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 7/30/2026 and 8/19/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments and remarks, filed on 7/30/2026, have been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-7, 9-16, and 27 are pending and being examined.
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 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.
Claim(s) 1, 4-5, 9-12, 16, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al (Immobilizing Enzymes onto Electrode Arrays by Hydrogel Photolithography to Fabricate Multi-Analyte Electrochemical Biosensors, 2010, ACS Applied Materials & Interfaces, 2, 3, 748-755; hereinafter “Yan”; already of record on IDS filed 8/25/2025) in view of Kato et al (US 20090309116 A1; hereinafter “Kato”; already of record).
Regarding claim 1, Yan teaches a method of fabricating a biosensor (Yan; Abstract), the method comprising:
providing a wafer or other solid material with an electrode on a surface of the wafer or other solid material (Yan; Fig. 1; page 749, col 1; To fabricate gold electrode arrays, we sputter-coated standard (75 mm ×25mm) glass slides);
placing a drop of hydrogel on the electrode (Yan; Fig. 1; page 749, col 2; PEG prepolymer solution containing enzyme molecules and redox species was photopolymerized on top of the Au electrodes in a process similar to photolithography);
spinning the wafer or other solid material while the wafer is subjected to a partial vacuum (Yan; Fig. 1; page 749, col 2; PEG-based prepolymer solution was spin-coated at 800 rpm for 4 s onto glass slides containing Au electrode patterns; the examiner notes that the process of spin coating is well known in the art to be conducted under a partial vacuum as taught by evidentiary refence cited below).
Yan does not teach heating the wafer or other solid material, wherein the heating the wafer or other solid material is in an aqueous medium and at a temperature being in the range from 25°C to 70°C for at least one hour.
However, Kato teaches a method of treating a glass plate (Kato; para [767]) wherein the wafer is heated in an aqueous medium and at a temperature being in the range from 25°C to 70°C for at least one hour (Kato; para [767]; A borosilicate glass plate was immersed in the hydrolyzing liquid and subjected to a surface treatment using a hot water bath at 50° C. for 1 hour). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the heating step of Yan to be heated in an aqueous medium as taught by Kato, because Kato teaches the post-treated glass plate improves adhesion onto the glass plate (Kato; para [768]). The examiner notes that Yan teaches heating step is placed in the oven, thus the modification would result in heating the wafer prior to drying in the oven.
Regarding claim 4, modified Yan teaches the method of claim 1, wherein the electrode is platinum, gold, graphite, or titanium or nanoparticles (Yan; Fig. 1; page 749, col 1; fabricate gold electrode arrays).
Regarding claim 5, modified Yan teaches the method of claim 1, wherein the spinning has a maximum speed of up to 10000 rpm (Yan; Fig. 1; page 749, col 2; PEG-based prepolymer solution was spin-coated at 800 rpm for 4 s onto glass slides containing Au electrode patterns). Yan teaches spinning the substrate with the PEG-based prepolymer solution at a speed less than the maximum speed, thus the limitation is met.
Regarding claim 9, modified Yan teaches the method of claim 1, wherein the hydrogel comprises one or more immobilized enzyme(s) (Yan; page 750, col 1; GOX- and redox species-carrying PEG prepolymer solution was spin-coated and photopolymerized in registration with the desired electrodes of the array).
Regarding claim 10, modified Yan teaches the method of claim 1, further comprising depositing a further hydrogel layer, not containing an enzyme (Yan; page 749, col 2-page 750, col 1; The first hydrogel layer contained no enzymes or redox species and was deposited selectively onto the leads). Applicants do not specify the order in which the hydrogel layer containing no enzyme is deposited with respect to the other layers. Thus, Yan teaches the claimed limitation.
Regarding claim 11, modified Yan teaches the method of claim 1, wherein the hydrogel layer contains enzymes from the oxidase family (Yan; page 750, col 1; GOX- and redox species-carrying PEG prepolymer solution was spin-coated and photopolymerized in registration with the desired electrodes of the array).
Regarding claim 12, modified Yan teaches the method of claim 11, wherein the enzymes from the oxidase family comprise at least one of glucose oxidase, lactate oxidase, uricase oxidase, alcohol oxidase, cortisol oxidase, xanthine oxidase, cholesterol oxidase, sarcosine oxidase (Yan; page 750, col 1; GOX- and redox species-carrying PEG prepolymer solution was spin-coated and photopolymerized in registration with the desired electrodes of the array).
Regarding claim 16, modified Yan teaches the method of any of claim 1, wherein the drop is over 100 µL (Yan; page 749, col 2; Enzyme and prepolymer solution were combined by adding 0.2 mL of the enzyme solution to 0.8 mL).
Regarding claim 27, modified Yan teaches the method of any of claim 1 (the method of Yan is modified to comprise the heating step as taught by Kato), wherein the heating the wafer or other solid material is at a temperature being in the range from 30°C to 60°C for at least one hour (Kato; para [767]; A borosilicate glass plate was immersed in the hydrolyzing liquid and subjected to a surface treatment using a hot water bath at 50° C. for 1 hour)
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Kato, and in further view of Forrow et al (US 20090255811 A1; hereinafter “Forrow”; already of record on IDS filed 2/28/2023).
