensor; “graphite colloidal dispersion in 1% chitosan in 0.01 M acetic acid buffer and 10 mg mL 1 BSA stabilizer in 1x PBS solution was dropped on the PB-PEDOT NC-modified SPCE and dried in a vacuum chamber at room temperature”) and poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) (1.3. Fabrication of the PB-PEDOT NC electrode; “SPCE modified with PEDOT was also prepared and the electrode was deposited, which contained 5 mL 0.01 M EDOT, 5 μL 18% PSS”).
Regarding claim 13, Lin teaches the epidermal biosensor of claim 12, wherein the electrode further comprises at least one selected from a group consisting of iron (II, III) hexacyanoferrate (II, III) (1.3. Fabrication of the PB-PEDOT NC electrode; The electrode includes Prussian Blue (PB), which is a common name for Iron(III) hexacyanoferrate(II)), and is included in the electrode.), waterborne polyurethane, dimethyl sulfoxide (DMSO) and (3-glycidyloxypropyl)trimethoxy silane (GPTMS).
Regarding claim 16, Lin teaches the epidermal biosensor of claim 1, further comprising an adhesive layer encapsulating a portion of the substrate (2.2. Natural sweat sampling, pg. 123187, col. 1, par 1; “A thin layer of agarose hydrogel micropatches… In the sampling process, the patch was attached to the surface of skin and covered with elastic, water-proof adhesive film”).
Claims 1 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2024/0049994 by Yin et al., hereinafter, “Yin”.
Regarding claim 1, Yin teaches an epidermal biosensor (Figs. 1 and 17), comprising: a diffusion layer operable to dissolve a solid-phase epidermal analyte ([0087]; the sweat collecting layer includes a hydrogel, which diffuses the sweat); an enzymatic bioreceptor operable to oxidise the dissolved epidermal analyte from the diffusion layer ([0087, 0092]; The sensor system can be modified with the enzyme glucose oxidase); a transducer having an interface with the diffusion layer (Fig. 1B, [0095]; electrode assembly 120); a processor configured to process electrochemical data from the transducer (Fig. 1A, [0094]; data processing device 150); and a substrate to which the enzymatic bioreceptor and the transducer are attached (Fig. 1C, substrate 110).
Regarding claim 14, Yin teaches the epidermal biosensor of claim 1, further comprising a plurality of interconnects electronically connecting the transducer to the processor ([0096-0097]; “electrical interconnects 117 to couple the electrode assembly 120 to an interface region (e.g., contact pads) of the sensor 100” and “The electrical signal detectable by the electrode assembly 120 is processed by a data processing device, such as the portable sensor data processing device 150 shown in FIG. 1A, to determine a parameter of the glucose.”).
Regarding claim 15, Yin teaches the epidermal biosensor of claim 1, herein the substrate comprises styrene-ethylene-butylene-styrene (SEBS) ([0172]; The substrate 110 comprises PET and can additionally comprise SEBS to insulate electrodes).
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of US Patent Publication 2017/0238851 by Duhamel et al., hereinafter “Duhamel”.
Lin teaches the epidermal biosensor of claims 1 and 3, but does not teach wherein the diffusion layer further comprises at least one selected from a group consisting of glycerol and gelatin, or wherein the hydrogel material consists of between about 0.1% w/v and about 10% w/v gelatin hydrogel.
Duhamel teaches an epidermal sensor comprising a hydrogel, enzymatic bioreceptor, and transducer. Duhamel teaches that the hydrogel can be an agarose-based hydrogel, ([0050]), but also teaches that hydrogels can be formed of other polymers, including gelatin ([0042]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the sensor of Lin, such that the diffusion layer further comprises at least one selected from a group consisting of glycerol and gelatin, as taught by Duhamel ([0042]). This combination merely comprising a simple substitution of one known element for another to obtain predictable results. See MPEP 2143.I-B. It is noted that Lin teaches a hydrogel comprising 2% agarose. A simple substitution of gelatin for agarose in the composition of the hydrogel would yield a hydrogel with 2% gelatin (between about 0.1% w/v and about 10% w/v gelatin).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Duhamel, evidenced by US Patent Publication 2018/0242913 by Zhu et al. – cited by Applicant, hereinafter “Zhu” and Non-Patent Literature Product Information: Triton X-100 by Sigma-Aldrich Inc., hereinafter “Triton X-100 Product Information”.
Lin teaches the epidermal biosensor of claim 1, but des not teach wherein the diffusion layer further comprises a surfactant, and wherein the surfactant comprises between about 0.1% w/v and about 10% w/v 2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol.
Duhamel teaches an epidermal sensor comprising a hydrogel, enzymatic bioreceptor, and a transducer. Duhamel teaches that the hydrogel can be an agarose-based hydrogel, formed of other biocompatible components such as Triton X-100 (i.e., 2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol) ([0050]).
Zhu teaches an epidermal sensor comprising a hydrogel, enzymatic bioreceptor, and transducer. Zhu teaches that the inclusion of surfactants, such as Triton X-100, can assist the sensor in obtaining desirable contact with the skin ([0031]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the sensor of Lin such that the diffusion layer further comprises a surfactant, and wherein the surfactant comprises between about 0.1% w/v and about 10% w/v 2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol, in order to assist the sensor in obtaining desirable contact with the skin, as taught by Zhu ([0031]). It is noted that Duhamel teaches that the buffer solution used to create the hydrogel can contain 0-1M of Triton X-100. Triton X-100 has a molecular weight of 625g/mol (Triton X-100 Product Information), and therefore 1 L of the solution can contain from 0-625 g of Triton X-100. Assuming the solution has the density of water, this corresponds to a weight by volume of 0-62.5% w/v, overlapping with the range of 0.1-10% w/v.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of WIPO Patent Publication 90/15568 by Stanley et al. – cited by Applicant, hereinafter “Stanley”.
Lin teaches the epidermal biosensor of claim 1, but does not teach wherein the diffusion layer further comprises between about 0.1% w/v and about 10% w/v ethanol.
Fig. 1 of Stanley teaches a device for monitoring glucose with an electrochemical biosensor comprising a hydrogel layer. Connolly teaches that the addition of ethanol in the layer that contacts the skin can increase the dermal glucose permeability (Page 13, line 31 – Page 14, line 6). The table on Pages 14-15 teaches that ethanol can be included in the concentration of 5-100%, which overlaps with the range of 0.1% to 10%.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Lin such that the diffusion layer further comprises between about 0.1% w/v and about 10% w/v ethanol, in order to enhance the dermal glucose permeability layer, as taught by Stanley (Page 13, line 31 – Page 14, line 6).
Conclusion
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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