DETAILED ACTION
Applicant’s arguments, filed on 11/13/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 11/13/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-11 and 35-43 are hereby under examination with claims 12-14 and 30-34 withdrawn from consideration.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because multiple reference characters have been used to designate the same part:
Reference characters “140” and “150” have both been used to designate “fingerprint scanner”
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters have been used to designate more than one part:
Reference character “140” has been used to designate both “biological surface” and “fingerprint scanner”
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. 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.
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 35 and 42 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.
Regarding claim 35, the claim recites the limitation “about 340 µm to about 510 µm” in line 2. It is unclear what constitutes as “about” 340 µm or “about” 510 µm, and how far away from these values will still constitute as teaching on this limitation. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any value that is +/- 50 µm will teach on this limitation.
Regarding claim 42, the claim recites the limitation “about 2% agarose” in line 2. It is unclear what constitutes as “about” 2%, and how far away from these values will still constitute as teaching on this limitation. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any value that is +/- 5% will teach on this limitation.
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.
Claims 1-3, 6-7, 9-11, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20170325724) in view of Spencer (US 20160354034).
Regarding independent claim 1, Wang teaches a biochemical sensor device ([0002]: “This patent document relates to electrochemical sensor devices, systems, and techniques.”), comprising:
a substrate ([0006]: “a non-invasive epidermal electrochemical sensor device includes a flexible substrate”);
a first base electrode layer disposed on the substrate (Abstract: “The device includes a cathodic electrode assembly disposed adjacent to the anodic electrode assembly over the flexible or stretchable substrate and includes an iontophoretic electrode.”); and
a hydrogel layer disposed over the first base electrode layer ([0009]: “the device further includes a first insulating layer formed over the anodic electrode assembly and a second insulating layer formed over the cathodic electrode assembly, the first and second insulating layers to confine electrode and contact areas of the device. In some implementations, for example, the layer includes a hydrogel layer”).
However, Wang is silent on the structure of the hydrogel layer.
Spencer discloses a neural implant that contains electrodes. Specifically, Spencer teaches wherein the hydrogel layer is formed as a thin hydrogel micropatch (THMP) ([0073]: “the swollen hydrogel coating thickness may range from 20 microns to 500 microns, e.g., from 30 microns to 500 microns, from 40 microns to 400 microns, from 50 microns to 500 microns, from 50 microns to 400 microns, from 50 microns to 300 microns, or from 50 microns to 250 microns. The swollen hydrogel coating thickness may be any suitable thickness”). Wang and Spencer are analogous arts as they are both related to devices that includes biological sensing devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the thickness from Spencer into the device from Wang as Wang is silent on the structure of the hydrogel layer and Spencer provides a suitable structure in an analogous device.
Regarding claim 2, the Wang/Spencer combination teaches the biochemical sensor device of claim 1, further comprising: a carbon nanotube layer disposed on the first base electrode layer (Wang, [0219]: “the electrode pattern can further include an electrically semi-conductive material. For example, the electrically semi-conductive material can include a semi-conductive ink, e.g., including, but not limited to, amorphous carbon, carbon black, graphite, carbon nanotubes, and/or graphene”; [0225]: “the method can further include depositing multi-walled carbon nanotubes on the surface of at least one of the two or more electrodes”).
Regarding claim 3, the Wang/Spencer combination teaches the biochemical sensor device of claim 2, further comprising: a platinum layer disposed on the carbon nanotube layer (Wang, [0238]: “the electrically conductive ink can include, but is not limited to, gold, platinum, nickel, silver, and silver chloride inks. For example, the electrically insulative ink can include, but is not limited to, PET and PTFE inks. In some examples, the electrode structures 3111 can also include electrically semi-conductive materials including semi-conductive ink, e.g., including, but not limited to, amorphous carbon, carbon black, or graphite”; [0340]: “include dispersed carbon fibers within the ink used to print the anode and cathode electrodes, multi-walled carbon nanotubes incorporated in the electrode”).
Regarding claim 6, the Wang/Spencer combination teaches the biochemical sensor device of claim1, further comprising: a second base electrode layer disposed on the substrate (Wang, [0010]: “an anode electrode assembly and a cathode electrode assembly separately disposed on the substrate and each including an iontophoretic electrode and two or more electrochemical sensor electrodes”).
