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 statement (IDS) submitted on 12/19/2024 was
considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No limitations were interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “24” has been used to designate both a curable adhesive in at least Figs. 2 and 3 and holes in Fig. 14. 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.
Specification
The disclosure is objected to because of the following informalities:
The reference number “24” is used to designate “a curable adhesive” in ¶ [0100] of the published application, “the tube” in ¶ [0123], and hole(s) in ¶¶ [0176]-[178], [0182]-[0183]. Different reference numbers should be used for the different parts. The Examiner notes that the reference number “22” was used to designate the tube in other parts of the specification.
Appropriate correction is required.
Claim Objections
Claims 19, 23, 25, 27, and 34-35 are objected to because of the following informalities:
Claim 19, line 5: –the– should be inserted before “sensor bead”;
Claim 19, lines 6-7: “a bodily fluid of a user” should be replaced with –the bodily fluid–;
Claim 23, line 2: –of a user– should be inserted after “fluid”;
Claim 23, line 5: “a bodily fluid of a user” should be replaced with –the bodily fluid of the user–;
Claim 25, line 3: “the material of” should be replaced with –a material of–;
Claim 27, line 2: “the surface” should be replaced with –a surface–;
Claim 34 and 35: “A method” in the preambles should be replaced with –The method–;
Claim 35, line 1: –the– should be inserted before “at least one”; and
Claim 35, line 2: “a sensor body” should be replaced with –the sensor body–.
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 7 and 20 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 7 recites “for example a cured adhesive” in line 2. The phrase "for example" renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The Examiner suggests either deleting the phrase in line 2 or using a “wherein” clause which indicates that the material comprises a cured adhesive. For the purposes of examination, the recitation is not being given patentable weight.
Claim 20 recites “the sensor head being disposed at one of the sensor body the at least one electrode being disposed in the sensor body” in lines 2-3. The phrase so grammatically awkward that the meaning is not clear. For the purposes of examination the recitation will be interpreted to be “the sensor head being disposed at and the at least one electrode being disposed in the sensor body”.
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 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/065339 A1 (Boutelle 2020)
With regards to claim 19, Boutelle 2020 teaches a sensor patch for measuring a biometric parameter of a bodily fluid (Figs. 1a-1c and Page 3 depict a skin patch which is an active measuring device for monitoring various biometric parameters such as the chemical composition of sweat), the patch comprising: a patch body (Fig. 1c depicts a skin patch 10 which forms a body); a sensor bead (Fig. 3 and Page 5 depict the patch comprising hydrophilic sensing beads 24 in layer 12); and at least one electrode in contact with sensor bead (Fig. 4 and Page 8 depict the two electrodes 30 embedded within each hydrophilic sensing bead 24), wherein the sensor bead is on a first side of the patch for contacting a bodily fluid of the user (Fig. 1c and Page 5 depict the hydrophilic sensing beads 24 being on layer 12 (i.e., a first side of the patch 10) which is configured to contact sweat)
With regards to claim 20, Boutelle 2020 further teaches a sensor body disposed in or on the patch body (Fig. 3 and Page 5 depict a sensor section 20 in the first layer 12 of the patch), the sensor bead being disposed at one of the sensor body the at least one electrode being disposed in the sensor body (Figs. 3 and 4 depict the sensor section comprising the hydrophilic sensing beads 24 and the electrodes 30).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 11, 23, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/065339 A1 (Boutelle 2020) in view of 2007/0027385 A1 (Brister)
With regards to claim 1, Boutelle 2020 teaches a sensor for measuring a biometric parameter of a bodily fluid (Figs. 1a-1c and Page 3 depict a skin patch which is an active measuring device for monitoring various biometric parameters such as the chemical composition of sweat), the sensor comprising: a sensor body (Fig. 4 depict a combination of sensing bead 24 and sensor embedded within the bead 24 which forms a body); at least one electrode (Pages 4 and 6 depict the first layer 12 comprises a sensor section 20 having a plurality of microsensors each of which includes at least one electrode 30, wherein a plurality of hydrophilic sensing beads 24 is provided for the plurality of sensors; Fig. 4 and Page 7-8 depict a hydrophilic sensing bead 24 with embedded electrodes 30), whereby an end of the at least one electrode is exposed (Fig. 4 and Page 8 depict the electrodes 30 being exposed to the hydrophilic sensing beads 24), a sensor bead in contact with the exposed end of the at least one electrode (Fig. 4 and Page 8 depict the exposed end of the electrodes 30 being in contact with the hydrophilic sensing beads 24).