Regarding claim 2, modified Yan teaches the method of claim 1, with the hydrogel.
Modified Yan does not teach wherein the hydrogel consists of pullulan, dextran, alginate, hyaluronic acid or mixtures thereof.
However, Forrow teaches an analogous art of a biosensor (Forrow; Abstract) comprising a substrate with electrodes (Forrow; Fig. 3; para [196]; an electrode support 111, such as an elongated strip of polymeric material (e.g., polyvinyl chloride, polycarbonate, polyester, or the like) supports three tracks 112 a, 112 b, and 112 c of electrically conductive ink) and hydrogel layer, wherein the hydrogel consists of pullulan (Forrow; para [159]; synthetic water-soluble polymers can be used, such as polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, polyethylene oxide, etc., water-soluble polydextrose, saccharides and polysaccharides, such as pullulan). The examiner notes that Forrow teaches the release polymer to be comprised of polyethylene glycol (Forrow; para [140]) which is the same material taught by modified Yan. However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the polymer (hydrogel) material of modified Yan with the polymer material of pullulan as taught by Forrow as the substitute polymer (hydrogel) material and their functions were known in the art. Thus, an ordinarily skilled artisan at the time of invention could have substituted the polymer (hydrogel) material of modified Yan which is polyethylene glycol with pullulan as taught by Forrow, and the results of the substitution polymer (hydrogel) material comprising pullulan would have been predictable. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 3, modified Yan teaches the method of claim 1, with the hydrogel.
Modified Yan does not teach wherein the hydrogel consists of pullulan.
However, Forrow teaches an analogous art of a biosensor (Forrow; Abstract) comprising a substrate with electrodes (Forrow; Fig. 3; para [196]; an electrode support 111, such as an elongated strip of polymeric material (e.g., polyvinyl chloride, polycarbonate, polyester, or the like) supports three tracks 112 a, 112 b, and 112 c of electrically conductive ink) and hydrogel layer, wherein the hydrogel consists of pullulan (Forrow; para [159]; synthetic water-soluble polymers can be used, such as polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, polyethylene oxide, etc., water-soluble polydextrose, saccharides and polysaccharides, such as pullulan). The examiner notes that Forrow teaches the release polymer to be comprised of polyethylene glycol (Forrow; para [140]) which is the same material taught by Yan. However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the polymer (hydrogel) material of modified Yan with the polymer material of pullulan as taught by Forrow as the substitute polymer (hydrogel) material and their functions were known in the art. Thus, an ordinarily skilled artisan at the time of invention could have substituted the polymer (hydrogel) material of modified Yan which is polyethylene glycol with pullulan as taught by Forrow, and the results of the substitution polymer (hydrogel) material comprising pullulan would have been predictable. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Kato, and in further view of Zhao et al (US 20140262777 A1; hereinafter “Zhao”; already of record).
Regarding claim 6, modified Yan teaches the method of claim 1, with spinning the wafer.
Modified Yan does not teach wherein spinning goes from a lower speed for a first interval of time to a higher speed at a second interval of time.
However, Zhao teaches an analogous art of fabricating biosensors comprising a substrate with electrodes (Zhao; para [4]; the biosensor substrate usually contains three electrodes) and hydrogel layer (Zhao; para [35]; the present invention may be directed to a method of microdispensing (e.g., printing) enzyme-biolayer matrixes onto a substrate), wherein the substrate spins from a lower speed for a first interval of time to a higher speed at a second interval of time (Zhao; para [54]; The biolayer 110 may be spun (e.g., at a speed in a range of 1000 to 2000 rpm) onto the wafer 103 and the working electrode 105. For example, biolayer 110 may be spun onto the wafer 103 and working electrode 105 by dispensing about 6 mL of solution onto the center of the wafer 103 and spinning at about 1200 rpm for 4 seconds and then at about 1850 rpm for 15 seconds). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the spinning step of modified Yan to comprise two different speeds as taught by Zhao, because Zhao teaches that the spin-coat process determines the biolayer thickness (Zhao; para [54]).
Regarding claim 7, modified Yan teaches the method of claim 6 (the spinning step of Yan is modified to comprise a lower speed and higher speed as taught by Zhao discussed above in claim 6), wherein the lower speed is less than 1000 rpm and the higher speed is greater than 1000 rpm (Zhao; para [54]). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of the lower speed is less than 1000 rpm and the higher speed is greater than 1000 rpm is a result effective variable that gives the well-known and expected results of distributing the biolayer with the desired thickness. In the absence of a showing of unexpected results, the Office maintains the speed at which the wafer is spun would have been within the skill of the art as optimization of a results effective variable. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum lower speed and higher speed to be less than 1000 rpm and greater than 1000 rpm which would allow the desired thickness (MPEP § 2144.05 (II)).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Kato, and in further view of Adalian et al (US 20190307378 A1; hereinafter “Adalian”; already of record).