Regarding claim 7, the Wang/Spencer combination teaches the biochemical sensor device of claim 6, further comprising: a silver chloride layer disposed on the second base electrode layer (Wang, [0219]: “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”; [0164]: “A sequence of the silver/silver chloride (Ag/AgCl) ink (E2141 Ercon Inc., Wareham, Mass.) and prussian blue conductive carbon (Gwent Group, UK) were screen-printed on the substrate by using an MPM-SPM semi-automatic screen printer”).
Regarding claim 9, the Wang/Spencer combination teaches the biochemical sensor device of claim1, wherein the substrate comprises polyethylene terephthalate (PET) (Wang, [0238]: “The exemplary inks employed can include a wide variety of materials (e.g., such as graphite, gold, platinum, nickel, silver, silver chloride, polyethylene terephthalate (PET)”).
Regarding claim 10, the Wang/Spencer combination teaches the biochemical sensor device of claim 1, wherein the first base electrode layer comprises gold (Wang, [0236]: “the process 3110 can include screen printing the electrically conductive material (e.g., electrically conductive ink) and the electrically insulative material (e.g., electrically insulative ink), and in some examples an electrically semi-conducting ink, in the patterned design to form the electrode structures”; [0238]: “The exemplary inks employed can include a wide variety of materials (e.g., such as graphite, gold”).
Regarding claim 11, the Wang/Spencer combination teaches the biochemical sensor device of claim1, wherein the second base electrode layer comprises gold (Wang, [0236]: “the process 3110 can include screen printing the electrically conductive material (e.g., electrically conductive ink) and the electrically insulative material (e.g., electrically insulative ink), and in some examples an electrically semi-conducting ink, in the patterned design to form the electrode structures”; [0238]: “The exemplary inks employed can include a wide variety of materials (e.g., such as graphite, gold”).
Regarding claim 35, the Wang/Spencer combination teaches the biochemical sensor device of claim 1, wherein the THMP has a thickness ranging between about 340 µm to about 510 µm (Spencer, [0073]: “the swollen hydrogel coating thickness may range from 20 microns to 500 microns, e.g., from 30 microns to 500 microns, from 40 microns to 400 microns, from 50 microns to 500 microns, from 50 microns to 400 microns, from 50 microns to 300 microns, or from 50 microns to 250 microns. The swollen hydrogel coating thickness may be any suitable thickness”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer combination as applied to claim 3 above, and further in view of Boutelle (US 20180136247).
Regarding claim 4, the Wang/Spencer combination teaches the biochemical sensor device of claim 3.
However, the Wang/Spencer combination does not teach further comprising: a poly-m-phenylenediamine (PPD) layer disposed on the platinum layer.
Boutelle discloses a microfluidic flow controller that analyzes analyte fluid. Specifically, Boutelle teaches further comprising: a poly-m-phenylenediamine (PPD) layer disposed on the platinum layer ([0338]: “The working electrode was first coated with poly-m-phenylenediamine”). Wang and Boutelle are analogous arts as they are both devices used to measure health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the poly-m-phenylenediamine layer from Boutelle into the sensor device from the Wang/Spencer combination as it adds another effective layer into the sensor, which can improve the function of the sensor and provide a more accurate result.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer/Boutelle combination as applied to claim 4 above, and further in view of JP 254 (JP 2008523254). Citations to JP 2008523254 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 5, the Wang/Spencer/Boutelle combination teaches the biochemical sensor device of claim 4.
However, the Wang/Spencer/Boutelle combination does not teach further comprising: a lithium oxide layer disposed on the PPD layer.
JP 254 discloses nanofiber materials for use in different devices, for example, biochemical sensors. Specifically, JP 254 teaches further comprising: a lithium oxide layer disposed on the PPD layer (Page 39: “Other selectively preferred gel electrolytes include lithium oxides”). Wang, Boutelle, and JP 254 are analogous arts as they are all related to devices used for sensing health parameters in a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the lithium oxide layer from JP 254 in the sensor device from the Wang/Spencer/Boutelle combination as it provides another layer that can allow for high electrical conductivity, elastic properties, and more that can improve the device and provide more accurate results.
Claims 8 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer combination as applied to claims 1 and 6 above, and further in view of Ionescu (US 20190246959).
Regarding claim 8, the Wang/Spencer combination teaches the biochemical sensor device of claim 6.