Boutelle 2020 is silent regarding whether the sensor body has first and second ends, at least one electrode extends in the sensor body, whereby an end of the at least one electrode is exposed at a first end of the sensor body; the sensor bead is disposed at the first end of the sensor body.
In the same field of endeavor of measuring a biometric parameter of a bodily fluid, Brister teaches a sensor body having first and second ends (Fig. 7L and ¶ [0344] depict a sensor having a body with front and back ends) at least one electrode extends in the sensor body (Fig. 7L and ¶ [0344] depict electrodes E1, E2 which extend through the body), whereby an end of the at least one electrode is exposed at a first end of the sensor body (Fig 7L and ¶ [0344] depict a cut end providing an exposed electroactive electrode surface which is treated); a sensor element disposed at the first end of the sensor body (¶ [0344] depicts the exposed surface of the electrode being treated; ¶ [0343] depict the electrodes being functionalized with enzymes; also see ¶ [0432] and Fig. 3A with regards to the electrodes being in contact with sensitive elements). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Boutelle 2020 to incorporate, based on the teachings a sensor body having first and second ends, at least one electrode extends in the sensor body, whereby an end of the at least one electrode is exposed at a first end of the sensor body, and the sensor bead being disposed at the first end of the sensor body as taught by Brister. Because both structural arrangements of Boutelle 2020 and Brister are suitable for measuring parameters of a bodily fluid, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 2, the above combination teaches or suggests wherein the sensor bead is hydrophilic and is configured to equilibrate with the bodily fluid by molecular or ionic exchange with the bodily fluid (Pages 7-8 of Boutelle 2020 teaches the hydrophilic sensing beads are sized to increase the flux of molecular or ionic exchange at the surfaces of the beds, thereby increasing the rate of charge equilibrium); and the at least one electrode is configured to obtain a signal relating to the concentration of the hydrophilic sensor bead relating to the parameter (Pages 7-8 of Boutelle 2020 teaches the signals of the electrodes 30 being used to measure concentration or composition changes).
With regards to claim 11, the above combination teaches or suggests the sensor bead is coated with a diffusion limiting layer (Pages 10-11 of Boutelle 2020 teaches a diffusional layer 32 or membrane that coats each hydrophilic sensing bead 24, wherein the diffusional layer 32 is selectively permeable and only allows predetermined ions or molecules to pass).
With regards to claim 23, the above combination teaches a sensor patch for measuring a biometric parameter of a bodily fluid (Figs. 1a-1c and Page 3 of Boutelle 2020 depict a skin patch which is an active measuring device for monitoring various biometric parameters such as the chemical composition of sweat, wherein the layer 12 is being interpreted to correspond to the sensor patch), the patch comprising: a patch body (Fig. 1c of Boutelle 2020 depicts a layer 12); the sensor according to claim 1 (see the above combination regarding the sensor of claim 1); wherein the sensor bead is on a first side of the patch for contacting a bodily fluid of the user (Fig. 1c and Page 5 of Boutelle 2020 depict the hydrophilic sensing beads 24 being on layer 12 which is configured to contact sweat).