Regarding claim 13, modified Yan teaches the method of claim 10, with the hydrogel layer.
Modified Yan does not teach the method further comprising depositing a metal layer on the further hydrogel layer.
However, Adalian teaches an analogous art of an enzyme-based sensor (Adalian; Abstract) comprising the step of depositing a metal layer (Adalian; para [39]; a substrate (625), a first metallic, patterned layer (620), an enzyme hydrogel layer (615), and a second, metallic patterned layer to protect the enzyme hydrogel). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method to further comprise the step of depositing a metal layer as taught by Adalian, because Adalian teaches that the metal layer prolongs the lifetime of the sensor and selectively diffuses chemical species (Adalian; para [23, 39]). The step does not specify whether the metal layer is directly onto the “further hydrogel”. Thus, modified Yan in view of Adalian teaches depositing a metal layer on the further hydrogel layer as the second metallic patterned layer is the outermost layer (Adalian; Fig. 6).
Regarding claim 14, modified Yan teaches the method of claim 1, with the hydrogel and wafer.
Modified Yan does not teach the method further comprising depositing a metal layer on the hydrogel after the heating the wafer.
However, Adalian teaches an analogous art of an enzyme-based sensor (Adalian; Abstract) comprising the step of depositing a metal layer (Adalian; para [39]; a substrate (625), a first metallic, patterned layer (620), an enzyme hydrogel layer (615), and a second, metallic patterned layer to protect the enzyme hydrogel). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method to further comprise the step of depositing a metal layer as taught by Adalian, because Adalian teaches that the metal layer prolongs the lifetime of the sensor and selectively diffuses chemical species (Adalian; para [23, 39]). Modified Yan teaches that the heating of the wafer occurs after the electrodes are positioned on the substrate, thus modified Yan in view of Adalian teaches depositing a metal layer on the hydrogel after the heating the wafer.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Kato, and in further view of Adalian (Development and Dynamics of Microfabricated Enzymatic Biosensors, 2019, Thesis by Dvin Adalian, California Institute of Technology; hereinafter “Adalian” ; already of record).
Regarding claim 15, modified Yan teaches the method of any of claim 1, with the drop.
Modified Yan does not teach wherein the drop is in the range of 2 µL to 100 µL.
However, Adalian teaches an analogous art of enzymatic sensors (Adalian; Abstract) comprising the method of providing a wafer or other solid material with an electrode on a surface of the wafer or other solid material (Adalian; Fig. 5.7; page 68); placing a drop of hydrogel on the electrode wherein the drop is in the range of 2 µL to 100 µL (Adalian; page 67; The sensing layer was then applied by dispensing 1μl of the GOx/BSA/GA solution via pipette onto the electrodes). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of the drop volume is a result effective variable that gives the well-known and expected results of providing the sensing layer. In the absence of a showing of unexpected results, the Office maintains the volume of the drop would have been within the skill of the art as optimization of a results effective variable. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum volume to a range of 2 µL to 100 µL which would provide the sensing layer onto the substrate and electrodes (MPEP § 2144.05 (II)).
Evidentiary Reference
Laurell Technologies Corporation, Spin Coating Basics, https://www.laurell.com/accessories/spin-coating-basics.php#:~:text=Mounting%20the%20substrate,picking%20the%20right%20option%20simple. Laurell teaches that spin coating films onto a rotating substrate requires a partial vacuum, specifically a vacuum chuck, in order to secure the substrate at high spin speeds. References cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention (see MPEP 2124).
Response to Arguments
Applicants’ arguments, filed on 7/30/2026, have been considered and some of the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments. Further, the argument not found to be persuasive is addressed below.
In the Applicants’ arguments, on page 5-6, the Applicant argues that Yan in view of Kato fails to teach the claim amendments the wafer is heated in an aqueous medium and at a temperature being in the range from 25°C to 70°C for at least one hour. The Examiner respectfully disagrees. Kato teaches a borosilicate glass plate was immersed in the hydrolyzing liquid and subjected to a surface treatment using a hot water bath at 50° C. for 1 hour (Kato; para [767]). The examiner notes that Yan teaches heating step provides is placed in the oven, thus the modification would result in heating the wafer prior to drying in the oven. Specifically, Kato teaches a borosilicate glass plate was immersed in the hydrolyzing liquid and subjected to a surface treatment using a hot water bath at 50° C. for 1 hour. The post-treated glass plate was taken out from the processing liquid and washed lightly with water, avoiding contact of hands with the treated surfaces, followed by draining. Subsequently, it was baked with a forced-air drier of 100° C. Specifically, the Applicant notes that Kato teaches a pretreatment step prior to coating. The Examiner notes that the instant claims do not specify the order of steps for which the heating occurs. Thus, the modification does not render the biosensor as inoperable as the Applicant claims, because the heating in the aqueous medium can occur Yans’ heating to cross-link the silane adhesion layer.
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 Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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