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 .
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 reli1ed 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 51-70 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Wang et al. (hereinafter ‘Wang’, U.S. Patent/PGPub No. 2018/0220967).
In regards to claim 51, Wang discloses a glucose monitoring device for detecting glucose in a biofluid sample from a skin surface, the device comprising: a substrate comprising a conductive layer ([0006]: "In one aspect of the disclosed technology, a method of producing an epidermal biosensor includes forming an electrode pattern onto a coated surface of a paper-based substrate to form an electrochemical sensor, the electrode pattern including an electrically conductive material and an electrically insulative material configured in a particular design layout, and attaching an adhesive sheet on a surface of the electrochemical sensor having the electrode pattern, the adhesive sheet capable of adhering to skin or a wearable item, in which the electrochemical sensor, when attached to the skin or the wearable item, is operable to detect chemical analytes within an external environment.", chemical analytes including glucose (see [0135])), a first electrode comprising a first electrode material deposited on the conductive layer, wherein the first electrode material comprises a transducer configured to generate an electrochemical signal from a reaction with the glucose from the biofluid sample ([0067]: "For example, the sensor circuit 177 can be configured to apply excitation waveforms and/or transduce the electrical signals generated by the electrochemical electrodes of the electrochemical sensor device 170 upon excitation."), and a second electrode comprising a second electrode material deposited on the conductive layer, wherein the first electrode comprises a first plurality of digits and the second electrode comprises a second plurality of digits, wherein the first plurality of digits is alternately arranged with the second plurality of digits, and wherein the electrochemical signal is used to provide a blood glucose concentration of a user ([0011]: "Implementations of the device can optionally include one or more of the following features. For example, in some implementations of the device, at least one of the first electrode or the second electrode can include an enzyme catalyst and an electroactive redox mediator, the electroactive redox mediator facilitating the transfer of electrons between the electrode and the active site of the enzyme catalyst configured to sustain a redox reaction.").
In regards to claim 52, Wang discloses that the substrate comprises at least one of glass, silicon, paper, textile, polymer, or elastomer ([0161]: "FIG. 16 shows a schematic illustration of an exemplary method to fabricate tattoo biofuel cells using screen printing techniques. The fabrication method includes a process 1610 to deposit electrodes 1613 on a tattoo paper substrate comprising a release agent 1612 coated on a base paper 1611. For example, the release agent 1612 can include hydrophobic material that releases upon exposure moisture, e.g., such as polydimethylsiloxane (PDMS), a cellulosic-based material, a silicone material, among others.").
In regards to claim 53, Wang discloses that the polymer comprises at least one of polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride, polystyrene, polysaccharide-based polymer, polystyrene-based block copolymer, polysaccharide, polyvinyl alcohol, or polyethylene vinyl acetate ([0007]: "For example, the electrically insulative material can include a nonconductive ink, e.g., including, but not limited to, polyethylene terephthalate (PET), polystyrene (PS), polyester (PE), and/or polytetrafluoroethylene (PTFE).").
In regards to claim 54, Wang discloses that the conductive layer comprises a metal ([0161]: "The electrodes 1613 can be formed of a carbon-based ink material or other electrically conductive material, which can include a catalyst, e.g., including, but not limited to, an enzyme biocatalyst or noble metal catalyst, dispersed within the ink.").
In regards to claim 55, Wang discloses that the metal comprises platinum, silver, gold, copper, titanium, ruthenium, palladium, rhodium, brass, or a combination thereof ([0007]: "For example, the electrically conductive material can include a conductive ink, e.g., including, but not limited to, gold, platinum, nickel, copper, silver, and/or silver chloride.").
In regards to claim 56, Wang discloses that the reaction comprises a redox reaction ([0066]: "In other examples, as shown in the diagram of FIG. 1E, the working electrode 172 includes an electrochemical sensing layer 174 to sustain a redox reaction to produce a detectable electrical signal that can be detected using, for example, amperometry and/or voltammetry.").
In regards to claim 57, Wang discloses that the transducer is glucose oxidase ([0159]: "Exemplary materials and methods to implement the disclosed embodiment of the technology are presented. The following chemicals and reagents were used in the described implementations, which included tetrathiafulvalene (TTF), glutaraldehyde solution (8%), chitosan, Pt black, bovine serum albumin (BSA), lactic acid, glucose, potassium phosphate monobasic (KH.sub.2PO4), potassium phosphate dibasic (K.sub.2HPO.sub.4), hydrochloric acid (HCl), ammonium hydroxide (NH.sub.4OH), sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl.sub.2), magnesium chloride (MgCl.sub.2), and sodium bicarbonate (NaHCO.sub.3). Lactate oxidase (LOx) and carboxy-functionalized multi-walled carbon nanotubes (MWNTs-COOH) were obtained for use in the exemplary implementations.").