With regards to claim 31, the above combination a sensor device (Figs. 1a-1c and Page 3 of Boutelle 2020 depict a skin patch which is an active measuring device for monitoring various biometric parameters such as the chemical composition of sweat) comprising: a base unit (Figs. 1c and 5 and Pages 11-14 of Boutelle 2020 depicts a layer 14); the sensor patch according to claim 23 (see the above combination regarding the sensor patch of claim 23); wherein the sensor patch is removably attachable to the base unit (Page 14 of Boutelle 2020 depict the first layer 12 may be disposable, while the second layer 14 may be reusable with a new first layer, so as to reuse the communications unit for other patches), and the base unit comprises electronics for processing signals received from the at least one electrode (Page 11 of Boutelle 2020 depicts a processing unit 60 is connected to the electrical connectors 26 and is for receiving data from the sensors and processing the received data).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2020 in view of Brister, as applied to claim 1 above, and further in view of US 4,986,271 A (Wilkins).
With regards to claim 4, the above combination is silent regarding whether the sensor body comprises one of a tube and a conduit.
In the same field of endeavor of measuring a biometric parameter of a bodily fluid, Wilkins teaches a sensor body comprises one of a tube and a conduit (Fig. 1 and Col. 2, lines 57-68 depict a glucose sensor 10 having a cylindrical housing 11 which has an inner chamber 25). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cylindrical sensor body of Brister with the tubular sensor body of Wilkins. Because both arrangements are capable of supporting electrode leads in relation to an analyte sensor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 5, the above combination is silent regarding whether a hole is formed in a wall of the one of the tube and the conduit, said hole extending in an axial direction of the one of the tube and the conduit and the at least one electrode is disposed in the hole.
In the same field of endeavor of measuring a biometric parameter of a bodily fluid, Wilkins teaches a hole is formed in a wall of the one of the tube and the conduit, said hole extending in an axial direction of the one of the tube and the conduit and the at least one electrode is disposed in the hole (Fig. 1 and Col. 3, lines 32-52 depict leads 39 and 43 which pass axially through the wall of the cylindrical housing 11, wherein the leads are necessarily in respective holes of the wall). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tube and the electrodes of the above combination to incorporate that they are disposed in holes formed in a wall of the one of the tube and the conduit, said holes extending in an axial direction of the one of the tube and the conduit as taught by Wilkins. It would have been the simple substitution of one known arrangement for housing an electrode/lead for another to obtain predictable results.
With regards to claim 6¸ the above combination teaches or suggests a plurality of electrodes and a plurality of holes in the wall of the sensor body, each electrode being disposed in a respective hole, whereby the electrodes are insulated from one another (See the combination of with regards to claim 5; Fig. 4 of Boutelle 2020 depicts at least two electrodes; Fig. 1 of Wilkins depicts the leads 39 and 43 which pass axially through the wall of the cylindrical housing 11; Col. 3, lines 32-52 of Wilkins depict the leads being electrically insulated).
With regards to claim 7, the recitation of “for example a cured adhesive” is not being given patentable weight in light of the rejection under 35 U.S.C. §112(b).
The above combination teaches or suggests wherein the sensor body comprises a material in which the at least one electrode is embedded (Fig. 1 of Wilkins depicts the leads 39 and 43 being embedded within the wall of the cylindrical housing 11).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2020 in view of Brister, as applied to claim 1 above, and further in view of US 2020/0298231 A1 (Francis).
With regards to claim 8, the above combination teaches or suggests the sensor bead comprises a hydrophilic hydrogel (Pages 7-8 of Boutelle 2020 depict the hydrophilic sensing bead 24 comprising a hydrogel 28, which is necessarily hydrophilic), wherein the sensor is configured to monitoring glucose (Pages 8-9 of Boutelle 2020).
The above combination is silent regarding whether the hydrophilic hydrogel encapsulates an enzyme.