However, the Wang/Spencer combination does not disclose further comprising: a polyvinyl chloride (PVC) layer disposed over the first electrode base layer, over the second base electrode layer, and below the hydrogel layer.
Ionescu discloses a sensing device for bio-fluid. Specifically, Ionescu teaches further comprising: a polyvinyl chloride (PVC) layer disposed over the first electrode base layer, over the second base electrode layer, and below the hydrogel layer ([0077]: “The wearable device may also include a body or envelope that envelops or encapsulates or covers (at least partially on one side) the bio-fluid collection and sensing device and or other parts such as the energy source or (user body) attachment. Exemplary materials of the envelope may be polymers such as polyethylene, polyurethane or polyvinyl chloride.”). Wang and Ionescu are analogous arts as they are both devices used to measure health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the PVC layer from Ionescu into the sensing device from the Wang/Spencer combination as it allows for a protective coating on the sensor, protecting it from outside influences and ensuring the sensor lasts longer.
Regarding claim 36, the Wang/Spencer combination teaches the biochemical sensor device of claim 1.
However, the Wang/Spencer combination does not teach the device further comprising a microfluidic layer operatively coupled to the hydrogel layer.
Ionescu teaches the device further comprising a microfluidic layer operatively coupled to the hydrogel layer ([0058]: “the device comprises a micro-fluidic or nano-fluidic layer to collect, and/or handle biological fluids. In one embodiment, the fluidic layer includes passive microfluidics that may comprise one or a plurality of inlets, one or a plurality of channels, one or a plurality of outlets. The passive microfluidics are configured to collect and transfer a fluid from the inlet(s), through the channels and expel it at the outlet(s). At the base of and integrated with this microfluidic layer, the channels are in contact with a plurality of sensors 002 and one or more reference electrodes 009 (to provide a stable potential biasing the biofluid) that are wetted by the collected bio-fluid, enabling the sensing functions on the collected liquid.”. If the layer is included in the sensor, then it is operably coupled to the hydrogel layer.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the microfluidic layer from Ionescu into the Wang/Spencer combination as it allows the device to easily transport fluid to the correct location so it can be sensed by the electrodes, ensuring a correct and easy measurement.
Regarding claim 37, the Wang/Spencer/Ionescu combination teaches the biochemical sensor device of claim 36, wherein the microfluidic layer includes at least one cavity in at least one structure operable to capture fluid (Ionescu, [0058]: “the device comprises a micro-fluidic or nano-fluidic layer to collect, and/or handle biological fluids. In one embodiment, the fluidic layer includes passive microfluidics that may comprise one or a plurality of inlets, one or a plurality of channels, one or a plurality of outlets. The passive microfluidics are configured to collect and transfer a fluid from the inlet(s), through the channels and expel it at the outlet(s). At the base of and integrated with this microfluidic layer, the channels are in contact with a plurality of sensors 002 and one or more reference electrodes 009 (to provide a stable potential biasing the biofluid) that are wetted by the collected bio-fluid, enabling the sensing functions on the collected liquid.”).
Regarding claim 38, the Wang/Spencer/Ionescu combination teaches the biochemical sensor device of claim 37, wherein the at least one cavity of the microfluidic layer includes at least one opening in a planar structure thereof (Ionescu, [0058]: “the device comprises a micro-fluidic or nano-fluidic layer to collect, and/or handle biological fluids. In one embodiment, the fluidic layer includes passive microfluidics that may comprise one or a plurality of inlets, one or a plurality of channels, one or a plurality of outlets. The passive microfluidics are configured to collect and transfer a fluid from the inlet(s), through the channels and expel it at the outlet(s). At the base of and integrated with this microfluidic layer, the channels are in contact with a plurality of sensors 002 and one or more reference electrodes 009 (to provide a stable potential biasing the biofluid) that are wetted by the collected bio-fluid, enabling the sensing functions on the collected liquid.”).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer/Ionescu combination as applied to claim 36 above, and further in view of Nguyen (US 20210007646).
Regarding claim 39, the Wang/Spencer/Ionescu combination teaches the biochemical sensor device of claim 36.
However, the Wang/Spencer/Ionescu combination is silent on the composition of the microfluidic structure.