In regards to claims 58 and 59, Wang discloses that the first electrode material comprises a cross- linker and that the cross-linker comprises one or more of glutaraldehyde, epoxy, dihydrazide, bisacrylamide, 1-Ethyl-3-(3- dimethylaminopropyl) carbodiimide/N-hydroxysuccinimide (EDC/NHS)), stabilizer, polymer, or surfactant ([0137]: "The electrodes were then cross-linked with glutaraldehyde vapor overnight at 4° C.").
In regards to claims 60 and 61, Wang discloses that the second electrode material comprises a redox mediator and that the redox mediator comprises an iron-based redox couple ([0131]: "The working electrode of the exemplary T3 sensor can be functionalized with monolayers, ligands, enzyme catalysts and/or electroactive redox mediators, among other molecules or substances to enhance the detectability of the target enzyme.").
In regards to claim 62, Wang discloses that the second electrode material comprises a conductive polymer ([0013]: "...for example, the method can further include depositing a catalyst to the surface of at least one of the electrodes, in which the depositing includes performing at least one of: (i) encasing the catalyst in a porous scaffold structure formed of a conducting polymer on the surface of the electrode...").
In regards to claim 63, Wang discloses that the conductive polymer comprises one or more of polyaniline, polypyrrole, polythiophene, or poly (3,4-ethylenedioxythiophene):polystyrene sulfonate (PEDOT:PSS) ([0098]: "The method 600 includes a process 620 to form electrically insulative material 626 and poly(aniline) (PANi) 625 to form a temporary transfer tattoo solid-contact ISE sensor 615.").
In regards to claim 64, Wang discloses that the first and second plurality of digits are separated by a predetermined distance of about 1 mm or less (see Fig. 1B, space is 250 µm).
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In regards to claim 66, Wang discloses that the biofluid sample of the skin surface is collected by direct contact of a fingertip to the device ([0077]: "For example, the images 208 and 209 demonstrate deformation of an exemplary tattoo sensor when pinched with the forefingers or upon stretching the skin, respectively.").
In regards to claim 67, Wang discloses that the biofluid comprises sweat ([0106]: "In some exemplary implementations, the tattoo ISE sensors were analyzed within the pH range of human sweat (e.g., pH 3-7, with a mean around pH 5) using standard McIlvaine's buffers. For example, since human perspiration can exhibit continuous fluctuations of pH, a practical pH sensor must encompass a rapid and near-instantaneous response to pH modulations over this range.").
In regards to claim 68, Wang discloses that the device comprises a second layer, wherein the second layer comprises one or more of chitosan, agarose, or polyethyleneimine ([0131]: "Also in this example, a layer of chitosan is deposited onto the enzyme-electrode to impede the efflux of the biocatalytic backbone from the electrode to the aqueous environment.").
In regards to claim 69, Wang discloses that the device comprises a third layer, wherein the third layer comprises one or more of Nafion or cellulosic material ([0062]: "FIG. 1D shows a schematic illustration of exemplary material layers of an exemplary epidermal electrochemical sensor device. In this example, the exemplary device includes a paper substrate and a releasing agent layer, e.g., formed of cellulose acetate, over the paper substrate.").
In regards to claim 70, Wang discloses that the device comprises a protection layer, wherein the protection layer comprises one or more of Nafion, polyethyleneimine, polyurethane, polyvinyl alcohol, polyvinyl chloride, poly (vinyl difluoroethylene), poly (tetrafluoro ethylene), tetrafluoro propylene, hexafluoro propylene, starch polymer, cellulose, nitrocellulose, chitosan, ethylcellulose, or methylcellulose ([0066]: "...the catalyst entrapped by a selectively permeable scaffold structure, e.g., such as Nafion or chitosan, formed on the surface of the working electrode 172…").
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.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Stowell et al. (hereinafter ‘Stowell’, U.S. PGPub No. 2019/0204265).
In regards to claim 65, Wang discloses the invention substantially as described in claim 51.
However, Wang does not disclose that the alternately arranged first and second plurality of digits are interdigitated.
Stowell teaches a biosensor wherein the electrode digits are arranged in an interdigitated fashion (Stowell, [0070]: "FIG. 9 shows an example of an electrochemical gas sensor 600 in another embodiment of an electrochemical sensor, where a first electrode 610 and a second electrode 611 are configured as interdigitated fingers to increase the area for electrical interaction between the electrodes, which can be beneficial for example in cases where the electrolyte contains the sensing material (e.g., reactive chemistry additives)."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the sensor for physiological testing to use an interdigitated electrode digit arrangement, as taught by Stowell, as doing so would allow for easier capacitance and electrode tuning (Stowell, [0070]: "Additionally, such an interdigitated electrode geometry can be used to tune the capacitance of the sensor element to allow it to be integrated with other circuit elements more advantageously.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796