In the same field of endeavor of measuring a biometric parameter of a bodily fluid, Francis teaches an analyte biosensor comprising an electrode and a hydrophilic hydrogel encapsulating an enzyme (¶ [0039] discloses analyte biosensor 18 comprising an electrode 1200 and an enzyme 1100 encapsulated in a matrix, for example, a hydrogel). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrophilic hydrogel of the above combination to incorporate that it encapsulates an enzyme as taught by Francis. The motivation would have been to provide the biological moiety for allowing for allowing for the measurement of glucose.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2020 in view of Brister, as applied to claim 1 above, and further in view of US 2018/0136247 A1 (Boutelle 2018).
With regards to claim 13, the above combination is silent regarding whether the at least one electrode comprises a working electrode, and an exclusion layer is provided on the working electrode at the interface between the working electrode and the sensor bead.
In the same field of endeavor of measuring a biometric parameter of a bodily fluid, Boutelle 2018 teaches a working electrode (Fig. 14B and ¶¶ [0314], [0338] depict a biosensor comprising a working electrode), and an exclusion layer is provided on the working electrode at the interface between the working electrode and the sensitive element (Fig. 14B and ¶¶ [0314], [0338] depict the working electrode being coated with poly-m-phenylenediamine (m-PD) at an interface between the working electrode WE and hydrogel which entraps substrate oxidase). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of the above combination to incorporate a working electrode, and an exclusion layer is provided on the working electrode at the interface between the working electrode and the sensitive element as taught by Boutelle 2018. Because both electrode arrangements are suitable for monitoring an analyte, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2020 in view of Brister, as applied to claim 23 above, and further in view of US 2023/0064744 A1 (Epstein)
With regards to claim 24, the above combination is silent regarding whether the sensor body extends to a second side of the patch body opposite the first side and the at least one electrode is exposed on the second side.
In a system relevant to the problem of arranging electrodes on a patch for physiological sensing, Epstein teaches a sensor body which extends to a second side of the patch body opposite the first side and the at least one electrode is exposed on the second side (Fig. 6 and ¶¶ [0116]-[0118] depict an electrode 618 which extends from a top side to a bottom side of the underlay patch 12, wherein Fig. 6 depicts the electrode is exposed on the top side). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate, based on the teachings of Epstein, the sensor body extends to a second side of the patch body opposite the first side and the at least one electrode is exposed on the second side. Because both of the electrode arrangement of Boutelle 2020 in view of Brister and the electrode arrangement of Epstein are suitable for having an electrode interface with a subject, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2020 in view of Brister, as applied to claim 23 above, and further in view of US 2018/0028071 A1 (Shi).
With regards to claim 25, the above combination is silent regarding a layer of polymer material on a second side of the patch body opposite to the first side, wherein he polymer material is harder than the material of the patch body, and the at least one electrode extends through the layer of polymer material.
In a system relevant to the problem of arranging electrodes on a patch for physiological sensing, Shi teaches a layer of polymer material on a second side of the patch body opposite to the first side (Fig. 4 and ¶ [0041] depict an elastic layer 450 on a top side of a permeable substrate 405, wherein layer 450 is formed of a soft stretchable foam such as EVA, PE, CR, PORON, EPD, SCF), wherein the polymer material is harder than the material of the patch body (Fig. 4 and ¶ [0038] depict the substrate 405 being made of soft foam materials such as EVA, PE, CR, PORON, EPD, SCF or fabric textile, wherein at least PE of the substrate 450 is harder than EVA of the substrate 405), and the at least one electrode extends through the layer of polymer material (Fig. 4 and ¶ [0040] depict conductive lines 414A, 414B extending through 450). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate a layer of polymer material on a second side of the patch body opposite to the first side, wherein he polymer material is harder than the material of the patch body, and the at least one electrode extends through the layer of polymer material as taught by Shi. Because both of the electrode arrangement of Boutelle 2020 in view of Brister and the electrode arrangement of Shi are suitable for having an electrode interface with a subject, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2020 in view of Brister, as applied to claim 23 above, and further in view of US 2020/0054285 A1 (Lemons).