Nguyen discloses a saliva testing strip. Specifically, Nguyen teaches wherein the microfluidic structure comprises one of a flexible plastic film, a flexible plastic adhesive tape, and a plurality of layers arranged in a stack ([0012]: “the test strip microfluidics are formed by layering multiple layers of materials together with an adhesive.”). Wang, Spencer, Ionescu, and Nguyen are analogous arts as they are all related to devices that includes biological sensing devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of the microfluidic layer from Nguyen into the Wang/Spencer/Ionescu combination as the combination is silent on the composition of the structure, and Nguyen provides a suitable composition in an analogous device.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer combination as applied to claim 1 above, and further in view of Lew (US 20030100822).
Regarding claim 40, the Wang/Spencer combination teaches the biochemical sensor device of claim 1.
However, the Wang/Spencer combination is silent on the composition of the hydrogel layer.
Lew discloses an analyte measuring device. Specifically, Lew teaches wherein the hydrogel layer comprises an acetate buffer (Table 1 shows a sodium acetate buffer in the hydrogel). Wang, Spencer, and Lew are analogous arts as they are all related to devices that includes biological sensing devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the hydrogel containing an acetate buffer from Lew into the Wang/Spencer combination as the combination is silent on the composition of the hydrogel layer and Lew discloses a suitable composition in an analogous device.
Regarding claim 41, the Wang/Spencer combination teaches the biochemical sensor device of claim 1.
However, the Wang/Spencer combination is silent on the composition of the hydrogel layer.
Spencer teaches wherein the hydrogel layer comprises agarose ([0121]: “Hydrogel coated capillaries were studied under an inverted optical microscope at different swelling states to determine the time evolution of swelling under free and constrained conditions. The capillary re-swelled in DI water in the unconstrained experiments. Constrained swelling experiments were conducted using a brain phantom composed of a 0.6% agarose gel with 0.005% w/v of Polybead@polystyrene 6.0 μm microparticles. Small 1 mm holes were drilled into the sides of 12-well cell culture plates and the agarose solution was gelled inside the wells. Hydrogel coated capillaries were immersed in DI water and allowed to swell to an equilibrium diameter (Ds)”).
Lew teaches wherein the hydrogel layer comprises sodium acetate buffer solution (Table 1 shows a sodium acetate buffer in the hydrogel).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the hydrogel containing an agarose and a sodium acetate buffer solution from Spencer and Lew into the Wang/Spencer combination as the combination is silent on the composition of the hydrogel layer and Spencer and Lew discloses a suitable components in analogous devices.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer/Lew combination as applied to claim 41 above, and further in view of Wikipedia (“Agarose”).
Regarding claim 42, the Wang/Spencer/Lew combination teaches the biochemical sensor device of claim 41.
However, the Wang/Spencer/Lew combination does not teach wherein the hydrogel layer contains about 2% agarose.
Wikipedia discloses concentrations of agarose in hydrogels. Specifically, Wikipedia teaches wherein the hydrogel layer contains about 2% agarose (Page 1: “Slabs of agarose gels (usually 0.7 - 2%)”). Spencer and Wikipedia are analogous arts as they are both related to hydrogels that contain agarose.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the 2% agarose from Wikipedia into the Wang/Spencer/Lew combination as Wikipedia discloses a normal range for agarose concentration, and therefore it would be a simple substitution to use a 2% concentration of agarose.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Spencer combination as applied to claim 1 above, and further in view of Beech (US 20190117132).
Regarding claim 43, the Wang/Spencer combination teaches the biochemical sensor device of claim 1.
However, the Wang/Spencer combination does not teach the device further comprising a fingerprint scanner.
Beech teaches a biofluid sensing device. Specifically, Beech teaches the device further comprising a fingerprint scanner ([0056]: “The biofluid sensing device may also communicate with other biometric scanners, such as a fingerprint or retina scanner”). Wang, Spencer, and Beech are analogous arts as they are all related to devices that includes biological sensing devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fingerprint scanner form Beech into the Wang/Spencer combination as it allows the combination to identify the user, which can allow for accurate processing and identification.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant amended the drawing and specification to overcome the drawing objections, however the drawing objections regarding reference character “140” are reiterated, as Figure 4 still shows reference character 140 as designating the fingerprint scanner.
The newly added claims have introduced new 112(b) rejections.
Applicant’s arguments with respect to claims 1-11 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.
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 ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791