With regards to claim 27, the above combination is silent regarding whether the sensor bead protrudes from the surface of the patch on the first side whereby it can be pressed in contact with the user's skin when the patch is worn
In a system relevant to the problem of applying a hydrogel interface to a subject, Lemons teaches a sensor bead protrudes from the surface of the patch on the first side whereby it can be pressed in contact with the user's skin when the patch is worn (Figs. 12-15 and ¶ [0059] depict hydrogel caps extending slightly beyond the skin-side surface of the electrode patch 10 so as to better contact skin). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination such that the sensor bead protrudes from the surface of the patch on the first side whereby it can be pressed in contact with the user's skin when the patch is worn as taught by Lemons. The motivation would have been to ensure better skin contact. See ¶ [0059] of Lemons.
With regards to claim 28, the above combination is silent regarding whether the sensor bead is at least partly recessed in the patch.
In a system relevant to the problem of applying a hydrogel interface to a subject, Lemons teaches a sensor bead is at least partly recessed in the patch (Fig. 1 and ¶ [0051] depicts the electrode patch 10 comprising a hydrogel cap 20 which is disposed partially within opening 27 of spacer 26). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination such that the sensor bead is at least partly recessed in the patch as taught by Lemon. The motivation would have been to at least partially protect the sensor bead.
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2018 in view of Boutelle 2020.
With regards to claim 33, Boutelle 2018 teaches a method of making a sensor (¶¶ [0337]-[0338] depict a method for electrode and biosensor fabrication; also see Fig. 14B with regards to the fabricated sensor), comprising: disposing at least one electrode in a sensor body (¶ [0337] and Fig. 14B depict inserting insulated wires into a 27 G hypodermic needle); depositing a sensor element on the end of the sensor body in contact with the at least one electrode (¶ [0338] and Fig. 14B depict depositing layers i, ii, and iii onto the needle electrode).
Boutelle 2018 is silent regarding whether the sensor element is a sensor bead.
In the same field of endeavor of measuring a biometric sensors, Boutelle 2020 teaches a sensor element being a sensor bead (Pages 7-8 depict a hydrophilic sensing bead 24). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor element of Boutelle 2018 with the sensor bead of Boutelle 2020. Because both elements are suitable sensing elements for electrochemical sensing of analytes, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 34, the above combination teaches or suggests the sensor body comprises a tube (¶ [0337] and Fig. 14B of Boutelle 2018 depict the needle being a tube), the method comprising: introducing an adhesive into the tube surrounding the at least one electrode (¶ [0337] of Boutelle 2018 depicts filling the needle with epoxy resin); curing the adhesive (¶ [0337] of Boutelle 2018 depicts curing the epoxy); removing an end of the tube to expose an end of the at least one electrode (¶ [0337] of Boutelle 2018 depicts treating the sharp tip of the needle to create silver and platinum disc electrodes).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Boutelle 2018 in view of Boutelle 2020, as applied to claim 33 above, and further in view of Wilkins
With regards to claim 35, the above combination is silent regarding whether disposing at least one electrode in a sensor body comprises disposing the at least one electrode to extend in a wall of the sensor body in an axial direction of the sensor body.
In the same field of endeavor of measuring a biometric parameter of a bodily fluid, Wilkins teaches disposing at least one electrode in a sensor body comprises disposing the at least one electrode to extend in a wall of the sensor body in an axial direction of the sensor body (Fig. 1 and Col. 3, lines 32-52 depict leads 39 and 43 which pass axially through the wall of the cylindrical housing 11, wherein the leads are necessarily disposed to extend in the wall of the sensor body). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of the above combination to incorporate that they are disposed to extend in a wall of the sensor body in an axial direction of the sensor body as taught by Wilkins. It would have been the simple substitution of one known arrangement for housing an electrode/lead for another to obtain predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
